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On Wednesday evening, GHTC was joined on Capitol Hill by congressional champions—Congressman Adam Smith (WA-9) and Congresswoman Betty McCollum (MN-4)—and global health community members for a reception celebrating US leadership in global health research and development (R&D) and the launch of the 2015 G-FINDER report, which tracks investment in neglected disease R&D.A message repeated throughout the evening was that the United States’ world-leading investment in global health R&D has been critical to catalyzing the development of technologies that have driven enormous health gains worldwide.Congressman Adam Smith (WA-9) speaks at GHTC briefing. Photo: GHTC/Marissa ChmiolaCongressman Smith opened his remarks by noting that the evening should be about celebration, citing the incredible, but often overlooked progress made in global health over the past several decades—progress driven in part by advancements in the development of new vaccines, drugs, and other health technologies. Yet, he also spoke to the critical need to sustain US investments in health R&D to further accelerate these gains. The Congressman pointed out that US global health R&D investments not only benefit people in the world’s poorest places, but can lead to new insights and innovations that improve access to care for people here in the United States. Congresswoman Betty McCollum (MN-9). Photo: GHTC/Marissa Chmiola Congresswoman McCollum emphasized that global health is a bipartisan issue in Congress. “Every member of Congress knows no child should die of a vaccine preventable disease,” she said. The Congresswoman noted that global health is a foundational element on which all other development gains are built. Discussing her own experience as a mother and grandmother, she talked about the universal desire shared by parents in all parts of the world to see their children survive and thrive, and the role the US government can play in helping make that possible through innovation.In anticipation of the launch of the G-FINDER report the following day, Dr. Nick Chapman, director of research at Policy Cures and the report’s lead author, previewed key findings from this year’s report. The report found that funding for neglected disease R&D increased in 2014, but that increase was entirely the result of increases in funding for Ebola R&D in response to the West African Ebola crisis. Non-Ebola R&D funding actually decreased slightly from the previous calendar year. Dr. Nick Chapman of policy cures previews findings from the report. Photo: GHTC/Marissa Chmiola Dr. Chapman also emphasized the critical role the US plays in neglected disease R&D, noting that the “US government is the single most important funder of global health R&D.” This year’s report found that the US government was responsible for 71 percent of all investment in neglected disease R&D. While Dr. Chapman said this leadership should be celebrated, he also noted that US investment has largely been on the decline over the last several years with non-Ebola R&D investment declining in 2014 to the lowest level since the survey began in 2007. Given the US’s dominant role in this area, continued cuts or stagnation in US funding could lead to significant detrimental impacts on neglected disease R&D overall. Wendy Taylor, director of the USAID Center for Accelerating Innovation and Impact. Photo: GHTC/Marissa Chmiola Wendy Taylor, director of the Center for Accelerating Innovation and Impact at the US Agency for International Development (USAID) echoed statements from other speakers on the need to sustain health R&D investment, emphasizing that the gains we are seeing now in global health are the result of investments made decades ago. She highlighted the importance of partnerships in advancing product development, citing USAID’s work with the private sector and product development partnerships, and the importance of sourcing innovative ideas from all over, highlighting success stories from USAID’s Saving Lives at Birth Grand Challenge Program.

Pyramax® Granules (Photo: MMV) After four successful Phase 3 clinical trials enrolling more than 3,500 patients in 18 countries, the European Medicines Agency (EMA) has granted Pyramax® Granules, a pediatric malaria medicine, a positive opinion under Article 58—a mechanism through which the EMA reviews and issues a scientific opinion on products that are not intended for use in Europe. Pyramax® Granules is a combination of two antimalarials and was developed by Medicines for Malaria Venture (MMV), a member of the GHTC, in partnership with Shin Poong Pharmaceutical Co. Ltd. The treatment is designed to be easy for children to consume: its bitter taste is masked and it is taken in liquid form, as children often struggle to swallow pills. Next, MMV and Shin Poong will work to introduce Pyramax® Granules as well as Pyramax®, the tablet version which is suitable for adults, in malaria-endemic countries. A recent article in NPR: Goats & Soda examines Zika virus, a disease transmitted by the same mosquito vector of dengue fever and chikungunya, that has been rapidly spreading throughout South America and the Pacific Islands in recent years. One in five individuals infected with the virus experience Zika fever, which in addition to fever involves rashes, joint pain, conjunctivitis, headaches, vomiting, and muscle pain. Cases of Zika fever are likely underdiagnosed, as awareness of the disease is limited and its symptoms are similar to infections associated with other members of the Flaviviridae virus family, including dengue fever, yellow fever, West Nile, and Japanese encephalitis. There are no reported deaths to date, but there is growing evidence that the virus can be transmitted sexually or from mother to infant during pregnancy. As there are no vaccines or drugs for Zika fever, treatment involves addressing the symptoms, using fever reducers and painkillers. A group of global health advocacy organizations—including GHTC members the Drugs for Neglected Diseases initiative, TB Alliance, Infectious Diseases Society of America Center for Global Health Policy, Sabin Vaccine Institute, and Treatment Action Group—sent an open letter to the US Senate Health, Education, Labor and Pensions (HELP) committee, calling for amendments to the priority review voucher (PRV) program at the US Food and Drug Administration (FDA) to ensure it adequately incentivizes research and development (R&D) for neglected diseases, as intended. Under the program, companies that receive FDA approval for a drug for a neglected disease (see list of eligible diseases) are awarded a voucher for expedited FDA review (six months rather than ten) of a future product. The vouchers are transferable and have been sold at increasing rates, the most recent going for US$350 million. The letter calls for PRVs to only be awarded for products that are "truly new" as two of the six vouchers that have been awarded were for products that had long been in use outside of the United States.[1] The organizations are also calling for recipients of the voucher to be required to develop a strategy to ensure the product is made affordable and accessible to patients in the countries in which the eligible disease is endemic. The United Kingdom (UK) announced last week the creation of the Ross Fund which will provide £1 billion ($1.5 billion) over five years to fight malaria and other infectious diseases. The funding, which will come from the UK overseas aid budget, includes £90 million for malaria eradication; £100 million for infectious disease R&D; £115 million for the development of drugs, diagnostic, and insecticides for malaria, tuberculosis, and other infectious disease resistance; and £188 million for biodefense and rapid response systems for epidemic preparedness. Global Good has developed a cooler that can store and transport vaccines at freezing temperatures for over a month using just ice and no electricity. The Arktek cooler uses vacuum thermal insulation, an approach used to preserve spacecraft entering extreme temperatures. The cooler has been tested in Senegal (with support from GHTC member PATH) and Ethiopia, and last year, the Arktek was modified for use in Ebola vaccine clinical trials, during which the cooler kept the vaccines between -76 and -112 degrees Fahrenheit for three days. [1] There are two separate PRV programs at the FDA, one for neglected tropical diseases and one for rare pediatric diseases. Of the six PRVs that have been awarded, three each have been for neglected tropical diseases and rare pediatric diseases. Since the beginning of the PRV program, six PRVs have been awarded—three for neglected tropical diseases and three for rare pediatric diseases.  

It’s that time of year when Americans chow down on turkey with family and friends and express gratitude for the many things in life for which they are most thankful. In the spirit of Thanksgiving, GHTC asked our members and staff to share what they are most thankful for when it comes to research, development, and delivery of lifesaving global health technologies. Here’s what they had to say:  

Snakebites, which Médecins Sans Frontières describes as “one of the world's most neglected public health emergencies,” kill 200,000 people each year. This makes snakes the second deadliest animal after mosquitoes. However, not only has research and development for snakebite antivenoms received little investment, but production of existing treatments is also declining due to their low profitability for pharmaceutical companies. Antivenoms are traditionally developed using antibodies produced by animals that have been bitten by snakes, but a number of small biotech companies and even individuals are testing innovative ways to create new, multipurpose antivenoms. Dr. Claire Komives, a professor of Chemical Engineering at San Jose State University, is working to enlist the E. coli bacteria to produce a promising antivenom, as the use of bacteria could make production significantly cheaper and easier to scale up. Meanwhile, a team of researchers across Europe and Central America are developing a treatment for a myriad of common venoms, starting with an antivenom that is effective against three different venoms. Their plan is to identify deadly venoms against which their product is not effective and then develop and incorporate a treatment for that venom into their product. Finally, a team at the California Academy of Sciences is screening chemical compounds in existing, approved drugs to develop a product that could stabilize a bitten patient, giving them more time to seek treatment. The World Health Organization estimates that one-third of the world’s population has latent tuberculosis (TB), only 10 percent of whom will actually contract the disease. However, co-infection with a helminth, a parasitic worm, increases one’s chance of developing TB and exacerbates the symptoms, particularly lung damage. Scientists have long suspected that the parasitic infection impeded the immune system’s ability to fight TB, inhibiting immune cells that provide protection against TB. However, new research out of Washington University in St. Louis suggests that a specific molecule produced by helminths’ eggs prompts an inflammatory immune response that increases one’s susceptibility to TB and its symptoms. The team was able to engineer immune cells that do not produce the molecule, and mice co-infected with TB and the parasite who were given the engineered immune cells did not have the damaging, inflammatory immune response. Analyses of blood samples from TB patients also demonstrated a correlation between the presence of the molecule and the severity of TB symptoms. Photo: PATH/Wendy Stone Researchers at The Scripps Research Institute (TSRI) are developing an HIV and AIDS vaccine candidate that targets a region found on 90 percent of known strains of the HIV virus. The team at TSRI has been conducting experiments to prompt the immune system to generate broadly neutralizing antibodies—proteins which fight multiple strains of the HIV virus—and discovered that four of these antibodies all targeted the same part of the virus, the V2 apex. Further, two of the antibodies have an unusual advantage. While most antibodies mutate from their original form to become more effective at fighting a virus, two of the antibodies were able to bind to the V2 apex in their initial form, consequently speeding up the immune response. However, the body doesn’t naturally make a large number of these antibodies, instead focusing on the further developed antibodies. To address this, the team at TSRI engineered a version of an HIV protein to which those basic antibodies bind with the anticipation that it will lead to their increased production. The engineered protein is being used in a vaccine candidate that will next be tested in animal studies.