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The Global Health Technologies Coalition (GHTC) has opened nominations for its 2019 Innovating for Impact Awards. Now in its third year, this initiative recognizes the research partnerships and political champions that help transform breakthrough scientific research into lifesaving drugs, diagnostics, vaccines, and other tools for devastating, unmet global health challenges.Awards will be presented in two categories:The PARTNERSHIP AWARD honors an innovative research and development (R&D) partnership that brings together multisector partners to advance a high-impact, game-changing global health technology. The partnership must have received federally funded research support or in-kind support from a US government agency.The CONGRESSIONAL CHAMPION AWARD honors two US Members of Congress whose actions have strengthened political will and advanced US efforts to develop technologies to fight the world’s most challenging diseases and health conditions.Nominations will be open until Wednesday, July 31, 2019. Awardees will be editorially selected by a committee of leaders from the global health and research communities. Honorees will be celebrated at a recognition dinner in Washington, DC in November before an audience of policymakers, US government officials, media, and leaders of the global health and medical research communities.Previous honorees for the Congressional Champion Award include Senator Roy Blunt (R-MO), Congresswoman Rosa DeLauro (D-CT), Senator Chris Coons (D-DE), and Congressman Tom Cole (R-OK). Past Partnership Award honorees include the respective partnerships that developed the dapivirine microbicide ring for HIV prevention and improved child-friendly tuberculosis medicines.

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. A clinical trial in four African nations found no substantial difference in HIV risk among women using three different methods of contraception—an injectable, progestin-only contraceptive, a nonhormonal intrauterine device, or IUD, and a progestin-based implant. However, the study—conducted by a consortium led by FHI 360—revealed high rates of HIV contracted among each group of women studied, prompting calls for deeper integration of HIV prevention and family planning services. The World Health Organization (WHO) will begin synthesizing and sharing findings from the Evidence for Contraceptive Options and HIV Outcomes, or ECHO trial, with WHO’s Guideline Development Group, which will convene at the end of July 2019. This group will consider the trial’s results, along with other research, to determine whether changes are needed to the global guidance on contraceptive use and issue recommendations at the end of August. A study performed by researchers at the University of Oxford, along with partners at five other institutions, has identified the human antibodies that prevent the malaria parasite from entering blood cells—potentially key to creating a highly effective malaria vaccine. The study was done as part of a clinical trial in Oxford of the first vaccine candidate that targets the RH5 malaria protein, a protein contained in the parasite which must bind to a human protein on red blood cells in order to infect them. This study demonstrated which human antibodies effectively block RH5 from binding, thus preventing the parasite from spreading through the blood. Another key finding of the study is the discovery of a new antibody which slows down the speed with which RH5 binds to red blood cells, giving antibodies that do block RH5 from binding more time to act. Researchers aim to use these findings to develop an improved RH5 vaccine that induces more of the effective antibodies. A new civil society group, the Drug Transparency Observatory, has formed in France to monitor the French government’s implementation of a resolution on the transparency of medicines markets adopted at the World Health Assembly last month. A statement released by the new group calls on the French government and all countries to not only implement the adopted resolution, but also the transparency measures included in the initial resolution draft, which go beyond just medicines pricing to include disclosure of research and development costs. The statement noted that the Drug Transparency Observatory will monitor “the advancement on the implementation of the transparency resolution in pricing, clinical trials, research and development, marketing and patenting.”

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. Independent experts of a US Food and Drug Administration (FDA) advisory panel voted in favor of TB Alliance’s treatment for multi-drug resistant and extensively drug-resistant tuberculosis (TB)— pretomanid—as part of a three-drug combination regimen with Johnson & Johnson’s bedaquiline and linezolid. Although the FDA is not bound to follow the advice of its advisory panel, it usually does. The FDA granted priority review for pretomanid and the marketing application is based on interim data from the first 45 patients in an ongoing study with a total of 109 participants. Current treatments for TB involve a cocktail of drugs and multiple injections, making adherence difficult for patients. Thus, “having a three-drug oral regimen will be a benefit,” said Philip LoBue, a panel member who voted in favor of the treatment. The FDA is expected to make a final decision on pretomanid’s approval by the third quarter of this year. A new affordable option for combating post-partum hemorrhage—the number one killer of women during childbirth—was announced last week at the Women Deliver conference. The new device, Ellavi, is a high-quality uterine balloon tamponade (UBT) designed for low-resources settings that can be manufactured for US$10, as opposed to a typical cost of $200-250 for a UBT in most industrialized countries. Ellavi, developed by PATH and its South African partner Sinapi Biomedical, has achieved CE marking in Europe, signifying it meets regulatory requirements—an important mark of confidence that eases a product’s path to market in many countries. Ellavi is expected to be on the shelf initially in Kenya and Ghana by 2020, with plans for further expansion. PATH also announced the Nigerian National Agency for Food and Drug Administration’s marketing approval of Caya®—an updated, one-size-fits most, easier to grip, silicone-based diaphragm developed by PATH. Caya® will be introduced in Nigeria within the next year by DKT International, the largest family planning products and services provider in the country. Oxford-based Enesi Pharma has developed a needle-free instrument, called ImplaVax, that can deliver vaccinations under the skin with practically no pain for the patient. Instead of being in liquid form, the vaccine is formed into a tiny, solid stick measuring 0.85mm in diameter and 3.5mm long, with a point at the end, which the ImplaVax device injects into the patient. In addition to being pain-free, this solid dose vaccination does not need to be kept cool—a particular benefit for countries with warmer climates and unreliable cold chains. With ImplaVax, there is also no risk of needle breakage and as a pre-measured solid dose, it is easy to administer, allowing the potential for lower-skilled health workers to administer rather than doctors or nurses. ImplaVax is still being tested in animals with the hope of beginning the first human studies next year.

An estimated 125 million pregnancies around the world are at risk from malaria annually.[1] For both mother and baby, the disease is potentially life-threatening and babies that do survive are often born with low birth weight, which is associated with negative impact on development.[2] These mothers-to-be need medicines to both protect them from getting infected with malaria and to treat them should they fall ill. Yet, these needs remain inadequately addressed.Medicines for Malaria Venture (MMV) is working with partners to improve the quality of global supplies of the World Health Organization (WHO)-recommended medicine sulphadoxine-pyrimethamine (SP) for use as intermittent preventive treatment in pregnancy (IPTp). As a partner in the Unitaid-funded Jhpiego-led consortium TIPTOP, MMV is supporting improved coverage of SP for IPTp in Africa through community health workers by strengthening the supply side for WHO-prequalified SP. For women who become infected with malaria during pregnancy, WHO currently recommends artemisinin combination therapies (ACTs) for the treatment of malaria in the second or third trimesters, and quinine with the antibiotic clindamycin in the first trimester. Angela Kangulumais is a primary school teacher in Zambia. She is 6 months pregnant with her second child.  Angela is no stranger to malaria—she fell ill just before her first pregnancy and was treated with an ACT. Pregnant women at risk of malaria like Angela benefit from IPTp to protect themselves and their unborn babies from malaria. Photo: Medicines for Malaria VentureBased on meta-analyses comparing treatment outcomes using the ACT artemether-lumefantrine (AL) versus quinine in first trimester pregnancies and following a recommendation for policy change from an Expert Review Group, WHO is considering whether to recommend the use of all ACTs in all trimesters of pregnancy. That said, the data set regarding the use ACTs other than AL in the first trimester is comparatively small. MMV is working with the Liverpool School of Tropical Medicine’s Timika Research Facility in Indonesia to analyse historical data and to capture new evidence regarding the use of the ACT dihydroartemisinin-piperaquine (DHA-PQP) in the first trimester of pregnancy. These new analyses will contribute to the evidence base regarding safety and tolerability of this ACT during pregnancy.In addition to expanded use of ACTs for treatment in pregnancy, the malaria research community is also focused on exploring the use of DHA-PQP as a potential substitute for SP for IPTp in the future, should SP’s preventive efficacy decline. MMV is working with the London School of Hygiene and Tropical Medicine in Tanzania on a study to evaluate the cardiac safety of a single course of IPTp with DHA-PQP in pregnant women with and without asymptomatic infection.For the future, we are also looking at the medicines we have in development and how they might be used for pregnant women. Traditionally, most drugs are tested for safety in pregnancy quite late in development (if at all), since in many therapeutic areas, a product that cannot be used in pregnancy can still have enormous therapeutic value. However, in the case of malaria, the needs of pregnant women are clear and compelling. MMV thus focuses early on in its drug development process to identify molecules that may have an acceptable safety profile in pregnancy. This focus includes conducting standard embryo-foetal development studies in parallel with other non-clinical safety assessment or phase I studies. A favorable safety report early on means that these molecules could be prioritized for development. In addition, with MMV’s support, a review was carried out and published to help guide the prioritization of antimalarial drugs for development. It detailed the non-clinical safety of all non-artemisinin antimalarial drugs. [3] The article summarized data that was previously not easily accessible to health experts and is helping to guide the development of next-generation antimalarial medicines that could have an appropriate safety profile in pregnant women. With our partners, MMV is committed to investigating all the avenues to improve pregnancy outcomes for women at risk of malaria. By focusing on protecting and treating pregnant women at risk, we safeguard two lives, not just one.[1] Dellicour S et al. “Quantifying the Number of Pregnancies at Risk of Malaria in 2007: A Demographic Study”. PLos Med; 7(1): e1000221 (2010).[2] Schantz-Dunn J & Nour NM. “Malaria and Pregnancy: a global health perspective”. Rev Obstet Gynecol; 2(3):186–192 (2009).[3] Clark RL. “Animal Embryotoxicity Studies of Key Non-Artemisinin Antimalarials and Use in Women in the First Trimester.” Birth Defects Res. 109(14):1075-1126 (2017).