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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.

In countries like Kenya, some of the most incredible global health research is taking place to develop new drugs, vaccines, diagnostics and other health products. In addition, previous research has lead to the roll-out of lifesaving health tools such as HIV and AIDS drugs, vaccines to protect children from pneumonia, and insecticide-treated bednets to prevent malaria. Last week, the GHTC hosted a photo reception that represented the people, both Kenyan and American, who are making new lifesaving health tools a reality, as well as the families benefitting from ongoing research and past research successes. 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. Lifesaving tools are making a difference A historical commitment to research from the US government has led to the development of innovative health tools that are saving lives around the world. People worldwide have benefited from the development of critical medicines like antiretrovirals to treat HIV and AIDS and drugs to treat childhood killers like diarrhea, vaccines to protect infants from pneumonia and polio, and insecticide-treated bednets to prevent malaria. In Kenya, many individuals and families credit these valuable health tools with saving their lives and ensuring their children can have healthy and long futures. Researchers at agencies like the Centers for Disease Control and Prevention, the Department of Defense, and the US Agency for International Development are making a difference on the ground in Kenya by leading the development and delivery of drugs, vaccines, diagnostics, and other health products. With sustained support from the United States, countries like Kenya will continue to see the impact of these lifesaving health tools that are helping people abroad and right here at home. Kisumu, Kenya: Calvin Lang'at, a nurse at Vihiga District Hospital, gives an infant an oral polio vaccine. Immunization campaigns have reduced polio rates by more than 99 percent worldwide, and the disease is now near eradication. Photo credit: PATH/Evelyn Hockstein Kibera, Kenya: The Centers for Disease Control and Prevention use technologies to control the spread of infectious disease and to act as a warning system for the emergence of possible epidemics. Handheld PDAs—like the one health worker Joseph Thomas is using above—help officials conduct disease surveillance among 28,500 residents in Kibera. Disease surveillance can also help drive research for new health products, by alerting officials to large disease burdens and the need for new prevention and treatment options. Photo credit: PATH/Evelyn Hockstein Kombewa, Kenya: Martha Omondi puts her daughter Mercy Gloria, who is three years old, under a mosquito net to take a nap. Insecticide-treated nets have prevented millions of children from contracting malaria in Africa. Photo credit: PATH/Evelyn Hockstein Siaya, Kenya: Faith Oduor holds her daughter Brittany’s hand while she receives treatment for malaria at the Siaya District Hospital in western Kenya. Malaria treatments, including pediatric artemisinin therapies such as Coartem, help to save the lives of children like Brittany across Africa. Photo credit: PATH/Evelyn Hockstein Elwesero, Kenya: Peter Lumumba, a father of six, was first diagnosed with HIV in 1987 and started antiretroviral treatment in 2006 through the Aids, Population, and Health Integrated Assistance (APHIA II) program. He said of his treatment, “I am now well. People are totally astonished … when we are telling people we are (HIV) positive, they will say, ‘No, you are lying.’ Without the research that led to this lifesaving medicine, I would have already died.” Photo credit: PATH/Evelyn Hockstein Elwesero, Kenya: Peter Lumumba, pictured above with his son, was first diagnosed with HIV in 1987 and started antiretroviral treatment in 2006. Peter is open with his family about the fact that he is HIV-positive and is taking antiretroviral drugs. In the year 2000, Kenya had just a handful of HIV-positive people taking antiretroviral drugs. Today, the country has a half-million people on these drugs, which have saved many from an early death. Photo credit: PATH/Evelyn Hockstein Vihiga, Kenya: Rister Kageha holds her daughter Sylvia Mboga, who is 14 months old, at the Vihiga District Hospital. Rister learned she was HIV-positive and was put on antiretrovirals one month before she gave birth to her daughter. Sylvia was given the antiretroviral nevirapine after birth and is HIV negative. Rister accessed drugs through the Aids, Population, and Health Integrated Assistance (APHIA II) program, which provides comprehensive health care and prevention services. APHIA II is supported by the US Agency for International Development and run by GHTC member PATH. Photo credit: PATH/Evelyn Hockstein On the cusp of new global health tools The world is on the cusp of some of the most exciting new global health tools in recent years, thanks in large part to groundbreaking research supported by the US government through agencies such as the Centers for Disease Control and Prevention, the Department of Defense, and the US Agency for International Development. Clinical trials are showing promising results for the first-ever malaria vaccine, as well as a host of new interventions to prevent HIV infections. Researchers are on the verge of developing new drugs to treat neglected diseases that affect the poorest of the poor. This incredible health research is producing breakthroughs that could save countless lives, and Kenya is among the countries at the forefront of these efforts. Several global health research projects in Kenya are on the verge of producing new lifesaving health tools, and the US government continues to be a key player in supporting these groundbreaking research efforts. In Kenya, researchers confirmed how critical continued support from the US will be in reaching the finish line to defeat malaria, tuberculosis, HIV and AIDS, pneumonia, and other neglected diseases. It is imperative that the United States continues to drive the momentum around these new tools, from discovery to delivery, so that this research can produce the results that will help communities across the globe. Siaya, Kenya: At the Kaminogeldo Primary School, two miles from Lake Victoria in western Kenya, a mother enrolls her child in a study that will provide new information about co-infection of malaria and schistosomiasis, which is a major problem in the area. Fishermen and children often contract schistosomiasis from snails that live in and around the lake. The study is being run by the Kenya Medical Research Institute/Centers for Disease Control and Prevention partnership. Photo credit: PATH/Evelyn Hockstein Nairobi, Kenya: Lucas Agura, a medical laboratory technologist who works with the Kenya Medical Research Institute on neglected tropical diseases, conducts research at the KEMRI headquarters laboratory. KEMRI works with GHTC member the Drugs for Neglected Diseases initiative on its efforts to create new treatments for visceral leishmaniasis, a painful and deadly disease that affects half a million people worldwide each year. Photo credit: PATH/Evelyn Hockstein Kisian, Kenya: Mosquito DNA samples are prepared for testing at the Kenya Medical Research Institute (KEMRI)/Centers for Disease Control and Prevention (CDC) Field Research Station. KEMRI and the CDC have been partnering together for more than 30 years in Kenya. Dr. Pauline Mwinzi, a principal research officer who works with KEMRI/CDC said, “Without the US funding…we wouldn’t be able to move the sophisticated research that we do now.” Photo credit: PATH/Evelyn Hockstein Siaya, Kenya: Mothers sign consent forms to enroll their children in a study to examine co-infection with malaria and schistosomiasis in the region, run by the Kenya Medical Research Institute/Centers for Disease Control and Prevention partnership. Local residents said they appreciated the study. "One in five children in this area do not survive to their fifth birthday," said Jack Oloo Otieno, the school board chair. "We don't really know the full extent of the problem of schistosomiasis. If all our kids have it—and that's what we suspect—it is doing such harm to them. So we want as much information as possible, and this study will help." Photo credit: PATH/Evelyn Hockstein Kisian, Kenya: Wilfred Murithi, assistant research officer at the Kenya Medical Research Institute/Centers for Disease Control and Prevention facility in Kisian, prepares a sample to detect tuberculosis (TB) resistance to ritampicin, a TB drug. Resistance to TB drugs has become a severe problem in parts of the world and is increasing. There are an estimated 440,000 cases of multi-drug resistant TB globally, and at least 58 countries have reported cases of extensively drug resistant TB, which can be incurable. New TB drugs are desperately needed. Photo credit: PATH/Evelyn Hockstein Rawa, Kenya: Sharon Akinyi Ouma holds her daughter Winfrey Juma, who is 16 months old, outside their rural home in western Kenya. Sharon said she was happy to join a tuberculosis vaccine trial run by GHTC member Aeras in collaboration with the Kenya Medical Research Institute/Centers for Disease Control and Prevention. “I think of so many babies, so many children in Africa and around the world, have been helped by vaccines,” she said. “If this vaccine works, that means all those children will be helped by my baby’s participation. That makes me feel very good.” Photo credit: PATH/Evelyn Hockstein Nairobi, Kenya: Robert Langat, a lab technologist at the Kenya AIDS Vaccine Initiative (KAVI) in Nairobi, checks on vaccine samples stored in deep freeze at the laboratory. The US Agency for International Development supports a partnership KAVI maintains with GHTC member the International AIDS Vaccine Initiative to identify prevention strategies and a response to HIV and AIDS. In 1999, the partnership helped discover broadly neutralizing HIV antibodies—a critical piece of progress developing an AIDS vaccine. Photo credit: PATH/Evelyn Hockstein Nairobi, Kenya: Irene Anne Wangari and Agatha Nyawira work with blood samples at the Kenya AIDS Vaccine Initiative (KAVI) lab in Nairobi. Through its partnership with the International AIDS Vaccine Initiative, KAVI has facilitated significant breakthroughs in the research and trained world-class scientists and technicians who will continue to build on the research progress in Kenya. Photo credit: PATH/Evelyn Hockstein