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Tag: hollow fiber model

CPTR 2017 Workshop: Summaries, Slides, and Videos — Day 4

Welcoming Remarks Marco Schito (Critical Path Institute) Marco Schito kicked off the final day of CPTR’s 2017 Workshop by affirming the essential role of diagnostics in effective TB treatment, and contrasting that importance with a lack of corresponding investment in the field, despite such a compelling value proposition. Schito outlined reasons why diagnostic development has […]

May 17, 2017 Drug Development Events RDST Regulatory Science Research Resources Assay Development biomarkers clinical trials Community Engagement CPTR Workshop 2017 diagnostics drug development drug resistance fluroquinolones hollow fiber model next-generation sequencing ReSeq TB ReseqTB TB-PACTS

CPTR 2017 Workshop: Summaries, Slides, and Videos — Day 3

Welcoming Remarks Jim Gallarda (Bill & Melinda Gates Foundation) Jim Gallarda opened the day’s agenda by reminding participants of the importance of collaboration and that silos often act as the largest impediments to progress in global health. Video     Keynote Address: Learning from the Impact of the Drug-Diagnostic Development Strategy in Oncology Jan Trost […]

May 17, 2017 Drug Development Events RDST Regulatory Science Research Resources Assay Development biomarkers clinical trials Community Engagement CPTR Workshop 2017 diagnostics drug development drug resistance fluroquinolones hollow fiber model next-generation sequencing ReSeq TB ReseqTB TB-PACTS

CPTR 2017 Workshop: Summaries, Slides, and Videos — Day 2

Welcoming Remarks Mel Spigelman (TB Alliance) Mel Spigelman opened the second day of the workshop by introducing the day’s agenda and drawing attention to the personal stories of TB patients, reinforcing the driving force behind CPTR and all TB research and development efforts. Video   Driving Progress Through Regulatory Innovation – Learnings from Oncology and […]

May 17, 2017 Drug Development Events RDST Regulatory Science Research Resources Uncategorized Assay Development biomarkers clinical trials Community Engagement CPTR Workshop 2017 diagnostics drug resistance fluroquinolones hollow fiber model ReSeq TB TB-PACTS

New publication highlights CPTR’s work on Hollow Fiber System Model for TB

The achievements and ongoing efforts of CPTR’s work on the Hollow Fiber System Model for TB (HFS-TB) are detailed in a new supplement published in the Clinical Infectious Diseases journal. The supplement includes an editorial by EMA on its qualification of this tool to reliably assess the potential efficacy of new drugs and combination regimens, […]

August 13, 2015 Drug Development drug development hollow fiber model

Regulatory Authorities Support First Drug Development Tool, Critical to Advance TB R&D Efforts

The first nonclinical drug development tools (DDTs), developed by working groups within CPTR, have been endorsed by leading global regulatory authorities. DDTs with demonstrated predictive accuracy for clinical and microbial outcomes are needed to support effective regimen development decision-making. Endorsement of these DDTs by regulatory authorities is critical for drug developers as it promotes confidence in […]

March 19, 2015 Drug Development Regulatory Science clinical trials hollow fiber model