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Session 1- Biomarkers and Surrogate Endpoints
Session Chair(s)
Gregory Levin, PhD
Associate Director for Statistical Science and Policy, OB, OTS, CDER
FDA, United States
Keaven Anderson, PhD
Scientific AVP, Methodology Research
Merck & Co., Inc., , United States
At the request of the FDA, the Institute of Medicine published a report on the evaluation of biomarkers and surrogate endpoints. In this session, we will review the principle recommendations of the report, provide a regulatory perspective, and discuss the ongoing I-SPY2 study. This study recently generated a Phase III candidate drug using a design that includes one biomarker as an endpoint and several others for subgroup identification. A discussant from the FDA will provide perspective for the session.
Speaker(s)
Issues in Qualifying Biomarkers As Surrogate Endpoints
Victor DeGruttola, PhD
Harvard School of Public Health, United States
Henry Pickering Walcott Prof of Biostatistics & Chair, Dept of Biostatistics
Choosing Outcomes in Clinical Research: Biomarkers and Other Indirect Outcome Measures
John H. Powers, MD, FACP
George Washington University School of Medicine, United States
Professor of Clinical Medicine
Biomarkers and Longitudinal Modeling in I-SPY 2 and I-SPY 3
Donald A Berry, PhD
M.D. Anderson Cancer Center, United States
Professor, Department of Biostatistics
Discussant
Sue-Jane Wang, PhD, MA, MS
FDA, United States
Mathematician Statistician
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