FDA awards $2.9 million to support tuberculosis research projects

The U.S. Food and Drug Administration today announced the award of $2.9 million to support six research projects that will help with the diagnosis, treatment, and prevention of tuberculosis (TB).

TB remains a major public health challenge with an increasing prevalence worldwide. Two recent articles published by FDA's Office of Critical Path Programs note that advances are urgently needed in TB drug development to shorten therapy and to treat drug-resistant disease.

"FDA recognized an urgent need for the engagement and leadership of public health institutions to promote this critical, but neglected, area of medical therapeutics," said FDA Commissioner Margaret A. Hamburg, M.D.

Funded with congressional support in FY2010, the following six grantees were chosen from among 30 applications:

• Michael Brennan, Ph.D., Aeras Global TB Vaccine Foundation – Discovery of biological and immunological biomarkers for TB vaccines
• Ann Ginsberg, M.D., Ph.D., Global Alliance for TB Drug Development – Frozen trials, developing a repository of clinical trial specimens
• Khisimuzi Mdluli, Ph.D., Global Alliance of TB Drug Development – Qualifying new preclinical models for the development of tuberculosis drug combinations
• Fred Quinn, Ph.D., the University of Georgia Research Foundation Inc. – Development of a diagnostic for latent TB
• John T. Belisle, Ph.D., Colorado State University – Small molecule biomarkers for tuberculosis treatment, relapse, and cure
• Marc D. Porter, Ph.D., the University of Utah – Development and validation of point-of-care tests for tuberculosis (ultrasensitive SERS detection technology for low concentration antigens).

Launched in 2004, the Critical Path Initiative is the FDA's strategy for driving innovation in the way medical products are developed, evaluated, and manufactured.