Stakeholders Association 2023 Annual Meeting
TB Alliance Stakeholders Share Progress and Real-World Experiences in Ensuring Access to New Therapies
On November 14th, 2023 TB Alliance held its annual meeting of its Stakeholders Association (SHA) and other tuberculosis (TB) and global health stakeholders to highlight recent advances in its drug development and delivery efforts. Key topics of the event included the announcement of a newly launched Pan-Phase 2 clinical trial testing the first potentially “universal TB regimen,” an update on the global rollout and uptake of pretomanid and BPaL regimen, and a panel discussion featuring health officials of TB-endemic countries relaying their experiences and insights regarding the adoption, use, and future plans for pretomanid and the BPaL regimen.
Mitchell Warren, SHA President, began the event by emphasizing the importance of not only developing but effectively delivering new health technologies to those in need, encapsulating this sentiment by noting, “We spend so much time thinking about the research and development of new tools – but if we don’t deliver them, they don’t really matter.”
Dr. Mel Spigelman, TB Alliance President and CEO, reflected on the evolving strategy of the organization over its history, noting its progress from focusing on developing single drugs to regimens and identifying that the organization is once again at an inflection point. Driven by advances in science, the promise of the pipeline, and growing opportunities for partnership, Dr. Spigelman commented, “We can now see a path forward to potentially treating latent TB in a day – and as short a time period as one month for active TB.” Dr. Spigelman closed his remarks by stating, with the input and support of key stakeholders, the organization is once again poised for a strategic expansion, remaining committed to all previous aspects of its work, while expanding its focus into latent TB, embracing new modalities of therapy, and deepening its commitment to ensuring widespread access to new TB treatments.
Dr. Spigelman's slides are available here
Dr. Eugene Sun, TB Alliance Senior Vice President, Research and Development, introduced the recently launched Pan-Phase 2 NC-009 trial, which will evaluate the safety and efficacy of a combination of a new experimental compound, TBAJ-876, with pretomanid and linezolid, components of TB Alliance’s BPaL regimen. This regimen has the potential to shorten and improve treatment for both drug-sensitive and drug-resistant tuberculosis (TB). Dr. Sun contextualized this trial—and new potential regimens—by tracing the development and modifications of the BPaL regimen, in pursuit of superior efficacy and tolerability. One of the chief potential benefits of the new regimens tested in NC-009 is their ability to further shorten therapy. Dr. Sun noted about the trial, “We will learn about the potential for a (TBAJ-)876, pretomanid, linezolid regimen to be a treatment regimen shorter than four-months.
Dr. Sun's slides are available here
Sandeep Juneja, TB Alliance Senior Vice President, Market Access provided an overview of progress in enabling and expanding access to pretomanid and the BPaL regimen. Mr. Juneja highlighted the speed at which TB Alliance has been able to achieve this, crediting that to planning, partnerships, and coordination, noting “We worked deliberately to ensure many access activities happened in parallel – that has allowed us to enable access to happen within three years.” Since approval, pretomanid has been ordered by 70 countries, in volume to treat 40,000 people with DR-TB. Mr. Juneja contextualized this achievement by stating that access has traditionally taken as long as nine years to achieve and the reach of pretomanid has expanded significantly more quickly than past new TB therapies. Mr. Juneja reiterated TB Alliance’s deepening commitment to access work, facilitating information and experience sharing, and beginning work for next stage products.
Mr. Juneja's slides are available here
A robust panel discussion was introduced and moderated by Oxana Rucsineanu of Moldova and Priyanka Aiyer of India. In introducing the panel, Ms. Rucsineanu recalled her experience as an MDR-TB survivor, recounting having to take 36 months of treatment and noting that shorter and efficient therapy, like BPaL, is “what we fight for.” Ms. Aiyer followed by emphasizing the importance of access, remarking that “The BPaL regimen offers an incredible chance to bring change” to past and ongoing struggles for access to key technologies and the discourse around them. Ms. Aiyer urged the community to “focus on what really matters—the wellbeing of people who are affected by TB.”
The panel discussion focused on real-world progress and challenges in adopting pretomanid-containing therapies and plans for further expanding the availability of new TB cures. Lada Bulakh, Member of Parliament, Committee on Epidemic Security, HIV/AIDS, and Socially Dangerous Diseases, Ukraine discussed the process of translating the evidence supporting the adoption of pretomanid and BPaL for treating drug-resistant TB into legislation and policy amid violence in the Ukraine. Ms. Bulakh is proud of Ukraine’s swift progress on this front (Ukraine was the first country to adopt BPaL), declaring, “Ukraine is one of the leaders in implementing—with support of WHO—innovative, shortened treatments and new drugs, such as pretomanid.”
Addul Ghafoor, MDR-TB Advisor to National TB Program, Ministry of Health, Pakistan focused on the importance of coordination and planning to quickly facilitate access. Mr. Ghafoor stated that Pakistan, which has recently updated its national TB treatment guidelines to include BPaL, intends to treat 85% of MDR-TB patients on BPaL beginning in 2024. Mr. Ghafoor remarked that to achieve this, “What we need to do is multipronged, simultaneous, and fast.”
Siti Nadia Tarmizi, Director of Communications Bureau, Ministry of Health Indonesia noted that in addition to operational challenges, trainings, and formal process of transitioning from operational research to programmatic scale-up of BPaL, addressing perception from TB affected communities and soliciting input from physicians was critical to the country’s process in rolling out pretomanid-containing regimens. In considering what it takes to achieve this transition, Ms. Tarmizi noted, it “reflects a comprehensive infrastructure to support implementation.”
Fernanda Dockhorn, National TB Program, Ministry of Health, Brazil stated that a significant source of challenges in accelerating access to pretomanid and BPaL is the process of integrating new health technologies into the national public health system. Ms. Dockhorn went on to report that, “The process is ongoing; we are planning to [to have] the medicine in the beginning of next year (2024).” A series of training programs will follow. Ms. Dockhorn praised the value of engaging civil society in this effort.
Norbert Ndjeka, Chief Director, TB Control and Management, National Department of Health, South Africa provided an update on South Africa’s progress in rolling out pretomanid-containing therapies, citing that seven of nine provinces are currently treating those with DR-TB with pretomanid. Mr. Ndjeka stated, “By the end of December (2023), all eligible people will be [treated with pretomanid], so we’ve developed a dashboard and we send the results to each province each week.”
The meeting concluded with a question-and-answer session featuring all panelists and speakers throughout the event, which was moderated by Mitchell Warren.