GOVERNMENT, INDUSTRY TO FORM BIOMARKER CONSORTIUM
A group of federal agencies is joining forces with the drug industry to form a public-private partnership to search for new biomarkers in an effort to speed drug development and lower costs.
Members of the coalition, announced Oct. 5, include the FDA, Foundation for the National Institutes of Health (FNIH), the Centers for Medicare & Medicaid Services, NIH and various industry groups and companies.
Biomarkers are molecular, biological or physical characteristics that are used to identify risk for disease, and also to diagnose and treat a disease. Cholesterol, blood sugar, proteins and genes are some examples of biomarkers.
The research also will help advance the FDA's Critical Path Initiative, part of which is dedicated to developing personalized treatments for patients, acting FDA Commissioner Andrew von Eschenbach said. Biomarkers can help the industry create treatments that are more predictable and more reliable at a faster pace, he said.
One way biomarkers can do this is by being used to indicate who is at risk of adverse effects from a drug, allowing a clinical trial sponsor to recruit suitable candidates and eliminate unsuitable candidates, according to FNIH. They can also help drug companies avoid investing in experimental drugs that are not likely to succeed in later stages of development.
The coalition is actively seeking additional partners to provide funding to operate the consortium and also to fund individual research projects. To date, $1.2 million has been donated by PhRMA, the Biotechnology Industry Organization, Bristol-Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Eli Lilly, Pfizer, F. Hoffman-La Roche and various patient advocacy groups. Caroline Loew, PhRMA's senior vice president for science and regulatory affairs, said that she expects more PhRMA members to lend their financial support to the initiative at some point.