The Biomarkers Consortium is a major public-private biomedical research partnership managed by the Foundation for the National Institutes of Health (FNIH) with broad participation from stakeholders across the health field, including government, industry, academia and patient advocacy and other not-for-profit organizations. In addition to the FNIH, founding members include the National Institutes of Health, Food and Drug Administration and the Pharmaceutical Research and Manufacturers of America. The Biomarkers Consortium brings together the expertise and resources of various partners to rapidly identify, develop and qualify potential high-impact biomarkers particularly to enable improvements in drug development, clinical care and regulatory decision-making. The Biomarkers Consortium was formally launched in late 2006.
The Biomarkers Consortium’s 10 Years of Research & Progress
The FNIH Biomarkers Consortium (BC) recently celebrated 10 years of collaboration, research and impact on regulatory science. This public-private partnership managed by the FNIH endeavors to discover, develop and seek regulatory approval for biological markers (biomarkers) to support new drug development, preventive medicine and medical diagnostics.
Over the past decade, the BC has raised more than $70 million for precompetitive, collaborative projects that include participants from the National Institutes of Health, the U.S. Food & Drug Administration, not-for-profit organizations, academic research organizations, and pharmaceutical and biotechnology companies. More than 20 projects have been launched in 13 different disease areas, resulting in 46 publications written on behalf of or sponsored by the BC. Its work also has been instrumental in testing new models for clinical trials. The BC sponsored one of the first trials to use genetic markers to guide the selection of treatments from among multiple drugs in a single trial, helping establish an accelerated approval pathway for new breast cancer medicines. To date, the work of the BC has supported the advancement of six therapeutics in the drug development process and helped generate four separate FDA Guidance documents.
The BC can solve these and other challenges head-on because it offers a unique environment in which the resources and scientific expertise of its partners can be freely shared. Biomarkers have become recognized as indispensable tools for effective drug development and the BC has equally established itself as the proven model for advancing the scientific validity and practical utility of biomarkers in treating patients. Its mission is as relevant as ever.
Learn more about the BC’s achievements in the following infographic.