William Looney: A signpost of progress against disease is the capacity of institutions to innovate—to stay one step ahead of the contagion. How do you read the current climate for innovation, and is the pace sufficient to register gains against TB?
Innovation is a hallmark of the TB Alliance. Our very organizational platform is in many ways an innovation. We were the first TB drug-based organization to be structured as a Product Development Partnership (PDP). Our sole purpose is to produce an innovative set of therapies that significantly advance the standard of care for treating TB and bring those innovations to where they are most needed. The establishment of the Alliance back in February 2000 occurred when there was not a single new drug in development to treat TB—the last real breakthroughs, the first combination therapies, date back to the 1950s and 1960s. We've worked to lower the barriers to TB drug development so that industry partners are more willing to participate. Today, we have more than 20 new drug projects in various stages of development; three are in advanced Phase II or III trials. There are 10 drugs in total in the global pipeline.More important, we recently completed the first clinical trial that validates a new drug development paradigm that could decrease the time it takes to develop novel TB treatments by about 75 percent—from decades to years. The trial, called NC001 or New Combination 1, tests multiple novel drugs together early in the development cycle, with the goal of advancing the best combination of drugs—the way TB treatment is given. This is an approach that could be used in other diseases areas for which combination treatment is also a necessity, like malaria, cancer, and hepatitis. For TB, this is a major innovation because a novel regimen could be used for treating both drug-sensitive and drug-resistant TB in a single, shorter, safer, and improved cycle of therapy—an advance that has the potential to be truly transformative.
WL: What you are saying is that innovation is as much about broad process improvements—of which the Alliance's NC001 trial is an example—as it is about individual product advances?
MS: Exactly. As a PDP, the science behind a new product is important, but if you do not innovate right through the entire value chain, all that is innovative about the science could come to naught. In addition to classical scientific innovation, the TB Alliance has a three-step test in evaluating the potential impact of our work: Will the therapy be affordable? Will it be made available? Will it be adopted? The premise is that we might have the most innovative single drug, but if it is not combined in the best regimen and we cannot get those drugs into the places where they will have a significant clinical impact, and the right patients cannot afford or do not have access to them, we will have failed. This is why one of our priorities is seeding our PDP delivery platform at the country level, such as the memorandum of understanding (MOU) we signed in March with the International Scientific Exchange Foundation of China (ISEFC). The agreement will pave the way for the formation of the first Chinese PDP dedicated to global health called the Global Health Research and Development Center of China, or GHRC, facilitating the transfer of technologies and skills between TB Alliance and GHRC to help develop new global health tools and contain the spread of TB both in and outside of China. We are also pursuing a similar arrangement with a government agency in India to engage that country in the global development of new drugs and regimens for TB.