Breakthroughs Blog: USAID

In this guest post, Claire Wingfield—product development policy officer at PATH—writes about a new paper that examines partnerships between the public and private sectors to advance global health innovation, research, and development. For more than 30 years, PATH has been working to advance innovative global health solutions. Partnering is a core part of PATH’s strategy and is fundamental to how we develop and deliver high-impact, cost-effective technologies. Our partners come from international health agencies, governments, universities, other nongovernmental organizations (NGOs), and private-sector companies. Each partnership is unique, but no matter who the partner is, the collaboration must be mutually beneficial and fulfill our mission to improve the health of people around the world. Public-private partnerships provide a forum for maximizing complementary areas of expertise. They improve knowledge of the most pressing global health needs and lead to solutions that improve health equity. By strengthening the capacity of different sectors, these partnerships accelerate the development and introduction of the most promising technologies for those most in need. Finally, forging new cross-sector partnerships with public institutions and commercial entities enable organizations like PATH to maximize the limited global health resources of both sectors—financial, technical, and structural—to reduce costs and avoid redundancy in our efforts to ensure the affordability of much-needed global health technologies. For instance, in many low-income countries, where budget resources are stretched thin, health systems may not be able to ensure the safety of health tools and products. This leads to situations where the very injections meant to prevent or treat disease can end up causing it instead because under-resourced, overburdened health care programs reuse or fail to properly sterilize contaminated injection equipment. Recognizing the tremendous negative impact that unsafe injection practices can cause, PATH researched how to improve injection practices to reduce the risk of transmitting bloodborne diseases such as HIV and hepatitis B in low-resource settings. The US government, through the US Agency for International Development, provided funding to PATH, enabling us to develop and patent a design for an auto disable (AD) syringe that automatically locks after a single injection. A partnership between PATH, the US government, and Becton, Dickinson and Company led to the development of SoloShot™, the world’s first commercially available auto-disable syringe. Credit: PATH/Eric Becker While PATH had the scientific and technical know-how to design the technology, a commercial partner was needed to validate the design, support large-scale production, and enable widespread distribution. PATH licensed the technology to Becton, Dickinson and Company (BD), the world’s largest syringe manufacturer. BD brought product development expertise to advance the technology beyond proof of concept, manufacturing capabilities to produce a global supply, and distribution channels to ensure the availability of the technology in the public and private sectors. The US government’s investment in the product’s development—harnessed many times over by BD’s own investment in the device—enabled PATH and BD to pursue an aggressive distribution program that led to SoloShot™, the world’s first commercially available AD syringe. A major boost to the introduction and use of AD syringes occurred when the United Nations Children’s Fund and the GAVI Alliance began purchasing and distributing AD syringes for their programs. The US government also accelerated the adoption of the technology by aggregating demandthrough the US President’s Emergency Plan for AIDS Relief (PEPFAR) program. Because injection safety was one of PEPFAR’s top priorities, the US government procured more than 250 million AD syringes for 11 countries through the Making Medical Injections Safer project over its five-year life. Since 1992, more than six billion vaccinations have been delivered using SoloShot™ in more than 40 countries. Studies have shown that transmission of bloodborne diseases caused by dirty needles has been reduced by 90 percent in programs using some form of AD syringe. Creating partnerships that harness the assets of the private sector and the public sector together is a powerful means to ensure impact, scale, and sustainability for the world’s most vulnerable populations. The partnerships help align the strengths and requirements of each sector to ensure that appropriate technologies and innovations reach communities and individuals with the greatest need.

Earlier this week, the GHTC and other global health and international development advocates called on the House Appropriations State and Foreign Operations subcommittee to fully fund key programs in the foreign affairs budget. Advocates presented testimony regarding the fiscal year (FY) 2014 budget for State and Foreign Operations, which includes funding for the US Agency for International Development (USAID) and many other global health and research programs. Subcommittee Chair Rep. Kay Granger (R-TX) and Ranking Member Rep. Nita Lowey (D-NY) ran the proceedings, and Reps. Barbara Lee (D-CA) and Henry Cuellar (D-TX) also attended. Granger and Lowey kicked off the hearing with statements in support of continued US leadership in global health and foreign aid programs. Lowey stated that she is “proud of the progress that US government funding has made against diseases like tuberculosis, malaria and HIV and AIDS.” Global health research and development (R&D) efforts funded by agencies like USAID play an inextricable role in this progress, through innovations such as new HIV drugs, tuberculosis (TB) diagnostics, and advanced insecticides to bolster the use of mosquito nets to prevent malaria. Rep. Kay Granger (R-TX) (right) and Rep. Nita Lowey (D-NY) (left) ran the hearing, which focused on the FY 2014 budget for USAID. Photo credit: PATH. The GHTC and many of its members were invited to testify at the hearing, and spoke about the value of global health research in terms of saving lives, improving health outcomes, furthering American innovation, and increasing cost-savings in public health over the long term. According to the GHTC’s written testimony, every day “more than 35,000 people die from AIDS, TB, malaria, and other neglected diseases around the world. … These issues highlight the urgent need for sustained investment in global health research to deliver new tools to combat these devastating diseases.” Fortunately, previous “US investment in global health R&D has generated great success in treating devastating diseases and improving the lives of millions through new technologies.” And there are “several very promising technology candidates in the R&D pipeline; however, these tools will never be available if the support needed to continue R&D is not supported and sustained.” Other GHTC members stressed the importance of sustained support from USAID and other US agencies for global health research initiatives. For example: Jennifer Katz, policy director for the North America office of the Drugs for Neglected Diseases initiative (DNDi), highlighted the need for USAID to expand its neglected tropical disease (NTD) program to include research and product development through the story of William, a boy stricken with sleeping sickness in Uganda a few years ago. William was treated with the only medicine available at the time—an arsenic-based drug called melarsoprol. Michael died not from sleeping sickness but from the side effects of the toxic medication. Katz then explained that if William were treated today, he would receive a non-toxic and effective drug developed by DNDi. Katz stressed that support from USAID to develop new and improved NTD treatments would mean that more lives could be saved worldwide. International AIDS Vaccine Initiative (IAVI) CEO Margaret McGlynn described how even a 70 percent efficacious HIV vaccine distributed to 40 percent of the population in low- and middle-income countries would avert 8.9 million new infectious over 10 years. This impact would be a groundbreaking step forward in public health. USAID is a leading funder of IAVI’s efforts to develop a safe and effective HIV and AIDS vaccine, and McGlynn emphasized that Congress should continue to support USAID’s HIV vaccine research programs so this research can continue. Sabin Global Network for Neglected Tropical Diseases Managing Director Dr. Neeraj Mistry described the success that USAID’s NTD control program has had in delivering more than 587 million treatments and training hundreds of thousands of community health workers. Mistry also noted that USAID should increase its support for NTD research and product development efforts. Indeed, USAID can repeat its success in delivering existing treatments by also funding NTD research and product development, as new and improved drugs and other tools are desperately needed. PATH’s Senior Director of Policy and Advocacy Rachel Wilson described how a New Jersey company, in partnership with PATH and USAID, developed and produced a vaccine vial monitor that is now used to ensure the quality of every vaccine that UNICEF and other global agencies deliver worldwide. This is just one example of the economic benefit global health research holds for the United States. For example, 64 cents of every dollar invested in global health R&D goes directly to US researchers, many of which conduct research with domestic universities and academic centers—thereby providing jobs and jumpstarting new economic activity. Other global health community members such as the Non-Communicable Disease Roundtable, Bread for the World, and the GAVI Alliance also testified in support of global health and development programs. Witnesses at the hearing strongly demonstrated that even in this extremely challenging fiscal climate, when difficult decisions must be made in the face of budget cuts, is it essential that Congress prioritize effective programs that save lives at home and abroad. Global health research and product development programs at USAID save millions of lives, spur economic activity in the United States, and save money in the long run. These programs must be protected, and the US leadership in this area must not falter. To achieve this goal, Congress must ensure that global health research programs at USAID and across the government are robustly funded in FY 2014.

“I can’t think of a reason why academic scientists should not engage in global health research,” Dr. Dennis Kyle, distinguished university health professor at the University of South Florida, said last week at the Consortium of Universities for Global Health (CUGH) annual conference. Kyle was speaking at a panel hosted by the GHTC, which focused on current fiscal and policy realities in the United States that will impact global health research and development (R&D) in the coming year and beyond. Kyle and other panelists stressed the importance of partnerships across a range of sectors to advance global health R&D and develop promising new global health tools. “Academic partners can be incredibly successful in product development,” Kyle said, adding that the university scientists are “great sources of innovation.” Dr. Dennis Schmatz—board chair and president of Medicines for Malaria Venture (MMV) North America—echoed that product development partnerships like MMV rely on collaborations with universities and other sectors, such as governments, pharmaceutical companies, and philanthropic donors. “Product development partnerships are a powerful model that brings together academia, the pharmaceutical industry, and many other sectors to focus on a single mission: developing lifesaving new health products,” he said. As an example of how successful such partnerships can be, Schmatz cited that to date, MMV has helped register or prequalify four new malaria medicines, with seven promising new treatments currently in development. The panel also focused on how sequestration and budget cuts could impact their work in global health R&D. “We know that the academic community has so much to offer,” Dr. Ticora Jones, Higher Education Solutions Network (HESN) manager at the US Agency for International Development (USAID) said. She added that USAID is “moving forward, building partnerships in spite of sequestration. USAID wholeheartedly supports harnessing science and technology to solve development challenges.” Jones cited HESN—which aims to create hubs for innovation at US colleges and universities—as an example of how USAID will continue to build partnerships for global health and other development issues. She also stressed that USAID frequently collaborates with other US federal agencies, such as the National Institutes of Health and NASA, on international development challenges. Karen Goraleski, executive director of the American Society for Tropical Medicine and Hygiene, emphasized that sequestration and other budget cuts have forever changed how global health researchers should advocate for continued support for their work. In addition to the humanitarian and lifesaving benefits of global health R&D, Goraleski stressed that researchers should discuss the domestic benefits of US government support, such as job creation and diplomacy. “Research is a good bet, and will always be a good bet, for creating jobs at home and forging diplomatic ties abroad,” she said, adding, “Researchers and scientists often develop long-lasting and hugely beneficial relationships with universities and communities overseas.” Kyle also argued that global health research creates economic benefits for US universities and state academic institutions. For instance, the Kyle Lab at the University of South Florida provides jobs for 90 people at the university. “Those are real dollars and real jobs,” he said. Kyle added that US support for global health research helps train the next generation of health scientists. If US support for global health R&D is severely cut due to sequestration, “we’d lose the next generation of scientists. We can’t just train these people and then have it turn into a situation where there’s no avenue for them to continue their work,” he said. Finally, all panelists highlighted that investments in global health research and product development are needed over the long-term, given the timeframe needed to create successful new products. “Innovation takes time,” Schmatz said, adding, “We need to keep vigilant, as new threats like drug resistance always create the need for new and better products. You can’t stop or you’ll lose all the ground you’ve gained.”

In this guest post, E. Callie Raulfs-Wang –research advisor for the US Agency for International Development’s (USAID) Center for Accelerating Innovation and Impact—writes about the relationship between research and evidence when developing and delivering new global health products. This post is the second in a series highlighting USAID’s new strategy for global health research and development (R&D). It originally appeared on the IMPACT blog. Like strands of human DNA, the genetic underpinnings of life, research and evidence are so closely intertwined they cannot be separated. Whether testing the efficacy of an HIV vaccine or the marketing strategy of a new contraceptive technology, quality research, careful methodology, and rigorous analysis are fundamental for acquiring evidence useful in decision-making. As outlined in USAID’s Report to Congress: Health-Related Research and Development Strategy, the agency supports a range of research activities, including both ‘upstream’ product research and ‘downstream’ implementation research. Along this continuum, USAID places a strong emphasis on evidence for informing development policies, practice, and strategy. As global health products are developed, we need evidence to demonstrate their effectiveness in developing country settings.For example, despite the fact that effective treatments exist for pneumonia, over 1.2 million children die each year from the disease. In the last few years, USAID has supported studies in Pakistan investigating the effectiveness of community-based treatment of severe pneumonia. Results from these studies have shown that oral antibiotics administered at home are as effective as injectable antibiotics administered in a hospital setting. This evidence prompted a 2012 revision of World Health Organization guidelines on outpatient management of severe pneumonia. Beyond effectiveness studies, like the one conducted in Pakistan, we need studies that focus on the implementation and adoption of public health interventions, also known as implementation science. USAID’s 2012 Global Health Strategic Framework: Better Health for Development iterates a commitment to implementation research and the “scale-up of evidence-based, equitable, inclusive, and locally adapted health solutions.” To increase understanding of the ‘what’ and ‘how’ of implementation research, USAID in partnership with Johns Hopkins University and The George Washington University, has launched an open-access peer-reviewed journal called Global Health: Science & Practice. To accelerate product development and the introduction of new technologies, USAID has initiated the Center for Accelerating Innovation and Impact (CII), which engages key experts to identify state-of-the-art ‘best practices’ around product marketing, introduction, and scale. To expand knowledge of interventions that have “high impact,” the Bureau for Global Health has developed several High-Impact Practices (HIPs) in family planning; maternal, newborn, and child health; nutrition; and health systems strengthening. For example High-Impact Practices in family planning are best practices that, when scaled up and institutionalized, will maximize investments in a comprehensive family planning strategy. Since 2011, USAID and partners have hosted three evidence summits addressing critical challenges in global health. Not an ordinary conference, an evidence summit is an organized process that convenes leading scholars and health practitioners to review the latest research and provide evidence-based guidance for improved health performance, an understanding of knowledge gaps, and research agenda recommendations. These summits have addressed: Protecting Children Outside of Family Care, Enhancing Provision and Use of Maternal Health Services through Financial Incentives, and Enhancing Community Health Worker Performance. A fourth evidence summit on Behavior Change Communication for Child Survival will be held later this year. The local adaptation of health solutions is where the rubber meets the road. Each developing country is characterized by its own unique population, culture, health challenges, and infrastructure. To enable the development of local solutions to local problems, USAID is supporting the Partnerships for Enhanced Engagement in Research (PEER) Health program. PEER Health is a capacity-building program which provides research grants to developing country investigators in partnership with National Institutes of Health researchers focused on addressing local health challenges. Asking the right question, at the right time, in the right way, is not easy. As global health moves into the 21st century, more complex health challenges, including non-communicable diseases, the integration of health services, and the strengthening of health systems, present themselves. Solid evidence based on rigorous research is an indispensable ingredient for the successful introduction and scale of health products and services. As the 2012 health research report to Congress attests, USAID remains committed to pursuing an evidence-based agenda in global health.