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From the Working Groups

Modeling & Simulation Workgroup (M&S-WG) Q4-2015 Update

Working closely with the Data Standards and Integration Workgroup (DSI-WG), the M&S-WG uses aggregated clinical trial data to create robust empirical, mechanistic, and systems biology models and quantitative simulation tools to facilitate TB drug and drug regimen development.

January 22, 2016

Data Standards & Integration Workgroup (DSI-WG) Q4-2015 Update

The DSI-WG provides the information technology (IT) infrastructure to support all CPTR data needs for developing regulatory science tools and methods to enable development of new TB drugs, drug regimens, and diagnostics. Aggregating all relevant data in a secure database for analysis by the CPTR Workgroups and authorized researchers is a key focus for this […]

January 22, 2016

Pre-Clinical and Clinical Sciences Workgroup (PCS-WG) Q4-2015 Update

The PCS-WG is focused on the evidence-based evaluation of translational tools to support effective decision-making and advance new agents from the pre-clinical to clinical development space.  These tools represent innovative approaches to address pre-clinical issues, including pre-clinical in vitro and in vivo efficacy, pre-clinical drug safety, and toxicology, pre-clinical PK/PD analyses involving the use of […]

January 22, 2016

Biomarkers & Clinical Endpoints Workgroup (BCE-WG) Q4-2015

The BCE-WG identifies, develops consensus, and builds the evidence base to submit potential biomarkers and clinical endpoints that have promise in the development of new TB medical products to FDA and EMA for regulatory review and qualification in a specific context of use when applicable.

January 22, 2016

Enabling Sciences Workgroup (ENS-WG) Q4-2015

The ENS-WG mission is to focus on discovery and validation of the molecular basis for resistance and correlation of resistance to clinical outcome. Objectives: Discover relevant drug resistant mutations for potential use in molecular assays. Correlate genetic resistance mutations with phenotypic resistance and clinical outcomes. Optimize phenotypic assays. Review existing genotypic, phenotypic or animal data […]

January 22, 2016

Assay Development Workgroup (AYD-WG) Q4-2015 Update

The AYD-WG’s focus is a DST for implementation at the microscopy center level or above. The work group also continues to monitor clinical drug trials to determine when and what changes need to be made to current Target Product Profiles (TPP’s) that have been developed. The AYD-WG is coordinating with academic partners, product development partnerships […]

January 22, 2016

Surveillance Workgroup (SRV-WG) Q4-2015 Update

The SRV-WG is defining the magnitude and trends of drug resistance in high burden countries, with particular focus on new and existing drugs for which resistance surveillance data are largely unavailable. Furthermore, the SRV-WG will explore the development of novel strategies for surveillance of TB drug resistance based on high-throughput molecular technologies.

January 22, 2016

ReSeqTB Data Sharing Platform Q4-2015 Update

Provide a one-stop data source for clinically relevant genotypic and phenotypic information on Mycobacterium tuberculosis (Mtb). This data, reviewed, validated, and accessible in one place, will support the development of new tests which can rapidly inform appropriate therapy for TB patients.

January 22, 2016

Stakeholder & Community Engagement Workgroup (SCE-WG) Q4-2015 Update

The Stakeholder and Community Engagement Workgroup (SCE-WG) facilitates the development of regimens by early, effective, and appropriate collaboration of key stakeholders and by building awareness and support among communities. The ability to successfully engage the community while conducting clinical trials is an essential component for regimen development.

January 22, 2016

Global Regulatory Pathways Workgroup (GRP-WG) Q4-2015

The Global Regulatory Pathways Workgroup (GRP-WG) identifies efficiencies in the regulatory pathway to develop a novel regimen by fostering dialogue among key regulatory agencies, the WHO, and National Tuberculosis Programs (NTPs). This Workgroup develops pathways for regulatory approval that incentivize regimen development. Regulators from countries or regions with high TB burden are included in this […]

January 22, 2016