Biomarkers are characteristics that are objectively measured and evaluated as indicators of normal biological processes, pathogenic processes, or pharmacologic responses to therapeutic intervention. 

Body temperature, for example, is a well-known biomarker for fever, and blood pressure is considered an effective biomarker for risk of stroke. Cholesterol is accepted as a biomarker of cardiovascular risk

Biomarkers can be used in clinical practice to identify risk for or diagnose a disease, stratify patients, assess disease severity or progression, predict prognosis, or guide treatment.  In drug development biomarkers may be used to help determine how a drug works in the body, to determine a biologically effective dose of a drug, to help assess whether a drug is safe or effective, and to help identify patients most likely to respond to a treatment, or are least likely to suffer an adverse event when treated with a drug.  Biomarkers can sometimes be used as part of the approval process for a drug or treatment, to inform regulatory decision-making

Because the use of biomarkers creates the potential for us to individualize treatment, biomarkers are critical to realizing a new era of “personalized medicine.”

The advent of molecular medicine has resulted in explosive growth in the discovery of new biomarkers and the scope of biomarker knowledge in drug development.  Much of this is related to new technologies such as genomics, proteomics, and imaging.  Yet in order to be useful, biomarkers must be rigorously and widely tested before they are deemed valid for specific medical uses.  Much of this testing to date has taken place within one company or research institution, where the resulting data may not be made public.  As a result many biomarkers have been available for decades, but their utility in drug development and the clinic is still unclear.
 
The Biomarkers Consortium provides the ideal setting in which to perform this work, because it brings together the capabilities of all the major stakeholders involved: NIH, FDA, CMS, the biopharmaceutical industry, academic medical research institutions, and non-profit disease research and patient advocacy groups.  Working together, the members of the Biomarkers Consortium are building uniquely powerful collaborations that will coordinate and accelerate the development of biomarker-based technologies, medicines, and therapies for the prevention, early detection, diagnosis, and treatment of disease.