Sessions Were Renumbered as of May 19.
Legend:
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
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
