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Category: Drug Development

Symposium on TB ReFLECT: An integrated analysis of the fluoroquinolone TB trials – October 27, 2016 – Liverpool

On October 27th, CPTR will co-chair a symposium with the World Health Organization (WHO) at the Union World Conference on Lung Health.  This session will highlight a joint initiative by WHO and CPTR to maximize learnings from recent Phase III fluoroquinolone treatment shortening TB clinical trials through integrated meta-analysis. Presentations and panel discussion will emphasize […]

October 9, 2016 Drug Development Events drug development IUATLD Conference TB-PACTS

CPTR and SIMCYP launch models to evaluate exposure and efficacy of TB drugs in combination

The Critical Path to TB Drug Regimens (CPTR) Initiative and SIMCYP have partnered to develop a TB-specific set of models and compound files to inform the design of first-in-human trials that will simultaneously evaluate the exposure and efficacy of novel anti-TB combination regimens of up to 4 drugs. This collection of models is comprised of: […]

October 1, 2016 Drug Development Partner News clinical trials Disease-Modeling drug development

CPTR Workshop 2016: Full Content Day 4

Opening Remarks Speaker: Marco Schito, Critical Path Institute March Schito opened the last day of the CPTR 2016 Workshop recapping the progresses and challenges relating to DST development and summarizing the diagnostic development pathway. Schito shared insight on the future of DST, including the need for new policies to support the work and implementation of […]

May 3, 2016 Drug Development RDST Regulatory Science Research Resources Assay Development clinical trials CPTR Workshop 2016 drug development ReSeq TB

CPTR Workshop 2016: Full Content Day 3

Opening Remarks Speaker: Jim Gallarda, Bill & Melinda Gates Foundation Jim Gallarda set the stage for the day by considering how success in improved diagnostics should be defined, and stressing the need for innovation from both the supply (developers) side and the demand (users, uptake, and implementers) side. Gallarda emphasized that incentives are needed on […]

May 2, 2016 Drug Development RDST Regulatory Science Research Resources Assay Development clinical trials CPTR Workshop 2016 drug development ReSeq TB

CPTR Workshop 2016: Full Content Day 2

Welcoming Remarks Speaker: Mel Spigelman, TB Alliance Mel Spigelman opened the day’s program by reflecting on the changing landscape of TB drug development from a sponsor perspective. Noting that the new drugs themselves are the “beef” of the CPTR initiative, he commented that the current state of TB research has seen the retreat of some […]

May 2, 2016 Drug Development RDST Regulatory Science Research Resources Assay Development clinical trials CPTR Workshop 2016 drug development ReSeq TB

CPTR Workshop 2016: Full Content Day 1

Opening Remarks Speaker: Jan Gheuens, Bill & Melinda Gates Foundation Jan Gheuens opened CPTR’s 2016 Workshop by reminding the audience of the principles and mission of the CPTR Initiative, stressing the urgency of accelerating the development and availability of new TB combination therapies and noting the role of partnership and coordination in achieving the mission. […]

May 2, 2016 Drug Development RDST Regulatory Science Research Resources Assay Development clinical trials Community Engagement CPTR Workshop 2016 drug development

New TB Clinical Trial Data-Sharing Platform Available for Researchers

TUCSON, Ariz., April 18, 2016 — The Critical Path Institute (C-Path), the Special Programme for Research and Training in Tropical Diseases (TDR), TB Alliance, andSt. George’s, University of London, are pleased to announce the launch of the TB-Platform for Aggregation of Clinical TB Studies (TB-PACTS). “TB-PACTS is a valuable tool in the fight against the […]

April 18, 2016 Drug Development Partner News Press Releases Regulatory Science Research Resources Uncategorized clinical trials drug development TB-PACTS

CPTR and WHO Partner to Improve Understanding of Past Phase III TB Drug Trials

CPTR and the WHO Global TB Programme have partnered to help maximize the knowledge and understanding gained from completed Phase III TB drug clinical trials. The partnership will bring together an expert steering committee to analyze three contemporary Phase III trials (REMox TB, Rifaquin, and OFLOTUB). The collaboration will improve the drug development community’s understanding […]

December 21, 2015 Drug Development clinical trials fluroquinolones

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

Host for new TB clinical trial data-sharing platform selected

TUCSON, Ariz., April 29, 2015 — The non-profit Critical Path Institute has been selected to host a new tuberculosis (TB) clinical trial data sharing platform. The initiative will start by creating a common database from three Phase III clinical trials earlier supported by the Special Programme for Research and Training in Tropical Diseases (TDR), the […]

May 4, 2015 Drug Development Press Releases clinical trials