November 13 – 19, 2020
Day 1: Modernizing Expedited Development Programs
Day 2: Optimizing the Use of Accelerated Approval
Friends of Cancer Research (Friends) was proud to host our 13th Annual Meeting to address critical issues in the development of new oncology drugs. Each 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 – DAY 1: Modernizing Expedited Development Programs
12:00 PM Welcoming Remarks
Ellen Sigal, Friends of Cancer Research
12:05 PM Keynote Address
Stephen Hahn, Commissioner, U.S. FDA
12:10 PM Fireside Chat
Richard Pazdur, Director, Oncology Center of Excellence, U.S. FDA
Ellen Sigal, Founder & Chair, Friends of Cancer Research
12:25 PM Session 1: Modernizing Expedited Development Programs
Objective: This session characterized current use and utility of expedited pathways in drug development and outline proposals for streamlining and enhancing their application for current drug development challenges and emerging complex therapies.
Amy McKee, Parexel (moderator)
Anne-Virginie Eggimann, Bluebird Bio
Scott Korn, Merck
Bea Lavery, Genentech
Paul Melmeyer, Muscular Dystrophy Association
Harpreet Singh, U.S. FDA
12:58 PM Closing remarks
Jeff Allen, Friends of Cancer Research
1:00 PM Adjourn
AGENDA – DAY 2: Optimizing the Use of Accelerated Approval
12:00 PM Welcoming Remarks
Jeff Allen, Friends of Cancer Research
12:05 PM Fireside Chat
Patrizia Cavazzoni, Acting Director, Center for Drug Evaluation and Research, U.S. FDA
Peter Marks, Director, Center for Biologics Evaluation and Research, U.S. FDA
Moderated by Kate Rawson, Prevision Policy
12:25 PM Session 2: Optimizing the Use of Accelerated Approval
Objective: This session characterized learnings from the accelerated approval program and describe regulatory and policy opportunities to optimize its use and facilitate oncology drug development.
George Demetri, Dana-Farber Cancer Institute (moderator)
Josh Bilenker, Loxo Oncology at Lilly
R. Angelo de Claro, U.S. FDA
Aaron Kesselheim, Harvard Medical School
David Mitchell, Multiple Myeloma patient
12:58 PM Closing Conversation
Richard Pazdur, U.S. FDA
Jeff Allen, Friends of Cancer Research
1:13 PM Closing remarks
Jeff Allen, Friends of Cancer Research