Nonclinical Biostatistics Bayesian CMC Scientific Working Group
About this workstream
Co-chairs: Christopher Thompson and Ji Young Kim
The Bayesian workstream was established in 2019 with the aim of advancing the use and acceptance of Bayesian methods within the nonclinical statistics space. The workstream, which falls under the umbrella of the ASA Biopharmaceutical Nonclinical Working Group (NCBWG), includes several industry and academia members who form small sub-teams to work on specific projects aimed promoting Bayesian methods.
How to get involved
If you are interested in staying up-to-date in our work or possibly jumping into a certain project, we would like to add you to our email list (please contact one of the co-chairs to be added to the list). There is no obligation to participate. As new projects are identified, we will reach out to the broad group and seek volunteers to fill specific roles in the projects. Therefore, you can choose to simply stay informed or become active in a particular initiative. Either way, our hope is to build a broader community of interest / contributors that will help to advance the use of Bayesian methods.
Current Projects
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Project
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Contributors
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Collaborate with IQ consortium on meeting with FDA on Bayes for CMC applications
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José Ramirez (Kite)
Stan Altan (JnJ)
Paul Faya (Lilly)
More members TBD
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Write a manuscript illustrating how Bayesian approach aligns with ICH updated guidance on assay validation
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Katherine Giacoletti (Merck)
Paul Faya (Lilly)
Buffy Hudson-Curtis (GSK)
Christopher Thompson (AstraZeneca)
Ji Young Kim (Merck)
David LeBlond (Robert Singer Consulting)
Tony Pourmohamad (Genentech)
Franz Innerbichler (Novartis)
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Write Industry Guidance for Bayesian methods in CMC
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Paul Faya (Lilly)
Stan Altan (JnJ)
David LeBlond (Robert Singer Consulting)
Steven Novick (Takeda)
John Seaman Jr. (Baylor University)
John Peterson (PDQ Consulting)
Tony Pourmohamad (Genentech)
Christopher Thompson (AstraZeneca)
Dwaine Banton (LabCorp)
Yanbing Zheng (Abbvie)
Katherine Giacoletti (Merck)
Jun Gao (Health Canada)
Ji Young Kim (Merck)
José Ramirez (Kite)
Tobias Eilert (Boehringer Ingelheim)
Buffy Hudson-Curtis (GSK)
More members TBD
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Past Projects
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Year
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Project
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Access
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2024
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Publication in ASA Biopharmaceutical report 2024 Spring
A call for a regulatory guidance on Bayesian methods in the statistical support of CMC development studies
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2023
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NCB 2023 Bayesian Workshop
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Diya Luwis (JNJ)
Will Landau (Lilly)
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2023
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Publication in Pharmaceutical Statistics:
Stability analysis using mixed models: A critique of tolerance interval methods and a probabilistic solution
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2022
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Book Publication: Case Studies in Bayesian Methods for Biopharmaceutical CMC
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2021
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Publication in Statistics in Biopharmaceutical Research:
Continuous method validation: beyond one-time studies to characterize analytical methods
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2021
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2021 Nonclinical Biostatistics Conference - Discussion Panel on Bayesian applications in CMC
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2021
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JSM 2021 Topic-Contributed Session: Toward a regulatory guidance for the use of Bayesian methods in nonclinical CMC Statistics
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2020
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JSM 2020 Topic Contributed Session: Informative Prior Applications in Nonclinical CMC Statistics
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2020
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Publication in Pharmaceutical Statistics:
The current state of Bayesian methods in nonclinical pharmaceutical statistics: Survey results and recommendations from the DIA/ASA‐BIOP Nonclinical Bayesian Working Group
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Resources
