An International Framework for Real-World Evidence: Day 2

 

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