JSM 2012 Online Program

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*491 !**	Wed, 8/1/2012, 10:30 AM - 12:20 PM	CC-Room 25C
Challenges in Biomarker and Surrogate Endpoint Qualification — Topic Contributed Papers
Biopharmaceutical Section , International Indian Statistical Association
Organizer(s): Qunming Dong, Vertex Pharmaceuticals
Chair(s): Qunming Dong, Vertex Pharmaceuticals
10:35 AM	Statistical Evaluation of Surrogate Endpoints: Validity, Efficiency, and Sensitivity — Pandurang Kulkarni, Eli Lilly and Company ; Yongming Qu, Eli Lilly and Company ; Wen Li, Singapore Clinical Research Institute
10:55 AM	Biomarker Qualification: FDA Experience — Aloka Chakravarty, FDA/CDER
11:15 AM	Design and Estimation for Evaluating Principal Surrogate Markers in Vaccine Trials — Ying Huang, Fred Hutchinson Cancer Research Center ; Peter B Gilbert, University of Washington/Fred Hutchinson Cancer Research Center
11:35 AM	Related Causal Frameworks for Surrogate Outcomes in Randomized Trials, with Extensions to Observational Studies and Beyond — Marshall Joffe, University of Pennsylvania
12:15 PM	Floor Discussion

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