Menu

Tag: clinical trials

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

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

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

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