Biomarkers Consortium - 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 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

Goals

  • 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.

Scientific Publications

Evidentiary Criteria Framework Final Version

FNIH FDA April Biomarker Evidentiary Criteria Meeting Public Report

Workshop Agenda

Additional Information for Registered Participants

Media

YouTube, Janet Woodcock, MD, Keynote address, April 14, 2016

Partners

Critical Path Institute – Predictive Safety Testing Consortium
Duke University
Food and Drug Administration
Genentech, Inc.
Merck Sharp & Dohme Corp.
National Cancer Institute (NCI)
National Institute of Mental Health (NIMH)
Pfizer Inc
Pharmaceutical Research and Manufacturers of America
Takeda Pharmaceuticals International, Inc.

Contact

Joseph Menetski, Deputy Director Research Partnerships, jmenetski@fnih.org