Abstract
This conference report summarized a full-day workshop, “best practices for the development and fit-for-purpose validation of biomarker methods,” which was held prior to the American Association of Pharmaceutical Scientists (AAPS) PharmSci360 Congress, San Antonio, TX, November 2019. The purpose of the workshop was to bring together thought leaders in biomarker assay development in order to identify which assay parameters and key statistical measures need to be considered when developing a biomarker assay. A diverse group of more than 40 scientists participated in the workshop. The workshop and subsequent working dinner stimulated robust discussion. While a consensus on best practices was not achieved, some common themes and major points to consider for biomarker assay development have been identified and agreed on. The focus of this conference report is to summarize the presentations and discussions which occurred at the workshop. Biomarker assay validation is a complex and an evolving area with discussions ongoing.
Highlights
The importance of biomarkers in decision-making during drug development continues to increase (Menetski et al 2019)
Workshop discussions one objective of this workshop was to craft minimal criteria for different levels of validation, consensus on best practices regarding the development and fit-for-purpose validation of biomarker methods was not achieved during the workshop, the participants did agree that the biomarker assay COU should be defined prior to assay development and is established by considering factors such as but not limited to (1) the biology of the biomarker, (2) the pharmacodynamic effects of the drug on the biomarker, (3) the intended use of the biomarker data, (4) the phase of drug development, and (5) the size of the trial
Fit-for-purpose, context-of-use, and iterative approaches are all familiar terms in biomarker analytical science
Summary
The importance of biomarkers in decision-making during drug development continues to increase (Menetski et al 2019). This term has come to mean that assays should be validated as appropriate for the intended use of the data and the associated regulatory requirements.
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