Key Initiatives

Biomarkers Consortium

The Biomarkers Consortium is a major public-private biomedical research partnership managed by the Foundation for the NIH with broad participation from a variety of stakeholders, including government, industry, academia and patient advocacy and other not-for-profit private sector organizations. In addition to the Foundation for the NIH, founding members of the Biomarkers Consortium include the NIH, FDA and the Pharmaceutical Research and Manufacturers of America. Other partners in the Biomarkers Consortium include the Centers for Medicare & Medicaid Services and the Biotechnology Industry Organization.

The Biomarkers Consortium brings together the expertise and resources of participants to rapidly identify and develop biological markers, or “biomarkers,” that are used in drug development or regulatory decision-making by FDA. Biomarkers are characteristics that are objectively measured and evaluated as indicators of normal biological processes, pathogenic processes, or pharmacologic responses to therapeutic intervention.

Biomarker research already has identified biological indicators that have had immense impact in the identification, prevention and treatment of disease. Body temperature, for example, is considered an effective biomarker for fever, and blood pressure is considered an effective biomarker for predicting the risk of stroke and coronary heart disease. Cholesterol is accepted as a biomarker of cardiovascular risk.

The Biomarkers Consortium facilitates partnerships with a broad range of key academic and pharmaceutical leaders, patient advocacy organizations, the NIH, FDA and other medical regulators to execute projects in areas such as Alzheimer’s disease, cardiovascular disease, osteoarthritis, and cancer imaging; a number of promising projects are also moving forward for implementation. The Biomarkers Consortium’s first project focused on the evaluation of the Utility of Adiponectin as a biomarker for predicting glycemic efficacy, in 2009.

Results from the Biomarkers Consortium’s first completed project, “Evaluate the Utility of Adiponectin as a Biomarker Predictive of Glycemic Efficacy by Pooling Existing Clinical Trial Data from Previously Conducted Studies,” were published in June 2009. Conducted entirely via in-kind contributions from F. Hoffman LaRoche, GlaxoSmithKline, Merck & Co and Quintiles Translational Corporation, the project involved aggregating data from clinical trials of peroxisome proliferator-activated receptor (PPAR) agonists at GlaxoSmithKline, Eli Lilly, Merck and Roche. These pooled data were then subjected to analysis by statisticians at Quintiles and at the National Institute of Diabetes and Digestive and Kidney Diseases.

Among the project’s results was evidence that adiponectin is a robust predictor of glycemic response to PPAR agonists in Type II diabetes patients and that adiponectin has potential utility across the spectrum of glucose tolerance. In addition, this project established that cross-company collaboration is a feasible and powerful approach to biomarker qualification.

Effective identification and deployment of biomarkers is essential to achieving a new era of predictive, preventive and targeted medicine. Working together, the members of the Biomarkers Consortium are building uniquely powerful collaborations that are accelerating the development of biomarker-based technologies, medicines and therapies for the prevention, early detection, diagnosis and treatment of disease.

For more information, visit the Biomarkers Consortium’s website at