“We cannot solve what we need to solve with existing interventions—we need science and technology,” said Gary Cohen, executive vice president at Becton, Dickinson and Company (BD), at an official side event at the 6th Session of the Opening Working Group on Sustainable Development Goals this week in New York City. The event—co-sponsored by GHTC, the International AIDS Vaccine Initiative (IAVI), and COHRED—aimed to ensure that a strong commitment to research and innovation for health is included in the post-2015 development framework. As the United Nations (UN) and Member States continue progress toward meeting the Millennium Development Goals, the goals’ 2015 expiration date is right around the corner, and the global community needs to come to consensus on what’s next. Earlier this year, a UN High Level Panel of Eminent Persons released a report outlining recommendations for the post-2015 development agenda, including twelve potential goal areas. The goal areas are a promising start, and a new GHTC position paper calls on the governments of the world to ensure that innovation is embedded as a key component of the post-2015 agenda. Ensuring that innovation is included in the post-2015 development agenda is necessary to maximize health impact for those most in need—namely populations in low- and middle-income countries. Products that are affordable, available, and accessible can contribute to more equitable health outcomes, ultimately ensuring that people are able to live healthy lives and reach their full potential. During the event this week, PATH President and CEO Steve Davis discussed the need for innovative ways to break the cycle of poor health and how PATH—a nonprofit product developer—is making a difference with some of its technologies. It is crucial that the patient is always the top priority in development of new tools. Davis noted that, “Innovation that doesn’t address the most vulnerable populations is not innovation.” From left to right: Steve Davis, PATH; Gary Cohen, BD; Kaitlin Christenson, GHTC; Margie McGlynn, IAVI; and Koki Muli, Kenyan Mission to the UN In order to fully address the need for new global health technologies, the post-2015 development framework must consider creating an enabling environment for health and development. Because of the lack of a commercial market for many products that address the health needs of low- and middle-income countries, for-profit pharmaceutical and biotechnology companies are sometime hesitant to take on the development of new tools on their own. Nonprofit product developers, including product development partnerships (PDPs), are able to address this gap by bringing together the public, philanthropic, and private sectors. Margie McGlynn, president and CEO of IAVI, noted at the event that partnerships like PDPs “are critical for delivering innovation and improving health in developing countries.” To achieve sustainable development, an increased number of good and decent jobs are essential. Science, technology, and innovation are key drivers in economic growth, the creation of new jobs—and ultimately—poverty reduction. Part of this economic growth comes from the private sector’s involvement in global health product development. Cohen of BD mentioned the many areas the private sector can contribute to the development of new technologies and economic growth, including: technology innovation, clinical testing, product development, manufacturing, regulatory processes, and global distribution. As the Open Working Group on Sustainable Development Goals and others continue to discuss what will be included in the post-2015 development agenda, the GHTC has four key recommendations for UN Member States that ensure the that the critical role of global health R&D is acknowledged. Specifically: Official development assistance, as well as domestic investments by low-and middle-income countries must prioritize support for the development of new global health technologies. All stakeholders involved in the development of new health tools must be accountable for ensuring timely and equitable access to new and effective technologies. Donors and national governments must prioritize scientific capacity building and strengthening local health innovation systems when investing in development programs. Donors and national governments must invest in building systems that promote and sustain innovation capacity in low- and middle-income countries to promote a truly enabling environment for achieving sustainable development goals. This includes investing in global R&D partnerships, improving health and regulatory systems, and creating national science, technology, and innovation policies. We’ve seen countless examples of how new technologies can make a difference in the health of vulnerable populations. “New technologies have contributed to saving millions of lives and billions of dollars,” Kaitlin Christenson, coalition director of the GHTC, said at the event. It now time to make sure that science, technology, and innovation have a clear place in what the final post-2015 development agenda looks like.

In the past, the United States has contributed to important breakthroughs in global health—from the eradication of smallpox to a 74 percent drop in measles deaths worldwide. Because of longstanding US leadership and support for global health research and development (R&D), Americans and millions around the world no longer live in fear of diseases like polio and measles, and many more are on treatment for diseases like HIV and AIDS and malaria. In fact, the US government is the largest supporter of global health R&D in the world, supporting the development and delivery of vaccines, drugs, diagnostics, microbicides, and devices. However, as we sit at a very important moment in global health product development, the political and economic environment in the United States is causing some to worry. Budget constraints have put funding at risk at many of the federal agencies involvement in global health R&D. Because of longstanding US leadership and support for global health research and development (R&D), Americans and millions around the world no longer live in fear of diseases like polio and measles, and many more are on treatment for diseases like HIV and AIDS and malaria. Photo: PATH/Evelyn Hockstein Today, the GHTC launches a new fact sheet outlining the important contributions the US government has made to global health R&D and why it’s critical the United States continues to robustly support the global health research pipeline. There are currently more global health products in the pipeline than ever before—with more than 365 new tools under development as of April 2012. Contributing to the success of many of these products is the US government’s partnerships with nonprofit product developers. These organizations partner with the public and private sectors to maximize resources and create tools for patients in low- and middle-income countries. Increased investments in global health research by the United States have the potential to increase the amount of tools combating global diseases. Just some of the products currently in the research pipeline include: The RTS,S malaria vaccine candidate, which is currently being tested and a policy recommendation for its use could be issued as early as 2015. Such a vaccine could reduce the burden of sickness and death from malaria. A new oral drug for sleeping sickness, fexinidazole, which recently entered late-stage clinical trials in patients in the Democratic Republic of the Congo. As a simple, short-course oral pill, fexinidazole could transform care for African sleeping sickness, which is fatal without treatment, and could potentially reduce its incidence among the most afflicted populations and accelerate elimination of the disease. Cost-effective diagnostics that are under development for malaria, tuberculosis, and neglected tropical diseases. These diagnostics could be administered in a variety of health care settings and could rapidly and accurately identify sick patients. An antiretroviral‐based microbicide which offers hope for women’s HIV prevention. Though more testing is needed following promising results from a 2010 advanced clinical trial, a microbicide could give women the power to protect themselves with or without their partners’ cooperation. In sub-Saharan Africa, where the epidemic has hit hardest, women 15 to 24 years old are at least twice as likely to be infected with HIV as young men.   In the research pipeline for global health products, 200 of the 365 products under development have some sort of US government support. With so much investment from the United States, there is even more at risk if funding is cut. Over the past several years, the US Congress has not been able to agree on a long-term budget for the federal government. Policymakers have allowed sequestration, or widespread automatic budget cuts, to affect all federal programs. These constraints have the potential to push back or halt promising research supported by several federal agencies involved in global health R&D—including the Centers for Disease Control and Prevention, the Department of Defense (DoD), the US Food and Drug Administration, the National Institutes of Health (NIH), and the US Agency for International Development (USAID). Due to sequestration: DoD is expected to receive budget cuts between 8 and 10 percent in fiscal year (FY) 2013. The DoD has been instrumental in the development of several global health technologies, many of which are used to protect Americans soldiers serving abroad. These cuts could affect the Walter Reed Army Institute of Research, the Naval Medical Research Center, and the Military HIV Research Program. NIH, the largest funder of global health R&D in the world, was forced to cut $1.7 billion from its budget by the end of FY 2013. NIH conducts nearly half the early-stage global health research, and supports thousands of domestic jobs all around the United States. USAID—with a presence in more than 100 countries—is best suited to support the clinical trials in low- and middle-income countries that ensure basic research is translated into appropriate health products. USAID is the largest supporter of HIV vaccine and microbicide development—both of which will be essential to achieve an AIDS-free generation. For many of the products currently in the global health research pipeline, continuous US support is essential. Without it, much of the breakthrough research that pushed these products to later-stage development will be lost—sometimes forever. US leaders should seize upon the recent successes in global health R&D and pass a long-term budget that ensures America’s legacy as a leader in innovation and science is not forgotten.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. At the annual Grand Challenges meeting in Brazil this month, the Bill & Melinda Gates Foundation announced a new partnership with pharmaceutical companies to accelerate vaccine research and development (R&D). For the first project, the Gates Foundation will partner with GlaxoSmithKline on early-stage research for vaccine thermostability. According to studies published in Nature, a potential new HIV treatment has a "profound and unprecedented" impact on the virus. The trials were performed by Harvard Medical School and the National Institute of Allergy and Infectious Diseases. GHTC member Treatment Action Group released a new report on tuberculosis (TB) research funding. The report finds that after seven years of slow and unsteady increases in funding, TB R&D investors reported a drop in spending in 2012 that threatens to undermine the tenuous gains made since 2005. The Centers of Disease Control and Prevention released a report stating that the number of malaria cases in the United States is at the highest level in forty years. Nearly all the cases were Americans or foreign travelers bringing it into the country. About two-thirds were infected in Africa, where malaria is common. A new analysis published in The Lancet Global Health found that only 37—or four percent—of the 850 drugs and vaccines registered from 2000 to 2011 were for neglected diseases. The study also found that just 1 percent of existing clinical trials are for the development of tools for neglected diseases.

  “You’re in a position to make such a difference and to be innovative with your thinking,” Margaret McCluskey, senior technical advisor at the US Agency for International Development (USAID), said to an audience of Congressional staffers at a briefing yesterday on Capitol Hill. The briefing, co-hosted by GHTC and PATH, focused on the critical role USAID plays in supporting lifesaving global health research and development (R&D) for new health tools. Panelists also stressed the need for policymakers in Congress and across the US government to support the development of new and innovative health products. All of the panelists at yesterday’s briefing called on the US government to continue its strong investment in global health research. Rep. Albio Sires (D-NJ)—lead co-sponsor of the 21st Century Global Health Technology Act, a bill that would strengthen health R&D and product development at USAID—spoke at the briefing and reiterated this important message. “New vaccines, drugs, and tests are desperately needed, but progress cannot be sustained without R&D,” he said, adding that the United States has a legacy of supporting global health R&D and that health R&D is a smart economic investment. Rep. Sires: “New vaccines, drugs, and tests are desperately needed, but progress cannot be sustained without R&D." Photo credit: Aeras/Liz Roll Much progress in global health R&D has been made over the years, and USAID has unquestionably supported many of today’s success stories—including new tools for malaria, HIV and AIDS, child health, family planning, and reproductive health. Several panelists stressed that product development for global health tools doesn’t happen overnight, and that USAID’s sustained commitment to research has been a crucial element of these health R&D success stories. Dr. Zeda Rosenberg, CEO of the International Partnership for Microbicides, stressed that R&D can take many years, and thanked USAID for its support for mircobicide research—as well as for providing dedicated resources and long-term investments in global health product development.   Panelists also emphasized that despite this progress, there is still a need for sustained investment in R&D today to ensure that there are appropriate tools for diseases of poverty tomorrow. Rosenberg warned that complacency with today’s current tools is the wrong mindset, saying, “As soon as you think you’ve got [a health issue] under control, you’ve lost.” Kari Stoever, vice president of external affairs at Aeras, noted that investing now in tuberculosis (TB) vaccine research will save billions of dollars in future spending for TB treatment programs in low- and middle-income countries, which currently costs $8-10 billion per year. She added, “Without an effective vaccine, many lives are at risk.” USAID does not currently fund TB vaccine R&D. Additionally, USAID’s partnerships with the private and nongovernmental sectors have been key to its success in developing effective public health tools. One particularly effective partnership is USAID’s support for nonprofit product developers (NPPDs). These organizations combine the resources of governments, the experience of the private sector, and the know-how of nonprofit groups. PATH is one such NPPD that, with USAID support, partnered with Becton, Dickenson and Company (BD) to develop the SoloShot™ syringe and Uniject™ system. Both devices are designed specifically for use in low- and middle-income countries. “Though BD is a for-profit company, we share a common goal of providing access to important devices where they are needed most,” said Renuka Gadde, vice president of Global Health at BD. She added at none of these successes would have happened without government agencies like USAID looking at complex global health problems and spurring various sectors to become involved through programs like the Saving Lives at Birth Grand Challenge. Dr. Zeda Rosenberg, CEO of the International Partnership for Microbicides, stressed that R&D can take many years, and thanked USAID for its continuous support. Photo credit: Aeras/Liz Roll While USAID is a key player in global health R&D, coordination between the other US agencies involved in this work—such as the Centers for Disease Control and Prevention, the Department of Defense, the US Food and Drug Administration, and the National Institutes of Health (NIH)—is crucial. The 21st Century Global Health Technology Act requests that USAID work to align its health-related research strategy with similar strategies at other agencies, with the goal of creating a whole-of government approach to global health R&D. Greater coordination among US agencies can held lead to more efficient health R&D—for example, Rosenberg noted at the briefing that both USAID and NIH are supporting the organization’s microbicide clinical trials. We are at a critical juncture in much of the global health R&D currently underway, and USAID will be instrumental in ensuring these technologies come to fruition. As McCluskey said at the end of the briefing, “Don’t be business as usual with infectious diseases.” Dr. Joanne Carter—executive director of RESULTS/RESULTS Educational Fund and moderator of the briefing—summed it up nicely: “Investments in R&D are what’s needed to take us to the next level in global health.”

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The National Institutes of Health has released a fact sheet on the impact of sequestration. The fact sheet states that, due to budget cuts, approximately 700 fewer research project grants will be awarded this year compared to fiscal year 2012. New statistics show that the vaccine MenAfriVac™—developed through a partnership between the World Health Organization and PATH—has significantly reduced the number of cases of meningitis A in Africa. The most recent meningitis season marks the lowest number of cases in ten years. Scientists at Virginia Tech and the University of Florida are making progress in developing a new species-specific insecticide that would be lethal only to insects that carry malaria. Though they have seen positive results, the scientists still think it will be four to five years before they are ready to submit the compound for federal approval. Drugmakers in Japan have agreed to release data on experimental compounds for possible use to create drugs to combat malaria, tuberculosis, and neglected tropical diseases. The pharmaceutical companies are part of a five-year partnership called the Global Health Innovative Technology Fund.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Marking the 10th anniversary of the President’s Emergency Plan for AIDS Relief (PEPFAR), US Global AIDS Coordinator Ambassador Eric Goosby, and National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci, write about how scientific innovation has played an important role in the successes of PEPFAR over the last decade. New resources from the Kaiser Family Foundation analyze the President’s fiscal year 2014 budget request and the funding implications for global health and HIV and AIDS. Member States at the 66th World Health Assembly approved the Consultative Expert Working Group on Research and Development (R&D): Financing and Coordination resolution that would establish a global health R&D observatory, set up demonstration projects, and develop norms and standards to better collect data on health R&D. GHTC member Aeras has launched a short film series called EXPOSED bringing attention to the global tuberculosis epidemic and the need for new tools to prevent this airborne disease’s spread.