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Tuesday, June 29 • 2:00pm - 3:15pm
#247 SL: Update on FDA's Real-World Evidence Program: Current FDA Demonstration Projects

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-582-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will combine an update on FDA’s Real-World Evidence (RWE) Program for drugs and biologic products with a discussion of interim results from ongoing trial replication analyses that advance our understanding of whether and how observational studies can contribute to evidence of the effectiveness of drug products.

Learning Objectives

Describe the current status of FDA’s RWE Program; report on results from the RCT-DUPLICATE project emulating randomized trials with analyses of real-world data (RWD); Identify emerging insights from trial replication efforts.


John Concato, MD, MPH, MS


FDA Update
John Concato, MD, MPH, MS

FDA Update
Michael Blum, MD, MPH

Calibrating RWE Against RCT Evidence: Key Findings From the RCT-Duplicate Project
Sebastian Schneeweiss, DrSc, MD

Industry Update
Robert Reynolds, DrSc, FISPE

Replication of RCTs with RWD: Potential Concerns
David Thompson, PhD

avatar for John Concato

John Concato

Associate Director for Real-World Evidence Analytics, OMP, CDER, FDA, United States
Dr. Concato is Associate Director for Real-World Evidence Analytics in the Office of Medical Policy (OMP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA). After conducting clinical research studies for more than 25 years as an independent investigator... Read More →
avatar for Michael Blum

Michael Blum

Deputy Director, Office of Pharmacovigilance and Epidemiology, CDER, FDA, United States
Michael Blum, MD, MPH is currently Deputy Director, Office of Pharmacovigilance and Epidemiology in FDA CDER. He is a pediatric infectious diseases specialist. Dr. Blum worked as a medical reviewer in the CDER Division of Anti-Infective Drug Products, followed by over 20 years in... Read More →
avatar for Robert Reynolds

Robert Reynolds

Vice President, Epidemiology & Patient-Centered Outcomes, GSK, United States
Dr. Reynolds is Vice President, Epidemiology & Patient-Centered Outcomes in Value Evidence and Outcomes, part of Research and Development at GSK. He heads a group responsible for leading the epidemiologic and patient components of integrated evidence plans. He is also an Adjunct Associate... Read More →
avatar for Sebastian Schneeweiss

Sebastian Schneeweiss

Professor, Medicine and Epidemiology; Chief of the Div of Pharmacoepidemiology, Harvard Medical School and Brigham and Women's Hospital, United States
Dr. Schneeweiss's research focuses on assessing the effectiveness and safety of biopharmaceuticals in clinical practice. He has developed analytic methods to improve the accuracy of estimating causal treatment effects of new drugs using complex digital healthcare databases. His work... Read More →
avatar for David Thompson

David Thompson

Senior Vice President, Real World Evidence, Syneos Health
David Thompson, Ph.D. is Senior Vice President, Real World Research for Syneos Health. Dave is a health economist by training with 25+ years of experience conducting real-world research and consulting for clients in the biopharmaceutical sector. He is Editor-in-Chief of ISPOR’s... Read More →

Tuesday June 29, 2021 2:00pm - 3:15pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session
  • Beginner Intermediate
  • Featured Topics RWD-RWE
  • Credit Type ACPE, CME, IACET, RN
  • Student Programming RWD-RWE,RWD-RWE
  • Featured Topics RWD-RWE,RWD-RWE
  • Tags Session