JSM 2015 Online Program

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Legend: Washington State Convention Center = CC, Sheraton Seattle = S, Grand Hyatt = GH and The Conference Center = TCC
* = applied session       ! = JSM meeting theme

Activity Details

680 * ! Thu, 8/13/2015, 10:30 AM - 12:20 PM CC-611
Benefit-Risk Assessment to Support Decision-Making in Drug Development and Regulatory Assessment — Topic Contributed Papers
Biopharmaceutical Section , Committee on Applied Statisticians
Organizer(s): Bo Fu, AbbVie
Chair(s): Bo Fu, AbbVie
10:35 AM Two Statistical Approaches to Incorporate Data Uncertainty into Multiple Criteria Decision Analysis (MCDA) for Benefit-Risk Assessment of Medical Products Shihua Wen, AbbVie
10:55 AM The Influence of Clinically and Statistically Meaningful Differences in Risk Benefit: A Case Study of the First Approved Allergenic Sublingual Immunotherapy (SLIT) Products Tammy Massie
11:15 AM Developing a Benefit-Risk Process That Becomes Fully Integrated into Developmental Processes and Decision-Making Within a Biopharmaceutical Organization Mondira Bhattacharya, AbbVie ; Rebecca B. Reindel, AbbVie
11:35 AM Benefit-Risk Assessment in the Absence of Established Definition of Responders Amarjot Kaur, Merck Research Laboratories ; Ziliang Li, Merck Research Laboratories
11:55 AM Discussant: Jerald Schindler, Merck Research Laboratories
12:15 PM Floor Discussion

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