Emily Halnon

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The Department of Health and Human Services releases its first-ever global health strategy, which includes a focus on catalyzing medical research worldwide. Science journal named an HIV prevention trial the breakthrough of 2011. The National Institutes of Health begins restructuring in an effort to make way for the new National Center for Advancing Translational Sciences. Scientists created a vaccine used to protect monkeys from HIV infection that could help researchers develop a vaccine for humans. A hepatitis C vaccine clinical trial shows promising results.

Emily Halnon is the Communications Associate at GHTC. Below is her reaction to Sustaining progress: Creating US policies to spur global health innovation, the third annual briefing hosted by GHTC. After attending GHTC’s annual briefing yesterday, it is nearly impossible, and arguably fully impossible, to come up with any reason as to why the US should not invest in global health research and development (R&D). The four panelists at the event, representing a range of US agencies and global health organizations, were full of countless examples that show what a remarkable difference US leadership in global health R&D has made around the world. The most obvious impact that this leadership has had is through saving millions of lives around the world through the development of health tools like drugs, vaccines, and diagnostics. As Kemy Monahan, the deputy executive director of the Global Health Initiative and one of the panelists, said: US investments in global health R&D have saved “not just a few lives, [but] lots of lives.” Kevin De Cock, the director of the Center for Global Health at the US Centers for Disease Control and Prevention, stressed that due to the “indivisibility of domestic and foreign health,”investing in global health R&D is not just benefiting communities in remote regions overseas. It also improves the health of Americans and protects people all around the world from infectious diseases. Col. Peter Weina, deputy commander of Walter Reed Army Institute of Research (WRAIR), reinforced the importance of global health R&D in our borderless society by listing numerous ways that WRAIR’s R&D successes—from producing the first influenza vaccine to starting work on almost every antimalarial in existence—have helped protect US troops from infectious diseases like malaria and leishmaniasis, and in turn, every community they reach across the globe. A theme that resonated through the message that every panelist delivered was the importance of US agency collaboration. Kemy Monahan emphasized the success that has come from the GHI encouraging US agencies to work together to maximize results. And Marc LaForce, the Director of the Meningitis Vaccine Project, talked about how MenAfriVac, a meningitis vaccine that is already saving countless lives in Africa, was made possible through the collaboration of several US agencies, including CDC, the National Institutes of Health, the US Agency for International Development, and the Food and Drug Adminstration. Marc also stressed the critical need for US funding to see this work to the finish line: “with sufficient funding, this epidemic is likely to be pretty much over in the next 10 years.” The speakers and Karen Goraleski, Executive Director of the American Society of Tropical Medicine and Hygiene and moderator at the briefing, also stressed the numerous domestic benefits of global health R&D in addition to the millions of lives saved across the globe. These benefits include increased national security, economic growth, and job creation. Goraleski emphasized that healthy populations produce stable economies, and countries with stable economies have stable governments, leading to a more secure global community. While there is no denying that this is a time of severe budget austerity, there was consensus in the room yesterday that investing in global health innovations is cost-effective and a smart decision for US policymakers. "These are difficult problems buy they are very, very solvable," said Senator Boozman at the GHTC annual briefing When US Senator John Boozman (R-AR) addressed the audience, he emphasized how far we’ve come, and how critical coordination between US agencies has been. “We’ve made tremendous progress. Working together, we can be proud of our progress.” As US policymakers consider whether to invest in global health R&D, they need to consider the countless achievements that yesterday’s speakers highlighted, and the fact that without a US commitment to the R&D needed to produce these lifesaving tools and technologies, many of these would not be possible. Col. Weina closed his remarks by stressing that the US cannot “rest on the laurels” of the past accomplishments made to address global health threats. A continued investment in global health R&D is critical to ensure that we continue to produce the game-changing innovations that are saving lives, fueling our economy, and providing good jobs across America.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Two GHTC members announced they are making critical gains in the development of new tools to treat and prevent tuberculosis. Several groups announced their commitment and financial support to control or eliminate 10 neglected tropical diseases, including support for research and development. After studies demonstrate how effective medical male circumcision is as a tool for HIV prevention, public health experts are working to make the process safer, more efficient, and more cost effective. Bill Gates has penned an op-ed for the New York Times urging continued investments in foreign aid funding, which is critical for global health and development efforts.

In this regular feature onBreakthroughs, we’ll highlight some of the most interesting reads in global health research from the past week. Secretary of State Hillary Clinton highlighted the importance of research and product development in the fight against AIDS. She declared that creating an AIDS-free generation is a policy priority for the United States. A new report from GHTC member the Treatment Action Group (TAG) shows funding for TB research and development is falling, but GHTC member the TB Alliance and several organizations are collaborating to accelerate development of drugs to fight the disease. The top innovators in medical research spent three days exploring the partnerships and alliances that could help speed medical progress at the Partnering for Cures meeting. An editorial in The Minnesota Daily urges Congress to preserve foreign aid funding as it has helped save lives and improve the quality of life for people around the world. Two GHTC members, the Drugs for Neglected Diseases initiative and One World Health, are among the organizations forming a partnership to launch a project that will fight visceral leishmaniasis. The Obama Administration is expanding the Global Health Initiative to include another 21 countries, bringing the total amount of focus countries to 29.

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.