JSM 2011 Online Program

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Activity Details

112 * Mon, 8/1/2011, 8:30 AM - 10:20 AM CC-D236
Progress in the Use of Genomic Biomarkers in Clinical Trials — Topic Contributed Papers
Biometrics Section , ENAR , International Chinese Statistical Association , Committee of Representatives to AAAS
Organizer(s): Peggy H. Wong, Merck & Co., Inc.
Chair(s): Sue-Jane Wang, U.S. Food and Drug Administration/CDER
8:35 AM The Role of the Cutoffs in Developing the Genomic Classifier for Clinical Utility Assessment Samir Lababidi, U.S. Food and Drug Administration ; Sue-Jane Wang, U.S. Food and Drug Administration/CDER
8:55 AM Statistical Challenges in Genetic Biomarker Treatment Association with Clinical Outcomes: Experience from an Infectious Disease Phase II and Phase III Trials Peggy H. Wong, Merck & Co., Inc. ; Navdeep Boparai, Merck & Co., Inc.
9:15 AM Challenges in Developing and Validating Biomarkers That Are Treatment Induced: Experiences from an Oncology Phase III Trial Bin Yao, Amgen Inc. ; Yining Ye, Amgen Inc.
9:35 AM Identifying Predictive Biomarkers in Oncology Trials: A Practical Example from a Randomized Phase II Study in Neo-Adjuvant Breast Cancer (BC) Pralay Mukhopadhyay, Bristol-Myers Squibb ; Guan Xing, Bristol-Myers Squibb ; Li-An Xu, Bristol-Myers Squibb ; David Liu, Bristol-Myers Squibb ; Christine Horak, Bristol-Myers Squibb
9:55 AM Robust and Reproducible Analysis of a Very Large Clinical Genomics Study John Storey, Princeton University
10:15 AM Floor Discussion

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