About The Biomarkers Consortium

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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 2018 Accomplishments

Therapeutics Advanced Using Tools Generated by Biomarkers Consortium Projects:

FDA Biomarker Qualification Milestones (Process results in a decision-making tool that the FDA is confident to use in the drug review and approval process.)

Consensus Statements and Documents Generated (Consensus decisions are to develop and release "FDA Guidance to Industry" that ensure understanding and consistency across the therapeutic development industry.)

  • 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 (Project teams characterize and operationalize tools to measure important aspects of disease biology that help drive new therapeutic development. These tools are being actively used by Biomarkers Consortium members in the drug development process.)

23 Scientific Publications (Providing detailed information on biomarker development to the public.)

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