2018 Stakeholders Association Meeting
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TB Alliance’s Stakeholders Association (SHA) held its annual meeting on Tuesday, October 23, ahead of the 49th Union World Conference on Lung Health in The Hague, Netherlands. In the wake of the United Nations High-Level Meeting (HLM) on TB, a WHO rapid communication on changes to MDR-TB treatment, key milestones in TB Alliance’s development of the novel BPaL and BPaMZ regimens, and ongoing scale-up of availability of its pediatric-friendly first-line TB therapy, the context was set for a discussion of progress and challenges impacting TB research and access to forthcoming therapies.
Karl Hofmann, president and CEO of PSI International and SHA president, opened the meeting. In his welcoming remarks, Hofmann acknowledged the increased attention paid to TB this past year, particularly due to the HLM, but cautioned that TB stakeholders must ensure commitments made to TB, including the full funding of TB research be met, noting that the HLM can’t be “the high-water mark” for TB, but rather an “onramp” for global leaders to follow through with investments in research and treatment.
Hofmann emphasized the importance of TB research and product development, including new regimens in TB Alliance’s pipeline, noting that “tremendous progress is possible. We have at our fingertips innovations that could begin to turn the tide on TB disease in the next 2-5 years, with better and shorter treatments.”
He warned, however, that “we need increased focus and investment in R&D to see these innovations come to market, to finance the next generation of innovations behind them, to meet the challenges of getting new regimes actually into the hands and mouths of people who need them, everywhere.”
SHA Community Representative Maurine Murenga followed Hofmann’s remarks, noting the role of civil society groups in shaping the five key asks ahead of the HLM and stressed the necessity of new tools – including novel drug regimens – to combat TB. Many existing TB drugs are highly toxic, especially those used to treat drug-resistant TB.
“As communities we say enough is enough,” said Murenga. “We can’t emphasize enough the fear of accessing TB treatment to stay alive and in the process losing our sight and hearing. We can’t express enough our disappointment in taking drugs that were developed in the central decades of the last century.”
In his State of the TB Alliance address, President and C.E.O. Dr. Mel Spigelman provided an update on progress made over the past year, including advances in the development of the novel BPaL and BPaMZ regimens (which are being evaluated in the Nix-TB, Zenix, and SimpliciTB clinical trials), as well as an update on the global uptake of child-friendly first-line therapies.
“This is the first time that we will be including clinical trial centers in Eastern Europe, Russia and South America in our clinical studies,” said Spigelman. “That to us is extremely important, as it ensures that we have clinical data in the global clinical trials from multiple geographic TB endemic regions.”
Spigelman added that “this expanded footprint not only ensures greater generalizability of the data but also may hasten local adoption of impactful new regimens on a broader geographic base.”
Spigelman highlighted the need for continued increased investment and attention for TB drug development, citing the history of TB treatment as a cautionary tale and warning that, as we approach the introduction of new regimens, precautions should be taken to avoid repeating the mistakes of the past.
A panel discussion on the impact of new TB regimens was moderated by Madhukar Pai, Director, McGill International TB Centre. The panel featured Saurabh Rane of Survivors Against TB, Dennis Falzon from WHO MDR-TB Policy & Innovations, Switzerland, Eunice Omesa from Kenya’s Ministry of Health and Sandeep Juneja, Senior Vice President, Market Access, TB Alliance.
Rane, a doctor and XDR-TB survivor opened the discussion by sharing what the promise of new regimens means to the patient community, stressing the importance of raising awareness of new tools in enabling access. He urged developers, regulators, health systems and all stakeholders to proceed with urgency. Falzon discussed how the WHO is working to be responsive to the evolving treatment landscape, evaluating and updating policy recommendations in a timely, responsive manner. Omesa spoke about how countries can prepare to accelerate the adoption of new tools, including the importance of creating and defining demand and capacity. Juneja outlined TB Alliance’s approach to address these and other concerns to enable rapid and widespread access to new TB regimens.
SHA Secretary Paul Sommerfeld led a Q&A session in which stakeholders considered how the TB community can collaborate to improve conditions for the discovery, development and delivery of new TB drug therapies. Topics raised included the investment case for TB Alliance’s work and forecasting of needs, the need for country-level advocacy to support introduction of new regimens, and the potential for accelerating regulatory approval of new products through harmonization or rapid review, as well as the role civil society and TB stakeholders can play in advocating for those changes.
Karl Hofmann closed the meeting with an emphasis on the plight of those suffering from TB around the world and stressing that, if those in the TB treatment community are to succeed, they must listen to the people they seek to help. Hofmann remarked that “all of us working in global health have not only an opportunity but an obligation” to think of those we are trying to reach.
The meeting was the last for Hofmann as President and Sommerfeld as Secretary, who, along with Community Representatives Maurine Murenga and Sarah Mulera, will complete their terms at the end of 2018.
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Please direct any inquiries about the event to SHA@tballiance.org.