About The Biomarkers Consortium


The Biomarkers Consortium is a major public-private biomedical research partnership managed by the Foundation for the National Institutes of Health (FNIH) with broad participation from stakeholders across the health field, including government, industry, academia and patient advocacy and other not-for-profit organizations. In addition to the FNIH, founding members include the National Institutes of Health, Food and Drug Administration and the Pharmaceutical Research and Manufacturers of America. The Biomarkers Consortium brings together the expertise and resources of various partners to rapidly identify, develop and qualify potential high-impact biomarkers particularly to enable improvements in drug development, clinical care and regulatory decision-making. The Biomarkers Consortium was formally launched in late 2006.

FNIH Biomarkers Consortium 2019 Accomplishments

Advancing Therapeutics

FDA Biomarker Qualification Milestones

Letter of Intent (LOI) Submissions:

LOI Approval: 

Qualification Plan Submissions:

Consensus Statements and Impact on Regulatory Decisions 

Sarcopenia 2 project released evidence-based disease diagnosis criteria - J Gerontol A Biol Sci Med Sci. 2019 Mar 14. pii: glz081. doi: 10.1093/gerona/glz081

Drug Development Clinical Tools

The FNIH Biomarkers Consortium Kidney Safety Biomarker Project Team and the Critical Path Institute’s Predictive Safety Testing Consortium’s Nephrotoxicity Working Group authored a comprehensive User's Guide: Kidney Safety Composite Measure Biomarker for Use in Clinical Development (May 15, 2019) that describes and outlines the use of the qualified composite measure biomarker for use in Phase 1 clinical trials

Scientific Publications

FNIH Biomarkers Consortium 2018 Accomplishments

  FDA Biomarker Qualification Milestones 
  Consensus Statements and Impact Regulatory Decisions
  • Contributions to FDA Guidance
    • FNIH/FDA Evidentiary Criteria Workshop - A whitepaper generated through the workshop contributed to the contents of the new “Biomarker Qualification: Evidentiary Framework Guidance for Industry and FDA Staff” released in December 2018 
    • HABP/VABP Project - Recommendations submitted to the FDA will be incorporated into updated 2019 Guidance 
    • OA Biomarkers Project - Contributed to the release of the “Osteoarthritis: Structural Endpoints for the Development of Drugs, Devices, and Biological Products for Treatment, Guidance for Industry” in August 2018 
  • Consensus Conference Activity
  Drug Development Clinical Tools 
  23 Scientific Publications 


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