TB Alliance: Putting science to work for a faster TB cure

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Developing Regimens

The TB Alliance and its partners are leading the clinical development of a new generation of markedly improved TB cures. These drugs are the building blocks of novel TB regimens, which will speed the introduction and unleash the transformative impact of new, faster, and better TB drugs for drug-sensitive and drug-resistant TB.

The Critical Path to TB Drug Regimens (CPTR) is a multi-sectoral initiative that is tackling the challenges associated with TB drug development to bring impactful new TB drug regimens to patients in need. Co-founded by the Bill & Melinda Gates Foundation, the Critical Path Institute, and the TB Alliance and launched in March 2010, CPTR has the potential to drastically reduce the time and cost associated with developing novel TB regimens.

There are a significant number of promising TB drug candidates in clinical development generated from the new momentum in global efforts to fight TB, owed largely to government investments in research and clinical trial capacity, increased philanthropic funding, industry commitments, the rise of product development partnerships, and overall increased attention to global health. Pioneered by CPTR, the innovative approach of collaboratively testing TB drug candidates in combination early in their development is emerging as the gold standard in the field. The development of corresponding regulatory science and infrastructure is steadily progressing as well.

A wide range of partners including the United States FDA, have shown their enthusiasm for this initiative. FDA Commissioner Dr. Margaret Hamburg provided the keynote address at the initiative's launch, while CDER Head Dr. Janet Woodcock editorialized that regimen development is a viable pathway for life-threatening diseases, including TB.

CPTR's structure is built around its three arms which include:

  • CPTR Drug Coalition — Led by the TB Alliance, drug sponsors work together to assemble and test the most effective treatment regimens.
  • Regulatory Science Consortium — Led by the Critical Path Institute, scientists develop consensus on innovative tools and testing methods for drug development that can be qualified by regulatory authorities
  • Research Resources Group — Led by the Bill & Melinda Gates Foundation, organizations advance the development of infrastructure by addressing clinical trial capacity, resource generation for late-stage clinical trials, access, and appropriate use of new TB drug regimens.
  • Drug Sensitivity Testing Group — Led by the Critical Path Institute and the U.S. National Institutes of Health, partners collaborate to advance the field of drug-susceptibility testing and enable the development of new diagnostic tools to complement novel drug regimens, thereby ensuring the maximum impact of new tools on the disease.

Through the CPTR Drug Coalition, the TB Alliance brings TB drug sponsors together to develop the best TB drug regimen, regardless of sponsor. The TB Alliance also used the regimen development paradigm championed through CPTR to develop the promising TB and MDR_TB treatment regimen, PaMZ.

Rooted in the spirit of innovative collaboration among diverse partners and a commitment to a "patient-first" approach to drug development, CPTR serves as a blueprint for collaboration in other disease areas for which combination therapy is standard, such as cancer and Hepatitis C.

The time has finally come for novel TB regimens to be conceived and realized in order to save millions of lives.

For more information on the CPTR Initiative, please visit www.CPTRinitiative.org.

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