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#457: Understanding the Misconceptions and Myths around Surrogate Endpoints
Monday June 15, 2026 4:00pm - 5:00pm EDT
204AB
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-548-L04-P; CME 1.00; RN 1.00

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 Objectives

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.

Chair

Bridget Doherty, MPH, MS

Speaker

Panelist
Kara Berasi, PHARMD, MS

Panelist
Jenny Myers Ahlstrom

Panelist
Alexis Reisin Miller, JD


Speakers
JA

Jenny Ahlstrom

Founder & CEO/Multiple Myeloma Patient, HealthTree, United States
KB

Kara Berasi

CEO, Haystack Project, United States
Kara Berasi started working in patient advocacy after her son was diagnosed with a rare disease. She has a personal passion to change the landscape of care as it relates to those living with rare diseases. She is the CEO of Haystack Project, an umbrella organization representing over... Read More →
avatar for Bridget Doherty

Bridget Doherty

Director, Access and Policy Research, Johnson & Johnson, United States
Bridget Doherty, MPH, MS, is a strategic policy, research, and communications professional with extensive experience in pharmaceuticals, medical devices, and healthcare publishing. Currently serving as the Director of Access and Policy Research at Johnson & Johnson Innovative Medicine... Read More →
avatar for Mary Thanh Hai

Mary Thanh Hai

Deputy Director for Clinical, OND, CDER, FDA, United States
Dr. Thanh Hai is the Director of the Office of New Drugs in the Center for Drug Evaluation and Research, overseeing the drug development programs for prescription and non-prescription drugs and therapeutic biologics. She is an internist/endocrinologist. She started her career at the... Read More →
avatar for Alexis Miller

Alexis Miller

Head, Global Regulatory Policy, MSD, United States
Alexis Reisin Miller leads Global Regulatory Policy at Merck & Co., Inc., helping shape and respond with agility to an evolving global regulatory landscape. Her work centers on advancing regulatory science, implementing practical policy frameworks, expanding use of data beyond traditional... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
204AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum |   10: Stats-EvidenceGeneration-RWE, Forum
  • Audience Basic
  • Area Evidence Innovation
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Biostatistics
  • Feature Topics Evidence Innovation
  • Tags Forum

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