Accelerated Approvals: The Viability of Surrogate Endpoints
Friday, May 31, 2024 09:15 AM - 10:15 AM
Room 217-219
Concurrent Session
Chair
This session addresses the use of surrogate endpoints in the US accelerated approval process, requirements for acceptance of surrogate biomarkers as primary endpoints in clinical trials and how such surrogate biomarkers of clinical efficacy can be qualified.
- Mo Heidaran, PhD, CellX Inc., United States
- Wilson Bryan, MD, Greenleaf Health, United States, "An Introduction to Surrogate Endpoints"
- Kemi Olugemo, MD, FAAN, Korro Bio, United States
- David Lebwohl, MD, Intellia Therapeutics, Inc., United States
This session addresses the use of surrogate endpoints in the US accelerated approval process, requirements for acceptance of surrogate biomarkers as primary endpoints in clinical trials and how such surrogate biomarkers of clinical efficacy can be qualified.
