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CC = Colorado Convention Center   H = Hyatt Regency Denver at Colorado Convention Center
* = applied session       ! = JSM meeting theme

Activity Details


148 * !
Mon, 7/29/2019, 10:30 AM - 12:20 PM CC-201
Statistical Methods, Challenges and Impacts on Early Phase Trials — Invited Papers
ENAR, Biopharmaceutical Section, Statistics in Biopharmaceutical Research Journal
Organizer(s): Yu Du, Eli Lilly and Company
Chair(s): Pandurang Kulkarni, Eli Lilly & Company
10:35 AM Model-Based Phase I Designs for Immuno-Oncology
Jun Yin, Mayo Clinic; Yu Du, Eli Lilly and Company; Sumithra Mandrekar, Mayo Clinic
10:55 AM The Use of Bayesian Basket Design in Early Phase Trials
Presentation
Shiling Ruan, Novartis; Matt Whiley, Novartis
11:15 AM Advancing Pharmacogenomics Analysis of Drug Response in Early-Phase Clinical Trials
Presentation
Judong Shen, Merck & Co., Inc.; Hong Zhang, Merck & Co., Inc.; Devan Mehrotra, Merck & Co., Inc
11:35 AM Revolutionizing the Early Drug Development
Yongming Qu, Eli Lilly and Company
11:55 AM Discussant: Ying Yuan, University of Texas M.D. Anderson Cancer Center
12:15 PM Floor Discussion
 
 

219168
Tue, 7/30/2019, 7:30 AM - 10:30 AM H-Mineral Hall C
SBR Editorial Board Meeting — Other Cmte/Business
Statistics in Biopharmaceutical Research Journal
Chair(s): Frank Bretz, Novartis Pharma AG
 
 

637 * !
Thu, 8/1/2019, 10:30 AM - 12:20 PM CC-703
Statistics in Biopharmaceutical Research Invited Session — Invited Papers
Statistics in Biopharmaceutical Research Journal
Organizer(s): Frank Bretz, Novartis Pharma AG
Chair(s): Frank Bretz, Novartis Pharma AG
10:35 AM Integration of Pharmacometric and Statistical Analyzes to Enhance Quantitative Decision Making in Clinical Drug Development
Presentation
Kenneth G. Kowalski, Kowalski PMetrics Consulting, LLC
11:00 AM Leveraging Parametric Longitudinal Modeling to Improve Drug Development Efficiency
Presentation
José Pinheiro, Janssen Pharmaceuticals
11:25 AM Complex and Innovative Clinical Trials in Pharmaceutical Regulation
Presentation
John Scott, FDA
11:50 AM Discussant: Frank Harrell, Vanderbilt University
12:10 PM Floor Discussion