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Real-World Evidence Conference

Translating Insights into Real-World Value.

Opening Remarks and Session 1: Year in Review

Session Chair(s)

Simon  Dagenais, PhD, MSc

Simon Dagenais, PhD, MSc

  • Senior Director, Real-World Evidence
  • Pfizer Inc, United States
This session is intended to provide an overview of recent events related to RWE in the past year, including regulatory decisions, guidance, and projects, as well as publications, guidelines, and industry activities. The session will choose a few key examples for discussion, provide a brief description of each event, place the event in a historical context to highlight what is new, and attempt op highlight key themes that may emerge in the future related to these events. This session may provide some background for other sessions that will delve into these events and themes in more depth.
Learning Objective : At the conclusion of this session, participants should be able to:
  • Describe recent events related to RWE in the past year
  • Discuss why these recent events are important to RWE
  • Identify new events in context of existing information on the topic


John  Concato, MD, MPH, MS

FDA Guidance related to RWE

John Concato, MD, MPH, MS

  • Associate Director for Real-World Evidence Analytics, OMP, CDER
  • FDA, United States
Nirosha  Lederer, PhD, MS

Recent Examples of RWE Submissions

Nirosha Lederer, PhD, MS

  • Director, Real-World Evidence Strategy
  • Aetion, United States
Shirley  Wang, PhD, MSc, FISPE

Update on RWE Reporting Quality

Shirley Wang, PhD, MSc, FISPE

  • Assistant Professor of Medicine
  • Harvard Medical School, United States
Jessica  Franklin, PhD

Update on RCT DUPLICATE Project

Jessica Franklin, PhD

  • Principal Consultant, Epidemiology and Real-World Evidence
  • Optum, United States
Dan  Gebremedhin, MD, MBA

Financial Trends in the RWE Industry

Dan Gebremedhin, MD, MBA

  • Partner
  • Flare Capital Partners, United States