The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, in co-sponsorship with the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium, hosted a public meeting titled Developing an Evidentiary Criteria Framework for Safety Biomarkers Qualification Workshop. The workshop was held on April 14 and 15, 2016.
This workshop aimed at creating alignment among scientific stakeholders including the FDA, the NIH, the biopharmaceutical industry, academic researchers and patient groups regarding a proposed framework for determining the levels of evidence required to qualify biomarkers for use in drug development, with an emphasis on biomarkers used in determinations of drug safety assessments. The participants elaborated a general framework for biomarker qualification along with specific application to different contexts of use related to drug safety, including assessment of several specific case studies involving qualifying clinical markers of toxicity in different organ systems.
The FNIH/FDA Evidentiary Framework Workshop,
Core Writing Group
Senior Director, Pfizer
Division Director, NIMH/NIH, and Biomarkers Consortium Neuroscience Steering Committee Co-Chair
President & CEO, Critical Path Institute
Executive VP Scientific and Regulatory Affairs and Biomarkers Consortium Executive Committee Member, PhRMA
Scientific Program Manager, Foundation for the National Institutes of Health
Special Advisor and Biomarkers Consortium Cancer Steering Committee Co-Chair, NCI/NIH
Research Director, Duke-Robert J. Margolis, MD Center for Health Policy (formally PhRMA)
Co-Director Biomarker Qualification Program and Biomarkers Consortium Executive Committee Member, FDA
Deputy Director Research Partnerships, Foundation for the National Institutes of Health
Vice President, Scientific & Regulatory Advocacy, (formally PhRMA)
Executive Director, Predictive Safety Testing Consortium, Critical Path Institute
Associate Vice President, Merck
Senior Vice President and Biomarkers Consortium Executive Committee Member, Takeda
Director Research Partnerships, Foundation for the National Institutes of Health
Pathologist/Senior Scientist, Genentech
Evidentiary Criteria Framework Final Version
FNIH FDA April Biomarker Evidentiary Criteria Meeting Public Report
Additional Information for Registered Participants
Framework for Biomarker Evidentiary Criteria Released Announcement
For additional information or to provide feedback about the workshop, please contact Joseph Menetski, Ph.D., Deputy Director of Research Partnerships at [email protected] or (301) 594-6596.