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Update: On Thursday, January 3, 2019, the President signed this legislation into law. WASHINGTON, DC—The Global Health Technologies Coalition (GHTC) applauds yesterday’s Senate passage of the Global Health Innovation Act, a bipartisan bill to support efforts by the US Agency for International Development (USAID) to develop affordable, appropriate technologies to advance the health of people in the world’s poorest places. The bill, which has already passed the House of Representatives, now heads to the President’s desk where he is expected to sign it into law.“Investments in research and development are critical to tackling the world’s greatest global health challenges and building a safer, healthier world for all,” said Emily Conron, US Policy and Advocacy Officer at GHTC. “Passage of this bill is a strong endorsement of the importance of continued US leadership in global health research and will help USAID continue to build upon and maximize the impact of its activities in this space.”This legislation, long championed by GHTC, will enhance transparency and oversight to provide a clearer picture of USAID’s strategic engagement in health research and development (R&D) as part of the agency’s broader mission to empower partner nations with the tools needed to solve their health and development challenges. Specifically, the bill directs USAID to report annually to Congress on its health R&D activities, progress, and impact and articulate how the agency is working in coordination with other US agencies, donors, and through public-private partnership to maximize the effectiveness and efficiency of programs.For decades, USAID has supported the development and scale up of low-cost, high-impact technologies to address the health needs of vulnerable populations worldwide. The agency has helped advance 22 new lifesaving global health technologies approved since 2000 and is supporting 36 promising products now in late-stage development.The Global Health Innovation Act was introduced by Representatives Albio Sires (D-NJ) and Mario Diaz-Balart (R-FL). It passed the House of Representatives in January 2018 before progressing without amendment to the Senate.“GHTC would like to thank Representatives Sires and Diaz-Balart and the many other members who supported this legislation and who have continued to make global health research a bipartisan priority,” said Conron.

Two thousand eighteen was a turbulent year in global health. Between reemerging crises, breakthrough scientific discoveries, and the continued looming threat of health research funding cuts, 2018 took us on a roller coaster ride of peril and promise. Now as the year comes to an end, GHTC is taking a moment to reflect on the global health innovation stories and news that shaped 2018.Here are the highlights from our year in review:1. A long-neglected disease sees a breakthroughA patient suffering from sleeping sickness visits a hospital in DRC. PATH/Georgina GoodwinIn 2018, a revolutionary treatment emerged for a neglected tropical disease, sleeping sickness. The first all-oral drug for sleeping sickness, developed by the Drugs for Neglected Diseases initiative (DNDi) and Sanofi, received a positive scientific opinion from the European Medicines Agency—paving the way for the treatment to be rolled out in endemic countries in 2019. This groundbreaking treatment, known as fexinidazole, is a tablet taken once daily for ten days that treats the most common form of sleeping sickness, a disease spread by tsetse flies, which causes neuropsychiatric symptoms and can be deadly if left untreated. Current treatments for sleeping sickness require a complicated series of infusions and pills, are costly, and involve long hospital stays. Fexinidazole is a simple once-a-day pill that could reduce the logistical burdens to treating a disease for which approximately 65 million people in sub-Saharan Africa are at risk. 2. TB captures the spotlight as new research demonstrates promiseThe world’s largest infectious disease killer finally received some well-deserved attention this year as world leaders convened the first-ever United Nations High-Level Meeting on Tuberculosis, at which member states committed to closing the US$1.3 billion annual gap in funding for tuberculosis (TB) research. While time will tell whether this moment will prove a powerful catalyst or an empty promise, the science continues to advance as we wait for the politics to play catch up. This year we saw several exciting new developments in TB research. Aeras and GlaxoSmithKline released the results of a phase 2b clinical trial that showed their candidate vaccine prevented TB from developing in half of those who received it. If it succeeds in additional testing, this vaccine would represent an improvement over the existing vaccine in use and would be the first new TB vaccine developed in over a century. On the treatment side, TB Alliance and partners launched the SimpliciTB trial, to test a new all-oral drug regimen for treating both drug-sensitive and drug-resistant TB, known as BPaMZ, which could slash treatment times for TB by one-third or more and is projected to be markedly less expensive than current therapy. Additionally, TB Alliance was honored this year by GHTC with an Innovating for Impact Partnership Award for the development of child-friendly TB medicines, which are now available in 86 countries and counting.3. A single dose cure for malaria is approvedA patient in Zambia receives a malaria diagnostic test. PATH/Gena Morgan This year, the global health community witnessed regulatory approval of the first new treatment for Plasmodium vivax malaria in 60 years by the US Food and Drug Administration (FDA). The new drug, tafenoquine, is a single-dose treatment developed by GlaxoSmithKline and Medicines for Malaria Venture. P. vivax malaria causes around 8.5 million infections every year in Asia, Latin America, and parts of Africa. It’s tricky to combat because the P. vivax parasite can lie dormant in the liver, where it reactivates, and can cause new episodes of malaria weeks, months, or even years after the initial infection. In a study of the treatment, 60 percent saw no relapse six months after taking the drug. Tafenoquine has been submitted for approval to the Australian regulatory authority and is slated to be submitted for approval in malaria-endemic countries. Experts hope this new treatment will accelerate the path to elimination of this mosquito-borne disease.4. Innovations show promise while the battle against Ebola rages onOne of the most disheartening stories of 2018 was the reemergence of Ebola in the Democratic Republic of Congo (DRC). Ongoing conflict in the region has hampered response efforts, with the outbreak now reaching 500 confirmed cases. Yet, amidst this crisis, there is one reason for optimism: An experimental vaccine appears to be helping those it reaches. Close to 45,000 people have received the experimental rVSV-ZEBOV Ebola vaccine—the largest use of the product since a clinical trial in 2015 showed it worked. While the vaccine’s effectiveness during this outbreak has not been formally assessed, World Health Organization (WHO) officials believe it is having a major impact. The vaccine’s developer, Merck, announced last month that it has begun the process of submitting evidence to seek FDA approval, a crucial step to bring the vaccine to market. Meanwhile, new preliminary research also suggests experimental treatments deployed during the outbreak are improving survival rates, and researchers have begun clinical trials in eastern DRC to test the effectiveness of four of these experimental drugs. This research raises new hope that science may soon offer us both a vaccine and treatments to combat Ebola.5. Congress pushes back against cuts to global health and medical researchWhile the Trump Administration proposed in its fiscal year (FY) 2018 and 2019 budgets to slash funding for global health and medical research programs, in the end Congress pushed back. In March, Congress passed the FY18 omnibus, which protected, and in many cases increased, funding to key US agencies and programs that advance global health research and development (R&D). In September, Congress passed an FY19 spending bill covering the Defense, Labor, Health and Human Services (LHHS), and Education departments. The bill boosted funding for medical research across the Department of Health and Human Services, with the National Institutes of Health receiving a $2 billion increase and the US Centers for Disease Control and Prevention and the Biomedical Advanced Research and Development Authority also receiving modest increases.These funding bills represent a forceful rebuke by Congress of the Administration’s proposals to draw back support for global health and medical research programs and demonstrate that Congressional policymakers on both sides of the aisle want to see the US continue its leadership in advancing innovation to improve the health of those in need around the world. Given that funding for the US Agency for International Development (USAID) was maintained through a continuing resolution that expires on December 21, we now await further action by Congress to determine how FY19 funding for global health accounts at USAID will shake out.6. New vaccines give us a better shot at saving livesA healthworker in Laos prepares a vaccine. PATH/Aaron Joel Santos Two thousand eighteen was a year of innovations in vaccines. In what could be the first new polio vaccine in more than 50 years, researchers have developed a way to freeze-dry an inactivated poliovirus vaccine (IPV) so that it can be stored at higher temperatures and reconstituted for use without losing its potency—potentially offering a new tool to help eradicate the disease. In other vaccine news, Johnson & Johnson (J&J) unveiled promising early-stage results for a tetravalent mosaic-based HIV preventative vaccine regimen. Currently in large-scale clinical trials in sub-Saharan Africa, the vaccine marks only the fifth time in history an HIV vaccine candidate has advanced to human clinical trials, offering new hope for a breakthrough in HIV prevention. Additionally, WHO prequalified new vaccines to combat typhoid and rotavirus, which is the most common cause of severe diarrheal disease in children worldwide. In January, WHO approved a new, highly effective and low-cost typhoid vaccine for global use. In the same month, it prequalified Rotavac, an oral rotavirus vaccine, and later in the year, approved Rotasiil, a first-of-its-kind thermostable vaccine to prevent rotavirus.7. Innovators strive to put greater choice in the hands of patientsOne of the exciting themes we saw across so many global health stories this year was the power of innovation to put greater choice in the hands of patients. People have unique needs, and our toolbox of global health technologies must reflect that. Several scientific developments this year promise to expand family planning choices for women and their families. The first-of-its-kind, self-insertable and removable one-year contraceptive vaginal ring received regulatory approval from the FDA; new research from Uganda showed a self-injectable form of contraception can help women overcome barriers to consistent use; and the first clinical trial was launched for a male contraceptive gel, a technology that could bring more equality to the burden of family planning. In addition, researchers are also advancing long-acting injectable forms of medicines to provide an alternative for individuals who struggle to take frequent pills. For example, HIV-positive patients may soon be able to choose whether they want to use long-acting injectable antiretroviral treatments or daily pills as a form of Pre-Exposure Prophylaxis, and scientists are also working on injectable formulations of medicines for malaria prevention. 8. Scientists pursue wild and weird ways to fight deadly diseases A dog in India. PATH/Gabe BienczyckiWinston Churchill once said, “No idea is so outlandish that it should not be considered.” That’s clearly a motto researchers have taken to heart, as evidenced by the number of stories we read this year about unusual and creative ways scientists are trying to fight infectious diseases. Here’s a sample of some of our favorites. One could say it’s a bacteria-eat-bacteria world out there, with researchers studying whether germ-eating microbes could be used to combat drug-resistant infections. Man’s best friend may also be man’s diagnostic tool, according to new research showing that dogs can be trained to detect malaria in people. In the future, administering a vaccine could be as easy and pain-free as putting on a Band-Aid if microneedle patches in development come to fruition. The contents of your takeout dinner might be the next frontier in HIV prevention, as scientists have developed a technique to modify a strain of rice to produce HIV-neutralizing proteins. While these ideas may seem fantastical, history has taught us that groundbreaking discoveries can come from unusual places. For other fascinating global health news delivered to your inbox weekly and to stay abreast of developments in 2019 and beyond, sign-up now to receive GHTC’s R&D News Roundup newsletter.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email. For the first time, scientists have mapped how the world’s deadliest malaria parasite, plasmodium falciparum, is able to enter and infect human blood cells—a key advancement in the quest for a vaccine against a parasite that kills more than 500,000 people each year. An international team of scientists, led by researchers at the Walter and Eliza Hall Institute in Australia, used the world’s most advanced cryo-electron microscope, the Titan Krios, to create a three-dimensional image of the parasite’s “key” to infection—a complex of three parasite proteins which work together to unlock and enter a human cell. This mapping provides scientists with a clear picture of how infection takes place, with lead researcher Professor Alan Cowman noting, "We now have the information required to design a vaccine that gives the immune system precise instructions about how to stop the malaria parasite." According to a report released by the Treatment Action Group, global spending on tuberculosis (TB) research hit an all-time high in 2017—reaching US$772 million, up from $726 million in 2016. Despite this upward trend, according to the TB research community, total TB research funding for 2017 still falls short of the $2 billion per year needed to end the disease by 2030—a target that is one of the United Nations’ Sustainable Development Goals and part of the World Health Organization’s Global Plan to End TB. The report also notes that most of the $46 million increase in TB research funding from 2016 to 2017 was driven by funding from the public sector, with the US government as the largest investor with a contribution of $312 million. An earlier version of this report was released in September to inform the first-ever United Nations High Level Meeting on TB, where member states committed to closing the $1.3 billion annual gap in funding TB research. Using multiple state-of-the-art microscopes, researchers at the University of Missouri were able to see how the chikungunya virus moves within a mosquito’s body—contributing to new understanding that could help one day lead to the prevention of mosquito-borne diseases. According to one researcher, it was previously common understanding that “…when a mosquito has picked up a virus, it first needs some time to build up inside the midgut, or stomach, before infecting other tissues in the mosquito." However, this study proved there is a narrow window of 32–48 hours between the time when a mosquito picks up a virus to when the virus leaves the mosquito’s stomach to infect someone it has bitten. One day, researchers aim to inhibit the genes involved with the release of the virus from within the mosquito’s stomach to prevent transmission of mosquito-borne diseases.