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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.

Emily Halnon is the Communications Associate at GHTC. Below is her reaction to a photo reception documenting programs in Kenya that GHTC hosted last week. As someone new to the field of global health, I am constantly gaining an appreciation for just how much progress has been made in very recent years, how fragile that progress is, and how critical it is to sustain support for the research efforts that will build upon this momentum. I’ve quickly learned that rhetoric does not exist in this field; when my colleagues, our incredible member organizations, or other leaders in global health stress that the world is on the brink of incredible breakthroughs that will save millions of lives around the world, it is because it is true. The photo reception hosted by the Global Health Technologies Coalition (GHTC) last week offered a visual reaffirmation of this fact, while the experiences of the speakers confirmed how impactful the last few years of research have been and how critical current research efforts are to lives across the globe. The photos were all taken during GHTC’s recent trip to Kenya to observe and document research projects supported by member organizations like the International Partnership for Microbicides (IPM), the International AIDS Vaccine Initiative (IAVI), Aeras, PATH, and the Drugs for Neglected Diseases initiative (DNDi) and US government agencies like the US Agency for International Development (USAID), the Department of Defense (DoD), and the Centers for Disease Control and Prevention (CDC). Speakers at the event included Dr. Ariel Pablos-Méndez, assistant administrator for USAID's Global Health Bureau, Dr. Robert Breiman, country director for CDC-Kenya, and Dr. Kayla Laserson, director of the Kenya Medical Research Institute/CDC Field Research Station. Speakers at the event included Dr. Ariel Pablos-Méndez, assistant administrator for USAID’s Global Health Bureau, Dr. Robert Breiman, country director for CDC-Kenya, and Dr. Kayla Laserson, director of the Kenya Medical Research Institute/CDC Field Research Station The display of photos at the event was physically split into two stories. Event attendees entered the room and saw the first story laid out in a semi-circle, showing the families and communities who have benefited from a longstanding US commitment to research and recent successes−polio vaccines that have reduced rates of the disease by more than 99 percent, technologies to detect emerging epidemics, and antiretrovirals that are giving new hope to people battling HIV. The second story lay on the other half of the room, forming another semi-circle, and focused on the ongoing research that has the potential to produce more lifesaving tools−a tuberculosis vaccine, progress toward an AIDS vaccine, and critical drugs to treat neglected tropical diseases. The reception centered around two stories. One showed how lifesaving tools are making a difference in communities across Kenya. The second showed how current research is on the cusp of developing some of the most exciting new tools in global public health in recent years. Dr. Laserson spoke about the significance of this physical layout, highlighting the impact of the “moving circle” of research breakthroughs. As someone, unlike me, who has been immersed in global health for years, Dr. Laserson has seen firsthand what a difference the tools shown through the first story have made in communities in both Kenya and around the world. As she pointed to the first half of the room, she talked about how it was within very recent memory that tools represented in the photos there, like insecticide-treated bednets to protect people from malaria, were in the research pipeline, with vital trials being conducted to test their efficacy. Now, bednets are standard across the world, protecting millions of children from the disease. Tools like insecticide-treated bednets to protect people from malaria, were in the research pipeline within recent memory. Now, bednets are standard across the world, protecting millions of children from the disease. Photo: Evelyn Hockstein/PATH The two other speakers, Dr. Pablos-Méndez and Dr. Breiman, reinforced the significance of recent years and the investments that have helped make tools that were once unimaginable a reality. Dr. Breiman reflected on the CDC’s partnership with the Kenyan government and how vital capacity building has been to fueling these research efforts. Dr. Pablos-Méndez discussed how important it is that USAID continue to prioritize the science and technology that is enabling the world to tackle long-standing health and development challenges. These efforts include USAID’s support for the work of GHTC members IAVI and the TB Alliance. Through listening to both speakers, it was clear they believe it is critical to continue supporting cutting edge efforts, inter-agency cooperation, and investments in science and technology that will continue to save the lives of people like those shown so captivatingly through the photos. As Dr. Laserson transitioned from lauding the success of current tools to treat malaria, she gestured around the circle to the other half of the room and stressed how incredible it is that we are now looking at a malaria vaccine to prevent the disease. The same is true for a number of health tools and diseases, she said. Thanks to the President’s Emergency Plan for AIDS Relief (PEPFAR) and the investments of the US Government, HIV treatment is now the norm. And the world is on the cusp of breakthroughs for new prevention and treatment options, such as using HIV treatment as prevention among discordant couples, a method that research has shown can reduce the risk of HIV transmission by 96 percent. If donors like the US government can sustain their commitment to research on HIV and AIDS and other global health diseases, then we can bring these lifesaving tools to the half of the room, where they will be introduced into communities and can become game changers that will save lives and bring the world one step closer to eliminating these diseases.