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Photo: Medicines for Malaria Venture The Medicines for Malaria Venture (MMV)—a member of the GHTC—and the University of Dundee’s Drug Discovery Unit have developed an antimalarial compound that could treat drug-resistant cases of malaria with a single dose. The compound has been tested in both human blood and mice and the researchers involved believe it could ultimately be administered for only US$1 per dose. MMV has entered an agreement with pharmaceutical company Merck KGaA to advance the compound through the research and development (R&D) pipeline, transferring the rights to develop and commercialize any resulting product. Researchers at the US National Institutes of Health (NIH) have developed a vaccine that has protected against leishmaniasis in monkeys. Leishmaniasis infects one million people per year and is caused by the Leishmania parasite, transmitted through the bite of phlebotomine sand flies. Scientists noted that monkeys bitten by uninfected phlebotomine sand flies were less susceptible to future infections, and subsequently determined that a protein in the flies’ saliva—known as PdSP15—triggers an immune response. Seven of ten monkeys receiving an injection of PdSP15 developed immune cells against the Leishmania parasite and were significantly less likely to get the disease than members of the control group. Human cells also reacted to PdSP15 in a laboratory setting, indicating the potential of the protein in protecting humans from leishmaniasis. The fastest and most accurate tuberculosis (TB) test is expensive—$17,000 per machine and an additional $10 per test—and not conducive for use in rural settings because it requires electricity, refrigeration, and access to a computer. The test, known as GeneXpert is significantly more sensitive than traditional TB diagnostics, and its use increases successful diagnosis by 39 percent. Its popularity among health officials and donors has demonstrated that there is a major market for TB diagnostics, and has galvanized private-sector investments in TB R&D. There are now 191 TB diagnostics in the pipeline, and the manufacturers of GeneXpert are working to make the technology cheaper and to develop a remote, cloud-based version of the test. Since 2010, the Pediatric Trials Network has been conducting research to determine the safety and appropriate dosage of different medicines for young children, including premature infants. Children are often excluded from clinical trials, due to issues of consent and communication, and consequently, many drugs are not tested on children before entering the market. The NIH-funded Pediatric Trials Network has gathered research from nearly 90 sites and 3,500 children across the United States, and the results have often been counterintuitive. Medical professionals often determine the appropriate dosage of a drug based on a child’s weight, however the Network’s research has indicated that underdeveloped organs, particularly in premature infants, may struggle to fully process the drugs, ultimately requiring a higher dose per pound.

The zoonotic Middle East Respiratory Syndrome (MERS), which World Health Organization (WHO) Director-General Dr. Margaret Chan called “a threat to the entire world” has spread to South Korea. More than 100 cases and 10 deaths have been reported, making it the largest outbreak outside of the Arabian Peninsula. While there are currently no vaccines or treatments for MERS, researchers are confident that with adequate political will and funding, such products could be rapidly advanced. Photo: PATH/Nguyen Ba Quang Dr. Matthew Frieman, a professor and researcher at the University of Maryland School of Medicine, has developed an experimental vaccine in partnership with vaccine company Novavax Inc. that successfully protected mice against the MERS virus. Greffex, another vaccine company, has already worked with the US National Institute of Allergy and Infectious Diseases to develop a vaccine that triggers the production of antibodies—proteins that protect against the disease—in mice. Dr. Frieman and Greffex CEO John Price agree that funding and political will are the only barriers to the development of a MERS vaccine. According to Price, Greffex could develop a MERS vaccine candidate in less than a month with a sample of the virus, but they lack the funding to conduct clinical trials. Researchers have also struggled to obtain the needed information and materials—including samples of the virus—from scientists in Saudi Arabia. In the meantime, Frieman is working to test existing, approved drugs for the treatment of MERS, and has identified 27 drugs that have demonstrated potential in combatting MERS in a laboratory setting. At this year’s G7 summit, leaders of seven countries—including Canada, France, Germany, Italy, Japan, the United Kingdom, and the United States— pledged to advance research and development (R&D) for neglected tropical diseases and new antibiotics. The members of the G7 committed to supporting everything from basic research through the development of “easily usable and affordable drugs, vaccines and point-of-care [diagnostics].” The G7 Leaders' Declaration also endorses the WHO Global Action Plan on Antimicrobial Resistance and the WHO Global Observatory on Health Research and Development, highlighting the need for improved coordination of global health R&D. In a New York Times op-ed, Gregg Gonsalves and Mark Harrington, co-founders of the Treatment Action Group, reflected on lessons learned about the US Food and Drug Administration’s (FDA) drug approval process during the US HIV and AIDS epidemic. The article comes as Congress is considering the 21st Century Cures Act, a bill intended to advance medical breakthroughs, in part through FDA reform. The legislation includes several provisions to expedite the approval of drugs and medical devices based on what Gonsalves and Harrington consider to be “lower standards.” The authors assert that while innovative regulatory pathways—such as the Accelerated Approval Program—enabled early access to new HIV and AIDS drugs, pharmaceutical companies were still required to demonstrate the safety and efficacy of products before they entered the market. Additionally, in the case of preliminary approval, companies were expected to continue and complete clinical trials. To protect patient safety, Gonsalves and Harrington argue that such standards should be upheld, reminding Congress that those standards “paved the way for the development and approval of breakthrough drugs [that] have been proven to be effective and safe.” There are nearly 170 contraceptives products in the R&D pipeline, from discovery, through product development, to regulatory review. Researchers, advocates, funders, and procurement agencies can now find information about these products all in one place through Calliope, the Contraceptive Pipeline Database, a new resource developed by GHTC member FHI 360. Calliope includes information regarding the R&D stage, the partners, the active pharmaceutical ingredients, the delivery and duration, and the mechanism by which the technologies prevent pregnancy. The contraceptive pipeline is diverse, and includes vaccines, microbicides, implants intrauterine devices and balls, pills, and even microchips. The exchange was created to galvanize contraceptive R&D for low-resource settings through knowledge sharing and the facilitation of cross-sector partnerships.

Leishmania sp. protozoan (Photo: CDC/ Dr. George Healy) The Drugs for Neglected Diseases initiative (DNDi)—a member of the GHTC—is partnering with pharmaceutical companies Eisai Co., Shionogi & Co., Takeda Pharmaceutical, and AstraZeneca to accelerate early-stage research for drugs against Chagas and leishmaniasis. The project, known as the Drug Discovery Booster, will enable DNDi to search through all the pharmaceutical companies’ vast libraries of chemical compounds simultaneously. DNDi will provide each company with a ‘seed’ compound which has shown some ability to combat the parasites responsible for the diseases, and the companies will subsequently scan their libraries for similar, and potentially more promising, compounds. DNDi will then test the compounds identified by the pharmaceutical companies and pick a new seed compound from the results. This process will be repeated up to three times. The GHIT Fund—a member of the GHTC that subsidizes research and development for neglected tropical diseases—is supporting the involvement of the three Japanese pharmaceutical companies. The World Health Organization updated its medical eligibility criteria for contraceptive use last week, adding long-acting, hormonal contraceptives to the list of recommended contraceptives. The list is widely used by medical practitioners to identify the best contraceptive methods for their patients and by policy-makers in shaping national strategies that determine the availability of different methods within their countries. Under previous guidelines, health professionals were advised not to prescribe hormonal contraceptives to women within the first six weeks after giving birth. Revising that recommendation is expected to increase contraceptive access for new mothers, enabling healthy birth spacing and ultimately reducing maternal and child mortality. This is particularly important in light of the results of a recent study in Contraception across 21 low- and middle-income countries, which indicates that more than half of pregnancies in women who have previously given birth occur too soon after delivery to be safe. An experimental diagnostic known as VirScan can identify virtually every virus a person has ever been exposed to using just a drop of blood. VirScan detects antibodies—proteins that the immune system makes to combat infection—and has been tested on 569 people across the United States, South Africa, Thailand, and Peru. The test costs US$25 and currently takes two days to two months to complete. However, the researchers believe that if a company were to lead and streamline its use, the process could reliably be cut to two to three days. Initial results indicate that the average person has been exposed to 10 virus species, however, those in the United States have generally been exposed to fewer viruses, which could be attributable to “differences in population density, cultural practices, sanitation or genetic susceptibility.” VirScan could be used to identify viral causes or catalysts of chronic or autoimmune diseases, as well as global disease patterns.

Dr Margaret Chan, WHO director-general opens the assembly. Photo: WHO The 68th World Health Assembly (WHA) in Geneva wrapped up last week after addressing several items that will shape the next few years of global health innovation. While we’re very excited by the progress made, much hinges on the connections between this year’s assembly decisions, the finalization of the post-2015 Sustainable Development Goals (SDGs), and next year’s WHA, which will likely have an even greater focus on global health research and development (R&D). Here are some highlights from the last two weeks: First, there were several decisions that will impact the work of the entire global health community: WHO budget increase approved Member states approved WHO’s proposed program budget for 2016-17, increasing the biennial budget by US$236 million—a five percent increase from the previous cycle. The renewed push for malaria elimination through the Global Technical Strategy for Malaria was mentioned as one of the reasons behind the funding increase. Work on non-State actors’ engagement framework continues The Assembly also welcomed a report on progress of a draft framework for engagement with non-State actors—including nongovernmental organizations, private-sector entities, philanthropic foundations, and academic institutions—noting that it wishes to finalize the framework by the next WHA. Delegates requested that the director-general convene an intergovernmental meeting as soon as possible and submit a finalized draft for adoption at next year’s WHA, as well as submit a register of non-State actors. Delegates acknowledged the importance of WHO engaging with non-State actors, which may facilitate greater alliances between WHO and nonprofit product development organizations, as well as global health innovation advocacy groups. It was also a big week for global health innovation: Pooled R&D fund, CEWG recommendations progress WHO delegates consider draft resolutions. Photo: Pierre Albouy/WHO Member states officially noted a report outlining the role the WHO Special Programme for Research and Training in Tropical Diseases would play in hosting and managing a pooled R&D fund. The fund, which will be financed by voluntary contributions, is intended to support R&D for new technologies to meet the needs of low- and middle-income countries. Priorities areas for the fund will be identified by the WHO Global Health Research Observatory, which will be formally launched in January 2016. It remains to be seen how the structure of the observatory will ultimately be implemented, and how that will impact the work of the pooled fund. The pooled fund and observatory were developed as a result of recommendations from a 2012 report by the WHO Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) which was looking for ways to fund R&D for and achieve access to treatments and technologies for diseases predominantly impacting the poor. To demystify this conversation, GHTC and the Council on Health Research for Development cosponsored a live event and webinar at WHA that examined approaches to incentivizing global health R&D and ensuring access to technologies. The discussion featured panelists from PATH, Médecins Sans Frontières, Cipla, and the Norwegian Institute of Public Health. The webinar is available on demand here. Timeframe for global strategy on public health, innovation, and intellectual property extended Member states also agreed to extend the timeframe for action on The Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPA) from 2015 to 2022. The GSPA was adopted by members in 2008 “to promote new thinking on innovation and access to medicines.” The agreement also extends the timeframe of an overall program review of the global strategy on its achievement, remaining challenges, and recommendations on the way forward. A panel of experts to conduct the evaluation will not be established until early 2017, with their report to be presented at the 71st WHA in 2018. WHO endorses Global Vaccine Action plan which includes support for R&D During discussion around the Global Vaccine Action Plan (GVAP), member states approved a resolution that includes language directed at strengthening WHO’s prequalification program, which provides tentative evaluation of new vaccines and medicines. The resolution also included a call for increased capacity-building for R&D, technology transfer, and other elements of vaccine development. Ebola epidemic prompts creation of new emergency response capabilities, greater emphasis on development of new technologies As the Ebola outbreak in West Africa winds down, WHO’s efforts and preparedness for future health emergencies was a hot topic at the Assembly. Delegates welcomed WHO's commitment to make important changes in its emergency response work. Through an approved resolution, WHO will establish a new emergency response capability based on all-hazards preparedness with an emphasis on adaptability, flexibility, accountability, humanitarian principles, predictability, opportunity and country ownership. WHO also plans to establish a contingency fund of $100 million to finance emergency field operations for up to three months. R&D language was also included in the resolution, which supports the development of a ‘blueprint’ for accelerating R&D in epidemics or health emergencies where few or no technological solutions exist. WHO approves global malaria strategy which emphasizes importance of research and innovation Delegates showing support for the proceedings. Photo: WHO Member states approved the Global Technical Strategy for Malaria, which aims to eliminate malaria in at least 35 countries by 2030. The strategy emphasizes the importance of research and innovation, and the need for political commitment, sustainable financing, strong health systems, and collaboration across different sectors. Dr. Pedro Alonso, head of the Global Malaria Program, cited R&D as a necessary endeavor to reach the lofty elimination goals outlined in the strategy.WHO adopts global plan to combat antimicrobial resistance   A key item under discussion by governments was the draft WHO Global Action Plan on Antimicrobial Resistance (AMR) which was approve by member states. Angela Merkel, chancellor of Germany, opened the Assembly by calling AMR "an issue of crucial importance to humankind." Germany has made AMR a key priority during their current chairmanship of the G7. The plan calls for countries to put in place by 2017 systems to monitor drug resistance. It also calls for reductions in overuse of antibiotics and for more investment in new drugs and other health technologies. GHTC member RESULTS, along with the Stop TB Partnership and Global Health Advocates, highlighted the need for drug-resistant tuberculosis to be central to the AMR Global Action Plan throughout the Assembly, and the Global Health Council and Global Health Advocates France delivered a statement calling for drug-resistant TB to be central to the plan and included in the Communiqué of the G7 Summit.Role of Health in SDGs discussed As the finalization of the SDGs approaches this fall, the Assembly discussed the need to secure a strong role for health goals in the overarching framework, and adopted a resolution urging member states to emphasize, among other priorities, “medical products, vaccines and technologies.” Through the Global Health Council, GHTC presented a statement highlighting the need to include health innovation targets and indicators in the SDGs. Looking ahead to the 69th WHA: Several R&D topics to be revisited In comparison with last year’s WHA, this year’s agenda did not include as much substantive decision-making regarding global health R&D activities, such as the global health R&D observatory, the ongoing pilot demonstration projects, or the previously proposed R&D treaty. These topics will be revisited at the 69th WHA in 2016. Regulatory strengthening expected to be discussed We also expect that regulatory systems strengthening will be on the agenda in 2016, an area that is of interest to the US delegation in particular. Since the 2014 Ebola outbreak, interest has been revived in strengthening the involvement of stringent regulatory authorities, like the US Food and Drug Administration, in supporting quick review of emergency tools, as well as building capacity for regulation and increasing regulatory harmonization around the world. As you can see, it was a very busy few weeks! We’re pleased with the outcomes from the WHA, but also see a need to ensure that the important agreements and resolutions are carried forward by member state governments and partners. Hopefully with the upcoming final post-2015 discussions and the next WHO Executive Board meeting only six months away, we’ll see the momentum for global health R&D continue.