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  As 2014 gets into full swing, the GHTC is looking ahead to many exciting developments on both the global health research and development (R&D) and policy landscapes: A step in the right direction: Policymakers in Congress recently passed both a budget deal for fiscal year (FY) 2014 and FY 2015, as well as a final appropriations package for FY 2014. The package included mixed results for global health research, however the compromise may hallmark a step towards a more “normal” appropriations process for FY 2015. We’ll be watching to see if policymakers boost support for the accounts—like those at the National Institutes of Health—that were hammered by the shutdown and budget sequester. Progress towards new malaria tools: In late 2013, GHTC member Medicines for Malaria Ventures received expedited regulatory approval from the US Food and Drug Administration to move treatment candidate tafenoquine into Phase III trials. And, the most recent clinical trial results of the RTS,S malaria vaccine candidate, released last year by partners PATH Malaria Vaccine Initiative and GlaxoSmithKline (GSK), have spurred excitement that the vaccine may be WHO-approved by 2015. To start the process, GSK announced plans to submit a regulatory application through the European Medicines Agency later this year. 21st Century Global Health Technology Act: Now that Congress has finalized its FY 2014 budget and moved on to other priorities, at the top of our list is the 21st Century Global Health Technology Act. The legislation was introduced in April of 2013 in the House of Representatives by Reps. Albio Sires (D-NJ) and Mario Diaz-Balart (R-FL) and boosts global health R&D programming at the US Agency for International Development. Rumors are a companion Senate version is coming very soon, so stay tuned! Exciting new research is coming up in 2014. Photo: PATH/Evelyn Hockstein R&D takes the stage at WHO: The World Health Organization (WHO) has made some progress in implementing the health R&D resolution it passed in 2013—including reviewing proposals for demonstration projects aimed at promoting R&D for medical products. The World Health Assembly will have eight finalists to choose from at its meeting this May. Horizon 2020 begins: In late 2013, the European Union approved €80 billion in funding for Horizon 2020—the European Parliament’s framework for research and innovation. This represents an increase in funding compared with previous years, and includes an emphasis on public-private partnerships for research. It will be interesting to see how this program affects the global health R&D landscape. State of the Union: This time last year, we were anticipating the start of President Obama’s 2nd term, and what shifts in agency and congressional leadership would mean for US global health research programs. The 2012 and 2013 State of the Union addresses emphasized harnessing innovation to make progress in health, education, and other areas. We’ll be watching this Tuesday night to see how the President plans to build on progress made in the remainder of his term. A new era for the President’s Emergency Plan for AIDS Relief: In other Administration news, Dr. Deborah Birx was recently nominated to be the new US Global AIDS Coordinator. Dr. Birx currently heads the Global HIV and AIDS program at the Centers for Disease Control and Prevention (CDC), and previously ran the Military HIV Research Program (MHRP) at the Department of Defense. We’re excited to see a leader in global health research take the reins of one of the US government’s most important global health programs. Pending her confirmation, it will be intriguing to see where Dr. Birx takes the agency, and how research for new global health tools will play a role. All health is global: Speaking of the CDC, two of the five most pressing health priorities that CDC’s Director Dr. Tom Frieden identified in a recent interview involve big impacts in global health research: eradicating polio and combating disease that originates outside of the United States. Between new research advancements and policy progress, there is clearly a lot we’re excited about for 2014. What new developments in global health R&D are you looking forward to? Ashley Bennett is GHTC's policy officer.

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 International Vaccine Institute and the Institute for Translational Vaccinology have agree to collaborate on vaccine research and development and to promote capacity building in low- and middle-income countries. The partnership will focus on improving available technologies, as well as regulatory processes. The House and Senate Committees on Appropriations have released a fiscal year (FY) 2014 omnibus appropriations bill . Funding for global health programs at the US Agency for International Development saw some increases, while the National Institutes of Health remains woefully underfunded—even with an increase of $1 billion over last year’s post-sequestration levels. Results of an early-stage clinical trial show that stem cells taken from patients’ own bone marrow could be used to treat multidrug-resistant and extensively drug-resistant tuberculosis (TB). More tests will be required before this treatment option is validated as a possible alternative to current TB drugs. New research from Washington University in St. Louis School of Medicine has found that a form of malaria attacks red blood cells by “clamping down on cells with a pair of proteins.” This finding may aid scientists in the design of better vaccines and drugs against malaria.

UPDATE: since this post, the Senate also approved the spending package and President Obama has signed the final 2014 omnibus bill into law. In an increasingly rare show of bipartisanship, Congress has moved forward an appropriations agreement that should finally settle the issue of fiscal year (FY) 2014 funding levels. Yesterday, the House of Representatives approved the $1.1 trillion Omnibus spending bill, and the Senate is likely to pass the legislation later this week. In line with budget numbers previously agreed to, the bill includes an increase in discretionary spending of $45 billion, split equally between defense and non-defense spending. For global health research, the news is mixed. Funding for many accounts that fund research for new global health tools—such as those at the US Agency for International Development (USAID)—was higher than FY 2013 sequestered levels, and a few accounts even saw further increases. However, the National Institutes of Health (NIH) remains woefully underfunded, even as Congress increased its budget by $1 billion over last year’s post-sequestration levels. Below are a few key highlights from the omnibus agreement: State and Foreign Operations (SFOPS)—Although overall International Affairs funding saw a cut of $6.5 billion (39.7 percent) from last year’s levels, funding for global health actually increased by 4.7 percent over FY 2013 levels to $8.44 billion. Certain subaccounts that contain global health research programs within the SFOPs budget fared particularly well, including funding for the Maternal and Child Health account ($705 million) which saw a 12.4 percent increase from 2013 levels. Additionally, appropriators went above and beyond the President’s request for tuberculosis (TB) funding, allocating $236 million for bilateral TB programs, $45 million over the President’s request and an increase of 5.1 percent from 2013 enacted levels. In another positive move, the USAID Neglected Tropical Diseases program is funded at $100 million—potentially opening the door for the inclusion of research and development (R&D) programming. The bill also provides for $4.067 in funding for the President’s Emergency Plan for AIDS Relief program—which includes key product development programs for malaria, HIV and AIDS, and TB—an overall increase of 3.9 percent. Funding for both family planning and malaria remained similar to last year’s levels. Policy language that accompanied the omnibus also contained support for the continuation of important global health research programming. NIH—The omnibus sets overall 2014 funding for the NIH at $29.934 billion—a $1 billion increase from 2013 post-sequester levels. While this is certainly an improvement from the current situation, this number falls short of White House and Senate requests and represents a $950 million cut from 2012 levels. In more reassuring news, the NIH National Center for Advancing Translational Science (NCATS) was funded at a fairly robust $633 million, however report language included in the omnibus text requested that all funding for the Clinical and Translational Science Awards come out of NCATS funding in FY 2014, whereas in the past funding has been drawn from several centers. Other important centers such as the National Institute of Allergy and Infectious Diseases and the National Institute of Child Health were funded at $4.359 billion and $1.283 billion, respectively—both decreases from FY 2012 levels and the FY 2014 budget request. Centers for Disease Control and Prevention (CDC)—Overall funding for the CDCis set at $6.9 billion, a $567 million increase from 2013 post-sequestration levels. Within the CDC, the National Center for Emerging and Zoonotic Infectious Diseases was funded at $287.3 million, $93 million below the President’s request. CDC’s Global Health account, which includes funding for HIV and AIDS was funding at $383 million, slightly below the President’s request, but a $24 million increase from 2013 post-sequestration levels. In an intriguing move, language included in the CDC section calls for increase coordination of research programming between CDC, the US Food and Drug Administration (FDA), and NIH. You can read the full report here. FDA—Out of the major US agencies involved in global health research, FDA fared the best in the omnibus. FDA is funded at a total of $2.552 billion in discretionary spending, an increase of $91 million from 2013 post-sequestration levels. Notably the omnibus allows FDA to get back $85 million in user fee money that was withheld as a result of the sequester. Department of Defense (DoD)—While we’re still poring through the DoD’s appropriation package, early analysis reports that medical R&D funding saw increases, even as DoD’s overall budget was decreased. This may be a positive sign; as AAAS reports, research programs here may help lessen the impact of dire cuts at NIH. While Congress should be applauded for protecting many of the programs that fund global health research in the omnibus package, the recent downward trend in NIH funding is troubling. NIH is the world’s leading research institution, and has funded the groundbreaking work behind the majority of global health tools available today. The role of NIH in the global health product development cannot be replaced or replicated elsewhere; if support continues to decline, urgently needed innovations will not reach those who need them. Congress and the Administration must continue to push global health progress forward by supporting robust funding for all US agencies that fund global health R&D during the FY 2015 budget and appropriations process. Additional analyses: Kaiser Family Foundation AAAS InterAction budget table

The US Agency for International Development (USAID) is the nation’s lead foreign assistance agency. Throughout its 50-year history, USAID has worked with other government agencies, the private sector, and nongovernmental organizations to support the development and introduction of affordable health products appropriate for addressing the diseases and health issues in developing countries. The GHTC has launched a new blog series to highlight the impact of USAID’s commitment to global health research and development (R&D). The series will showcase stories from individuals who have benefited from the agency’s support and investment in R&D—as well as people whose lives would vastly improve if USAID were to expand its support for health R&D into new areas. Our fourth and final post in the series is by Dr. Cynthia Gama, a principal investigator with MatCH and works with the International Partnership for Microbicides (IPM) in South Africa. Based on her experiences, Cynthia writes about the need for USAID to support R&D for microbicides to protect women from HIV. Q: As a microbicide researcher working in South Africa, you witness every day the impact of HIV on women. Can you tell us about the effect of HIV on women in your community? A: It is very difficult to not see the face of HIV and AIDS every single day when working in communities such as ours. The KwaZulu Natal province in South Africa has a high incidence of HIV and while we all know that women bear the brunt of the epidemic, the resulting impact can been seen not only in the women but also in the young children who have lost their parents; the old grandmothers who care for orphans; the daughters who often drop out of school to help them; and the impact that HIV has had on all aspects of people’s lives. What gives me hope is knowing that we are working toward a product—a microbicide for women— that may help to reverse this trend in our community and give women and their families a better future. Dr. Cynthia Gama of MatCH. Photo: IPM Q: Why are microbicides and other women-controlled prevention methods so important in the fight against HIV? Are currently available prevention methods, like male condoms, realistic options for women in your community and other parts of the world? A: We know that condoms work—both male and female condoms—and we know that South Africa has one of the largest and best-established public-sector male and female condom programs worldwide. Women in our community receive HIV prevention and contraception advice from various sources. While women may have access to these prevention products, the challenge is that women may not always have the ability to negotiate their use with their partners. This could explain the disproportionately high numbers of our women being infected with HIV. As a researcher, I know that women desire more options to protect themselves, hence my commitment to making sure that collectively we can deliver more options to our communities. Our research center and community is involved in The Ring Study, which is evaluating a unique product, a long-acting microbicide ring. Women who participate are shown how to insert the ring themselves, which is designed to stay in place for a month at a time and release an antiretroviral drug to prevent HIV. Q: How has USAID support helped advance your research and the microbicide field as a whole? A: The support that our study sponsor, IPM, receives from donors such as USAID ensures that new products for women are developed, and that we can do the much needed work and research that would one day turn the hope of a microbicide product into reality. Without funding, none of what has been achieved thus far could have been possible. Q: What other benefits of clinical research for microbicide development—such as capacity building and infrastructure development—has USAID support had in your community? A: HIV prevention research has most certainly strengthened the scientific and medical research sector overall. Expertise in conducting large clinical trials is now available and well-developed, and has offered more employment opportunities. USAID support has helped to bring communities closer to science, and helped communities appreciate the need for clinical research and understand its benefits. Q: When a safe and effective microbicide becomes available, what impact are you hoping to see for women in your community and around the world? What role will USAID have played in this effort? A: On that day of jubilation we would know that our sisters, daughters, and granddaughters have much to look forward to. I hope that once a product shows efficacy, that our policy makers will ensure that it is made available as soon as possible. Organizations such as USAID and others together are making it possible for this dream to become reality.