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Programs

Overview

The CPTR initiative is organized around four operating arms. Each operating arm determines its specific structure, membership, and leadership, allowing it to take whatever shape is necessary to most effectively achieve their goals. Each arm generally operates through a series of workgroups, each with a targeted mission and project management plan to implement CPTR’s broader goals, and is governed by a Coordinating Committee that guides its operations.

A Coordinating Group with representatives from the operating arms provides overall guidance to the initiative. An Advisory Panel, comprised of a diverse group of experts, also provides stewardship, particularly on  related policy issues.

Drug Development Coalition

Led by the TB Alliance, the Drug Development Coalition consists of drug developers who allow their TB drug candidates to be tested in combination with one another with the goal of assembling the most effective TB drug regimens, regardless of sponsor. The Drug Development Coalition is responsible for selecting promising combinations and conducting the appropriate clinical trials to evaluate them and bring such regimens forth to registration.

Rapid Drug Susceptibility Testing Group

Led by the Critical Path Institute the RDST Consortium’s partners collaborate to facilitate development of new diagnostic tools to complement novel drug regimens. Treating TB patients with appropriate drugs (to which their bacteria are susceptible) is integral to improving patient outcomes, slowing the development of drug resistance, and maximizing the impact of new TB regimens. For these reasons, the development of new TB cures and corresponding diagnostics must be synergized. The RDST advances the diagnostic field through the development of innovative tools, like the Relational Sequencing TB Data Platform (ReSeqTB) database platform, which standardizes and curates drug-resistance and other meta-data to advance diagnostic assays and assist in the clinical interpretation of genetic polymorphisms.

Regulatory Science Consortium

Led by the Critical Path Institute, the Regulatory Science Consortium participants are leading scientists from industry, regulatory authorities, and academia. This arm focuses on establishing and improving the framework for combination drug development, which includes advancing innovative drug development tools such as data standards, data platforms, biomarkers, clinical endpoints, and disease progression models. These teams establish scientific consensus on and seek regulatory endorsement – such as qualification – of preferred tools for developing TB drug regimens

Research Resources Group

Led by the Bill & Melinda Gates Foundation, with support from Critical Path Institute and Reagan Udall Foundation, the Research Resources Group works to create the framework and infrastructure that will support the development of novel TB regimens. This arm is responsible for increasing clinical trial capacity, raising funding for late-stage clinical development, promoting understanding of the potential ethical challenges along the path to TB drug development, expanding regulatory guidance globally, providing relevant information on TB drug markets, and ensuring effective and appropriate stakeholder and community engagement.