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15: Content Hubs [clear filter]
Monday, June 28
 

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

Volunteer, DIA Study Endpoints Community, United States
Mr. Wenzel 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 with... Read More →

Monday June 28, 2021 12:00pm - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044
  15: Content Hubs, Workshop |   02: ClinTrials -ClinOps, Workshop

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
  15: Content Hubs, Workshop |   03: Data-Data Standards, Workshop
 
Tuesday, June 29
 

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
  15: Content Hubs, Workshop |   03: Data-Data Standards, Workshop

11:00am EDT

#222 CH L: Patient-Reported Outcomes: Going Beyond Clinical Trials
Component Type: Workshop
Level: Intermediate

A more holistic approach to patient engagement needs to be considered to achieve patient-centered care. This discussion will engage with peers to explore the opportunities and challenges with broader applications of PROs, beyond just clinical trials. 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

Identify broader opportunities to apply patient-reported outcomes (PROs) in healthcare decision-making and clinical practice; Discuss key elements around measuring, analyzing, and interpreting PROs for successful implementation across these broader applications.

Chair

Fabian TW D'Souza, MD, MBA

Speakers
avatar for Fabian D'Souza

Fabian D'Souza

Founder and President, Boston Strategic Partners, Inc, United States
Dr. D’Souza is the Founder and President of Boston Strategic Partners, Inc. a consultancy dedicated to serving pharma-biotech, devices/ diagnostics, and Health-IT through different practices: business and clinical strategy, HEOR, and medical communications. He has also led projects... Read More →

Tuesday June 29, 2021 11:00am - 11:30am EDT
TBD Virtual Event Horsham, PA 19044
  15: Content Hubs, Workshop |   04: MedAffairs-SciComm, Workshop

1:30pm EDT

#233 CH L: The Clinical Impact of Medical Information for Healthcare Professionals
Component Type: Workshop
Level: Intermediate

This workshop will highlight the value pharmaceutical company’s Medical Information brings to healthcare professionals (HCP) based on two recent surveys of the impact of medical information. Additional barriers for HCPs using MI will be reviewed. 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

Identify the strategic role and value of medical information services; Describe ways medical information impacts patient outcomes; Review barriers that healthcare professionals have concerning the use of medical information (including MSLs and MI departments).

Chair

Evelyn R. Hermes-DeSantis, PharmD

Speakers
avatar for Evelyn Hermes-DeSantis

Evelyn Hermes-DeSantis

Director, Research and Publications, phactMI, United States
Evelyn Hermes-DeSantis, PharmD, BCPS, the Director of Research and Publications for phactMI and Professor Emerita at the Ernest Mario School of Pharmacy at Rutgers, the State University of New Jersey. She received her undergraduate and graduate degrees from Rutgers University and... Read More →

Tuesday June 29, 2021 1:30pm - 2:00pm EDT
TBD Virtual Event Horsham, PA 19044
  15: Content Hubs, Workshop |   04: MedAffairs-SciComm, Workshop
 
Wednesday, June 30
 

9:30am EDT

#305 CH L: Including Data Science in DIA
Component Type: Workshop
Level: Basic

Data science has been increasingly trending over the last few years. What is it? Why is it important? Do I need to learn about it? How is DIA including data science in its content? Are data scientists drawn to join DIA? Let’s discuss together! 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

Describe how the DIA Statistics & Data Science Community is taking steps to include data science topics within DIA; Hear from attendees other ways data science topics are included within DIA Brainstorm additional ways data science topics can be included within DIA.

Chair

Faisal Khan, PhD

Speakers
avatar for Faisal Khan

Faisal Khan

Executive Director, Advanced Analytics and AI, Astrazeneca, United States
Faisal M. Khan, Ph.D. is the Executive Director of Advanced Analytics and Artificial Intelligence at Astrazeneca. His team focuses on the applications of AI and data science throughout the drug discovery lifecycle, from target identification through Phase 3 trials and beyond. His... Read More →

Wednesday June 30, 2021 9:30am - 10:00am EDT
TBD Virtual Event Horsham, PA 19044
  15: Content Hubs, Workshop |   11: Statistics, Workshop

11:00am EDT

#324 CH L: Serving Two Masters: Research Glossaries for Industry and Patients
Component Type: Workshop
Level: Intermediate

Social media discussions about vaccines indicate that common understanding of research and drug development is severely lacking. Health literacy would be bolstered by caregivers and prospective patients having access to clear concepts and visuals. 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

Describe the need for better understanding of clinical research concepts and cite plain language resources; Summarize how understanding of basic concepts help increase study enrollment, facilitate accurate translation, support understanding of labeling, and study documents like informed consent forms.

Chair

Deborah Collyar

Speakers
avatar for Deborah Collyar

Deborah Collyar

President, Patient Advocates In Research (PAIR), United States
Deborah Collyar has been a patient engagement leader since her first cancer diagnosis. She founded Patient Advocates in Research (PAIR) international communication network in 1996, "where research meets reality." Deborah infuses hundreds of patient advocates into research programs... Read More →

Wednesday June 30, 2021 11:00am - 11:30am EDT
TBD Virtual Event Horsham, PA 19044
  15: Content Hubs, Workshop |   05: Patient Engagement, Workshop

1:30pm EDT

#331 CH L: Six Secrets for Successfully Leading Remote Teams
Component Type: Workshop
Level: Basic

This discussion focuses on proven leadership techniques to help global leaders engage remote teams to maximize performance and engagement while keeping personal well-being in check. 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

Describe how to apply strategies and tools to enhance leadership skills and drive engagement in virtual teams; Practice communication and engagement techniques; Recognize the balance of digital collaboration and analog strategies to ensure connectedness and productivity while avoiding digital overload.

Chair

Chris Baker, MBA

Speakers
avatar for Chris Baker

Chris Baker

EVP, Global Head Parexel FSP, Parexel, United States
Chris Baker is the Executive Vice President and Global Head of Parexel’s FSP business. In this role, Chris provides leadership and strategic direction for the Parexel FSP business. With more than 25 years of biopharmaceutical experience, Chris’ expertise spans clinical research... Read More →

Wednesday June 30, 2021 1:30pm - 2:00pm EDT
TBD Virtual Event Horsham, PA 19044
  13: ProfDevelopment, Workshop |   15: Content Hubs, Workshop
 
Thursday, July 1
 

9:30am EDT

#404 CH L: Speed to Submission: How Fast Can You Truly Go?
Component Type: Workshop
Level: Advanced

Does your company get from database lock on the final clinical study to submission to a health authority in 3 months? 6 months? Longer? In this Content Hub, we'll discuss case studies to identify how to get your own duration closer to 3 months. 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

Identify the three key stages on the critical path to submissions; Diagnose the critical path in a submission: For marketing submissions, clinical is typically the rate-limiting factor, but recognizing each piece of a critical path is critical; Share key pitfalls and strategies with their own teams: Participants will be able to speak to common pitfalls and strategies for addressing them.

Chair

Steve Sibley, MS

Speakers
avatar for Steve Sibley

Steve Sibley

Vice President, Global Submissions and Submission Leadership, Certara Synchrogenix, United States
With a career spanning more than 30 years in the pharmaceutical industry, Mr. Sibley has extensive experience across regulatory writing, consulting, and regulatory project leadership roles. He has successfully supported projects from discovery through approval and life cycle management... Read More →

Thursday July 1, 2021 9:30am - 10:00am EDT
TBD Virtual Event Horsham, PA 19044
  15: Content Hubs, Workshop |   04: MedAffairs-SciComm, Workshop

1:30pm EDT

#433 CH L: Value-Based Contracting in Action
Component Type: Workshop
Level: Intermediate

Value-based contracting (VBC) is emerging as a potential platform for pharma companies to demonstrate the value of their products. This discussion will help participants appreciate the complexity of VBC through case studies and interactive discussions. 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

Identify opportunities and challenges associated with value-based contracting (VBC); Discuss approaches to more effectively develop VBC strategies; Apply best practices to future VBC planning and implementation.

Chair

Fabian TW D'Souza, MD, MBA

Speakers
avatar for Fabian D'Souza

Fabian D'Souza

Founder and President, Boston Strategic Partners, Inc, United States
Dr. D’Souza is the Founder and President of Boston Strategic Partners, Inc. a consultancy dedicated to serving pharma-biotech, devices/ diagnostics, and Health-IT through different practices: business and clinical strategy, HEOR, and medical communications. He has also led projects... Read More →

Thursday July 1, 2021 1:30pm - 2:00pm EDT
TBD Virtual Event Horsham, PA 19044
  15: Content Hubs, Workshop |   12: Value-Access, Workshop
 
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  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials -ClinOps
  • 03: Data-Data Standards
  • 04: MedAffairs-SciComm
  • 05: Patient Engagement
  • 06: PreClin Dev-EarlyPhaseCR
  • 07: ProjMgt-StrategicPlanning
  • 08: RD Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics
  • 12: Value-Access
  • 13: ProfDevelopment
  • 14: DIAmond
  • 15: Content Hubs
  • 16: Community Rounds
  • 17: Posters
  • 18: Networking Opportunities
  • 19: Short Courses
  • 20: Early Access Content
  • 21: InnovationTheaters
  • 22: Solution Circles
  • 23: Spotlight Symposia
  • 24: Lunch-and-Learn
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TBD
Virtual Event
  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials -ClinOps
  • 03: Data-Data Standards
  • 04: MedAffairs-SciComm
  • 05: Patient Engagement
  • 06: PreClin Dev-EarlyPhaseCR
  • 07: ProjMgt-StrategicPlanning
  • 08: RD Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics
  • 12: Value-Access
  • 13: ProfDevelopment
  • 14: DIAmond
  • 15: Content Hubs
  • 16: Community Rounds
  • 17: Posters
  • 18: Networking Opportunities
  • 19: Short Courses
  • 20: Early Access Content
  • 21: InnovationTheaters
  • 22: Solution Circles
  • 23: Spotlight Symposia
  • 24: Lunch-and-Learn
  • Beginner
  • Advanced
  • Beginner
  • Intermediate
  • Featured Topics
  • Artificial Intelligence
  • Collaboration
  • COVID-19 - Pandemic
  • Digital Technology
  • Diversity Equity and Inclusion
  • HTA
  • Innovative Trial Design
  • Novel Therapeutic Approaches
  • Patient Focused
  • Regulator Thinking
  • RWD-RWE
  • Special Populations
  • Student Programming
  • What's Next