The Critical Path to TB Drug Regimens (CPTR Initiative) is a public‐private partnership initiated in March 2010 by Critical Path Institute (C-Path), the Bill & Melinda Gates Foundation (BMGF) and the Global Alliance for TB Drug Development (TB Alliance). C-Path leads the CPTR Regulatory Science Consortium and the CPTR Rapid Drug Susceptibility Testing (RDST) Consortium, with participation from the pharmaceutical industry, academia, as well as, national and global government agencies, in order to:
- Develop and integrate data standards
- Qualify biomarkers through the FDA/EMA
- Develop quantitative disease progression (natural history) models
- Create disease response metrics, develop target product profiles and supporting assays
- Develop new pharmacokinetic/dynamic measures of drug interactions
Often considered a disease of the past, TB kills 1.7 million people every year. It is one of the world’s deadliest pandemic diseases, exacerbated by global poverty, the AIDS epidemic, and drug resistance. With a person dying of TB every 20 seconds and currently available drugs (almost 50 years old) that require unacceptably long, complicated and expensive regimens (6-30 month regimens with multiple drugs), there is a dire need for faster-acting drugs to treat TB in all its forms that are effective, affordable, and accessible. The treatment of active TB requires a combination of multiple drugs to be effective. In recent years, there has been a greater understanding of the importance of developing novel treatments using drug combinations from the start of the drug development process, rather than waiting for new single agent drugs to receive regulatory approval before combining them. It’s time to bring TB science into the 21st century.
The CPTR initiative is dedicated to delivering a safer, more efficacious, and faster-acting tuberculosis (TB) regimen by developing and promoting innovative regulatory science essential for supporting new combination drug development in collaboration with its partners across industry, academia, and government.