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THE US GRANT, a Luxury Collection Hotel, San Diego

Nov 10, 2022 7:00 AM - Nov 11, 2022 12:30 PM

326 Broadway, San Diego, CA 92101

Real-World Evidence Conference

Translating Insights into Real-World Value

Session 1: A Year in Review

Session Chair(s)

Simon  Dagenais, PhD, MSc

Simon Dagenais, PhD, MSc

Real-World Evidence Lead, Internal Medicine

Pfizer Inc, United States

This opening session will provide an overview of key recent events related to RWE in the past year (2021-2022) and help set the stage for more detailed discussions about these events throughout the 2022 DIA RWE Conference. This session will place events in a historical context, describe how they build on previous events, and provide a framework for understanding the recent evolution of RWE. This session will focus primarily on the following groups of stakeholders:

  1. Biopharmaceutical companies who analyze RWD and develop RWE
  2. Regulatory agencies who review and make decisions based on RWE
  3. Academic researchers who propose methods and standards for RWE
  4. Vendors who collect, disseminate, and analyze RWD

Learning Objective : At the conclusion of this session, participants should be able to:
  • Identify key events related to RWE in the past year
  • Place these events in a historical context to describe how they build on previous events
  • Understand how these events are interrelated and contribute to the advancement of RWE


John  Concato, MD, MPH, MS

Overview of Recent FDA Activities Related to RWE

John Concato, MD, MPH, MS

FDA, United States

Associate Director for Real-World Evidence Analytics, OMP, CDER

Shirley  Wang, PhD, MSc, FISPE

Recent Findings from RCT DUPLICATE Demonstration Project

Shirley Wang, PhD, MSc, FISPE

Harvard Medical School, United States

Associate Professor of Medicine

Jennifer  Christian, PharmD, PhD, MPH, FISPE

Overview of RWE Alliance

Jennifer Christian, PharmD, PhD, MPH, FISPE

Target RWE, United States

Chief Scientific Officer

Nicholaas  Honig, JD

Recent FDA Approvals of Submissions with RWE

Nicholaas Honig, JD

Aetion, United States

Senior Regulatory Counsel, Aetion; Representing

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