2014 Stakeholders Association Meeting
On the heels of a year full of clinical advances and pivotal trial results, TB Alliance held its annual Stakeholders Association meeting in Barcelona, Spain on October 27, 2014, ahead of the Union World Conference on Lung Health.
Nearly 100 key stakeholders attended the meeting to hear updates from TB Alliance, to discuss progress and opportunities to capitalize on the recent momentum in TB drug development and to strategize on overcoming challenges in the field. Stakeholders Association President Karl Hofmann, of PSI, led the meeting.
Dr. Mel Spigelman, President and CEO, opened the meeting by summarizing the state of TB Alliance, highlighting exciting advances within the TB Alliance portfolio; including the initiation of an unprecedented number of clinical trials this year as well as progress in the discovery and development of promising new compounds. He described a year of accelerated partnerships in areas of market access, research and development and funding. Such partnerships will impact the scope, breadth, and pace of research, while strengthening key relationships that will be critical to the successful introduction and adoption of new products, especially in middle-income countries.
Dr. Spigelman also discussed the many needs that remain unmet in treatment for all types of TB infection; reinforcing the urgency of new, more effective tools to both diagnose and treat all forms of tuberculosis.
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Dr. Carl Mendel, Senior Vice President of Research & Development, presented significant updates in the TB Alliance's clinical development plans, including the status of the five active clinical trials. Highlights included an overview of the upcoming Phase III STAND trial, which will be studying the three-drug PaMZ regimen (Pretomanid, Moxifloxacin, and Pyrazinamide) in drug sensitive (DS) and multi drug resistant (MDR) TB patients over a 4-6 month treatment period.
Additional trials discussed included an 8-week Phase IIb clinical trial testing the three-drug regimen BPaZ (Bedaquiline, Pretomanid, and Pyrazinamide) in DS- and MDR-TB patients; a Phase III "rescue study" NiX-TB, studying the efficacy of a three-drug regimen BPaOx (Bedaquilne, Pretomanid, [Oxazolidinone]) in XDR-TB patients and a dose-ranging study on the drug Linezolid.
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Dr. Nader Fotouhi, Chief Scientific Officer, discussed substantial advancements in the TB Alliance's discovery and pre-clinical portfolio. He highlighted a more balanced and robust early-stage portfolio, bolstered by new funding partners, but during the later discussion the TB Alliance also highlighted the need for significant further development. Dr. Fotouhi highlighted the organization's long-term discovery vision as maintaining a balanced portfolio of innovative targets and approaches to shorten and simplify treatment of TB in all its forms.
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Ms. Elana Robertson, Senior Vice President of Market Access, stressed TB Alliance's commitment to ensure patients get rapid and sustainable access to affordable new TB drugs.
She articulated a current focus on preparing for the introduction of reformulated, WHO pre-qualified, first-line pediatric TB drugs, which TB Alliance plans to deliver in 2016; and for the future introduction and adoption of PaMZ. She highlighted many of the challenges that still exist in the pediatric TB drug market and focused on TB Alliance's collaborative efforts with WHO, product manufacturers, and funders to overcome current obstacles and achieve a well-functioning market for child-friendly TB treatments.
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Mr. Willo Brock, Senior Vice President of External Affairs, provided updates on the TB Alliance's resource mobilization, advocacy and community engagement efforts. He emphasized in particular newly granted funding from major foundations and governmental agencies in the UK, US and Australia, country specific funding to support clinical trial implementation in China, Brazil and potentially India, as well as a vision of building a "network of people not living with TB".
He also discussed plans to expand TB Alliance's community engagement program with the upcoming STAND trial, as well as newly-developed tools to help capture and quantify the impact of community engagement efforts.
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Mr. Mayowa Joel, Community Representative to the Stakeholders Association, provided a more intimate perspective, as he spoke on the need for partnerships with all levels of stakeholders, and the importance of community involvement in the R&D and TB drug introduction process.
Following the presentations, Karl Hofmann and the SHA Secretary, Paul Sommerfeld, led a lively discussion that sought audience feedback on the scientific direction, financial standing, and community engagement efforts of TB Alliance. Mr. Sommerfeld also asked the group to consider whether they, as individuals and representatives of global health stakeholders, are doing all they should to help support the TB Alliance.
These questions provoked refreshingly frank, and largely supportive feedback and discussion. A good discussion about the design of the STAND trial took place, including whether its targets were too ambitious. Some reminded the organization of the stark need for a compassionate use program for Pretomanid (which is currently being planned).
Dr. Spigelman responded to concerns by reiterating the regulatory review and support for the design of the STAND trial, while acknowledging that, depending on the outcome of current and future trials, TB Alliance could enter uncharted regulatory territory in the disease field. He stressed that those driving the innovation and regulators will have to chart this new course together. Dr. Spigelman asked the group to reflect on the state of TB drug development at large and realize the enormity of the task at hand in comparison to the limited resources available—and with so few compounds in the global pipeline—as compared to other research fields. Recognizing that some of the topics touched upon could not sufficiently be covered in this meeting alone, Dr. Mendel also invited those interested in discussing such issues to meet with the TB Alliance team, either virtually or in-person, to further discuss their questions.
Though most stakeholders expressed satisfaction with TB Alliance's efforts to engage community in their work, a concern around the importance of measuring community engagement (CE) activities was raised. Mr. Brock explained that there is a need to build an evidence base for how CE impacts clinical research to help increase sustainable funding for this activity as well as to increase understanding about how CE may contribute to certain research outcomes.
On the subject of funding, stakeholders were clear that currently available funding is insufficient and a fair number of attendees indicated to be uncertain whether sufficient funding will be available. Many stakeholders talked about the need for increased advocacy for funding in TB R&D and noted that participating in such efforts is a key component of their organization's commitment as a TB Alliance Stakeholder.
The open discussion session energized the audience and reflected the true potential of events such as this one. TB Alliance is already beginning the process of planning next year's meeting, and considering ways to further promote this kind of engagement with the attendees throughout the coming year.
Please direct any inquiries about the event to SHA_President@tballiance.org