2013 Stakeholders Association Meeting
The TB Alliance held its annual Stakeholders Association meeting in Paris, France on October 28, 2013, ahead of the Union World Conference on Lung Health. 90 participants attended to hear updates from the TB Alliance and discuss challenges and exciting new opportunities in the coming months and years.
The meeting was presided over by Karl Hofmann, of PSI, the newly elected President of the Stakeholders Association and a member of the TB Alliance Board of Directors. Mr. Hofmann began his three year term in early 2013.
Dr. Mel Spigelman, President and CEO, opened the meeting with a presentation on the state of the TB Alliance and articulated the accelerated progress seen in many areas of our portfolio. He discussed children no longer being the "neglected of the neglected" as new funds have recently been dedicated to moving forward the development of appropriate formulations and new treatments for children with TB; the need to prepare for the impact of new TB regimens, which may soon be approved and moved into the market; exciting advances in the development of novel TB regimens; as well as new and ongoing donor support. Dr. Spigelman highlighted the need to accelerate partnerships in the coming years to ensure newly available treatments are introduced and adopted; to enhance clinical trial capacity and coordination to increase data and compound sharing efforts to continue accelerating progress towards new TB regimens; and for funders in middle-income countries to increase their involvement and move towards "consortia" funding for higher cost initiatives.
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Dr. Cherise Scott, Director of Pediatric Programs, moderated a panel discussion on the challenges of developing pediatric TB drugs and the next steps needed to address the challenges of this market. Panelists included Janet Ginnard from UNITAID, Dr. Rajneesh Taneja of the TB Alliance, and Dr. Grania Brigden from Médecins Sans Frontières. Dr. Scott opened the panel by highlighting the major challenges facing children who suffer from TB — their susceptibility to the most severe forms of the disease, frequent misdiagnosis, and the lack of appropriately dosed treatments available. She presented an overview of TB Alliance's plan to bring improved and appropriate TB medications to children. Key areas of the plan include improving understanding of the market, development of new products, engaging with manufacturers and regulatory agencies, and working with countries to update treatment policies and practices as correctly formulated pediatric TB drug treatments become available.
Ms. Ginnard discussed market challenges in pediatric TB, focusing on the unknown scale of pediatric TB cases globally and poorly adapted products creating limited market incentives. Dr. Taneja discussed the challenges of manufacturing appropriately formulated drugs for children that are tolerable and affordable, as well as challenges to obtain regulatory approval for such products, and suggested that bringing data to regulators from other existing dispersible medications could potentially assist in the development of guidelines for approving future pediatric TB medicines. Dr. Brigden discussed the challenges of adapting country-level policies to adopt new guidelines, lack of funds to procure drugs, and difficulties in uptake given the lack of appropriate formulations for children. She suggested that there should be an increase in training at all levels to improve dosing issues, and that WHO will need to give clear guidance to countries and manufactures. Countries will also need to prioritize childhood TB programs, integrating them into current national treatment programs.
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After the pediatric panel, attendees view a brief video highlighting TB Alliance's Community Engagement Program. The video documents site-level efforts to engage and educate communities around TB research, and features various experts discussing the importance and benefits of incorporating community engagement efforts into clinical research.
Ms. Elizabeth Gardiner, Vice President of Market Access, moderated a panel discussion on planning for new regimen introduction, focusing on strategic considerations for introducing new drugs and the technical assistance, funding, and advocacy that will be needed to ensure smooth introduction and adoption. The panelists included the Cambodian NTP Manager, H.E. Mao Tan Eang, Dr. Maarten van Cleeff of KNCV, Dr. Ya Diul Mukadi of USAID and Dr. Jane Ong'ang'o of KEMRI in Nairobi. H.E. Eang shared some of the considerations that National TB Programs will weigh when deciding whether to adopt a new TB regimen, while Dr. van Cleeff shared lessons learned from the roll-out of Gene Xpert, highlighting the need for early preparation at the regulatory, programmatic, epidemiologic and resource levels to ensure readiness for global policy shift. Dr. Mukadi emphasized the need for funding to introduce new TB regimens and the inclusion of more middle-income countries in efforts to mobilize resources. Dr. Ong'ang'o shared her experience engaging community in the REMox trial and her work preparing advocates for introduction and adoption. Dr. Ong'ang'o emphasized utilizing the community stakeholders who have been engaged in a clinical trial from the beginning as powerful tools in efforts to advocate for in-country adoption of new regimens.
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Dr. Carl Mendel, Senior Vice President of Research & Development, presented significant updates in the TB Alliance's pipeline, including the completion of three signature clinical trials and the initiation of a robust pediatric program. Highlights included the completion of the treatment phase of the REMox TB trial, which tested two moxifloxacin-containing regimens with the potential to shorten treatment to four months and the timeline for the completion of data analysis and results dissemination; the completion of both NC-002, the first trial to employ a unified pathway for the development of new regimens for both drug-sensitive and drug-resistant TB disease, and NC-003, a trial that tested several shorter regimens and building blocks of regimens, including clofazimine. Results of all three trials will be available in 2014.
Dr. Mendel also spoke about the many key firsts from the NC-002 clinical trial, including NC-002 as the first eight-week trial of a novel TB regimen, the first enrollment of both drug-sensitive and MDR-TB patients into a single trial with the same treatment; a new approach to treatment focusing on sensitivity to drugs as compared to resistance, and the first use of fixed dose pyrazinamide.
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Stakeholders expressed their interest in involvement as countries ready themselves for the introduction of new regimens, particularly around engaging and building the capacity of advocates and community stakeholders to work with in-country policy makers and regulators to establish a base of support for the uptake of new regimens.