Bioanalytics

Hot Topic: 2025 FDA Guidance BMV for Biomarkers: Impact and Path Forward

Hot Topic Moderator(s)

• 

  Carmen Fernandez-Metzler, PhD

  President
  PharmaCadence
  Hatfield, Pennsylvania

Hot Topic Speaker(s)

• 

  Steven Piccoli, PhD (he/him/his)

  Head, Clinical Biomarkers
  SPARC
  Princeton, New Jersey
• 

  Lauren Stevenson, PhD (she/her/hers)

  Chief Scientific Officer
  Immunologix
  Tampa, Florida
• 

  Karen Quadrini, PhD

  Director, Clinical Biomarkers
  Prothena Biosciences, Pennsylvania
• LA

  Lakshmi Amaravadi, PhD (she/her/hers)

  Head of Oncology Integrated Bioanalysis
  AstraZeneca
  Waltham, Massachusetts

The FDA issued the long-awaited guidance on bioanalytical method validation for biomarkers (BMVB), which replaces the 2018 FDA BMV. The new guidance for biomarker assays does not introduce significant changes compared to the original 2018 FDA BMV and points to PK method validation via ICH M10 as the starting point for the analytical validation of biomarker assays. The 2025 BMVB acknowledges that many aspects of ICH M10 cannot be directly applied to biomarker assays or to different bioanalytical platforms, and that different assay characterization should be considered, justified, and reported accordingly. Further, it is consistent with the long-standing view of the biomarker community, specifically that 1) there are differences between PK and biomarker assays which impact analytical method validation strategies, 2) the FDA's fit-for-purpose approach should be used considering the biology of the biomarkers and different analytical characteristics to ensure that the data are reliable, and 3) the assay parameters tested and the approach taken for biomarker method validation should always exactly support the biomarker's proposed Context of Use (COU).
This Hot Topic is planned as a panel discussion to deliberate the impact and concerns, of and about the new biomarker assay guidance and the path forward. The discussion aims to provide analysts with the tools to navigate challenges related to biomarker assay validation in their organizations. We will continue to stress the importance of implementing a fit-for-purpose analytical validation approach that supports the COU. COU remains the cornerstone of biomarker assay validation.