The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, in co-sponsorship with The 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
Jiri Aubrecht Senior Director, Pfizer
Linda Brady Division Director and Biomarkers Consortium Neuroscience Steering Committee Co-Chair, NIMH/NIH
Martha Brumfield President & CEO, Critical Path Institute
Bill Chin Executive VP Scientific and Regulatory Affairs and Biomarkers Consortium Executive Committee Member, PhRMA
Steve Hoffmann Scientific Program Manager, Foundation for the National Institutes of Health
Gary Kelloff Special Advisor and Biomarkers Consortium Cancer Steering Committee Co-Chair, NCI/NIH
Gabriela Lavezzari Research Director, Duke-Robert J. Margolis, MD Center for Health Policy (formally PhRMA)
Chris Leptak Co-Director Biomarker Qualification Program and Biomarkers Consortium Executive Committee Member, FDA
Joseph Menetski Deputy Director Research Partnerships, Foundation for the National Institutes of Health
Rajesh Ranganathan Vice President, Scientific & Regulatory Advocacy, (formally PhRMA)
John-Michael Sauer Executive Director, Predictive Safety Testing Consortium, Critical Path Institute
Frank Sistare Associate Vice President, Merck
John Wagner Senior Vice President and Biomarkers Consortium Executive Committee Member, Takeda
David Wholley Director Research Partnerships, Foundation for the National Institutes of Health
Tanja Zabka Pathologist/Senior Scientist, Genentech
- Improve the quality of submissions to the FDA.
- Enhance the predictability of the qualification process.
- Clarify the type and extent of EC needed to support the biomarker’s context of use (COU).
Results & Accomplishments
This multi-stakeholder effort has generated a Framework Document that may prove useful to the FDA and other regulators in creation of new guidance.
Critical Path Institute – Predictive Safety Testing Consortium
Food and Drug Administration
Merck Sharp & Dohme Corp.
National Cancer Institute (NCI)
National Institute of Mental Health (NIMH)
Pharmaceutical Research and Manufacturers of America
Takeda Pharmaceuticals International, Inc.
Joseph Menetski, Deputy Director Research Partnerships, email@example.com