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Elena Pantjushenko is a communications associate for GHTC member OneWorld Health (OWH). She wrote this blog post to share the news of a major consortium project launched to boost elimination strategies for Visceral Leishmaniasis (VL, also known as kala-azar or black fever) in India and Bangladesh, where the disease burden is the world’s highest. The international consortium is led by another GHTC member, the Drugs for Neglected Diseases initiative (DNDi), together with OWH and the Special Programme for Research and Training in Tropical Diseases (TDR). A comprehensive four-year project to boost kala-azar elimination strategies in India and Bangladesh, where the concentration of disease burden is among the world's highest, was launched by an international consortium formed last month to support the countries' control and elimination strategies. The project aims to introduce the most effective treatment modalities to support control and elimination programs for this deadly disease. About Kala-Azar Kala-azar (VL) is a potentially fatal infectious disease that is transmitted through the bite of a sandfly and affects the visceral organs (e.g., enlargement of spleen and liver), causing chronic fever, weight loss and anemia. VL is endemic in 65 countries, primarily in the developing world, and the population at risk is estimated at 200 million. The disease often strikes impoverished populations living in rural villages who may not be able to afford the treatments currently available. If left untreated, VL is nearly always fatal. OneWorld Health developed Paromomycin Intramuscular Injection (PMIM) as an effective, inexpensive and safe treatment for VL, and worked with the Indian Government and Indian pharmaceutical company Gland Pharma to manufacture and distribute the treatment. PMIM received regulatory approval by the Drug Controller General in India, was designated for the WHO’s Model List of Essential Medicines, and was included in Essential Drug Lists of Nepal and Bangladesh. Collaboration Project Led by the Drugs for Neglected Diseases Initiative (DNDi), in collaboration with OneWorld Health (OWH), and the Special Programme for Research Training in Tropical Diseases (TDR), the project aims at establishing and implementing new treatment modalities as successful tools to control and support the elimination of VL in most endemic regions of South Asia. This four-year international consortium, established in October 2011, will generate the data necessary for Indian and Bangladeshi Ministries of Health to select, adopt and implement the best case management strategies to boost control and elimination of this deadly disease. OneWorld Health’s Role OneWorld Health will investigate the rationale for use of combination therapies with miltefosine, paromomycin and AmBisome® in the private sector in India as tools to control and support the elimination of VL. Project activities include pilot implementation of VL combination treatments at selected private sector clinics in India (target: 2,500 patients). In addition to development of the combination kits, this will include: working on drug inventory management and supply; site selection; site initiation (practicum and training); tracking of patients for compliance and pharmacovigilance; establishing adequate safe waste disposal methods; and establishing passive disease surveillance by the end of the project period. After completing the study, a feasibility report will be published. It will include recommendations for the private sector engagement in using new treatment modalities. Listen to Podcast

In a recent guest post for the ONE blog, GHTC director Kaitlin Christenson highlighted four game-changing HIV and AIDS interventions under development and the leadership from the US government that has helped foster these critical research breakthroughs. The fight against HIV and AIDS is not over, and a concerted effort must be made to prioritize research to develop new tools Photo: Robin Biellik/PATH The past three years have been historic in the number of breakthroughs in research to prevent, diagnose, and treat HIV and AIDS. For the first time, researchers proved that an HIV vaccine could prevent infection; an HIV prevention gel called a microbicide was shown to prevent infection among women; studies showed that a once-daily pill could reduce the risk of infection in high-risk individuals; and antiretroviral treatment among HIV-positive individuals was proven to reduce the risk of infecting their partners. "The fight against HIV and AIDS is not over, and a concerted effort must be made to prioritize research to develop new tools." Photo: Robin Biellik/PATHIt’s been incredible to see such progress over the past three years. But to be clear: these breakthroughs are a result of a long-standing commitment by international donors to boost research for HIV and AIDS. Innovations like these come as a result of years of work conducted by a variety of players—the private sector, NGOs, academic institutions and product development partnerships. In many cases, they are a direct result of the support provided by the US government. This commitment to research will continue to result in tools that change the way we approach the epidemic. Some impressive work is currently underway and promises to yield new interventions: Microbicides. Last year, a clinical trial in South Africa provided the first-ever proof that a vaginal microbicide could safely and effectively reduce the risk of HIV transmission to women. The trial was supported by the US Agency for International Development and two GHTC members, FHI360 and CONRAD. It provided new hope that an HIV-prevention tool designed for women could work. Additional research is needed on this product, though, and over the next two years, a follow-on trial will seek to confirm these results. Treatment as prevention. This summer, research supported by NIH demonstrated an astounding 96 percent reduction in transmission of HIV to an uninfected partner when his or her HIV-infected partner begins an antiretroviral regimen. Some questions remain about how this intervention might be implemented, and additional research is needed to understand how treatment as prevention will be operationalized. Oral pre-exposure prophylaxis (PrEP). Recent studies funded by the US National Institutes of Health (NIH) and others have confirmed that a daily dose of oral antiretrovirals can reduce the threat of HIV infection in high-risk groups. While additional research is needed to understand the implications of PrEP, many government agencies are considering adapting their HIV prevention guidelines to account for this new intervention. HIV vaccines. Two years ago, a clinical trial conducted in Thailand and funded by the US Department of Defense provided the first demonstration that a vaccine can prevent HIV infection in humans. While the results from this trial were too modest to support licensing this particular vaccine, trial data will help to inform the development of what researchers hope will be a more effective vaccine. On a recent trip to Kenya, my colleagues and I had the opportunity to meet with some of the research heroes who are leading the way in studying these and other interventions. The excitement they felt about the promise these new tools might provide was palpable. Lisa Mills, an American based with the CDC in Kenya, co-led a clinical trial which provided evidence for treatment as prevention. She told us that this intervention will have a “huge impact on communities. It will make HIV-positive people in these communities non-contagious. It’s also more cost-effective to do treatment as prevention, since you’re only treating HIV-positive people.” In speaking about research for microbicides, another of the individuals we met, Elizabeth Bukusi, deputy director at the Kenya Medical Research Institute (KEMRI), told us, “I think this is one of the tools that gives us the opportunity that we could actually end the epidemic. I think we can move towards a complete AIDS-free generation that will completely stop the epidemic in its track using microbicides as part of the armament.” She added that the “US has been a critical partner in providing catalystic funds and also in funding a large number of the trials that have looked at microbicides. So US funding is absolutely critical to moving this agenda forward.” Today, it is in our hands to decide the fate of future generations. The fight against HIV and AIDS is not over, and a concerted effort must be made to prioritize research to develop new tools — both those that are within arm’s reach, and those which still require much more study. Research is a long-term investment, and we must not give up on the commitments which have taken us this far. The US government is a leading supporter for research that has yielded many of the innovations we have today, and this support must not waiver even in the midst of today’s constrained budget environment. Will our leaders continue to set the stage? Imagine the breakthroughs that would be possible if so.

Tiffany Moy is the Global Health Research & Development Advocacy Intern at Research!America (R!A). R!A is the nation's largest not-for-profit public education and advocacy alliance committed to making research to improve health a higher national priority. R!A, in partnership with Aeras, the International AIDS Vaccine Initiative, the International Partnership for Microbicides and OneWorld Health, hosted a Capitol Hill briefing Nov. 15 on the role of product development partnerships (PDPs) in global health R&D. The event was co-sponsored by Reps. Brian Bilbray (R-CA) and Chris Van Hollen (D-MD). During the event, Bilbray acknowledged that the health challenges ahead of us will require sustained investment in the R&D process from both the public and private sectors, and he called for bipartisan support for both funding streams. “We can’t spend time patting ourselves on the backs,” Bilbray said. “[While we can’t] forget to celebrate our successes, we must continue to look at the challenges.” He declared the public and private collaborative network essential, saying without the basic research—or what he called the “sea plankton”—there would be no venture capital or opportunity to invest in the “krill.” Rep. Brian Bilbray (R-CA) speaks at Research!America's event on product development partnerships at the Rayburn House Office Building in Washington, DC, on Tuesday. “We must create the opportunity for people to invest their funds,” he said, “not just for the next iPhone for but the next breakthrough cancer treatment. Otherwise we just have good intentions without good solutions.” Mary Woolley, president and CEO of Research!America, moderated the discussion between panelists Ann Ginsberg, MD, PhD, vice president of Scientific Affairs at Aeras; Brid Devlin, PhD, executive vice president of Product Development at the International Partnership for Microbicides (IPM); Eugenio de Hostos, PhD, MBA, director of Research and Pre-Clinical Development at OneWorld Health; and Steve Fling, PhD, site director of the International AIDS Vaccine Initiative (IAVI) Neutralizing Antibodies Center at The Scripps Research Institute. Woolley’s opening remarks emphasized the role of health research as a major driver of the American economy and a key factor in our country’s global leadership. The panelists discussed how the non-profit PDP model speeds medical progress on diseases like HIV and AIDS, tuberculosis (TB), malaria and diarrheal diseases. PDPs play a vital role in accelerating the research and development of critical health technologies like vaccines, drugs, and diagnostics. The model allows risk sharing but also the sharing of technical resources and scientific expertise. Fling expressed pride in IAVI’s breakthroughs in the field of HIV and AIDS, as well as in its partnership with Seattle-based biotech Theraclone, which has led to additional partnerships with Pfizer and other drug companies. Devlin noted that IPM’s microbicide ring, designed to give women greater control over protecting themselves from HIV, is the first such product to come so far in the R&D pipeline. “HIV is the leading cause of death for women ages 15 to 44 worldwide,” she noted. The ring will enter late-stage clinical trials in early 2012. OneWorld’s de Hostos added that “this is not just about bringing technologies to bear on these diseases but it’s also about capturing the intellectual capital we have here.” Of solving one of the world’s greatest health challenges through the PDP model, Ginsberg said, “Using business practices, we are combining the public health need and expertise wherever we can find it. Ten years ago, there were no candidates and now there are 12 TB vaccine candidates in the R&D pipeline. [This is] the first time in history that so many TB vaccines have gotten so far” in the development process. A new, more effective TB vaccine could reach the market as early as 2020 and has the potential to greatly reduce the 1.4 million lives lost to TB each year. “This,” Ginsberg said, “could not have happened without the PDP model.” To learn more about how global health R&D is impacting the health and economies of other states, click here.

John Donnelly is a writer who accompanied the GHTC on its recent trip to Kenya. One of the most overlooked benefits of US-funded global health research is the training provided to scientists to do the work in their own communities.During the GHTC’s trip to Kenya last month, this type of capacity building was evident in several stops. One was from conversations with scientific investigators who have been researching the RTS,S malaria vaccine candidate. The first Phase 3 efficacy results of RTS,S—which is a public–private venture between the PATH Malaria Vaccine Initiative (MVI) and the pharmaceutical company GlaxoSmithKline (GSK), supported by funding from the Bill & Melinda Gates Foundation—found that it reduces the risk of clinical and severe malaria by roughly half in African children ages five to 17 months over a 12 month period.At one of the 11 trial sites, the Kombewa Clinical Trial Centre in western Kenya, the research has helped build a large staff of Kenyan researchers, doctors, nurses, and field workers. The Mal 55 trial, which was the main RTS,S research project at Kombewa, employed 124 Kenyans and just a handful of Americans.“Americans should know that we are not just giving people fish—we are teaching them how to fish,” said Dr. Louis Macareo of the US Army Medical Research Unit-Kenya and director of the Kombewa trial centre. “The biggest thing we are leaving behind is intellectual capital. They are becoming some of the best researchers in the world, even better than people in our own organization because of the volume of the work in the trials that they are involved in.”One of the most overlooked benefits of US-funded global health research is the training provided to scientists to do the work in their own communities.The research also provided the opportunity for many of the scientists to access education and training. In one case, physician investigator Dr. Lucas Otieno received his master’s degree in public health at the London School of Hygiene and Tropical Medicine partially due to support from the project. In return, Dr. Otieno agreed to stay for several years on the project.The RTS,S trial was just one example of capacity building. Dr. Pauline Mwinzi, a Kenyan, is the principal research officer at the neglected tropical diseases branch at the KEMRI-CDC office in Kisumu. The Kenya Medical Research Institute (KEMRI) and the US Centers for Disease Control and Prevention (CDC) have been partnering together in Kenya for more than 30 years. She said US training made all the difference for her.“We have benefitted from US government funding in terms of capacity building,” she said. “I was trained through the CDC. I wouldn’t be here without the CDC training that allows me to design these experiments that we are conducting at the moment and it’s not just me, but my entire department, my colleagues, and the funding that continues to come from the US government through the CDC” and the US Agency for International Development (USAID).Mwinzi added: “Without the US funding, we wouldn’t have moved much. We wouldn’t be able to move the sophisticated research that we do now.”Lynn Adrian, USAID’s health team leader in Kenya, told us that the training of Kenyan staff was one of those little-told stories that will have impact for years to come.“If I look at my own office, to start, in Nairobi, I have 38 staff and just three are Americans. The rest are Kenyans with incredible educational backgrounds and who very, very dedicated, very able to be able to influence policy and oversee programs,” she said. “This is not just true of the people in our office but as I go to the Ministry of Health I am also surrounded by technical experts who deliver leadership in fields like tuberculosis, in fields like malaria, maternal child health.”Adrian said the results of these trainings are being seen now, but will be even greater in just a few years.“For me as an American, as a taxpayer, and as a mom, these are the kinds of investments that we want to be making to be able to see out in five years or 10 years and see that the kinds of capacity building means institution strengthening going on all over this country,” she said. “It really will have a long-lasting effect.”