Following the release of the FDA BMVB guidance in Jan 2025, the Biomarkers and Precision Medicine Community engaged in community-wide discussions which led to an AAPSJ editorial that provides insight into how the Community interprets the new biomarker guidance.
The authors hope this article raises attention to the differences between PK and biomarker assays. We reaffirm our long-standing position that biomarker assay validation should follow a fit-for-purpose (FFP), scientifically-driven approach to generate quality data that supports the biomarker's context of use during drug development.
There will be a hot topic session on the 2025 FDA BMVB guidance on Tuesday, Nov 11th from 10:30-11:30 AM CT. Please join us for the discussion if you are attending PS360. We look forward to seeing you there!
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Karen Quadrini, PhD
Director, Clinical Biomarkers
Prothena Biosciences
Brisbane, CA
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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