2007 Stakeholders Association Meeting
The 2007 Meeting of the TB Alliance Stakeholders Association was held on November 5 in Cape Town, South Africa — where the TB Alliance was first conceived nearly eight years ago.
Stakeholder representatives from academia, industry, major health agencies, non-governmental organizations, and donors gathered to discuss recent progress in the accelerated drive to develop new, faster-acting TB drugs.
Dr. Maria Freire, CEO and President of the TB Alliance, began the meeting by announcing the movement of two of the TB Alliance's most advanced drug candidates into the next phases of research in patients. A groundbreaking, large scale, pivotal Phase III clinical trial in TB patients is beginning with the antibiotic moxifloxacin, already approved for other respiratory indications. The study — launching initially at six clinical trial sites in Africa — is designed to test whether a four-drug combination regimen including moxifloxacin can reduce treatment time for TB from six months to four. At the same time, the TB Alliance drug candidate PA-824 — the first novel TB drug developed by a not-for-profit organization to reach clinical trials and the first compound in the TB Alliance portfolio — is now in its first test in TB patients.
Dr. Mel Spigelman, Director of Research and Development for the TB Alliance, provided an overview of progress in advancing the TB Alliance scientific portfolio, as well as updates on the TB Alliance's strategic initiatives — programs aimed at enhancing and supporting the field of new TB drug research and development. Additionally, Dr. Spigelman announced that the TB Alliance's third Open Forum on Key Regulatory Issues in TB Drug Development will be held in New Delhi, India, May 5-6, and will focus on preparing for the introduction of new drugs in Southeast Asia and India.
Stakeholders also learned more about the milestone advances of the TB Alliance clinical program for moxifloxacin and PA-824. Dr. Ann Ginsberg, Head of Clinical Development for the TB Alliance, also presented preliminary findings from the TB Alliance's Global Clinical Trial Site and Laboratory Assessment, which included an assessment of the preparedness of 51 sites around the world to support large-scale clinical trials of new TB drug candidates. As the TB Alliance and others continue to advance promising new TB drug compounds, there is a growing need to improve and modernize the global TB clinical trials infrastructure.
> click here to view results from the TB Alliance Global Clinical Site and Laboratory Assessment
The TB Alliance policy team's Heather Ignatius presented results from two pioneering market research initiatives, designed to help prepare for the widespread adoption and availability of new TB drug regimens. Stakeholders were given a preview of the findings from the first value proposition study of TB drugs, designed to gain a better understanding of what those on the front-lines of TB control would ideally require from a new TB regimen. The study was designed to provide the TB Alliance and its drug development partners with insight and perspectives from adopters, payers, providers, and patients in various regions. Stakeholders were also given a summary of the detailed analysis of the groundbreaking TB Alliance study Pathway to Patients: Charting the Dynamics of the Global TB Drug Market, the first comprehensive analysis of how today's TB drugs reach patients on a global scale which revealed fragmentation and variation of the drug supply chain at the global, national, and regional levels.
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.