2009 Stakeholders Association Meeting

The 2009 TB Alliance Stakeholders Association convened on December 4, 2009 in Cancun, Mexico, just before the start of the 40th Annual International Union Against Tobacco and Lung Disease Conference.

Representatives from more than 30 organizations attended the event to review the TB Alliance's progress and also to engage with other stakeholders who are leading the fight against tuberculosis.

Dr. Mel Spigelman, the TB Alliance's CEO and President, opened the meeting with news of the organization's rapid advances. In the past two years, the TB Alliance has doubled its pipeline and now has more than 20 compounds in development, with three drugs in late-stage testing.

"We are now at an inflection point," said Dr. Spigelman. "The dream of developing a new regimen for TB has never been closer. With this success, however, comes great challenges and responsibility, particularly in mobilizing resources and building the necessary infrastructure to bring promising candidates through clinical trials so they can reach patients most in need."

To support this progress, the TB Alliance has expanded its management team to increase its institutional, organizational, and financial strength. The expanded leadership team includes Colleen Pero, Chief Administrative Officer; Stephen Jasko, Chief Financial Officer; Elizabeth Gardiner, MSc, Vice President, Market Access; and most recently, Carl Mendel, MD, Senior Vice President, Research and Development. All present offered an overview of their functional areas.

Dr. Ann Ginsberg, Chief Medical Officer, updated stakeholders on the progress of the three clinical development programs. For the Phase III REMox TB program to test moxifloxacin for treatment-shortening of TB, 2009 was a year of capacity building, said Dr. Ginsberg. The REMoxTB trial continued to enroll patients while simultaneously growing the number of clinical sites it supported. The TB Alliance's Small Grants Program also funded Community Advisory Boards around six clinical sites that promote meaningful, open communication between the community and researchers.

Dr. Ginsberg announced that progress had resumed on PA-824, a Phase II clinical project, which had been placed on clinical hold for much of the previous year. Supplemental studies were conducted to investigate all concerns and were submitted to the appropriate regulatory bodies. All issues were found to be satisfactorily resolved. Since then, the TB Alliance has completed enrollment of a low-dose EBA study on PA-824 in South Africa.

Another Phase II candidate, TMC207, entered the TB Alliance pipeline in June 2009 through a partnership with Tibotec. This novel compound is the first development program to undergo parallel development tracks for drug-sensitive and MDR-TB, which should be considered the new paradigm for TB drug development.

Dr. Ginsberg also offered an update on an initiative led by the Bill & Melinda Gates Foundation in association with the Critical Path, which seeks to identify one or more optimized novel regimens by testing all available compounds in combination. "These initiatives mean that we can begin to conceive of one treatment for both drug-sensitive and resistant disease," says Dr. Ginsberg.

With such progress, the TB Alliance is ramping up its Market Access activities to prepare the groundwork for the introduction of new TB drugs. Elizabeth Gardiner shared plans surrounding the Market Access strategy and also invited audience members to participate in research conducted by the group, such as its most recent report, "What Countries Want" which maps the value proposition of individual countries to adopt new TB drug regimens.

Dr. Zhenkun Ma, Chief Scientific Officer, discussed preclinical-stage research with the audience, noting that there were 5 new discovery projects added to the TB Alliance portfolio in 2009, which included projects in partnership with New York Medical College, Colorado State University, Institute of Microbiology and the Chinese Academy of Sciences, Anacor Pharmaceuticals, and Johnson & Johnson/Tibotec. The nitroimidazoles, mycobacterial DNA gyrase inhibitors, and riminophenazines projects advanced, while two other existing projects were terminated.

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.

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2009 Stakeholders Association Meeting

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