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Supporting the Use of RWD in Oncology Drug Development

Supporting the Use of RWD in Oncology Drug Development

Friends of Cancer Research Public Meeting

Supporting the Use of RWD in Oncology Drug Development

Thank you to all that attended!

Click HERE to view the meeting recording
Click HERE to view the Meeting Discussion Document
Click HERE to read the Meeting Recap
Click HERE to view the Meeting Presentation

Monday, September 11th, 2023
11:00AM – 2:30PM ET
The Ritz-Carlton
1150 22nd St NW
Washington, DC 20037

The meeting will also be streamed virtually

Friends of Cancer Research (Friends) is proud to announce our next public meeting, Supporting the Use of RWD in Oncology Drug Development.

This meeting will bring together experts to discuss opportunities for the use of real-world data (RWD) in oncology drug development. Recent FDA guidance and legislation have highlighted the possibility of using RWD and real-world evidence (RWE) to support drug development, however, aligning on strategies and methodologies for analyzing RWD are needed. Results from the Friends of Cancer Research (Friends) real-world Response (rw-Response) Pilot will be shared, which focuses on establishing a framework for measuring rw-response and assessing the consistency of the measure across RWD sources.

Discussions during the meeting will focus on the regulatory and policy implications for RWD and real-world evidence (RWE) given the findings, and additional uses of RWD in oncology drug development. This meeting builds on Friends’ multi-year portfolio of projects on Real-World Data.



10:30AM: Registration Opens11:00AM: Welcoming Remarks 

  • Jeff Allen, President & CEO of Friends of Cancer Research

11:05AM: Morning Keynote 

  • Amy Abernethy, Verily
  • Steve Usdin, BioCentury — Moderator

Session 1: Establishing a Framework for Evaluating Real-world Response Objectives: In this session, discussions will focus on opportunities for using RWD to evaluate response to treatment. The presentation will describe key findings from the Friends’ rw-Response Pilot followed by a panel discussion on methodological learnings and opportunities to generate robust RWD/E.

11:35AM: Presentation — Assessment of rw-Response in an Aligned Patient Population Across RWD Sources

  • Brittany McKelvey, Friends of Cancer Research

11:50AM: Session 1 Panel Discussion

  • Elizabeth Garrett-Mayer, American Society of Clinical Oncology — Moderator
  • Amanda Bruno, Syneos Health, formerly Bayer Pharmaceuticals
  • Pallavi Mishra-Kalyani, U.S. FDA
  • Yana Natanzon, ConcertAI
  • Nick Robert, Ontada
  • Lawrence Schwartz, Memorial Sloan Kettering Cancer Center

12:40PM: Lunch 

1:10PM: Lunch Keynote

  • Robert Califf, Commissioner, U.S. Food and Drug Administration
  • Kate Rawson, Prevision Policy — Moderator

Session 2: Lessons Learned from Real-world Endpoint Analyses and Opportunities for Use in Drug DevelopmentObjectives: This session will focus on applying learnings from Friends’ RWE pilots to support the optimal use of rw-endpoints when leveraging RWD-sources in oncology drug development and for regulatory decision-making.

1:30PM: Session 2 Panel Discussion

  • Irene Nunes, Flatiron Health — Moderator
  • Ashita Batavia, Janssen R&D
  • Thomas Brown, Syapse
  • Laura Fernandes, COTA
  • Jane Perlmutter, Patient Advocate
  • Donna Rivera, U.S. FDA

2:28PM: Closing Remarks 

2:30PM: Meeting Conclusion