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 ), 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.org.
U.S. Food and Drug Administration
Academy of Molecular Imaging
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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.
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