The Biomarkers Consortium
The Biomarkers Consortium (BC), launched in October 2006, is a public-private partnership including the National Institutes of Health (NIH); the U.S. Food and Drug Administration (FDA) as part of FDA’s Critical Path Initiative; the Centers for Medicare & Medicaid Services; the pharmaceutical, biotechnology, diagnostics, and medical device industries; non-profit organizations and associations; and advocacy groups. The BC is managed by the Foundation for the National Institutes of Health (FNIH).
The BC promotes the discovery, qualification, development, and regulatory acceptance of biological markers – biomarkers –in order to accelerate the delivery of successful new technologies, medicines, and therapies for prevention, early detection, diagnosis, and treatment of disease. Biomarkers are objective measures of risk, disease status, and/or health outcomes and include, for example, cholesterol and blood pressure which are well known biomarkers of cardiovascular health.
The BC is structured such that an Executive Committee, representing founding partners and stakeholders, sets BC policy and makes decisions regarding projects of the BC. Subject matter Steering Committees oversee the development and implementation of projects by dedicated project teams. BC policies have been developed through a multi-sector process of discussion and negotiation and apply to all BC activities. The BC accommodates a number of discrete projects, each devoted to biomarker discovery, qualification, or use in targeted areas of disease-related biomedical and clinical science, with the ultimate aim to improve the public health. Projects are proposed by members of the BC, academics, patient advocates, and the public, and are developed and implemented according to their scientific merit, public health need and opportunity, and availability of support and funding. For more information about The Biomarkers Consortium structure, policies, and activities and to find project concept proposal instructions, visit http:/www.biomarkersconsortium.org.
Examples of BC Approved Project Concepts
The Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Lung and Lymphoma Projects; Systemic Lupus Biomarkers Working Group; Diabetes and Pre-Diabetes Biomarker Project; and Metabolomics Signatures and Biomarkers for Depression are some examples of current activities.
Clinical Research Partnerships
The National Institutes of Health (NIH) has a robust and nuanced program of clinical research and clinical trials. Partnerships allow for the enhancement of our capacity to reach more patients, more clinical conditions, develop new methodologies and metrics, and improve public health by translating basic discovery to clinical practice.
New areas of partnership development include:
- Pain – new metrics and treatments
- Science Education – focus on K-12
- Nanobiology – new science and applications
- Integrative Medicine – health promotion and patient centered care
Osteoarthritis (OA) is a disease causing significant pain and disability in the U.S. and throughout the world. Understanding the biology of OA and the development of safe and effective interventions are hindered by the absence of good biomarkers for OA diagnosis, staging and prognosis. In the interest of advancing the field of OA research and clinical care, the NIH’s Osteoarthritis Initiative (OAI) is a public-private partnership between the NIH and industry that funds a multi-site contract to create a resource to hasten discovery of biological markers for osteoarthritis. The initiative is conducted under a Federal contract funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute on Aging, Office of Research on Women's Health, National Institute of Dental and Craniofacial Research, National Institute on Minority Health and Health Disparities, and National Center for Complementary and Alternative Medicine. Private partners include Merck Research Laboratories, Novartis Pharmaceuticals Corporation, and Pfizer Inc. Private sector funding for the OAI is being managed by the FNIH. For more information about the Osteoarthritis Initiative, visit http://www.niams.nih.gov/Funding/Funded_Research/Osteoarthritis_Initiative/default.asp.
Alzheimer’s Disease Neuroimaging Initiative
Alzheimer’s Disease is a process leading to progressive dementia and impaired global functioning. Diagnosis is determined on the basis of clinical findings at this time and may be confirmed by brain biopsy. Non-invasive means of making a diagnosis of Alzheimer’s disease and/or predicting prognosis would be very useful. The NIH’s National Institute on Aging, in conjunction with the National Institute of Biomedical Imaging and Bioengineering and the Food and Drug Administration, is partnering with private companies and organizations to find neuroimaging and other biomarkers for the cognitive changes associated with mild cognitive impairment and early Alzheimer's disease. The FNIH is managing corporate and other private participation, and has received commitments totaling more than $20 million from the following companies and organizations: Pfizer Inc, Wyeth Research, Eli Lilly and Company, Merck & Co, Inc., GlaxoSmithKline, AstraZeneca AB, Novartis Pharmaceuticals Corporation, Eisai Global Clinical Development, Elan Corporation, the Institute for the Study of Aging, and the Alzheimer's Association. Visit http://www.nia.nih.gov/NewsAndEvents/PressReleases/PR20041013ADNI.htm to find more information about the Alzheimer’s Disease Neuroimaging Initiative.
Grand Challenges for Global Health
The Grand Challenges in Global Health initiative, a major effort to achieve scientific breakthroughs against diseases that kill millions of people each year in the world’s poorest countries, has offered 43 grants totaling $436.6 million for a broad range of innovative research projects involving scientists in 33 countries. The ultimate goal of the initiative is to create “deliverable technologies” – health tools that are not only effective, but also inexpensive to produce, easy to distribute, and simple to use in developing countries.
As a partner in this initiative, the NIH is providing scientific expertise to the FNIH as well as identifying activities that are appropriate for government funding. Possibilities include the parallel release of announcements to fund joint or associated projects, funding shared resources and training, and announcing funding opportunities for follow-up grants that complement the Grand Challenges in Global Health initiative. The initiative is supported by the Bill & Melinda Gates Foundation, as well as the Wellcome Trust and the Canadian Institutes of Health Research (CIHR). The initiative is managed by global health experts at the FNIH, the Gates Foundation, the Wellcome Trust, and CIHR. For more information on Grand Challenges for Global Health, visit http://www.gcgh.org.
Genetic Association Identification Network
The Genetic Association Identification Network (GAIN) is designed to answer key questions about the complex contributions of genes and gene-gene interactions to human health—with potentially major consequences for prevention, diagnosis, treatment, and cure. Through a series of whole genome association studies, using samples from existing case-control studies of common disorders or diseases, the project will contribute to the identification of genetic pathways that make us susceptible to these diseases and will highlight new molecular targets for prevention, diagnosis, and treatment. The resulting data will be made available—in a single, central database managed by NIH—for no-cost access by the scientific community. GAIN is being managed by FNIH. GAIN is a partnership of multiple NIH Institutes and Centers, FNIH, Pfizer Inc, Affymetrix Inc, and Abbott Laboratories. For more information on GAIN, visit http://www.genome.gov/19518664.