2010 Stakeholders Association Meeting
A decade ago, an interested group of stakeholders joined together to articulate the need for new TB drugs. Ten years later, the TB Alliance's Stakeholders Association, which includes many of those original organizations along with newer members, met at its annual session to discuss opportunities in the next era.
Representatives from more than 28 organizations attended the November 9, 2010 event in Berlin, Germany. A broad range of topics were discussed, including the progress in the pipeline, a changing paradigm for TB R&D, and the critical funding gap that must be closed in order for the TB Alliance to accomplish its mission.
download Dr. Spigelman's introduction (.pdf - 2,200kb)
In his presentation, Dr. Carl Mendel, Senior Vice President of Research & Development, discussed the TB Alliance's progress throughout 2010, and focused specifically on the organization's approach to regimen development. The platform, championed by the Critical Path to TB Drug Regimens, aims to telescope the time to develop better and faster novel regimens by simultaneously testing multiple new chemical entities with novel mechanisms of action together. "The goal," said Dr. Mendel, "is to create one regimen that treats both drug-sensitive and drug-resistant disease in less than four months."
The launch of the NC001 study is the first TB clinical trial to leverage this paradigm and tests PA-824 with moxifloxacin and pyrazinamide. As part of the14-day early bactericidal activity (EBA) study, additional combinations are also being tested including TMC207 and pyrazinimide as well as PA-824 and pyrazinamide. Study results are expected next year, says Dr. Mendel. In addition, in 2010 the TB Alliance continued to advance enrollment for the Phase III REMox trial and completed dose-ranging EBA studies for PA-824 and TMC207.
From the discovery portfolio, Dr. Mendel reported on a new collaboration with AstraZeneca and a unique partnership with the Drugs for Neglected Diseases initiative, where the TB Alliance has extended a royalty-free license to DNDi to develop a preclinical candidate for visceral leishmaniasis. In another new project, the TB Alliance is partnering with ACTG and TBTC in the Consortium for TB Biomarkers Substudy to find biomarkers that can streamline clinical trials for TB. Discovery-stage projects that did not meet milestones and were terminated include bifunctional molecules, tryptanthrins, and benzoxaboroles (LeuRS).
download Dr. Mendel's presentation (.pdf - 256kb)
To bring new TB regimens to patients, innovative science is a must. However, it's important to understand the other factors that can play a role in countries' adoption of new TB treatments. To this end, Elizabeth Gardiner, Vice President of Market Access, articulated new thinking about where TB patients seek treatment. "Although TB is considered primarily a public health, public-sector disease," says Gardiner, "the private sector provides large volume of treatments and can't be ignored." Indeed, Gardiner presented results from a study that show enormous volumes of TB drugs are being sold in the private sectors of some high-burden countries. She also reviewed how lower-cost regimens would enable the scale up of MDR-TB treatment with the potential to save billions on drug treatment costs alone.
download Dr. Gardiner's presentation (.pdf - 256kb)
Certainly, a vital part of the access equation is engagement with relevant constituencies. Dr. Ann Ginsberg, Chief Medical Officer, recapped highlights from the Open Forum, which was held in August 2010 in Addis Ababa, Ethiopia and attended by many African regulators, and also discussed relevant regulatory issues. The TB Alliance's Community Engagement Specialist, Stephanie Seidel, presented alongside Erica Sanga, from the Mbeya Medical Research Program, on Community Advisory Boards. Ms. Seidel explained the overall scope of the program and its role as an important feedback mechanism between the community and the clinical trial sites. Ms. Sanga offered the Mbeya clinical trial site as a case study of CABs and explained best practices and learnings, including how the use of a research literacy tool can effectively educate community members about TB R&D.
download Dr. Ginsberg's presentation (.pdf - 672kb)
download Ms. Seidel's and Ms. Sanga's presentation (.pdf - 548kb)
The Stakeholders Association comprises institutions which have formally pledged to support the TB Alliance in its mission, and includes a range of organizations worldwide that share a clear interest, and a significant stake, in ensuring the development of a faster, better cure for TB. Many stakeholder organizations are original signatories of the 2000 Cape Town Declaration, which formed the TB Alliance. They include representatives from developing nations, governments, NGOs, professional organizations, academia, foundations, and industry. Stakeholders participate in the TB Alliance's outreach and advocacy efforts, and they also advise and support the TB Alliance Board of Directors on various matters.