Nonclinical Biostatistics Manufacturing Comparability CMC Scientific Working Group
About this workstream
Chair: Aili Cheng (Pfizer)
The Manufacturing Comparability workstream was established in 2023 with the aim of providing guidance on statistical approaches, design, and criteria for analytical and method comparability studies. The workstream falls under the umbrella of the ASA Biopharmaceutical Nonclinical Working Group (NCBWG), which includes several industry and academia members who form small sub-teams to work on specific projects.
How to get involved
If you are interested in staying up to date with the workstream progress on projects identified below, please contact the chair to be added to our email list. There is no obligation to participate beyond being a member of the email list.
If you may be interested in volunteering to help with team efforts, please contact the chair or someone else in the current team membership below to discuss your interests.
Current Projects
|
Project
|
Contributors
|
|
Write a manuscript on Statistical Methods for Analytical Comparability between Pre-change and Post-change Processes
|
Aili Cheng (Pfizer)
Bill Pikounis (JnJ)
Irina Gershgorin (Novartis)
José Ramirez (Kite)
Sayli Pokal (Zoetis)
Stone Wang (Novartis)
|
|
Write a manuscript on Statistical Methods for Method Comparability and Applications using JMP.
|
José Ramirez (Kite)
Aili Cheng (Pfizer)
Bill Pikounis (JnJ)
Irina Gershgorin (Novartis)
Sayli Pokal (Zoetis)
Stone Wang (Novartis)
|
Upcoming Forums