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Understanding the Misconceptions and Myths around Surrogate Endpoints
Session Chair(s)
Bridget Doherty, MPH, MS
Director, Access and Policy Research
Johnson & Johnson, United States
Explore the science and debate surrounding the FDA’s use of surrogate endpoints in drug approvals, with a focus on their role in addressing unmet medical needs. This session will bring together diverse perspectives to clarify misconceptions.
Learning Objective : Describe an evidence-based overview of the development and utilization of surrogate endpoints in FDA approvals; Examine the increasing reliance on surrogates, particularly case studies in fields like rare diseases and oncology, where overall survival data may be years away; Discuss ways to incorporate the patient and provider perspective to understand what constitutes “meaningful” endpoints.
Speaker(s)
Panelist
Kara Berasi, PHARMD, MS
Haystack Project, United States
CEO
Panelist
Jenny Myers Ahlstrom
HealthTree, United States
Founder & CEO/Multiple Myeloma Patient
Panelist
Alexis Reisin Miller, JD
MSD, United States
Head, Global Regulatory Policy
Panelist
Representative Invited
FDA, United States
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