The Critical Path Institute in Tucson, Arizona, has announced a three-year, $11.8 grant from the Bill & Melinda Gates Foundation to develop mathematical models that optimize the design of clinical trials and address challenges associated with the development of effective treatments for tuberculosis.

Co-founded by C-Path, the Gates Foundation, and the Global Alliance for TB Drug Development, the Critical Path to TB Drug Regimens Initiative (CPTR) seeks to advance the science behind TB drug treatments. To that end, the initiative is working to develop physiologically based pharmacokinetic models that enable improved understanding of the absorption and distribution of TB drugs in the lungs, as well as a population-based pharmacodynamic model to help determine effective treatment doses. In addition, the project will work to develop and test promising drug combinations that lead to entirely new multi-drug treatments.

In support of the initiative, Janssen Research & Development will provide data from its clinical trials of Sirturo (bedaquiline) to CPTR's Regulatory Science Consortium, which is working to develop and integrate data standards, develop disease progression and response metrics, and facilitate new pharmacokinetic measures for TB drug interactions.

"TB is a pressing global public health issue and stopping its spread requires new treatment options," said C-Path president and CEO Martha Brumfield. "This grant and the collaborative work of CPTR will reduce the time and uncertainty in developing innovative regimens from decades to years."