Tuesday, November 14, 2023
Friends of Cancer Research (Friends) was proud to host our 16th Annual Meeting to address critical issues in the development of new oncology drugs. Each Friends Annual Meeting brings together leaders from federal health and regulatory agencies, academic research, the private sector, and patient advocates to propose unique approaches toward current challenges in drug development.
AGENDA
9:30 AM: Meeting Registration
10:00 AM: Welcome
- Ellen Sigal, Friends of Cancer Research
10:02 AM: Morning Keynote Conversation
- Jeff Allen, Friends of Cancer Research (Moderator)
- Monica Bertagnolli, NIH
- Robert Califf, U.S. FDA
10:30 AM: Panel 1 Discussion – Early Phase Trials: Data Implementation and Interpretation for Dose-Finding
- Julie Bullock, Certara (Moderator)
- Judith Fitzgerald, Patient Advocate
- Ramon Kemp, GSK
- Enrique Sanz Garcia, Princess Margaret Cancer Centre
- Mirat Shah, U.S. FDA
- Gita Thanarajasingam, Mayo Clinic
11:30 AM: Break
11:45 AM: Panel 2 Discussion – Incorporating Pragmatic Trial Elements into Oncology Drug Development
- Nafsika Kronidou Horst, F. Hoffmann-La Roche (Moderator)
- Erin Larkins, U.S. FDA
- Boris Kin Lin, Eli Lilly and Company
- Sumithra Mandrekar, Mayo Clinic/The Alliance for Clinical Trials in Oncology
- Kristin McJunkins, Patient Advocate
- Margaret Mooney, NCI Cancer Therapy Evaluation Program
12:45 PM: Lunch
1:15 PM: Lunch Keynote – Overview of OCE Projects
- Richard Pazdur, U.S. FDA OCE (Moderator)
- Rea Blakey, U.S. FDA OCE – Project Community
- Mitchell Chan, U.S. FDA OCE – Project Facilitate
- R. Angelo de Claro, U.S. FDA OCE – Project ORBIS
- Gautam Mehta, U.S. FDA OCE – Project Confirm
- Jeff Summers, U.S. FDA OCE – Project Catalyst
1:55 PM: Panel 3 Discussion – Maximizing Use of Data from Academic-Led Studies for Regulatory Decision-Making
- Kathleen Winson, Genentech (Moderator)
- Kristina Laumann, Mayo Clinic
- Margaret Mooney, NCI Cancer Therapy Evaluation Program
- Christy Osgood, U.S. FDA
- Russ Palmer, EMD Serono
- Sunita Zalani, Merck & Co., Inc.
2:55 PM: Closing Remarks
3:00 PM: Meeting Adjournment