The Preclinical Sciences Workgroup (PCS-WG) is pursuing regulatory review and endorsement of the Hollow Fiber System Model for TB (HFS-TB) as a major advancement for early and effective evaluation of drug dosing and drug combinations. This in vitro model allows for the evaluation of drug combinations under relevant conditions that mimic the various disease states of the TB organism. Drugs and their combinations can be evaluated under dynamic dosing conditions consistent with human paradigms allowing for the rational design of confirmatory in vivo studies and support early clinical dosing strategies when partnered with in silico PK-PD modeling approaches.
CPTR is working with the FDA on a three-tiered approach for the HFS-TB; the PCS-WG’s completed and planned activities:
- Submitted comments on the HFS-TB to the docket for FDA’s draft guidance “Pulmonary Tuberculosis: Developing Drugs for Treatment”
- Developing a manuscript on the systematic review of the HFS-TB for publication with FDA authoring a companion commentary
- Co-sponsoring a workshop with FDA on the HFS-TB with published proceedings