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“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 regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Congresswoman Barbara Lee (D-CA) has released the Ending the HIV and AIDS Epidemic Act of 2012, a bill that outlines a policy and financing framework to achieve an AIDS-free generation in the United States and globally. The bill was introduced in advance of the XIX International AIDS Conference next week. The Drugs for Neglected Diseases initiative, in collaboration with Indian drug manufacturer Cipla, has announced plans to develop and produce an improved first-line antiretroviral combination therapy specifically adapted to meet the treatment needs of infants and toddlers living with HIV and AIDS. A recent blog post on AIDS.gov by Col. Nelson Michael, director of the US Military HIV Research Program at the Walter Reed Army Institute of Research, discusses efforts to develop an HIV vaccine through an ongoing public-private partnership. The first-ever global scientific strategy to develop an HIV and AIDS cure was launched ahead of the XIX International AIDS Conference. The strategy identifies seven important priority areas for basic, translational, and clinical research. It also maps a path for future research collaboration and funding opportunities. The European Commission has announced plans to open access to scientific research results to foster increased innovation. The commission hopes that the new policy will allow broader and quicker access to scientific papers, as well as make it easier for researchers and businesses to build on the findings of publicly funded research.

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.

In this guest post, Molly Schmalzbach—public affairs analyst in the Office of HIV and AIDS at the US Agency for International Development (USAID)—discusses the agency’s support for research to develop new HIV and AIDS and tuberculosis (TB) products. This post is the first in a series highlighting USAID’s new strategy for global health research and development (R&D). It originally appeared on the IMPACT blog. Nearly all great scientific advances can be traced back to methodical R&D. R&D is a critical step in meeting goals and achieving health results that are cost-effective, sustainable, and grounded in evidence. In December 2012, USAID released its new strategy for global health R&D. The report outlines how the agency plans to address some of the world’s most challenging health and development issues through new technologies, research, and evaluation, as well as the scale-up of interventions backed by scientific evidence. HIV and AIDS is a large component of this effort, and the agency—through the US President’s Emergency Plan for AIDS Relief (PEPFAR)—is supporting very promising HIV research in several areas, including microbicides, vaccines, and diagnostic tools to detect TB in HIV-positive patients. Microbicides: Microbicides are substances that can be applied vaginally or rectally to reduce the risk of HIV transmission during sex. Vaginal microbicides are a particularly desirable innovation because women can use these products on their own to protect themselves from HIV infection. Given that women make up almost 60 percent of people living with HIV in sub-Saharan Africa and struggle to negotiate other HIV prevention methods—such as condoms—with their partners, USAID supports microbicide R&D as a key intervention in reaching an AIDS-free generation. Women can use this ARV-based vaginal gel to protect themselves against HIV. Photo credit: International Partnership for Microbicides. In 2010, the CAPRISA 004 clinical trial showed that a vaginal microbicide made up of 1 percent tenofovir gel (a topical form of the antiretroviral drug) protected women against HIV. Following this success, a new public-private joint venture, known as Propreven, is preparing to obtain regulatory approvals, create manufacturing capacity, and support product distribution of tenofovir gel in various African countries. Two additional studies are also underway—the FACTS 001 clinical trial, which is a follow-on to CAPRISA 004 and is currently in year two, and the CAPRISA 008, a study that is examining and addressing implementation issues for future microbicide programs. Both of these studies are supported by a US and South African partnership made up of USAID, the Bill & Melinda Gates Foundation, and the Government of South Africa. Vaccines: While microbicides are an important method in preventing HIV when tailored to specific populations, no single approach is likely to have as dramatic an impact on the HIV pandemic as an effective vaccine. That is why USAID has supported HIV vaccine R&D through the International AIDS Vaccine Initiative (IAVI) since 2001. IAVI is a public-private product development partnership that acts as a virtual pharmaceutical company to accelerate the development and clinical testing of HIV vaccine candidates. On the vaccine design front, IAVI and its partners in the Neutralizing Antibody Consortium (NAC) have designed four new immunogens—the active ingredients of vaccines that stimulate the immune system—and are testing these structures as part of potential HIV vaccines. Two clinical trials involving IAVI’s work are examining new HIV vaccine regimens. One trial nearing completion in East Africa is evaluating a vaccine regimen that uses a new technique called electroporation, and some exciting results are expected in the coming year. Electroporation applies a small charge to effectively distribute the contents of the vaccine in the muscle and enhance uptake of the DNA. Another trial poised to begin within the next few weeks will evaluate new viral vectors carrying HIV antigens. TB Diagnostics: Microbicides and vaccines are critical priorities for USAID’s HIV prevention efforts; however, we must also provide care and support to people already living with HIV. Since TB is the leading cause of death among HIV-positive people, USAID supports the coordination of TB and HIV services to better care for people living with each disease. In recent years the prevention, diagnosis, and treatment of TB has become more complicated because of two factors: HIV-associated TB and multidrug-resistant (MDR) TB. HIV-associated TB often goes undetected because the most common TB diagnostic, called sputum smear microscopy, is not very effective in people infected with HIV. The Cepheid Xpert is a rapid TB diagnostic and sensitive to HIV-associated TB. Photo credit: Cepheid. Fortunately, there is a promising new diagnostic for TB, including HIV-associated TB, on the horizon! This rapid and sensitive test, called the Cepheid Xpert MTB/RIF® assay, has the potential to revolutionize the diagnosis of TB. While Xpert still faces some operational and programmatic barriers, such as high costs and the need for a sustained power supply, USAID has already begun supporting the roll-out of this new tool by helping countries obtain Xpert machines, designing associated policy guidance and strategies, and developing technical approaches to guide implementation. R&D in these three key areas is what keeps USAID at the forefront in the fight against HIV and AIDS. As David Stanton, the director of the Office of HIV and AIDS at USAID said, “These clinical trials and new technologies have the potential to dramatically change the HIV and AIDS landscape and reverse the trajectory of the global HIV pandemic.” To learn more about USAID’s strategy for global health R&D in the coming years, be sure to check out our latest Report to Congress: Health-Related Research and Development Strategy 2011-2015.