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Eleonora Jiménez–Levi is a senior researcher for the Treatment Action Group (TAG), a GHTC member, and wrote this blog post in conjunction with the release of a new report from TAG about funding for tuberculosis (TB) research and development (R&D). TAG has released a new report in collaboration with the Stop TB Partnership, which finds that in 2010 the world invested just $617 million in TB R&D—less than one-third of the estimated $2 billion annual investment needed to eliminate TB as a public health threat by the year 2050. The report, Tuberculosis Research and Development: 2011 Report on Tuberculosis Research Funding Trends, 2005-2010, tracks annual research spending across six TB R&D areas against funding targets set by the Global Plan to Stop TB 2011-2015. The report offers year-to-year data on the leading TB research funders and underscores the urgency of adequate and sustained funding. Dr. Lucica Ditiu, Executive Secretary of the Stop TB Partnership, emphasized this critical need for sufficient funding by saying “with current levels of funding it will be impossible to meet the research targets of the Global Plan to Stop TB 2011-2015. This is a completely unacceptable situation, because those targets are, I would dare to say, even modest. Where is the funding to push ahead research for a point-of-care diagnostic test accessible to all, new drugs for a shorter treatment time and a fully effective vaccine?” For the sixth consecutive year, R&D for TB treatment was the most well-funded research area—growing by 19% from $192 million to $227 million. However, this was just 31% of the $740 million annual Global Plan target for TB treatment research. The report also documents significant funding declines in basic science and vaccines research, which dropped 27% and 29%, to $126.6 million and $78 million, respectively. TB diagnostics accounted for 7% of global total spending with $44.6 million—a 15% increase from 2009. The infrastructure/unspecified category grew 46% to $83 million and operational research rose 17% to $58.1 million in 2010. Measuring these totals against the Global Plan targets, the only category to come close to its annual target was operational research and the farthest one was TB diagnostics. According to the World Health Organization, there were 8.8 million people newly diagnosed with TB and 1.45 million deaths in 2010, including 1.1 million new cases and .35 million deaths among people with HIV. Resources to develop new tools to prevent, detect, and treat TB have never been more urgent. “Recent progress in TB research is clearly threatened by stagnating funding,” said TAG’s executive director, Mark Harrington. “After several years of increasing investment, TB research is finally making headway with two new promising drugs for the treatment of multi-drug resistant TB and a new drug combination active against both drug sensitive and drug resistant TB. Cutting investments now will cost lives in the future.”

Some of the most incredible health research is taking place in Kenya right now. Because of this work, we are on the cusp of the most exciting new tools in global public health in recent years—the first ever malaria vaccine, gels women can use to protect themselves from HIV, new drugs for neglected diseases that affect the poorest of the poor. Kenya is also rolling out an array of lifesaving new health products that research has already made available, like HIV and AIDS drugs, vaccines to protect children from pneumonia, and insecticide-treated wallpaper that prevents malaria inside people’s homes. During the GHTC’s recent trip to Kenya, I was fortunate to visit several of these global health research projects, most of them run by our dedicated coalition members like the Drugs for Neglected Diseases initiative (DNDi), PATH, the International Partnership for Microbicides (IPM), Aeras, and the International AIDS Vaccine Initiative (IAVI). We also saw firsthand how the US is making a huge impact in health research in the country, through the work of agencies like the US Agency for International Development (USAID), Centers for Disease Control and Prevention (CDC), and the Department of Defense (DoD). 3935 - Siaya, Kenya - Kayla Laserson is the Director of the KEMRI/CDC Field Research Station . Photo: Evelyn Hockstain/PATH. Although we visited a range of projects, I was left with the lasting impression that much of this research is so close to producing new health tools that can lead to amazing innovations in public health. “We are on the verge of breakthroughs in malaria and in TB and in other diseases,” Kayla Laserson, director of the CDC/KEMRI Field Research Station in Kisian, said. “What we really need is continued support so we can get the job done, we can finish it, we can show the impact, we can save hundreds of thousands of lives here and globally.” We also saw how past commitments to research are already saving lives. For example, research that led to the development of antiretroviral drugs is one of global public health’s biggest success stories. Rister Kageha, a woman living with HIV close to the town of Kakamega, told us how these drugs had not only saved her life, but also prevented her daughter Sylvia from contracting HIV. Because of these drugs, “I expect to live long,” Rister said, adding that she also hopes for a long life for Sylvia due to the drugs that kept her daughter HIV-negative. Rister Kageha says antiretroviral drugs saved her life. Photo: Evelyn Hockstein/PATH. And while past research has led to some health tools already in use, and current research is producing breakthroughs we could see in next five years, other innovations aren’t as far along down the research pipeline. This is why continued US support is critical to sustain the momentum around these new tools, from discovery to delivery. US support for microbicides, for example, has been vital to recent research successes, and must continue while the research continues over the next several years. A microbicide “is one of the tools that gives us the opportunity that we could actually end the epidemic,” Elizabeth Bukusi, deputy director at the Kenya Medical Research Institute (KEMRI) who works with IPM, said. “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.” The same can be said of US support for all global health tools, not just microbicides. Fortunately, if Kenya is any indication, the US has a long history of supporting research for health products like vaccines and drugs.This long history should not end anytime soon. It’s imperative that this historical leadership continues, so the groundbreaking research the GHTC saw in Kenya can produce the next generation of lifesaving health tools.

Claire Wingfield is a Product Development Policy Officer with PATH. This week, she’s blogging from the World Health Summit in Berlin, Germany. The third annual World Health Summit is currently underway in Berlin. The Summit brings together researchers, policymakers, funders, advocates, and health care providers to discuss global public health policy and research. This year’s theme is “Today’s Science – Tomorrow’s Agenda,” but the hot topic in almost every session that I have attended so far has been the need for innovative and sustainable funding mechanisms for global health in this time of financial uncertainty. Incentive prizes were highlighted as a mechanism for encouraging investment in research and development (R&D) of neglected and orphan diseases. These results-based rewards (as opposed to recognition awards like the Nobel Prize) “pull” innovation by encouraging applicants to submit ideas. The models and types of prizes vary. Some may offer millions of dollars while others provide the winner with access to laboratory services for future research. The first incentive prize, sponsored by the British Parliament in 1714, resulted in breakthroughs in navigation with the winner getting a whopping £100,000. The prize model often attracts new ideas and people to a field and is results focused which is attractive in an environment where funders want to see “quick wins.” Product development partnerships (PDPs) have also been highlighted at the summit as a successful model for accelerating R&D. Regina Rabinovitch of the Bill & Melinda Gates Foundation attributed the PDP model with feeding the largest research pipeline for neglected disease tools, increasing collaboration across the public and private sectors, and promoting a better understanding of the complexity of the product development process. While the successes are promising, she warned that as the number of products moving through the pipeline grows, so do the costs. Each phase of clinical studies requires more volunteers, more data points, more demands on the research site, longer trials, and increased regulatory complexity. Given these challenges in a constrained financial environment, PDPs and other research networks must increase collaboration and share costs by doing things like site sharing and harmonized training. They also need to focus their research efforts by prioritizing the products in the pipeline and weighing their potential public health impact. Bernard Pécoul, Executive Director of the Drugs for Neglected Diseases initiative (DNDi), stressed that it is critical for public sector partners to set objectives and priorities to ensure that product development is driven by health needs. Representatives from pharmaceutical companies—Novartis and Sanofi in the sessions that I attended—acknowledged that there are inherent difficulties with trying to reconcile limited profit potential with great public health need. There are many differing views on how to address this challenge with no clear consensus. One suggestion that seemed to be well received was that pharmaceutical companies can offer untapped areas of expertise, specifically in regulatory science, manufacturing, distribution, and pharmacovigilance. These are critical components of the R&D process, and many academic and public sector research institutions would benefit from training and mentoring in these areas. Recognizing that there is no magic bullet and that no one organizational or funding model can address the R&D needs for all neglected diseases, it is clear that limited resources must be leveraged, communication and coordination among research institutions across sectors needs to be increased, funding sources must be diversified, and current levels of support need to be sustained in order to maintain the recent momentum in global health research.

Dr. Christopher J. Elias is president and CEO of PATH, an international nonprofit organization that creates sustainable, culturally relevant solutions, enabling communities worldwide to break longstanding cycles of poor health. A new mother experiencing excessive bleeding after childbirth can die within minutes if the bleeding isn’t stopped. For women in developing countries, time too often runs out before they can get help. Postpartum hemorrhage is the leading cause of maternal mortality—deaths that cause a ripple effect on the children, families, and communities left behind. What if a simple device costing less than $10 could save a new mother’s life? USAID is building on its decades-long partnership with PATH by investing in our effort to develop a cost-effective solution: a balloon tamponade that can stop postpartum bleeding within 5 to 15 minutes and can be used in peripheral health facilities. Chris Elias leads USAID Administrator Raj Shah and Amie Batson, deputy assistant administrator, global health at USAID on a tour of PATH's product development shop. Photo Credit: PATH With a new grant of approximately $100,000 from Development Innovation Ventures—USAID’s new venture capital–style fund—we will adapt this existing technology to make it affordable in developing countries. Our goal is to lower the price from as much as $312 per device to less than $10 by streamlining the design and manufacturing process. Since 1987, PATH and USAID have worked together under a separate collaboration, the HealthTech program, to advance high-impact, low-cost health tools and technology breakthroughs designed for use in low-income countries. USAID recently announced it will renew its investment in the program through the HealthTech V Cooperative Agreement, committing $3 million in the first year. This partnership will continue to leverage USAID’s investment to attract additional resources and expertise from the private sector, ensuring the sustainability needed to scale up lifesaving innovations. Our public-private partnership approach has led to innovative solutions for some of the world’s most pressing health concerns, including: The SoloShot™ syringe that automatically disables after a single use to prevent reuse and infection from contaminated needles. Since commercial introduction by our private-sector partner, BD, 6 billion vaccinations have been delivered using SoloShot™ syringes by public health programs in more than 40 countries. HIV dipstick technology that provides point-of-care diagnosis for patients and inexpensive data collection for field surveillance and epidemiological use. PATH transferred the technology to manufacturers in four developing countries, with total sales now exceeding 19 million tests. Development of a malaria immunochromatographic strip test for the most deadly malaria parasite, Plasmodium falciparum, allowing same-day results. This technology was transferred to private-sector partners, with more than 40 million tests sold to date. The vaccine vial monitor, a dime-sized sticker that adheres to a vaccine vial and changes color to warn health workers if a vaccine has been spoiled by heat exposure. It prevents workers from having to throw out vaccines if they aren’t sure whether they can be safely used. We estimate the monitors, manufactured by our private-sector partner, Temptime, will allow health workers to identify more than 230 million doses of damaged vaccine and to deliver 1.4 billion more doses in remote settings, saving more than 140,000 lives. In a time of fiscal constraints, investing in simple, practical, and affordable health technologies is money well spent in the effort to solve global health challenges. USAID’s commitment to bringing cost-efficient and effective innovations to scale will be an essential driver in ensuring health solutions developed by PATH and others reach those who need them most.