Workshop: Developing an Evidentiary Criteria Framework for Safety Biomarkers Qualification

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

Jiri Aubrecht
Senior Director, Pfizer

Linda Brady
Division Director, NIMH/NIH, and Biomarkers Consortium Neuroscience Steering Committee Co-Chair

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

Related Resources:

Evidentiary Criteria Framework Final Version
FNIH FDA April Biomarker Evidentiary Criteria Meeting Public Report

Workshop Agenda
Additional Information for Registered Participants

Framework for Biomarker Evidentiary Criteria Released Announcement

Contact:

For additional information or to provide feedback about the workshop, please contact Joseph Menetski, Ph.D., Deputy Director of Research Partnerships at jmenetski@fnih.org or (301) 594-6596.