Biomarkers Consortium – Workshop: Defining an Evidentiary Criteria Framework for Surrogate Endpoint Qualification


The Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium, in partnership with the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, hosted a public meeting entitled Framework for Defining Evidentiary Criteria: Surrogate Endpoint Qualification Workshop on July 30th and 31st, 2018.

This workshop aimed to create alignment among scientific stakeholders including FDA, 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 surrogate endpoints. A primary aim of the meeting was to elaborate the general framework for biomarker qualification along with specific application to different contexts of use (COUs), including assessment of several representative case studies involving surrogate endpoint markers of specific clinical outcome measures.


  • Children’s Hospital of Philadelphia
  • Critical Path Institute
  • Dana-Farber Cancer Institute
  • Food and Drug Administration
  • National Cancer Institute (NCI)
  • National Center for Advancing Translational Sciences (NCATS)
  • Pfizer Inc
  • University of Chicago


Surrogate Endpoint Core Program Committee:

  • Stacey Adam – Associate Vice President, Research Partnerships, FNIH
  • Ken Anderson -Program Director, Dana–Farber Cancer Institute
  • Steve Broadbent – Chief Operating Officer, Critical Path Institute
  • Martha Brumfield – President & CEO, Critical Path Institute
  • Sara Eggers – Office of Strategic Programs, FDA/CDER
  • Steve Hoffmann – Associate Vice President, Research Partnerships, FNIH
  • Laura Jaeger – Scientific Policy Advisor, FDA/CDER
  • Reza Kazemi-Tabriz – Operations Research Analyst, FDA/CDER
  • Gary Kelloff – Special Advisor and Biomarkers Consortium Cancer Steering Committee Co-Chair, NCI/NIH
  • Leila Lackey – Operations Research Analyst, FDA/CDER
  • Chris Leptak – Director Biomarker Qualification Program and Biomarkers Consortium Executive Committee Member, FDA
  • Lisa McShane – Sr. Statistician, NIH/NCI
  • Joseph Menetski – Associate VP Research Partnerships, FNIH
  • Theresa Mullin – Associate Director for Strategic Initiatives, FDA/CDER
  • Elizabeth Ottinger – Senior Project Manager, NIH/NCATS
  • James Revkin – Senior Director, Pfizer
  • John-Michael Sauer – Executive Director, Predictive Safety Testing Consortium, Critical Path Institute
  • Myrlene Staten – Program Director and Biomarkers Consortium Metabolic Disorders Steering Committee Co-Chair NIH/NIDDK
  • Adeline Vanderver – Program Director of the Leukodystrophy CoE, Children’s Hospital of Philadelphia
  • John Wagner – Senior VP and Biomarkers Consortium Executive Committee Member, Takeda
  • Steve Williams – Chief Medical Officer, SomaLogic Inc
  • Robert Wolk – Director, Pfizer

Presentations from the Workshop:


  • Improve the quality and standardization of submissions to the FDA
  • Better characterize and define surrogate endpoints for drug development through example case studies
  • Support FDA in the development of Guidance(s) for the level of evidentiary criteria sufficient for surrogate endpoint qualification

Results & Accomplishments

Guidance Documents

Scientific Publications


FNIH Web Announcement (Dec. 7, 2017): Science Translational Medicine Publishes Article on Evidence Needed for Biomarker Qualification

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