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Activity Number: 172 - Quantitative Decision Making in Clinical Trials
Type: Contributed
Date/Time: Monday, July 29, 2019 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #305095 Presentation
Title: Infusing Bayesian Strategies for Pharmaceutical Manufacturing and Development
Author(s): Bill Pikounis* and Dwaine Banton and John Oleynick and Jyh-Ming Shoung
Companies: Johnson & Johnson and Janssen R&D and Johnson & Johnson and Janssen R&D
Keywords: Bayes; Informative Priors; Multilevel Models; R; Stan

No technological barriers remain to approach with, and execute, Bayesian statistical perspectives, models, and strategies for pharmaceutical manufacturing data evaluation needs, especially multilevel ones. Critical questions to help ensure quality can be readily developed and answered for areas such as, but not only, stability data specifications, product shelf-life, comparability, and analytical methods development. There are cultural transition opportunities from multiple stakeholders within our industry research organization that we are focusing upon to fulfill the potential benefits of “Bayesian-first” solutions in our toolkit. Illustrative examples will be presented on issues including choice of priors, construction of uncertainty intervals, and probabilistic interpretations.

Authors who are presenting talks have a * after their name.

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