2008 Stakeholders Association Meeting
The 2008 Meeting of the TB Alliance Stakeholders Association was held on October 13 in Paris, France, to review recent progress to accelerate the development of new, faster-acting drugs that could revolutionize TB control.
Dr. Gijs Elzinga, Chairman of the Board of Directors of the TB Alliance, began the meeting by thanking Dr. Jerome Premmereur for his excellent service to the TB Alliance as CEO and President. Dr. Elzinga said he was delighted to announce that Dr. Mel Spigelman, currently Director of Research and Development for the TB Alliance, would be assuming the position of CEO and President as of January 1st, 2009.
Dr. Jorge Bermudez, Executive-Secretary, UNITAID, then gave the keynote address on "Innovative Financing for Medicines and Diagnostics." He reviewed the origins of UNITAID, the funding gaps that it fills, and its ability to impact prices, drug quality, and delivery mechanisms. Finally, he reviewed UNITAID's current and future goals within TB diagnostics and first-line, second-line and pediatric TB drugs.
Dr. Spigelman reviewed the significant progress that has been made in all major functional areas over the previous year. In Market Access, a comprehensive approach is being taken to create a pathway from drug development to patient realities. New partnerships, including a collaboration with sanofi-aventis announced for the first time at the Stakeholders Association meeting, have driven the continued growth of the portfolio to include a total of 2 clinical projects and 13 additional projects. Increased research and development investments have driven a sharp rise in disbursements from $27 million in 2007 to $40 million in 2008, while management expenses have remained low at just 8% of the overall budget.
For the Research and Development review, Dr. Spigelman first discussed progress in the area of Discovery. Over the past year, the quinolone TBK-613 was advanced into preclinical development, the back-up nitroimidazole project was brought to the final drug candidate selection stage, the preclinical drug combination studies completed in vitro testing, the riminophenazine project moved into the lead optimization stage, and three new projects (the NITD drug portfolio, energy metabolism inhibitors, and protease inhibitors) were brought into the TB Alliance drug portfolio. In addition, multiple other new projects and collaborations are in advanced stages of negotiation.
The clinical program includes two projects. The first, REMoxTB, is the pivotal Phase III trial of moxifloxacin-containing regimens. The requirements of meeting global registration standards have presented challenges for meeting enrollment projections at the 4 existing REMoxTB sites. However, assessment of 81 potential trial sites in 37 countries has resulted in the selection of 16 additional sites for inclusion in REMoxTB. Preparation of these sites is going well, and trial completion and results are expected in 2011.
> click here to view results from the TB Alliance Global Clinical Site and Laboratory Assessment
Dr. Ann Ginsberg, Head of Clinical Development, presented results from the first test of PA-824 in TB patients. In the Phase II study, PA-824 was dosed as a single drug for 14 days. PA-824 appeared to be safe and well-tolerated, and significant early bactericidal activity was seen at all doses. This result is extremely encouraging and supports the potential of PA-824 to contribute to treatment-shortening for both drug-sensitive and drug-resistant TB.
> Learn more about the latest PA-824 results.
Dr. William Wells, Director of Market Access, introduced two recent projects. The demand forecast is an estimate of how much moxifloxacin will be required for TB between regulatory approval and 2022. Variables in this forecast allow for consideration of the timing and criteria for adoption decisions, and results will help with manufacturing plans and deals. The second project, the Country Introduction Study, is an analysis of the history of past regimen changes, and the processes and factors affecting future regimen change in the 22 high burden countries for TB. The outcome will be a prioritization of future launch and access activities and the definition of an orderly pathway for the worldwide introduction of a new TB regimen.
Policy Officer Heather Ignatius presented an update of the TB Alliance's Community Engagement Program. This program works to develop communication pathways between REMoxTB clinical trial researchers and the communities involved in the trial (including patients, their families, activists, local leaders and NGOs), and promotes transparency, feedback, education, and local ownership. Small grants to two initial sites have provided lessons on some of the different approaches to community engagement required for TB drug trials and the need for individualized strategies at each different site. The program is now in the planning and discussion phase at 11 additional REMoxTB sites.
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. These responsibilities are exercised through ongoing contact with the Alliance, the nomination of candidates for the Board of Directors, and the biennial election of a Stakeholders Association President.
Since the input of the broader global health community is an important component of the annual meeting, outside participants are considered for election to the Association each year.