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
Managing Associate

Kishan Parikh

Christina Silcox, PhD
Research Associate

Jonathan Bryan
Research Assistant

Katherine Frank
Senior Research Assistant

Advisory Group

Amy Abernethy
Senior Vice President, Oncology
Flatiron Health

Marc Berger
Co-Chair, Joint ISPOR/ISPE Special Task Force on RWE in Healthcare Decision-Making

Barbara Bierer
Faculty Director, Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard

Paul Bleicher
Chief Executive Officer, OptumLabs

Riad Dirani
Vice President, Global Health Economics and Outcomes Research, Teva Pharmaceuticals

Nancy Dreyer
Global Chief of Scientific Affairs, QuintiilesIMS Real-World Insights
IQVIA 

Carlos Garner
Vice President, Global Regulatory Affairs
Eli Lilly and Company

John Graham
Vice President and Head, Value Evidence and Outcomes
GlaxoSmithKline

Jacqueline Law
Vice President, Global Head Real World Data Science
Genentech, A member of the Roche Group

Sally Okun
Vice President of Policy & Ethics
PatientsLikeMe

Eleanor Perfetto
Senior Vice President, Strategic Initiatives
National Health Council

Richard Platt
Executive Director, Harvard Pilgrim Health Care Institute and Chair, Department of Population Medicine
Harvard Medical School

Amy Rudolph
Vice President and Head of HE&OR and Digital Medicine
Novartis Pharmaceuticals Corporation

Joanne Waldstreicher
Chief Medical Officer
Johnson & Johnson

Richard Willke
Chief Science Officer
International Society for Pharmacoeconomics and Outcomes Research

Marcus Wilson
Co-Founder and President
Healthcore

Observers

Jacqueline Corrigan-Curay
Director, Office of Medical Policy, CDER
U.S. Food and Drug Administration

Kathy Hudson
Executive Director
People-Centered Research Foundation

Joe Selby
Executive Director
Patient-Centered Outcomes Research Institute 

Amanda Wagner-Gee
Program Officer
National Academies of Sciences, Engineering, and Medicine

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 Eli Lilly and Company; Genentech, a member of the Roche Group; GlaxoSmithKline; Johnson & Johnson; Novartis and Teva.

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.