Back To Schedule
Thursday, June 17 • 12:00pm - 1:00pm
#502 OD: Artificial Intelligence: Real Applications and Regulatory Perspectives

Sign up or log in to save this to your schedule, view media, leave feedback and see who's attending!

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.


Jeremy Jokinen, PhD, MS


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

avatar for Jeremy Jokinen

Jeremy Jokinen

Vice President and Head, Global Risk Management & International Patient Safety, Bristol-Myers Squibb Company, United States
Jeremy is the Vice President and Head, Global Risk Management and International Patient Safety at Bristol Myers Squibb. In this role, he leads a global team of risk management and safety science leaders responsible for insights, evidence generation, and risk minimization efforts ensuring... 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

Executive Director, IT Worldwide Patient Safety, 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 →

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

Chief Data Officer, OCD, 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