Room: 309 (Level 300)
In 2016, through the 21st Century Cures Act, Congress gave the directive for the FDA to develop a regulatory framework to evaluate how real-world evidence (RWE) should be used to support regulatory filings. However, this opened the door to many complex questions that the FDA is currently considering: How much weight should be given to RWE when making regulatory decisions? Which decisions could be supported with RWE alone? What are the acceptable methodologies? Using a modified Oxford-style debate format, this lively discussion will feature experts deliberating the extent to which the FDA should use RWE in their decision-making process - and the audience will have the ultimate say in which argument was most persuasive.

Moderator: Peter Pitts, PhD
President, Center for Medicine in the Public Interest, New York, NY, USA

Speaker: Nancy Dreyer, MPH, PhD
Chief Scientific Officer, Real-World & Analytic Solutions, IQVIA, Cambridge, MA, USA

Speaker: Marni Hall, PhD, MPH
Vice President of Clinical Evidence, Center of Advanced Evidence Generation, IQVIA, Rockville, MD, USA

Speaker: Gregory Daniel, PHD, MPH
Deputy Director, Policy, Duke-Robert J. Margolis, MD, Center for Health Policy, Washington, DC, USA

Speaker: Marc Berger, MD
Consultant, Self Employed, New York, NY, USA

(Sponsored by AbbVie)