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304 * ! Wed, 8/5/2020, 10:00 AM - 11:50 AM Virtual
Extrapolation as a Default Strategy in Pediatric Drug Development: Implications to Clinical Trial Designs and Statistical Analysis — Topic Contributed Papers
Biopharmaceutical Section, Health Policy Statistics Section, Biometrics Section
Organizer(s): Margaret Gamalo, Eli Lilly & Co
Chair(s): Junjing Lin, Takeda
10:05 AM Clinical Development Using Pediatric Extrapolation
Robert "Skip" Nelson, J7J
10:25 AM Real World Evidence Utilization in Pediatric Clinical Development Reflected by US Product Labeling: Statistical Review
Yodit Seifu; Freda Cooner, Amgen Inc.; Margaret Gamalo-Siebers, Eli Lilly & Co; Junjing Lin, Takeda; Junshan Qiu, FDA/CDER; Shiling Ruan, Novartis; Ros Walley, UCB Celltech ; Sophie Barthel, PRA Health Sciences
10:45 AM Hierarchical Models for Clinical Trials Involving Multiple Pediatric Cohorts
Margaret Gamalo-Siebers, Eli Lilly & Co
11:05 AM A Quantitative Method to Evaluate Exposure-Response Similarity Between Pediatrics and Adults to Support Efficacy Extrapolation
Junshan Qiu, FDA/CDER; Margaret Gamalo-Siebers, Eli Lilly & Co; Freda Cooner, Amgen Inc.; Junjing Lin, Takeda; Yodit Seifu; Yaning Wang, FDA/CDER/DPM
11:25 AM Bayesian Analysis in Pediatric Settings
Mark Rothmann, Division of Biometrics II, Office of Biostatistics, OTS, CDER, FDA
11:45 AM Floor Discussion