July 10th, 2018
Washington Marriott Georgetown
1221 22nd St NW
Washington, DC 20037
Thank you all who attended our past event! The meeting whitepaper, Establishing a Framework to Evaluate Real-World Endpoints, has been officially released. All videos from the event can now be viewed on our YouTube page here. Check out our Engaging Innovation Blog for a full event recap. In the meantime we will be linking meeting slides below in the agenda as they become available.
Friends of Cancer Research (Friends) is proud to announce a public meeting involving multiple stakeholders across industry, Real-World Evidence (RWE) data partners, FDA, academics, and research and advocacy organizations. The meeting will include results from a pilot study determining how endpoints generated from real-world data correlate with overall survival and other key measures. Panels will discuss policies related to the use of RWE, as well as provide vital information about the long-term value of a product including its safety and efficacy.
A draft agenda is provided below. For more information on the meeting topic, please click HERE.
Finalized Agenda
8:30am – Registration and Breakfast
9:00am – Opening Remarks
- Ellen Sigal, Friends of Cancer Research
- Jeff Allen, Friends of Cancer Research
9:20am – Panel 1: Assessment and reaction to pilot project results
Moderator: Elad Sharon, National Cancer Institute
- Amy Abernethy, Flatiron Health
- Andrew Norden, Cota
- Elizabeth Chrischilles, UIowa/PCORnet
- Henry Joe Henk, Optum Labs
- Larry Kushi, Kaiser Permanente/CRN
- Nancy Dreyer, IQVIA
10:05am – Q&A with audience
10:35am – Break
10:55am – Real-world evidence to supplement clinical trial data
- Gideon Blumenthal, U.S. Food and Drug Administration (FDA)
- Pallavi Mishra-Kalyani, FDA
11:15am – Panel 2: Applying real-world endpoints to oncology drug development and regulatory decision-making
Moderator: Michael Maitland, Inova Center for Personalized Health and Inova Schar Cancer Institute
- Eric Rubin, Merck & Co.
- John Penrod, Bristol-Myers Squibb
- Michael Taylor, Genentech
- Pallavi Mishra-Kalyani, FDA
- Sean Khozin, FDA
12:00pm – Q&A with audience
12:30pm – Lunch
1:30pm – Panel 3: Regulatory and policy implications of real-world endpoints
Moderator: Michael McCaughan, Prevision Policy
- Jane Perlmutter, Gemini Group
- Janet Woodcock, FDA
- Jason Spangler, Amgen
- Jennifer Malin, United Healthcare
- Joe Selby, PCORI
2:30pm – Q&A with audience
3:00pm – Closing Remarks
- Jeff Allen, Friends of Cancer Research
For more information, contact Heather Chaney at hchaney@focr.org or (202) 944-6719.
