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Tag: drug development

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

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

TB Alliance Advances Next-Generation TB Drug Candidate into Clinical Testing

TBA-354 is the first potential tuberculosis drug to advance toPhase 1 trial in six years TB Alliance has announced the start of the first human trial of a new tuberculosis (TB) drug candidate, designated TBA-354. It is the first new TB drug candidate to begin a Phase 1 clinical trial since 2009. “There is a […]

February 19, 2015 Drug Development Partner News clinical trials drug development