Facilitating Accelerated Science and Translation for TB Regimen Development 

Through creative approaches in translation science, FAST-TB will foster a more efficient and streamlined process for the development, evaluation and introduction of novel treatment regimens.

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Tuberculosis (TB) is a global health crisis. An estimated 10.6 million people developed TB disease in 2021, and 1.6 million died of it. Combating this epidemic requires the development of effective anti-TB regimens. 

With an increasing number of new chemical entities expected to transition into clinical testing in the next 5 years, high quality clinical trials are necessary to identify shorter, safer, and more efficacious regimens for TB treatment.

Development of new TB drugs and regimens is complex, lengthy, costly, and fraught with many obstacles and uncertainties. The therapeutics research community must establish rational approaches to identify the best drug combinations and develop novel trial designs to advance clinical development.

goals and objectives

Development of new TB regimens should be based on evolving knowledge of the pharmacokinetic/pharmacodynamic (PK/PD) and microbial characteristics of the drugs, informed by novel biomarkers that can predict treatment response to accelerate and TB treatment trials.

Given the long duration and high costs of clinical development, and limited funding for TB research and development (R&D), it is crucial to streamline processes for the development of new TB treatments while addressing gaps and avoiding duplication of efforts.

This global health crisis requires a systematic and globalized approach to ensure that best practices and research designs are used to accelerate development of new TB regimens that can be procured and delivered efficiently to all those in needs.

Goal and objectives

Goal

The goal of FAST-TB is to accelerate the development and implementation of novel TB regimens through supporting more efficient communication, coordination, and collaboration among key stakeholders and research groups throughout the treatment development and implementation pathway.

FAST-TB will serve as a platform for promoting global collaboration and sharing of preclinical and clinical knowledge among clinical trial networks, funders, and other stakeholders to facilitate integrated approaches to R&D. 

Objectives

FAST-TB will establish a coordinated global framework to accelerate the development of new TB treatments with the following objectives:

  • Support sharing of preclinical and clinical knowledge and data to accelerate phase 2 regimen development and testing;
  • Support/facilitate research to develop biomarkers that advance clinical development;
  • Support/facilitate research to better understand factors associated with drug resistance and development of easily implementable assays for drug susceptibility testing;
  • Support/facilitate research to enhance seamless progression from phase 2 to phase 3 trials;
  • Accelerate the translation of advances in clinical research into clinical benefit and accessibility to new TB drugs and regimens in high burden countries including communities affected by HIV.

FAST-TB will shape a globally coordinated approach to TB Therapeutic Development by serving as a platform to link organizations working at different points along the TB drug regimen development pathway.