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Sessions Were Renumbered as of May 19.

CC-W = McCormick Place Convention Center, West Building,   CC-N = McCormick Place Convention Center, North Building
H = Hilton Chicago,   UC= Conference Chicago at University Center
* = applied session       ! = JSM meeting theme

Activity Details

397 * Tue, 8/2/2016, 2:00 PM - 3:50 PM CC-W196b
Innovative Trial Designs and Data Analysis Models in Rare Diseases — Invited Papers
Biopharmaceutical Section , International Chinese Statistical Association
Organizer(s): Freda Cooner, FDA/CDER/OTS/OB/DB2
Chair(s): Freda Cooner, FDA/CDER/OTS/OB/DB2
2:05 PM Efficient Use of Deficient (Limited) Information: A Rare Disease Perspective Sandeep M. Menon, Pfizer
2:20 PM The Statisticians Role as a Strategic Drug Developer in Rare Disease Indications Jeff Palmer, Pfizer
2:35 PM Case Studies for Biologics Trials in Very Rare Diseases John Scott, FDA
2:50 PM Issues and Solutions Encountered in the Design of Trials for Rare Diseases Brenda Gaydos, Eli Lilly and Company ; Karen Price, Eli Lilly and Company ; Bill Prucka, Eli Lilly and Company
3:05 PM Hierarchical Bayesian Approaches for Clinical Trials in Orphan and Pediatric Diseases Cynthia Basu, University of Minnesota ; Freda Cooner, FDA/CDER/OTS/OB/DB2 ; Ram Tiwari, FDA/CDER/OT/OB ; Bradley Carlin, University of Minnesota
3:20 PM Discussant: Amy Xia, Amgen
3:35 PM Floor Discussion
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