Thank you to all for attending. Click HERE to view the full event.
Click the link below for the meeting whitepaper:
Considerations for Use of Real-World Evidence in Oncology
Friends of Cancer Research Virtual Meeting
An International Framework for Real-World Evidence
Day 2: Regulatory & Policy Needs for RWE
Tuesday, September 22, 2020
12:00 PM EDT – 1:00 PM EDT
Friends of Cancer Research (Friends) is proud to announce our next virtual meeting series, An International Framework for Real-World Evidence. This meeting series will focus on our Real-World Evidence (RWE) Pilot Project results aimed at building a body of evidence to inform how RWE can be used to benefit patients and support drug development and regulatory decisions. During Day 2 of our virtual meeting, we will focus on regulatory and policy implications for RWE surrounding this framework.
Day 1 of the virtual meeting will discuss the framework and pilot project results. Click HERE to find out more.
The final agenda for Day 2 is included below. For more information on the project, please click HERE.
The RWE Pilot Project is a unique research partnership in collaboration with Aetion, ASCO CancerLinQ & ConcertAI, Cancer Research Network, COTA, FDA, Flatiron Health, IQVIA™, McKesson, NCI SEER-Medicare Linked Database, OptumLabs® & Mayo Clinic, Syapse, Tempus
Day 2 Final Agenda
12:00 PM – Welcoming Remarks
- Ellen Sigal, Friends of Cancer Research
- Jeff Allen, Friends of Cancer Research
12:05 PM – Session 3: Integrating Real-World Evidence into Drug Development and Regulatory Decision-Making
Objectives: This session will discuss near term opportunities and recommendations to foster a regulatory ecosystem to facilitate the collection and generation of fit-for-purpose data to support clinical research and drug development.
Keynote Conversation
- Amy Abernethy, Principal Deputy Commissioner, US Food and Drug Administration
- Michelle McMurry-Heath, President & CEO, Biotechnology Innovation Organization
12:25 PM – Panel: Operationalizing RWE for Regulatory Applications
- Adrian Cassidy, Novartis Pharmaceuticals
- John Concato, U.S. FDA
- Mark McClellan, Duke-Margolis Center for Health Policy
- Michael Vasconcelles, Flatiron Health
- Kate Rawson, Prevision Policy (Moderator)
Panel Q&A
12:58 PM – Closing remarks
- Jeff Allen, Friends of Cancer Research
1:00 PM – Adjourn
