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#509: Integrating Artificial Intelligence and Real-World Evidence: FDA's Framework for Advancing Medical Product Development
Tuesday June 16, 2026 10:15am - 11:30am EDT
109AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-559-L04-P; CME 1.25; RN 1.25

This session will provide FDA perspective on opportunities for AI and RWE to enhance drug and biologic development and improve patient outcomes. FDA presenters will discuss key RWE and AI program updates, including new Agency level initiatives.

Learning Objectives

Describe FDA's current AI and RWE regulatory frameworks and key guidance documents and how these align with FDA’s mission; Identify the promise and the limitations of AI in the context of drug and biologics development and identify opportunities for integrating AI and RWE approaches; Apply FDA recommendations for use of AI/RWE in regulatory submissions.

Chair

Marie Bradley, MPH

Speaker

Panelist
Hussein Ezzeldin, PHD


Speakers
avatar for Marie Bradley

Marie Bradley

Senior Advisor, Real-World Evidence , Office of Medical Policy, CDER, FDA, United States
Dr. Marie Bradley is a Senior Advisor for RWE in the Office of Medical Policy, Center for Drug Evaluation and Research (CDER). Her responsibilities related to real-world evidence (RWE) include serving as lead for the Advancing Real-World Evidence Program, the Real-World Evidence Subcommittee... Read More →
avatar for Hussein Ezzeldin

Hussein Ezzeldin

Associate Director for Advanced Technologies, OBPV, OMP, CBER, FDA, United States
Dr. Ezzeldin is the Associate Director for Advanced Technologies in the Office of Biostatistics and Pharmacovigilance (OBPV), in the Center for Biologics Evaluation and Research (CBER). Dr. Ezzeldin supported multiple programs in previous roles, for example, leading the digital health... Read More →
Tuesday June 16, 2026 10:15am - 11:30am EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Session |   10: Stats-EvidenceGeneration-RWE, Session |   08: RegPolicy-Strategy-GlobalCollaboration, Session

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