November 2015

Evidence-based in vitro drug development tool qualified by the European Medicines Agency

The TB Alliance, along with the Critical Path Institute and the Bill and Melinda Gates Foundation, established the Critical Path to TB Drug Regimens (CPTR) in 2010. The CPTR is a collaborative effort of product developers, government agencies, academia, and other stakeholders working toward the goal of accelerating the development of new and effective treatment regimens for tuberculosis (TB). In 2015, the Hollow Fiber System Model for Tuberculosis (HFS-TB) became the first nonclinical drug development tool developed by CPTR working groups to be qualified by a regulatory authority.

The HFS-TB has the potential to accelerate TB drug development due to its ability to rapidly and reliably assess the efficacy of individual drugs or multiple drug regimens, and to identify optimal drug combinations, doses, and dosing schedules. A key advantage explained in the CPTR submission to the European Medicines Agency (EMA) was the HFS-TB tool’s superior performance over animal models for TB drug development. While the HFS-TB model cannot replace preclinical animal or clinical data, one of EMA’s conclusions was that the HSF-TB tool can be used reduce the number of regimens that are tested in vivo at the nonclinical and clinical phases, and limit the doses tested in vivo.

This month’s In the Spotlight explains the significance of this achievement, the function of the device, and the different approaches CPTR took in submitting this drug development tool (DDT) to the European Medicines Agency and the US Food and Drug Administration. Read the full article here.

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