• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail

Biomarker Consortium (BC)

Public Health Context:

Personalized medicine – the ability to individualize medical treatment – is one of the most exciting and promising fields in biomedicine.  Instrumental to realizing its potential are biological markers (biomarkers) – objective measures of risk, disease status, and/or health outcomes.  The Biomarkers Consortium (BC) is a public-private biomedical research partnership founded by the FDA, NIH, and the pharmaceutical industry and managed by the Foundation for the National Institutes of Health (FNIH) that provides the framework to identify and qualify new and existing biomarkers for use by biomedical researchers, regulators and health care providers.

Effective identification and deployment of biomarkers are essential to achieving a new era of predictive, preventive, and personalized medicine.  Biomarkers have the promise to:

  • Accelerate basic and translational research.
  • Speed the development of safe and effective medicines and treatments for a wide range of diseases.
  • Help guide clinical practices and accelerate the development of biomarker-based technologies, medicines, and therapies, for the prevention, early detection, diagnosis, and treatment of disease.

Mission & Program Objectives:

  • Promote the qualification, development, and regulatory acceptance of biomarkers using new and existing technologies.
  • Speed the development of medicines and therapies for prevention, early detection, diagnosis, and treatment of disease.
  • Ensure consortium project results are made available to the scientific community.
  • Conduct joint research in “pre-competitive” areas with partners that share common interest in advancing human health and improving patient care.

Accomplishments as of August 2010:

  • Launched nine projects in areas such as metabolic disorders, Alzheimer’s disease, lung cancer, and lymphoma.
  • Completed one project that tested and confirmed the protein adiponectin as an important biomarker in monitoring one facet of treatment in Type II diabetes.


The BC is managed by the Foundation for National Institutes of Health (www.fnih.org disclaimer icon), an independent, non-profit organization established by the U.S. Congress to facilitate groundbreaking research at NIH and worldwide.  There is broad participation in the BC from stakeholders across the health enterprise, including government, industry, academia, patient advocacy, and other non-profit private sector organizations.  For an in-depth listing of the partners, visit www.biomarkersconsortium.orgdisclaimer icon


U.S. Food and Drug Administration
National Institutes of Health
Center for Medicare & Medicaid Services


Abbott Laboratories
Amgen, Inc.
Amylin Pharmaceuticals
Banyan Biomarkers
BG Medicine
Boehringer-Ingelheim Pharmaceuticals LP
Bristol-Myers Squibb Company
Celgene Corporation
Daiichi-Sankyo, Inc.
Eisai, Inc.
Eli Lilly and Company
F. Hoffmann-La Roche Ltd.
Genstruct, Inc.
InfraReDx, Inc.
Johnson & Johnson, LLC
Merck and Co., Inc.
Meso Scale Discovery
Metabolon, Inc.
NextGen Sciences
Orasi Medical, Inc.
Pfizer Inc.
RareCytle, Inc.
Scout Diagnostics
Takeda Pharmaceuticals
XOMA, Ltd.


Academy of Molecular Imaging
Advanced Medical Technology Association
Alliance for Aging Research
Alzheimer’s Association
American Association for Cancer Research
American College of Neuropsychopharmacology
American Diabetes Association
American Health Assistance Foundation
American Society of Clinical Oncology
American Society for Clinical Pharmacology and Therapeutics
American Society for Therapeutic Radiology and Oncology
Arthritis Foundation
Association of Clinical Research Organizations
Autism Speaks
Avon Foundation
Battelle Memorial Institute
Biotechnology Industry Organization
CHDI Foundation
Cystic Fibrosis Foundation Therapeutics
Federation of Clinical Immunology Societies
The Hamner Institutes for Health Sciences
The Immune Tolerance Institute, Inc.
International Society of Biological Therapy of Cancer
Juvenile Diabetes Research Foundation
Kidney Cancer Association
The Leukemia and Lymphoma Society
Michael J. Fox Foundation for Parkinson’s Research
Ontario Cancer Biomarker Network
Osteoarthritis Research Society International
Pharmaceutical Research and Manufacturers of America
PROOF Centre of Excellence
Radiological Society of North America
Society for Nuclear Medicine
University of Illinois

Relevant Publications:

Allison, Malorye. "Biomarker-led Adaptive Trial Blazes a Trail in Breast Cancer." Nature Biotechnology. 28. (2010): 383-84. Print.

Barker, AD, CC Sigman, GJ Kelloff, NM Hylton, DA Berry, et al. "I-SPY 2: An Adaptive Breast Cancer Trial Design in the Setting of Neoadjuvant Chemotherapy." Clinical Pharmacology & Therapeutics. 86.1 (2009): 97-100. Print.

Eck, SL, and SM Paul. "Biomarker Qualification via Public-Private Partnerships." Clinical Pharmacology & Therapeutics. 87.1 (2010): 21-23. Print.

Hampel, Harald, Richard Frank, Karl Broich, Stefan J. Teipel, Russell G. Katz, et al. "Biomarkers for Alzheimer's disease: Academic, Industry, and Regulatory Perspectives." Nature Reviews Drug Discovery. 9.7 (2010): 560-74. Print.

Kusminski, CM, and PE Scherer. "The Road From Discovery to Clinic: Adiponectin as a Biomarker of Metabolic Status." Clinical Pharmacology & Therapeutics. 86.6 (2009): 592-95. Print.

Patlak, Margie. "Competitors Try Collaboration to Speed Drug Development." Journal of the National Cancer Institute. 102.12 (2010): 841-43. Print.

Wagner, JA, M Prince, EC Wright, MM Ennis, J Kochan, et al. "The Biomarkers Consortium: Practice and Pitfalls of Open-source Precompetitive Collaboration." Clinical Pharmacology & Therapeutics. 87.5 (2010): 539-42. Print.

Wagner, JA, EC Wright, MM Ennis, M Prince, J Kochan, et al. "Utility of Adiponectin as a Biomarker Predictive of Glycemic Efficacy is Demonstrated by Collaborative Pooling of Data from Clinical Trials Conducted by Multiple Sponsors." Clinical Pharmacology & Therapeutics. 86.6 (2009): 619-25. Print.