The Center for Drug Evaluation and Research has debuted a new on-line series, “Spotlight on CDER Science” that features noteworthy scientific and research-oriented activities conducted within CDER.
The first article, “Tuberculosis Biorepository Aims To Bolster TB Drug Development by Facilitating Research on Biomarkers” is written by Leonard Sacks, M.D., Associate Director for Clinical Methodology, Office of Medical Policy, CDER.
Tuberculosis (TB) remains a major public health concern. It continues to affect millions of people worldwide each year, and a significant portion of these cases are resistant to first-line treatment. Reliable biomarkers to assess treatment outcome are critical tools that would revitalize TB drug development. The TB Biorepository Project, first established in 2010 with a grant from FDA, offers prospectively collected, sequential biospecimens from TB patients to researchers and drug developers who are working to identify biomarkers that can be used in clinical trials of new drugs.
Access to the TB patient biospecimens, which are currently held in a state-of-the-art facility in London, U.K., requires a peer review application process. The current application cycle deadline is May 5, 2017. For more information about the application process and to contact the CTB2, see the CTB2 Biorepository website.