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374 * ! Thu, 8/12/2021, 12:00 PM - 1:50 PM Virtual
Statistical Approaches for Evidence Integration and Considerations to Communication in Product Labeling — Topic-Contributed Papers
Biopharmaceutical Section, Health Policy Statistics Section, Biometrics Section
Organizer(s): Jennifer Clark, FDA
Chair(s): Ross Bray, Eli Lilly and Company
12:05 PM Unified Framework of Meta-Analysis, Composite Likelihoods, and Bayesian Methods for Evidence Integration in Pediatric Extrapolation Development Archetypes
Margaret Gamalo-Siebers, Pfizer Inc.; Junjing Lin, Takeda Pharmaceuticals
12:25 PM Using Robust Bayesian Priors to Borrow Information from Historical Adult Trials for a Clinical Trial in Pediatric Multiple Sclerosis
Marius Thomas, Novartis; David Ohlssen, Novartis; Heinz Schmidli, Novartis; Dieter Haering, Novartis
12:45 PM Extrapolating Adult Efficacy Data to Pediatric Populations via Bayesian Hierarchical Models
Benjamin R Saville, Berry Consultants; Kert Viele, Berry Consultants
1:05 PM Partial Extrapolating of Efficacy from Adult to Pediatrics: A Case Study in Systemic Lupus Erythematosus
Juan Jose Abellan, GSK
1:25 PM Discussant: James Travis, FDA
1:45 PM Floor Discussion