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Tuesday, June 1
 

12:30pm EDT

#01 LL L: UBC Lunch and Learn: A Multi-Disciplinary Perspective on Decentralized Study Design
Component Type: Session
Level: Intermediate

The biopharmaceutical industry is rapidly adopting methodologies that decentralize research by harnessing transformative data acquisition and patient engagement thus taking the research beyond the walls of the legacy study setting. To truly realize the promise of decentralized research models, a dynamic array of technological capabilities, traditional research core competencies, and innovative study design expertise is required.

UBC and Thread will be hosting an open discussion about the current techniques and strategies that are occurring in decentralized research. Join this multi-disciplinary team as they explore operational challenges, technical solutions, and design considerations.

  • The intersection between technology and practical decentralized protocol design
  • Optimized data acquisition in DCTs with patient mediated medical record release and healthcare data interoperability
  • Selection of the appropriate hardware and successful integration of modernized data collection modalities into study design
  • Direct to patient recruitment strategies
  • Real-world case studies for the design and conduct of successful decentralized trials
  • Patient focused study design tactics that enrich the patient experience and drive retention


Chair

UBC


Speakers
avatar for UBC

UBC

United BioSource Corporation, United States
avatar for Aaron Berger

Aaron Berger

Executive Director, US Late Stage Operations & Real World Evidence, UBC, United States
Mr. Berger joined the UBC team in 2003 and has since served in a range of diverse roles leveraging global capabilities in the execution of Real World Evidence generation. In this role, Mr. Berger is responsible for thought leadership, technology development and data partnerships that... Read More →
avatar for Justin Wilson

Justin Wilson

Director, Software Development & Technology, UBC, United States
Mr. Wilson has over 17 years of experience in the healthcare industry, 9 of which involve REMS and Registry implementations at UBC. Mr. Wilson leads several implementation teams consisting of software development engineers, project managers, business analysts, and testers in delivering... Read More →
avatar for John Reites

John Reites

CEO, THREAD, United States
Executive intrapreneur turned digital health entrepreneur, my career includes 18+ years leading global drug development, clinical research and decentralized trials. As CEO of THREAD, I lead our efforts to change the way clinical research is conducted focused on decentralized approaches... Read More →


Tuesday June 1, 2021 12:30pm - 1:30pm EDT
TBD Virtual Event Horsham, PA 19044
 
Thursday, June 3
 

12:30pm EDT

#02 LL L: Bioclinica Lunch and Learn: The Power of AI in Advancing the Clinical Trial Lifecycle
Component Type: Session
Level: Intermediate

Artificial Intelligence (AI) technology is pushing the boundaries of what’s possible across all aspects of life sciences, particularly in the clinical trial lifecycle. Join us for an important discussion about how integrating AI capabilities within cloud-native solutions is giving Sponsors and Core Labs a competitive edge while meeting project timelines and complying with regulatory guidelines.

Utilizing AI throughout workflows for trial eligibility, data collection, adjudication, and image reviews enhances efficiency and reduces the risk of manual error. Learn how AI-enabled clinical trial products, processes, and services save time, reduce costs, and mitigate the risk of non-compliance in three critical areas of the clinical trial lifecycle

  • PHI redaction of source documents
  • Automatic segmentation, classification, and measurements in imaging
  • PHI redaction in videos and movement studies


Chair

Bioclinica


Speakers
avatar for Bioclinica

Bioclinica

United States
avatar for Janine Jones

Janine Jones

Senior Product Manager, Bioclinica, an ERT Company
Janine Jones, a registered nurse by training, works as a Senior Product Manager at Bioclinica, managing the Clinical Adjudication System. There she helps to drive the product vision by seeking to understand, at a deep level, the unique needs of clients.  She brings her adjudication... Read More →
avatar for Kevin Thomas

Kevin Thomas

Director, Medical Imaging Technologies, Research & Development, Bioclinica, an ERT Company, United States


Thursday June 3, 2021 12:30pm - 1:30pm EDT
TBD Virtual Event Horsham, PA 19044
 
Tuesday, June 8
 

12:30pm EDT

#03 LL L: Greenphire Lunch and Learn: Optimizing the Financial Lifecycle from Budgets Through Payments
Component Type: Session
Level: Intermediate

With heightened clinical trial protocol complexity, there is a surge in back and forth CTA negotiation, contract amendments and ultimately delays in study start up. As such, it is more critical than ever to streamline and centralize the traditionally manual start up processes that may impact study timelines. By introducing technology that connects inter-dependent workflows (from budgets through payments) and delivers near real-time data reflective of the industry, visibility is improved for all stakeholders, efficiency is gained and accuracy is achieved for better trial outcomes and increased site satisfaction.

  • Discuss complexity of clinical trial protocols and associated challenges
  • Illustrate how technology can connect workflows to drive efficiency, transparency and study acceleration
  • Divulge the importance of data insights in planning, budgeting for a clinical trial


Learning Objectives

Gain insight into how the structure of financial processes can significantly impact the success of a trial.

Chair

Greenphire


Speakers
avatar for Greenphire

Greenphire

United States
avatar for Ashley Baxter

Ashley Baxter

Sr. Business Optimization Specialist, Greenphire, United States
avatar for Ryan Kelly

Ryan Kelly

Associate Director, Product Management, Greenphire, United States
avatar for Lenny Parrnelli

Lenny Parrnelli

Financial Consultant, CATO SMS, United States
avatar for Kyle Cunningham

Kyle Cunningham

Chief Product Officer, Greenphire, United States


Tuesday June 8, 2021 12:30pm - 1:30pm EDT
TBD Virtual Event Horsham, PA 19044
 
Thursday, June 10
 

12:30pm EDT

#04 LL L: WCG Lunch and Learn: Site Training in Clinical Trials - Preparedness Without Site Burden
Component Type: Session
Level: Intermediate

Investigator training is a necessity in clinical trial execution. So, how can this be done without burdening the sites with hours of training content requirements? This session will include practical and actionable steps you can take to ensure site personnel are optimally prepared and to avoid significant risks to quality and compliance.

  • Variation in Clinical Trial Training Delivery
  • OnDemand and Virtual Training becoming the NEW Standard
  • Perpetual Inspection Readiness - All in a single source


Chair

WCG Clinical Services


Speakers
avatar for Amanda Steenbergen

Amanda Steenbergen

Senior Director - Global Clinical Training, WCG Trifecta, United States
Amanda has over 20 years of biopharma experience, including over 8 years of clinical site experience as a certified clinical research coordinator. In 2015, Amanda transitioned from the clinical research site space to the pharma/CRO space where she was responsible for training strategy... Read More →


Thursday June 10, 2021 12:30pm - 1:30pm EDT
TBD Virtual Event Horsham, PA 19044
 
Thursday, June 17
 

12:00pm EDT

#501 OD: Safety Compliance
Component Type: Session
Level: Intermediate

This session will provide an update on key topics related to compliance with pharmacovigilance regulations, including information on inspection findings and procedures in general and with a specific focus on risk management, as well as the broader compliance implications of Clinical Trial Regulation.

Learning Objectives

Examine how a risk-based approach leads to more efficient PV; Identify the systems gaps that have been revealed by inspections; Describe practical ways to globally harmonize PV and GCP compliance; Assess MHRA inspection Metrics and find the prominent areas of the risk management system which lead to critical and major findings.

Chair

Alan M Hochberg

Speaker

MHRA GPvP Inspections: Trends in Compliance and Evolution of Inspections
Mandy Budwal-Jagait, MSc

Clinical Trial Regulation is an Opportunity to Revisit Compliance at the Pharmacovigilance and GCP Interface
Shelley Gandhi, MSc

Risk Management System: An Area of Specific Concern : Analysis of MHRA GPvP Inspection Metrics Reports from June 2009-March 2020
Garima Mishra, MPharm



Speakers
avatar for Alan Hochberg

Alan Hochberg

Principal Scientific Enablement Director, F. Hoffmann- La Roche, Switzerland
Alan Hochberg is a Scientific Enablement Leader at Roche in Basel, involved in bringing innovations into the pharmacovigilance system. He was formerly with ProSanos, where he developed and evaluated signal-detection algorithms. He has worked in bioinformatics and biomedical engineering... Read More →
avatar for Shelley Gandhi

Shelley Gandhi

Strategic Advisor, Pharmacovigilance and Drug Safety, NDA Group
Shelley is an experienced and highly motivated pharmacovigilance and risk management expert, with an international reputation in her field, specialising in delivering global safety solutions including safety governance models. Former senior manager at MHRA for over 19 years and represented... Read More →
avatar for Garima Mishra

Garima Mishra

Senior Pharmacovigilance Associate, APCER Life Sciences, India
Garima Mishra is a Senior Pharmacovigilance Associate in APCER Life Sciences, with overall experience of 4.5 years in Pharmacovigilance. In her current role, she is associated with risk management department wherein she is involved in maintenance of risk management plans and tracking... Read More →
avatar for Mandy Budwal-Jagait

Mandy Budwal-Jagait

GPvP Operations Manager and Senior GCP Inspector, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Mandy Budwal-Jagait is a GPvP Operations Manager and Lead Senior GCP inspector with the MHRA. She joined the Agency in April 2014 as a GCP Inspector and became GPvP Operations Manager in 2020, responsible for the Pharmacovigilance Inspection programme. Mandy conducts a variety of... Read More →


Thursday June 17, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Session |   20: Early Access Content, Session

12:00pm EDT

#502 OD: Artificial Intelligence: Real Applications and Regulatory Perspectives
Component Type: Session
Level: Intermediate

Artificial Intelligence (AI) remains a commonly used phrase with few examples of use within the pharmaceutical industry. In this session, speakers will share their experience with artificial intelligence applications across the healthcare industry. Speakers will discuss real-world applications of artificial intelligence and near-term opportunities currently being pursued by pharmaceutical and technology companies and healthcare systems. Additionally, this session will cover the perspective of regulators to this rapidly changing field. Speakers will share their perspectives regarding the future of these technologies to influence patient safety and healthcare broadly. Join the Clinical Safety & Pharmacovigilance Community for a follow up round table discussion (session #330.2 RT L) on Wednesday, June 30, 12:00PM - 1:00PM EDT.

Learning Objectives

Describe current applications of AI within pharmaceutical, technology, and healthcare settings; Discuss evolving regulation and regulatory perspective; Identify the barriers to implementation of AI in healthcare; Assess the promise and pitfalls of these advanced technologies.

Chair

Jeremy Jokinen, PhD, MS

Speaker

Developing a Deep Learning MedDRA Encoder (MedDRA-DeepCoder) for Patient Narratives
Tom Sabo, MS

Deep Learning at the FDA
Qais Hatim, PhD

Tailoring FDA's Regulatory Framework to Encourage Responsible Innovation in Artificial Intelligence and Machine Learning
Bakul Patel, MBA, MS

Image Fingerprinting as a Means for Individual Case Safety Report Classification: A Convolutional Neural Network
Sameen Desai, MBA, MS

Human Factors and Responsible Use of Artificial Intelligence
Raj Ratwani, PhD



Speakers
avatar for Jeremy Jokinen

Jeremy Jokinen

Vice President, Epidemiology, Safety Science, Capabilities and Innovation, Bristol-Myers Squibb Company, United States
Jeremy is the Vice President of Epidemiology, Safety Sciences, Capabilities and Innovation at Bristol-Myers Squibb. In this role, he leads a team of scientists responsible for insights and evidence generation ensuring the safety of patients worldwide. Jeremy is also active within... Read More →
avatar for Tom Sabo

Tom Sabo

Principal Solutions Architect, SAS Institute Inc., United States
Tom Sabo is a principal solutions architect at SAS. Since 2005, he has been immersed in the field of text analytics and AI as it applies to federal and state government challenges. Tom presents work internationally on diverse topics including modeling applied to government procurement... Read More →
avatar for Sameen Desai

Sameen Desai

Senior Director, Head Digital Insights and Innovation, Bristol-Myers Squibb Company, United States
avatar for Raj Ratwani

Raj Ratwani

Vice President of Scientific Affairs, MedStar Health Research Institute, United States
Raj is the director of the MedStar Health National Center for Human Factors in Healthcare, vice president of scientific affairs at the MedStar Health Research Institute, and an associate professor at the Georgetown University School of Medicine. As director, he oversees the Center’s... Read More →
QH

Qais Hatim

Data Scientist, OTS, CDER, FDA, United States
In my role as data scientist at U.S. Food and Drug Administration (FDA) I am leading research in artificial intelligence/machine learning, and statistical/operational modeling. I am applying advanced AI/ML, statistical modeling and scientific computing techniques to computationally... Read More →
avatar for Bakul Patel

Bakul Patel

Director, Digital Health Center of Excellence (DHCoE), CDRH, FDA, United States
BAKUL PATEL is the Director for Digital Health Center of Excellence, at the Food and Drug Administration (FDA). Mr. Patel is responsible for providing leadership, development, implementing, execution, management and setting strategic direction and regulatory policy and coordinate... Read More →


Thursday June 17, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Session |   20: Early Access Content, Session

12:00pm EDT

#503 OD: Planning for Diversity: A Focus on Site Feasibility and Recruitment Strategies
Component Type: Session
Level: Intermediate

In multi-site trials, rigorous site feasibility assessment and strategic recruitment planning are important components of early planning. This session will present recommendations and actionable tools to address site feasibility and recruitment planning.

Learning Objectives

Describe strategies for successful site selection and accurate feasibility assessments; Discuss experience in proactive and continued approaches to achieving clinical trial diversity as well as the challenges and opportunities in site selection; Discuss success and failure stories from experts in the field.

Chair

Sarah A. White, MPH

Speaker

Industry Update
Paul Underwood

Industry Update
Rachael Tarleton Fones



Speakers
avatar for Rachael Fones

Rachael Fones

Director, Government and Public Affairs, IQVIA, United States
Rachael Fones is Director, Government & Public Affairs for IQVIA and co-lead of IQVIA’s Diversity in Clinical Trials Steering Committee. With 16 years at the company and 7 in her current role, Fones works with trade associations, advocacy groups and government officials to identify... Read More →
avatar for Sarah White

Sarah White

Executive Director, MRCT Center, United States
Ms. White is the Executive Director at The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard. In this capacity, she is responsible for developing and implementing the overall strategy and vision for the Center as well as oversee all management functions... Read More →
PU

Paul Underwood

Medical Director, Boston Scientific Corporation, United States


Thursday June 17, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  02: ClinTrials -ClinOps, Session |   20: Early Access Content, Session

12:00pm EDT

#505 OD: Challenges for Medical Information Sharing
Component Type: Session
Level: Intermediate

Globalization is challenging, and a pandemic creates a different challenge. Medical Information will share best practices and key learnings for leveraging technology, collaboration and communication to globalize MI teams amidst a pandemic. This session will examine the best practices and shared lessons learned in medical information and communications.

Learning Objectives

Discuss best practices for Medical Information (MI) to connect and align with geographically dispersed teams; Identify technology for global collaboration and alignment; Share best practices on remote leadership and offering guidance in a virtual environment; Describe implementation, key advantages and challenges of a shared model in a global medical information

Chair

Sonia Sandhu, PharmD

Speaker

Globalization of Medical Information During COVID-19
Sonia Sandhu, PharmD

Company Perspective on our Globalization Journey
Rebecca Falcone, PharmD

Industry Update
Marielle Lacambra



Speakers
avatar for Sonia Sandhu

Sonia Sandhu

Director, Medical Information, Gilead Sciences, Inc., United States
Sonia Sandhu is a Director of Global Medical Information at Gilead Sciences overseeing COVID-19 and Liver Diseases therapeutic areas. Sonia has 14 years of experience in medical information and medical affairs across multiple therapeutic areas and is actively involved in PhactMI and... Read More →
avatar for Rebecca Falcone

Rebecca Falcone

Global Medical Information Systems Lead, GMI Operations, Sanofi, United States
Rebecca Falcone, PharmD has over 20 years of pharmaceutical industry experience and is currently the Global Medical Information (GMI) Systems Lead in the GMI Operations group at Sanofi. Rebecca is responsible for the implementation and management of a medical information system for... Read More →
avatar for Marielle Lacambra

Marielle Lacambra

Associate Director, Operations, PPD, Philippines
Graduated with a degree in BS Agricultural Economics, Major in Marketing and Prices. Joined PPD in 2018 as Associate Director for Operations, overseeing the Medical Communications teams based in the Asia Pacific. Prior to PPD, worked in the banking and the BPO industry, establishing... Read More →


Thursday June 17, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  04: MedAffairs-SciComm, Session |   20: Early Access Content, Session

12:00pm EDT

#506 OD: Automation in Scientific Writing Deliverables
Component Type: Session
Level: Intermediate

This session will include presentations in automating scientific writing deliverables.

Learning Objectives

Describe automation of regulatory writing activities for complex documents that require extraction of distinct types of information from multiple sources.

Chair

Boris Reznichenko, MS

Speaker

eWriter: An Automated Authoring Tool for Patient Narratives
Boris Reznichenko, MS

Application to Automate CSR Generation Using ML/NLP
Farha Fathima Feroze



Speakers
avatar for Boris Reznichenko

Boris Reznichenko

Director, Regulatory Operations, Otsuka Pharmaceutical Development & Commercialization, Inc., United States
Boris Reznichenko is currently a Director, Regulatory Operations in the Global Regulatory Affairs team at Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC). In this role, he is leading global regulatory publishing activities. Prior to joining OPDC in 2013, Boris worked... Read More →
avatar for Farha Fathima Feroze

Farha Fathima Feroze

Business Analyst, Symbiance Inc., United States
Farha Feroze is a Senior Business Analyst at Symbiance. She has been in the path of Business Analysis for good few years now. She is known and appreciated for her sharp acumen and logical mind that easily grasp new business concepts. Her current focus is in providing business solutions... Read More →


Thursday June 17, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  04: MedAffairs-SciComm, Session |   20: Early Access Content, Session

12:00pm EDT

#507 OD: Patient-Led Special Initiatives
Component Type: Session
Level: Intermediate

In this session, we will share the experiences of practitioners in a wide range of healthcare, research, and patient settings.

Learning Objectives

Identify how patient involvement and engagement can inform protocol design, improve clinical trial experiences, and help shape policy and practice; Describe case studies of fit-for-purpose patient engagement; Explain the need for and components of a framework/toolkit that can be used to help organizations facilitate patient engagement.

Chair

Jennifer Farmer, MS

Speaker

Coping and Hoping: Patient-Led Initiatives To Improve Cancer Patient Experiences in the UK
Richard Stephens, MA

New Insights on Pediatric Clinical Trials: Parent and Child Perspectives
Annick De Bruin, MBA

Developing an Enterprise-Wide Patient Engagement Framework
Valerie Powell, MS



Speakers
avatar for Valerie Powell

Valerie Powell

Vice President, Research Services, Healthivibe, A Division of Corevitas, LLC, United States
Valerie Powell has over 30 years of experience in the pharmaceutical space and an advanced degree in Instructional and Performance Technology. She leads a team of Research Specialists in conducting a range of qualitative and quantitative research methodologies to uncover insights... Read More →
avatar for Richard Stephens

Richard Stephens

Former Chair, Consumer Forum (Patient Advocates), National Cancer Research Institute (NCRI), United Kingdom
Richard Stephens has survived two cancers, a heart emergency, and continued co-morbidities and late effects. He has participated in four interventional studies and nine others. He chaired the NCRI Consumer Forum 2012-2019 and now chairs BBMRI-ERIC’s Stakeholder Forum (Europe’s... Read More →
avatar for Annick De Bruin

Annick De Bruin

Senior Director, Research Services, CISCRP, United States
Annick de Bruin is the Senior Director of Research Services at the Center for Information and Study on Clinical Research Participation (CISCRP). She is responsible for the design, implementation, analysis and reporting of a variety of CISCRP research studies including the Perceptions... Read More →
avatar for Jennifer Farmer

Jennifer Farmer

Chief Executive Officer, Friedreich's Ataxia Research Alliance (FARA), United States
Jennifer Farmer is the Chief Executive Officer of the Friedreich’s Ataxia Research Alliance (FARA). She is one of the founders and the coordinator for the Collaborative Clinical Research Network in FA. In her current role at FARA as CEO, she helps to carry out the strategic mission... Read More →


Thursday June 17, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  05: Patient Engagement, Session |   20: Early Access Content, Session

12:00pm EDT

#504 OD: Right the First Time: Integrating Diagnostic Strategies into Clinical Development Plans
Component Type: Session
Level: Intermediate

Having a product approved does not guarantee uptake post approval. This session will provide recommendations to insert evidence generating diagnostic strategies earlier in clinical development and will discuss case studies on different tactics.

Learning Objectives

Identify areas of opportunity to insert diagnostic strategies to generate real-world evidence into clinical development plans; Assess existing clinical development plans for new therapeutics and integrate evidence collection to support post approval product uptake.

Chair

Earl Seltzer, MBA

Speaker

Right the First Time: Integrating Diagnostic Strategies into Clinical Development Plans
Patrick Short

Right the First Time: Integrating Diagnostic Strategies into Clinical Development Plans
Keith Hanigan

Right the First Time: Integrating Diagnostic Strategies into Clinical Development Plans
Jeffrey Shuster, PhD



Speakers
avatar for Earl Seltzer

Earl Seltzer

Senior Director, Feasibility and Site Selection, Labcorp Drug Development, United States
Earl Seltzer has over 16 years of industry experience working in the clinical investigator site space as well as at several large CROs. Earl has spent most of his time at CROs in strategic feasibility working to optimize study planning and design with data driven techniques. He has... Read More →
KH

Keith Hanigan

US Head of Precision Medicine, Blueprint Medicines , United States
PS

Patrick Short

Chief Executive Officer, Sano Genetics, United Kingdom
JS

Jeffrey Shuster

Director, Companion Diagnostics, Covance Central Laboratory Services, United States


Thursday June 17, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044

12:00pm EDT

#509 OD: Artificial Intelligence Validation Framework: Is it New and Different?
Component Type: Session
Level: Intermediate

How will artificial intelligence and machine learning align with the validation documentation to affirm compliance. What are risk-based approaches? What are the challenges of validating machine learning and artificial intelligence?

Learning Objectives

Recognize the definitions of artificial intelligence; Explain and apply the risk-based framework that applies to artificial intelligence; Describe challenges and potential approaches for affirming compliance.

Chair

Kristof Huysentruyt, MSc

Speaker

Industry Update
Kristof Huysentruyt, MSc

Industry Update
Oeystein Kjoersvik, MSc

Industry Update
Beth Savage, BSN, MBA



Speakers
KH

Kristof Huysentruyt

Head of Safety Data PROS, UCB Pharma S.A., Belgium
Kristof is a PV professional with more than 10 years experience in pharmacovigilance. He joined UCB in 2009 and has been heading PV systems and data management. Kristof has been leading several initiatives such as the implementation of a new safety database system and several automation... Read More →
BS

Beth Savage

Senior Director, Head of Global Case and Safety Data Management, Johnson & Johnson, United States
Beth is Head of Global Case and Safety Data Management at Janssen Research & Development, LLC a division of Johnson & Johnson. Beth has more than 25 years of global Pharmacovigilance leadership experience developing strategies, driving operational excellence, and ensuring compliance... Read More →
avatar for Oeystein Kjoersvik

Oeystein Kjoersvik

Product Owner/Business Analyst, Merck & Co., Inc., Czech Republic
Oeystein Kjoersvik is currently a Product Owner/Business Analyst at MSD, functioning as a squad lead for an analytics group supporting QA through utilizing data science and other analytics tools. Oeystein also serves as a Machine Learning SME for TransCelerate's Intelligent Automation... Read More →


Thursday June 17, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  08: RD Quality-Compliance, Session |   01: ClinSafety-PV, Session |   20: Early Access Content, Session

12:00pm EDT

#512 OD: Electronic Labeling: Where are we Now and What are the Next Steps in the World?
Component Type: Session
Level: Intermediate

The most updated eLabeling initiatives in the US, EU, Canada, and Japan, and the trends for eLabeling in emerging markets will be shared. The possibility of the convergence of the eLabeling initiatives will be discussed in the digital health.v

Learning Objectives

Describe the most updated electronic labeling initiatives in the US, EU, Canada, Japan, and emerging countries; Discuss the possibility of the convergence for electronic labeling across regions.

Chair

Rie Matsui, RPh

Speaker

eLabeling Updates in Japan and Collaboration with Asia Countries
Shinobu Uzu, MSc

Electronic Product Information (ePI) in the EU: Progress and the Road Ahead
Elizabeth Scanlan, PhD, MSc

Behind the Scenes in Implementing eLabeling: COVID-19 Vaccine Label Development During a Global Pandemic
Christine Wood, PhD



Speakers
avatar for Shinobu Uzu

Shinobu Uzu

Senior Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Mr. Shinobu Uzu is senior Executive Director, PMDA since April 2020. As Chief Safety Officer, PMDA, he was responsible for post-market surveillance and GMP/QMS audit of pharmaceuticals, medical devices regulated by Pharmaceuticals and Medical Devices Law until March 2018. Mr. Uzu... Read More →
avatar for Rie Matsui

Rie Matsui

Senior Director, Regional Labeling Head for APAC, Pfizer R&D, Japan
Rie Matsui is Senior Director, Regional Labeling Head for APAC, International Labeling Group(ILG), Global Regulatory Affairs, Pfizer Japan. She is also the Head, External Engagements for ILG. She is the founder of Asia Labeling Hub at Pfizer that has created various local label updates... Read More →
CW

Christine Wood

Global Labeling TA Director (Respiratory and Immunology), AstraZeneca, United Kingdom
Christine Wood has been with AstraZeneca for 24 years. Following a degree and PhD in Chemistry she joined AstraZeneca and has had multiple roles in the business including Medicinal Chemistry, Procurement, Global Regulatory Affairs and Operations Quality. She is now a Therapy Area... Read More →
avatar for Elizabeth Scanlan

Elizabeth Scanlan

Scientific Communication Officer, Stakeholders and Communication Division, European Medicines Agency, Netherlands
Elizabeth Scanlan joined the European Medicines Agency in 2016 where she is a Scientific Communication Officer, with a focus on communication of information on safe and effective use of medicines to patients and healthcare professionals. Prior to joining EMA, she worked in communication... Read More →


Thursday June 17, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session |   01: ClinSafety-PV, Session |   20: Early Access Content, Session

12:00pm EDT

#510 OD: If You Have Questions, Contact the Regulatory Project Manager: Best Practices When Interacting with US FDA Regulatory Project Managers
Component Type: Session
Level: Basic

A panel of FDA and industry representatives will share best practices when forming a relationship with the FDA regulatory project managers including recommendations on how to work together to support timely and consistent interactions during the drug development process.

Learning Objectives

Identify best practices when developing a strategy to support effective and consistent interactions between the sponsor and FDA Regulatory Project Manager during the drug development lifecycle; Describe opportunities to enhance FDA-sponsor interactions including the use of digital technology; Discuss FDA actions to date based on third-party assessments, public meetings, and industry feedback.

Chair

Todd Paporello, PharmD, MBA

Speaker

Industry Perspective
Deepika Jalota, PharmD

Industry Perspective
Rachael Steiner-Swiat, MBA, MSc

FDA Perspective
Jacqueline Ware, PharmD



Speakers
avatar for Deepika Jalota

Deepika Jalota

Chief Regulatory and Quality Officer, PMV Pharmaceuticals, United States
Dr. Jalota is Chief Regulatory and Quality Officer at PMV Pharma, a precision oncology company. Prior to joining PMV Pharma, Dr. Jalota was Vice President, Global Regulatory Strategy, Oncology I at Bayer where she was responsible for overseeing the development of global regulatory... Read More →
avatar for Rachael Steiner-Swiat

Rachael Steiner-Swiat

Vice President, Global Regulatory Affairs, Oncology- Solid Tumors, Novartis Pharmaceuticals Corporation, United States
Rachael Steiner-Swiat is a global regulatory affairs leader with over 20 years experience. She is responsible for leading and managing employees to develop the global regulatory strategy for a broad portfolio of approved and investigational biologics and drugs across oncology, respiratory... Read More →
avatar for Todd Paporello

Todd Paporello

Vice President and Head of Regulatory Affairs Americas, Bayer, United States
Todd Paporello is Vice President and Head of Regulatory Affairs Americas at Bayer Pharmaceuticals. Before joining Bayer, he held leadership positions of increasing responsibility within regulatory affairs at Roche, Genentech, Merck, and Schering-Plough. Todd holds pharmacy (PharmD... Read More →
avatar for Jacqueline Ware

Jacqueline Ware

Deputy Director, Office of Regulatory Operations, Office of New Drugs, CDER, FDA, United States
Jacqueline Ware, PharmD, is the Deputy Director of the newly formed Office of Regulatory Operations (ORO) in CDER’s Office of New Drugs (OND). In partnership with ORO’s Director, she is responsible for oversight of OND’s regulatory review processes and regulatory project management... Read More →


Thursday June 17, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session |   20: Early Access Content, Session

12:00pm EDT

#511 OD: Global Trends in Regulatory Reliance: Will the COVID-19 Experience Accelerate Implementation?
Component Type: Session
Level: Intermediate

Explore growing trend of regulatory reliance, providing a global environmental scan of regulatory definitions and application of reliance policies. Feature perspectives on benefits and challenges to industry highlighting COVID-19 experiences.

Learning Objectives

Discuss the concepts of regulatory reliance and global trends in applying reliance; Explore the benefits and challenges to industry as a result of these trends; Identify from shared insights on reliance approaches related to licensing of COVID vaccines and therapeutics.

Chair

Jayne C. Ware, MPH, MS

Speaker

An Industry Perspective on Regulatory Reliance Trends
Rebecca Lumsden, PhD

Trends in Regulatory Reliance
Lawrence Liberti, PhD, RPh, RAC

Examples of Reliance Activities Implemented by Regulators and Their Perspectives Based on The International Pharmaceutical Regulators Programme (IPRP) Studies
Nobumasa Nakashima, PhD



Speakers
avatar for Jayne Ware

Jayne Ware

Director Global Regulatory Policy, Merck & Co., Inc., United States
Jayne Ware is a Director for Global Regulatory Policy at Merck. She joined Merck in 2012 after 15 years at the US FDA. Jayne is responsible for coordinating regulatory policy intelligence and advocacy activities for key topic areas at Merck such as digital health issues, safety/pharmacovigilance... Read More →
avatar for Nobumasa Nakashima

Nobumasa Nakashima

Associate Executive Director for International Programs and Asia Training Centre, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Nakashima holds the position of Associate Executive Director for International Programs and Asia Training Centre (ATC) at PMDA since January 2020. Before this position, he had joined MHLW in April 1992, where he worked as Director of Office of International Regulatory Affairs... Read More →
avatar for Lawrence Liberti

Lawrence Liberti

Adjunct Research Professor, Temple University School of Pharmacy, Reg. Affairs and QA Grad Program, United States
Dr Liberti has worked in pharmaceutical regulatory affairs, communications and clinical R&D for the past four decades. Since 2009 he has served as the Executive Director of CIRS (the Centre for Innovation in Regulatory Science, Ltd, forming part of Clarivate Analytics). He has been... Read More →
avatar for Rebecca Lumsden

Rebecca Lumsden

Director, Regulatory Policy and Intelligence, Pfizer Inc, United Kingdom
Rebecca is a Director in the Pfizer Global Regulatory Policy and Intelligence group. Focus areas include expedited and reliance approval pathways, regulatory system strengthening and evolving standards of evidence especially in International regions. Prior to joining Pfizer in 2017... Read More →


Thursday June 17, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session |   20: Early Access Content, Session

12:00pm EDT

#513 OD: NMPA Town Hall
Component Type: Forum
Level: Intermediate

Regulatory speakers will present and discuss the following topics: NMPA's action plan on accelerating the advancement of Smart Drug Supervision, NMPA's initiative on regulatory science and an update from CDE on new drug review and approval.

Learning Objectives

Present and discuss the latest information on the NMPA's initiatives on regulatory science and drug supervision; Describe the update on drug review and approval.

Chair

Ling Su, PhD

Speaker

Digitalization Promotes Medical Products Intelligent Administration
Wenjia Qiang

NMPA Guidance and Progress in Real-World Evidence
Jun Zhao

A Brief Introduction of Regulatory Science Initiative of NMPA
Yue Yang, PhD, MS



Speakers
avatar for Ling Su

Ling Su

Professor, Shenyang Pharmaceutical University, China
Ling Su, PhD, is Professor in Shenyang Pharmaceutical University, and a Venture Partner with Lilly Asia Ventures. Dr. Su has over 25 years of experience in drug regulatory and development. He had worked in the Chinese regulatory agency and US FDA, as well as in various R&D management... Read More →
avatar for Wenjia Qiang

Wenjia Qiang

Staff Member, Office of Big Data Management, Center for Information, NMPA, China
Miss Qiang is an engineer of the Center for Information, responsible for data collection, data curation, governance, sharing and exchange, and statistics and analysis related to drugs, cosmetics and medical devices. Miss Qiang has been at Center for Information for nearly 4 years... Read More →
avatar for Yue Yang

Yue Yang

Research Professor and Doctoral Supervisor, School of Pharmaceutical Sciences, Tsinghua University, China
Yue Yang is the researcher and doctoral supervisor at the School of Pharmacy. She is mainly engaged in research on regulatory science, pharmaceutical regulations and drug policy, member of the Expert Group on the revision of the Drug Administration Law, participated in the formulation... Read More →
avatar for Jun Zhao

Jun Zhao

Office of Statistics and Clinical Pharmacology, Center for Drug Evaluation, NMPA, China
Mr. Zhao is a statistical reviewer for oncology drugs, he participated in the development of 2 RWE guidelines, “Guidance on Using Real World Evidence to Support Drug Development and Decision-making” and “Guidance on Real World Data Used to Generate Real World Evidence”, He... Read More →


Thursday June 17, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Forum |   20: Early Access Content, Forum

12:00pm EDT

#514 OD: Value-Based Evidence Generation: What are the Regulatory and HTA Strategies that Companies Could Take in Development?
Component Type: Session
Level: Intermediate

This session will aim to propose how companies can build the value proposition early into development to enable evidence generation that articulates the value during development, review and reimbursement

Learning Objectives

Discuss challenge faced by companies to accommodate different perspectives on value during development, review and reimbursement; Describe approaches that build management or resolution of regulatory or HTA uncertainties into the development space;Identify the strategy to build value into drug development and to effectively articulate the value of new medicines during review and reimbursement.

Chair

Neil McAuslane, PhD, MSc

Speaker

Patient Access to Innovative Medicines: What Strategies are Regulators Using to Encourage Companies to Undertake Value-Based Evidence Development?
Michael Berntgen, PhD

Value-Based Development: What are the Main HTA Considerations Companies Should be Considering Incorporating into Their Early Development Decisions?
Nicole Mittmann, MSc

What are the Challenges Faced by a Company to Align Different Stakeholders’ Perspective of Value into Their Development Decisions?
Indranil Bagchi, PhD, MSc



Speakers
avatar for Neil McAuslane

Neil McAuslane

Director, Centre for Innovation in Regulatory Science (CIRS), United Kingdom
Neil McAuslane is Director of the Centre for Innovation in Regulatory Science (CIRS, previously CMR International) and works in the area of regulatory and HTA strategy and R&D performance. Prior to joining CMR International in 1988, Neil completed his PhD degree in Clinical Pharmacology... Read More →
avatar for Indranil Bagchi

Indranil Bagchi

Senior Vice President and Head, Global Value and Access, Novartis Oncology, United States
Dr. Indranil Bagchi is Senior Vice President and Global Head of Value and Access at Novartis Oncology. In this role, Indranil drives the overall strategy on value demonstration and market access, through efforts on pricing & reimbursement, health economic modelling, outcomes research... Read More →
avatar for Michael Berntgen

Michael Berntgen

Head of Scientific Evidence Generation, European Medicines Agency, Netherlands
The Scientific Evidence Generation Department aims to support the development of medicines to ensure generation of robust and relevant scientific evidence, also in collaboration with other stakeholders. Activities include the provision of scientific advice & methodology qualification... Read More →
NM

Nicole Mittmann

Chief Scientist and Vice President of Evidence Standards, Canadian Agency for Drugs and Technologies in Health (CADTH), Canada
Dr. Nicole Mittmann is CADTH’s Chief Scientist and Vice-President of Evidence Standards. At CADTH, Dr. Mittmann leads a diverse portfolio that encompasses Health Economics, Research Information Services, Scientific Affairs, including Scientific Advice and Patient Engagement, and... Read More →


Thursday June 17, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044

12:00pm EDT

#508 OD: Leveling Up: How Building Your Emotional Intelligence Will Make You an Effective Leader
Component Type: Session
Level: Intermediate

Across the globe, there has not been a better time to stand witness to watch our world and corporate leaders stand strong or fall short. We rely on our leaders to operate in multicultural environments, establish and build relationships, manage difficult situations, navigate fluctuating business marketplaces, possess strategic vision, and inspire trust. The most successful among them are those who possess emotional intelligence (EI). Leaders with high emotional intelligence are needed to allow organizations to remain competitive, build a followership, create new leaders, and thrive in a VUCA environment.

Learning Objectives

Discuss emotional intelligence skills and how to develop them; Discuss how and why they are critical to the success of a team; Identify tools and strategies to immediately apply your learning.

Chair

Gretchen Griffin, MS

Speaker

Utilizing Soft Skills to Navigate Hard Times
Gretchen Griffin, MS

Intuitive Leadership: A Practical Guide to Leading with Vision, Values, and Heart
Liimu McGill



Speakers
avatar for Liimu McGill

Liimu McGill

Chief Executive Officer and Partner, LSM Consulting, United States
Liimu Mcgill has more than 20 years of experience consulting to the pharmaceutical industry, and for the past 12 years has had the honor of building LSM Consulting to be one of the leading providers of training and documentation services for regulated environments within the pharmaceutical... Read More →
avatar for Gretchen Griffin

Gretchen Griffin

Vice President and Head of North America Operations, Trilogy Writing & Consulting, United States
Gretchen Griffin is a pharmaceutical professional with over 20 years of experience. The majority of her career has been spent in regulatory writing, particularly for oncology therapeutics. Her experience spans from operational (writing complex regulatory documents) to managerial (leading... Read More →


Thursday June 17, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044

12:00pm EDT

#515 OD: Should I be Nice or be Productive? Are These Two Things Mutually Exclusive? Or Can Values and Communication Aid How We Collaborate?
Component Type: Session
Level: Intermediate

This session will discuss how civility and productivity are not mutually exclusive and how it allows for collaboration.

Learning Objectives

Recognize the day-to-day challenges that are faced in a global, virtual work atmosphere; Identify the impact to their personal and organizational relationships; Demonstrate impactful, cost-effective methods to elevate your communications and stakeholder engagement.

Chair

Brian Egan, MA

Speaker

Busting the Myth that Nice People Finish Last: A Revisit of the Golden Rule
Brian Egan, MA

Benefits of Promoting Civility Within the Workplace
Cecilia Almeida, JD

Is Niceness a Liability?
John Z. Sun, PhD, MBA, PMP



Speakers
avatar for Brian Egan

Brian Egan

Senior Manager, Communications and Engagement, TransCelerate BioPharma Inc., United States
Brian currently manages communication and engagement efforts for TransCelerate membership, including leadership from 20 pharmaceutical companies. With a focus on raising awareness of solutions globally, Brian oversees the activities of a member network that spans more than 30 countries... Read More →
avatar for Cecilia Almeida

Cecilia Almeida

Regulatory Counsel, DMPD, Office of Medical Policy, CDER, FDA, United States
Cecilia holds a Certificate of International Law from Loyola University New Orleans College of Law. She has been with FDA since 2017, where she began at the Center for Tobacco Products before switching to the Center for Drug Evaluation and Research in early 2020. Prior to her work... Read More →
avatar for John Sun

John Sun

Global Program Lead, Clinical Technology and Innovation, Novartis Pharmaceuticals Corporation, United States
John is a Global Program Lead at Novartis, and had served as Global Analytics Project Manager and Global Program Team Director in different franchises. Before Novartis, he held positions at Whitehall-Robins, Kos Pharmaceuticals, Schering-Plough, and Sanofi-Aventis. John has actively... Read More →


Thursday June 17, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  13: ProfDevelopment, Session |   20: Early Access Content, Session
 
Friday, June 18
 

12:00pm EDT

#516 OD: Aggregated Clinical Safety Evaluation Utilizing Real-World Data and Randomized Clinical Trial for Safety Decision Making
Component Type: Session
Level: Intermediate

Aggregated clinical safety evaluation is a continual and iterative process. Well-designed observational study and advanced statistical analysis in integrating randomized clinical trials (RCTs) and real-world data (RWD) can be used to answer regulatory safety question, both pre- and post- marketing.

Learning Objectives

Describe the potential role for randomized clinical trials (RCTs) and real-world data (RWD) in safety decision-making; Discuss the opportunities and challenges in aggregated clinical safety evaluation with both real world and clinical trial data sources.

Chair

Li-An Lin, PhD

Speaker

Industry Perspective
Ranjeeta Sinvhal, MD

Integrative Analysis of Randomized Clinical Trial and Real-World Study
Li-An Lin, PhD

Advanced Machine Learning Methods for Casual Inference
Birol Emir, PhD

Panelist
Walter Straus, DrMed, MD, MPH, FACP



Speakers
avatar for Walter Straus

Walter Straus

Vice President, Safety and PV, Moderna, United States
Dr. Straus’ team oversees global clinical safety for investigational products as well as post-licensure safety monitoring and assessment for the Merck portfolio in vaccines and infectious disease therapeutics. He is trained as an internist, gastroenterologist, and epidemiologist... Read More →
RS

Ranjeeta Sinvhal

Group Medical Director, Medical Safety Evaluation, AbbVie, United States
Have extensive experience in both post-marketing and clinical trials in pharmacovigilance for 15 years. In-depth global filing experience as a safety lead for both small molecule and biologics. Intimate knowledge of processes and regulations in ICSR, aggregate reporting and signal... Read More →
LL

Li-An Lin

Associate Principal Biostatistician, Merck & Co., Inc., United States
Li-An Lin is associate principal biostatistician supporting late stage oncology and general medicine therapeutic areas at Merck. Prior to Merck, he received a PhD degree in biostatistics from The University of Texas at Houston. Dr. Lin’s research areas include safety signal detection... Read More →
BE

Birol Emir

Adjunct Professor, Columbia University; Senior Director, Pfizer Inc, United States
Birol Emir, PhD, is Senior Director and RWE Statistics Group Lead in the Statistical Research and Data Science Center at Pfizer Inc. In addition, he is a lecturer at Columbia University in New York and External PhD Committee Member at Rutgers University. Recently, his primary focuses... Read More →


Friday June 18, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Session |   11: Statistics, Session |   20: Early Access Content, Session

12:00pm EDT

#518 OD: Impact of COVID-19 on Clinical Trial Execution
Component Type: Session
Level: Basic

Senior clinical operations executives at major pharmaceutical and biotech companies within the US shared their insights and lessons learned regarding transition to remote and virtual clinical trials due to COVID-19 through in-depth interviews.

Learning Objectives

Describe how COVID-19 has impacted the execution of ongoing clinical trials at pharmaceutical and biotech organizations, including remote and virtual approaches adopted; Discuss how the pandemic will influence clinical trial development in the long-term including increased use of telehealth and other technologies.

Chair

Mary Jo Lamberti, PhD, MA

Speaker

Decentralized Trials Scale and Commitment Following the Pandemic
Craig Lipset, MPH

Supporting Clinical Trial Recruitment During COVID-19
Melanie Goodwin, MS, MSc



Speakers
avatar for Mary Jo Lamberti

Mary Jo Lamberti

Associate Director of Sponsored Research, Research Assistant Professor, Tufts Center for the Study of Drug Development, United States
Mary Jo Lamberti is on the faculty at Tufts University and is Associate Director of Sponsored Research at Tufts Center for the Study of Drug Development (CSDD). She leads multi-company sponsored research studies and has extensive experience conducting research on biopharmaceutical... Read More →
avatar for Craig Lipset

Craig Lipset

Co-Chair, Decentralized Trials & Research Alliance, United States
Craig Lipset is Founder and Managing Partner of Clinical Innovation Partners, a growth advisory practice for clinical trial innovation. He is Co-Chair of the Decentralized Trials & Research Alliance, Assistant Professor of Health Informatics at Rutgers University, and adjunct faculty... Read More →
MG

Melanie Goodwin

Director, Patient Recruitment Programs, Pfizer Inc, United States
Melanie is the Director of Patient Recruitment Programs at Pfizer focused on ensuring enrollment success for the Inflammation, Immunology, and Internal Medicine franchises. She has been working in the Clinical Trial Recruitment and Retention field for almost 20 years educating sites... Read More →


Friday June 18, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  02: ClinTrials -ClinOps, Session |   20: Early Access Content, Session

12:00pm EDT

#519 OD: Enabling Patient-Centric Experience Using Connected Data Hub and Wearable Technologies
Component Type: Session
Level: Intermediate

This session will provide an overview of the data technology platform being re-imagined to enable such connected patient experience.

Learning Objectives

Describes the approach, architecture and challenges for connected data hub for enabling the use of mobile and wearable technologies.

Chair

Gian Prakash

Speaker

Swimming in a Data Lake of eCOA Wearables
Mark Wade



Speakers
MW

Mark Wade

Global Practice Leader COA, TransPerfect, United States
Mark P. Wade is currently Global Practice Leader TransPerfect, a global Life Sciences translation and eClinical Services company. Mark holds an SME position in eClinical and eCOA. Mark has held a number of Senior Management positions over a 20 yr span. Beginning at Johnson & Johnson... Read More →
GP

Gian Prakash

Associate Director, Data Engineering, AbbVie, Inc., United States


Friday June 18, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  03: Data-Data Standards, Session |   20: Early Access Content, Session

12:00pm EDT

#517 OD: Trial Designs to Minimize Bias and Non-Specific Effects
Component Type: Session
Level: Advanced

To address how trials are designed to minimize bias and non-specific effects, this session will review historic trends and research in placebo response. Data and evidence for intervention methods will be discussed, including the use of advanced analytic approaches, participant and investigator training, and measurement strategies. We will also discuss how in addition to clinical outcomes such as disease progression, patient-reported outcomes (PROs) are commonly included in oncology clinical trials because they provide important insight into how patients feel or function. To investigate potential bias in results, we performed statistical simulations and analyzed all collected data versus only data collected at the start of the cycle using different repeated measurement models.

Learning Objectives

Identify mitigation strategies and techniques for reducing placebo response and recommendations for future strategies will be reviewed; Describe through statistical simulations how bias can be introduced, depending on how and what data are analyzed.

Chair

Mark Gregory Opler, PhD, MPH

Speaker

Patient-Reported Outcomes Assessment Scheduling in Oncology: Are We Introducing Potential Bias?
Costel Chirila, PhD

Swimming Against a Rising Tide: Combating Placebo Response in Clinical Trials
Mark Gregory Opler, PhD, MPH



Speakers
avatar for Mark Opler

Mark Opler

Chief Research Officer, WCG MedAvante-ProPhase, United States
Dr. Mark Opler is Chief Research Officer at WCG MedAvante-ProPhase Inc., managing and directing global research programs. Dr. Opler has served on the faculties of New York University Medical School and in the Department of Clinical Neuroscience at Columbia University’s College of... Read More →
CC

Costel Chirila

Director, Biostatistics, RTI International, United States
Dr. Chirila is director of Biostatistics in RTI Health Solutions with 15 years of experience as a biostatistician in the pharmaceutical industry. Before joining RTI-HS, he worked as a biostatistician with pharmaceutical companies designing and analyzing clinical trials and providing... Read More →


Friday June 18, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044

12:00pm EDT

#520 OD: Patient Engagement in the Early Stage of Medicines’ Development: A Co-Created How-to Guide and its Piloting Results
Component Type: Forum
Level: Intermediate

Patient engagement is ideally done in a systematic way and early on, but there is very little evidence and best practices showing patient engagement and its benefits as early as in the discovery and preclinical phases. This panel session presents a co-created ‘How-to’ guide for patient engagement in the early stages of medicines’ development and initial results from organizations piloting the guide. This session walks through the main points in the new guide that helps industry and researchers to make plans to involve patients in a systematic way early in the discovery phase and presents a four-step approach to guide research teams through. Two piloting cases have started to implement the guide and will share their early learnings to inspire more organizations and research teams to involve patients as true partners. Download the guide and join us as we take you through the key parts and guide you on your journey to involving patients in early research.

Learning Objectives

Implement and plan patient engagement in the early stages of medicines’ development WITH patient partners; Define how to identify and reach out to potential patient partners and distinguish the possibilities and concerns regarding PE in this stage; Apply tips and lessons learned in your everyday work to implement patient engagement in the early stages of research.

Chair

Chi Pakarinen, MA

Speaker

Panelist
Carole Sian Scrafton, MBA

Panelist
Schiffon Wong, MPH

Panelist
Merlin Williams, MS

Panelist
Dawn P. Richards, PhD

Panelist
Oleksandr Gorbenko, MD, PhD



Speakers
avatar for Schiffon Wong

Schiffon Wong

Executive Director, Global Evidence and Value Development, Global R&D, EMD Serono, United States
Schiffon has interdisciplinary experience partnering with diverse stakeholders to improve healthcare quality and outcomes. She provides global strategic leadership in the use of diverse methods to develop evidence that demonstrates the value innovative medicines provide to patients... Read More →
avatar for Chi Pakarinen

Chi Pakarinen

R&D Patient Engagement Lead, GI, Takeda, United States
Chi Pakarinen has worked with The Synergist/ Patient Focused Medicines Development in the past 5 years to bring stakeholders together to collaborate and co-create fit-for-purpose tools to involve patients in medicines development. Her experience and expertise lies in driving co-creation... Read More →
avatar for Dawn Richards

Dawn Richards

Director, Patient and Public Engagement, Clinical Trials Ontario, Canada
Dawn Richards, PhD, lives with rheumatoid arthritis and is a volunteer Vice President of the Canadian Arthritis Patient Alliance. She advocates for arthritis awareness, access to treatments, patient participation in decision-making and as research collaborators, and the importance... Read More →
avatar for Merlin Williams

Merlin Williams

Senior Consultant, Executive Insight, Switzerland
Merlin is a Senior Consultant at Executive Insight, a specialized healthcare consulting firm supporting biopharmaceutical companies. Merlin has life science research experience in neurodegenerative disease and is passionate in enabling patient engagement and true patient-focussed... Read More →
avatar for Oleksandr Gorbenko

Oleksandr Gorbenko

Global Patient Centricity Director, Ipsen, United Kingdom
Dr Oleksandr Gorbenko is an expert in public health, patient advocacy and engagement with overall 20 years’ experience in pharma. He graduated as a medical doctor (general practice) in O.Bogomolets National Medical University and Shupyk National Medical Academy of Postgraduate Education... Read More →
CS

Carole Scrafton

Co-Founder, Chair, Patient Advocate, FibroFlutters Patient Advovacy Organisation, United Kingdom
As a patient with multiple chronic/rare disease, I have developed a vocation in patient advocacy. Using the skills developed from gaining my Master Business Studies I have set up and developed a local support group into a patient Advocacy Organisation with a Social Media Network for... Read More →


Friday June 18, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044

12:00pm EDT

#525 OD: Gene Therapy: Getting Back on Track After COVID-19
Component Type: Session
Level: Intermediate

This session will explore the effect of the COVID-19 pandemic on the development of gene therapies across the spectrum from discovery through clinical trials on to approvals. Although work on gene therapy has continued to advance during the pandemic, initiating clinical trials during the pandemic has been challenging, and continuing trials has not always been easy. Particularly, those trials that required medical procedures, such as biopsies, have been adversely affected, since elective medical procedures were curtailed during periods of lockdown and otherwise sometimes difficult to schedule. As we come out of the pandemic period, careful assessment of individual studies will be needed in order to salvage the maximum amount of patient data from clinical trials. Additionally, new policy initiatives may be considered to help expedite the development of gene therapy both in the United States and globally. These initiatives include resumption of efforts to achieve better international harmonization regarding the regulation of gene therapies.

Learning Objectives

Discuss the effect of the COVID-19 pandemic on the development of gene therapies; Identify the need for new policy iniatives to help expedite the gene therapies both in the US and globally.

Chair

Janet Lynch Lambert

Speaker

FDA Update
Peter W. Marks, MD, PhD

Update from EMA Committee on Advanced Therapies
Martina Schüssler-Lenz, DrMed

Industry Update
Adora Ndu, JD, PharmD



Speakers
avatar for Peter Marks

Peter Marks

Director, Center for Biologics Evaluation and Research, FDA, United States
Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching... Read More →
avatar for Adora Ndu

Adora Ndu

Group Vice President, Head of WWRD Strategy, Scientific Collaborations & Policy, Biomarin, United States
Adora Ndu, PharmD, JD, is Group Vice President, and Head of Worldwide Research and Development (WWRD) Strategy, Scientific Collaborations and Policy with oversight for Strategic Risk and Opportunity Assessment across BioMarin’s drug development programs, R&D Scientific Communications... Read More →
avatar for Janet Lynch Lambert

Janet Lynch Lambert

Chief Executive Officer, Alliance for Regenerative Medicine, United States
Janet Lynch Lambert joined ARM in 2017 as the organization’s first CEO. With more than 25 years in public and private sector management, Janet is an experienced government relations and business professional with an extensive record of accomplishment. Janet most recently served... Read More →
avatar for Martina Schüssler-Lenz

Martina Schüssler-Lenz

Deputy Head of ATMT; Chair, EMA Committee for Advanced Therapies, Paul-Erhlich-Institut
In January 2020, Dr. Martina Schüssler-Lenz was elected on her second mandate as the Chair of the Committee for Advanced Therapies (CAT) of the European Medicines Agency's (EMA). The CAT is the committee responsible for evaluating the quality, safety and efficacy of marketing authorisations... Read More →


Friday June 18, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  06: PreClin Dev-EarlyPhaseCR, Session |   09: Regulatory, Session |   20: Early Access Content, Session

12:00pm EDT

#521 OD: Continuing the Conversation: What’s New in Gene Therapy and Gene Editing
Component Type: Session
Level: Intermediate

This session will cover specific considerations for the nonclinical evaluation of GTP from a US regulatory perspective. In addition, we will present specific case studies to demonstrate the unique variability in nonclinical testing strategies for GTP.

Learning Objectives

Describe the nonclinical safety requirements for gene therapy products (GTP)(oncolytic virus, CRISPR/Cas9, therapeutic vaccine); Discuss specific considerations for the nonclinical evaluation of GTP from a US regulatory perspective; Identify specific case studies to demonstrate the unique variability in nonclinical testing strategies for unique GTP.

Chair

Philip (P.J.) Brooks, PhD

Speaker

Nonclinical Safety Evaluation Strategies Enabling IND and Marketing for Gene Therapy Products
Zeck Huang, MD, PhD

Immunogenicity Issues Related to CRISPR Cas-Mediated Gene Editing
Zuben Erach Sauna, PhD, MS



Speakers
avatar for Zuben Sauna

Zuben Sauna

Principal Investigator, OTAT, CBER, FDA, United States
Zuben E. Sauna is a Principal Investigator and also a CMC Reviewer at the US Food and Drug Administration. His research interests lie in understanding the pharmacogenetic basis of the immune response to proteins used in therapeutic interventions as these affect efficacy and safety... Read More →
avatar for Philip (P.J.) Brooks

Philip (P.J.) Brooks

Program Director, Office of Rare Diseases Research, National Center for Advancing Translational Sciences (NCATS), NIH, United States
Philip John (P.J.) Brooks is a Program Director in the NCATS Office of Rare Diseases Research. He is also the Working Group Coordinator for the NIH Common Fund program on Somatic Cell Genome Editing. He earned his Ph.D. in neurobiology from the University of North Carolina at Chapel... Read More →
avatar for Zeck Huang

Zeck Huang

Director, Topalliance Bioscience, United States
Zeck has over 20 years experience in drug discovery and development, especially in the therapeutic areas of oncology, CNS, autoimmune diseases (RA, SLE, MS, etc), infectious diseases (COVID-19, HIV, HBV, HVC, etc). He provided regulatory support for Cell and Gene therapeutic products... Read More →


Friday June 18, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  06: PreClin Dev-EarlyPhaseCR, Session |   20: Early Access Content, Session

12:00pm EDT

#522 OD: Gene Therapy Research in Pediatric Populations: Ethical Issues
Component Type: Forum
Level: Basic

Many gene therapy trials enroll pediatric patients. Clinical research in children raises discrete ethical challenges, as does clinical research involving gene therapy; this forum identifies these challenges and identifies relevant guidance documents.

Learning Objectives

Identify the primary ethical challenges facing pediatric gene therapy trials; Assess which ethical challenges are common to all clinical research in children versus which are unique to gene therapy trials in this population; Recognize existing ethical guidance on these issues.

Chair

Alison Bateman-House, PhD, MA, MPH

Speaker

Panelist
Rafael Escandon, DrPH, PhD, MPH, MS

Panelist
Alexandra Hall, MA

Panelist
Lesha D. Shah, MD, FAPA



Speakers
avatar for Alison Bateman-House

Alison Bateman-House

Assistant Professor, Division of Medical Ethics, Dept of Population Health, NYU Langone Health, United States
Alison Bateman-House, PhD, MPH, MA, is an assistant professor in the Division of Medical Ethics at NYU Langone Health's School of Medicine. She is co-chair, with Arthur Caplan PhD, of the Working Group on Compassionate Use and Preapproval Access (CUPA), an academic group that studies... Read More →
avatar for Lesha Shah

Lesha Shah

Assistant Professor; Medical Director, Icahn School of Medicine at Mount Sinai, United States
Dr. Shah is Assistant Professor of psychiatry and the Medical Director of Child, Adolescent & Family Services at the Icahn School of Medicine at Mount Sinai, with dual board certification in psychiatry and child and adolescent psychiatry. She co-chairs the Pediatric Gene Therapy... Read More →
avatar for Rafael Escandon

Rafael Escandon

Senior Vice President Medical Affairs, Policy and Patient Engagement, Bridgebio Gene Therapy, United States
Rafael has been involved in clinical research and development for the past 25 years and developed interests in public health ethics, justice and human rights while conducting clinical trials in the developing world. He believes that sponsors and investigators alike owe great debts... Read More →
AH

Alexandra Hall

Managing Director: Policy, Patient Support, and Industry, The Isaac Foundation, Canada
Alix is the Managing Director of Policy, Patient Support and Industry Liaison at The Isaac Foundation and Equal Access for Rare Disorders, where her work focuses on advocating for patients’ safe and ethical access to treatment, and managing patient education and rare disease awareness... Read More →


Friday June 18, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  06: PreClin Dev-EarlyPhaseCR, Forum |   20: Early Access Content, Forum

12:00pm EDT

#523 OD: FDA Oncology Center of Excellence Pilot Programs: Past, Present, and Future
Component Type: Session
Level: Intermediate

Since 2018, FDA’s Oncology Center of Excellence (OCE) has led the way in transforming the oncology drug review process by piloting several initiatives. The first pilots were the Real Time Oncology Review (RTOR) and Assessment Aid. RTOR focuses on a more efficient review through data and analysis standardization, and presubmission of datasets allowing for early iterative engagement with the applicant aiming to bring treatments to patients earlier. The Assessment Aid presents the sponsor’s position and the FDA assessment in one document allowing the review team to focus on a critical evaluation of the data as well as increasing review efficiency and consistency. Project Orbis, introduced in 2019, provides a framework for concurrent submission and review of products by FDA and international regulators providing for potential earlier access to oncology drugs in other countries. The RTOR and Assessment Aid Pilots have already demonstrated success by shortening the review time and expanding from supplements to original applications. This has created an interest in expanding these pilots across other FDA Centers/Divisions to accelerate the review of products that address unmet medical needs. Project Orbis, although only a little over a year old, began as a pilot with FDA, TGA and Health Canada and due to the success of that first experience quickly expanded to include Swissmedic, Singapore HSA, ANVISA, and MHRA as international collaborators. This session will review each FDA OCE pilot program and present the industry and FDA views highlighting lessons learned and adjustments made by both sponsor and review teams to enable their effective use and suggested modifications for future improvements. Additionally, expansion of the pilots within FDA to other divisions and thoughts from an international regulator’s perspective on their involvement in Project Orbis will be discussed.

Learning Objectives

Describe the different FDA Oncology Pilot programs (Real Time Oncology Review, Project Orbis, and Assessment Aid) with a focus on their origin and purpose; Identify the most effective and efficient ways to employ these pilot programs; Discuss the future potential of these pilot programs across FDA Divisions and inclusion of other countries into Project Orbis.

Chair

Robert Kester, MA, MS

Speaker

FDA Perspective on OCE Review Programs
R. Angelo De Claro

Early Experience with the FDA Real-Time Oncology Review, Assessment Aid, and Project Orbis Pilots
Kathleen Winson, MPH, MS

Project Orbis: MHRA Experience Challenges and Opportunities
Krishna Prasad, DrMed, MD, FRCP

Expanding Real-Time Review Beyond Oncology
Cartier Esham, PhD, MSc



Speakers
avatar for Robert Kester

Robert Kester

Senior Director, Global Regulatory Affairs, Merck & Co., Inc., United States
Robert Kester is a Senior Director, Global Regulatory Liaison Oncology at Merck & Co. Inc. He has been at Merck for more than eight years and began as a Regulatory Liaison focused on developing Rest of World regulatory strategies before transitioning to his current role in 2016 supporting... Read More →
RA

R. Angelo De Claro

Associate Director for Global Clinical Sciences, OCE; Div Dir, DHM, OOD, CDER, FDA, United States
avatar for Cartier Esham

Cartier Esham

Chief Scientific Officer, Biotechnology Innovation Organization (BIO), United States
Cartier Esham serves as Executive Vice President for Emerging Companies at the Biotechnology Innovation Organization (BIO). In this role, Dr. Esham manages and directs BIO’s policy development, advocacy, research and educational initiatives for BIO’s emerging companies, which... Read More →
avatar for Krishna Prasad

Krishna Prasad

Group Manager (CardioVasc, Oncology, and Antiinfective Product Team), Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Krishna Prasad is a Group Manager at the UK Regulatory Agency with management responsibility for Cardiovascular- diabetes, anti-infective agents, oncology and musckuloskeletal therapy areas for the last 18 months. Dr Prasad’s additional roles include Cardiology consultancy at St... Read More →
KW

Kathleen Winson

Executive Group Director, Regulatory, Genentech, A Member of the Roche Group, United States
Kathleen Winson is an Executive Group Director in Regulatory at Genentech/Roche, where she oversees regulatory strategy for the Oncology Lung and GU programs. She has been involved in clinical research for over 24 years accumulating a broad breadth of experience in pharmaceutical... Read More →


Friday June 18, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session |   20: Early Access Content, Session

12:00pm EDT

#524 OD: How to Engage with EMA Early in Development? Navigating the European Ecosystem to Bring Innovation to Patients
Component Type: Session
Level: Basic

The European Medicines Agency offers medicine developers various platforms for dialogue and interaction. This session will provide an overview of such platforms and for which type of product developments they could be more suited and beneficial.

Learning Objectives

Discuss EMA’s offers to support developers in early stages of their programmes; Describe value of early interaction for future successful marketing authorisation application; Identify opportunities to involve other stakeholders such as patients, health technology assessment bodies and payers; Describe the opportunities to engage with other international regulators at the same time.

Chair

Michael Berntgen, PhD

Speaker

Overview of EMA Platforms for Interaction During Medicines Development
Iordanis Gravanis, DrMed, PhD

A Product Journey by an SME: Interacting with Regulators - A Case Study
Marie Deneux, PhD, MSc

Value of Early Interaction with EMA, Also for Successful Steps Toward Access, i.e. HTA and Payers Involvement: A Case Study
Anja Langeneckert, PhD, RPh, RAC

HTA Perspective
Niklas Hedberg, MPharm



Speakers
avatar for Michael Berntgen

Michael Berntgen

Head of Scientific Evidence Generation, European Medicines Agency, Netherlands
The Scientific Evidence Generation Department aims to support the development of medicines to ensure generation of robust and relevant scientific evidence, also in collaboration with other stakeholders. Activities include the provision of scientific advice & methodology qualification... Read More →
avatar for Iordanis Gravanis

Iordanis Gravanis

Scientififc Advice, Scientific Evidence Generation, Human Medicines, European Medicines Agency, Netherlands
Iordanis Gravanis is a medical doctor by training and has a PhD in molecular and cellular pharmacology. He has been at the European Medicines Agency for almost 13 years, having worked initially as scientific officer in the oncology office for 5.5 years managing managing new authorisations... Read More →
avatar for Niklas Hedberg

Niklas Hedberg

Chair EUnetHTA Executive Board; Chief Pharmacist, Dental and Pharmaceutical Benefits Agency, TLV, Sweden
Niklas Hedberg is the Chief Pharmacist at the Swedish national governmental authority, the Dental and Pharmaceuticals Benefits Agency (TLV). He is the Chair of the EUnetHTA Executive Board and the TLV lead partner in EUnetHTA WP 3 Evaluation. Niklas has been working with pricing and... Read More →
avatar for Anja Langeneckert

Anja Langeneckert

Head EU Regulator Affairs, Product Development, F. Hoffmann-La Roche Ltd., Switzerland
Anja is currently Head of EU Regulatory Affairs at F. Hoffmann-La Roche and her group acts as a strategic and procedural advisory body on EU questions. In her 20 years with Roche she spent most of her time in Regulatory between Headquarter and affiliate role (e.g 5 years as the DRA... Read More →
avatar for Marie Deneux

Marie Deneux

Chief Regulatory Officer, Lysogene S.A., France
Marie Deneux is in charge of defining and executing the regulatory strategy for the development and registration of Lysogene’s gene therapy products. Prior to joining Lysogene, Marie Deneux spent 15 years in consulting, where she assisted life sciences companies throughout the development... Read More →


Friday June 18, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session |   20: Early Access Content, Session

12:00pm EDT

#526 OD: Modernizing CMC Dossier Format and Review
Component Type: Session
Level: Intermediate

As several accelerated review pathways (e.g., Breakthrough Therapies) are increasingly being utilized and pressure continues to mount to bring new and generic drug products to market quickly, innovative solutions for assembling, distributing, and reviewing quality regulatory data are being considered. Examples of such innovative solutions include the Structured Content and Data Management (SCDM), Knowledge-Aided Assessment and Structured Application (KASA), and the Pharmaceutical Quality and Chemistry, Manufacturing and Controls (PQ-CMC) initiatives.

Learning Objectives

Describe some of the latest developments in several initiatives to streamline compilation of quality data in regulatory submissions, including the Structured Content and Data Management (SCDM), Knowledge-Aided Assessment and Structured Application (KASA), and the Pharmaceutical Quality and Chemistry, Manufacturing and Controls (PQ-CMC) initiatives.

Chair

M. Scott Furness, PhD

Speaker

Streamlining CMC Information in Regulatory Submissions Using Structured Content and Data Management (SCDM)
Nina S. Cauchon, PhD, RAC

Modernizing Drug Substance Assessment Through KASA
Larisa Wu, PhD, MS

FDA Update
Norman Robert Schmuff, PhD



Speakers
MS

M. Scott Furness

Deputy Director, Office of New Drug Products, OPQ, CDER, FDA, United States
Scott Furness, Ph.D., Deputy Director, ONDP, OPQ, joined CDER’s OPS/OGD in 2000, serving as a Chemistry reviewer and team leader. In 2007, he was named Director of the Division of Nonprescription Regulation Development in the Office of New Drugs’ (OND). During his time in OND... Read More →
avatar for Nina Cauchon

Nina Cauchon

Director Regulatory Affairs CMC, Amgen, United States
Nina S. Cauchon, PhD, leads external engagement activities within RA-CMC. She has experience leading both early phase & commercial programs, including small molecules and biologics. Her areas of interest are regulatory challenges for innovative modalities and emerging technologies... Read More →
avatar for Norman Schmuff

Norman Schmuff

Associate Director for Science, OPMA, OPQ, FDA, United States
Norman R. Schmuff joined the FDA in 1990. For more than 20 years, he has participated in ICH as a member of several Expert Working Groups. He is currently the Rapporteur for the M4 CTD (eCTD) – Quality Implementation Working Group. He is involved in many FDA electronic submission... Read More →
avatar for Larisa Wu

Larisa Wu

Chemist, ONDP, OPQ, CDER, FDA, United States
Larisa Wu, Ph.D., is the Acting Associate Director for Science and Communication in ONDP/OPQ/CDER. Since she joined FDA in 2011, Larisa contributed significantly to various initiatives that became pivotal to the launch of OPQ. In her most recent roles, Larisa worked extensively on... Read More →


Friday June 18, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  10: RegCMC-Product Quality, Session |   20: Early Access Content, Session

12:00pm EDT

#527 OD: Building on Opportunities from a Pandemic to Influence the Future of Clinical Research
Component Type: Session
Level: Advanced

Responding and adapting to the changes invoked by the COVID-19 pandemic on clinical research foster new opportunities in many aspects of clinical research. At the heart of these opportunities are the need for statistical and analytical innovation. This session will highlight several areas where statistical and analytical innovation have informed our response to the COVID-19 pandemic and what this means for the future of clinical research. There will be a talk on the use of artificial intelligence for the rapid identification and determination of potential therapeutics that have the best chance of treating against those infected with the SAR-COV-2 virus. Another talk will discuss how the COVID-19 pandemic has magnified the vulnerability and unsustainability of the current clinical development which emphasizes the need to move towards more pragmatic, patient-centric, and adaptive trial designs that make extensive use of computer technology. The final talk will discuss how analytics and data visualization foster an ability to make timely decisions that impact the healthcare sector and clinical development.

Learning Objectives

Describe an artificial intelligence/machine learning approach that can be used to identify candidate treatments; Describe the immediate, and potential long-term, impact of the COVID-19 pandemic on the clinical-research enterprise, both in terms of trials in this disease as well as non-COVID-19 trials; Assess how data and analytics can be used to respond to public health challenges.

Chair

Mat Soukup, PhD

Speaker

Fighting COVID-19 with Trusted Analytics
Mark Lambrecht, PhD

Randomized Controlled Trials (RCTs): Lessons from COVID-19
Marc E. Buyse, DrSc

Industry Update
Sherrine Eid, MPH



Speakers
avatar for Marc Buyse

Marc Buyse

Chief Scientific Officer, IDDI, United States
Marc Buyse holds master’s degrees from Brussels University (Belgium), the Cranfield School of Management (UK) and a doctorate degree from the Harvard School of Public Health (USA). He had worked for 12 years at the EORTC in Brussels and for 2 years at the Dana Farber Cancer Institute... Read More →
avatar for Mat Soukup

Mat Soukup

Deputy Director, Division of Biometrics VII, OB, OTS CDER, FDA, United States
Following his educational endeavors in statistics at the University of Minnesota-Morris and the University of Virginia, Mat joined FDA/CDER in September 2004. His first 6 years were spent reviewing dermatology and dental products before joining the Division of Biometrics 7 as Team... Read More →
ML

Mark Lambrecht

Director, Global Health and Life Sciences Practice, SAS Institute Inc., Belgium
Mark Lambrecht leads a senior team that is responsible for SAS’ global health care and life sciences market strategy. In 2020, he led the COVID-19 Scientific Advisory Team, a response within SAS to help organizations analytically manage the impact of the pandemic. Lambrecht is an... Read More →
avatar for Sherrine Eid

Sherrine Eid

Principal Industry Consultant, SAS Institute Inc, United States
Sherrine Eid is an Industry Consultant with Health and Life Sciences at SAS. She has over 20 years of experience in Real-World Evidence, Epidemiology and Biostatistics. Previous positions include both private sector and public service roles, including work for USAID, CDC, the City... Read More →


Friday June 18, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  11: Statistics, Session |   20: Early Access Content, Session
  • Beginner Intermediate
  • Student Programming Regulator Thinking,COVID-19 - Pandemic,What's Next,Innovative Trial Design
  • Tags Session

12:00pm EDT

#528 OD: Turbo Charged Professional Development: We're Not in Kansas Anymore!
Component Type: Session
Level: Intermediate

Using the profession of “Medical Writing”, this session explores the productivity dissonance created when skills are not properly described, understood or communicated. Although Medical Writing is the use case presented here, this session addresses issues that are common throughout the organization. Also discussed is the idea of a tailored “Competency Model” to assist the organization with clarifying roles, skills and where they should ideally be applied. The net result is not only greater productivity for the organization, but greater job satisfaction overall.

Learning Objectives

Recognize how clear understanding of roles facilitates collaboration within a team, department or organization; Describe how competencies, knowledge, skills and abilities translate to success in projects and careers.

Chair

Radha Naik-Murti, PhD

Speaker

Developing and Using a Competency Model as an Unbiased Means for Recruiting and Professional Development
Radha Naik-Murti, PhD

Origins: Medical Writing Competency Model
Julie A. Ely, PhD

A Medical Writing Paradigm
Mitali Purohit, PhD, MS



Speakers
RN

Radha Naik-Murti

Director, GCTO MW, Merck & Co., Inc., United States
Radha D. Naik-Murti, Head of Medical Writing, Primary Care, is based in NJ. She has over 20 years of experience in Medical Writing. She has led writers and teams to develop documents for Phase 1 to 4 studies, global submissions, and over the counter switches. Radha has also worked... Read More →
avatar for Julie Ely

Julie Ely

Principal Medical Writer, Julie A. Ely Medical Writing Services, Australia
Julie Ely, PhD, is an independent contract medical writer with her own business, Julie A. Ely Medical Writing Services, based in Sydney, Australia. She has over 18 years of experience as both a regulatory and publications medical writer and works with clients all over the world, from... Read More →
MP

Mitali Purohit

Associate Director, CSL Behring, United States


Friday June 18, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  13: ProfDevelopment, Session |   20: Early Access Content, Session
  • Beginner Intermediate
  • Student Programming Artificial Intelligence,RWD-RWE,Diversity Equity and Inclusion
  • Tags Session
 
Saturday, June 19
 

12:00pm EDT

#534 OD: The Promise of Digital Health Tools in Delivering Value to Patients and Health Systems
Component Type: Session
Level: Basic

This session will, by way of illustration, refer to some of the main tools and applications of digital health in clinical research and crucially in showing the value of therapeutic interventions in a real- world setting.

Learning Objectives

Explore examples of artificial intelligence and digital tools in furthering clinical development; Analyze the potential of these tools in enabling remote trials, better patient engagement and data collection; Explain the potential of these tools in establishing certainty in health technology assessment with ongoing data and real-world data collection.

Chair

Zina Chatzidimitriadou, LLM

Speaker

Healthcare Update
Roberto Liddi, PhD

Industry Update
Sarina Rivera, JD

Payer/HTA Perspective
Seamus Kent



Speakers
avatar for Zina Chatzidimitriadou

Zina Chatzidimitriadou

Associate, Sidley Austin LLP, United Kingdom
Zina is an associate in the Life Sciences team at Sidley Austin. With an academic and research background in molecular biology, Zina has a deep understanding of and keen interest in developments in biotech and advanced therapies, often advising clients in this space on all aspects... Read More →
SK

Seamus Kent

Scientific Adviser, Data Analytics, National Institute for Health and Care Excellence, United Kingdom
RL

Roberto Liddi

Chief Regulatory, Quality and Information Governance Officer (CRQO), Sensyne Health, United Kingdom
Roberto heads QARA divisions at Renishaw, products range from IVDs, neurosurgical medical devices & cranio-maxillofacial implants. He has lectured at universities and authored several immunology & diabetes papers. 20 years’ experience in industry, Roberto’s tenure in the medical... Read More →
SR

Sarina Rivera

Assistant General Counsel, Hoffmann-La Roche Inc., United States


Saturday June 19, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  02: ClinTrials -ClinOps, Session |   12: Value-Access, Session |   20: Early Access Content, Session
  • Beginner Intermediate
  • Student Programming RWD-RWE,Digital Technology,Artificial Intelligence,HTA
  • Tags Session

12:00pm EDT

#530 OD: Improving the Ways We Communicate with Patients and Research Participants
Component Type: Session
Level: Intermediate

This session we will look at different factors that should influence when and how you make clinical trial information publicly available.

Learning Objectives

Discuss different factors in deciding when and how to make clinical trial information available.

Chair

Brian Mundy

Speaker

Building a Decision Tree for How and When to Make Trial Information Available to Potential Patients
Brian Mundy

Realizing the Potential of Plain Language: Developing a Clinical Research Glossary for the Public
Sylvia Baedorf Kassis, MPH

The Currency of Engagement: Meeting Patient Communication Needs
Amanda Wright



Speakers
avatar for Brian Mundy

Brian Mundy

Sr. Director, Product Strategy and Governance, WCG ePharmaSolutions, United States
Brian is currently the Sr. Director, Product Strategy & Governance at WCG - ePharmaSolutions responsible for the applications supporting the Study Planning and Site Optimization Division, including CenterWatch iConnect and Site Feasibility. Brian has over 15 years of experience working... Read More →
avatar for Sylvia Baedorf Kassis

Sylvia Baedorf Kassis

Program Manager, MRCT Center, United States
Sylvia Baedorf Kassis, MPH is a Program Manager at the Multi-Regional Clinical Trials Center. Her primary focus over the past three years has been on health literacy in clinical research and improving participant-facing communications. Her clinical research interests include understanding... Read More →
avatar for Amanda Wright

Amanda Wright

Vice President of Partnership Development, Javara, United States
Amanda Wright is the Vice President of Partnership Development at Javara, Inc. She began her career in clinical research in 1998, working as a Clinical Research Coordinator at PMG Research. She has served in various roles across the site enterprise, including leadership roles in operations... Read More →


Saturday June 19, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  02: ClinTrials -ClinOps, Session |   20: Early Access Content, Session

12:00pm EDT

#531 OD: Antibody-Drug Conjugate Drug Development: From Novel Technology to New Patient Therapy
Component Type: Session
Level: Intermediate

In this session, the expert speakers will describe and discuss the key learnings from this cutting-edge and arguably intriguing topic and promote open thoughts on how to innovate next-generation of ADC development and identify new opportunities to broaden ADC applications to deliver new therapies to help fulfill unmet medical needs.

Learning Objectives

Illustrate up-to-date ADCs drug development landscape along with therapeutic applications and opportunities; Describe scientific rationales for Antibody-Drug Conjugate (ADC) drug design and novel technological platforms; Discuss case studies of novel ADCs development from bench to clinical and from clinical to successful launch; Discuss strategic and operational considerations unique to ADC including key challenges and translational needs for ADC drugs from preclinical into clinical.

Chair

Angela Qu, MD, PhD

Speaker

The Evolution of Antibody-Drug Conjugates in the Era of Precision Medicine Development
Angela Qu, MD, PhD

Bispecific ADC Technology Platforms and M1231: A Bispecific ADC Targeting EGFR and MUC1
Joern-Peter Halle, PhD

Before the DREAMM: Preclinical Findings Leading to Development of Belantamab Mafodotin
Joanna B. Opalinska, MD



Speakers
avatar for Angela Qu

Angela Qu

Vice President, Translational Medicine, Parexel, United States
Dr. Qu is Vice President in Parexel Translational Medicine, leading therapeutic strategy development and implementation of genomics and biomarker clinical studies, provision of scientific guidance, and consulting on partnerships across therapeutic areas. She serves as a core member... Read More →
avatar for Joern-Peter Halle

Joern-Peter Halle

Senior Vice President, Global Head of Research, Merck KGaA, Germany
Peter is leading the global discovery and research organization at Merck and a member of the Healthcare Executive Committee. He oversees the discovery and development technology platforms and the research and translational activities across three focus areas of oncology, immune-oncology... Read More →
avatar for Joanna Opalinska

Joanna Opalinska

Senior Director, Oncology Clinical Development, GlaxoSmithKline, United States
Joanna Opalinska trained as clinical hematologist/oncologist in Poland and in Germany. Joanna developed further skills in basic and translational research in the area of normal and malignant hematopoiesis and modulation of gene expression by antisense technology at the University... Read More →


Saturday June 19, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  06: PreClin Dev-EarlyPhaseCR, Session |   20: Early Access Content, Session

12:00pm EDT

#532 OD: PMDA Town Hall
Component Type: Forum
Level: Intermediate

PMDA’s activity is based on "4Fs" (Patient First, Access First, Safety First, Asia First) as priority policy, which Dr. Fujiwara, chief executive, has set up. In this session, PMDA will introduce its efforts around "4Fs" including those for COVID19.

Learning Objectives

Describe the latest information regarding PMDA and Japanese regulations; Discuss how to foster dialogue between participants and senior PMDA officials concerning drug/device regulatory challenges.

Chair

Nobumasa Nakashima, PhD

Speaker

Panelist
Fumi Yamamoto

Panelist
Yasuhiro Fujiwara, MD, PhD

Panelist
Kenichi Tamiya, MSc, RPh



Speakers
avatar for Nobumasa Nakashima

Nobumasa Nakashima

Associate Executive Director for International Programs and Asia Training Centre, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Nakashima holds the position of Associate Executive Director for International Programs and Asia Training Centre (ATC) at PMDA since January 2020. Before this position, he had joined MHLW in April 1992, where he worked as Director of Office of International Regulatory Affairs... Read More →
avatar for Yasuhiro Fujiwara

Yasuhiro Fujiwara

Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. FUJIWARA Yasuhiro has been Chief Executive, PMDA since April 2019. He is a medical oncologist, specializing in breast cancer. He was previously Director-General, Strategic Planning Bureau of the National Cancer Center, and the Deputy Director of the Hospital (Research), National... Read More →
KT

Kenichi Tamiya

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
avatar for Fumi Yamamoto

Fumi Yamamoto

Councilor for Pharmaceutical Affairs, Minister’s Secretariat, Ministry of Health, Labour and Welfare (MHLW), Japan
After graduating the Graduate School of Pharmaceutical Sciences of the University of Tokyo in 1988, Ms. Yamamoto entered Ministry of Health, Labour and Welfare in the same year. Ms. Yamamoto has served in numerous positions on drug regulation and food safety, including Director, Office... Read More →


Saturday June 19, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Forum |   20: Early Access Content, Forum

12:00pm EDT

#533 OD: Comparing Accelerated Approval Pathways Among EMA, FDA, and PMDA
Component Type: Session
Level: Intermediate

Early access programs are implemented in EU, Japan, US and many other countries/regions, and many products are approved by utilizing these programs. In this session, speakers share and review the programs and discuss its future direction.

Learning Objectives

Outline early access programs provided by each regulatory agency; Discuss the achievements of the early access programs offered by each regulatory agency; Identify how to foster a dialogue among stakeholders on what is expected for the early access programs to further address regulatory needs.

Chair

Nobumasa Nakashima, PhD

Speaker

FDA Update
Theresa Mullin, PhD

EMA Update
Agnès Saint-Raymond, DrMed

Industry Update
Peter Honig, MD, MPH, FACP



Speakers
avatar for Nobumasa Nakashima

Nobumasa Nakashima

Associate Executive Director for International Programs and Asia Training Centre, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Nakashima holds the position of Associate Executive Director for International Programs and Asia Training Centre (ATC) at PMDA since January 2020. Before this position, he had joined MHLW in April 1992, where he worked as Director of Office of International Regulatory Affairs... Read More →
avatar for Peter Honig

Peter Honig

Senior Vice President Global Regulatory Affairs and Group Head Development China, Pfizer Inc, United States
Peter Honig, M.D., M.P.H, is the Senior Vice President and Head of Worldwide Safety and Regulatory at Pfizer with expertise in clinical pharmacology, clinical program and clinical trial design, compliance, medical product safety, and medical product regulation. He is a past President... Read More →
avatar for Theresa Mullin

Theresa Mullin

Associate Director for Strategic Initiatives, CDER, FDA, United States
Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads efforts including Patient-Focused Drug Development, Rare Disease Cures Accelerator, and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee... Read More →
avatar for Agnès Saint-Raymond

Agnès Saint-Raymond

Head of Division International Affairs, European Medicines Agency, Netherlands
Agnes is an MD and qualified French Paediatrician. She worked as a paediatrician in a paediatric Hospital in Paris, France, then in pharmaceutical industry, and then moved to the French Medicines Agency. In 2000 she joined the European Medicines Agency (EMA) and was responsible for... Read More →


Saturday June 19, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session |   20: Early Access Content, Session

12:00pm EDT

#529 OD: A Collaborative Cross-Company Pediatric Platform Trial in Pediatric Crohn’s Disease Using an Innovative Bayesian Analysis
Component Type: Session
Level: Intermediate

Innovative approaches to pediatric drug development are needed to reduce the delay between adult and pediatric marketing approval. This session presents a cross-company pediatric platform trial in Crohn's disease using a Bayesian analysis.

Learning Objectives

Identify some of the recruitment challenges in pediatric drug development; Identify the role of platform trials in addressing these challenges; Discuss the clinical, scientific, regulatory, and operational challenges in designing and implementing a cross-company pediatric platform trial.

Chair

Robert Nelson, MD, PhD

Speaker

Industry Update
Laurie Conklin, DrMed, MD

Industry Update
Wendy Komocsar

Industry Update
Forrest Williamson, PhD



Speakers
avatar for Robert Nelson

Robert Nelson

Senior Director, Pediatric Drug Development (CHILD), Johnson & Johnson, United States
Robert “Skip” Nelson, MD, MDiv, PhD. is currently Senior Director, Pediatric Product Development and Pediatric Strategy Lead in Immunology at Johnson & Johnson. Previously, he was the Deputy Director and Senior Pediatric Ethicist in the Office of Pediatric Therapeutics, Office... Read More →
LC

Laurie Conklin

Director, Pediatric Immunology, Janssen, United States
Laurie Conklin joined the Pediatric Development Team at Janssen in September 2020. Her primary responsibilities are leading regulatory strategy in pediatric inflammatory bowel disease (IBD), and trials of Stelara in pediatric IBD. Prior to joining Janssen, Dr. Conklin worked with... Read More →
avatar for Wendy Komocsar

Wendy Komocsar

Research Advisor, Immunology, Eli Lilly and Company , United States
Wendy Komocsar, BSMT (ASCP) SI is currently a Research Advisor with the Immunology Platform at Eli Lilly & Company in Indianapolis, IN. As part of the medical team, she leads pediatric development for an asset being studied in both ulcerative colitis and Crohn’s disease. This work... Read More →
FW

Forrest Williamson

Senior Research Scientist, Statistics Data and Analytics, Eli Lilly and Company, United States


Saturday June 19, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  11: Statistics, Session |   02: ClinTrials -ClinOps, Session |   20: Early Access Content, Session

12:00pm EDT

#535 OD: The Ultimate Collaboration: Diversity, Inclusion and Professional Development
Component Type: Session
Level: Basic

The corporate setting is not the place to have open conversations about heavy issues. It is a place to keep everything nice and polite, to focus on the work, move corporate objectives forward, analyze metrics, and above all- avoid controversy and keep one’s head down. Diversity and Inclusion has challenged this tradition of “don’t rock the boat” in a way that is as yet unresolved. Thankfully there is a constant theme running through most official corporate value statements: a commitment to achieving diversity and inclusion both in the corporate ranks as well as in clinical trials. That said, many of us are flying blind, well intended but not sure how to proceed, what to say or not say. Miss steps are frighteningly easy to make. Tensions are high. So the default is to say nothing at all. Silence is not necessarily a bad thing in many cases, but nor does it actively help us evolve towards greater collaboration in these challenging times. Unfortunately this session does not provide the answers, but it does provide a dialog. Cynthia Morris and Sheila Mahoney have been professional colleagues for over 20 years. Operating in a regulatory operations capacity, each reporting into different organizations, they collaborated on hundreds of submissions to health authorities all over the world. This collaboration included coordination of various teams, many different organizations, relatively high budgets, and extremely tight timelines. The sailing has not always been smooth. Project issues happen. In fact one could argue that in pharma, almost no project is entirely predictable or easy to achieve. And yet together, they found a way to create value for their organizations and the patients we all serve, while learning from each other in countless ways. This session is their open and honest conversation about diversity and inclusion. This is dialog we wish everyone in the corporate setting could have, but are unable to for a million reasons. At the end of the day, the corporate objective is not social change. It is and always will be profit. But against that backdrop we can unify in unprecedented ways to collaborate for mutual interest. This is not a hope for distant future, it is a reality we all live in right now. Collaboration is the only way forward. Come explore with us!

Learning Objectives

Descrbe an unusually open and honest dialog about diversity and inclusion; Discuss new insights and perspectives that may be otherwise accessible; Gain confidence about the topic of diversity and inclusion.

Chair

Cynthia Morris

Speaker

Moderator
Sheila Mahoney Jewels, MBA



Speakers
avatar for Sheila Mahoney Jewels

Sheila Mahoney Jewels

Independent Workforce Advocate, LifeSciHub , United States
Sheila has over 25 years of experience in reg/clin ops, having operated as an SME on both the sponsor and vendor sides. Her current focus as an independent consultant (IC) is advocating for the independent workforce, and helping sponsors engage with them. Sheila has spent the last... Read More →
CM

Cynthia Morris

Owner, Morris LLC, United States


Saturday June 19, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  13: ProfDevelopment, Session |   20: Early Access Content, Session
  • Beginner Beginner
  • Student Programming Collaboration,Diversity Equity and Inclusion
  • Featured Topics Collaboration,Diversity Equity and Inclusion
  • Tags Session

12:00pm EDT

#536 OD: Workforce Transformation: The Care and Feeding of a Remote Team
Component Type: Session
Level: Intermediate

Remote workers and teams are here to stay; however, a decentralized workforce doesn’t mean it is disengaged or disconnected. This session will discuss how to build, retain, and support a happy and productive remote team.

Learning Objectives

Discuss the different needs of a remote vs. an onsite worker; Describe how to utilize soft skills to maximize team interactions; Share how to use digital communication platforms and events to connect and engage team members; Assess the future of remote work based on real-world business response to the pandemic.

Chair

Gretchen Griffin, MS


Speakers
avatar for Gretchen Griffin

Gretchen Griffin

Vice President and Head of North America Operations, Trilogy Writing & Consulting, United States
Gretchen Griffin is a pharmaceutical professional with over 20 years of experience. The majority of her career has been spent in regulatory writing, particularly for oncology therapeutics. Her experience spans from operational (writing complex regulatory documents) to managerial (leading... Read More →


Saturday June 19, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  13: ProfDevelopment, Session |   20: Early Access Content, Session
 
Sunday, June 20
 

12:00pm EDT

#537 OD: Using Real-World Data in Single-Arm Trials: When It’s Done, Why It’s Done, How It’s Done
Component Type: Session
Level: Intermediate

As real-world data increasingly provide synthetic controls in single-arm drug registration studies, terminology and insights have evolved. The structured, multistep assessment process described addresses why, when, and where to use new approaches.

Learning Objectives

Describe fundamentals of synthetic control arms and real-world data integration into clinical trials; Discuss relevant key terminology; Evaluate feasibility of using an external control arm in a clinical trial; Identify how to weigh pros and cons of historical versus concurrent control arm data; Identify potential external sources for control populations.

Chair

David Thompson, PhD

Speaker

Application of Real-World Evidence to Support Breakthrough Drug Development
Mark Stewart, PhD

Toward Greater Use of RWD-Based External Controls in Regulatory Decisions: Design and Methods Considerations
Khaled Sarsour, PhD, MPH

Industry Update
Craig White, PhD



Speakers
avatar for David Thompson

David Thompson

Senior Vice President, Real World Research, Syneos Health, United States
David Thompson, PhD is a health economist with 25+ years of experience in HEOR consulting and real-world research design. He currently holds the position of Senior Vice President for Real-World Research at Syneos Health, where he provides RWE design solutions to study sponsors. Dr... Read More →
avatar for Craig White

Craig White

Senior Vice President and Managing Director, Outcomes Science, Concertai, United States
Craig White, PhD, is a researcher with >20 years’ experience in healthcare data and analytics. Craig’s research has covered pharmaceutical pricing methodologies, innovative uses of RWD in clinical development and traditional health economic models and cost-effectiveness analyses... Read More →
avatar for Mark Stewart

Mark Stewart

Vice President, Science Policy, Friends of Cancer Research, United States
Mark Stewart is vice president of science policy at Friends of Cancer Research (Friends), an advocacy organization based in Washington, DC that drives collaboration among partners of every healthcare sector and creates and implements policies ensuring patients receive the best treatments... Read More →
avatar for Khaled Sarsour

Khaled Sarsour

Global Head, RWD Hematology-Oncology, Genentech, A Member of the Roche Group, United States
Khaled Sarsour joined Genentech in 2012 where he currently is the global head of RWE hematology leading a team of multidisciplinary scientists delivering RWE and insights across the phases of drug development. Before joining Genentech, Khaled spent 5 years at Eli Lilly and company... Read More →


Sunday June 20, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  03: Data-Data Standards, Session |   02: ClinTrials -ClinOps, Session |   20: Early Access Content, Session

12:00pm EDT

#539 OD: Optimizing Cell and Gene Therapy Clinical Trial Virtualization and Remote Monitoring in the Time of COVID-19
Component Type: Session
Level: Intermediate

Using virtual-hybrid and remote solutions, we describe an innovative model for monitoring and executing cell and gene therapy clinical trials during COVID-19. These approaches serve as an instructive path forward for the future of these therapies.

Learning Objectives

Describe evolving strategies with innovative solutions for delivering cell and gene therapy trials during COVID-19; Discuss specific areas of trial risk, patient safety, data quality, and how virtual and remote activities are being successfully deployed; Analyze metrics to date and how these support a paradigm shift in the operation of these trials.

Chair

Monica Ravindra Shah, DrMed, FACC

Speaker

Industry Update
Chris Ashby Learn, PhD, PMP

Industry Update
Erin Finot, MBA, MS

Industry Update
Molly Mjolsness, MBA



Speakers
MS

Monica Shah

Therapeutic Science and Strategy Unit Vice President and Head, CAGT COE, IQVIA, United States
Dr. Shah is Vice President and Head of the Cell and Gene Therapy Center of Excellence (CAGT COE). In this role, Dr. Shah works collaboratively with sponsors, the scientific community, and other stakeholders to develop and implement innovative, patient-centered, data-driven strategic... Read More →
EF

Erin Finot

Vice President, Immuno-Oncology, IQVIA, United States
Erin Finot, MS MSA, the Vice President of Immuno-Oncology at?IQVIA Biotech, is responsible for leading the team’s strategic direction to help sponsors focused on immuno-oncology trial programs meet their goals with high quality and delivery of our innovative services and solutions... Read More →
avatar for Chris Learn

Chris Learn

Senior Director, Clinical Development, Istari Oncology, United States
Chris is a clinical research professional with 20+ years of trial execution and team management experience. He is enthusiastic and passionate about oncology cell and gene therapy clinical development, and served as a team leader in the registrational development, agency submission... Read More →
MM

Molly Mjolsness

Senior Client Delivery Manager, Be The Match Biotherapies, United States
Molly Mjolsness is the Senior Client Delivery Manager for Be The Match BioTherapies®. In her role, Molly’s focus is on envisioning and building a best-in class client delivery capability that supports cell and gene therapy clients from clinical trial through commercial approval... Read More →


Sunday June 20, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  06: PreClin Dev-EarlyPhaseCR, Session |   02: ClinTrials -ClinOps, Session |   20: Early Access Content, Session

12:00pm EDT

#540 OD: Considerations for Innovative Trial Design in CNS
Component Type: Session
Level: Intermediate

It is clear that what was a slow trend towards decentralized healthcare and clinical research has recently undergone a major inflection point due to the COVID-19 pandemic and consequently, the ability to support decentralized trials and implement remote and unsupervised assessments is a high priority. Clinical outcomes assessments (COAs) may present unique challenges, but also important opportunities related to their suitability and validity for remote conduct, as well as their practical implementation. The continued and successful application of both traditional clinical evaluations and emerging digital technologies is critical to the evaluation of novel therapies and consequently, the field must identify and promote good practice in this area.

Learning Objectives

Review practical examples and case studies of remote and decentralized clinical trial implementation; Identify good practice in the validation and implementation of clinical outcome assessments (COAs) including clinician reported outcome (ClinRO), performance outcome (PerfO), and Digital Health Technology (DHT)/Passive Monitoring assessments.

Chair

Christopher Edgar, PhD, MSc

Speaker

Precision Motion Wearables Technology and Patient Centricity: A Match Made for Hybrid and Decentralized Trials
Kristen Sowalsky, PhD

Implementing A Fully Decentralized Clinical Trial for Major Depression
Chris Reist, MD, MBA

The Rater will Zoom You Now: Considerations for Equivalency, Reliability, and Feasibility of Remote ClinRO Assessments
Daniel Debonis



Speakers
DD

Daniel Debonis

Principal, Signant Health, United States
Dan is a founder and leader in clinical trail technologies, with a focus in Neuroscience and data analytics. He was a founder of a company developed one of the industry's first eCOA and Endpoint Quality platform in 2005, and has served in leadership roles in product and commercial... Read More →
CR

Chris Reist

Medical Director, Psychiatry and Behavioral Science, Science 37, United States
avatar for Christopher Edgar

Christopher Edgar

Chief Scientific Officer, Cogstate, United States
Dr. Chris Edgar has an extensive background in drug development and clinical trials methodology, and is an expert in the development, validation and application of clinical outcome assessments (COAs). He has held positions as scientific director at Cognitive Drug Research Ltd, senior... Read More →
avatar for Kristen Sowalsky

Kristen Sowalsky

Director, Clinical Science and Consulting - Wearables and Digital Biomarkers, ERT, United States


Sunday June 20, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  06: PreClin Dev-EarlyPhaseCR, Session |   03: Data-Data Standards, Session |   02: ClinTrials -ClinOps, Session |   20: Early Access Content, Session

12:00pm EDT

#541 OD: Asian Town Hall
Component Type: Session
Level: Intermediate

“Regulatory convergence” has been advancing in Asia and expectation to this region as a field of drug development is also increasing. This session shares latest efforts for “regulatory convergence” in Asia and discuss future direction.

Learning Objectives

Describe activities to promote convergence in Asian country; Discuss activities based on convergence in Asian country; Discuss findings from FDA’s perspective.

Chair

Nobumasa Nakashima, PhD

Speaker

NMPA Perspective
Si Yuan Zhou

ASEAN Convergence in Pharmaceutical Inspections
Sia Chong Hock, MSc

FDA Perspective
Michelle Limoli, PharmD, RPh



Speakers
avatar for Nobumasa Nakashima

Nobumasa Nakashima

Associate Executive Director for International Programs and Asia Training Centre, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Nakashima holds the position of Associate Executive Director for International Programs and Asia Training Centre (ATC) at PMDA since January 2020. Before this position, he had joined MHLW in April 1992, where he worked as Director of Office of International Regulatory Affairs... Read More →
avatar for Sia Chong Hock

Sia Chong Hock

Senior Consultant, Audit and Licensing, Director Quality Assurance, Health Sciences Authority (HSA), Singapore
He is the Director of Quality Assurance and Senior Consultant at the Health Products Regulation Group of the Singapore Health Sciences Authority. Mr Sia is also an Adjunct Associate Professor with the National University of Singapore and immediate past Chair of the ASEAN Joint Sectoral... Read More →
avatar for Michelle Limoli

Michelle Limoli

Senior International Health Science Advisor, Office of the Director, CBER, FDA, United States
Michelle Limoli is the Senior International Health Science Advisor in FDA’s CBER. She is responsible for coordinating and collaborating on activities and strategic programs with various international organizations and governments, as well as within the CBER. During her career at... Read More →
SY

Si Yuan Zhou

Deputy Director of CDE, Head of ICH China Office, National Medical Products Adminsitration (NMPA), China
Mr. Zhou is the deputy director of the Center for Drug Evaluation (CDE), NMPA, China. He has been entitled in 2017 council member for Chinese Pharmaceutical Association and executive member for China Pharmacopoeia Commission. Mr. Zhou has 12-years’ clinical review experience, as... Read More →


Sunday June 20, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session |   20: Early Access Content, Session

12:00pm EDT

#538 OD: Assessment Methods and Analytics to Ensure Data Capture from Heterogeneous Populations
Component Type: Session
Level: Intermediate

This session will present an overview of the challenges with assessment methods and analytics in heterogeneous populations with case studies focusing on dermatology assessments in people of color and on methods to address heterogeneity in rare disease populations.

Learning Objectives

Identify the challenges that heterogeneity poses in clinical trial research; Describe assessment methods to address phenotypic heterogeneity to improve accurate data capture; Discuss analytic methods to address heterogenous manifestations of signs, symptoms, and impacts, which are a challenge in rare diseases.

Chair

Sonya Eremenco, MA

Speaker

The Importance of Accounting for Diversity When Training Clinicians to Apply Dermatological Rating Scales in Clinical Trials
Alexandra Kalpadakis, PhD, MSc

Multi-Domain Responder Index: A Novel Analysis Tool to Capture Broad Clinical Benefit in Heterogeneous Complex Rare Diseases
P. K. Tandon, PhD



Speakers
avatar for Sonya Eremenco

Sonya Eremenco

Director, PRO Consortium, Critical Path Institute, United States
Sonya Eremenco is Director of the Patient-Reported Outcome (PRO) Consortium. Sonya has over 20 years of experience in PRO (and other clinical outcome assessment) instrument development, with a focus on multicultural development, linguistic validation, and electronic implementation... Read More →
PK

P. K. Tandon

Senior Vice President, Biometrics and Development Strategy, Ultragenyx Pharmaceutical, United States
P. K. Tandon, Ph.D. is Senior Vice President of Biometrics and Development Strategy at Ultragenyx Pharmaceuticals, Inc. based in Cambridge, MA. He joined Ultragenyx Pharmaceuticals in January, 2017. Prior to Ultragenyx, he was Clinical Science Officer and SVP at Sanofi-Genzyme and... Read More →
AK

Alexandra Kalpadakis

Scientific Advisor, Signant Health, United Kingdom
Alexandra Kalpadakis-Smith is a Scientific Advisor at Signant Health, where she provides scientific expertise on digitising the capture of Clinical Outcome Assessments (COA) and the use of connected health devices in clinical trials. She participates in research activities on the... Read More →


Sunday June 20, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044

12:00pm EDT

#542 OD: Basics of Healthcare Reform for Lifesciences Professionals
Component Type: Forum
Level: Basic

This forum provides an overview of healthcare reform basics for pharmaceutical industry staff amid the ongoing impact of COVID-19 and calls for health equity. Topics discussed include major US health care programs, pharmaceutical pricing and innovation models.

Learning Objectives

Summarize major health care programs of interest to the pharmaceutical industry such as Medicare and Medicaid; Describe recent steps by federal and state governments to promote innovation; Discuss drug pricing and how ongoing health system delivery reform changes, such as value-based design and comparative effectiveness may impact the pharmaceutical industry.

Chair

Mitchell Berger, JD, MPH, RAC

Speaker

Potential Health Reform Approaches (e.g., Public Option, Medicare for All)
Ed Weisbart, MD, FAAFP

Overview of Drug Pricing (US)
Barry Berger, JD, MBA

CMS Innovation Models
Rebecca Yip, MS



Speakers
MB

Mitchell Berger

Public Health Advisor, HHS, United States
Mitchell Berger, MPH, JD, serves as a Public Health Advisor for the Substance Abuse and Mental Health Services Administration (SAMHSA), where he contributes to the agency’s work on such topics as mental health and substance use disorder integration, confidentiality, human immunodeficiency... Read More →
BB

Barry Berger

Retired, Former Professor of Regulatory Affairs, Temple University, United States
avatar for Ed Weisbart MD

Ed Weisbart MD

Chair, MO Chapter, Physicians for a National Health Program, United States
Ed Weisbart MD, CPE, FAAFP is a family physician in St. Louis MO and chairs the Missouri chapter of Physicians for a National Health Program. After practicing family medicine for 20 years at Rush Medical Center in Chicago, he moved to St. Louis in 2003 to serve as chief medical officer... Read More →
RY

Rebecca Yip

Principal, Avalere Health, United States
Rebecca Yip is a Principal in the Policy Practice at Avalere. She provides clients with data-driven analyses to understand the impact of policy and regulatory changes. Rebecca has more than 20 years’ experience in both the public and private sectors, providing analyses of health... Read More →


Sunday June 20, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
 
Monday, June 21
 

9:30am EDT

011A: #011A: Core Labeling
Component Type: Tutorial
CE: ACPE 2.75 Knowledge UAN: 0286-0000-21-500-L04-P; CME 2.75; IACET 2.75; RN 2.75

Preregistration required and is an additional fee. Already registered? Log in to DIA's My Account>My Events.

This half day short course will present the basic labeling requirements for global labeling documents. It will cover the concept of the Company Core Data Sheet (CCDS), the impact inside and outside of the company, how local labeling changes and regulatory requirements may have an impact on Company Core Data Sheet (CCDS). In addition, it will discuss the consequence for a company of having a CCDS and how that will impact local labeling and labeling departments. Need approval in order to attend? Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.
Enhance your experience and register for two or more short courses at the same time and receive $50 in savings.
Purchase must happen at same time. Discount will be reflected on the last page of the cart.
Download Registration Form
Registration Questions? Send Email
1.888.257.6457 Return to DIA 2021

Learning Objectives

Discuss the concept and use of Company Core Data Sheet (CCDS); Analyze with the detailed content of CCDS; Discuss knowledge of core labeling implementation and deviations; Identify options to bridge different local/regional requirements in the CCDS; Examine the potential impact of CCDS on the company, e.g. tracking, deviation management.


Instructors
avatar for Gerrit Nijveldt

Gerrit Nijveldt

Consultant Labeling, Opus Regulatory, United States
Gerrit Nijveldt is currently Labeling consultant with Opus Regulatory. Gerrit has more than 20 years of experience in Global labeling. He has a broad experience in developing and maintaining Company Core Data Sheets, US Prescribing Information and EU Summary of Product Characterisation... Read More →

Monday June 21, 2021 9:30am - 12:30pm EDT
Virtual Event Virtual Event Horsham, PA 19044
  19: Short Courses, Tutorial |   01: ClinSafety-PV, Tutorial
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial

9:30am EDT

012A: #012A: Real-World Evidence: The Evolving Landscape of Regulators, Data, and Integrated Use
Component Type: Tutorial
CE: ACPE 2.75 Knowledge UAN: 0286-0000-21-501-L04-P; CME 2.75; IACET 2.75; RN 2.75

Preregistration required and is an additional fee. Already registered? Log in to DIA's My Account>My Events.

This short course will provide an overview of how real-world evidence is being used today for evidence generation in major markets. The primary focus is evidence generation for regulatory use, with a particular focus on comparative effectiveness, but the approaches described here are useful for health technology assessments for payers. Following the major points identified by the FDA in the Frameworks document released in December, 2019, we will explain how the fitness of evidence from real-world data are assessed for any use case, key elements of design and analysis, and the current status of FDA guidance on when real-world studies will be sufficient to meet regulatory evidence requirements. Although much of the focus will be on the FDA, the course will also include an update of recent activities by the EMA regarding use of real-world (big) data.Need approval in order to attend? Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.
Enhance your experience and register for two or more short courses at the same time and receive $50 in savings.
Purchase must happen at same time. Discount will be reflected on the last page of the cart.
Download Registration Form
Registration Questions? Send Email
1.888.257.6457 Return to DIA 2021

Who should attend?

This short course is designed for members of the clinical research and regulatory audiences.

Learning Objectives

Describe key epidemiological design principles central to interpreting the quality and validity of real-world evidence (RWE) studies; Apply these learnings by evaluating and discussing case presentations focused on CV safety assessments; Recognize when RWE based approaches are of sufficient quality to enable decision making.


Instructors
avatar for Gillis Carrigan

Gillis Carrigan

Director, Center for Observational Research, Amgen, United States
Dr. Carrigan has over 20 years of experience in observational studies with a focus on study design and methodology. He is experienced with the use of electronic medical records (EMR), administrative claims data, and registry data. He has worked with observational data in a number... Read More →
avatar for Nancy Dreyer

Nancy Dreyer

Chief Scientific Officer and Senior Vice President, IQVIA, United States
Nancy Dreyer is Chief Scientific Officer and SVP at IQVIA and Adjunct Professor of Epidemiology at the U of N Carolina School of Global Public Health. She leads the IQVIA Center for Advanced Evidence Generation. A fellow of both the International Society for Pharmacoepidemiology and... Read More →
MK

Michael Kelsh

Principal Scientist, Amgen, United States
avatar for Matthew Reynolds

Matthew Reynolds

Vice President, Real World Evidence, IQVIA, United States
Dr. Reynolds is a member of the Center for Advanced Evidence Generation, Real World Solutions at IQVIA. He designs innovative solutions for real world evidence on effectiveness and safety. Dr. Reynolds brings more than 20 years of diverse experience in non-interventional research... Read More →

Monday June 21, 2021 9:30am - 12:30pm EDT
Virtual Event Virtual Event Horsham, PA 19044
  19: Short Courses, Tutorial |   03: Data-Data Standards, Tutorial
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial

9:30am EDT

013A: #013A: “Has it Happened Already?” Questions of Precedent from which Regulatory Intelligence Can Save You
Component Type: Tutorial
CE: ACPE 2.75 Knowledge UAN: 0286-0000-21-502-L04-P; CME 2.75; IACET 2.75; RN 2.75

Preregistration required and is an additional fee. Already registered? Log in to DIA's My Account>My Events.

This intent of this short course is to provide a quick overview and practical insight into locating, analyzing and applying precedent as an aid to making better strategic regulatory decisions. In a rapidly evolving regulatory environment, it is critical for regulatory professionals to employ research skills in locating precedent, determining those that are deemed meaningful and discarding those that are misleading, and developing an understanding of the bigger picture as a critical deliverable in a time of data-driven decision-making.Need approval in order to attend? Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.
Enhance your experience and register for two or more short courses at the same time and receive $50 in savings.
Purchase must happen at same time. Discount will be reflected on the last page of the cart.
Download Registration Form
Registration Questions? Send Email
1.888.257.6457 Return to DIA 2021

Who should attend?

This short course is designed for members involved in: Regulatory affairs, regulatory intelligence and policy professionals, professionals engaged in regulatory research and precedent analysis to support regulatory decision-making.

Learning Objectives

Describe the importance and context of precedent in regulatory strategy; Discuss locating and analyzing precedent from EU and US drug and biologic sources;Identify the impact of precedent for regulatory decision-making.


Instructors
avatar for Linda Bowen

Linda Bowen

Head of Regulatory Policy and Intelligence, Seagen, United States
Linda joined the BioPharma industry in 1983 and has spent the last 28 years in regulatory strategy, intelligence and policy roles. She is Head of Regulatory Policy and Intelligence at Seagen (formerly Seattle Genetics) and Assistant Professor in the Temple University RAQA graduate... Read More →
avatar for João Duarte

João Duarte

Director, Chief of Staff & Regulatory Science, Alexion Pharmaceuticals, France
João Duarte is currently Chief of Staff and Regulatory Science within the Global Regulatory Affairs team at Alexion Pharmaceuticals. João leads the regulatory intelligence and policy activities globally and supports Senior Management in steering internal activities based on the... Read More →

Monday June 21, 2021 9:30am - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044
  19: Short Courses, Tutorial |   09: Regulatory, Tutorial
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial

1:00pm EDT

014P: #014P: Data Visualization in the Lifesciences
Component Type: Tutorial
CE: ACPE 2.75 Knowledge UAN: 0286-0000-21-503-L04-P; CME 2.75; IACET 2.75; RN 2.75

Preregistration required and is an additional fee. Already registered? Log in to DIA's My Account>My Events.

Traditional approaches to medical product development rely on generating pages upon pages of analysis results to describe the safety and effectiveness of novel therapies. Study teams struggle to understand and communicate the story hidden within the data to their colleagues. First and foremost, with the high cost of conducting translational clinical research, it is common to collect as much data as possible on as many endpoints as possible. This phenomenon is further reinforced due to our limited understanding of biological mechanisms and pathways, including the potential genomic underpinnings of a disease or treatment response.

Ben Shneiderman stated that “the purpose of visualization is insight.” Therefore, the goal of this short course is to describe data visualization techniques to aid in the understanding and communication of results from applications in clinical trials and genomics research. Numerous practical illustrations and examples from the literature will be presented. To be accessible to a wide audience, this course will focus on principles and interpretation, and limit technical jargon.Need approval in order to attend? Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.
Enhance your experience and register for two or more short courses at the same time and receive $50 in savings.
Purchase must happen at same time. Discount will be reflected on the last page of the cart.
Download Registration Form
Registration Questions? Send Email
1.888.257.6457 Return to DIA 2021

Who should attend?

This short course is designed to be accessible to a wide audience, it will focus on principles, limit technical jargon, and interpret numerous examples of data visualization using data from the life sciences literature. The audience may include any individual interested in developing their skills for more efficient interpretation and communication of various aspects of study design and analysis.

Learning Objectives

Describe the transition from traditional methods of data analysis to visual approaches; Identify life science data using one or more data visualizations; Assess the strengths and limitations of various graphical techniques; Explain the “data story” of numerous clinical research, examples using data visualization techniques.


Instructors
avatar for Kelci Miclaus

Kelci Miclaus

Senior Director, Veeva Systems, United States
Dr. Kelci Miclaus is Senior Director of Veeva Stats, head of product and engineering for the Veeva Systems statistical computing environment solutions. Previously, she helped create, develop, and manage the JMP Genomics and JMP Clinical software solutions as Advanced Analytics Sr... Read More →
avatar for Richard Zink

Richard Zink

Vice President, Data Management, Biostatistics, and Statistical Programming, Lexitas Pharma Services, United States
Richard C. Zink is Vice President of Data Management, Biostatistics, and Statistical Programming at Lexitas Pharma Services, Inc. He was the 2019 Chair of the Biopharmaceutical Section of the American Statistical Association, and is currently host of the Biopharmaceutical Section... Read More →

Monday June 21, 2021 1:00pm - 4:00pm EDT
Virtual Event Virtual Event Horsham, PA 19044
  19: Short Courses, Tutorial |   03: Data-Data Standards, Tutorial
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial
 
Tuesday, June 22
 

9:30am EDT

022A: #022A: Medical Writing Training Programs: Teaching the Next Generation of Regulatory Medical Writers
Component Type: Tutorial
CE: ACPE 2.75 Knowledge UAN: 0286-0000-21-506-L04-P; CME 2.75; IACET 2.75; RN 2.75

Preregistration required and is an additional fee. Already registered? Log in to DIA's My Account>My Events.

How can we better train regulatory writers to acquire the skills needed to successfully do their jobs? The importance of standardized training programs for regulatory writers will be discussed, along with experiences developing training programs.Need approval in order to attend? Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.
Enhance your experience and register for two or more short courses at the same time and receive $50 in savings. 
Purchase must happen at same time. Discount will be reflected on the last page of the cart.
Download Registration Form
Registration Questions? Send Email
1.888.257.6457 Return to DIA 2021 

Learning Objectives

Describe the importance of organizations having standardized training programs for regulatory medical writers; Explain and apply the available industry-level guidance that can help with developing training programs for regulatory writers; Compare the approaches used by a sponsor and by a CRO to develop training programs for new medical writers.


Instructors
avatar for Julia Forjanic-Klapproth

Julia Forjanic-Klapproth

Senior Partner/President, Trilogy Writing & Consulting
After receiving her PhD in Developmental Neurobiology, Julia became a medical writer in 1997. In 2002, she co-founded Trilogy Writing & Consulting, a company specialized in medical writing of regulatory documentation. She is now Senior Partner and CEO, and continues to bring her enthusiasm... Read More →
avatar for Kim Jochman

Kim Jochman

Senior Principal Medical Writer, Merck & Co., Inc., United States
Kim Jochman is a Senior Principal Medical Writer at Merck. She has a Ph.D in biological psychology and has been a regulatory medical writer since 2007, with experience across a broad range of document types, development phases, and therapeutic areas. Kim is passionate about training... Read More →
avatar for Linda Yih

Linda Yih

Senior Director, Medical Writing Services, Parexel International, United States
Linda Yih is a Senior Director in Medical Writing Services at Parexel International. As the global lead for People Development, Linda focuses on professional development and retention of writers as well as managers. She is decentralized in CT, USA.

Tuesday June 22, 2021 9:30am - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044
  04: MedAffairs-SciComm, Tutorial |   19: Short Courses, Tutorial
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial

9:30am EDT

021A: #021A: R&D QA Comprehensive Quality Strategy: An Approach to Managing Quality Risks Throughout the Drug Development Lifecycle
Component Type: Tutorial
CE: ACPE 2.75 Application UAN: 0286-0000-21-505-L04-P; CME 2.75; IACET 2.75; RN 2.75

Preregistration required and is an additional fee. Already registered? Log in to DIA's My Account>My Events.

Quality oversight of drugs throughout the product development lifecycle is complex and crosses many functions, and at times it can be challenging to communicate and manage the quality risks identified along the way. This short course will begin with a brief review of ICH E6 (R2) and the impact to the clinical development enterprise. The group will then examine points to consider regarding the principles and benefits of a quality management framework as a foundation in setting tolerance limits, managing issues, identifying and mitigating risks, and applying analytics as part of quality risk management.

The instructors will take you through the development of a cross functional quality strategy frame work in an R&D QA organization which, when implemented, will proactively identify, manage, and communicate quality risks across the R&D GxP functions throughout drug development lifecycle. Examples will be workshopped to demonstrate how this methodology can help assure confidence in the quality oversight in preparation for submission to regulatory agencies and for inspections.Need approval in order to attend? Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.
Enhance your experience and register for two or more short courses at the same time and receive $50 in savings. 
Purchase must happen at same time. Discount will be reflected on the last page of the cart.
Download Registration Form
Registration Questions? Send Email
1.888.257.6457 Return to DIA 2021 

Who should attend?

This short course is designed for professionals within sponsor, CRO, and regulatory agency organizations interested in research and development, clinical research, and/or clinical quality assurance.

Learning Objectives

Describe the risk process; Design a comprehensive quality strategy to manage risk throughout the drug lifecycle; Establish quality tolerance limits and issue management; Discuss ways to implement a cross functional quality strategy frame work to identify, manage, and communicate quality risks across the R&D GxP functions.


Instructors
avatar for Victoria Burk

Victoria Burk

Senior Director R&D Quality Assurance, AbbVie, Inc.
Vicki Burk is the Sr. Director R&D Quality Assurance Clinical QA Program Management, Combination Products and Medical Devices and the Comprehensive Quality Strategy at AbbVie.  She leads teams responsible for Clinical QA across all stages of development and Combination Product/Medical... Read More →
avatar for Matthew Burtt

Matthew Burtt

Director Clinical QA Program Management, AbbVie, United States
After completing a Biomedical Engineering undergraduate degree, I built upon my internship with Abbott (eventually AbbVie) in a 2 year rotational program with different assignments every six months across the business landscape. Since then I've been in the R&D Quality Assurance world... Read More →
avatar for Arun Mathew

Arun Mathew

Associate Director, Abbvie, United States
Business process owner for quality risk management in R&D(1.6yrs) Risk Management experience(18 yrs.) Medical devices experience (16yrs). Contributed and reviewed the book Foundations of Quality Risk Management.

Tuesday June 22, 2021 9:30am - 12:30pm EDT
Virtual Event Virtual Event Horsham, PA 19044
  19: Short Courses, Tutorial |   08: RD Quality-Compliance, Tutorial
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial

9:30am EDT

025A: #025A: Optimizing Your Interaction With EU Regulatory Authorities: How to Prepare and Perform
Component Type: Tutorial
CE: ACPE 2.75 Application UAN: 0286-0000-21-509-L04-P; CME 2.75; IACET 2.75; RN 2.75

Preregistration required and is an additional fee. Already registered? Log in to DIA's My Account>My Events.

The possibilities to meet and engage with EU regulators to discuss/explain your clinical development plans are few. A successful outcome of such meetings will often be critical for your decisions and could in the end be decisive for approval of your product. Having mapped out a plan for your regulatory interactions throughout product development and having your team prepared to present in its most persuasive manner is critical for success. Being well-prepared and performing professional is key to success. This include demonstrating intimate knowledge of your data to meet regulator’s concern as well as being able to present this in a crisp and clear manner. To get to this stage takes meticulous preparation of key messages, slides and the actual speech and may additionally include training key opinion leaders and/or patient representatives to speak or respond to questions in your support. Finally, preparing a head of questions and being able to respond clear and unequivocally to these are equally important to increase chances of success.

This short course focuses on how best to plan, manage, prepare, and execute successfully at EU high-stakes meetings. A former CHMP member and a communication specialist will walk you through the key steps in preparing as well as the “do’s and don’ts” when presenting and engaging with regulators. We will discuss how best to present your key massages and supporting slides and manuscript. This short course will include anonymized examples from real or imagined meetings and enable the participants to better understand the process and its challenges as well as how best to cope with these. Need approval in order to attend? Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.
Enhance your experience and register for two or more short courses at the same time and receive $50 in savings. 
Purchase must happen at same time. Discount will be reflected on the last page of the cart.
Download Registration Form
Registration Questions? Send Email
1.888.257.6457 Return to DIA 2021 

Who should attend?

This short course is designed for members involved in: Regulatory professionals independent on company size who are planning to are are actively engaged with EU regulatory authorities in particular during marketing authorization review.

Learning Objectives

Summarize a high-level understanding of the EU regulatory system; Define a basic knowledge of the EU centralized procedure; Describe how best to prepare your team for an EU regulatory agency meeting; Recognize effective communication; Define an oral explanation, oral hearing, regulatory meetings, communication, and authority interaction.


Instructors
avatar for John Ellis

John Ellis

Communications Coach, PharmApprove, United States
John Ellis has been communications coach at PharmApprove since 2008. He has coached upwards of thirty teams as they have prepared for FDA advisory committee meetings, as well as OE's and SAG's in Europe. In addition, he creates and delivers workshops on a range of communications skills... Read More →
avatar for Steffen Thirstrup

Steffen Thirstrup

Director, NDA Regulatory Advisory Board, NDA Advisory Services Ltd, United Kingdom
Steffen Thirstrup is a medical doctor and board certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine. He is an adjunct professor in pharmacotherapy at the Faculty of Health Sciences... Read More →

Tuesday June 22, 2021 9:30am - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044
  19: Short Courses, Tutorial |   09: Regulatory, Tutorial
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial

1:00pm EDT

024P: #024P: Optimizing the Document Review Process
Component Type: Tutorial
CE: ACPE 2.75 Knowledge UAN: 0286-0000-21-508-L04-P; CME 2.75; IACET 2.75; RN 2.75

Preregistration required and is an additional fee. Already registered? Log in to DIA's My Account>My Events.

This short course will include new approaches to document review and finalization are urgently needed. There are tools and techniques that can be used to make document review more effective and thus produce higher quality clinical documentation in shorter times.Need approval in order to attend? Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.
Enhance your experience and register for two or more short courses at the same time and receive $50 in savings.
Purchase must happen at same time. Discount will be reflected on the last page of the cart.
Download Registration Form
Registration Questions? Send Email
1.888.257.6457 Return to DIA 2021

Who should attend?

This short course is designed for professionals involved in clinical document review.

Learning Objectives

Describe the basic principles of document review processes; Discuss the tools and techniques that can make review processes more efficient and effective.


Instructors
avatar for Barry Drees

Barry Drees

Senior Partner, Trilogy Writing & Consulting, Germany
Barry holds a Ph.D. in molecular genetics. Following his postdoctoral work as a fellow of the NIH, he worked as a medical writer in the pharmaceutical industry for 12 years, and leading several regulatory submission teams. Barry is a frequent speaker on medical writing, statistics... Read More →

Tuesday June 22, 2021 1:00pm - 4:00pm EDT
Virtual Event Virtual Event Horsham, PA 19044
  04: MedAffairs-SciComm, Tutorial |   19: Short Courses, Tutorial
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial

1:00pm EDT

023P: #023P: Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable Model
Component Type: Tutorial
CE: ACPE 2.75 Knowledge UAN: 0286-0000-21-507-L04-P; CME 2.75; IACET 2.75; RN 2.75

Preregistration required and is an additional fee. Already registered? Log in to DIA's My Account>My Events.

The current clinical trial climate demands that sponsors find ways to reduce clinical trial complexity, drug development costs, and get more value from R&D budgets. Risk-based monitoring (RBM) allows organizations to target site monitoring activities for which risks can be best managed and deliver the greatest benefit to the study, and to become more effective and efficient in using resources, while increasing quality and patient safety.

Participating TransCelerate Member Companies came together in 2012 to establish a model approach to high-quality RBM. To date, this effort has published a position paper on risk based monitoring, as well as several articles focused on sharing advancements, best practices and lessons learned from member companies adoption experience, all of which are publicly available.

This short course, will define core concepts and main principles of the methodology, share key tools and discuss their use, share experiences and lessons learned, and address important questions about RBM and its implementation.Need approval in order to attend? Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.
Enhance your experience and register for two or more short courses at the same time and receive $50 in savings.
Purchase must happen at same time. Discount will be reflected on the last page of the cart.
Download Registration Form
Registration Questions? Send Email
1.888.257.6457 Return to DIA 2021

Who should attend?

This short course is designed for professionals involved with clinical and data operations.

Learning Objectives

Define core concepts and main principles of the risk-based monitoring (RBM) methodology; Discuss the use of key tools in the RBM process; Identify common challenges with effective monitoring and discuss how they can be addressed through appropriate use of the RBM methodology.


Instructors
avatar for Samantha Hewlett

Samantha Hewlett

Risk-Based Study Execution Capability Lead, Amgen, South Africa
Samantha qualified as a pharmacist and has worked in the pharmaceutical industry in varying roles and countries for over 20 years. She moved back to South Africa in 2014 and transitioned in to clinical research where she lead local clinical operations for both GSK and Amgen. She has... Read More →

Speakers
avatar for Rodrigo Perez

Rodrigo Perez

Risk Management and Monitoring Lead, Sanofi, Mexico
Rodrigo Perez, based in Mexico City, has more than 14 years of experience in clinical research working for Sanofi’s Clinical Study Unit (CSU) in different roles (CRA, Study Manager, and Operations Manager, among others). Graduated from Universidad La Salle, Rodrigo has a bachelor’s... Read More →


Tuesday June 22, 2021 1:00pm - 4:00pm EDT
TBD Virtual Event Horsham, PA 19044
  19: Short Courses, Tutorial |   08: RD Quality-Compliance, Tutorial
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial
 
Wednesday, June 23
 

9:30am EDT

031A: #031A: Developing, Implementing, and Operating REMS Programs
Component Type: Tutorial
CE: ACPE 2.75 Knowledge UAN: 0286-0000-21-510-L04-P; CME 2.75; IACET 2.75; RN 2.75

Preregistration required and is an additional fee. Already registered? Log in to DIA's My Account>My Events.

Data from randomized controlled clinical trials (RCTs) have traditionally played a primary role in regulatory decision making. However, the increasing cost of clinical development coupled with challenges in studying hard to reach populations, rare diseases, and rare endpoints (such as for safety outcomes), along with a general lack of understanding as to how medical products are used in practice, has motivated regulators and pharmaceutical industry sponsors to explore the utility of other sources of data. The 21st Century Cures Act passed by the US Congress in 2016 empowers the US Food and Drug Administration to accelerate the approval process by allowing data from real-world data (RWD) sources to support new indications for approved drugs, or to support or satisfy post-approval requirements.There is a growing demand for fast, timely, and relevant public health data on patient safety. This has resulted in increased expectations for well-designed, well-executed, and well-reported observational studies. In addition, there is a rise in the demand for using RCTs to understand treatment effects in a more real-world setting. To face these challenges and potential opportunities, the ICH and various regulatory authorities are developing guidance to incorporate data from RCTs and RWD to enable relevant decision making. These ideas are reflected in the recent updates of ICH E2C for periodic benefit-risk evaluation report, the E6/E8 renovation paper, the ICH E9 R1 estimand discussion, as well as the recent FDA framework on the use of real-world evidence (2018).

Throughout the course, we cover lessons learned over the last decade of REMS implementation, and how implementation approaches continue to evolve to support safe use and product access, while reducing overall burden of REMS on the healthcare landscape. Using examples from approved REMS programs, we explore how key concepts are applied in the real world. By the end of this course, participants have an expanded understanding of REMS and the knowledge necessary to be involved in development, approval, implementation, and/or administration of a REMS program.Need approval in order to attend? Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.
Enhance your experience and register for two or more short courses at the same time and receive $50 in savings.
Purchase must happen at same time. Discount will be reflected on the last page of the cart.
Download Registration Form
Registration Questions? Send Email
1.888.257.6457 Return to DIA 2021

Who should attend?

This short course is designed for: Professionals who may become involved in the development, implementation, or administration of a REMS program, which includes biopharmaceutical companies, vendors serving the biopharmaceutical industry, and those who regulate the biopharmaceutical industry. It’s also intended for those who wish to expand their overall knowledge of the drug safety landscape of which REMS is a notable component.

Learning Objectives

Describe business and regulatory challenges unique to products with an associated REMS; Summarize how REMS programs are initiated, developed, approved, launched, and operated; Discuss the differences and similarities between new product and generic product REMS programs.


Instructors
avatar for Jemma Contreras

Jemma Contreras

Executive Managing Director, Advisory Group Lead, Syneos Health, United States
Jemma Contreras brings over 15 years of biopharmaceutical consulting to her role as Advisory Group Lead for the Risk and Program Management team at Syneos Health. Over the past decade Jemma has established and grown the Risk and Program Management team, leading the development and... Read More →
avatar for Melissa Landers

Melissa Landers

Managing Director, Syneos Health, United States
Melissa brings almost 20 years of management consulting experience—15 in the biopharmaceutical industry—to her role as a Managing Director in Syneos Health Consulting’s Risk and Program Management Advisory Group. In this role, she oversees teams of consultants working on both... Read More →

Speakers
avatar for Melissa Landers

Melissa Landers

Managing Director, Syneos Health, United States
Melissa brings almost 20 years of management consulting experience—15 in the biopharmaceutical industry—to her role as a Managing Director in Syneos Health Consulting’s Risk and Program Management Advisory Group. In this role, she oversees teams of consultants working on both... Read More →


Wednesday June 23, 2021 9:30am - 12:30pm EDT
Virtual Event Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Tutorial |   19: Short Courses, Tutorial
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial

9:30am EDT

032A: #032A: Leadership: How to Organize and Lead People in a Work Group
Component Type: Tutorial
CE: ACPE 2.75 Knowledge UAN: 0286-0000-21-511-L04-P; CME 2.75; IACET 2.75; PDU 2.75 PMI 21668NC9ZN; RN 2.75

Preregistration required and is an additional fee. Already registered? Log in to DIA's My Account>My Events.

The role of a leader in organizing and leading a group is often misunderstood and, as a consequence, the group may not perform up to expectations, or it may spend a considerable amount of time dealing with dysfunctional group dynamics instead of the work to be accomplished. This short course addresses those issues by exploring the types of work groups, how they can be more effective, and how individuals can correct group dynamics and help the group achieve higher levels of performance.Need approval in order to attend? Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.
Enhance your experience and register for two or more short courses at the same time and receive $50 in savings.
Purchase must happen at same time. Discount will be reflected on the last page of the cart.
Download Registration Form
Registration Questions? Send Email
1.888.257.6457 Return to DIA 2021

Who should attend?

This short course is designed for individuals who must manage group activities on a permanent or project basis, for those who must work on teams but are not in charge of teams and want to learn how to exert influence on group behavior. This course will also benefit individuals to whom project managers report.

Learning Objectives

Identify the different types of work group structures and be able to predict the quality of work the group will produce;Identify ways to correct dysfunctional group dynamics;Create and maintain cooperation among team members, including cross-functional teams.


Instructors
avatar for Michael Laddin

Michael Laddin

Managing Partner, ResultsMatter, United States
Mike Laddin is the principal and owner of ResultsMatter. ResultsMatter provides leadership development workshops, strategic consulting, and executive coaching and management team assessments to clients worldwide. The premise of ResultsMatter’s work is that management is a science... Read More →

Wednesday June 23, 2021 9:30am - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044
  19: Short Courses, Tutorial |   13: ProfDevelopment, Tutorial
  • Credit Type ACPE, CME, IACET, PMI, RN
  • Tags Tutorial

1:00pm EDT

033P: #033P: eCOA 102: Beyond the Basics - Operational, Scientific, and Best Practices for eCOA and Wearable Devices in Clinical Trials
Component Type: Tutorial
CE: ACPE 2.75 Knowledge UAN: 0286-0000-21-512-L04-P; CME 2.75; IACET 2.75; RN 2.75

Preregistration required and is an additional fee. Already registered? Log in to DIA's My Account>My Events.

Capturing clinical outcome assessment data electronically (eCOA) brings many benefits over traditional paper-based methodologies. However, uncertainty and barriers to adoption still remain. This may be due to challenges with poor experiences during study start-up, conduct or close out, absence of clear definitions of roles and responsibilities among sponsors and providers, and misalignment of expectations among all stakeholders. Scientific and regulatory thinking, particularly in relation to issues of translation of measures and comparability of modes of data collection, can also create significant confusion, not helped by the fact that recommendations relating to these topics are evolving over time. Finally, a whole new area of technology-driven outcomes, namely those supported by mobile sensors and wearable devices, is emerging, raising a host of new questions and challenges for study teams.

Topics covered include:
  • The benefits and basics of eCOA
  • Best practices for the implementation, deployment, and operations of eCOA from provider and sponsor perspectives
  • Introduction to the Getting Better Together Initiative
  • Defining roles and responsibilities in an eCOA study
  • Five phases of an eCOA study
  • Operational best practices
  • Scientific and regulatory principles underlying eCOA data
  • Faithful Migration
  • Translation
  • Comparability between modes of data collection
  • Bring Your Own Device
  • Wearables and mobile sensors
  • Important considerations during sensor or wearable selection
  • Preparing a protocol for the logistics of using a wearable device
  • Choosing the right wearable measurement
Need approval in order to attend? Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.
Enhance your experience and register for two or more short courses at the same time and receive $50 in savings. 
Purchase must happen at same time. Discount will be reflected on the last page of the cart.
Download Registration Form
Registration Questions? Send Email
1.888.257.6457 Return to DIA 2021 

Who should attend?

This short course is designed for individuals in the clinical operations, data science, outcomes research, data management, eCOA, mobile or sensor technologies and innovation groups at biopharmaceutical companies who are considering, or have begun, collection of eCOA and/or wearable data in clinical trials. eCOA provider staff and developers new to the field would also benefit from this course.

Learning Objectives

Describe best practices for implementation, deployment, and operations of eCOA studies; Discuss scientific and regulatory principles underlying eCOA data capture and the evolving thinking relating to translation and comparability between modes of data collection; Discuss the emerging science of wearables/mobile sensors, and how to get the most out of these data to support trial endpoints.


Instructors
avatar for Estelle Haenel

Estelle Haenel

Medical Director, Kayentis, France
avatar for Paul O'Donohoe

Paul O'Donohoe

Senior Director, eCOA Product and Science, Medidata Solutions, United States
Paul O’Donohoe is Senior Director, eCOA Product and Science at Medidata Solutions, a clinical software platform provider. He is responsible for providing strategic oversight of the development of Medidata's electronic clinical outcome assessment technologies, and supporting internal... Read More →
avatar for Jeremy Wyatt

Jeremy Wyatt

CEO, ActiGraph, United States
Jeremy Wyatt is the CEO of ActiGraph, a leading provider of motion-sensing wearable technology solutions for pharmaceutical and academic research. With two decades of embedded hardware systems development and related cloud technology expertise, Jeremy has a uniquely well-rounded perspective... Read More →
avatar for Katherine Zarzar

Katherine Zarzar

Head of Agile Execution, Patient-Centered Outcomes Research, Genentech, A Member of the Roche Group, United States
Kate Zarzar is a Principal PCOR Scientist and Head of Agile Execution focused on designing and delivering COA strategies at Roche. As head of Agile Execution, she focuses on leveraging agile methodology to improve how the business executes paper COA and eCOA strategies to generate... Read More →

Wednesday June 23, 2021 1:00pm - 4:00pm EDT
TBD Virtual Event Horsham, PA 19044
  02: ClinTrials -ClinOps, Tutorial |   19: Short Courses, Tutorial
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial

1:00pm EDT

034P: #034P: Best Practices for Business Communications: How to Communicate with Maximum Impact
Component Type: Tutorial
CE: ACPE 2.75 Application UAN: 0286-0000-21-513-L04-P; CME 2.75; IACET 2.75; PDU 2.75 PMI 21660N94F4; RN 2.75

Preregistration required and is an additional fee. Already registered? Log in to DIA's My Account>My Events.

Most people think they are effective communicators but how many of us are truly impactful in our communication? This short course will focus on the best practices for effective business communication using the mnemonic “CATCH’EM”:
  • Cut to the chase: Punchline comes first, followed by details or justifications
  • Anticipate your audience: Research them in advance to establish common ground or purpose
  • Talk to reach agreement; email to document agreement, not vice versa
  • Clarify your references: Don’t assume others understand your business or jargon
  • Hone your ask: Be specific on what you need from your audience, and set a deadline for response
  • Enthrall their attention: Use vivid language to illustrate to peak their interest
  • Maximize win-win: Make clear how your collaboration will help both parties

Real life examples will be discussed, and role play will be used to enforce concepts and deepen understanding.Need approval in order to attend? Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.
Enhance your experience and register for two or more short courses at the same time and receive $50 in savings.
Purchase must happen at same time. Discount will be reflected on the last page of the cart.
Download Registration Form
Registration Questions? Send Email
1.888.257.6457 Return to DIA 2021

Who should attend?

This short course is designed for business professionals looking to sharpen their communication skills.

Learning Objectives

Define awareness on different ways to communicate; Describe business and interpersonal communication.


Instructors
avatar for Donny Chen

Donny Chen

VP Medical Writing and Healthcare Communications, PPD, United States
Donny Chen, executive director of real world evidence at PPD, has spent 20+ years designing and spearheading observational research studies in a variety of therapeutic areas, with particular expertise in strategy, analysis and project management. Mr. Chen graduated Phi Beta Kappa... Read More →

Wednesday June 23, 2021 1:00pm - 4:00pm EDT
Virtual Event Virtual Event Horsham, PA 19044
  19: Short Courses, Tutorial |   13: ProfDevelopment, Tutorial
  • Credit Type ACPE, CME, IACET, PMI, RN
  • Tags Tutorial
 
Thursday, June 24
 

9:30am EDT

041A: #041A: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Effecting Pharmaceutical Development
Component Type: Tutorial
CE: ACPE 2.75 Knowledge UAN: 0286-0000-21-515-L04-P; CME 2.75; IACET 2.75; RN 2.75

Preregistration required and is an additional fee. Already registered? Log in to DIA's My Account>My Events.

Significant changes in Japanese pharmaceutical regulations and procedures are impacting the development of new drugs in Japan as well as global development programs. This short course will describe the major drivers of the regulatory system, including the Pharmaceuticals and Medical Devices Agency (PMDA) and Ministry of Health, Labor and Welfare (MHLW), regulatory procedures during drug development (consultations with PMDA and clinical trial notifications), the integration of Japanese drug development with East Asian and global drug development, orphan drug regulation, and J-NDA preparation and review. Several development strategies available to address Japanese requirements for new drug approval, as well as selected post-approval requirements, will be discussed.Need approval in order to attend? Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.
Enhance your experience and register for two or more short courses at the same time and receive $50 in savings.
Purchase must happen at same time. Discount will be reflected on the last page of the cart.
Download Registration Form
Registration Questions? Send Email
1.888.257.6457 Return to DIA 2021

Who should attend?

This short course is designed for professionals involved in regulatory affairs, project management, and clinical development who are involved with global development projects involving Japan.

Learning Objectives

Explain the major elements of the Japanese regulatory system; Describe the regulatory procedures during development, registration, and post-approval; Discuss specific attributes of the Japanese regulatory system and their impact on local and global development strategies.


Instructors
avatar for Alberto Grignolo

Alberto Grignolo

Corporate Vice President, Parexel, United States
Alberto Grignolo, PhD is a Corporate Vice President at Parexel, and established the firm's Japan Consulting Services during a two-year assignment in Tokyo. Dr. Grignolo has served as an adviser on human subject protection in clinical trials to the Institute of Medicine of the National... Read More →
avatar for Yoshiaki Uyama

Yoshiaki Uyama

Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Yoshiaki Uyama, PhD, is Director, Office of Medical Informatics and Epidemiology, for the Pharmaceuticals & Medical Devices Agency (PMDA), Japan. His experience in the safety review and assessment of new drugs for PMDA includes serving as the Review Director; as International Conference... Read More →

Thursday June 24, 2021 9:30am - 12:30pm EDT
Virtual Event Virtual Event Horsham, PA 19044
  19: Short Courses, Tutorial |   09: Regulatory, Tutorial
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial

1:00pm EDT

042P: #042P: Compliance by Design: Blockchain in Clinical Research and Drug Development
Component Type: Tutorial
CE: ACPE 2.75 Knowledge UAN: 0286-0000-21-516-L04-P; CME 2.75; IACET 2.75; RN 2.75

Preregistration required and is an additional fee. Already registered? Log in to DIA's My Account>My Events.

With any system used for clinical research, the technology must comply with current research laws, regulations, and statutes. However, blockchain developers and operators are often unfamiliar with clinical research regulations and related data and technology standards. Even for stakeholders aware of regulatory requirements, there is uncertainty about regulatory research interpretations applied to blockchain.

In this course, we will provide an overview of this emerging technology: how it is being used in healthcare and life sciences, where it is being explored for future use, how it operates from a non-technical perspective, and the risks, benefits, and trade-offs of its use in the lifesciences.

We will encourage researchers and administrators exploring blockchain applications to build regulatory compliance requirements into their processes so they can meet required controls and safeguards. Further, when blockchain systems are used to collect, store, and distribute data for research purposes, regulatory agencies also expect detailed compliance documentation, such as initial and ongoing testing, validation, methods for updates and upgrades, training, physical security, access controls, and policies that pertain to all of these things. Blockchain developers should also provide appropriate documentation to organizations using the technology for the organizations’ due diligence.

While our course focuses primarily on regulations in the United States, the concepts of patient-centric design, data integrity, appropriate informed consent, and privacy apply to all research settings. Ultimately, we aim to provide life sciences stakeholders with a stronger understanding of responsibilities for compliant implementation and typical uses.

No prior knowledge of blockchain technology is required for this short course.Need approval in order to attend? Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.
Enhance your experience and register for two or more short courses at the same time and receive $50 in savings.
Purchase must happen at same time. Discount will be reflected on the last page of the cart.
Download Registration Form
Registration Questions? Send Email
1.888.257.6457 Return to DIA 2021

Who should attend?

This short course is designed for: Lifescience leaders, researchers, regulators, administrators, technologists and informaticists. We assume a functional knowledge of lifesciences research and related regulations. We will provide a beginners-level look at this technology and how it can innovate and accelerate life sciences research.

Learning Objectives

Describe what blockchain is, how it operates from a non-technical perspective, and how it is currently being used in lifesciences research; Discuss approaches that regulatory agencies have taken toward blockchain technologies in contract, drug, and device development; Design documentation / testing strategies for IRB submissions, privacy laws, and electronic record/signature regulations.


Instructors
avatar for Wendy Charles

Wendy Charles

Chief Scientific Officer, BurstIQ, United States
Dr. Wendy Charles has been involved in clinical trials from every perspective for nearly 30 years with a strong background in operations and compliance of digital health technologies. She currently works as Chief Scientific Officer for a blockchain healthcare company where she leads... Read More →
avatar for Sean Manion

Sean Manion

Chief Scientific Officer, ConsenSys Health, United States
Sean Manion, PhD is a neuroscientist with two decades of federal brain research and leadership experience. He is the Chief Scientific Officer of ConsenSys Health, a start-up focused on the application of emerging technology (blockchain, decentralized machine learning, and privacy-preserving... Read More →

Thursday June 24, 2021 1:00pm - 4:00pm EDT
Virtual Event Virtual Event Horsham, PA 19044
  09: Regulatory, Tutorial |   19: Short Courses, Tutorial
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial
 
Friday, June 25
 

9:30am EDT

051A: #051A: Regulatory Submissions and Interactions with NMPA: What You Need to Know
Component Type: Tutorial
CE: ACPE 2.75 Knowledge UAN: 0286-0000-21-519-L04-P; CME 2.75; IACET 2.75; RN 2.75

Preregistration required and is an additional fee. Already registered? Log in to DIA's My Account>My Events.

New Drug Administration Law and more than 100 regulations, guidance, policies and implementing rules are effective in 2020. The framework for regulatory oversight of China’s National Medical Products Administration (NMPA) and NMPA’s Center for Drug Evaluation (CDE) has changed significantly in the decision-making for the supervision and administration of drugs, and in the evaluation of drug clinical trial applications, drug marketing authorization applications, supplementary applications, and overseas drug production registration applications. This short course will highlight most relevant requirements and regulatory strategy to submit IND/NDA in China and discuss how to interact with NMPA/CDE effectively in the submission and approval process. Need approval in order to attend? Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.
Enhance your experience and register for two or more short courses at the same time and receive $50 in savings.
Purchase must happen at same time. Discount will be reflected on the last page of the cart.
Download Registration Form
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1.888.257.6457 Return to DIA 2021

Who should attend?

Regulatory affair professionals, senior management executives, drug development professionals, project managers, clinical trial specialists, people investing in biotech product development projects, consultants and foreign regulators.

Learning Objectives

Define the drug regulatory system, reforms, and hot topics in China; Highlight the key elements of an IND and NDA application for a drug/biological product; Describe the accelerated regulatory pathways for the examination and approval of innovative drugs, e.g., oncology, orphan and cell/gene therapies; Discuss strategic considerations for the acceptance of global clinical data in China submissions; Review good practices for effective CDE interactions; Provide real-life case studies.


Speakers
avatar for Chang Lee

Chang Lee

Vice President, R &A APAC, Parexel International, United States
Have a unique experience in the combination of FDA medical reviewer, CRO and pharmaceutical-biotech industries for overall regulatory and clinical strategies in new drug development. Keep track of the new paradigm and best industry practices for product development and risk management... Read More →


Friday June 25, 2021 9:30am - 12:30pm EDT
Virtual Event Virtual Event Horsham, PA 19044
  19: Short Courses, Tutorial |   09: Regulatory, Tutorial
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial
 
Sunday, June 27
 

9:00am EDT

#ePosters: Professional and Student ePoster Gallery
Component Type: Poster Presentation
Level: Basic

Professional ePosters will be featured in an online gallery within the virtual meeting platform that is hosting DIA 2021. Attendees are invited to scroll through and search ePosters throughout the duration of virtual meeting. ePosters run continuously during the meeting. There are no formal or LIVE ePoster presentations during the DIA 2021 virtual meeting.
View our ePoster abstracts



Speakers
SD

Sahith Doppalapudi

Manager, Safety Data Management and Analytics, Bristol-Myers Squibb Company, United States
Sahith Doppalapudi, has graduated with masters degree in Chemical Engineering from Oklahoma State University, he has been part of the pharmaceutical industry for over 10 yrs in varying capacities such as Quality Analyst, Validation lead, Pharmacovigilance Data manager. Currently he... Read More →
avatar for Stephen Doogan

Stephen Doogan

Chief Product Officer, Real Life Sciences, Inc., United States
Stephen is a founding member of Real Life Sciences, Inc. (RLS), a software as a service company that automates the extraction, integration and analysis of unstructured patient data for life sciences organizations. Stephen brings over a decade of experience in natural language processing... Read More →
avatar for Magda Bujar

Magda Bujar

Manager, Strategic Development, Centre for Innovation in Regulatory Science (CIRS), United Kingdom
Dr Magda Bujar is Manager of Strategic Development at CIRS and has over 7 years’ experience working in Regulatory Policy and Science. In her current role, she is responsible for developing and executing strategies for engaging with pharmaceutical companies and major regulatory authorities... Read More →
avatar for Karen Roy

Karen Roy

Chief Strategy Officer, Phlexglobal, United Kingdom
Karen Roy has been responsible for the development of the TMF business at Phlexglobal since 2007, with a focus on creating solutions for our Clients’ TMF challenges. She started in Business Development, moving to Client Solutions, and now her focus is on strategy. In her role as... Read More →
avatar for Jorg Taubel

Jorg Taubel

Chief Executive Officer, Richmond Pharmacology, United Kingdom
avatar for Keith Wenzel

Keith Wenzel

Senior Director, Scientific Data Organization, Parexel International, United States
Mr. Wenzel has worked for Parexel for over fifteen years. His background includes product, corporate, and personnel management; sales and marketing; and information systems experience. These skills have been applied within the life sciences and health care industries through working... Read More →
avatar for Jenny Ly

Jenny Ly

Senior Scientific Advisor, ERT, United States
Jenny Ly is currently a Senior Clinical Science Advisor at ERT. She is a neuropsychologist with over 15 years of experience in the management and design of clinical trials. She has extensive experience consulting on best practices for eCOA design/implementation and developing training... Read More →
avatar for Krystle Pianka

Krystle Pianka

Associate Director, Global Strategic Management Office, Otsuka Pharmaceutical Development & Commercialization, Inc., United States
Krystle Pianka is an experienced public health professional, having 14 years of experience in research and pharmaceutical industries with 10 years in global pharmacovigilance (GPV). She received her bachelor’s degree from the University of Pennsylvania in Biological Basis of Behavior... Read More →
avatar for Philip Schneider

Philip Schneider

Chair, Advisory Board, Alliance for Safe Biologic Medicines, United States
Philip J. Schneider is founder and principal of MediHealthInsight, which provides consultation to the industry and others on matters related to improving the use of medicines including the application of new technologies in healthcare. He is also Chair of the International Advisory... Read More →
avatar for Jennifer Cichone

Jennifer Cichone

Director, GPV Strategic Management Office, Otsuka Pharmaceutical Development and Commercialization Inc., United States
Jennifer Cichone joined Otsuka Development & Commercialization (OPDC) as Director in Global Pharmacovigilance in 2013. She has experience in Pharmacovigilance for the past 17 years, specifically in the aggregate reporting and risk management plans space. In addition, Jennifer is a... Read More →
avatar for Kelly Dumais

Kelly Dumais

Senior Scientific Advisor, ERT, United States
Kelly is a Senior Scientific Advisor at ERT, a global data and technology company that helps minimize risk in clinical trials. She has extensive experience in electronic clinical outcome assessments (eCOA) and the development and validation of patient reported outcomes (PROs) to support... Read More →
avatar for Kim Olsen

Kim Olsen

Associate Director, Global Regulatory Policy and Intelligence, Global Regulatory, Janssen Research and Development, United States
Kim Olsen is an Associate Director of Regulatory Policy and Intelligence for the Janssen Pharmaceutical Companies of Johnson and Johnson. Her primary responsibilities are providing intelligence to support the regulatory leaders. Kim has spent most of her career at Janssen, most recently... Read More →
avatar for Valerie Powell

Valerie Powell

Vice President, Research Services, Healthivibe, A Division of Corevitas, LLC, United States
Valerie Powell has over 30 years of experience in the pharmaceutical space and an advanced degree in Instructional and Performance Technology. She leads a team of Research Specialists in conducting a range of qualitative and quantitative research methodologies to uncover insights... Read More →
avatar for Yunjung Shin

Yunjung Shin

Student, Rutgers University, United States
A fifth year pharmacy student at Rutgers University, Ernest Mario School of Pharmacy. Passionate about research.
avatar for Timothy Kline

Timothy Kline

Manager, Global Regulatory Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, United States
A tactful, methodical, self-starter programmed to change the trajectory of human health by investing in the talent of tomorrow (former professor, mentor to at-risk youth, and Big Brother); infusing science and curiosity into dynamic regulatory topics; and advocating for equitable... Read More →
KE

Kathryn Evans

Associate Clinical Scientist, WCG Analgesic Solutions, United States
Kathryn Evans MS, MPH, uses her background in epidemiology and biostatistics to inform clinical trial research, monitoring, and outcomes analyses. She also manages medical communications and publications.
avatar for Annie Ly

Annie Ly

Project Assistant, University of Southern California, United States
Annie Ly, M.S. ‘21, is currently pursuing a Master of Science degree in Regulatory Science. Annie completed her Bachelor of Arts in Health and Human Sciences with a minor in English at USC. She has been conducting research in the Department of Regulatory and Quality Sciences within... Read More →
avatar for Kelsey Lee

Kelsey Lee

Post-Doctoral Fellow, Global Medical Affairs Oncology, Bayer Healthcare Pharmaceuticals, Inc., United States
avatar for Christian Reyes

Christian Reyes

Undergraduate Research Associate, USC Department of Regulatory Science, United States
Christian Reyes is currently a fourth-year undergraduate student at the University of Southern California pursuing a degree in Pharmacology and Drug Development at the USC School of Pharmacy. In addition, he is also completing a Master of Science degree in Regulatory Science at the... Read More →
avatar for Cammilla Horta Gomes

Cammilla Horta Gomes

LATAM Regulatory Policy Lead, Roche, Brazil
Specialist in Global Health and Health Regulation, with a Master’s Degree in Development and International Cooperation. Broad experience in regulatory policy, both as regulator and industry, leading or contributing to bilateral and multilateral negotiations, harmonization and convergence... Read More →
avatar for Truc Dinh

Truc Dinh

Senior Manager, Global Medical Information, Gilead Sciences, Inc.
Truc Dinh is a Senior Manager in Global Medical Information at Gilead Sciences where she is responsible for managing global medical information content for the COVID-19 and Liver Diseases therapeutic areas. She received a Bachelors of Art degree in Public Health and Public Policy... Read More →
avatar for Marie-Ange Noue

Marie-Ange Noue

Senior Director, Head of Scientific Communications, EMD Serono, Canada
Marie-Ange Noue is a PhD chemist trained at Curie University in Paris and at the University of Houston. She started her career working as a research scientist in petrochemicals. She later found her niche upon joining EMD Serono in 2008, where she’s held a number of positions of... Read More →
KF

Kimberly Fuller

Director, Case Management Operations, Bristol-Myers Squibb Company, United States
Kim is a Director of Case Management Operations at Bristol Myers Squibb. Kim has 14 years of Pharmacovigilance experience working in Phase I through post-market, with a particular focus on small biotech and immuno-oncology. Kim has experience in all aspects of case management activities... Read More →
avatar for Sagar Shah

Sagar Shah

Global Medical Information Manager, Sanofi, United States
JK

Jason Krastein

ORISE Fellow, ORDPURM, OND, CDER, FDA, United States
TF

Thomas Finnegan

Director, CNS Clinical Strategist, Medscape Education, United States
Thomas received his PhD in neuroscience from the Penn State College of Medicine in 2006. Following his graduate studies, he began his career in medical education at Curatio CME Institute, where he started as medical writer. Over the next 7 years, Thomas was responsible for the development... Read More →
avatar for Samuel Poryanda

Samuel Poryanda

Consultant, ConvergeHEALTH By Deloitte, United States
Samuel Poryanda is a consultant on the Expert Services team at ConvergeHEALTH by Deloitte. In this role, he specializes in leveraging technology and real-world data within the healthcare ecosystem to improve patient engagement and outcomes. Prior to joining Deloitte, Sam managed Phase... Read More →
avatar for Alexandra Thoenes

Alexandra Thoenes

Project Safety Physician, Pharmacovigilance, UBC, Switzerland
MF

Maria Florez

Research Consultant, Tufts Center For the Study of Drug Development, Tufts Medical School, United States
Maria Florez is a research consultant affiliated with the Tufts Center for the Study of Drug Development. Her research looks at the impact of digital transformation in clinical research; practices, strategies and incentives driving improvements in the pharmaceutical R&D process; and... Read More →
SR

Sandeepa Raina

Director, IT Business Partner, WorldWide Patient Safety, Bristol-Myers Squibb Company, United States
Sandeepa Raina is IT Business Partner, Worldwide Patient Safety, at BMS. In her role, Sandeepa is responsible for aligning systems and service strategies with business goals and objectives to ensure business outcomes are realized. Her main goal is to create value by transforming complex... Read More →
VK

Vikas Kumar

Senior Data Scientist, OMNY Health, United States
Dr. Vikas Kumar is a Senior Data Scientist at OMNY Health in Atlanta, GA.
LR

Lawrence Rasouliyan

Head, Biostatistics & Data Science, OMNY Health, United States
avatar for Neil Kapil

Neil Kapil

Associate Director, Clinical Safety Strategy and Solutions, WW Patient Safety, Bristol-Myers Squibb Company, United States
Neil Kapil is a licensed pharmacist with over 10+ years of experience within the community, clinical, and pharmaceutical industry settings with a great understanding of Public Health, Regulatory, Medical, and Pharmacovigilance disciplines.
avatar for Yafei Zhang

Yafei Zhang

PostDoc Fellow, Merck & Co., Inc., United States
avatar for Brian Cohn

Brian Cohn

Director of Research, ObvioHealth, United States
Dr. Cohn is a Computational Biologist and NSF Graduate Fellow who focuses on creative digital applications in healthcare. He currently is the Director of Research at ObvioHealth, a vCRO. His portfolio of work extends across clinical research firms, hospital networks, and biotechnology... Read More →
avatar for Arianna Burton

Arianna Burton

Senior Manager, US Medical Affairs, Rare Disease, Pfizer Inc, United States
avatar for Christopher Torres

Christopher Torres

Strategic Planning and Integration Lead, Bristol-Myers Squibb Company, United States
YZ

Yan Zhang

Senior Manager, Oncology Epidemiology, Bristol-Myers Squibb Company, United States
Yan Zhang is an epidemiologist at BMS. Her research is around drug safety and effectiveness. Right now Yan's therapy area is cancer immunotherapy.
WO

William O'Brien

Senior Director, Medical Safety Assessment Physician, Bristol-Myers Squibb Company, United States
William O'Brien MD, MS is Sr. Director, Medical Assessment Physician, Fibrosis at BMS. He previously accomplished several seminal advances in HIV pathogenesis and treatment, including the first report to demonstrate the need for HIV coreceptors (O’Brien et al., Nature 1990), the... Read More →
avatar for Julie O'Brien

Julie O'Brien

Director Global Regulatory Policy and Intelligence, Pfizer Inc, Ireland
Julie is a regulatory affairs professional specialising in international regulatory policy with impact to innovative medicines. She focuses on advancing science-based regulatory policy, including in the area of global regulatory system strengthening. In her role, she implements strategic... Read More →
avatar for Erica Lee

Erica Lee

undergraduate researcher, University of Southern California, United States
Erica Lee, B.S. '22, is a third year undergraduate student at the University of Southern California pursuing a Bachelor of Science in Pharmacology and Drug Development. She is a Provost Research Fellow in the Department of Regulatory and Quality Sciences within the USC School of Pharmacy... Read More →
XG

Xabier García De Albéniz

Director, Research Triangle Institute HS, Spain
avatar for Angela Wagner

Angela Wagner

Biomedical Writing Graduate Student, University of the Sciences, United States
Angela Greeley Wagner is a recent graduate of the Biomedical Writing MS program at the University of the Sciences in Philadelphia. Her experience in healthcare spans 14 years and encompasses a variety of roles from health information management to product development. She has a particular... Read More →
avatar for Viola Brown

Viola Brown

Graduate Student, Temple University, United States
I am Viola Brown, a Professional Science Masters student in Scientific Writing at Temple University in Philadelphia. My passion for scientific communication stems from wanting patients to receive the best possible medical care by applying health literacy principles. As a caregiver... Read More →
avatar for Sitong Liu

Sitong Liu

postgraduate, Peking University, China
Sitong Liu graduated from Shenyang Pharmaceutical University and is studying for master degree in Peking University Health Science Center.She focuses on hospital pharmacy and drug rational use,and she is also studying drug policy and clinical use.
avatar for Griffin Riggs

Griffin Riggs

Research Assistant, University of Southern California, United States
avatar for Qian Bai

Qian Bai

PhD Candidate, University of Macau, Macao
Qian Bai, a PhD candidate in University of Macau, Institute of Chinese Medical Sciences. My current research fields include hospital efficiency evaluation, health policy evaluation, disease economic burden and population health with statistical approaches. I hope to explore the econometric... Read More →
DL

Dongmin Ling

Masters Student, University of Macau, Macao
Dongmin Ling 2019.9-Now, postgraduate, University of Macau, majoring in Medicinal Administration, from State Key Laboratory of Quality Research of Chinese Medicine. interested in Public Health, Policymaking, and statistics. 2015.9-2019.6, undergraduate, Shanghai Ocean University... Read More →
avatar for Stephen Drehobl

Stephen Drehobl

Student, Temple University, United States
Stephen Drehobl is a first-year graduate student in Temple University's Scientific Writing P.S.M. program. As a documentary filmmaker and science journalist, he uses his communication skills to educate non-scientists about public health topics. A science communicator and Health Justice... Read More →
avatar for Victoria Ramirez

Victoria Ramirez

Research Assistant, Temple University, United States
Victoria Ramirez is a graduate student in Temple University's Scientific Writing PSM program. She is a full-time research assistant and graduate of Temple's Honors Program with a B.S. in Biology. Victoria has gained hands-on experience in laboratory experiments, field studies, and... Read More →
avatar for Xinyu Ke

Xinyu Ke

Student, Institute of Chinese Medical Sciences, University of Macau, Macao
Interested in Costing Study & Efficiency Evaluation for Health Science and Marketing Study for Medical & Pharmaceutical Services. Thrived in fast-paced deadline driven environment and getting things done. Curious learning new things and absorbing new ideas. A graduate and an adventurer... Read More →
TH

Tali Homsey

Regulatory Manager, University of Southern California, United States
My name is Tali Homsey, and I live in Los Angeles, CA. I graduated from CSU Northridge with a B.A. in Psychology and completed a Post-Baccalaureate Pre-Medicine program at Loyola Marymount University. Over the past 7 years, I have coordinated and managed 50+ clinical research studies... Read More →
avatar for Deanna Rubin

Deanna Rubin

Postdoctoral Fellow, UNC Eshelman School of Pharmacy, United States
I am currently a first year Global Regulatory Affairs Fellow with UNC/GSK. Originally from Miami Beach, I obtained my bachelor's from the University of Maryland and my PharmD from UNC. Since beginning my fellowship, I have been supporting GSK's oncology assets throughout all phases... Read More →
avatar for Tyler Fukunaga

Tyler Fukunaga

PharmD and MS Regulatory Science Candidate 2023, University of Southern California, United States
Tyler Fukunaga is a PharmD and MS in Regulatory Science candidate at the University of Southern California. His current research focuses on evaluating Alzheimer’s Disease pharmacotherapy clinical development failure from the perspective of clinical trial design. Tyler hopes to pursue... Read More →
avatar for Rachel Brunner

Rachel Brunner

Drug Information Pharmacy Resident, University of Illinois-Chicago, College of Pharmacy, United States
Rachel received her BS in Neuroscience from the University of Michigan and went on to attend the University of North Carolina, where she received her PharmD. Post-graduation, she completed a general health system pharmacy residency at Northwestern Memorial Hospital in downtown Chicago... Read More →
avatar for Ivar Van Der Zee

Ivar Van Der Zee

MSc Student, Utrecht University, Netherlands
Ivar is a first-year master's student enrolled in the Drug Innovation programme at Utrecht University. Within this programme he mainly focusses on regulatory affairs, an interest he discovered during his previous studies in Innovation Sciences. Currently Ivar's research is centred... Read More →
avatar for Carly Yang

Carly Yang

Student, University of Southern California, United States
Carly Yang is a rising senior at the University of Southern California majoring in Pharmacology and Drug Development with a minor in Substance Abuse. She is an undergraduate researcher at the USC School of Pharmacy International Center for Regulatory Science, conducting research on... Read More →
KG

Kelsey Genda

Student Researcher, University of Southern California, United States
Kelsey is a senior studying Pharmacology & Drug Development at the University of Southern California and is also pursuing her MS in Regulatory Science. Her research project centers around the current regulatory landscape for dietary supplements.
avatar for Emily Donahue

Emily Donahue

Student Researcher, University of Southern California, United States
Emily Donahue is a rising senior majoring in Pharmacology and Drug Development, with a minor in Legal Studies and is originally from Lake Tahoe, NV. She is currently a pre-law student and is planning on pursuing a career in patent law. On-campus Emily is involved in Undergraduate... Read More →
avatar for Sunyoung (Stacy) Uhm

Sunyoung (Stacy) Uhm

Student Researcher, USC, United States
Stacy Uhm, B.A. ‘21 is a student researcher at the University of Southern California (USC) School of Pharmacy with a Bachelor of Arts in Psychology and minor in Health Care Studies. Having been the Co-Assistant Director of the Asian Pacific American Student Assembly of USC, she... Read More →
MA

Moyra Aziz

Post-Doctoral Fellow, Novartis Pharmaceutical Corporation, United States
SN

Sumit Nagpal

Director Digital Insights and Data Governance, Bristol-Myers Squibb Company, United States
OB

Omer Baker

Regulatory Science Student Researcher, University of Southern California, United States
avatar for Debu Baruah

Debu Baruah

Business Title Mgr, Software Development, IQVIA, India
Debu Moni Baruah's background spans the fields of clinical data management, research, marketing, and data analytics. He is lean six sigma black-belt certified and led many key innovation projects with a major focus on the areas of people, process, and technology in CROs and technology... Read More →
avatar for Jane Snowdon

Jane Snowdon

Associate Chief Health Officer, IBM Watson Health, United States
Dr. Jane L. Snowdon is Associate Chief Health Officer and heads operations of the Center for Artificial Intelligence, Research and Evaluation at IBM Watson Health. Previously, Jane managed global efforts to design and implement research evaluation studies for IBM’s life sciences... Read More →
LH

Lloryn Hubbard

Associate Director, Diversity and Inclusion in Clinical Trials, PPD, United States
With more than 10 years of clinical operations experience, Lloryn has made ensuring diverse populations are represented in clinical trial research a priority throughout her career. As a project lead for Health Equity and Population Science, she has led several efforts at Genentech... Read More →
SD

Susan Dallabrida

Vice President of Clinical Science and Consulting, ObvioHealth, SPRIM Global, United States
avatar for Raymond Huml

Raymond Huml

Vice President, Medical & Scientific Management, Head, Rare Disease Consortium, Syneos Health, United States
Raymond A. Huml, MS, DVM, RAC is Vice President of Medical and Scientific Strategy and Head of Syneos Health’s Rare Disease Consortium. Dr. Huml has over 30 years of experience in the clinical and biopharmaceutical industries and over 20 years in the Contract Research Organization... Read More →
BS

Bradley Smith

Vice President, Translational Medicine, IQVIA, United States
Brad Smith is a leader in the development and implementation of biomarkers, companion diagnostics and novel technologies in laboratory and clinical research. His expertise includes technical, scientific, regulatory and business aspects of biomarker use gained from 20 years of experience... Read More →
avatar for Nancy Sherman

Nancy Sherman

Clinician, Post-Approval Clinical Development, Biopharmaceuticals Group, Pfizer Inc, United States
Nancy Ann Sherman is a Director, Clinician at Pfizer Inc, in the Post-Approval Commitment Clinical Development group of . She has over 25 years experience developing and conducting clinical trials across a broad range of therapeutic areas, study phases and global regions of the w... Read More →
DW

David Walsh

Statistician, Unlearn.Ai, United States
David Walsh is a statistician at Unlearn.AI. He is working to develop novel statistical methods, which improve the efficiency of clinical trials.
JC

Jessica Cerullo Merrill

Vice President, VOZ Advisors, United States
Jessica has a strong background in communications and policy having started her career at government relations and public affairs firms. She also has experience in uniting diverse stakeholders around mutual goals through alliance-development, advocacy and relationship building. At... Read More →
TT

Tim Turnham

Vice President, VOZ Advisors, United States
As Vice President of VOZ Advisors Tim works with pharmaceutical and biotech companies to understand and engage with patients and patient advocacy groups. Prior to his time at VOZ, Tim spent most of his career in the non-profit space and has twenty years experience in the healthcare... Read More →
BH

Benjamin Holmes

Senior Clinical Data Analyst, Syapse, United States
Benjamin Holmes is a data scientist and machine learning practitioner, passionate about developing and implementing tools to allow insights into complex data, and using those tools to fuel discovery and action. His career has fueled an appreciation for the transformative power of... Read More →
AS

Alejandro Schuler

Statistician, Unlearn.Ai, United States
Data scientist and biostatistician with expertise in the intersection of causal inference, machine learning, and health data. I hold a Ph.D. in Biomedical Informatics from Stanford University, where I worked with Professors Nigam Shah, Rob Tibshirani, and others to develop methods... Read More →
avatar for Don Lazas

Don Lazas

Chief Medical Officer, ObjectiveGI, United States
Dr. Lazas is a physician leader specializing in the care of digestive diseases with over 25 years of experience in patient care, healthcare management & delivery, clinical research, and entrepreneurial innovation. He is the co-founder and Chief Medical Officer of the transformative... Read More →
SK

Sujith Kurup

Director, Software Development, IQVIA, India
SN

Sinead Nally

Clinical Development Director, Novartis, Ireland
Sinéad Nally is a Clinical Development Director with experience across Phase II/III clinical trials across several neuroscience programs. Prior to working with Novartis, Sinéad worked as the Clinical Program Manager for the National Children's Research Centre, Ireland. Sinéad has... Read More →
SR

Samuel Ramsden

Head of Risk Management Office, Boehringer Ingelheim International Gmbh, Germany
Samuel is currently Head of the Risk Management Office in Global Pharmacovigilance at Boehringer Ingelheim, located in Germany. He is responsible for processes and best practice within the company related to all aspects of the global risk management system. Before joining Boehringer... Read More →
avatar for Thomas Coquelle

Thomas Coquelle

Principal Clinical Project Manager, LEO Pharma A/S, Denmark
With more than 20 years experience in Clinical Research, I am working in the innovative space for transforming the conventional approach of clinical trials to implement new technologies hereunder working with decentralized clinical trials. During my career I have has multiple positions... Read More →
avatar for Mads Christensen

Mads Christensen

R&D Project Manager, LEO Pharma A/S, Denmark
Experienced IT Project Manager with a demonstrated history of working in the pharmaceuticals industry. Strong research professional skilled in Clinical Development, Trial Management, GxP, Quality Assurance, Biomedical Engineering, IT Project Management and Pharmaceutical Industry... Read More →
BD

Brian Dreyfus

Senior Director, Bristol-Myers Squibb Company, United States
Solid Tumor Oncology Epidemiology Lead at Bristol Myers Squibb.
avatar for Keira Ledger

Keira Ledger

Associate Director, Regulatory Affairs, Syneos Health, United Kingdom
avatar for Debu Baruah

Debu Baruah

Business Title Manager, Software Development, IQVIA, India
Debu Moni Baruah's background spans the fields of clinical data management, research, marketing, and data analytics. He is lean six sigma black-belt certified and led many key innovation projects with a major focus on the areas of people, process, and technology in CROs and technology... Read More →
avatar for Mabel Crescioni

Mabel Crescioni

Director, Public Health & Outcomes Research, Hemophilia Federation of America, United States
Mabel Crescioni is currently Director of Public Health and Outcomes Projects at the Hemophilia Federation of America (HFA), where she leads a patient-focused interdisciplinary team of researchers examining issues affecting the bleeding disorder community. Mabel is also a Professor... Read More →
avatar for Lisa Kim

Lisa Kim

Director of Capstone / Lecturer, Rutgers School of Health Professions, United States
Lisa Palladino Kim, is the Director of Capstone (Field Mentorship) and a Lecturer at Rutgers School of Health Professions MS in Clinical Research Management Program. Lisa has 15 yrs of Pharmaceutical expertise, concentrated in Clinical Ops (Pt Recruitment, Data Mgt, and Project Mgt... Read More →
avatar for Debra Schaumberg

Debra Schaumberg

Vice President, Epidemiology & Head Strategic and Scientific Affairs, Evidera | PPD, United States
Debra Schaumberg is Vice President, Epidemiology and Head, Strategic & Scientific Affairs at Evidera, a business unit of PPD. An internationally recognized expert in epidemiology and ophthalmology, she brings >25 years of experience in clinical research, designing and leading research... Read More →
MS

Michelle Shogren

Head of Innovation Portfolio and Operations, Bayer, United States
Michelle is the Sr. Director of Innovation in Pharma R&D Clinical Operations at Bayer. She has over 20 years of experience in Clinical Research across many different roles. She began her journey as a research nurse and site director. From there she became a Clinical Research Associate... Read More →
avatar for Yafei Zhang

Yafei Zhang

PostDoc Fellow, Merck & Co., Inc., United States


Sunday June 27, 2021 9:00am - Thursday July 1, 2021 5:00pm EDT
TBD Virtual Event Horsham, PA 19044

11:00am EDT

#001 L: Student and Young Professional Forum
Component Type: Workshop
Level: Basic

This one hour interactive session will utilize prerecorded materials about the current state of the drug industry and jobs outlooks, as well as a live session with panelist who will share with students and young/new/emerging professionals their career paths and tips for securing those “first jobs” and answer questions from participants.

Chair

Nancy Pire Smerkanich, DrSc, MS

Speaker

Facilitator
Margaret Richards, PhD, MPH

Facilitator
Kenneth Hu, PharmD, MBA



Speakers
avatar for Nancy Smerkanich

Nancy Smerkanich

Assistant Professor Regulatory & Quality Sciences, University of Southern California School of Pharmacy, United States
Dr. Smerkanich has her doctorate and is an Assistant Professor in the Department of Regulatory and Quality Sciences at the University of Southern California. She leads the clinical/regulatory courses while continuing to provide regulatory knowledge support to her academic and industry... Read More →
avatar for Kenneth Hu

Kenneth Hu

Senior Manager (US Regulatory Lead), Global Regulatory Strategy and Policy - Onc, Bristol Myers Squibb, United States
Kenneth is a US Regulatory Lead and former Fellow with the Rutgers Pharmaceutical Industry Fellowship Program. As a Fellow he supported Regulatory Science and Policy, Strategy, and Advertising and Promotion across I&I, oncology, and primary care while also gaining insight into digital... Read More →
avatar for Margaret Richards

Margaret Richards

Senior Research Leader, Real World Evidence, Evidera, United States
Dr. Meg Richards has nearly 30 years' experience as an epidemiologist in the public health, biotech/pharmaceutical, and contract research sectors. Dr. Richards currently serves as a Senior Research Leader in Real-World Evidence at Evidera by PPD. Prior to rejoining the PPD family... Read More →


Sunday June 27, 2021 11:00am - 12:00pm EDT
TBD Virtual Event Horsham, PA 19044
  13: ProfDevelopment, Workshop

1:00pm EDT

#002 L: Resume Workshop
Component Type: Workshop
Level: Basic

This interactive workshop will introduce students and young/new/emerging professionals to the fundamentals of resume/CV writing skills. Participants will be able to understand the difference between a resume and a curriculum vitae. The workshop will also discuss components of an effective document; action verbs, transferable skills, KSAs, value-added bullet points, etc. Common mistakes and information to not include on the documents due to legal considerations and self-protection from identity theft will also be discussed.

Learning Objectives

Share their resume/CV for a peer review after the presentation; Discuss questions during and after the peer review session.

Chair

Kristen Felthousen, MS

Speaker

Facilitator
Nancy Pire Smerkanich, DrSc, MS



Speakers
avatar for Kristen Felthousen

Kristen Felthousen

Program Administrator, Department of Regulatory and Quality Sciences, University of Southern California School of Pharmacy, United States
Kristen Felthousen has more than 15 years of experience in HR, higher education, teaching, training and development. She earned her MS in HR Development from Rochester Institute of Technology. For the past 13 years, she has focused on career, professional and leadership development... Read More →
avatar for Nancy Smerkanich

Nancy Smerkanich

Assistant Professor Regulatory & Quality Sciences, University of Southern California School of Pharmacy, United States
Dr. Smerkanich has her doctorate and is an Assistant Professor in the Department of Regulatory and Quality Sciences at the University of Southern California. She leads the clinical/regulatory courses while continuing to provide regulatory knowledge support to her academic and industry... Read More →


Sunday June 27, 2021 1:00pm - 2:00pm EDT
TBD Virtual Event Horsham, PA 19044
  13: ProfDevelopment, Workshop
  • Featured Topics Student Programming
  • Tags Workshop

3:00pm EDT

#002.5 L: Interviews: The Obvious and Not-So-Obvious Tips
Component Type: Workshop
Level: Basic

A fun, interactive workshop focused on making interviewing easy for you. Learn tips on preparation, answering interview questions, following up, and evaluating the job offer.

Learning Objectives

Discuss some tips to make interviews easy from preparation, interviewing, following up, and evaluating the job offer.

Speaker

Facilitator
Denise McNerney



Speakers
avatar for Denise McNerney

Denise McNerney

Partner, Global Life Sciences Alliance (GLSA), United States
Denise has over 25 years of experience in Business, Marketing, and Technology in the life sciences industry. Her entrepreneurial spirit coupled with her knowledge and resources has led her to build several businesses, processes, and teams. During that time, she has launched new products... Read More →
avatar for Nancy Smerkanich

Nancy Smerkanich

Assistant Professor Regulatory & Quality Sciences, University of Southern California School of Pharmacy, United States
Dr. Smerkanich has her doctorate and is an Assistant Professor in the Department of Regulatory and Quality Sciences at the University of Southern California. She leads the clinical/regulatory courses while continuing to provide regulatory knowledge support to her academic and industry... Read More →


Sunday June 27, 2021 3:00pm - 4:00pm EDT
TBD Virtual Event Horsham, PA 19044
  13: ProfDevelopment, Workshop
  • Featured Topics Student Programming
  • Tags Workshop

4:00pm EDT

#003 L: Networking: Understand Yourself and Others for Career Success
Component Type: Workshop
Level: Intermediate

This workshop will focus on how to network based on personality type. Myths about who makes a better networker will be discussed and dispelled. The breadth of our networks will be demonstrated.

Learning Objectives

Describe the reasons for networking; Identify personality types and their impact on networking; Discuss how to dispel networking myths.

Chair

Chris Matheus, MBA

Speaker

Networking for Career Success; Know yourself
Heather Hollick, MBA, MSc



Speakers
avatar for Chris Matheus

Chris Matheus

President, Matheus BD Connections LLC, United States
Chris has over 20 years of experience in clinical research business development. He has focused on clinical trial technologies while working in large CROs and smaller eclinical companies. Chris establishes strong working relationships with customers and co-workers and has built a... Read More →
avatar for Heather Hollick

Heather Hollick

Teacher, Writer, Coach, Rizers, United States
Heather Hollick has been helping others become better leaders and craft more meaningful careers for more than 25 years. Her experience spans both business and technology, operations and organizational development. Oh, and she was born in Canada, so she can't help but be helpful... Read More →


Sunday June 27, 2021 4:00pm - 5:15pm EDT
TBD Virtual Event Horsham, PA 19044
 
Monday, June 28
 

10:00am EDT

#100 SL: DIA Global Annual Meeting - Opening DIAmond and Plenary Session
Component Type: Session
CE: ACPE 1.25 Knowledge UAN: 0286-0000-21-668-L04-P; CME 1.25; IACET 1.25; RN 1.25

We are excited to welcome you to the DIA 2021 Virtual Global Annual Meeting
Join us for the Global Annual Meeting Welcome Remarks, Keynote Address, and Opening DIAmond Session!

Keynote Address: Kenneth Frazier, JD, Chairman of the Board and Chief Executive Officer, Merck & Co.
For most of us, the novel coronavirus represents an unprecedented time in our lives. However, history is full of accounts of humans grappling with viral invaders, and the positive innovations and learnings that we derive from these circumstances. Ken Frazier, Chairman and CEO of Merck, reflects on the discoveries that were made during pandemics of the past and their durable effects on science and society. Mr. Frazier also discusses the adaptations and accelerations required to develop vaccines and therapeutics to address the current pandemic, and their implications for the future of drug development. The lasting transformations of the COVID-19 pandemic may yet to be fully characterized, but we know they will be documented in the history books.

Opening Plenary Panel: Combating Misinformation in Health and Health Care
The COVID-19 era has been characterized by a strong anti-science bias among large swaths of the public in many countries. This includes those who deny the existence of COVID; those who oppose vaccines based on spurious science, correlation that does not reflect causality, or an unsupported belief that vaccines are untrustworthy or harmful; those who believe that science comes from an elite that may not have the best interests of the general public at heart; and many others.

All of these beliefs pose significant challenges to public health efforts to contain the spread of COVID and encourage widespread vaccination. The problem is compounded by the tremendous amounts of misinformation that have been circulating since the beginning of the pandemic. This misinformation has been promulgated through many channels, particularly on social media. While reputable sources have made many attempts to remove or discredit such information, these efforts have been far from successful. People also continue to receive misinformation from family, friends, and public figures.
The panel will address the following high-level topics:
  • How does misinformation about health and health care spread? Why do people believe it?
  • What do we know about how to successfully help people identify and question misinformation?
  • Who is best positioned to counter misinformation about COVID, and what do we know about how to do so effectively?
  • Are there specific approaches to combating misinformation that can help address known disparities in health and health care, particularly those that are COVID-related?


Learning Objectives

Identify two ways in which misinformation about health and health care spread; Identify one way in which to counter misinformation about COVID-19 effectively; Describe how known disparities in health and health care relate to the spread of misinformation about COVID-19.

Chair

Barbara Lopez Kunz, MBA, MS, MSc

Speaker

Opening Remarks
Judith Ng-Cashin, MD

Honorary Co-Chair
Emer Cooke, MBA, MSc

Honorary Co-Chair
Janet Woodcock, MD

Honorary Co-Chair
Yasuhiro Fujiwara, MD, PhD

Introduction of Keynote Speaker
Michael Rosenblatt, MD

Keynote Speaker
Kenneth Frazier, JD

Moderator: Combating Misinformation in Health and Health Care
Susan C. Winckler, JD, RPh

Panelist
Briony Swire-Thompson

Panelist
Brian Southwell, PhD

Panelist
Melanie Carr

Panelist
Richardae Araojo, PharmD, MS



Speakers
avatar for Barbara Lopez Kunz

Barbara Lopez Kunz

Global Chief Executive, DIA, United States
Barbara Lopez Kunz serves as President and Global Chief Executive of DIA, driving thought leadership and innovation in therapeutic development to improve the health of people worldwide. She previously served as President of Health and Life Sciences at Battelle, one of the world’s... Read More →
avatar for Emer Cooke

Emer Cooke

Chair, ICMRA; Executive Director, European Medicines Agency, Netherlands
Ms Cooke was nominated as Executive Director with a renewable five-year mandate by the Agency’s Management Board on 25 June 2020 and is the first woman at the helm of EMA. "I take up the role of Executive Director of EMA amid a public health crisis of unprecedented scale,” said... Read More →
avatar for Janet Woodcock

Janet Woodcock

Acting Commissioner, FDA, United States
Dr. Janet Woodcock began her long and distinguished FDA career in 1986. In 1994, Dr. Woodcock was named Director of the CDER, overseeing the center’s work that is the world’s gold standard for drug approval and safety. In that position, she has led many of the FDA’s groundbreaking... Read More →
avatar for Yasuhiro Fujiwara

Yasuhiro Fujiwara

Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. FUJIWARA Yasuhiro has been Chief Executive, PMDA since April 2019. He is a medical oncologist, specializing in breast cancer. He was previously Director-General, Strategic Planning Bureau of the National Cancer Center, and the Deputy Director of the Hospital (Research), National... Read More →
avatar for Michael Rosenblatt

Michael Rosenblatt

Chief Medical Officer, Flagship Pioneering, United States
Michael Rosenblatt, MD, Chief Medical Officer of Flagship Pioneering, has advanced academic and biopharmaceutical research and development throughout his career. He was previously Chief Medical Officer for Merck, after serving as Dean of Tufts Medical School. Formerly, he was Ebert... Read More →
avatar for Kenneth Frazier

Kenneth Frazier

Chairman of the Board and Chief Executive Officer, Merck & Co., Inc., United States
Kenneth C. Frazier has served as the Chairman of the Board and Chief Executive Officer of Merck & Co., Inc. since 2011. Under Ken’s leadership, Merck is delivering innovative lifesaving medicines and vaccines as well as long-term and sustainable value to its multiple stakeholders... Read More →
avatar for Susan Winckler

Susan Winckler

Chief Executive Officer, Reagan-Udall Foundation for the FDA, United States
Prior to accepting the post at the FDA’s Foundation in May of 2020, she served as President of Leavitt Partners Solutions. She advised corporate executives on policy and business matters. As CEO of the Food & Drug Law Institute, she provided attorneys, regulators, industry leaders... Read More →
avatar for Brian Southwell

Brian Southwell

Senior Director, Science in the Public Sphere, Center for Communication Science, RTI International, United States
Dr. Brian Southwell is Senior Director of the Science in the Public Sphere Program in the Center for Communication Science at RTI International. He also is Adjunct Professor and Duke-RTI Scholar with Duke University and a graduate faculty member at the University of North Carolina... Read More →
avatar for Briony Swire-Thompson

Briony Swire-Thompson

Senior Research Scientist, Lazer Lab, Northeastern University Network Science Institute, United States
Briony Swire-Thompson is a Senior Research Scientist in the Lazer Lab, and fellow at Harvard University’s Institute for Quantitative Social Science. Her research investigates what drives belief in inaccurate information, why certain individuals are predisposed to refrain from belief... Read More →
avatar for Melanie Carr

Melanie Carr

Head of Stakeholders and Communication Division, European Medicines Agency, Netherlands
Melanie Carr is Head of the Stakeholders and Communication Division and a member of the Executive Board at the European Medicines Agency (EMA). She joined EMA in 1996 and has held various roles in pharmacovigilance, the centralised procedure for marketing authorisation, orphan medicines... Read More →
avatar for Richardae Araojo

Richardae Araojo

Associate Commissioner for Minority Health, Director, Office of Minority Health, FDA, United States
RADM Richardae Araojo serves as the Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity at the U.S. Food and Drug Administration. In this role, she provides leadership, oversight, and direction on minority health, health disparity... Read More →
avatar for Judith Ng-Cashin

Judith Ng-Cashin

Chief Medical Officer, Eagle Pharmaceuticals, United States
Judith Ng-Cashin, MD, is currently the Chief Medical Officer at Eagle Pharmaceuticals, leading R&D across the development pipeline and marketed products. Prior to this role, she served as CMO for AOBiome Therapeutics, leading end-to-end asset development strategy, medical governance... Read More →


Monday June 28, 2021 10:00am - 11:45am EDT
TBD Virtual Event Horsham, PA 19044
  00: Plenary, Session |   14: DIAmond, Session

12:00pm EDT

#101 CH L: Results from a Survey of Biopharmaceutical on Attitudes Towards the Use of Wearables and Sensors in Clinical Research
Component Type: Workshop
Level: Intermediate

We will present the results of a survey of 146 individuals currently working for pharmaceutical or biotech companies including phases and therapeutic areas holding the most promise and perspectives on internal versus CRO conducted research. Space is limited. When the virtual room is full, attendees attempting to access the session will receive a message noting that the session has reached maximum capacity.

Learning Objectives

Share the results of a recent survey of biopharma around the use of wearables and sensors; Elicit feedback from Content Hub attendees to hear differing opinions and/or to confirm the survey's findings; Educate attendees about biopharma's expectations with respect to wearables and sensors in clinical research.

Chair

Keith Wenzel
Julia Lakeland


Speakers
avatar for Julia Lakeland

Julia Lakeland

Senior Director,Sensor Solutions, Parexel, United Kingdom
Julia is a Product Director at PAREXEL who is passionate about improving the patient experience within the Clinical Trial. She has 20 years experience in industry and plays a key role in identifying and understanding market problems, managing the product portfolio life cycle and leading... Read More →
avatar for Keith Wenzel

Keith Wenzel

Senior Director, Scientific Data Organization, Parexel International, United States
Mr. Wenzel has worked for Parexel for over fifteen years. His background includes product, corporate, and personnel management; sales and marketing; and information systems experience. These skills have been applied within the life sciences and health care industries through working... Read More →


Monday June 28, 2021 12:00pm - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044

12:00pm EDT

#102 CH L: How to Share Individual Patient-Level Data Safely for Pharma Innovation
Component Type: Workshop
Level: Basic

Attendees will be presented with a fictional scenario and will learn about the different decisions which can determine the safety and defensibility of a patient-level data-sharing strategy. Space is limited. When the virtual room is full, attendees attempting to access the session will receive a message noting that the session has reached maximum capacity.

Learning Objectives

Recognize the importance of engaging in clinical data-sharing; Compare the various avenues through which clinical data can be shared; Identify statistical anonymization as an approach which can demonstrably protect patient privacy while preserving utility.

Chair

Niamh Catherine McGuinness, PhD


Speakers
avatar for Niamh McGuinness

Niamh McGuinness

Clinical Trial Transparency Anonymization Expert, Privacy Analytics, Canada
Niamh McGuinness is a technical lead with Privacy Analytics’ Clinical Trial Transparency (CTT) business unit, having joined the company in 2016. Her team specializes in statistical anonymization of clinical trial assets - both structured individual patient data and clinical trial... Read More →


Monday June 28, 2021 12:00pm - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044

12:00pm EDT

#105 IT: IQVIA Innovation Theater: Redefining Patient Engagement and Recruitment Beyond 2021
Component Type: Session
Level: Intermediate

The past 16 months have redefined the relationship between patients and clinical research. Patient engagement has never been more front and center – and we must rise to the occasion. This session will explore new approaches to recruitment and retention using the latest AIML technology, EMR data and commercial patient insights applied to clinical development programs.

Chair

IQVIA


Speakers
avatar for IQVIA

IQVIA

IQVIA, United States
avatar for Becky Johnson

Becky Johnson

Associate Director, Global Patient & Site Solutions, IQVIA, United States
In her current role at IQVIA, Becky is accountable for the strategic direction of communication initiatives to support recruiting, engaging and retaining patients in clinical trials. Becky leverages her 20 years of experience in the biopharmaceutical industry and expertise in diversity... Read More →
avatar for Katie Shaw

Katie Shaw

Senior Director, Global Patient and Site Solutions, IQVIA, United States


Monday June 28, 2021 12:00pm - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044

12:00pm EDT

#104 IT: Syneos Health Innovation Theater: Accelerating Clinical Trial Recruitment - A New Path To Speed Enrollment
Component Type: Session
Level: Intermediate

The operational expense of trials is both direct and opportunity. Reducing those costs often hinges on a key variable: speed to enrollment. The unique data and media environment in the high-impact, high-competition US market gives us the ability to bend the curve of typical enrollment by increasing the number of trial candidates via an underutilized channel. In this presentation, Syneos Health will introduce and share cases about Digital Amplifier, an important lever in enrolling trials faster.

Chair

Syneos Health


Speakers
avatar for Syneos Health

Syneos Health

United States
avatar for Brooke Belk

Brooke Belk

Vice President, Program Strategy - Kinetic, Syneos Health, United States
Brooke Belk is an experienced digital strategy leader with more than a decade of expertise in omnichannel customer engagement. She specializes in reaching niche audiences, right where they are, with the right message, at the right time. As a VP of Program Strategy for Kinetic, TM... Read More →
avatar for Claire Riches

Claire Riches

SVP Global Client Solutions, Syneos Health, United Kingdom
Claire is an industry veteran with over 25 years experience in the clinical, peri/post approval and commercial arena. Having worked in large pharma, biotech and CRO settings, Claire currently oversees strategic partnerships at Syneos Health with a clear remit of bringing innovation... Read More →


Monday June 28, 2021 12:00pm - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044

12:00pm EDT

#103 IT: Advanced Clinical Innovation Theater: Decentralized Clinical Trials: The Wave of the Future
Component Type: Session
Level: Intermediate

The impact of COVID-19 on clinical trials has been substantial. For example, travel bans and site closures have forced a rapid shift in the running of physical clinical investigative sites toward purely virtual environments. While the concept of virtual clinical trials has been around for a number of years, the decision to actually run a trial has remained somewhat optional. Now, sponsors are now finding themselves forced into either fully virtualized trials and/or hybrid trials, out of necessity. However, there are silver linings – especially when it comes to the potential for adapting quickly to unforeseen situations like remaining efficient and profitable amidst a pandemic. We will explore how the required adoption of virtual recruiting, telemedicine, remote monitoring and at-home healthcare visits have taught us valuable lessons about how to run more agile and adaptive trials; and how these learnings will shape the future of R&D.

Learning Objectives

Describe how COVID-19 has impacted trial operations across the globe; Discuss how trial sites have adapted through the use of virtual trial elements; Identify the challenges both sponsors and CROs have faced in this process - and how to overcome them.

Chair

Advanced Clinical


Speakers
avatar for Advanced Clinical

Advanced Clinical

United States
avatar for Graham Belgrave

Graham Belgrave

SVP, European Operations, Advanced Clinical, United Kingdom
A graduate of Warwick University, Graham Belgrave has 36+ years of experience leading pharmaceutical development across Clinical Operations (Phases I-IV), Outsourcing & Contract Management, Project, Program and Vendor Management. After starting his career in clinical operations, Mr... Read More →
avatar for Domantas Gurevicius

Domantas Gurevicius

Sr. Director, Clinical Monitoring, Advanced Clinical, United States
Domantas is a highly experienced, knowledgeable, and driven Clinical Monitoring professional responsible for leading and managing the North American Clinical Monitoring functional area at Advanced Clinical. Domantas’ 12+ years of clinical research industry experience includes direct... Read More →


Monday June 28, 2021 12:00pm - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044

12:00pm EDT

#105.1 NTW: Meet the DIA Fellows
Component Type: Forum

Stop in our themed lounge and SEE who you meet!

Our featured topic lounges are all about networking and working the "virtual meeting room". These lounges can accommodate up to 40 attendees and are designed for attendees to speak out loud and for cameras to be on.

Chair

Barbara Lopez Kunz, MBA, MS, MSc


Speakers
avatar for Barbara Lopez Kunz

Barbara Lopez Kunz

Global Chief Executive, DIA, United States
Barbara Lopez Kunz serves as President and Global Chief Executive of DIA, driving thought leadership and innovation in therapeutic development to improve the health of people worldwide. She previously served as President of Health and Life Sciences at Battelle, one of the world’s... Read More →
avatar for Rebecca Vermeulen

Rebecca Vermeulen

Vice President Patients and Society Strategy Lead Product Development, Hoffmann-La Roche Ltd., United States
Rebecca Vermeulen, RPh, brings a variety of experiences to her role as VP of Strategy for Patients and Society, Product Development, at Hoffman La Roche. She has served in numerous functions including Medical Affairs, Clinical Research, Sales, Medical Communications, Medical Science... Read More →


Monday June 28, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044

12:30pm EDT

#106 IT: Anju Software Innovation Theater: Utilizing Adaptive Technology Systems to Get the Most from Decentralized Trials
Component Type: Session
Level: Intermediate

Harnessing technology will help you transition from traditional trials to hybrid/decentralized trials. This presentation will share insights on how technology can assist you with country/investigator selection, gain a complete view of your trials from multiple data sources, design a hybrid monitoring strategy, reduce study set-up time, and minimize cost and disruption during mid-study protocol amendments.

Chair

Anju Software


Speakers
avatar for Laura Acosta

Laura Acosta

Vice President of Product Management, eClinical, Anju Software, United States
Laura Acosta is Vice President of Product Management and is responsible for the product direction of the eClinical suite at Anju Software. Laura has 23+ years of experience providing software products to the Life Sciences industry. Laura has played many roles in that time including... Read More →
avatar for Kim Rejndrup

Kim Rejndrup

SVP of Development, Anju Software, United States
Kim joined Anju Software with the acquisition of OmniComm Systems, which he had been at since 2017, managing the eClinical Suite's product development. His expertise in clinical operations software is driving Anju’s products to new levels of innovation. Prior to Anju, Kim gained... Read More →
avatar for Anju Software

Anju Software

Anju Software, United States


Monday June 28, 2021 12:30pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044

12:30pm EDT

#107 IT: UBC Innovation Theater: Critical Components for Successful Vendor Selection: CRO, PV, Registries and REMS Services
Component Type: Session
Level: Intermediate

Before the selection of important safety, clinical development and late stage vendors, it’s paramount to understand what is the best match for your company. Join this session to understand how Consultants can improve the overall experience of working with a CRO; and discuss how consultants can help problem solve your companies challenges and the importance of the appropriate vendor selection.

Chair

UBC


Speakers
avatar for Elizabeth Delmaestro

Elizabeth Delmaestro

Pharmacovigilance Consultant, EDM Pharma Consulting, LLC, United States
Elizabeth Delmaestro is an independent consultant and a dynamic, forward-thinking pharmacovigilance leader with a unique blend of “big pharma” and small biotech experience. Ms. Delmaestro’ s experience in pharmacovigilance activities span from development through regulatory... Read More →
avatar for Natalie O'Donnell

Natalie O'Donnell

Corporate Vice President, REMS, Safety and Strategic Engagement, UBC, United States
Mrs. O’Donnell leads the UBC REMS SERRM team that develops REMS strategies, develops REMS and REMS Supporting Documents and leads the REMS evaluations. As the Corporate Vice President, REMS, Safety and Strategic Engagement, she is responsible for UBC Pharmacovigilance, designs REMS... Read More →
avatar for UBC

UBC

United BioSource Corporation, United States


Monday June 28, 2021 12:30pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044

12:30pm EDT

#108 IT: Deloitte (ConvergeHEALTH) Innovation Theater: Automating Adverse Event Case Processing Through Machine Learning and Innovation
Component Type: Session
Level: Intermediate

Adverse Event (AE) collection, assessment and reporting is a foundational activity of Sanofi’s pharmacovigilance and license to operate. With 600K+ AE cases expected annually, it is an intensive, manual, expensive, and time-consuming activity. Hear about Sanofi’s success with case processing automation via natural language processing, machine learning and artificial intelligence with Deloitte’s ConvergeHEALTH Safety Cognitive Platform. And the benefits of using cloud-based automation technology.

Chair

Deloitte


Speakers
avatar for Amanda Bowles

Amanda Bowles

Managing Director, Deloitte Consulting LLP, United States
Amanda has over 13 years of life sciences experience including over 10 years specializing as a pharmacovigilance and drug safety systems subject matter advisor. Amanda has in depth experience in drug safety, pharmacovigilance and regulatory affairs, including extensive experience... Read More →
avatar for Glenn Carroll

Glenn Carroll

Principal, Deloitte Consulting LLP, United States
Glenn Carroll is a principal in our life science strategy practice with over 15 years pharmaceutical and biotech experience. Glenn leads Deloitte's US Safety and Medical practices. He has a strong track record in delivering strategic and operational excellence, specifically in the... Read More →
avatar for Deloitte

Deloitte

United States
avatar for Stephen Kuske

Stephen Kuske

Global Pharmacovigilance Operations Head, Sanofi, United States
avatar for Anand Ramanathan

Anand Ramanathan

Global Pharmacovigilance ITS Head, Sanofi, United States


Monday June 28, 2021 12:30pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044

12:30pm EDT

#109 SC L: Solution Circle: QPPV Perspective on Brexit - Is Your Pharmacovigilance System Compliant?
Component Type: Session
Level: Intermediate

Brexit has brought about changes in pharmacovigilance requirements for products authorized in the United Kingdom. Get a perspective from a qualified person for pharmacovigilance in the European Union (EU-QPPV) and the United Kingdom (UK-QPPV) on the guidance about new regulations, their impact on established pharmacovigilance systems and processes, impact of Brexit on pharma industry, major challenges related to MAH, QPPV and PV system in North Ireland and lessons learned by the Pharmaceuticals.

Chair

APCER Life Sciences


Speakers
avatar for Frank Laschewski

Frank Laschewski

QPPV, APCER Life Sciences, United Kingdom
Frank Laschewski is a physician specialised in internal medicine with 8 years of clinical experience in a university hospital and 20 years of experience in pharmaceutical industry covering medical affairs and all areas of pharmacovigilance. He started his career in pharmaceutical... Read More →
avatar for Sameen Wasif

Sameen Wasif

UK QPPV, APCER Life Sciences, United Kingdom
Ms. Sameen Wasif has eight years of overall experience in pharmacovigilance. She transitioned from clinical biochemistry and started her career with APCER Life Sciences in October 2012. Over the years, she has been involved in various aspects of pharmacovigilance including management... Read More →
avatar for Kanwalpreet Kaur

Kanwalpreet Kaur

Senior Safety Lead & QPPV Physician Suport, APCER Life Sciences, United Kingdom
Dr. Kanwalpreet Kaur is a physician by qualification and has 14 years of overall experience in clinical practice, healthcare operations, and PV. She has managed simple to complex projects and actively participated in training and compliance, process improvement and thought leadership... Read More →


Monday June 28, 2021 12:30pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044

12:30pm EDT

#110 SC L: Solution Circle: Where Do We Go From Here? DCTs and Patient Centricity Post-COVID-19
Component Type: Session
Level: Intermediate

Join us to discuss lessons learned from the COVID-19 pandemic and how they'll shape the future of patient centricity and decentralized clinical trials. We'll review DCT strategies used as risk mitigation tactics over the past year, and how we can use this adoption to drive the future of patient centric clinical research.

Chair

Accellacare In-Home Services


Speakers
avatar for Michael Keens

Michael Keens

Executive Director, Sales Strategy, Accellacare In-Home Services, United States
Michael has over 20 years of experience in clinical trial operations, decentralised and hybrid clinical trials, business development, global home health, and patient advocacy to drive innovation in drug development. Mike served as Chief Commercial Officer and later as Chief Operating... Read More →
avatar for Jodie Huddleston

Jodie Huddleston

Vice President, Accellacare In-Home Services, United States
Jodie Huddleston, Vice President of Accellacare In-Home Services at ICON plc, has over 25 years of experience in clinical trials leadership in translational research, clinical strategy, business development and clinical operations. Prior to joining ICON, Jodie was the Senior Director... Read More →


Monday June 28, 2021 12:30pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044

1:00pm EDT

#111 SL: COVID-19 Real-World Data Analysis and Vaccine Surveillance: Examples from FDA and The Danish Medicines Agency’s Approaches
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-522-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will include presentations of the Danish Medicines Agency's COVID-19 cohort data analyses, the FDA’s N3C Data Enclave and the vaccine surveillance on COVID-19 patients using real-world data (RWD) from registries as examples of regulatory use of RWD during the COVID-19 pandemic.

Learning Objectives

Describe the novel use of real-world data (RWD) during the COVID-19 pandemic; Describe, discuss, and evaluate the different opportunities and challenges in use of RWD given different healthcare settings and access to healthcare data.

Chair

Jesper Kjær, MS

Speaker

DAC COVID: Exemplified by the Most Recent Analysis on Post-Acute Effects of Covid 19
Stine Hasling Mogensen, MPharm

Arterial Events, Venous Thromboembolism, Thrombocytopenia, and Bleeding After Vaccination in Denmark and Norway: Population-Based Cohort Study
Anton Pottegaard, DrSc, PhD, MPharm

Off-Label Use Monitoring Through Danish Registries
Mona Vestergaard Laursen, MPharm

FDA Real-World Evidence Activities Related to Covid19
Mitra Rocca, MSc

COVID-19 Real-World Data Analysis and Vaccine Surveillance: Examples from FDA and Their Novel Approach to Rapid Safety Surveillance
Richard Forshee, PhD



Speakers
avatar for Jesper Kjær

Jesper Kjær

Head of Danish Medicines Agency’s Data Analytics Centre, Danish Medicines Agency (DKMA), Denmark
Director of Data Analytics Centre at the Danish Medicines Agency and co-chair of HMA / EMA Big Data Steering Group. 20 years for life science experience in academia and industry. Been leading EU framework programme workpackages, IMI and TransCelerate Biopharma workstreams in the past... Read More →
avatar for Richard Forshee

Richard Forshee

Associate Director for Analytics and Benefit-Risk Assessment, CBER, FDA, United States
Richard Forshee is the Acting Deputy Office Director for the Office of Biostatistics and Epidemiology in the Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration. He works on a wide range of issues related to the risks and benefits of blood and blood... Read More →
avatar for Mona Vestergaard Laursen

Mona Vestergaard Laursen

Senior Advisor, Data Analytics Centre, Danish Medicines Agency, Denmark
SH

Stine Hasling Mogensen

Senior Scientific Advisor, Danish Medicines Agency, Denmark
Stine Mogensen holds a M.Sc. degree in Pharmacy (2010) and a PhD in Clinical Cancer Research, within drug development from Copenhagen University (2017). She has worked in the Danish Medicines Agency since 2017 and has been located in the Data Analytics Centre since 2019 after 2 years... Read More →
avatar for Anton Pottegaard

Anton Pottegaard

Head of Research at the Hospital Pharmacy; Professor, University of Southern Denmark, Denmark
avatar for Mitra Rocca

Mitra Rocca

Associate Director, Medical Informatics, Office of Translational Science, CDER, FDA, United States
Mitra Rocca joined FDA in 2009 as the Senior Medical Informatician responsible for developing the health information architecture of the Sentinel System. She leads the FDA CDER Health Information Technology board and serves as the medical informatics expert at CDER. Prior to joining... Read More →


Monday June 28, 2021 1:00pm - 2:00pm EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Forum

1:00pm EDT

#113 SL: Technology Changes Needed to Manage Drug Supply for Decentralized Trials
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-524-L04-P; CME 1.00; IACET 1.00; RN 1.00

Interact with drug supply industry experts during a lively panel discussion focused on how technology can enable decentralized trials.

Learning Objectives

Discuss what to consider when planning decentralized trials; Describe how to use technology to enable smarter decentralized trials; Describe lessons learnt from industry experts.

Chair

Stefan Dürr, MBA, MSc

Speaker

Panelist
Aman Thukral, MPharm, MS

Panelist
Nina Vas

Panelist
Harald van Weeren, DrSc, MS



Speakers
avatar for Stefan Dürr

Stefan Dürr

Senior Director, Client Delivery Head of Drug Supply Center of Excellence, Cendiut - an IQVIA business, Switzerland
Stefan has worked in the IRT for 16+ years and has been with Cenduit since its inception in 2007 and with IQVIA since 2019. He worked in various project management roles including leading the global project management team at Cenduit. Stefan currently is responsible for client delivery... Read More →
avatar for Aman Thukral

Aman Thukral

Director, Global Head-Digital Operations and Clinical Systems, AbbVie, Inc., United States
Aman Thukral is the Head of Clinical Systems and Digital Operations at AbbVie. In this position, Aman is responsible for leading clinical systems such as EDC, IRT, ePRO, CDR, Medical Coding. Also, he manages the implementation and roll-out of novel digital technologies at AbbVie... Read More →
avatar for Nina Vas

Nina Vas

Vice President, Clinical Distribution, Cell and Gene Supply Chain, Marken, Switzerland
Nina Vas is Marken’s Vice President, Clinical Distribution, Cell & Gene Supply Chain and focuses on leading Marken’s global GMP depot network as well as its fast-growing cell and gene division. She oversees their global GMP network and Marken's designated Centers of Excellence... Read More →
HV

Harald van Weeren

Team Lead Segment Management, Berlinger, Switzerland
Harald van Weeren is Segment Manager Clinical Trials and Team Lead Segment Management at Berlinger & Co. AG. He has 15 years of experience in Product Management and Market Segment Management in various high-tech industries. Harald has a PhD in physics from the University of Twente... Read More →


Monday June 28, 2021 1:00pm - 2:00pm EDT
TBD Virtual Event Horsham, PA 19044
  02: ClinTrials -ClinOps, Forum
  • Beginner Intermediate
  • Featured Topics Patient Focused
  • Credit Type ACPE, CME, IACET, RN
  • Student Programming Patient Focused
  • Featured Topics Patient Focused
  • Tags Forum

1:00pm EDT

#115 SL: Patient-Centric Engagement Strategies
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-526-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will provide insights on stakeholder engagement for clinical trials from beginning to end by identifying and incorporating the best tools and resources to support a shift toward virtual research. Recognizing the need to keep patients engaged, the session will propose a framework to support patient adherence for digital health technologies, as well as identify communication tools to support recruitment. Additionally, the session will identify avenues to collect patient input on study design that overcome potential internal barriers to patient engagement.

Learning Objectives

Provide insights on stakeholder engagement for clinical trials from beginning to end; Recognize the need to keep patients engaged using a framework to support patient adherence for digital health technologies; Identify avenues to collect patient input on study design that overcome potential internal barriers to patient engagement.

Chair

Kristina Bowyer

Speaker

Community Voices in Research (CVR): A Patient-Centric Approach to Study Design Phase Through Community Research Network
Rosaura P Vidal, MPH

Managing Patient Adherence for Digital Devices
Aman Thukral, MPharm, MS

Communicating at the Speed of 0-17K: Facilitating Rapid Research Recruitment in a Pandemic
Jennifer Cook, MPH



Speakers
avatar for Kristina Bowyer

Kristina Bowyer

Vice President, Patient Centric Drug Development, Ionis, United States
Kristina Bowyer joined Ionis in 1992 and currently serves as the Vice President of Patient Centric Drug Development. She founded Ionis’ Patient Advocacy program 2012 to ensure that the patient perspective is incorporated into every aspect of drug development including market authorization... Read More →
avatar for Aman Thukral

Aman Thukral

Director, Global Head-Digital Operations and Clinical Systems, AbbVie, Inc., United States
Aman Thukral is the Head of Clinical Systems and Digital Operations at AbbVie. In this position, Aman is responsible for leading clinical systems such as EDC, IRT, ePRO, CDR, Medical Coding. Also, he manages the implementation and roll-out of novel digital technologies at AbbVie... Read More →
avatar for Rosaura Vidal

Rosaura Vidal

Clinical Research Education Specialist, National Hemophilia Foundation, United States
Rosaura Vidal, MPH, is a Clinical Research Education Specialist at The National Hemophilia Foundation (NHF). In her current role she develops & designs educational content for the CVR platform; a patient-powered registry, and manages NHF’s Community Research Network consisting of... Read More →
JC

Jennifer Cook

Study and Project Engagement Specialist, Duke Clinical Research Institute, United States
Jennifer Cook, MPH, is a clinical research communications project manager on the DCRI's Research Communications & Engagement team. She has over 25 years of experience in healthcare communication and research including politics and policy, community engagement, ethics, global health... Read More →


Monday June 28, 2021 1:00pm - 2:00pm EDT
TBD Virtual Event Horsham, PA 19044
  02: ClinTrials -ClinOps, Session |   05: Patient Engagement, Session

1:00pm EDT

#112 SL: Measuring Clinically Meaningful Change of Function: A Case Study of Patient-Centered Clinical Outcome Assessments in Early Parkinson’s Disease
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-532-L04-P; CME 1.00; IACET 1.00; RN 1.00

The FDA has been encouraging patient-focused drug development and, as part of that, incorporating patients into the development of clinical outcomes assessments (COAs) to ensure that they are meaningful to patients and appropriate to measure treatment benefit.

Outcome assessments used in clinical trials need to fit the needs of multiple stakeholders; it is beneficial to engage with multiple stakeholders throughout the development/modification of COAs.

Panelists will discuss the need for patient-centred measures to capture a clinically meaningful effect of an intervention in the context of early Parkinson's disease.

Learning Objectives

Describe how to better incorporate patient viewpoints into both legacy clinical outcome assessment (COA) measures and novel instruments (with the case of early Parkinson's disease as illustration); Define more informed COA strategies based on FDA's current thinking and approach; Discuss the state FDA’s PFDD program.

Chair

Thomas Morel, DrSc

Speaker

Panelist
Karlin Schroeder, MA

Panelist
Michelle Campbell, PhD

Panelist
Roger Barker, MD, PhD



Speakers
avatar for Thomas Morel

Thomas Morel

Director, Patient-Centred Outcomes Research, UCB Biopharma, Belgium
Thomas Morel (DrSc) is Director for Patient-Centred Outcomes Research, Global Clinical Development at UCB. Through his role, Thomas ensures that the patient perspective is at the very heart of drug development by promoting the use in clinical trials of PROs and of clinical outcome... Read More →
RB

Roger Barker

Professor, Department of Clinical Neurosciences, Cambridge University, United Kingdom
Roger Barker is the Professor of Clinical Neuroscience at the University of Cambridge and Consultant Neurologist at the Addenbrooke’s Hospital Cambridge. He is a PI in the MRC-Wellcome Trust Stem Cell Institute in Cambridge and Director of the MRC funded UKRMP Stem and Engineered... Read More →
avatar for Michelle Campbell

Michelle Campbell

Senior Clinical Analyst for Stakeholder Engagement, ON, OND, CDER, FDA, United States
Michelle Campbell is the Sr. Clinical Analyst for Stakeholder Engagement and Clinical Outcomes in the Office of Neuroscience, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Previously, Dr. Campbell was a reviewer... Read More →
avatar for Karlin Schroeder

Karlin Schroeder

Associate Vice President, Community Engagement, Parkinson's Foundation, United States
Karlin Schroeder, M.A., is the Associate Vice President of Community Engagement at the Parkinson’s Foundation, where she leads the Research Advocacy program. Through this program, Karlin creates and directs projects to incorporate patient expertise into research design and implementation... Read More →


Monday June 28, 2021 1:00pm - 2:00pm EDT
TBD Virtual Event Horsham, PA 19044
  02: ClinTrials -ClinOps, Forum |   09: Regulatory, Forum
  • Beginner Intermediate
  • Featured Topics Patient Focused
  • Credit Type ACPE, CME, IACET, RN
  • Student Programming Patient Focused,Patient Focused
  • Featured Topics Patient Focused,Patient Focused
  • Tags Forum

1:00pm EDT

#119 SL: FDA Perspectives on Modernization of Clinical Trials: Clinical Practice Data, Decentralized Trials, Digital Health Technologies
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-530-L04-P; CME 1.00; IACET 1.00; RN 1.00

This forum will discuss FDA efforts to modernize clinical trials using clinical practice data, decentralized clinical trials and the inclusion of digital health technologies. FDA experts will provide their perspectives regarding 21 CFR 11. Join us for a student-led follow up round table discussion (session #250.1 RT L) on Tuesday, June 29, 3:00PM - 4:00PM EDT.

Learning Objectives

Design and conduct clinical trials using clinical practice data; Discuss the latest developments on decentralized clinical trials for their implementation; Identify how to plan for the inclusion of digital health technologies for remote data acquisition in clinical trials; Discuss how to consider the application of 21 CFR 11 in the conduct of modern clinical trials.

Chair

Elizabeth Kunkoski, MS

Speaker

Panelist
Leonard Sacks, MD

Panelist
Heather Stone, MPH

Panelist
Isaac R Rodriguez-Chavez, MHS, PhD, MS



Speakers
avatar for Elizabeth Kunkoski

Elizabeth Kunkoski

Health Science Policy Analyst, OMP, CDER, FDA, United States
Beth Kunkoski currently works in the FDA’s Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP). She oversees several projects involving digital health technologies and electronic records and storage in clinical investigations. She worked for 15 years in... Read More →
avatar for Isaac Rodriguez-Chavez

Isaac Rodriguez-Chavez

Senior Vice President, Scientific and Clinical Affairs, Head, Global COE, PRA Health Sciences, United States
Dr. Isaac R. Rodriguez-Chavez is a biomedical and regulatory leader with expertise in Infectious Diseases, Viral Immunology, Viral Oncology, Microbiology, and Vaccinology. His experience covers the entire life cycle of medical products from basic, preclinical, interventional clinical... Read More →
avatar for Leonard Sacks

Leonard Sacks

Associate Director for Clinical Methodology, Office of Medical Policy, CDER, FDA, United States
Leonard Sacks is an Associate Director for Clinical Methodology in the Office off Medical Policy, CDER, FDA, where he has worked on integrating IT opportunities into drug development. He has extensive experience with clinical trials, both as a clinical investigator and subsequently... Read More →
avatar for Heather Stone

Heather Stone

Health Science Policy Analyst, Office of Medical Policy, CDER, FDA, United States
Ms. Stone received her undergraduate degree from Smith College and her masters in public health (epidemiology) from the University of Maryland's School of Public Health. Her research focus is on the creation of policies that will encourage drug development for infectious diseases... Read More →


Monday June 28, 2021 1:00pm - 2:00pm EDT
TBD Virtual Event Horsham, PA 19044
  02: ClinTrials -ClinOps, Forum |   09: Regulatory, Forum

1:00pm EDT

#114 SL: Machine Learning Enabled Digital Data Flow and Advanced Real-World Evidence
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-525-L04-P; CME 1.00; IACET 1.00; RN 1.00

In this session, our experience in implementing AI driven solutions that established a digital data flow and how it improved cycle times will be discussed along with an approach to advanced real-world evidence using artifical intelligence, non-tradional data sources, and linkage. We will also discuss an enterprise-level real-world evidence/real-world data framework for data driven decision making in pharma and healthcare.

Learning Objectives

Describe digital data flow in clinical trials; Discuss advanced real-world evidence and artificial intelligence; Describe ontology and dynamic linking of data for enterprise-wide insights.

Chair

Prasanna Rao

Speaker

Machine Learning Enabled Digital Data Flow
Prasanna Rao

Enterprise-Level Real-World Evidence/Real-World Data Framework For Data-Driven Decision Making In Pharma and Healthcare
Reena Gollapudy, PhD

Advanced Real World Evidence: Artificial Intelligence, Non-Traditional Data Sources, and Linkage
Dan Riskin, MD, MBA



Speakers
avatar for Prasanna Rao

Prasanna Rao

Head, Artificial Intelligence and Data Science, Pfizer Inc, United States
Prasanna Rao is an AI practitioner and Industry Thought Leader whose current role is the Head of Artificial Intelligence and Data Science for Data Management and Monitoring at Pfizer. He has over 25 years of experience in Information technology and Analytics, with 10 years in Healthcare... Read More →
avatar for Dan Riskin

Dan Riskin

Chief Executive Officer, Verantos, United States
Dan Riskin is Chief Executive Officer of Verantos and Adjunct Professor of Surgery and Adjunct Professor of Biomedical Informatics Research at Stanford University. Dr. Riskin is an expert in healthcare artificial intelligence and successful serial entrepreneur. Products he has developed... Read More →
RG

Reena Gollapudy

Senior Director, Real World Data/Evidence and Advanced Data Analytics, Indegene Inc., United States


Monday June 28, 2021 1:00pm - 2:00pm EDT
TBD Virtual Event Horsham, PA 19044
  04: MedAffairs-SciComm, Session |   03: Data-Data Standards, Session

1:00pm EDT

#121 SL: Statistical Considerations with the Patient in Mind
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-523-L04-P; CME 1.00; IACET 1.00; RN 1.00

Expand your statistical toolkit by learning some innovative approaches that will lead to improved interventions for patients.

Learning Objectives

Discuss how to pave the way towards personalized medicine with generalized pairwise comparisons; Identify how to predict patient-reported outcomes after hip and knee replacement surgeries with examples in super learning; Describe the implications of using recurrent episodes in a rare disease setting.

Chair

Matt Baldwin, MS

Speaker

Predicting Patient-Reported Outcomes After Hip and Knee Replacement Surgeries: Examples in Super Learning
Maciej Maruszczak, MSc

Implications of Using Recurrent Episodes: Statistical Considerations in a Rare Disease Setting
Hengrui Sun, DrPH, MD

Generalized Pairwise Comparisons: Paving the Way Towards Personalized Medicine
Vaiva Deltuvaite-Thomas, MS



Speakers
avatar for Matt Baldwin

Matt Baldwin

Senior Biostatistician, Advance Research Associates, Inc (ARA), United States
Matt Baldwin is a Senior Biostatistician who works with Advance Research Associates to advance clinical solutions through analysis. Matt’s various positions have provided experience in randomization, generic and new drugs, statistical clinical development, DMC support, and analysis... Read More →
avatar for Maciej Maruszczak

Maciej Maruszczak

Consultant in Data Analytics and Machine Learning, Parexel, United Kingdom
Maciej is a machine learning specialist, with a particular interest in neural networks, who also has a background in health economic modelling. Over the course of his career, he has delivered a range of projects from simple cost-minimization models through Markov cost-effectiveness... Read More →
avatar for Vaiva Deltuvaite-Thomas

Vaiva Deltuvaite-Thomas

Research Statistician, IDDI, Belgium
Vaiva Deltuvaite-Thomas is a Research Statistician at International Drug Development Institute, IDDI. Her research focuses on Generalized Pairwise Comparisons based methods in multivariate data analysis, with or without missingness/censoring. After 15 years working as a Community... Read More →
avatar for Hengrui Sun

Hengrui Sun

Statistician, OB, OTS, CDER, FDA, United States
Dr. Sun is currently a statistical reviewer in the Anti-viral team, Division IV, Office of Biostatistics, CDER, FDA. She is also a member in the FDA Office of Biostat Pediatric Subcommittee and ASA Biopharm Section pediatric working group. Before joining FDA, Dr. Sun served as Senior... Read More →


Monday June 28, 2021 1:00pm - 2:00pm EDT
TBD Virtual Event Horsham, PA 19044
  05: Patient Engagement, Session |   11: Statistics, Session

1:00pm EDT

#116 SL: Implicit Bias in Early Phase Clinical Trials: The Sociocultural Implications of Advancing the Science
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-527-L04-P; CME 1.00; IACET 1.00; RN 1.00

Implicit bias against diversity and inclusion (D&I) are inherent in early phase clinical trial designs. Although addressing representation is important from a sociocultural perspective, it is also tantamount to ensuring representation in studies involving sophisticated biomarker approaches and precision medicine. Unfortunately, research protocols do not lend themselves to D&I due to requirements tied to proficiency with the English language, minimum required years of education, binary gender/sex requirements, and the need for a ‘informant’ or ‘study partner’. Behavioral and cognitive outcomes that are often used in clinical research also have limited applicability in non-English speaking populations. As a result of these various factors, representation in trial populations become imbalanced and absent, limiting our ability to make inferences about safety and tolerability to homogenous populations. This panel will address aspects of trial design that is most heavily influenced by the lack of diversity and inclusion such as enrollment criteria, biomarker and clinical outcomes, as well as models to consider when creating patient centric environments in research settings. We will identify the scientific, regulatory, and social challenges facing the industry while providing tangible solutions that will align with D&I initiatives as we advance the science through clinical development. Join the DIA Patient Engagement Community for a follow up round table discussion (session #229 RT L) on Tuesday, June 29, 1:00PM - 2:00PM EDT.

Learning Objectives

Discuss participation in early phase clinical trials among underrepresented groups; Identify common barriers and solutions to D&I in early phase clinical research; Describe the current trends in addressing D&I in the industry and provide a framework for advancing the field from both the investigator, sponsor, and participant perspectives.

Chair

Lovingly Park, PhD

Speaker

FDA Guidance on Diversity
Lucas Kempf, MD

Ensuring Representation in Early Phase Clinical Trials: The Importance of Diversity and Inclusion
Lovingly Park, PhD

Academic Update
Mandi L. Pratt-Chapman, PhD



Speakers
avatar for Lovingly Park

Lovingly Park

Director, Scientific Affairs, Parexel International, United States
Lovingly Park, Ph.D. is a Director in Scientific Affairs with Parexel International. She is responsible for the high-level scientific oversight of Early Phase studies ranging from First-In-Human to Proof-of-Concept, across a number of therapeutic areas. Dr. Park continually lends... Read More →
avatar for Lucas Kempf

Lucas Kempf

Vice President, RCS, Parexel, United States
Lucas Kempf, MD works as a regulatory consultant for CNS drugs and Rare Diseases. He has 8 years of experience in drug review, development, and regulatory experience at the U.S. Food and Drug Administration most recently in the role of Associate Director of Rare Diseases in CDER... Read More →
avatar for Mandi Pratt-Chapman

Mandi Pratt-Chapman

Associate Center Director, Patient Centered Initiatives & Health Equity, The GW Cancer Center, United States
Mandi Pratt-Chapman, MA, PhD is Associate Center Director, Patient-Centered Initiatives and Health Equity for the GW Cancer Center. Her personal mission is to make evidence-based health care and disease prevention strategies available to more people as quickly as possible. Her research... Read More →


Monday June 28, 2021 1:00pm - 2:00pm EDT
TBD Virtual Event Horsham, PA 19044
  06: PreClin Dev-EarlyPhaseCR, Forum

1:00pm EDT

#117 SL: Leveraging Pharma Intelligence Data and Statistical Modeling to Inform Project Strategies
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-528-L04-P; CME 1.00; IACET 1.00; PDU 1.00 PMI 21660EX90U; RN 1.00

This session will explore use of external intelligence data sources in advanced statistical modeling to inform program strategies and clinical designs. Case studies will be shared.

Learning Objectives

Describe various external data sources that can be used for statistical modeling; Identify how to use statistical modeling approaches leveraging this external data; Discuss how statistical modeling can inform and influence project strategies and clinical designs.

Chair

Mark Kryah, PMP

Speaker

Informing Drug Development via Landscape Modeling Using Pharma Intelligence Data
Zhaoling Meng, PhD, MS

Application of Advanced Modeling on Development Programs
Shameer Khader, PhD, MPH



Speakers
avatar for Mark Kryah

Mark Kryah

Senior Advisor/COO, Bio-Medicines Business Unit, Eli Lilly and Company, United States
Mark Kryah is COO/Senior Advisor in Eli Lilly’s Bio-Medicines Business Unit, leading Phase 3 development in Immunology. He has been leading global development projects for 20+ years, with extensive international and partnership experience. Mark has been involved with DIA for over... Read More →
avatar for Zhaoling Meng

Zhaoling Meng

AVP, Global Head of Clinical Modeling and Evidence Integration, Sanofi, United States
SK

Shameer Khader

Senior Director, Data Science and Artificial Intelligence, AstraZeneca, United States
Dr. Shameer Khader is currently working as a Senior Director of Data Science and Artificial Intelligence at AstraZeneca, USA. He leads a global team that focuses on leveraging trans-disciplinary (biomedical, healthcare, and clinical) big data and machine intelligence to accelerate... Read More →


Monday June 28, 2021 1:00pm - 2:00pm EDT
TBD Virtual Event Horsham, PA 19044
  07: ProjMgt-StrategicPlanning, Session |   11: Statistics, Session

1:00pm EDT

#118 SL: Advanced Analytics, Cross-Industry Collaboration, and Data Sharing to Change the Paradigm in Clinical Quality
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-529-L04-P; CME 1.00; IACET 1.00; RN 1.00

In this session, we will share selected use cases on our collaboration framework. We will also engage with the audience on how we (industry, regulators, patients) can all contribute to a change in paradigm for QA, i.e. where advanced analytics can help detecting and mitigating issues faster, and ultimately accelerate approval and patient access of innovative drugs.

Learning Objectives

Examine how advanced analytics are utilized throughout the development lifecycle and how this could lead to a paradigm shift in clinical quality; Describe how the inter company quality analytics (IMPALA) group members collaborate to accelerate the development of advanced analytics for clinical quality; Identify how cross-company data sharing can foster development and validation of advanced analytics.

Chair

Timothe Claude Menard, PharmD, MSc

Speaker

Industry Update
Jennifer Emerson, PhD, MPH, RN, PMP

Industry Update
David Donohue, MBA

Industry Update
Robert Studt



Speakers
avatar for Robert Studt

Robert Studt

Head of Quality Analytics, BioResearch Quality and Compliance, Johnson & Johnson, United States
Rob is currently the head of Quality Analytics in Johnson & Johnson's BioResearch Quality & Compliance. He began his career as a drug discovery chemist, and has worked in leadership roles in Drug Discovery, R&D IT, and Quality & Compliance. Current interests are in applications of... Read More →
DD

David Donohue

Head, Quality Systems and Data Analytics, GlaxoSmithKline, United States
David Donohue leads Quality Systems and Data Analytics, Global Quality Assurance He is accountable for defining and delivering the data analytics program to proactively identify trends, emerging issues and shared learnings for Pharma R&D.
avatar for Timothe Menard

Timothe Menard

Head of Quality Data Science, F. Hoffmann- La Roche, Switzerland
Dr. Timothé Ménard, PharmD has been leading the PD Quality Data Science Team at Roche since January 2018. From simple analytics methods to machine learning, his team is creating and implementing data-driven solutions that help understand, early detect or predict clinical quality... Read More →
avatar for Jennifer Emerson

Jennifer Emerson

Head of Audit Excellence, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
Clinical research professional with 19 years' experience in Quality Management, Project Management, Monitoring & Pharmacovigilance. PhD in Public Health - Epidemiology, Project Management Professional (PMP) Certified, ISO 9001:2015 certified Auditor.


Monday June 28, 2021 1:00pm - 2:00pm EDT
TBD Virtual Event Horsham, PA 19044
  08: RD Quality-Compliance, Session |   03: Data-Data Standards, Session

1:00pm EDT

#122 SL: Market Access, Medical Affairs, and Regulatory Affairs Functions Working Together to Address Payor and Regulatory Requirements
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-533-L04-P; CME 1.00; IACET 1.00; RN 1.00

Drug development is evolving to address payor and regulatory requirements. Market access, medical affairs, and regulatory affairs functions are working together in this complex payor and regulatory ecosystem to sustain patient access to medicine.

Learning Objectives

Summarize how the market access, medical affairs, and Regulatory Affairs functions within a pharmaceutical company are working together differently now then they have in the past to address both payor and regulatory requirements; Name the ways the drug development is evolving to ensure clinical trials are addressing coverage and regulatory decisions.

Chair

Todd Paporello, PharmD, MBA

Speaker

Industry Perspective
I-Fen Chang, PharmD

Industry Perspective
Todd Paporello, PharmD, MBA

Industry Perspective
Cindy McDonald-Everett



Speakers
IC

I-Fen Chang

Vice President, Head of Oncology Global Medical, Amgen, United States
I-Fen Chang is the Vice President of Global Medical Therapeutic Area Head for Hematology/Oncology at Amgen. In this capacity, I-Fen is directly responsible for oversight of US and Global medical strategy, external engagement and evidence generation. I-Fen has over 17 years of experience... Read More →
avatar for Todd Paporello

Todd Paporello

Vice President and Head of Regulatory Affairs Americas, Bayer, United States
Todd Paporello is Vice President and Head of Regulatory Affairs Americas at Bayer Pharmaceuticals. Before joining Bayer, he held leadership positions of increasing responsibility within regulatory affairs at Roche, Genentech, Merck, and Schering-Plough. Todd holds pharmacy (PharmD... Read More →
avatar for Cindy McDonald-Everett

Cindy McDonald-Everett

Senior Vice President, Global Value Access, Seagen, United States
Cindy McDonald-Everett is Senior Vice President of Global Value Access at Seagen. She leads a team dedicated to demonstrating value to key stakeholders in the healthcare system to ensure patient access. She has extensive industry experience leading global market access and pricing... Read More →


Monday June 28, 2021 1:00pm - 2:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session |   04: MedAffairs-SciComm, Session |   12: Value-Access, Session
  • Beginner Intermediate
  • Credit Type ACPE, CME, IACET, RN
  • Student Programming Regulator Thinking,RWD-RWE
  • Tags Session

1:00pm EDT

#120 SL: Defining Quality for Cell and Gene Therapy Products
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-531-L04-P; CME 1.00; IACET 1.00; RN 1.00

Cell and Gene Therapy products are rapidly moving from early proof of concept and investigational studies to demonstration of clinical benefit and commercial approval. US and global regions have certainly helped bring important life-changing therapies to patients with remarkable expediency. However, development of robust product quality implementation and characterization often lags behind their rapid clinical programs. To help fill this gap, FDA has encouraged early product characterization, the evaluation of multiple product attributes, and development of a broad set of analytics. This “cast a wide net” approach allows for pruning of different methodologies during the product lifecycle and elevating tests for attributes associated with discernable changes and impacts to product safety, quality and efficacy. FDA has allowed flexibility in method development, specification setting and the identification of CQA in early phases.However, FDA expectation is that fully validated methods will be in place for licensure and that acceptance criteria will be established based on clinical efficacy studies. The transition from the flexible early phase to a more robust late phase expectation, highlights the critical importance for well-planned and step-wise control strategy and control system.

Learning Objectives

Explain how to identify critical quality attributes for cell and gene therapy products; Outline when it is appropriate to set quality standards during investigational studies; Identify resources available for standard setting for cells and gene therapies.

Chair

Michael Havert, PhD

Speaker

Industry Update
Keith Wonnacott, PhD

Data Analytics and Consistency for CAR-T Methods
Prentice Curry



Speakers
avatar for Michael Havert

Michael Havert

Vice President, Regulatory affairs, StrideBio, United States
Mike was trained as a virologist and has experience in the development of genetic medicines for the treatment of rare diseases and cancer. Mike recently worked at the CMC/regulatory interface for HSCT gene therapy programs at bluebird bio. Prior to his current position, Mike served... Read More →
avatar for Prentice Curry

Prentice Curry

Senior Vice President, Quality and Compliance, Kite Pharma, United States
Prentice Curry has been a biotechnology and pharmaceutical professional for more than 30 years. He started his career at Cetus Corporation, one of the first biotechnology start-up companies in quality laboratory and manufacturing roles. Prentice then subsequently worked for Amgen... Read More →
avatar for Keith Wonnacott

Keith Wonnacott

Executive Director, Regulatory Affairs, Pfizer Inc, United States
Dr. Keith Wonnacott has 20 years of regulatory experience in the field of cell and gene therapies. He joined Pfizer as an Executive Director of Regulatory Affairs in their Rare Diseases Unit in 2017. At Pfizer, Dr. Wonnacott has a combined role working on regulatory strategy and regulatory... Read More →


Monday June 28, 2021 1:00pm - 2:00pm EDT
TBD Virtual Event Horsham, PA 19044
  10: RegCMC-Product Quality, Session |   06: PreClin Dev-EarlyPhaseCR, Session

1:00pm EDT

#123 SL: Skills of the Future/The Future of Work
Component Type: Session
Level: Intermediate

Whether you are a full time employee, independent consultant, work at a drug sponsor, CRO, vendor, or even government and academia, the skills required to achieve, maintain and grow a career are vastly different today than they were 30 years go- even 10 years ago! As most Human Resources are starting to realize (with no small sense of alarm), even 5 years ago is quite different from today. Even 2 years ago. Humanity has never experienced the rate of change brought on by digitization. We are only in the dawn of how everything is being transformed. The World Economic Forum is calling the digital age’s impact on business and the economy the “Fourth Industrial Revolution”. No subject matter expertise has been left untouched, and company training programs can’t keep up. There is only one thing for certain- no department, expertise domain or career path will remain static. The rule of today will shift, tomorrow. It is inevitable. Resistance is futile. Forewarned is forearmed. This session is focused on what to expect in 2021 and beyond. The goal is to survive. The bonus is to thrive.

Learning Objectives

Describe what skills will be necessary to survive and thrive in 2021 and beyond; Identify potential gaps re: what the economy, your company and role could need moving forward; Discuss the value of personal branding and skills associated, no matter what job you have now or in the future.

Chair

Sheila Mahoney Jewels, MBA


Speakers
avatar for Sheila Mahoney Jewels

Sheila Mahoney Jewels

Independent Workforce Advocate, LifeSciHub , United States
Sheila has over 25 years of experience in reg/clin ops, having operated as an SME on both the sponsor and vendor sides. Her current focus as an independent consultant (IC) is advocating for the independent workforce, and helping sponsors engage with them. Sheila has spent the last... Read More →


Monday June 28, 2021 1:00pm - 2:00pm EDT
TBD Virtual Event Horsham, PA 19044

2:00pm EDT

#124 IT: ArisGlobal Innovation Theater: Minimizing Noise to Improve Your PV Case Processing
Component Type: Session
Level: Intermediate

Join us for this thought-provoking webinar that discusses how automation can illuminate opportunities to improve the efficiency and quality of your pharmacovigilance program. Learn how process noise, in the form of subconscious biases and differences in judgment of case processors, creates variances in case data interpretation, the subsequent data entry, and overall case quality. We’ll discuss how applying automation techniques eliminates this noise by driving consistency across your case processing workflows, enabling systematic assessments that highlight areas to be optimized. Discover how to use automation to pinpoint case processing improvements and how to address common automation adoption barriers.

Chair

ArisGlobal, LLC


Speakers
avatar for Emmanuel Belabe

Emmanuel Belabe

Associate Vice President, Safety, ArisGlobal, United States
Emmanuel Belabe, better known as “Manny”, has worked within ArisGlobal in a number of different roles over his 15 years with the company. During that time, he developed an approach that sought to educate clients on best practices for leveraging ArisGlobal products, while advocating... Read More →
avatar for ArisGlobal, LLC

ArisGlobal, LLC

United States


Monday June 28, 2021 2:00pm - 2:30pm EDT
TBD Virtual Event Horsham, PA 19044

2:00pm EDT

#125 IT: PPD Innovation Theater: Continuous Development and Flexible Architecture of the PPD® Laboratories’ Central Lab Preclarus® Portal to Meet the Changing Needs of Clinical Trials
Component Type: Session
Level: Intermediate

Clinical trial complexity has dramatically increased over the past decade. Implementation of site- and customer-facing systems to adequately track sample chain of custody and drive data integrity have experienced numerous challenges, both in functionality and adoption. While the central lab industry has historically invested in testing platforms and internal lab information systems, they did little to solve the aforementioned issues plaguing clinical trials with regard to sample chain of custody, data integrity, and tools for sites or customers to use for real-time assessment. IT development of platforms in this space therefore require the ability to create a flexible architecture intimately linked to the lab information system and, more importantly, the need for continuous quality improvements with regular release schedules based on real user feedback for ease of use. PPD Laboratories designed the Preclarus central lab database to specifically address the common issues experienced, constructed with flexibility that can be adapted for multiple use cases. We will discuss the core functionality in the initial release and the subsequent flexibility upgrades, barriers to adoption, solutions and proposed future state that will fundamentally change the way central lab services are viewed and utilized in the industry.

Chair

PPD, Inc.


Speakers
avatar for Chris Clendening

Chris Clendening

Senior Vice President, PPD Laboratories Central Labs, PPD, United States
Chris Clendening has been the vice president of PPD Laboratories’ central labs since 2019. Chris joined PPD in 2006 as a project manager, and has served in many roles, including project management, project account management, global manager of technical operations, director of project... Read More →
avatar for PPD, Inc.

PPD, Inc.

Pharmaceutical Product Development, Inc, United States


Monday June 28, 2021 2:00pm - 2:30pm EDT
TBD Virtual Event Horsham, PA 19044

2:00pm EDT

#126 IT: IBM Innovation Theater: Embracing Hybrid - How New Technologies, Synergized with Proven Solutions, Will Shape the Journey to Commonplace Decentralized Trials
Component Type: Session
Level: Intermediate

While all eyes are on decentralized trial technologies to improve patient centricity, it's important to recognize the critical role that hybrid trials plays as our industry is still adapting to changes from the past two years. Join IBM Watson Health to learn how IBM clinical development users have leveraged both new decentralized trial technologies and proven cloud-based solutions to manage highly-successful hybrid trials with record-breaking cycle time.

Chair

IBM Watson Health


Speakers
avatar for Walker Bradham

Walker Bradham

Offering Manager, IBM Watson Health, United States
Walker Bradham is the Product Leader for IBM Clinical Development. He brings 20 years of experience defining, designing and deploying web applications to the marketplace. A champion of user empowerment through SaaS principles, he works to provide intuitive tools to solve complex problems... Read More →
avatar for Wes Fishburne

Wes Fishburne

Product Manager, IBM Clinical Development, IBM Watson Health, United States
Wes has 21 years experience leading development efforts, supporting, and deploying offerings in the clinical trials space. The majority of his career has been focused on supporting Clinical Trial Management Systems (CTMS) used at research sites, as well as EDC and Sponsor facing CTMS... Read More →
avatar for IBM Watson Health

IBM Watson Health

United States
avatar for Mark Laney

Mark Laney

Global Manager, Sales Engineering, IBM Watson Health, United States
Mark has over 20 years in the healthcare IT space in a variety of roles focused on customer solutions and clinical trials. Mark joined IBM in 2015 through the acquisition of Merge Healthcare. At IBM, Mark leads a global team of technical consultants focused on identifying the right... Read More →


Monday June 28, 2021 2:00pm - 2:30pm EDT
TBD Virtual Event Horsham, PA 19044

2:30pm EDT

#127 SL: Are You Ready for a NISS? Industry and Regulatory Perspectives on the US FDA Newly Identified Safety Signal Process
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-534-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will review FDA’s Newly Identified Safety Signal (NISS) process, and also assess its impact to industry. The impact assessment considers approaches to integrate signal detection methodology and internal processes to address a NISS.

Learning Objectives

Describe the FDA Newly Identified Safety Signal (NISS) evaluation process; Explain the analysis of safety data sources, intake and analysis relevant to a NISS undertaken by a large pharmaceutical company; Identify key information within the session which could be used to formulate a plan to address a NISS received by the participant’s organization.

Chair

Jamie Wilkins, PharmD

Speaker

FDA Update
Jason Bunting, PharmD

Industry Update
Bertha V Ferrer, MSc, RPh

Industry Update
Adrian Dana, MD



Speakers
avatar for Jamie Wilkins

Jamie Wilkins

Director, Risk Management Product Lead, Pfizer Inc
Jamie Wilkins, Pharm.D. is an experienced pharmacist and former regulator currently responsible for partnering with internal and external stakeholders on delivering innovative, strategic global safety and risk management excellence for Pfizer’s drug and biologics portfolio. Prior... Read More →
BF

Bertha Ferrer

Senior Director, Head of Quality Management and Inspections, Pfizer Inc, United States
Bertha Ferrer ,Senior Director , Head of Quality Management and Inspections , Pfizer Inc- Based in Peapack, NJ, Bertha l leads a team that collaborates with the Pharmacovigilance Organization to create strategies for inspection readiness and support of inspections and audits globally... Read More →
avatar for Jason Bunting

Jason Bunting

Science Policy Analyst, OCD, CDER, FDA, United States
Jason Bunting, PharmD, is a Science Policy Analyst in Drug Safety Operations (DSO), in the Office of the Center Director, Center for Drug Evaluation and Research. DSO is responsible for the management of significant and timely drug safety issues, as well as the creation and oversight... Read More →
avatar for Adrian Dana

Adrian Dana

Vice President, Global Patient Safety and Risk Management, Aimmune Therapeutics, United States
Dr Adrian Dana is the VP of Global Patient Safety and Risk Management for Aimmune, a leader in the development of treatments for food allergies. In this role, she is building an innovative safety organization to support the development of these new therapies. Her past positions include... Read More →


Monday June 28, 2021 2:30pm - 3:30pm EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Session

2:30pm EDT

#130 SL: Real-World Response: Harnessing Electronic Health Records to Develop Robust Clinical Endpoints in Solid Tumors
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-537-L04-P; CME 1.00; IACET 1.00; RN 1.00

RECIST-based response is an established endpoint in clinical trials, but how do you assess response in routine patient care? This session presents efforts to develop a real-world response endpoint and its utility in clinical development.

Learning Objectives

Describe the utility of measuring treatment response in clinical trials and challenges of accessing it in routine clinical care; Discuss methods, data elements, and rigor needed to evaluate this endpoint and future implications for clinical development.

Chair

Michael W. Lu, PharmD

Speaker

Real-World Response: Harnessing Electronic Health Records to Develop Robust Clinical Endpoints in Solid Tumors
Ariel Bourla, MD, PhD

Application of Real-World Response in Prospective Studies
Michael W. Lu, PharmD

Exploring Real-World Response and Progression Free Survival in the AACR GENIE Biopharma Collaborative
Gregory Riely, MD, PhD



Speakers
avatar for Michael Lu

Michael Lu

Platform Strategy Leader, RWD, Personalized Healthcare Oncology, Genentech, A Member of the Roche Group, United States
Michael Lu serves as a Real World Data Platform Strategy Leader at Genentech. He oversees development efforts in Prospective Evidence Generation and real world endpoints. Leveraging his clinical development experience across Phase I-IV studies with global filing experience, he is... Read More →
AB

Ariel Bourla

Medical Director, Flatiron Health, United States
Ariel Bourla serves as Medical Director at Flatiron Health. She oversees the development of new real-world endpoints and the incorporation of clinical images into the endpoint portfolio. She is also responsible for working with Flatiron’s partners to design prospective real-world... Read More →
GR

Gregory Riely

Vice Chair, Clinical Research, Department of Medicine, Memorial Sloan Kettering Cancer Center, United States
Dr. Gregory Riely is a medical oncologist in the Department of Medicine at Memorial Sloan-Kettering Cancer Center. His primary research focus is in clinical research of patients with non-small cell lung cancer. He completed fellowship training in Medical Oncology at Memorial Sloan-Kettering... Read More →


Monday June 28, 2021 2:30pm - 3:30pm EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Session |   03: Data-Data Standards, Session

2:30pm EDT

#128 SL: FDA Science Strategies: Purposeful Scientific Leadership to Advance Innovation and Improve Patient Outcomes
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-535-L04-P; CME 1.00; IACET 1.00; RN 1.00

This forum will provide an overview of FDA CDER’s Science Strategies Program. It will also provide an opportunity for stakeholders, including patients and drug developers, to share their experiences, perspectives and priorities to inform FDA’s efforts.

Learning Objectives

Describe FDA Center for Drug Evaluation and Research’s Office of New Drugs' efforts to enhance therapeutic-specific strategic planning and scientific leadership; Discuss the opportunities for key stakeholders including, patients, academia, drug developers, health care providers, and payers, to help advance FDA’s therapeutic-specific science strategies.

Chair

Meghana Chalasani, MHA

Speaker

Panelist
Klaus Romero, MD, MS

Panelist
Jeffrey Siegel, MD

Panelist
Michelle Campbell, PhD

Panelist
Meaghan Malley



Speakers
avatar for Meghana Chalasani

Meghana Chalasani

Lead, Science Strategies, Office of New Drugs, CDER, FDA, United States
Meghana Chalasani leads the Science Strategies program in the Office of New Drugs in FDA’s Center for Drug Evaluation and Research. She also manages the New Drug Regulatory Program’s Advisory Committee modernization effort. Previously, Meghana worked closely on CDER’s Patient-Focused... Read More →
avatar for Michelle Campbell

Michelle Campbell

Senior Clinical Analyst for Stakeholder Engagement, ON, OND, CDER, FDA, United States
Michelle Campbell is the Sr. Clinical Analyst for Stakeholder Engagement and Clinical Outcomes in the Office of Neuroscience, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Previously, Dr. Campbell was a reviewer... Read More →
avatar for Meaghan Malley

Meaghan Malley

Senior Project Associate, Kidney Health Initiative, ASN Alliance for Kidney Health, United States
Meaghan Malley is the Senior Project Associate for the Kidney Health Initiative (KHI) at the ASN Alliance for Kidney Health (ASN). KHI is a public-private partnership between ASN, the U.S. Food and Drug Administration and over 100 member companies and organizations focused on fostering... Read More →
KR

Klaus Romero

Chief Scientific Officer, Critical Path Institute, United States
Klaus Romero MD, MS, FCP is a clinical pharmacologist and epidemiologist by training, with 15 years combined experience in academic clinical research. Dr. Romero has been with C-Path since December of 2007, and during his tenure, he has helped lead clinical pharmacology, pharmacoepidemiology... Read More →
JS

Jeffrey Siegel

Director, Office of Drug Evaluation Sciences, Office of New Drugs, CDER, FDA, United States
Jeffrey Siegel is the director of the Office of Drug Evaluation Sciences (ODES) in the Office of New Drugs (OND), CDER, FDA. ODES oversees Clinical Outcome Assessments, Biomarker Qualification, Research and Bioinformatics in OND. Dr Siegel has over 20 years of experience in research... Read More →


Monday June 28, 2021 2:30pm - 3:30pm EDT
TBD Virtual Event Horsham, PA 19044
  02: ClinTrials -ClinOps, Forum |   09: Regulatory, Forum

2:30pm EDT

#132 SL: Ensuring Patient Engagement Methodologies Are ‘Fit for Purpose’ from the Beginning: A Key Factor for Meaningful Outcomes
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-539-L04-P; CME 1.00; IACET 1.00; RN 1.00

Patient data helps ensure more patient-relevant regulatory outcomes. Patients are integrated within EMA and FDA’s regulatory procedures with demonstrated value. Relevant, robust and adaptable methodologies are vital to meet the changing health landscape.

Learning Objectives

Discuss patient engagement methodologies within regulatory procedures; Identify value of patient input with tangible evidence; Describe the need for continuous, and adaptable, leveraging of the patient perspective for a better balance between scientific objectives and patient goals and ultimately reach more patient-relevant regulatory outcomes.

Chair

Nathalie Bere, MPH

Speaker

Panelist
Marco Greco, PhD

Panelist
Bruno Sepodes, PharmD, PhD, MPH, MSc

Panelist
Andrea Furia-Helms, MPH



Speakers
avatar for Bruno Sepodes

Bruno Sepodes

Vice-Chair-CHMP; Senior Nonclinical Expert INFARMED, INFARMED, Portugal
Bruno Sepodes is a Professor of Pharmacology and Pharmacotherapy at the Faculty of Pharmacy of the University of Lisbon (Portugal). Besides being Senior non-clinical expert for INFARMED (Portuguese National Authority for Medicines and Health Products), he became a member of the European... Read More →
avatar for Nathalie Bere

Nathalie Bere

Patient Engagement, European Medicines Agency, Netherlands
Nathalie Bere has a BSc in Psychology and a Master in Public Health. Nathalie has been working with European Medicines Agency (EMA)since 1998 and is currently responsible for its engagement with patients and consumers. Patients bring specific knowledge and expertise from their real-life... Read More →
avatar for Andrea Furia-Helms

Andrea Furia-Helms

Director, Office of Patient Affairs, FDA, United States
Andrea Furia-Helms is the Director of the Office of Patient Affairs (OPA) in the Office of the Commissioner. She collaborates with patient communities, the FDA medical product Centers and other offices to incorporate patient and caregiver perspectives in cross-cutting regulatory meetings... Read More →
avatar for Marco Greco

Marco Greco

President, European Patients' Forum, Belgium
Dr Marco Greco is the President of the European Patients' Forum (EPF).He currently sits on the Management Board of the European Medicines Agency (EMA) and acts as an observer on the Patients and Consumers Working Party,on behalf of the Board.He works as an attorney at his law firm,focusing... Read More →


Monday June 28, 2021 2:30pm - 3:30pm EDT
TBD Virtual Event Horsham, PA 19044
  05: Patient Engagement, Forum

2:30pm EDT

#129 SL: Walking the Talk: What Happens When Clinical Trialists Join Clinical Trials?
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-536-L04-P; CME 1.00; IACET 1.00; RN 1.00

In this forum we share experiences as volunteers in Phase 3 COVID-19 vaccine trials. Few of us enroll in trials, even though our work is designing, executing, and analyzing clinical trials. This is a way to learn through our participation.

Learning Objectives

Discuss stories of participating in a COVID-19 vaccine trial as a healthy volunteer; Evaluate insights on the patient experience in the trial, and the key takeaways as a clinical trialist that are made clear by participation; Identify potential options for a different patient experience in future trials that leverage technology and other patient-centric trial solutions.

Chair

Jane Myles, MS

Speaker

Panelist
Kelly Johnston McKee, MS

Panelist
Angela Radcliffe

Panelist
Craig Serra, MBA, MS



Speakers
avatar for Jane Myles

Jane Myles

Director, DCT Implementation, Hybrid & Virtual Trials, Labcorp Drug Development, United States
Jane is driving the global implementation of decentralized trials at Covance with a team of tech and trial experts. She is the Founder of JemTech consulting and the former Head, Operational Intelligence and Innovation for Roche, working at Genentech. Her passion is driving innovation... Read More →
avatar for Kelly McKee

Kelly McKee

Vice President, Patient Recruitment and Registries, Medidata Solutions, United States
Kelly McKee recently joined Medidata as the Sr. Director of Patient Registries and Recruitment with 20 years of experience in clinical trial operations, patient recruitment and innovation. She is a proven clinical trial leader and trailblazer in operationalizing global patient-focused... Read More →
AR

Angela Radcliffe

Head, Data Governance and Stewardship, Bristol-Myers Squibb Company , United States
Angela Radcliffe is a brand transformer and clinical trials expert who has been innovating in healthcare for two decades. Angela’s has been responsible for the strategic oversight, implementation, and evaluation of clinical trial programs, data and AI ambition, and digital transformation... Read More →
CS

Craig Serra

Clinical Technology and Innovation, Novartis Pharmaceuticals Corporation, United States
Craig Serra is a senior leader within the clinical development operations space with his most recent experience at Novartis. Prior, he was Senior Director in Clinical Delivery Transformation at IQVIA and Senior Director in Clinical Sciences and Operations at Pfizer. He was also the... Read More →


Monday June 28, 2021 2:30pm - 3:30pm EDT
TBD Virtual Event Horsham, PA 19044
  05: Patient Engagement, Forum |   02: ClinTrials -ClinOps, Forum

2:30pm EDT

#139 SL: Hiding in Plain Sight: Quantifying Underdiagnosed Populations
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-546-L04-P; CME 1.00; IACET 1.00; RN 1.00

Underdiagnosis is a factor in many diseases especially for racial and ethnic minorities. The panel will discuss systemic reasons for underdiagnosis and quantitative data-mining approaches.

Learning Objectives

Explain problem and systemic reasons for underdiagnosis or misdiagnosis, especially for racial and ethnic minority populations; Describe quantitative approaches and data sources for documenting demographic and geographic characteristics of underdiagnosed populations; Discuss examples of visualizations related to revealing the impact of underdiagnosis for clinical and policy initiatives.

Chair

Mary Murray, MBA, MPH

Speaker

Harnessing Moments of Empathy and Machine Learning to Engage More Diverse Populations
Scott Shalett

#CeliacExposed
Salvatore Alesci, MD, PhD



Speakers
avatar for Mary Murray

Mary Murray

Vice President, Collaborative Action Networks, National Minority Quality Forum, United States
Mary Stober Murray is a leading voice and collaboration-builder for health equity and patient engagement in pharmaceutical development operations. In her role at National Minority Quality Forum, Mary leads multi-stakeholder collaborative networks to improve lives in high-risk communities... Read More →
SA

Salvatore Alesci

Chief Scientist and Strategy Officer, Beyond Celiac, United States
Dr. Alesci is a highly regarded physician-scientist and science policy and advocacy influencer. A visionary healthcare executive, Dr. Alesci has distinguished himself, through multiple leadership roles in the public and private sector, by transforming organizations, championing and... Read More →
SS

Scott Shalett

Director, Public Democracy America, United States
Scott Shalett is a result oriented, critical thinker with a background in strategic planning, policy analysis, business growth and political organizing. He has a diverse background in political and community organizing, policy, and civic engagement and has worked in positions of leadership... Read More →


Monday June 28, 2021 2:30pm - 3:30pm EDT
TBD Virtual Event Horsham, PA 19044
  05: Patient Engagement, Forum |   11: Statistics, Forum

2:30pm EDT

#133 SL: Role of Clinical Pharmacology Guidances and Policies in Enhancing Drug Development
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-540-L04-P; CME 1.00; IACET 1.00; RN 1.00

Clinical pharmacology informs dose selection, dose optimization, and therapeutic individualization. Effective clinical pharmacology guidances and policies support an efficient drug development process and consistent regulatory evaluation.

Learning Objectives

Describe the value of clinical pharmacology guidances and policies in drug development;Recognize the lifecycle approach supporting the development and implementation of clinical pharmacology guidances; Discuss the role of regulatory research and other stakeholder input in the development of clinical pharmacology guidances and policies.

Chair

Anuradha Ramamoorthy, PhD

Speaker

Role of Guidance and Policy in Advancing Clinical Pharmacology
Rajanikanth Madabushi, PhD

Advancing Clinical Pharmacology Through Regulatory Policy and Partnership
Samantha Roberts, PhD

Academia Update
Kathleen M. Giacomini, PhD

Panelist
David Boulton, PhD



Speakers
SR

Samantha Roberts

Director, US Regulatory Policy, Genentech, A Member of the Roche Group, United States
Samantha Roberts is currently a Group Director in Roche/Genentech's US Regulatory Policy office where she focuses on the implementation of regulatory policy priorities to modernize and improve the efficiency of drug development and review. Before joining Roche/GNE in 2016, she worked... Read More →
avatar for Kathleen Giacomini

Kathleen Giacomini

Professor, Bioengineering and Therapeutic Sciences; CERSI Co-Director, University of California San Francisco, United States
Kathleen M. Giacomini, Ph.D. Kathy Giacomini, a professor in the School of Pharmacy at the University of California, San Francisco, is a leader in the field of membrane transporters with a focus on genetic polymorphisms. She cloned, characterized and discovered the endogenous role... Read More →
DB

David Boulton

Clinical Pharmacology and Quantitative Pharmacology Head of Post Marketing, AstraZeneca, United States
avatar for Rajanikanth Madabushi

Rajanikanth Madabushi

Associated Director for Guidance and Scientific Policy, OCP, OTS, CDER, FDA, United States
Dr. Madabushi has 10 years of regulatory review experience as Pharmacometrics Review and as Team Leader in the Office of Clinical Pharmacology. He was predominantly involved in the application of quantitative clinical pharmacology approaches for regulatory decision making and addressing... Read More →
AR

Anuradha Ramamoorthy

Policy Lead, OCP, OTS, CDER, FDA, United States
Anuradha Ramamoorthy, Ph.D. is a Policy Lead at the Office of Clinical Pharmacology (OCP), Food and Drug Administration (FDA). She received her Ph.D. in Medical and Molecular Genetics from Indiana University and was a postdoctoral fellow at the NIH and FDA. In her current role, she... Read More →


Monday June 28, 2021 2:30pm - 3:30pm EDT
TBD Virtual Event Horsham, PA 19044
  06: PreClin Dev-EarlyPhaseCR, Session

2:30pm EDT

#134 L: Risky Business: How to Successfully Manage Project Risk
Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-21-541-L04-P; CME 1.00; IACET 1.00; PDU 1.00 PMI 2166ZTRTIJ; RN 1.00

Pharmaceutical drug programs by their very nature are a risky business. However, too often program risk management is overlooked. In this workshop, participants will learn how to effectively and efficiently manage risk within program teams.

Learning Objectives

Define, articulate, and analyze risks clearly; Apply the concepts learned to manage risk as a continuous process and not a one-time activity.

Chair

Matthew S Curin, PharmD

Speaker

Facilitator
Nita Ichhpurani, PMP

Facilitator
Dwayne Stanley, MBA



Speakers
avatar for Nita Ichhpurani

Nita Ichhpurani

Consultant To Daiichi Sankyo, Inc., Phase One Forward, Consultant, Canada
At Pharmacia (now Pfizer), Nita was a discovery Chemist and then PM in Clinical Pharmacology in oncology and CNS research. At MDS PS, she managed Global Central lab teams and later become the Latin American Lab Manager. At MDS PS and Celerion, she managed drug development consulting... Read More →
avatar for Dwayne Stanley

Dwayne Stanley

Director, Program Management, Kaleido Biosciences, United States
Dwayne Stanley is a Program Leadership professional who partners with cross-functional teams to design, develop and deliver products within the medical device and pharmaceutical industries. After spending almost two decades in the medical device industry, Dwayne transitioned to the... Read More →
avatar for Matthew Curin

Matthew Curin

Nemolizumab Project Management Lead, Galderma, United States
Matt has been working in the pharmaceutical industry for more than 20 years, spending the first 8 years in clinical manufacturing before moving into project management in 2007. Since then, Matt has provided project, program, and portfolio management leadership in clinical development... Read More →


Monday June 28, 2021 2:30pm - 3:30pm EDT
TBD Virtual Event Horsham, PA 19044
  07: ProjMgt-StrategicPlanning, Workshop

2:30pm EDT

#135 SL: Risk-Based Remote Site Monitoring
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-542-L04-P; CME 1.00; IACET 1.00; RN 1.00

COVID-19 has forced pharmaceutical companies to go remote for many of their processes. Remote site monitoring is best conducted through a risk-based approach that uses digital systems and AI/ML applications to inform decision-making.

Learning Objectives

Discuss how to use risk-based assessments to improve effectiveness of remote site monitoring; Identify ways that Artificial Intelligence/Machine Learning can expedite risk-based decision-making; Compare remote monitoring methods and identify ones likely to persist after the COVID-19 pandemic.

Chair

Patricia Santos-Serrao, RAC

Speaker

Technology in Risk-Based Remote Monitoring and Oversight
Patricia Santos-Serrao, RAC

Overcome Site Regulatory (ISF) Issues Part 1
Richard Arlow, MS

Overcome Site Regulatory (ISF) Issues Part 2
Len Rosenberg, PhD, RPh



Speakers
avatar for Patricia Santos-Serrao

Patricia Santos-Serrao

Director of Product Management, Pharmaceuticals and Biologics, MasterControl, United States
Patricia entered the Life Sciences Industry in 1994 starting her career at Schering-Plough in Kenilworth, NJ and later joining Boehringer Ingelheim Pharmaceutical in Ridgefield, CT. Within both organizations she took a leading role in transitioning business processes, document management... Read More →
avatar for Richard Arlow

Richard Arlow

Founder and Chief Executive Officer, Complion, United States
Drawing on his engineering background and inspired by his work in clinical medical research as an MD/PhD candidate, Rick Arlow built the first version of the Complion software platform. In close collaboration with leading medical centers, Complion’s industry-leading workflow and... Read More →
avatar for Len Rosenberg

Len Rosenberg

Head of Clinical Operations, Beat AML, a division of The Leukemia and Lymphoma Society, United States
Len Rosenberg is an executive with proven experience in driving operational excellence at all levels within the pharmaceutical, biotechnology, CRO and eClinical sectors - diverse background includes executive management, clinical and regulatory operations, business development and... Read More →


Monday June 28, 2021 2:30pm - 3:30pm EDT
TBD Virtual Event Horsham, PA 19044
  08: RD Quality-Compliance, Session

2:30pm EDT

#136 SL: Parallel Scientific Advice: Increasing International Dialogue Early in the Product Lifecycle
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-543-L04-P; CME 1.00; IACET 1.00; RN 1.00

The Parallel Scientific Advice (PSA) procedure is a process for EMA and FDA to concurrently exchange with sponsors their views on scientific issues during the development phase of new medicinal products (i.e., new human drugs and biologics). Such interactions are expected to increase dialogue between the two agencies and sponsors from the beginning of the lifecycle of a new product, provide a deeper understanding of the bases of regulatory decisions, optimize product development, and avoid unnecessary testing replication or unnecessary diverse testing methodologies. This session will be led by EMA and FDA PSA participants and program managers, as well as a participant offering the industry perspective. Attendees will better understand the PSA procedure, how to apply, and expectations on outcomes.

Learning Objectives

Explain the Parallel Scientific Advice (PSA) procedure framework and timelines; Identify best candidates for PSA and best practices for request letters; review statistics on utilization of the PSA procedure; Describe Industry’s and each Agency’s unique perspective and contribution to PSA.

Chair

Shannon Thor, PharmD, MS

Speaker

PSA: FDA Division Perspective
Kelly Richards, MSN, RN, RAC

PSA: EMA Perspective
Thorsten Vetter, DrMed

PSA: A Sponsor Perspective
Petra Pavlickova, PhD, RAC



Speakers
avatar for Shannon Thor

Shannon Thor

International Policy Analyst, Office of Global Policy & Strategy, Europe Office, FDA, United States
Lieutenant Commander Shannon Thor is a pharmacist and officer in the United States Public Health Service, serving as an international policy analyst in FDA's Europe Office, working closely with European regulatory counterparts to accomplish international public heath goals. Previous... Read More →
avatar for Petra Pavlickova

Petra Pavlickova

Associate Director, Regulatory Affairs, Bristol-Myers Squibb Company, United States
Petra Pavlickova is an Associate Director of Regulatory Affairs at Bristol Myers Squibb (BMS). In her current role, Petra is leading regulatory strategy and submissions for new immunology and fibrosis pharmaceutical products in US. She joined BMS two years ago. Prior to joining BMS... Read More →
avatar for Kelly Richards

Kelly Richards

Senior Regulatory Health Project Manager, Gastroenterology , ORO, OND, CDER, FDA, United States
Senior Regulatory Health Project Manager, Gastroenterology with FDA's Division of Regulatory Operations for Immunology and Inflammation, Office of Regulatory Operations in the Center for Drug Evaluation and Research
avatar for Thorsten Vetter

Thorsten Vetter

Senior Scientific Officer, Scientific Advice, European Medicines Agency, Netherlands
MD, Board certified Clinical Pharmacologist, Senior Scientific Officer, Scientific Advice Office, European Medicines Agency


Monday June 28, 2021 2:30pm - 3:30pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session

2:30pm EDT

#137 SL: Health Canada Town Hall
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-544-L04-P; CME 1.00; IACET 1.00; RN 1.00

Health Canada will be providing updates on its regulatory innovation agenda and invite questions of general interest.

Learning Objectives

Describe the modernization of the Clinical Trial Regulations, renewal of the Special Access Program, and the Advanced Therapeutics Pathway.

Chair

Evelyn Soo, PhD

Speaker

Panelist
Elizabeth Toller, MA

Modernizing Health Canada’s Clinical Trial Framework: Toward a Risk-Based Approach
Carole Legare, MD

Panelist
Kenneth Joly, MS, MSc



Speakers
avatar for Evelyn Soo

Evelyn Soo

Director, Bureau of Gastroenterology, Infection and Viral Diseases, HPFD, Health Canada, Canada
Evelyn Soo has been with Health Canada since 2009 where she has held various scientific and regulatory positions. She is currently the Director of the Bureau of Gastroenterology, Infection and Viral Diseases in Health Canada's Therapeutic Products Directorate. Prior to joining Health... Read More →
avatar for Kenneth Joly

Kenneth Joly

Policy Analyst, Office of Policy and International Collaboration, BRDD, Health Canada, Canada
Kenneth Joly is a Policy Analyst in the Office of Policy and International Collaboration at the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) of Health Canada, and he has worked at BRDD since 2008. Ken is one of the policy leads working to bring the Advanced Therapeutic... Read More →
avatar for Carole Legare

Carole Legare

Director, Office of Clinical Trials, TPD, Health Canada, Canada
After gaining experience in clinical practice and public health, Dr Carole Légaré joined Health Canada in 2002 where she initially worked in pharmacovigilance. She also worked as a senior medical advisor for the Centre for Biologics Evaluation during the H1N1 influenza pandemic... Read More →
avatar for Elizabeth Toller

Elizabeth Toller

Associate Director General, Policy, Planning and International Affairs, Health Canada, Canada
Elizabeth Toller is an experienced policy specialist and public sector leader with over eleven years’ experience working in the Government of Canada. Her passion for health issues and social policy has seen Elizabeth split her time in government between Health Canada, Immigration... Read More →


Monday June 28, 2021 2:30pm - 3:30pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Forum
  • Beginner Intermediate
  • Featured Topics Regulator Thinking
  • Credit Type ACPE, CME, IACET, RN
  • Student Programming Regulator Thinking
  • Featured Topics Regulator Thinking
  • Tags Forum

2:30pm EDT

#138 SL: Advancing ICH Quality Standards to Support Continual Improvement and Innovation in Manufacturing Technologies and Approaches
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-545-L04-P; CME 1.00; IACET 1.00; RN 1.00

Global leaders will convene to discuss the latest developments in the progression of harmonized ICH guidelines for pharmaceutical quality. This session will highlight the significance of guidelines currently under development and discuss considerations for their implementation. There will also be an opportunity for the audience to ask questions and engage with the original authors of these important guidelines.

Learning Objectives

Describe the role of ICH quality guidelines in creating efficiency and allowing for the implementation of modern technologies, increased patient access, and fewer disruptions to manufacturing; Discuss ICH guidelines recently issued for public consultation and their anticipated impact; Discuss ICH’s multi-year strategy for modernization of ICH quality guidelines and what topic areas will be important for harmonization in the future.

Chair

Amanda Marie Roache, MS

Speaker

Q9(R1) Revision of ICH Quality Risk Management Framework to Support More Proactive Approach to Continual Improvement
Rick Friedman, MSc

ICH Quality Discussion Group and the Future of Quality Guidelines
Roger Nosal, PhD

Q13 Continuous Manufacturing to Improve Efficiency, Agility, and Flexibility of Pharmaceutical Manufacturing
Wendy Zwolenski-Lambert, MSc



Speakers
avatar for Amanda Roache

Amanda Roache

Senior Director, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA), United States
Amanda Roache, MPP, is a Senior Director in PhRMA’s Science and Regulatory Advocacy Department. She leads PhRMA’s work under the International Council for Harmonisation (ICH) as well as key science and regulatory activities related international regulatory policy, advocacy in... Read More →
RF

Rick Friedman

Deputy Director, OMQ, Office of Compliance, CDER, FDA, United States
Richard L. Friedman is Deputy Director, Office of Manufacturing and Product Quality, in the compliance office in FDA/CDER. This position includes review of regulatory actions and policy development. Prior to joining FDA in 1990, he worked in toxicology research at Parke-Davis. Mr... Read More →
avatar for Roger Nosal

Roger Nosal

Vice President, Head of Global CMC, Pfizer Inc, United States
Roger Nosal is Vice President & Head of Global Chemistry, Manufacturing & Controls at Pfizer. Roger has contributed to the evolution of Quality by Design & has advocated for global regulatory harmonization through several ICH, PhRMA, ISPE, PQRI, AAPS, IFPAC, ACS & DIA technical committees... Read More →
avatar for Wendy Zwolenski-Lambert

Wendy Zwolenski-Lambert

Director, Regulatory Affairs CMC Strategy and Policy, Novartis Pharma AG, Switzerland
Wendy Zwolenski-Lambert Wendy Zwolenski-Lambert is the Efpia topic lead on the ICH Q13 Continuous Manufacturing Expert Working Group. Following a decade working in medical devices and drug delivery systems, she moved to biopharmaceutical manufacturing of monoclonal antibodies. She... Read More →


Monday June 28, 2021 2:30pm - 3:30pm EDT
TBD Virtual Event Horsham, PA 19044
  10: RegCMC-Product Quality, Forum
  • Beginner Intermediate
  • Featured Topics Regulator Thinking
  • Credit Type ACPE, CME, IACET, RN
  • Student Programming Regulator Thinking
  • Featured Topics Regulator Thinking
  • Tags Forum

2:30pm EDT

#131 SL: How are Medical and Health Economics Data Generated and Disseminated to Various Customer Segments?
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-538-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will educate professionals in the pharmaceutical, biotech, and device industries and government employees on how medical and health economics data is generated and disseminated to different customer segments in support of both approved and investigational agents. Participants will benefit from an improved understanding of how the regulatory environment is modifying the requirements for pharmaceutical companies to disseminate this data to both the prescribing and decision maker communities.

Learning Objectives

Describe health economic and outcomes research and potential consumers of this research; Examine how health economic and outcomes research data is communicated and the expansion of customer segments in this field; Discuss a case study on the benefits and challenges of communicating health economics and outcomes research to a variety of customer segments.

Chair

J. Lynn Bass, PharmD, RPh

Speaker

A Discussion: The Communication of Clinical and Health Economic Data to Different Customer Segments - A Global Industry Perspective
Cameron Tew, MBA

A Discussion: The Communication of Clinical and Health Economic Data to Different Customer Segments - An Individual Company Perspective
Donna Booth, PharmD



Speakers
avatar for J. Lynn Bass

J. Lynn Bass

Senior Director, Medical Sciences, Medexus Pharma, Canada
With 20+ years of experience in Medical Science Liaison and Medical Affairs roles across the pharmaceutical industry, Lynn is currently the Senior Director, Medical Sciences at Medexus Pharma. Her industry career has spanned many therapeutic areas and she has authored/ co-authored... Read More →
avatar for Cameron Tew

Cameron Tew

Senior Vice President, Research Services/Business Operations, Best Practices LLC, United States
Cameron Tew is Sr. Vice President of Research for Best Practices, LLC. He oversees its Medical Affairs practice, facilitating the work done via its Medical Affairs Consortium He has 17 years of executive experience spanning consulting and advisory services for those in the Medical... Read More →
avatar for Donna Booth

Donna Booth

Director, Field Medical HTA and Policy, US Medical Affairs, GlaxoSmithKline, United States
Donna V. Booth, B.S, PharmD. is the Director of Field Medical HTA and Policy at GlaxoSmithKline. She has extensive experience across Medical Affairs as Medical Information leader aligned to various therapeutic areas as well as Payers & Policymakers; as Health Policy Liaison focused... Read More →


Monday June 28, 2021 2:30pm - 3:30pm EDT
TBD Virtual Event Horsham, PA 19044
  12: Value-Access, Session |   04: MedAffairs-SciComm, Session

3:30pm EDT

#140 IT: Phlexglobal Innovation Theater: Streamlining TMF Documentation Through Clinical Automation
Component Type: Session
Level: Intermediate

Maintaining a healthy TMF means properly filing documents in a timely manner. The answer to this challenge? Automation! In this session we will explore how Phlexglobal (the leading technology and services organization for clinical and regulatory matters) has been using AI technology to implement the latest TMF best practices directly into the system so you can automate time-consuming manual processes. Join us to discover our vision for improving TMF Quality.

Chair

Phlexglobal Inc


Speakers
avatar for Christopher Englerth

Christopher Englerth

Head Global Marketing, Phlexglobal, United States
avatar for Phlexglobal Inc

Phlexglobal Inc

United States
avatar for James Nichols

James Nichols

Chief Product Officer, Phlexglobal, United States
Jim has nearly 30 years of experience with compliant software solutions for regulated processes in both the insurance and life sciences industries. He has held senior management positions at Intracorp (a CIGNA company), Liquent, Thomson Reuters, ePharmaSolutions, DitaExchange and... Read More →
avatar for Sarah Tucker

Sarah Tucker

Senior Vice President, Customer Success, Operations, Phlexglobal, United States
Sarah has 20 years’ experience working with Trial Master Files having started her career at Pfizer and moved from the Sponsor side of TMFs to Phlexglobal in 2007 to grow out TMF services. Sarah now resides in Pennsylvania, USA and is the SVP Customer Management for Phlexglobal ensuring... Read More →


Monday June 28, 2021 3:30pm - 4:00pm EDT
TBD Virtual Event Horsham, PA 19044

3:30pm EDT

#141 IT: Medidata Innovation Theater: Bench to Market in Record Time with Decentralized Technology
Component Type: Session
Level: Intermediate

How do you develop COVID-19 vaccines and treatments safely in less than a year, virtually? The answer is decentralized technologies, which allowed for patient participation outside of the traditional trial site and virtual clinical oversight activities, on a single platform. Through remote data capture linked to real time data insights - enabling faster decision making and issue resolution - learn how Medidata was able to help customers get life saving vaccines to patients in record time.

Chair

Medidata, a Dassault Systemes Company


Speakers
avatar for Anthony Costello

Anthony Costello

SVP and President, Patient Cloud, Medidata, a Dassault Systèmes company, United States
Anthony Costello is SVP of Patient Cloud at Medidata. After beginning his clinical research career at Genentech 20 years ago, Anthony Costello has gone on to co-found several clinical trials technology start-up companies including Nextrials (acquired by PRA Health Sciences) and Mytrus... Read More →
avatar for Lisa Moneymaker

Lisa Moneymaker

SVP, Clinical Operations Technologies, Medidata, a Dassault Systèmes company, United States
Lisa is the Vice President of Clinical Operations Technology at Medidata. She has over 20 years of pharma, biotech, and medical device industry experience, delivering complex system solutions in support of excellence in clinical trial execution. Lisa's background spans consulting... Read More →


Monday June 28, 2021 3:30pm - 4:00pm EDT
TBD Virtual Event Horsham, PA 19044

3:30pm EDT

#142 IT: Microsoft Innovation Theater: Massive Deep Learning Language Models and the Application to Life Sciences
Component Type: Session
Level: Intermediate

Massive deep learning language models, such as BERT and GPT-3, have improved the state of the art on nearly every natural language processing task. Microsoft continues to advance this field and believe that better natural language generation can be transformational for a variety of life science applications. Microsoft Project Turing is introducing Turing Natural Language Generation (T-NLG), one of the largest models ever published at 17 billion parameters, which outperforms the state of the art on a variety of benchmarks and excels when applied to practical tasks in life sciences.

Chair

Microsoft Corporation


Speakers
avatar for Microsoft Corporation

Microsoft Corporation

Microsoft Corporation, United States
avatar for Robert Horton

Robert Horton

Senior Data and Applied Scientist, Microsoft, United States
Robert Dr. Horton is a senior data scientist with the Azure AI Customer Engineering (ACE) Team, where he works with customers to develop machine learning models and to design and evaluate approaches for extracting knowledge from data. Bob earned his PhD in Biomedical Sciences at the... Read More →
avatar for Mario Inchiosa

Mario Inchiosa

Principal Data Scientist, Microsoft, United States
Mario’s passion for data science and computing at scale drives his work at Microsoft, where he focuses on delivering scalable machine learning and AI platforms. Previously, Mario served as Revolution Analytics’ Chief Scientist and as Analytics Architect in IBM’s Big Data organization... Read More →
avatar for Casey King

Casey King

Director of Strategy and Innovation, Office of the CTO, HLS, Microsoft, United States
William Casey King is the Director of the Capstone Program at the Jackson Institute for Global Affairs, Yale University and a Director of Strategy and innovation in the Office of the CTO for Healthcare and Life Sciences at Microsoft. Previously, King was the founding Executive Director... Read More →


Monday June 28, 2021 3:30pm - 4:00pm EDT
TBD Virtual Event Horsham, PA 19044

4:00pm EDT

#146 SL: Driving Innovation in Data Standards and Regulatory Submissions at FDA
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-550-L04-P; CME 1.00; IACET 1.00; RN 1.00

The FDA session will focus on data strategy and data standards initiatives, e.g., SPL to FHIR, IDMP, RWD, CDISC Study Data, HL7 Vulcan, Technology Modernization.

Learning Objectives

Explain current and emerging data standards; Describe activities underway in the areas of data standards and regulatory submissions; Explain the FDA data strategy.

Chair

Ron Fitzmartin, PhD, MBA

Speaker

Panelist
Mitra Rocca, MSc

Panelist
Brenda Baldwin, PhD

Panelist
Ta-Jen Chen, MS



Speakers
avatar for Ron Fitzmartin

Ron Fitzmartin

Senior Informatics Advisor, Office of the Director, CBER, FDA, United States
Ron Fitzmartin is Senior Informatics Advisor, Office of the Director, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory submissions... Read More →
avatar for Brenda Baldwin

Brenda Baldwin

Microbiologist/Primary Reviewer, OVRR/DVRPA, CBER, FDA, United States
Dr. Baldwin is a Primary Reviewer in the Office of Vaccines Research and Review (OVRR) at the FDA. In addition to her review activities, Dr. Baldwin has become the leading expert in OVRR on the use of clinical study standardized data. Dr. Baldwin’s involvement with CDISC began in... Read More →
avatar for Ta-Jen Chen

Ta-Jen Chen

Project Management Officer, OSP, CDER, FDA, United States
Mr. Chen is a project management Officer at Office of Strategic Programs, CDER, US Food and Drug Administration, where he is responsible for the development and implementation of electronic data standards for CDER regulatory review. As an FDA delegate to ICH E2B Expert Working Group... Read More →
avatar for Mitra Rocca

Mitra Rocca

Associate Director, Medical Informatics, Office of Translational Science, CDER, FDA, United States
Mitra Rocca joined FDA in 2009 as the Senior Medical Informatician responsible for developing the health information architecture of the Sentinel System. She leads the FDA CDER Health Information Technology board and serves as the medical informatics expert at CDER. Prior to joining... Read More →


Monday June 28, 2021 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  03: Data-Data Standards, Session

4:00pm EDT

#145 SL: Realizing the Value of Digital Biomarkers Across the Product Lifecycle
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-549-L04-P; CME 1.00; IACET 1.00; RN 1.00

How should your organization be using digital biomarkers? Do you have a roadmap for digital biomarkers? This session will share examples of best practices of how digital biomarkers can be used to add value across the product lifecycle.

Learning Objectives

Demonstrate the basics of a digital biomarker and the value it can add to diagnostics and therapies across their lifecycle; Evaluate challenges in the development, deployment and reimbursement of digital biomarkers; Identify pathways to integrate digital biomarkers into their pipelines; Define the questions that organizations should answer before beginning digital biomarker development.

Chair

John Hall, PhD

Speaker

Panelist
Tim McCarthy, PhD, MBA

Panelist
Diane Stephenson, PhD

Panelist
Matthew Bonam

Panelist
Mo Ali



Speakers
MA

Mo Ali

Vice President, Digital Analytics and Performance, GlaxoSmithKline, United States
MB

Matthew Bonam

Global Head, BioPharma R&D Digital Health, AstraZeneca, United Kingdom
avatar for John Hall

John Hall

Head of Life Sciences, Huma, United Kingdom
John joined Huma as Head of Life Sciences in April 2020 and leads Huma's relationships with pharma companies across a portfolio of decentralized trial, digital biomarker and companion product solutions. John has over 20 years of experience in the life sciences industry. He spent his... Read More →
avatar for John Hall

John Hall

Head of Life Sciences, Huma, United Kingdom
John joined Huma as Head of Life Sciences in April 2020 and leads Huma's relationships with pharma companies across a portfolio of decentralized trial, digital biomarker and companion product solutions. John has over 20 years of experience in the life sciences industry. He spent his... Read More →
avatar for Tim McCarthy

Tim McCarthy

Head, Digital Medicine and Translational Imaging, Pfizer Inc, United States
Tim leads the Digital Medicine & Translational Imaging group at Pfizer. This team is dedicated to applying sensor- and non-invasive imaging-based technologies to clinical development programs across the Pfizer enterprise. He has a background in Positron Emission Tomography which he... Read More →
avatar for Diane Stephenson

Diane Stephenson

Executive Director, Critical Path Institute, United States
Diane Stephenson is a neuroscientist by training with 30 years combined experience in academic neuroscience and drug discovery. Dr. Stephenson received her undergraduate degree in Biochemistry at University of California and her Ph.D. in Medical Neurobiology from Indiana University... Read More →


Monday June 28, 2021 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  03: Data-Data Standards, Forum |   02: ClinTrials -ClinOps, Forum

4:00pm EDT

#147 SL: Advancing the Science of Patient Input: How are WE doing? Multi-Stakeholder Perspective
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-551-L04-P; CME 1.00; IACET 1.00; RN 1.00

This forum will present current efforts and future opportunities to advance the incorporation of patient input into the medical product lifecycle. A panel of experts will discuss examples of how patient input have informed medical product decisions.

Learning Objectives

Discuss current progress by key stakeholders in incorporating patient input into medical product development and regulatory decision-making; Discuss approaches and best practices to collect, analyze, assess quality, and present patient input; Identify opportunities for further enhancing the incorporation of patient input across the medical product lifecycle.

Chair

Pujita Vaidya, MPH

Speaker

Panelist
Michelle Tarver, MD, PhD

Panelist
David S. Reasner, PhD

Panelist
Annie Kennedy

Panelist
Jessica S. Scott, JD, MD

Panelist
Robyn T. Carson, MPH



Speakers
avatar for Jessica Scott

Jessica Scott

Head of R&D Patient Engagement Office, Takeda Pharmaceutical Company, United States
Dr. Jessica Scott is the Head of R&D Patient Engagement at Takeda. Prior to Takeda, she was with Global Medical Organization, leading efforts related to clinical trial transparency, patient centricity initiatives, bioethical issues and the development of GSK’s approach to sharing... Read More →
avatar for Annie Kennedy

Annie Kennedy

Chief of Policy and Advocacy, EveryLife Foundation for Rare Diseases, United States
Annie has served within the community for nearly three decades through her roles with Parent Project Muscular Dystrophy (PPMD) and the Muscular Dystrophy Association (MDA). In that time she helped lead legislative efforts around passage and implementation of the MD-CARE Act (2001... Read More →
avatar for Pujita Vaidya

Pujita Vaidya

Global Regulatory and R&D Policy Director, Amgen, United States
Pujita Vaidya serves as a Global Regulatory and R&D Policy Director at Amgen, working to develop, advocate for, and implement Amgen positions on regulatory policies, specifically Patient Centricity, Pediatrics, and Rare Diseases. Her work includes partnering with cross-functional... Read More →
avatar for Robyn Carson

Robyn Carson

Vice President, Patient-Centered Outcomes Research, AbbVie, United States
Robyn Carson has worked in the pharmaceutical industry for 15 years and leads the Patient-Centered Outcomes Research (PCOR) function at AbbVie. In this role, Robyn is responsible for leading a team responsible for the development of innovative strategies to evaluate meaningful outcomes... Read More →
avatar for David Reasner

David Reasner

Division Director, Division of Clinical Outcome Assessment, OND, CDER, FDA, United States
David is VP, Data Science and Head, Study Endpoints at Ironwood Pharmaceuticals located in Cambridge, Massachusetts. The Data Science group is responsible for development of analytical strategies bridging early phase research through development into the biopharmaceutical product... Read More →
avatar for Michelle Tarver

Michelle Tarver

Deputy Director, Office of Strategic Partnerships & Technology Innovation, CDRH, FDA, United States
As the Deputy Director of the Office of Strategic Partnerships and Technology Innovation (OST), Dr. Tarver helps provide leadership for all scientific collaborative and emerging technology-related activities at the Center for Devices and Radiological Health (CDRH). The Patient Science... Read More →
avatar for Pujita Vaidya

Pujita Vaidya

Global Regulatory and R&D Policy Director, Amgen, United States
Pujita Vaidya serves as a Global Regulatory and R&D Policy Director at Amgen, working to develop, advocate for, and implement Amgen positions on regulatory policies, specifically Patient Centricity, Pediatrics, and Rare Diseases. Her work includes partnering with cross-functional... Read More →


Monday June 28, 2021 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  05: Patient Engagement, Forum

4:00pm EDT

#148 SL: Challenges and Opportunities in Early Development of RNA Therapeutics
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-552-L04-P; CME 1.00; IACET 1.00; RN 1.00

RNA molecules play a variety of important roles in cells, including structural (ribosomal RNA), enzymatic (small nuclear RNA), and information transfer (messenger RNA). The relatively large size and well-known instability of RNA would make it an unlikely vehicle for drug development. However, in recent years, it has become clear that RNA molecules are an emerging as a class of therapeutics of relevance to multiple diseases, most recently including vaccines. In this session, we will be discussing different examples of RNA based therapeutics, as well as some regulatory considerations.

Learning Objectives

Describe different types of RNA therapeutics; Discuss some of the unique challenges involved in the production of RNA therapeutics.

Chair

Philip (P.J.) Brooks, PhD

Speaker

Messenger RNAs as Drugs
Philip Santangelo

Nonclinical Development of Oligonucleotide Therapeutics
Girish R Chopda, PhD

Regulatory Preclinical Considerations for mRNA Therapeutic Products
Christopher Saeui, PhD



Speakers
avatar for Philip (P.J.) Brooks

Philip (P.J.) Brooks

Program Director, Office of Rare Diseases Research, National Center for Advancing Translational Sciences (NCATS), NIH, United States
Philip John (P.J.) Brooks is a Program Director in the NCATS Office of Rare Diseases Research. He is also the Working Group Coordinator for the NIH Common Fund program on Somatic Cell Genome Editing. He earned his Ph.D. in neurobiology from the University of North Carolina at Chapel... Read More →
avatar for Girish Chopda

Girish Chopda

Associate Director, Nonclinical Development, Dicerna Pharmaceuticals, United States
Dr. Chopda is a an Associate Director in the nonclinical ADME group at Dicerna Pharmaceuticals for over 7 years. He received his PhD at Northeastern University and worked at Abbvie Worcester, MA for a year prior to transitioning to Dicerna. At Dicerna, he has worked towards transitioning... Read More →
CS

Christopher Saeui

Biologist, Pharm/Tox/OTAT, CBER, FDA, United States
Christopher Saeui has over 15 years combined experience working in the pharmaceutical, biomedical research, and regulatory review space. He currently serves as a pharmacology/toxicology reviewer for cellular and gene therapy products in the Division of Pharmacology/Toxicology in the... Read More →
PS

Philip Santangelo

Professor, Coulter Department of Biomedical Engineering, Georgia Institute of Technology & Emory University School of Medicine, United States


Monday June 28, 2021 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  06: PreClin Dev-EarlyPhaseCR, Session

4:00pm EDT

#144 SL: Launching Megatrials During a Pandemic: Lessons Learned from COVID-19 Vaccine Clinical Trials
Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-548-L04-P; CME 1.00; IACET 1.00; RN 1.00

As drug development moves toward precision and targeted medicines, megatrials which include tens of thousands of participants are uncommon. But the developers of COVID-19 vaccines launched complex trials of this size in 2020, encountering not just the challenges of massive clinical trials but also those of running clinical trials during the pandemic. In this forum, senior-level executives from biopharma companies which conducted COVID-19 vaccine trials will discuss the experience of clinical operations in this context, sharing what they expected and did not expect, lessons learned, and what they will take forward to the conduct of future research.

Learning Objectives

Describe some of the unique challenges of launching extremely large clinical trials; Discuss unique and innovative practices and solutions that clinical teams developed to manage these challenges; Assess ideas for best practices that can be applied to future clinical trial conduct.

Chair

Lindsay McNair, MD, MPH, MS

Speaker

Panelist
Melanie Ivarsson, PhD, MBA

Panelist
Dawn M Furey

Panelist
Sarah Tweedy



Speakers
avatar for Lindsay McNair

Lindsay McNair

Chief Medical Officer, WIRB-Copernicus Group (WCG), United States
Lindsay McNair, MD, MPH, MS in Bioethics is the Chief Medical Officer for the WIRB-Copernicus Group (WCG). She oversees the physician team within the WCG IRB, and provides consultation to institutions and biopharma companies on a wide range of issues related to clinical protocol design... Read More →
DF

Dawn Furey

Vice President, Portfolio Delivery Operations, Janssen, United States
Dawn Furey is a 20+ year clinical operations leader and currently VP and Head of Portfolio Delivery Operations (PDO) at Janssen, Research & Development where she leads central planning and delivery for Janssen’s active therapeutic areas (Oncology, Immunology, Neuroscience, Vaccines... Read More →
MI

Melanie Ivarsson

Chief Development Officer, Moderna, United States
avatar for Sarah Tweedy

Sarah Tweedy

Vice President, Clinical Operations Head – Vaccines, Pfizer Inc, United States


Monday June 28, 2021 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  07: ProjMgt-StrategicPlanning, Forum |   02: ClinTrials -ClinOps, Forum

4:00pm EDT

#149 SL: Culture of Quality: A Competitive Advantage
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-553-L04-P; CME 1.00; IACET 1.00; RN 1.00

ICH E8(R1) requires sponsors to “Create a culture that values and rewards critical thinking and open dialogue”. This session provides strategic and tactical approaches for optimizing an organization’s culture of quality and critical thinking approaches.

Learning Objectives

Summarize the state of research and development culture of quality; Recognize culture of quality values, behaviors, traditions; Describe phases for optimizing culture of quality; Describe critical thinking and why it is important to a quality culture; Explain the critical thinking 4As framework; Describe a maturity model for developing critical thinking skills focused on drug development.

Chair

Leslie Sam

Speaker

Critical Thinking: The MUST HAVE When Elevating your Business Through Quality Culture
Michael Torok, PhD

Regulators Perspective on the Value of a High Performing Culture of Quality in Clinical Trial Research
Jennifer Martin



Speakers
avatar for Michael Torok

Michael Torok

Senior Director, Clinical Quality Assurance, Astellas, United States
Michael Torok, Ph.D. is a Senior Director in Clinical Quality Assurance at Astellas. He currently leads Astellas’ CQA Process Improvement, Operational Excellence, and Audit Center of Excellence groups. His current work interests include using statistical processes to derive holistic... Read More →
avatar for Leslie Sam

Leslie Sam

Principal Consultant, Wool Consulting Group, United States
Principal Consultant, Wool Consulting Group, supporting development/refinement of quality management, issue management & risk management systems in clinical research. Accomplished, results-driven, passionate clinical research and quality professional with 20+ years of transferable... Read More →
avatar for Jennifer Martin

Jennifer Martin

GCP Operations Manager and Lead Senior GCP Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Jennifer has a BSc in Chemistry. Prior to joining the MHRA in 2006 as a Good Clinical Practice (GCP) Inspector, she spent 13 years in the Pharmaceutical industry in pre-clinical working to Good Laboratory Practice (GLP) then moving to Clinical Research as a Clinical Research Associate... Read More →


Monday June 28, 2021 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  08: RD Quality-Compliance, Session

4:00pm EDT

#151 SL: Next Generation of Combination Products: Insights from the FDA Office of Combination Products and Industry Expert Application
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-555-L04-P; CME 1.00; IACET 1.00; RN 1.00

This forum will present FDA regulatory insights and discuss examples of current trends in the space of combination products. A panel of FDA representatives will provide updates on FDA policy and industry experts will share practices on application.

Learning Objectives

Discuss and analyze the latest FDA regulatory expectations and challenges; Recognize current topics the FDA is observing and what industry should continue to do and what is causing challenging circumstances.

Chair

James Wabby, MHS

Speaker

FDA Update
John Barlow Weiner, JD

Panelist
Susan Neadle, MS

Panelist
Kate Gillespie, BSN, MBA



Speakers
avatar for John Weiner

John Weiner

Associate Director for Policy, Office of Combination Products, OCPP, OC, FDA, United States
John Barlow Weiner is the Associate Director for Policy in the Food and Drug Administration's Office of Combination Products, which is tasked with ensuring the sound and consistent regulation of combination products and also with the classification and assignment for regulation of... Read More →
avatar for James Wabby

James Wabby

Global Head, Regulatory Affairs, Emerging Technologies and Combination Products, Abbvie, United States
James Wabby is the Executive Director of Regulatory Affairs (Emerging Technologies and Combination Products) at AbbVie in Irvine, California. He has over 20 years of experience in increasing quality compliance and regulatory affairs responsibilities within the GxP regulated environment... Read More →
KG

Kate Gillespie

Senior Director, Global Product Vigilance and Post Market Reporting, Johnson & Johnson, United States
SN

Susan Neadle

Executive Director & Head, Combination Products, Devices, Diagnostics & Digital, Amgen, United States
Susan Neadle, MS, BS, FAAO, a DEx and PE Black Belt, is now Executive Director, Combination Products, Devices , Diagnostics & Digital Health RA, at Amgen. This follows a very successful career of 25+ years at Johnson & Johnson, where she held integral leadership roles in R&D and QA/QE... Read More →


Monday June 28, 2021 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Forum

4:00pm EDT

#152 SL: Implementation Progress of ICH Q12
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-556-L04-P; CME 1.00; IACET 1.00; RN 1.00

This guideline provides a globally agreed framework to facilitate the management of such post-approval CMC changes in a predictable and efficient manner across the product lifecycle. A globally harmonised approach regarding technical and regulatory considerations for lifecycle management will benefit patients, industry, and regulatory authorities by promoting innovation and continual improvement in the pharmaceutical sector, strengthening quality assurance and improving supply of medicinal products.

Learning Objectives

Define the application of Q12 principles that enable managing post-approval changes in a more predictable and efficient manner; Define key opportunities and challenges with Q12 implementation from industry and regulatory experts; Explain from the real-life case studies applying Q12 principles; Discuss learnings from the Established Conditions pilot.

Chair

Ingrid Markovic, PhD

Speaker

Use of ICH Q12 Lifecycle Management Tool Post Approval Change Management Protocol for Biologics/Plasma-Derived Proteins
Dieter Brazel, PhD

ICH Q12 Implementation Update and Reflections on the Established Conditions Pilot
Joel Welch, PhD

Industry Update
Roger Nosal, PhD



Speakers
avatar for Ingrid Markovic

Ingrid Markovic

Senior Science Advisor, Office of the Center Director, CBER, FDA, United States
Ingrid Markovic, Ph.D. is CMC Policy Lead in the CBER Immediate Office of the Center Director where she leads CMC Policy activities partnering with internal and external stakeholders to ensure consistent interpretation and application of CMC policies and programs. In the international... Read More →
avatar for Dieter Brazel

Dieter Brazel

Senior Director, Technical and Strategic Area Lead, Plasma, GRA CMC, CSL Behring GmbH, Germany
After obtaining his Diploma in Chemistry Dieter Brazel has earned a Ph.D. from Stuttgart University (thesis Max Planck Institute for Biochemistry). Further he holds a Masters in Regulatory Affairs in Regulatory Affairs University of Bonn. He has spent his entire career in the biopharmaceutical... Read More →
avatar for Roger Nosal

Roger Nosal

Vice President, Head of Global CMC, Pfizer Inc, United States
Roger Nosal is Vice President & Head of Global Chemistry, Manufacturing & Controls at Pfizer. Roger has contributed to the evolution of Quality by Design & has advocated for global regulatory harmonization through several ICH, PhRMA, ISPE, PQRI, AAPS, IFPAC, ACS & DIA technical committees... Read More →
JW

Joel Welch

Associate Director for Biosimilar& Regulatory Strategy, OBP, OPQ, CDER, FDA, United States
Joel Welch is the Associate Director for Biosimilar & Strategy in the Office of Biotechnology Products in the Office of Pharmaceutical Quality at the US Food and Drug Administration. He is responsible for assessing emerging, complex, or precedent-setting issues impacting science policies... Read More →


Monday June 28, 2021 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  10: RegCMC-Product Quality, Session

4:00pm EDT

#143 SL: A Journey of Interdisciplinary Collaboration to Improve Safety Evaluation in Drug Development
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-547-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss the outputs from the DIA-ASA joint scientific working group which include an aggregate safety assessment planning tool, benefit risk assessment planning, and open source interactive graphical tools, and how to implement them.

Learning Objectives

Describe the importance of multidisciplinary collaboration; Evaluate the aggregate safety assessment planning tool; Discuss the status of benefit risk evaluation planning and how pre-marketing safety monitoring interconnects with benefit-risk evaluation; Identify open source interactive safety graphics tools with pragmatic guidance that can be easily applied to routine safety evaluation.

Chair

Mengchun Li, MD, MPA

Speaker

Aggregated Safety Assessment Planning
Barbara Hendrickson, MD

Benefit-Risk Planning Across the Industry and Best Practice Sharing
Brian Edwards, DrMed

Interactive Safety Graphics
James Buchanan, PharmD

Panelist
Lothar Tremmel, PhD



Speakers
avatar for Brian Edwards

Brian Edwards

Principal Consultant, Pharmacovigilance and Drug Safety, Vice-President ACRES, NDA Group, United Kingdom
After his training in hospital medicine and clinical research for 14 years, Dr. Edwards joined the UK Medicines Control Agency (MHRA) in 1994 where he had various responsibilities as a pharmacovigilance assessor. In 1999 he joined Parexel to become Senior Medical Director before joining... Read More →
avatar for James Buchanan

James Buchanan

President, Covilance LLC, United States
Dr. James Buchanan is presently an independent drug safety consultant. After leaving Gilead Sciences, Dr. Buchanan started the drug safety department at Tularik Inc where he acted as Chief Safety Officer until the company was acquired 5 years later by Amgen. Following the merger with... Read More →
avatar for Barbara Hendrickson

Barbara Hendrickson

Immunology Therapeutic Area Head, Pharmacovigilance and Patient Safety, AbbVie, Inc., United States
Dr. Barbara Hendrickson is the Immunology Therapeutic Area Head in Pharmacovigilance and Patient Safety. She is a physician with subspecialty training in pediatrics and infectious diseases and has over 16 years of pharmaceutical industry experience. In addition, Dr. Hendrickson participates... Read More →
avatar for Mengchun Li

Mengchun Li

Director, Phamacovigilance, Global Alliance For TB Drug Development, United States
Dr. Mengchun Li is the Director of Pharmacovigilance at TB Alliance. In this position, Dr. Li chairs the multidisciplinary safety management team for all compounds and is responsible for clinical safety and pharmacovigilance. Prior to this, Dr. Li worked at Janssen Pharmaceutical... Read More →
avatar for Lothar Tremmel

Lothar Tremmel

VP, Quantitative Clinical Sciences and Reporting, CSL Behring, United States
Dr. Tremmel worked in the pharmaceutical industry for over 25 years, where he built and led highly effective groups of statisticians, programmers, and data managers. He is currently the VP of Quantitative Clinical Sciences and Reporting at CSL Behring. Recent appointments include... Read More →


Monday June 28, 2021 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  11: Statistics, Session |   01: ClinSafety-PV, Session

4:00pm EDT

#150 SL: Continuity of Randomized Controlled Trials During the Trying Times of COVID-19 and What We’ve Learned
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-554-L04-P; CME 1.00; IACET 1.00; RN 1.00

There were unprecedented challenges associated with conducting clinical trials during COVID-19. This session will explore how sponsors and HAs worked together to address these issues and continue efforts to develop medical products and the lessons learned from making those adaptations. The session will also consider adaptations that may be applicable to trials post-pandemic.

Learning Objectives

Describe how COVID-19 impacted randomized controlled trials (RCTs) including examples of deviations from study protocols; Discuss how sponsors interacted with Health Authorities to maintain awareness of protocol deviations and receive guidance on planned modifications; Identify the best practices that were learned and how we can apply them to future trials.

Chair

Lauren Hetrick

Speaker

Industry Update
David Hilfiker, MS

FDA Perspective
Leonard Sacks, MD

Industry Update
David Vulcano, MBA, RAC



Speakers
avatar for Lauren Hetrick

Lauren Hetrick

Senior Director, Regulatory Policy and Intelligence, AbbVie, Inc., United States
Ms. Hetrick serves in AbbVie’s Regulatory Policy function where she attends to evolving regulations and policies governing pharmaceutical development issued by the US FDA. She monitors policies in their formative stages, analyzes their impact on the company, informs executive staff... Read More →
avatar for David Hilfiker

David Hilfiker

Senior Director, Bioresearch Quality and Compliance, Janssen R&D, United States
David Hilfiker, Senior Director, Janssen Bioresearch Quality and Compliance, has been a part of Johnson & Johnson Family of Companies since 2005. He currently leads clinical quality planning and strategy for the Janssen Oncology therapeutic area, Established Products, and Medical... Read More →
avatar for Leonard Sacks

Leonard Sacks

Associate Director for Clinical Methodology, Office of Medical Policy, CDER, FDA, United States
Leonard Sacks is an Associate Director for Clinical Methodology in the Office off Medical Policy, CDER, FDA, where he has worked on integrating IT opportunities into drug development. He has extensive experience with clinical trials, both as a clinical investigator and subsequently... Read More →
avatar for David Vulcano

David Vulcano

Vice President, Clinical Research Compliance and Integrity, HCA Healthcare, United States
David is a well-known leader in the clinical research industry through numerous associations, boards and initiatives. Among other things he is currently employed by HCA Healthcare, the largest private healthcare provider in the United States, as the Responsible Executive for Clinical... Read More →


Monday June 28, 2021 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  11: Statistics, Session |   09: Regulatory, Session

4:00pm EDT

#153 SL: Regulatory, Industry, Patient, and Academic Perspectives on Machine Learning in Clinical Trials
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-557-L04-P; CME 1.00; IACET 1.00; RN 1.00

Machine / deep learning is being applied in an increasing number of industries, and biopharma is no exception. This session will examine regulator, patient, industry, and technical perspectives on machine learning applications in drug development

Learning Objectives

Identify opportunities to prospectively integrate machine learning approaches and expertise within the modern drug development process; Evaluate challenges in the application of machine learning approaches in clinical trials and assessing benefit/risk; Distinguish between the use and value of historical, contextual, synthetic, and real-world data.

Chair

Stuart Michael Bailey, PhD

Speaker

Industry Perspective
John Zhong, PhD

EMA Update on Machine Learning in Clinical Trials
Florence Butlen-Ducuing, MD, PhD, MS

Patient Perspective
Philip John Green



Speakers
avatar for John Zhong

John Zhong

Vice President, Head of Biometrics, REGENXBIO, Inc., United States
Dr. Zhong is the Vice President of Biometrics at REGENXBIO. Prior to REGENXBIO, he was a Group Head at Biogen, accountable for Innovative Analytics, Rare Disease Statistics, and others. He has 20 years of industry experience successfully bringing the needed treatments to patients... Read More →
SB

Stuart Bailey

Vice President, Head of Analytics and Data Sciences, Biogen, United States
Stuart leads the Analytics & Data Sciences team at Biogen supporting Research & Development of pioneering medicines for neuroscience patients. He holds a Doctorate in Mathematics from Sussex University, U.K. and is an expert in adaptive model-based dose-finding and Bayesian methods... Read More →
FB

Florence Butlen-Ducuing

Senior Scientific Officer, Office of Therapies for Neurological and Psychiatric, European Medicines Agency, Netherlands
avatar for Philip Green

Philip Green

Patient Advocate, Person Living With ALS, United States
Phil was diagnosed with ALS in August of 2018 and immediately dedicated himself to making a difference in the fight against ALS. Phil is active with multiple ALS organizations and institutions (Team Gleason, I AM ALS, Augie’s Quest, ALS TDI, ALS Cure Project, UW Medicine, ALSA... Read More →


Monday June 28, 2021 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  11: Statistics, Forum |   09: Regulatory, Forum

4:00pm EDT

#154 SL: How Can We Compliantly Exchange Pre-Approval Information with Payers
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-558-L04-P; CME 1.00; IACET 1.00; RN 1.00

Discuss the practical challenges with interpretation aspects of the FDA Payer guidance released in 2018 for pre-approval communications and and possible operationalization considerations.

Learning Objectives

Describe how we can proactively and compliantly communicate during pre-approval phase relevant coverage and reimbursement information from industry to payers for population-based coverage decisions.

Chair

Sissi Pham, PharmD

Speaker

Industry Perspective
Stephen Shinall, PhD

Industry Update
Susan A Cantrell, RPh

Industry Update
Lucy Rose, MBA



Speakers
avatar for Sissi Pham

Sissi Pham

Chief Executive Officer, AESARA, United States
Sissi Pham is a founder and CEO of AESARA, Inc. and AESARA Foundation, both established in 2016. AESARA, Inc. was established with the commitment to absorb the administrative cost of the AESARA Foundation to enable the charity to give 100% of the donations to directly to humanitarian... Read More →
SS

Stephen Shinall

Associate Director, Regulatory Affairs, US Advertising and Promotion, AbbVie, Inc., United States
avatar for Susan Cantrell

Susan Cantrell

Chief Executive Officer, Academy of Managed Care Pharmacy (AMCP), United States
Susan A. Cantrell, RPh, CAE Academy of Managed Care Pharmacy Susan Cantrell is Chief Executive Officer of AMCP, the professional association leading the way to help patients get the medications they need at a cost they can afford. AMCP’s diverse membership of pharmacists, physicians... Read More →
avatar for Lucy Rose

Lucy Rose

President, Lucy Rose and Associates, LLC, United States
Lucy graduated as a physician assistant, earned an MBA, and worked for seven years in sales and sales training with Bristol-Myers Squibb prior to serving as the Director of the Division of Drug Marketing, Advertising, and Communications and the Office of Training and Communications... Read More →


Monday June 28, 2021 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  12: Value-Access, Session
  • Beginner Intermediate
  • Credit Type ACPE, CME, IACET, RN
  • Student Programming Regulator Thinking
  • Tags Session

4:00pm EDT

#155 SL: Yes it's about Science, Yes it's about Patients but it's Also ALL About Business
Component Type: Forum
Level: Intermediate

This forum will focus on the many facets of the business of clinical research. Specific topics include: how to move from pharma employee to independent consultant, naming/branding your business, contracts (why, types and terms).

Learning Objectives

Educate on the need for and types of contractual documents; Develop an understanding of the necessary steps for starting a business; Discuss the importance of brand and image.

Chair

Nimita Limaye, PhD

Speaker

Panelist
Frank Hubbard, PhD, MS

Panelist
Chris Matheus, MBA

Panelist
Arturo Chiarella

Panelist
Denise McNerney



Speakers
avatar for Frank Hubbard

Frank Hubbard

President, Global Regulatory Writing Solutions Inc., United States
Following a 14-year career in the Medical Communications Science group at AstraZeneca, Frank founded Global Regulatory Writing Solutions Inc. in late 2013. GRW Solutions provides regulatory submission advice and Communications best practice to the pharmaceutical industry. From 2015... Read More →
avatar for Chris Matheus

Chris Matheus

President, Matheus BD Connections LLC, United States
Chris has over 20 years of experience in clinical research business development. He has focused on clinical trial technologies while working in large CROs and smaller eclinical companies. Chris establishes strong working relationships with customers and co-workers and has built a... Read More →
AC

Arturo Chiarella

Operations Portfolio Lead- Early Assets, Global Clinical Trial Strategy, Bristol-Myers Squibb Company , United States
avatar for Nimita Limaye

Nimita Limaye

Research Vice President, Life Sciences R&D Strategy and Technology, IDC, United States
Nimita Limaye leads R&D Strategy and Technology at IDC Health Insights, providing research-based advisory and consulting services as well as market analysis on key topics within the Life Sciences industry. She is an executive business leader with more than two decades of life sciences... Read More →
avatar for Nimita Limaye

Nimita Limaye

Research Vice President, Life Sciences R&D Strategy and Technology, IDC, United States
Nimita Limaye leads R&D Strategy and Technology at IDC Health Insights, providing research-based advisory and consulting services as well as market analysis on key topics within the Life Sciences industry. She is an executive business leader with more than two decades of life sciences... Read More →
avatar for Denise McNerney

Denise McNerney

Partner, Global Life Sciences Alliance (GLSA), United States
Denise has over 25 years of experience in Business, Marketing, and Technology in the life sciences industry. Her entrepreneurial spirit coupled with her knowledge and resources has led her to build several businesses, processes, and teams. During that time, she has launched new products... Read More →


Monday June 28, 2021 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
 
Tuesday, June 29
 

8:00am EDT

#201 IT: WCG Innovation Theater: Tailored Preparation for Site Success and Trial Continuity - WCG Site Augmentation
Component Type: Session
Level: Intermediate

  • Recruitment and enrollment challenges: Does the clinical trials industry address the root cause
  • Success from the start
  • COVID-19 case study: Top 5 sponsor enrolls 30,000+ patients in just over 3 months
  • 8 biggest challenges facing clinical trial professionals: How site burden continues to exacerbate resources
  • Creating critical time for study patients


Chair

WCG Clinical Services


Speakers
avatar for Tyler Bye

Tyler Bye

Director, Program Strategy and Product Development, WCG ThreeWire, United States
Tyler is currently the Director of Program Strategy and Product Development at WCG ThreeWire. In this role he oversees the strategic deployment of WCG ThreeWire solutions tailored for each indication, and personalized to ever site’s individual needs. With over 12 years of clinical... Read More →
avatar for Molly Hair

Molly Hair

Director, Clinical Strategic Solutions and New Product Development, WCG ThreeWire, United States
Molly is currently the Director of Clinical Strategic Solutions and New Product Development at WCG ThreeWire. With more than 14 years of experience in clinical trial patient recruitment, Molly works with clinical research sites to develop and deploy unique support strategies based... Read More →
avatar for Jamie Harper

Jamie Harper

Director, Site Engagement and Management, WCG ThreeWire, United States
Jamie Harper, MHA, CCRP is currently the Director, Site Engagement and Relations with WCG ThreeWire. With 13 years of experience at a private oncology practice, her main priority at WCG ThreeWIre is to help determine appropriate site strategy and messaging. As Past President of the... Read More →


Tuesday June 29, 2021 8:00am - 8:45am EDT
TBD Virtual Event Horsham, PA 19044

8:00am EDT

#202 IT: Unqork Innovation Theater: Unqork for Clinical Trials
Component Type: Session
Level: Intermediate

Life sciences organizations are looking to transform the patient experience for clinical trial sites, but many run into issues. Using Unqork, biopharma companies & CROs are able to rapidly deploy high-fidelity, complex applications in weeks that enable a broad range of initiatives from site activation to patient recruitment, all without writing a line of code. Unqork integrates seamlessly with client ecosystems, including legacy systems, third-party data sources, and other best-in class tools.

Chair

Unqork


Speakers
avatar for Kara Dennis

Kara Dennis

Head of Healthcare, Unqork, United States
Kara Dennis is the Healthcare go-to-market strategy lead owning Unqork's efforts with payers, providers, and life sciences companies. Kara is from Clarify Health Solutions, an advanced analytics company where she was SVP and GM of Life Sciences. Prior to Clarify, Kara was VP and Managing... Read More →
U

Unqork

United States


Tuesday June 29, 2021 8:00am - 8:45am EDT
TBD Virtual Event Horsham, PA 19044

9:00am EDT

#203 SS: Spotlight Symposia: Important Gaps to Fill with Diversity and Inclusion in Clinical Trials - Moving Beyond Recognition to Action
Component Type: Session
Level: Intermediate

Calls for diversity, equity, and inclusion have grown louder during the pandemic.Health inequalities manifesting in varying infection and mortality rates clearly show the disproportionate impact of COVID-19 on the Black, Latino, Asian, and Indigenous communities. This has heightened the need for more equitable access to healthcare and clinical trials.

This session, which includes patient and physician perspectives, will focus attention on how to overcome the barriers to participation.

Chair

Parexel


Speakers
avatar for Ila Gangotra

Ila Gangotra

Caregiver, United States
Ila Gangotra (BSc, MSc) is a physiologist and chemist, sports retail business owner, wife, mother and grandmother. She is also a caregiver and brings this viewpoint regularly to the medicines development and healthcare ecosystems. She is particularly passionate about ensuring the... Read More →
avatar for Clare Grace

Clare Grace

Chief Patient Officer, Parexel, United States
Dr. Grace leads Parexel's global patient advocacy and site efforts, including patient engagement strategies and efforts to enhance clinical trial diversity as well as new, innovative approaches to help teams and customers work more effectively with investigative sites. Most recently... Read More →
avatar for Parexel

Parexel

United States
avatar for Fabian Sandoval

Fabian Sandoval

Chief Executive Officer and Research Director, Emerson Clinical Research Institute, United States
Dr. Fabian Sandoval has over 25 years of bench to bedside research experience, including in academia, healthcare systems, and the public sector. Before opening the doors to ECRI Dr. Sandoval’s research activities have included bench research at the National Institutes of Neurological... Read More →
avatar for Yasmeem Watson

Yasmeem Watson

Patient, United States
Yasmeem Watson, a Stage III colon cancer survivor, joined Fight Colorectal Cancer’s (CRC) Research Advocacy Training and Support (RATS) Program in 2015. Not only has Yasmeem completed numerous online and in-person trainings through the RATS program, but she has also dedicated herself... Read More →


Tuesday June 29, 2021 9:00am - 10:00am EDT
TBD Virtual Event Horsham, PA 19044

9:00am EDT

#204 SS: Spotlight Symposia: Tales from the Front: Patient Equity and Engagement in Practice from Trial Design Through Execution
Component Type: Session
Level: Intermediate



Chair

Labcorp Drug Development


Speakers
avatar for Gaynor Anders

Gaynor Anders

Senior Director, Patient Engagement Strategy, Innovation and Delivery, Labcorp Drug Development, United States
Gaynor has been working in clinical research for 24 years, exclusively in patient recruitment and engagement. Before joining Covance, Gaynor worked for specialty patient recruitment groups as a senior strategist supporting pharmaceutical, biotech and CRO clients alike. She combines... Read More →
avatar for Labcorp Drug Development

Labcorp Drug Development

Covance Inc., United States
avatar for Kate Griffin

Kate Griffin

Vice President, Digital Strategy and Enablement, Labcorp Drug Development, United States
avatar for Elke Jahn

Elke Jahn

Senior Director, Operational Strategy & Planning Phase IV Solutions, Labcorp Drug Development, United States
As Leader of the Phase IV Strategy & Planning (S&P) team, Elke is globally accountable for providing client specific strategies to address the need for Real World Evidence generation and Phase IIIb/IV Clinical Trial execution requests. This includes proposal generation on a global... Read More →
avatar for Daniel Martin

Daniel Martin

Vice President, Global Laboratory and Extended Services, Labcorp Drug Development, United States
Daniel has over 22 years of Central Labs experience at Covance by LabCorp. His tenure has included both individual and leadership roles within the laboratory, project management, and global lab support & extended services teams. He currently has global oversight for the Clinical Trial... Read More →


Tuesday June 29, 2021 9:00am - 10:00am EDT
TBD Virtual Event Horsham, PA 19044

9:00am EDT

#205 SS: Spotlight Symposia: Three Paths to Success in a Post-COVID World
Component Type: Session
Level: Intermediate

- The status of market uptake for select CNS clinical trials by the pharma industry: rejuvenated interest and continued challenges ahead. - Continuously improved solutions are no longer a nice-to-have. - COVID implications on patient selection, study analytics, and placebo response reduction. - The future of CNS drug development.

Chair

WCG Clinical Services


Speakers
avatar for Bob Dagher

Bob Dagher

Chief Medical Officer, WCG MedAvante-ProPhase, United States
Dr. Bob Dagher is a seasoned executive leader with diverse biopharmaceutical roles in clinical development, medical affairs and commercial strategy. Most recently prior to joining WCG MA-PP, Dr. Dagher was the Chief Medical Officer of Cadent Therapeutics. Preceding that, he had occupied... Read More →
avatar for Mark Opler

Mark Opler

Chief Research Officer, WCG MedAvante-ProPhase, United States
Dr. Mark Opler is Chief Research Officer at WCG MedAvante-ProPhase Inc., managing and directing global research programs. Dr. Opler has served on the faculties of New York University Medical School and in the Department of Clinical Neuroscience at Columbia University’s College of... Read More →


Tuesday June 29, 2021 9:00am - 10:00am EDT
TBD Virtual Event Horsham, PA 19044

9:30am EDT

#206 CH L: Acceleration of Clinical Research by Simultaneously Leveraging Real-World and Clinical Trials Data
Component Type: Workshop
Level: Intermediate

The capability to link clinical trial and real-world (RWD) datasets now exists. The power of linking clinical trial data to real-world data is applicable to literally any indication where visibility into disease progression is of value. Space is limited. When the virtual room is full, attendees attempting to access the session will receive a message noting that the session has reached maximum capacity.

Learning Objectives

Discuss examples of how RWD is being utilized today; Describe the methods to link diverse datasets while protecting patient privacy.

Chair

Michelle Hoiseth


Speakers
avatar for Michelle Hoiseth

Michelle Hoiseth

Chief Data Officer, Parexel, United States
Michelle has been working in the drug and device development industry for 30 years. She has enjoyed a variety of positions that allowed her to create product development plans, run study operations, and support product commercialization objectives. Michelle presently serves Parexel... Read More →


Tuesday June 29, 2021 9:30am - 10:00am EDT
TBD Virtual Event Horsham, PA 19044

9:30am EDT

#209 IT: Medidata Innovation Theater: Engaging Patients Pre- and Post-trial with Registries
Component Type: Session
Level: Intermediate

Clinical trials are often transactional and impersonal. How can we elevate the patient experience while creating long lasting relationships with patients? Through myMedidata Registries, we are extending patient engagement from pre-trial to post-trial to educate, engage, and empower patients. Learn how registries provide patients with an everlasting communication platform including patient data return, sites with pre-screened and qualified referrals, and sponsors with long term follow up.

Chair

Medidata, a Dassault Systemes Company


Speakers
avatar for Kelly McKee

Kelly McKee

Vice President, Patient Recruitment and Registries, Medidata Solutions, United States
Kelly McKee recently joined Medidata as the Sr. Director of Patient Registries and Recruitment with 20 years of experience in clinical trial operations, patient recruitment and innovation. She is a proven clinical trial leader and trailblazer in operationalizing global patient-focused... Read More →


Tuesday June 29, 2021 9:30am - 10:00am EDT
TBD Virtual Event Horsham, PA 19044

9:30am EDT

#207 IT: IQVIA Innovation Theater: Driving the Digitization of Clinical Development – Understanding the Impact of Innovative Digital Approaches
Component Type: Session
Level: Intermediate

Clinical development methods are rapidly shifting to digital approaches, recently accelerated by COVID. The use of decentralized trials with data capture devices and remote monitoring capabilities are now seen as critical. They are driving need for additional data management and delivering deeper, faster insights for use across R&D. Learn how these digital approaches, and novel data analytics capabilities are changing the future of clinical development - now.

Chair

IQVIA


Speakers
avatar for IQVIA

IQVIA

IQVIA, United States
avatar for Nagaraja Srivatsan

Nagaraja Srivatsan

Senior Vice President, Chief Digital Officer, Technology Solutions, IQVIA, United States
As Senior Vice President and Chief Digital Officer, Technology Solutions at IQVIA, Nagaraja (Sri) Srivatsan is responsible for driving growth and leading product development and operations of Clinical Technologies. Srivatsan has over thirty years of experience in growing businesses... Read More →


Tuesday June 29, 2021 9:30am - 10:00am EDT
TBD Virtual Event Horsham, PA 19044

9:30am EDT

#208 IT: Oracle Innovation Theater: Untangling the Integration Mess of Today’s Digital eClinical
Component Type: Session
Level: Intermediate

The pandemic has introduced hundreds of new direct to patient data collection devices and applications, creating a much larger infrastructure of integrations. Current data collection technologies (EDC) are not designed for this data collection. Throwing everything into a data warehouse or data lake does not solve the issue of operational management. This session will provide an overview on emerging methods for integration for interoperability to help create an expanded path for digital data.

Chair

Oracle Health Sciences


Speakers
avatar for James Streeter

James Streeter

Global Vice President, Life Sciences Product Strategy, Oracle Health Sciences, United States
As the global head of life sciences product strategy for Oracle, Jim collaborates closely with Oracle customers, regulatory agencies, analysts, and industry thought leaders to develop and help execute the overall business and product strategy for Oracle Health Sciences. He previously... Read More →


Tuesday June 29, 2021 9:30am - 10:00am EDT
TBD Virtual Event Horsham, PA 19044

10:00am EDT

#210 SL: Assuring Access to Safe Medicines in Pregnancy and Lactation: International Regulators Perspective
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-559-L04-P; CME 1.00; IACET 1.00; RN 1.00

There is increasing interest in both Europe and the United States in establishing more formal methods and robust strategies to improve knowledge of the safety and efficacy of drugs and biological products when used during pregnancy and lactation. This session will recap a meeting of MHRA, EMA, and FDA held in January 2020 to discuss possibilities for addressing this challenge.

Learning Objectives

Explain current regulatory frameworks and authorities for Medicines and Healthcare products Regulatory Agency (MHRA), European Medicines Agency (EMA), and US Food and Drug Administration (FDA) surrounding pregnancy and lactation; Discuss potential future regulatory efforts that could enhance the safe use of medicines in pregnancy and lactation.

Chair

Shannon Thor, PharmD, MS

Speaker

EMA Perspective: COVID-19 as a Case Study
Agnès Saint-Raymond, DrMed

Overview through January 2020
Sandra L. Kweder, MD

MHRA Perspective
Janet Nooney, PhD, FFPM

FDA Update
Lynne Yao, MD



Speakers
avatar for Shannon Thor

Shannon Thor

International Policy Analyst, Office of Global Policy & Strategy, Europe Office, FDA, United States
Lieutenant Commander Shannon Thor is a pharmacist and officer in the United States Public Health Service, serving as an international policy analyst in FDA's Europe Office, working closely with European regulatory counterparts to accomplish international public heath goals. Previous... Read More →
avatar for Sandra Kweder

Sandra Kweder

Deputy Director, Europe Office, Office of Global Programs and Strategies, FDA, FDA, United States
Sandra L. Kweder, MD, is Deputy Director of the Europe Office in the FDA. She is posted in Amsterdam, working alongside colleagues in the European Medicines Agency (EMA) to oversee a large portfolio of regulatory science working partnerships and collaborations that include experts... Read More →
JN

Janet Nooney

Expert Scientific Assessor, VRMM- Benefit Risk Management, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Dr Janet Nooney is an expert scientific assessor in pharmacovigilance at the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Dr Nooney divides her time between co-ordinating the MHRA’s strategy on improving information for use of medicines during pregnancy... Read More →
avatar for Agnès Saint-Raymond

Agnès Saint-Raymond

Head of Division International Affairs, European Medicines Agency, Netherlands
Agnes is an MD and qualified French Paediatrician. She worked as a paediatrician in a paediatric Hospital in Paris, France, then in pharmaceutical industry, and then moved to the French Medicines Agency. In 2000 she joined the European Medicines Agency (EMA) and was responsible for... Read More →
avatar for Lynne Yao

Lynne Yao

Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA, United States
Lynne Yao, MD, is the Director, Office of New Drugs, Division of Pediatric and Maternal Health in the Center for Drug Evaluation and Research, US Food and Drug Administration. The Division of Pediatric and Maternal Health oversees quality initiatives within the Office of New Drugs... Read More →


Tuesday June 29, 2021 10:00am - 11:00am EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Session

10:00am EDT

#211 SL: Managing Global Trials in Latin America: Covid Impact Update
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-560-L04-P; CME 1.00; IACET 1.00; RN 1.00

This forum will examine actual case studies from Latin America, to consider what approaches worked well given COVID-19, to identify best practices and considerations for the future.

Learning Objectives

Discuss approaches to managing global trials in Latin America; Describe organizational needs, patients, health care professionals, and support teams.

Chair

Nancy Meyerson-Hess, MS, MSc

Speaker

Panelist
Eduardo F Motti, MD

Panelist
Lisa Palla Tavolaro

Panelist
Diogo Moia, MS



Speakers
avatar for Eduardo Motti

Eduardo Motti

Chief Executive Officer, Trials and Training, Brazil
Background education as a physician, specialized in Infectious Diseases. Over 30 years of experience in academia, CRO and pharmaceutical industry (Merck & Co, Schering AG, Pfizer, Aché). Certified Executive Coach by Royal Roads University (Victoria, BC, Canada). Global Fellow in... Read More →
avatar for Lisa Palla Tavolaro

Lisa Palla Tavolaro

Regional Senior Account Manager- Latin America, Thermo Fisher Scientific, Brazil
Lisa has over 20 years’ experience in multinational pharma companies, logistic companies, biotechnology and CROs working on commercial leadership and business development for clinical research and development of new drugs. From the past 9 years dedicated to the commercial department... Read More →
avatar for Nancy Meyerson-Hess

Nancy Meyerson-Hess

Quality Officer, Emqt, Germany
Nancy Meyerson-Hess, has over 30 years of experience in clinical research including working for large, medium and small pharma and contract research organizations. She has been responsible for establishing and leading global clinical research teams, in particular in emerging regions... Read More →
avatar for Diogo Moia

Diogo Moia

CRA Coordinator, Academic Research Organization at the Albert Einstein Hospital , Brazil
Diogo Moia has over 12 years’ experience in clinical trials activities CRO and ARO companies, working on as CRA and CRA Manager during the past 4 years. From the past 3 years dedicated to the ARO – Albert Einstein as a CRA manager and working in the operational manager team. Expert... Read More →


Tuesday June 29, 2021 10:00am - 11:00am EDT
TBD Virtual Event Horsham, PA 19044
  02: ClinTrials -ClinOps, Forum

10:00am EDT

#212 SL: Post COVID: Sites Evolving Role in the Clinical Trial Ecosystem
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-561-L04-P; CME 1.00; IACET 1.00; RN 1.00

Following COVID-19, there is a changing role for Sites in the decision-making framework for the selection, implementation, and use of various technologies for clinical trial execution. We will discuss how Sponsors, CROs and Sites can move forward.

Learning Objectives

Review the rapid response working group findings as it related to site execution and monitoring during the COVID-pandemic; Discuss how COVID-19 impacted traditional clinical trial execution decision making from dictating to sites how to conduct the research, to including/listening to sites for appropriate next steps; Identify how technology adoption in clinical trial execution will be decided upon.

Chair

Cristin MacDonald, PhD

Speaker

Panelist
Greg Tuyteleers

Panelist
Liz Rogers, MSc

Panelist
Andy Lee, MA

Panelist
Sandy Smith



Speakers
avatar for Cristin MacDonald

Cristin MacDonald

Vice President, Client Delivery, The Avoca Group, United States
Dr. Crissy MacDonald provides consulting services to top pharmaceutical, biotech, and contract research organizations, and oversees client deliverables, systems, and processes across Avoca. Crissy has over 5 years of pharmaceutical industry experience with expertise in clinical research... Read More →
avatar for Andy Lee

Andy Lee

Senior Vice President, Head of Global Clinical Trial Operations, Merck & Co., Inc., United States
Andy heads Global Clinical Operations at Merck and is responsible for all global/regional clinical trials. Andy has over 17 years industry experience with interests in Human Subject Protection, Multiregional Studies, Quality and Compliance and finding more efficient ways to run clinical... Read More →
LR

Liz Rogers

Vice President, Head of Global Site and Study Operations, Pfizer Inc, United States
As Vice President and Worldwide Head of Global Site and Study Operations at Pfizer, Liz is responsible for leading the management and oversight of global investigator site planning and clinical trial execution. Global Study and Site Operations supports the delivery of the Pfizer portfolio... Read More →
SS

Sandy Smith

SVP Clinical Solutions and Strategic Partnerships, WCG Cinical, United States
avatar for Greg Tuyteleers

Greg Tuyteleers

Global Operations Head Managed Access and Global Lead Decentralized Trials, Janssen, Belgium
Greg is the Global Lead for the decentralized trials program for Janssen Research & Development. In this role, he is responsible for leading the initiative that develops and implements the strategy and capabilities supporting decentralized trials. In addition, Greg is the Global Operations... Read More →


Tuesday June 29, 2021 10:00am - 11:00am EDT
TBD Virtual Event Horsham, PA 19044
  02: ClinTrials -ClinOps, Forum

10:00am EDT