Real-World Evidence Collaborative

Overview

Duke-Margolis has launched a Real-World Evidence Collaborative to advance policy development related to the regulatory acceptability of real-world evidence (RWE). The Collaborative will engage major stakeholders to help advise and guide high priority efforts aimed at improving the development and use of RWE, with the express aim of informing and supporting the FDA as it works to meet RWE milestones as established in the 21st Century Cures Act and the sixth Prescription Drug User Fee Act (PDUFA VI).

The RWE Collaborative will consist of an advisory group that will include senior representation from medical product developers, payers, research groups, providers, patient networks, and regulators. This group will steer Collaborative working groups and contribute to the Collaborative’s recommendations.

Initial projects in the Collaborative’s first year will explore primary considerations for assessing the quality of real-world data (RWD) sources, promising opportunities to improve the credibility of observational study designs, and lessons learned from actual industry experience with RWD- and RWE-enabled regulatory submissions.

 

Duke-Margolis Project Team

Mark B. McClellan, MD, PhD 
Director and Robert J. Margolis, M.D., Professor of Business, Medicine and Policy

Gregory W. Daniel, PhD, MPH, RPh 
Deputy Director, Policy and Clinical Professor, Fuqua School of Business

Adrian Hernandez, MD, MHS
Vice Dean for Clinical Research, School of Medicine
Professor of Medicine, Cardiology
Associate Director, Duke Clinical Research Institute

Morgan Romine, MPA
Research Director

Managing Associate
 
Christina Silcox, PhD
Managing Associate
 
 

Advisory Group

AbbVie
Ryan Kilpatrick, Head, Global Epidemiology
 
Eli Lilly and Company
Carlos Garner, Vice President, Global Regulatory Affairs
 
Evidation
Claire Meunier, Director, Strategic Partnerships
 
Evidera
Debra A. Schaumberg, Vice President, Scientific Affairs
 
Flatiron Health
Nicole Mahoney, Senior Director of Regulatory Policy
 
Genentech
Jacqueline Law, Vice President, Global Head Real World Data
 
GlaxoSmithKline
John Graham, Senior Vice President, Medical Engagement and Value Evidence & Outcomes
 
Harvard Medical School
Richard Platt, Executive Director, Harvard Pilgrim Health Care Institute and Chair, Department of Population Medicine
 
Healthcore
Marcus Wilson, Co-Founder and President
 
International Society for Pharmacoeconomics and Outcomes Research
Marc Berger, Consultant
 
International Society for Pharmacoeconomics and Outcomes Research
Richard Wilke, Chief Science Officer
 
IQVIA Real-World Insights
Nancy Dreyer, Global Chief of Scientific Affairs
 
Johnson & Johnson
Joanne Waldstreicher, Chief Medical Officer
 
Merck & Co.
Megan O’Brien, Executive Director, Center for Observational and Real World Evidence
 
Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard
Barbara Bierer, Faculty Director
 
National Health Council
Eleanor Perfetto, Senior Vice President, Strategic Initiatives
 
Novartis Pharmaceuticals Corporation
Amy Rudolph, Vice President and Head of HE&OR and Digital Medicine
 
OptumLabs
Paul Bleicher, Chief Executive Officer
 
PatientsLikeMe
Sally Okun, Vice President Policy & Ethics
 
Syneos Health
David Thompson, Senior Vice President
 
Teva Pharmaceuticals
Riad Dirani, Vice President, Global Health Economics and Outcomes Research
 
UCB
David Miller, Senior Director, RWE Methods Analysts & Safety
 
Veradigm Health
Stephanie Reisinger, Vice President and General Manager, Life Sciences
 
 

Observers

National Academies of Sciences, Engineering, and Medicine
Amanda Wagner-Gee, Program Officer
 
People-Centered Research Foundation
Kathy Hudson, Executive Director
 
Patient-Centered Outcomes Research Institute 
Joe Selby, Executive Director
 
U.S. Food and Drug Administration
Jacqueline Corrigan-Curay, Director, Office of Medical Policy, CDER
 

Funding

This project is made possible through the generosity of the Margolis Family Foundation, which provides core resources for the Center, as well as a combination of financial and in-kind contributions from consortium members including AbbVie; Eli Lilly and Company; Genentech, a member of the Roche Group; GlaxoSmithKline; Johnson & Johnson; Merck; Novartis; Teva and UCB.

Participation of private or non-profit organizations in Center activities does not imply an endorsement by Duke University or associated entities. As part of Duke University, Duke-Margolis honors the tradition of academic independence on the part of its faculty and scholars. Neither Duke nor the Margolis Center take partisan positions, but the individual members are free to speak their minds and express their opinions regarding important issues. Duke Margolis adheres to all institutional policies on research independence and conflict of interest.