Nonclinical Biostatistics Working Group

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

Project

Contributors

Collaborate with IQ consortium on meeting with FDA on Bayes for CMC applications

José Ramirez (Kite)

Stan Altan (JnJ)

More members TBD

 

Write a manuscript illustrating how Bayesian approach aligns with ICH updated guidance on assay validation

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)

 

Write Industry Guidance for Bayesian methods in CMC

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

 

 

Past Projects

Year

Project

Access

2023

NCB 2023 Bayesian Workshop

Diya Luwis (JNJ)

Will Landau (Lilly) 

2023

Publication in Pharmaceutical Statistics:

Stability analysis using mixed models: A critique of tolerance interval methods and a probabilistic solution

2022

Book Publication: Case Studies in Bayesian Methods for Biopharmaceutical CMC

2021

Publication in Statistics in Biopharmaceutical Research:

Continuous method validation: beyond one-time studies to characterize analytical methods

2021

2021 Nonclinical Biostatistics Conference - Discussion Panel on Bayesian applications in CMC

2021

JSM 2021 Topic-Contributed Session: Toward a regulatory guidance for the use of Bayesian methods in nonclinical CMC Statistics

2020

JSM 2020 Topic Contributed Session: Informative Prior Applications in Nonclinical CMC Statistics

2020

Publication in Pharmaceutical Statistics:

The current state of Bayesian methods in nonclinical pharmaceutical statistics: Survey results and recommendations from the DIA/ASABIOP Nonclinical Bayesian Working Group


Resources