2012 Stakeholders Association Meeting
The TB Alliance held its annual Stakeholders Association meeting in Kuala Lumpur, Malaysia on November 16, 2012, during the Union World Conference on Lung Health. More than 80 participants attended to hear updates from the TB Alliance and discuss challenges and opportunities facing the organization in the coming months and years.
Dr. Carl Mendel, Senior Vice President of R&D, presented significant research and development (R&D) updates in the TB Alliance's pipeline, including progress in six clinical trials that were initiated or ongoing this year. Highlights included the completion of the treatment phase of the REMox TB trial, which tests two moxifloxacin-containing regimens with the potential to shorten treatment to four months; NC-002, the first trial to employ a unified pathway for the development of new regimens for both drug-sensitive and drug-resistant disease, and NC-003, a trial that tests several shorter regimens and building blocks of regimens, particularly clofazimine, where there is little pre-existing resistance.
Dr. Mendel also spoke of several new initiatives. In 2012, the TB Alliance drafted a pediatric development plan that proposes to study new TB drugs more quickly in children. If approved, this pathway would be a major advance in streamlining the development of pediatric medicines which are urgently needed. The TB Alliance is seeking external funding to advance new pediatric treatments and implement a set of market interventions to catalyze the delivery of improved TB treatments to children.
Dr. Mendel also presented a proposal for a new study called NiX-TB (New Chemical Entities in XDR-TB), which will evaluate regimens composed of new chemical entities in people with extensively- and totally drug-resistant TB in carefully controlled conditions. The proposal was discussed by a panel which included Dr. Manica Balasegaram from Médecins Sans Frontières, Mr. Mark Harrington of Treatment Action Group, Dr. Michael Kimerling from the Bill & Melinda Gates Foundation, and Dr. David Mametja from the National Department of Health of South Africa. These panelists offered helpful feedback on the proposed design and shared thoughts about the positive impact of this study for programs and patients.
> Download Dr. Mendel's presentation (pdf - 955kb)
Ms. Elizabeth Gardiner, Vice President of Market Access, presented several components of the TB Alliance's plans to prepare for the potential launch of a 4 month moxifloxacin-containing regimen. If the REMox TB trial is successful, one or both of the regimens tested will be ready for launch as soon as 2014. Ms. Gardiner described the steps necessary to prepare for uptake of this regimen at the global and country levels. The TB Alliance's plan is to select and prepare for early introduction of this regimen in two to three settings where roll-out has a high likelihood of success. These pilot demonstration countries would generate information about the uptake process that might impact other countries' interest in adopting a moxifloxacin-containing regimen. Importantly, Ms. Gardiner shared top-line results of the TB Alliance's and Liverpool School of Tropical Medicine's recently completed study that highlighted the economic benefit to patients of a four-month regimen — allowing them to save money associated with treatment and improving their ability to go to work.
Additionally, Ms. Gardiner underscored the importance of a country's drug resistance profile as a component of the adoption decision-making process. She described collaborations planned to improve population-wide drug susceptibility surveillance efforts — particularly of fluoroquinolones — that will inform countries about background resistance among new patients. Improving the availability of drug susceptibility testing and updating diagnostic/treatment algorithms will also be critical in parallel to the launch of new regimens.
> Download Dr. Gardiner's presentation (pdf - 955kb)
Following the presentations, Dr. Mel Spigelman, CEO and President, discussed the importance of applying innovation to adoption, and lead the Stakeholders Association in a discussion on how best accelerate the introduction of new TB regimens. With two new drugs—bedaquiline and delamanid—under regulatory review, stakeholders expressed excitement about the prospect of new TB treatments, but also concern about balancing rapid access to new drugs in a manner that reinforces the programmatic advances of recent years. Stakeholders offered helpful feedback on how the TB Alliance might best navigate some of the major challenges it will face as its products advance through the pipeline to the people that need them. While the group did not reach a consensus about the clearest path forward, the SHA acknowledged that now is the time to begin preparations for coming change. The TB Alliance and its partners can generate the evidence that countries and providers will need to consider adoption and use new regimens well. However, there will be some risk involved if we are to ensure faster access to significantly-improved new regimens.
The meeting was presided over by Dr. Maarten van Cleeff, of KNCV, the outgoing Chair of the Stakeholders Association and a member of the TB Alliance Board of Directors, who completes his three-year term in December 2012. The Stakeholders Association thanked Dr. van Cleeff for his service and valuable contributions to the TB Alliance, not only as the President of the Stakeholders Association but also as a Board member. The Association also bid farewell to Mr. Francis George Apina, who held a productive three-year term as Community Representative. A new Chair and Community Representative will be elected in January 2013. Finally, the utmost thanks goes to Heather Ignatius, the secretariat of the TB Alliance Stakeholders Association, who has left the organization, and who has turned that position over to Stephanie Seidel.