Research Roundup: antimicrobial resistance, microbiomes, and more

At last week’s World Health Assembly, the World Health Organization (WHO) and the Drugs for Neglected Diseases initiative launched the Global Antibiotic Research and Development (GARD) Partnership, an initiative to develop new antibiotics to combat the growing threat of antimicrobial resistance. More than EU€2 million has been pledged to the GARD Partnership, from nonprofit Médecins Sans Frontières and the governments of Germany, the Netherlands, South Africa, and the United Kingdom. This innovative financing approach will enable the partnership to delink the costs of research and development (R&D) from sales and product price; new treatments can be sold affordably and promoted responsibly, without the pressure to recoup the costs of R&D. During the incubation period, the partnership will finance three to four projects while developing a long-term business plan, with the goal of becoming an independent entity by the end of 2017. At a recent meeting of G7 finance ministers and central bank governors, World Bank President Jim Yong Kim announced the creation of an insurance fund to fight pandemics, which will provide up to US$500 million for pandemic response in the world’s poorest countries. The Pandemic Emergency Financing Facility will be funded by reinsurance markets and World Bank–issued catastrophe bonds, which have been used to respond to natural disasters. Premiums will be covered by the World Bank and development partners. Funding eligibility will be determined by the size, growth, and spread of an outbreak and will be limited to pandemics in 78 low-income countries, caused by certain virulent, infectious diseases, including influenza, SARS, MERS, Ebola, and other zoonotic diseases. The facility was established in collaboration with the WHO and insurance providers Swiss Re and Munich Re. The Japanese government has committed US$50 million to the facility. Researchers at the Icahn School of Medicine in New York have identified a protein on the Zika virus that inhibits the human immune system from effectively combatting the virus. The protein—NS5—blocks signals between Zika-infected cells and the immune system; consequently, the immune system fails to produce the potent antiviral interferon. NS5 plays a similar role in other flaviviruses, including dengue and West Nile, but the mechanism by which NS5 prevents interferon production varies. The study suggests that altering or removing NS5 would enable the immune system to swiftly attack the virus. The team believes that a vaccine against the virus could be developed using a live strain of Zika, weakened by modifying or removing NS5. Meanwhile, Australian biotechnology company Biotron announced last week the identification of two compounds in its library that are effective against Zika virus in test tubes. The company specializes in HIV and AIDS and hepatitis C treatments and uses a broad antiviral platform to target specific proteins known as vioporins that are also found in the Ebola, MERS, and Zika viruses.

This coming week the “who’s who” of the global health community (as well as some much more modest global health advocates such as your humble author) will make the annual trek to Geneva, Switzerland, for the 69th World Health Assembly (WHA), where World Health Organization (WHO) member states will collectively decide WHO’s plans for the coming year. This year’s agenda is packed and includes many topics that could impact global health research and development (R&D). Below are the agenda items GHTC will be tracking in Geneva and topics we’ll dig into in more detail at a May 23 side event and webinar we are cohosting with the Geneva Centre for Security Policy, Global Health R&D: What’s at stake during the 69th WHA? Framework of engagement with non-State actors WHO routinely engages with a variety of non-State actors (NSAs)—any organization other than a member state. These collaborations support core components of WHO’s global health strategy. Some have argued, however, that WHO’s current ad-hoc approach to managing such engagements undermines its independence and impartiality. As I have written previously, the current draft framework runs the very real risk of excluding key WHO partners and actors in the global health R&D community. Given the significant member state pushback against the proposal, it will be fascinating to see how the tension is resolved.   Health in the 2030 Agenda for Sustainable Development With the approval of the Sustainable Development Goals (SDGs) in September 2015, the global development community has been trying to sort out how to implement and measure programming to achieve what are, by all admissions, extremely ambitious targets. WHO is no different, and has been hard at work laying out strategies to achieve the various components of goal 3, the “health SDG.” It is particularly heartening that target 3.b specifically commits member states to supporting health R&D. What shape this will take, and how WHO will engage are definitely hot topics to watch at this WHA.   Global Action Plan on Antimicrobial Resistance Following the 68th WHA’s adoption of the Global Action Plan on Antimicrobial Resistance (AMR), WHO has been working to develop strategic options to achieve the plan’s goals and will be presenting a progress update and an options paper to WHA this year for input. GHTC is closely monitoring plans for the R&D objective, which states: “… develop the economic case for sustainable investment that takes account of the needs of all countries, and increase investment in new medicines, diagnostic tools, vaccines and other interventions.” While the options paper is quite broad, in the R&D space the WHO Secretariat is specifically asking for input on methods to de-link R&D costs from sale price, how best to support access to innovative antimicrobials, and how to develop a prioritization mechanism to support appropriate R&D on AMR specifically. Given the danger that the global rise of AMR represents, the discussion is likely to be extensive and intense.   Follow-up to the report of the Consultative Expert Working Group (CEWG) on Research and Development: Financing and Coordination (Report of the open-ended meeting of Member States) GHTC has been following the CEWG process for some time as it winds its way forward after what has already been a decade-long process. The prototype R&D observatory is now online, and the demonstration projects are returning their progress reports. The WHO Special Program for Research and Training in Tropical Diseases (TDR) has prepared an analysis that outlines how a pooled fund and R&D observatory could work to identify unmet needs and channel funds to those R&D projects. While almost everyone agrees that additional funds and greater coordination are sorely needed, as we heard at GHTC’s webinar on CEWG, the jury is still split on the CEWG’s specific proposals. While it is unlikely that the CEWG process will come to an end at this WHA, the number of concerns that can be ironed out with all the decision-makers in the room will be telling in regards to future prospects.   For more analysis on these subjects, read GHTC’s fact sheet on Research and development at the 69th World Health Assembly.