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Last week, HHS released its first-ever global health strategy at an event that convened leaders from several US agencies involved in global health, as well as representatives from non-governmental organizations. Releasing the strategy, which highlights many priorities for global health research and development (R&D), is an important move for HHS, as it encompasses agencies such as the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA), all of which play crucial parts in global health R&D. HHS Secretary Dr. Kathleen Sebelius, who spoke at the event, stated that “we can no longer separate global health from America’s health … our only chance to keep Americans safe is if our systems for preventing, detecting, and containing disease stretch across the globe too.” She also noted that “every day, Americans benefit from efforts in global health, whether they know it or not.” Sebelius emphasized that the HHS global health strategy should not be an extra, isolated add-on to other programs, but must be an extension of HHS domestic programs and its already-existing programs in global health, with the following goals: To focus on areas where HHS can engage globally in work that benefits and improves the health and well-being of Americans. This will include promoting research partnerships that help develop new treatments to support this goal. To provide leadership in areas where HHS has unique technical expertise, “starting with the world’s leading researchers at the NIH, its leading epidemiologists at the CDC, and its leading regulators at the FDA.” To work with other US agencies and the Administration to advance US interests in global health and support the President’s Global Health Initiative. Sebelius' opening remarks were followed by a panel discussion moderated by KFF Executive Vice President Diane Rowland. Panelists included Nils Daulaire, director of the Office of Global Affairs at HHS; Ariel Pablos-Méndez, assistant administrator for Global Health at the US Agency for International Development; Kerri-Ann Jones, assistant secretary of state for Oceans and International Environmental and Scientific Affairs; Helene Gayle, president and CEO of CARE USA; Harvey Fineberg, president of the Institute of Medicine; and Jen Kates, vice president and director of Global Health and HIV Policy at KFF. While Sebelius’ speech emphasized the role of the strategy in meeting the health needs of the American population and US diplomatic goals, the panel discussion did the reverse—it examined how US agencies could be more engaged in global health work, and where they are strategically a best fit. The panel had several insights for the use of the HHS strategy and the future of HHS engagement in global health work abroad, including partnerships with HHS agencies not traditionally known as global health leaders—such the Centers for Medicare and Medicaid Services, which could help to strengthen health system capacity around the world. The new strategy includes many major objectives that seek to spur global health R&D in order to develop new tools and interventions to help improve health and save lives around the world. These objectives include: Preventing infectious diseases and other health threats, including through measures such as vaccine development, boosting manufacturing capacity, and improving vector control. Increasing investments in regulatory science and partnerships worldwide. Strengthening multilateral efforts to promote science-based standards and guidelines for global health. Amplifying research and innovation to promote the development of new tools and approaches to help prevent, diagnose, and control disease. Overall, the strategy represents a great step forward in global health R&D at the HHS agencies, and a recognition of how essential their programs are, both to the US and populations around the world.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. GHTC member the Sabin Vaccine Institute has launched a new campaign, called END7. The campaign is dedicated to eliminating seven major neglected tropical diseases as a public health threat by the end of 2020. The US Food and Drug Administration (FDA) recently launched a new blog, called FDAVoice. The blog will feature posts from FDA staff on news, announcements, and other information about the work done at the agency. The US Department of Health and Human Services (HHS) has committed $1.8 million to health initiatives in Guatemala, as well as funding to support research that will look into the impact of revising the HHS regulations on human subject research. The National Institutes of Health’s newly created National Center for Advancing Translational Sciences has launched a new website. The US Patent and Trademark Office has published four proposed rulemaking implementation provisions for the America Invents Act.

Welcome to the first Research Roundup post. In this regular feature, we’ll highlight some of the most interesting reads in global health research from the past week. In this op-ed in the Huffington Post, Orin Levine, executive director of GHTC member organization the International Vaccine Access Center, draws a parallel between the development of the polio vaccine and the development of RTS,S—the most advanced malaria vaccine candidate that showed breakthrough results last week. Chris Collins, vice president and director of public policy at GHTC member amfAR, argues in this op-ed that the US cannot afford to cut funding from foreign aid because it’s saving the lives of millions of people around the world. The Food and Drug Administration (FDA) is launching two new Centers of Excellence in Regulatory Science and Innovation to promote the development of new medicines and medical devices. And the National Institutes of Health (NIH) is pushing for a new center to spur innovation and new technologies. World Intellectual Property Organization (WIPO) and the World Health Organization (WHO) launch a new database to accelerate research for neglected diseases. China and the Bill & Melinda Gates Foundation join forces to improve health innovations in developing countries. The partnership will support the manufacturing of new global health products, including vaccines and diagnostics.

2011 was a year full of exciting advances in global health research and development, complicated by a volatile budget climate. While many research breakthroughs occurred this year, including preliminary clinical findings for a malaria vaccine, the first evidence that HIV treatment is effective as prevention, and promising new drug candidates for several neglected tropical diseases (NTDs), it is important to recognize the strides made in the policies that fuel this critical life-saving progress. Below is our list of the top ten global health R&D policy breakthroughs of 2011: 1) Protection of global health funding: In a year of severe budgetary issues, where nearly all discretionary US government spending for Fiscal Year 2011 (FY 2011) saw drastic cuts, most global health accounts at the US Agency for International Development (USAID) were modestly increased – a victory compared to the devastating reductions other accounts have seen. USAID needs this critical funding to support vital health technology product R&D in developing countries and helps deliver lifesaving tools around the globe. 2) NIH expands global health research activities: Congress has approved and funded the new NIH National Center for Advancing Translational Science, which will promote research aimed at speeding the development of therapeutics and diagnostic tools for a wide range of diseases, including global diseases. Additionally, NIH’s National Institute for Allergy and Infectious Diseases announced that its six current HIV and AIDS clinical trials networks (CTNs) will begin to include research for infectious diseases other than HIV and AIDS. Researchers in tuberculosis, other HIV and AIDS co-infections, and other global health advocates have called for this change since the success of the CTNs became evident. For its first phase, the focus of the expansion will be on antibacterial resistance. 3) USAID Administrator Shah highlights innovation: In February, USAID Administrator Rajiv Shah gave a groundbreaking speech at the National Institutes of Health (NIH) emphasizing the importance of science, technology and innovation in development programs, particularly global health. Shah also announced the creation of a Center of Excellence on product development and field introduction. 4) Congressman Howard Berman releases foreign aid proposal that includes global health priorities: Congressman Howard Berman (D-CA) released a discussion draft version of the Global Partnerships Act of 2011, a bill which would reform and improve the US foreign assistance act. The proposal includes several initiatives that emphasize a need to support global health research and innovation. The GHTC has worked with Congressional staff and community members to support the progress of the legislation, including holding a briefing and releasing a fact sheet on the role of global health technologies in foreign assistance. 5) FDA rolls out guidance for industry on developing products to combat neglected tropical diseases: In August, the FDA released a guidance to industry with recommendations on the development and review of drugs to treat NTDs. The guidance reflects FDA’s mandate to review and license technologies for diseases not endemic to the United States, as well as its commitment to work with private industry in moving such products through the regulatory pipeline. GHTC has submitted comments to the guidance, applauding its overall principles and recommending improvements. 6) USAID announces Saving Lives at Birth awards: In 2011, the Saving Lives at Birth program awarded 19 seed grants and 3 transition grants to global health products currently in development that could help save the lives of mothers and infants worldwide. The program is a partnership between USAID, the Bill and Melinda Gates Foundation, the Government of Norway, Grand Challenges Canada and the World Bank. 7) FDA budget increases in constrained times: In both FY 2011 and FY 2012, the FDA received small funding increases of $96 million and $50 million, respectively. In the current budget climate where most programs are seeing large cuts, it is a very positive result. 8) America COMPETES Act is implemented: Early in 2011, President Obama signed the America COMPETES Act into law, which among many other things gives US agencies the power to use prize competitions to spur research and innovation into new technologies or programs that will benefit US efforts. In August, the Office of Management and Budget released a memo to each agency head outlining how prize mechanisms could be used, and requesting feedback and reports on implementation of the new law. The prize mechanisms, as showcased by USAID’s Saving Lives at Birth program, are engaging non-traditional innovators from around the world to develop new technologies to solve global health challenges. 9) FDA restructuring increases agency’s role in international regulatory issues: FDA Commissioner Margaret Hamburg announced structural and personnel changes at the agency that will have huge implications for global health, including the creation of directories focused on global issues, and a new directorate for Global Regulatory Operations and Policy. In July 2011, FDA also announced a new “entrepreneur-in-residence” position to improve relationships with the private product development sector. 10) Creating Hope Act of 2011 is introduced in Congress: In March, Senator Robert Casey (D-PA) introduced the Creating Hope Act of 2011, which makes improvements to the Priority Review Voucher program at the Food and Drug Administration (FDA). In September, Congressman Michael McCaul (R-TX) introduced a companion version of the bill in the House. The House version now has more than 90 cosponsors. The PRV program provides a voucher to companies submitting a technology for a neglected disease for use for a later drug submission, incentivizing R&D for new global health tools. The legislation would alter the list of applicable diseases by adding Chagas disease and also adding a category of rare diseases.