The Biomarkers Consortium: Public and Private Sectors Working in Partnership to Improve the Public Health

The Biomarkers Consortium (BC), launched on November 5, 2006, is a public–private partnership whose goal is to identify and qualify new biological markers to accelerate the detection, diagnosis, and treatment of a range of diseases, including cancer. The Consortium is made up of a diverse list of partners with this common goal. It includes the Foundation for the National Institutes of Health (FNIH), the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services (CMS), the Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Industry Organization (BIO), and representatives of the public, including patient advocacy organizations. The NIH and its partners have long recognized a need for robust and objective measures of disease risk, underlying pathobiological processes, diagnosis and stage of disease, prognosis, treatment response, recurrence, and clinical outcomes. However, despite significant advances in our molecular understanding of many diseases and treatment outcomes, there are very few biomarkers that are qualified for clinical use and used widely to address medical needs. Some of the most widely accepted biomarkers in use today include blood pressure, total cholesterol, and highdensity lipoprotein to low-density lipoprotein (HDL/LDL) ratios as markers of cardiovascular risk and response to treatment; and HIV viral load and CD4 T-cell counts to assess HIV/AIDS disease severity, stage, and treatment response. The availability of such biomarkers would not only enable research, but also serve to streamline clinical care and potentially speed the development and availability of new drugs. Although the need is clear, there are several important impediments to developing reliable biomarkers. Biomarker development requires insight into disease risk, natural history, and outcomes. It also requires a sufficiently large number of adequate samples taken from well-characterized patients and handled in a standardized fashion. Analytical platforms that effectively and reproducibly measure the biomarker must also be available and standardized. Analytical approaches that assess the utility of biomarkers as signs or predictors of underlying biology or future outcomes must also be developed for the promise of biomarkers to be translated into clinical usefulness. Once such biomarkers and analytical approaches are developed, they will prove useful to promote and foster more discovery science and facilitate the conduct of translational and clinical research, all of which are activities central to the mission of the NIH. The NIH is certainly not alone in recognizing the need for robust biomarkers. The FDA will benefit tremendously from having biomarkers that can be objectively assessed as markers for effectively stopping or ameliorating the disease process, as well as indicators that drugs are not having adverse effects as well. Biomarkers that are consensually qualified for a particular use provide an opportunity for the FDA to compare across trials and across treatments, without having to devote scarce resources to assessing distinct and separate proposed markers in the setting of each new drug application. Industry, likewise, benefits from the development and