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Session Details

Accelerated Approvals: The Viability of Surrogate Endpoints
Friday, May 31, 2024 09:15 AM - 10:15 AM  
Room 217-219
From FIH to Clinical Acceleration
Concurrent Session
Chair
  • Mo Heidaran, PhD, CellX Inc., United States
Speakers
  • Wilson Bryan, MD, Independant Regulatory Consultant, United States, "An Introduction to Surrogate Endpoints"
​Panelists:
  • 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. 

Mohammad Heidaran
Cellx Inc
Moderator


David Lebwohl
Chief Medical Officer
Intellia Therapeutics
Panelist


Kemi Olugemo
Chief Medical Officer
Korro Bio
Panelist


Wilson Bryan
Regulatory Consultant
Greenleaf Health
Speaker