JSM2024
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Topic-Contributed Paper Session

Innovative Trial Designs and Novel Bayesian Techniques to Enhance Pediatric Drug Development

Wed, Aug 7, 10:30 AM - 12:20 PM
Jiani YinChair
Biopharmaceutical Section

4 Presentations

A Practical Model-based Approach in Pediatric Drug Development: Progress and Lessons Learned
10:35 AM - 10:55 AM
Satrajit Roychoudhury (Pfizer)
A Novel Bayesian Extrapolation Design for Assessing Equivalence in Exposure-Response Curves between Pediatric and Adult Populations
10:55 AM - 11:15 AM
Zhongheng Cai (Department of Biostatistics, St Jude Children's Research hospital)
Co-authors: Lian Ma (St. Jude Children's Research Hospital), Haitao Pan (St. Jude Children's Research Hospital), Jingjing Ye (BeiGene)
Propensity score weighted multi-source exchangeability models for incorporating external control data in pediatric trials
11:15 AM - 11:35 AM
Wei Wei (Yale University)
Bayesian Dynamic Borrowing Approaches in the Pediatric Trial Context
11:35 AM - 11:55 AM
Daphne Lin (FDA/CDER/Office of Biostatistics/BDIV)
Co-authors: Hengrui Sun (FDA)

Discussant

Ying Yuan (University of Texas, MD Anderson Cancer Center)
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