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The Critical Path to Tuberculosis Drug Regimens (CPTR) initiative aims to support the rational deployment of new tuberculosis (TB) therapies by speeding the development and impact of new and markedly improved drug regimens as well as rapid drug susceptibility tests. Co-founded by the  Bill & Melinda Gates Foundation , the  Critical Path Institute , and the  TB Alliance  in 2010, CPTR is a coalition comprised of the world’s leading pharmaceutical companies, product development sponsors, diagnostic companies, regulatory agencies, and civil society organizations which support and catalyze advances in regulatory science, the development of infrastructure, and other progress needed to accelerate the pace of development and introduction of novel regimens and rapid drug susceptibility tests. This manuscript summarizes the work of two sub groups within CPTR, the Regulatory Sciences and Rapid Drug Susceptibility Test consortia, and their efforts to drive innovation. These consortia are supported by a robust TB clinical data platform, which continues to evolve through contributions of contemporary TB clinical trial data sets as well whole genome sequence level data from isolates across the globe. Examples of innovation are described and include a recently qualified drug development tool and emerging programs to support the development of clinical trial simulation tools.

journal of medicines development sciences

Critical Path to Tuberculosis Drug Regimens: Global collaboration to accelerate development of novel drug regimens and rapid drug susceptibility tests for tuberculosis