About Biomarkers Consortium

The Biomarkers Consortium brings together various partners to identify, develop and qualify potential biomarkers to improve drug development and regulatory decision-making

Consortium Partners

This exceptional group of organizations has aligned to further efforts dedicated to the discovery, development and the seeking of regulatory approval for biological markers (i.e. biomarkers) that support new drug development, preventive medicine and medical diagnostics.

Working to support research and guide clinical practice is the main goal of The Biomarkers Consortium. This collaborative effort ensures that the voice of all stakeholders involved in biomarker research is heard and contributes to strides made in support of promising initiatives undertaken by The Consortium in areas such as cancer, immunity & inflammation, metabolic disorders and neuroscience.

Become a part of the growing list of contributing members from industry, foundations, professional associations and patient advocacy organizations, working together along with our government colleagues from the National Institutes of Health and U.S. Food and Drug Administration to achieve a new era of predictive, preventive and personalized medicine through biomarker research.

FDA logo
NIH Logo
For Profit
abbive logo
Adaptive Biotechnologies
ADX logo
Alector logo
alkermes logo
amgen logo
astellas logo
astrazeneca logo
Bayer logo
bio-rad logo
Biogen logo
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C2N 260px
celgene logo
Clario Transition
Clinical Ink
Gates Ventures
genetech logo
Genmab logo
Ikena logo
Jazz Pharma logo
johnson and johnson logo
labcorp logo
Lilly logo
Lumos Labs
merck logo
Nordic Bioscience logo
Novo Nordisk
Novartis logo
olink logo
Oxford BioDynamics
Path AI Logo
regeneron logo
Rhino Health
sage therapeutics logo
sengenics logo
takeda logo
UCB logo
Not-for-Profit Organizations
alzheimers logo
Alzheimers Drug Discovery Foundation logo
Arthritis Foundation logo
Association for Molecular Pathology logo
The Association for Frontotemporal Degeneration logo
Bright Focus Foundation logo
CHDI logo
Chrons & Colitis Foundation logo
Fredrick National Laboratory logo
Multiple Myeloma logo
National Dairy Council logo
Packard Center
Radiological Society of North America logo
Schizophrenia Alliance
Society for Immunotherapy of Cancer
Sjogrens Foundation

Founding Partners

The Biomarkers Consortium was established by the Foundation for the National Institutes of Health, the National Institutes of Health, the U.S. Food and Drug Administration and Pharmaceutical Research and Manufacturers of America. In addition, the Centers for Medicare & Medicaid Services and Biotechnology Industry Organization have been instrumental in the implementation and organization of The Biomarkers Consortium.


Policies and Procedures
The policies and procedures established by The Biomarkers Consortium include:
Membership Manual
Conflict of Interest Policy
Confidentiality Policy
Antitrust Policy and Guidelines
General Intellectual Property and Data Sharing Principles
Principles and Policies on Selection and Award of Grants or Contracts Funded by FNIH under The Biomarkers Consortium
Publication Guidelines

For more information about the policies and procedures of The Consortium, please contact us at biomarkers@fnih.org.


Key Resources

Publications about the Biomarkers Consortium: 


American Society for Clinical Pharmacology & Therapeutics (ASCPT): "How To Develop and Qualify Biomarkers: Biomarker Consortium Perspective" Speaker: Joseph P. Menetski, Ph.D., Associate Vice President of Research Partnerships, FNIH


FNIH Biomarkers Consortium - Beta Cell Project "A New Tool for Diabetes Research"

FNIH Biomarkers Consortium - VOL-PACT: A Novel Cancer Imaging Project

FNIH highlights success of the ABC-CT program in advancing neuropsychiatric biomarkers for autism