Since the launch of CPTR in 2010, the consortium has made significant progress. It has actively engaged the FDA, which has released updated regulatory guide-lines for developing new TB drug regimens with continued efforts to create a more favorable environment for combination regimen development. In 2011, CDER head Dr. Janet Woodcock authored an opinion piece in the New England Journal of Medicine expressing support for “co-development” of therapies for life-threatening diseases such as TB. In addition, the TB Alliance launched the first-ever clinical trial of a novel combination drug regimen for TB in October 2010. The trial tested new TB drug candidates in combination with an existing antibiotic. The study met its milestones, validating the approach to regimen development set forth by CPTR and highlighting the promise of a novel regimen. A new TB drug regimen known as PaMZ designed to treat both drug sensitive and multi drug resistant TB is moving to a landmark global phase III clinical trial named STAND.
An Integrated Sciences Team coordinates all activities among all working groups:
- Data Standards & Integration
- Biomarkers & Clinical Endpoints
- Preclinical & Clinical Sciences
- Modeling & Simulation
- Health Authority Submission
Drug Susceptibility Testing
- Assay Development
- Economic Assessment/Impact Modeling
- Enabling Sciences
- Global Regulatory Pathways
- Access and Appropriate Use
- Stakeholder & Community Engagement
- Clinical Trial Infrastructure
By engaging collaborators across the world, CPTR has established a legal framework allowing data sharing among scientists from the pharmaceutical industry, academia and regulatory authorities and delivered the following:
- Developed and published TB data standards in collaboration with the Clinical Data Interchange Standards Consortium (CDISC).
- Expanded scope in 2013 to include the CPTR Rapid Drug Susceptibility Testing (RDST) Consortium and an expanded Modeling and Simulation development program.
- Pursued several regulatory pathways with the FDA for the Hollow Fiber System Model for TB (HFS-TB).
- Submitted a dossier to the EMA on the HFS-TB for qualification opinion consideration.
- Submitted a ‘briefing book’ to the FDA via the pre-IND process to review CPTR’s data analysis plan and data inventory for liquid culture, with emphasis on time-to-positivity, as a quantitative measure of long-term outcome. Initiated planning to develop a database supporting the RDST Consortium’s goal to develop a rapid TB drug susceptibility test.