December 6, 2016 — The Foundation for the National Institutes of Health (FNIH) announced today the release of the “Framework for Defining Evidentiary Criteria for Biomarker Qualification.” Developed in partnership with government and industry stakeholders, the framework defines the level of evidence needed to support qualification of biological markers (biomarkers). The document is a result of a broad-based effort by the FNIH, the U.S. Food and Drug Administration (FDA), the National Institutes of Health (NIH), Critical Path Institute (C-Path), Pharmaceutical Research and Manufacturers of America (PhRMA) and multiple pharmaceutical companies including Genentech, Merck, Pfizer and Takeda and incorporates input from nearly 200 scientific leaders in the field.

“It’s hard to overestimate the potential impact of the work that is being done here,” Janet Woodcock, M.D., Director for the Center of Drug Evaluation and Research at the FDA, said about this effort during her keynote address at an April 2016 workshop on this topic.

Progress in the use of biomarkers in drug development has been hampered by the lack of clear, predictable and specific regulatory criteria for the evidence required to qualify new markers. The document seeks to address these issues through a defined framework that suggests biomarker developers focus on five specific steps: describing a statement of need, defining a specific context of use, performing a benefit analysis, performing a risk analysis and concisely describing available evidence. It is hoped that the framework will promote collaborative discussions between biomarker developers and the FDA, improve upon the quality of biomarker qualification submissions to the FDA and inform future FDA efforts to develop relevant guidance for evidentiary criteria in biomarker qualification.

For more information and to read the full framework, click here.