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Session 2: Approval Pathways and Endpoint Selection
Session Chair(s)
Ashley F. Slagle, PHD, MS
Principal, Scientific and Regulatory Consulting, Aspen Consulting, LLC, United States
Selecting and specifying study endpoints in clinical trials can present challenges to drug developers. Different approval pathways, including traditional approval and expedited pathways, as well as the various types of endpoint approaches that are available can indeed expedite drug development, but can also cause confusion and difficulty in decision-making. The objective of this session is to provide an overview of the approval pathways and endpoint selection considerations. FDA and Industry speakers will share a history, overview of approval pathways, endpoint examples, decision-making considerations, and case studies to help inform future endpoint decisions for drug development programs.
Speaker(s)
Stephen Joel Coons, PHD
Senior Advisor, Critical Path Institute, United States
Session Co-Chair
Paul Kluetz, MD
Deputy Director, Oncology Center of Excellence, OC, FDA, United States
Overview of Approval Pathways and Implications on Endpoint Selection
Laura Lee Johnson, PHD
Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER, FDA, United States
Endpoints Options and Considerations for Selection
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