Global TB collaboration pushes to generate more effective disease-fighting regimens

FDA Commissioner Margaret Hamburg, MD, addressed health leaders worldwide who represent industry, academia, government, and advocacy to help kick off a global consortium to fight tuberculosis (TB). She recently spoke at a press conference in Washington.

The worldwide effort, called Critical Path to TB Drug Regimens (CPTR), was developed by collaborations between the Critical Path Institute, the Global Alliance for TB Drug Development, and the Bill and Melinda Gates Foundation. The primary initiative is to save millions of lives by combining the efforts of industry, scientific, regulatory, and government groups to swiftly produce new, more effective TB regimens and to bring them to more than 2 billion people around the world within years rather than decades.

“We at the FDA want to be a gateway, not a barrier, linking scientific opportunity to unmet public health need,” Dr. Hamburg said.

According to the Global Alliance for TB Drug Development, TB ranks behind HIV as the second leading cause in adults of deaths related to infectious disease. Recent World Health Organization estimates suggest that one-third of the world’s population is infected with Mycobacterium tuberculosis, which takes the lives of approximately 5,000 people daily.

Dr. Hamburg noted during the conference that drug-resistant strains of TB “pose a new and larger threat to us all,” which highlights the necessity for new treatment advances.

Critical Path Institute CEO Raymond Woosley, MD, PhD, one of the collaborating partners, said that more than 9 favorable compounds among various antibiotic classes are being studied in clinical trials or are sitting in late pre-clinical development, while other compounds are being discovered or are in early pre-clinical stages. With the involvement of the Critical Path Institute, the focus is on speeding up development of combinations of the most promising compounds, rather than on individual formulations.

Pharmaceutical partners backing the CPTR Statement of Principles include Anacor, Astra Zeneca, Bayer, GSK, Johnson&Johnson, Novartis, Otsuka, Pfizer, and Sanofi-Aventis. Other partner groups include the Bill & Melinda Gates Foundation, European and Developing Country Clinical Trials Partnership, TB Alliance, and the Treatment Action Group.