The Biomarkers Consortium is a groundbreaking public–private biomedical research partnership managed by the Foundation for the National Institutes of Health (FNIH) (see Box 12.1) that endeavors to develop, validate, and qualify biomarkers to accelerate the development of new medicines and improve patient care.

The Consortium was founded in late 2006 by FNIH, the National Institutes of Health (NIH), the U.S. Food and Drug Administration (FDA), and the Pharmaceutical Research and Manufacturers of America (PhRMA). Other major stakeholders include the Centers for Medicare & Medicaid Services (CMS) and the Biotechnology Industry Organization (BIO). These stakeholders, and many others, are working together on an unprecedented scale to identify, develop, and qualify biomarkers that can be used to detect, prevent, diagnose, and treat disease. This integrated, cross-sector approach is helping to accelerate the use of biomarkers in research, development of treatments, and regulatory decision making.

The Consortium has more than 60 additional contributing members involved in helping to support its operations; these members represent the pharmaceutical and biotechnology industries, nonprofit organizations, and patient advocacy organizations. The biopharmaceutical members of the Consortium include Abbott Laboratories; Amgen; Amylin; AstraZeneca; Boehringer-Ingelheim; Bristol-Myers Squibb; Celgene Corporation; Daiichi Sanyko; Eisai, Inc.; GlaxoSmithKline; Johnson & Johnson; Eli Lilly and Company; Merck & Co., Inc.; Pfizer, Inc; F. Hoffman–La Roche, Ltd.; Sunovion; and Takeda Pharmaceuticals.