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Today’s TB drugs are over 40 years old, offering antiquated and inadequate tools to treat active TB, which is the primary cause of HIV-related death in Africa and the cause of more than 1.7 million deaths each year around the world.
It’s a dismal situation. So what makes the outlook for this year’s World TB Day any different?
Well, hope has emerged with the March 18 announcement of the newly-launched program, Critical Path to TB Drug Regiments (CPTR). This exciting new initiative, created in partnership between the TB Alliance, the Bill & Melinda Gates Foundation, and the Critical Path Institute will alter the way that TB drugs are developed. Currently, individual drugs are developed and registered separately by being substituted (or added) one at a time to existing combination therapies. But the nature of TB ensures that it will always require a combination, and the years of trials to gain approval of a four-drug regimen can take that many more years to obtain approval under this current framework. The world cannot wait, so the CPTR will work to advance regulatory science to help clearly evaluate experimental TB drugs both on their own and within the context of a regimen to optimize efficiency of combination treatment development.
Under CPTR, drug companies and other product developers will work together to test promising combinations of individual TB drug candidates as early as possible, and to identify the best new combinations. At the same time, CPTR partners will work with regulators to develop new pathways to evaluate and register these safe, effective combination TB therapies quickly. The parallel testing will hopefully reduce the timeline for developing novel TB drug regimens to as little as six years – cutting the time to approval by up to 75%.
Part of our mission here at BIO Ventures for Global Health is to engage companies in global health by designing and helping to drive the incentives that provide a return on investment to companies willing to commit their R&D efforts to combating diseases of the developing world. So it was of particular interest to me when the panelists and the audience of cross-sector participants at the CPTR launch event talked about the integration of market-based incentives into the structure of CPTR. During the Q&A session, the Advance Market Commitment and Priority Review Voucher were heralded as concrete incentives that are currently in place and perceived as effective. Still, all participants saw the need to identify and create more market-based incentives to draw companies into the global health space.
From the launch event, it is clear that highlighting incentives is an important part of the CPTR mission to engage companies. BIO Ventures for Global Health pledges to offer our expertise in R&D incentives and fully endorses and applauds this large-scale, multi-sectoral initiative toward finding new combination drug regimens for TB. We think this paradigm will work, and we look forward to its success so that it can rapidly be adapted to meet similar needs in product development for malaria and other neglected tropical diseases.
For more information, please visit the Web site:
http://www.c-path.org/CPTR.cfm
The official press release is available here:
http://www.prnewswire.com/news-releases/global-partners-join-forces-to-speed-development-of-new-tb-drug-combinations-88386012.html
Rianna Stefanakis is the Manager of Research & Policy at BIO Ventures for Global Health.