From the Working Groups

Global Regulatory Pathways Workgroup Q3-2015 Update

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, WHO, and National Tuberculosis Programs (NTPs). The Workgroup develops a pathway for regulatory approval that incentivizes regimens development. Regulators from countries or regions with high TB burden are included in this […]

December 21, 2015

Modeling & Simulation Workgroup Q2-2015 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.

July 1, 2015

Data Standards & Integration Workgroup Q2-2015 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. A key focus is aggregating all relevant data in a secure database for analysis by the CPTR Workgroups and authorized researchers. The DSI-WG […]

July 1, 2015

Pre-Clinical and Clinical Sciences Workgroup Q2-2015 Update

The PCS-WG is focused on the evidence-based evaluation of translational tools that support the effective decision making to 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 […]

July 1, 2015

Biomarkers & Clinical Endpoints Workgroup Q2-2015 Update

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. 2Q2015 Progress: The Biomarkers and Clinical Endpoints Workgroup (BCE-WG) conducted […]

July 1, 2015

Enabling Sciences Workgroup Q2-2015 Update

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 […]

July 1, 2015

Assay Development Workgroup Q2-2015 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 […]

July 1, 2015

Surveillance Workgroup Q2-2015 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 development of novel strategies for surveillance of TB drug resistance based on high-throughput molecular technologies will be explored. Objectives: Facilitate the production […]

July 1, 2015

Economic Assessment/Impact Modeling Workgroup Q2-2015 Update

The Economic Assessment/Impact Modeling Workgroup is developing models to inform decisions needed to develop TPPs and to inform policy about use of DST with anticipated TB drug regimens. Objectives: Develop a two-stage model for development and deployment of a Rapid DST. Harmonize efforts with other models related to novel first-line regimens. Create a risk management […]

July 1, 2015

ReSeqTB Data Sharing Platform Q2-2015 Update

Provide a one-stop data source for clinically relevant genotypic and phenotypic information on Mycobacterium tuberculosis (Mtb). Having such data reviewed and validated, and made accessible in one place would support the development of new tests that can rapidly inform appropriate therapy for TB patients. Objectives: Serve as a single repository for the compilation, curation and […]

July 1, 2015