Research Roundup: The rise of drug-resistant TB, ecosystems and pandemics, and a UN-made global mosquito tracker

As it does every year, the global health community is preparing for our collective trek to Geneva for the World Health Assembly (WHA) where the World Health Organization’s (WHO) 194 member states and various civil society or multilateral observers will come together to review WHO’s programming over the prior year, sets policy and program priorities for the upcoming one, and approve the budget with which to carry them out. As with most WHAs, there are a number of items related or relevant to research and development (R&D) at this year’s assembly: Director-General elections The highest profile issue on the agenda this year is the selection of the next WHO Director-General (DG) to succeed Margaret Chan. The three candidates still in the running are Dr. Tedros Ghebreyesus (Ethiopia), Dr. David Nabarro (United Kingdom), and Dr. Sania Nishtar (Pakistan). Dr. Ghebreyesus has previously served as Minister of Health and Foreign Affairs for Ethiopia, Dr. Nabarro boasts an extensive track record in the United Nations (UN) and other multilateral organizations, and Dr. Nishtar served as Minister of Health for Pakistan, in addition to founding and leading a successful nonprofit. From an R&D perspective, none of the candidates have direct experience in technology development, but all have indicated in general terms that they would be supportive of R&D. As the chief executive of WHO, the DG sets operational policies and priorities across a variety of programs important to R&D, from the pooled fund and observatory, to ongoing discussions around intellectual property and access to medicines. The influence of the DG is hard to overstate. The race remains very open, and member state delegation contacts have indicated that it is anyone’s race, though this was before news reports emerged containing allegations about Dr. Ghebreyesus’ tenure as Ethiopian Minister of Health. It is unclear to what extent these reports have shifted the race, but GHTC will be on the ground in Geneva providing daily updates as the final days of the campaign unfold and the election occurs on May 23. R&D for potentially epidemic diseases In examining the response to the West Africa Ebola outbreak; ongoing yellow fever and dengue outbreaks; and Zika, WHO recognizes the need for R&D to be a central component of the agency’s strategy to combat potentially epidemic diseases. To that end, WHO has undertaken a number of activities and will be presenting progress to date at WHA. One of the most impactful of these activities is the creation of an R&D blueprint for action to prevent epidemics. The blueprint lays out a number of areas that require global attention to prepare for outbreaks, including product development, as well as social science and epidemiology studies. GHTC is very pleased to see R&D getting its fair share of attention in the context of epidemic preparedness. Without the ability to rapidly develop new tools to address emerging diseases, we will not have the necessary tools in place to prevent or curb an epidemic. Although the blueprint is a step in the right direction, GHTC believes that WHO should also address regulatory guidance and health systems strengthening; new technologies won’t help stop outbreaks if they are held up in regulatory review, nor will it be possible to develop the right tools if health systems are too weak to collect the vital data and samples needed when an outbreak occurs. Antimicrobial resistance Another hot topic over the past year has been the global focus on antimicrobial resistance (AMR) coming out of last year’s UN General Assembly High-Level Meeting on AMR. WHO has been at the forefront of this movement to combat AMR and has committed to supporting countries in developing national action plans to fight AMR, setting up global surveillance systems to track AMR, and helping coordinate across the UN system to ensure a unified UN response. Support for R&D has been a central component in these discussions. GHTC welcomes all of these actions, but notes that WHO and member states have been slow to agree on an AMR stewardship and development framework, which is a vital next step. We will not make progress against AMR without the Framework helping guide investments in R&D, and ensuring that the products developed through that R&D remain effective in use. GHTC will continue pushing for the Framework and for WHO and countries to be held accountable to the promises they made at the UN General Assembly. Consultative Expert Working Group on Research and Development: Financing and Coordination The long-running Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) process continues for this year’s WHA, and the progress update report shows some progress, some treading water, and some disappointment. On a positive note, the WHO R&D Observatory—which will serve as a coordination clearinghouse for information on global health R&D—is moving toward implementation. Once active, the Observatory will be a key tool in helping ensure efficient R&D by facilitating coordination, exposing gaps, and helping researchers prioritize according to need. The second piece of the CEWG’s mandate is standing up a pooled fund to support neglected disease R&D. To be housed at the Special Programme for Research and Training in Tropical Diseases (TDR), the pooled fund would operate in a similar fashion to the Global Fund to Fight AIDS, TB and Malaria, accepting contributions from member states and making grants to research institutions pursuing R&D for neglected diseases that are not commercially viable. While TDR has developed a solid set of terms-of-reference for an expert advisory group to prioritize areas for the fund to focus on, it still has not come to grips with the elephant in the room for any funding mechanism—how they are going to raise the money to support it. Unfortunately, even the current set of demonstration projects to pilot the approach remain underfunded, and it does not appear that most member states or other donors are willing to reach into their pockets for this project. GHTC will continue advocating for them to do so, and for more resources to be made available for R&D in general, but it will be interesting to see the dynamics at this year’s WHA. Closing thoughts Overall, this year’s assembly is likely to be dominated by the DG election, with other topics only attracting attention once this heated content is wrapped up. It is not clear how the three DG candidates will approach R&D should they be elected, so it is very hard to predict what impact the decisions at this year’s WHA will have. Will they chart a direction for the new DG or will WHO’s new leader want to make his or her mark and change course entirely? GHTC will be on the ground providing updates as they happen, as well as the analysis of what they could mean for R&D. Follow us on Twitter at @GHTCoalition for live updates over the course of the week and check back here for a wrap-up blog on outcomes from the 70th WHA later this month.

Meet Grace, Denise, and Sarah. At age 21, Grace is a single mother of two living in South Africa. Because her children need routine check-ups and immunizations, Grace frequently sees pediatricians and nurses, but rarely visits doctors for her own health needs. In Namibia, 19-year-old Denise is a first-time mother. She wants contraceptives but the few times she’s asked, the local pharmacist said they were available only for married women. And in Malawi, 18-year-old Sarah has started having sex, sometimes with male partners twice her age.  These three young women lead very different lives, but they all have one thing in common—they’re at high risk for HIV infection. Although Grace, Denise, and Sarah are not real people, their stories illustrate diverse challenges young women face, particularly in sub-Saharan Africa, where young women ages 15-24 are at least twice as likely to have HIV as men their age—and, in some regions, are more than eight times as likely to get infected. IPM's Sharyn Tenn with workshop participantsExisting HIV prevention strategies are not doing enough to reduce the high rate of infection among women because women still lack a range of options that address their diverse needs. While some women may feel comfortable discussing available HIV prevention options such as condoms with their partners, negotiating safe sex is not a realistic option for many others, including those at risk of sexual violence. In addition, while some women may be able to use a daily oral HIV prevention pill known as PrEP, in the three African countries where it recently become available, others may prefer a long-acting prevention method.The payoff for all of these tools spans far beyond individual women—evidence shows that when women are both empowered and healthy, they are more likely to have healthy families, educate their children, and make positive social and economic contributions to society. New discreet and long-acting HIV prevention tools have the potential to empower women to protect their own health and unlock their potential.My organization, the International Partnership for Microbicides (IPM), has developed one such tool–the monthly dapivirine ring. This flexible, silicone vaginal ring is the first long-acting, self-initiated method shown to safely help prevent new HIV infections in women.Results from two Phase III clinical trials last year—The Ring Study and ASPIRE—found that the ring safely reduced HIV risk among women in four African countries. Data from one study suggests that women who used the ring most consistently saw greater risk reduction, and that the youngest women, who saw little to no protection, appeared to be the least likely to use the product. Such adherence challenges are consistent with studies of other HIV prevention methods and underscore the urgent need to identify and overcome barriers to product-use for young women. The dapivirine ring. (Photo: Andrew Loxley) IPM is committed to doing all we can to understand how to help young women who want to use new HIV prevention technologies, like the monthly dapivirine ring, to do so consistently. Last month, we, along with AVAC, the US Agency for International Development, and Dalberg Global Development Advisors, co-hosted an event during the United Nations Commission on the Status of Women to take a holistic view of young women’s lives. Presenters shared examples of the ways HIV-prevention efforts can be informed by the very people who would benefit leveraging an approach called human-centered design, which places end-users and other key stakeholders at the center of the design and implementation process. This approach is being used to create concepts and materials to increase the adoption and sustained use of the dapivirine ring.Several insights shared at the event could inform future steps for the dapivirine ring, should it be approved for use and added to HIV prevention programs in sub-Saharan Africa. For example, the ring could be offered where women already regularly access health services, whether for themselves or for their children.Doing so would make access to the ring more convenient, and subsequently, may increase its uptake. Participants also suggested that a welcoming, environment may also help facilitate uptake as fear of judgment can be a powerful barrier to accessing and using HIV prevention products and services.We’re encouraged by these discussions, recognizing that they are one step in a long and iterative process of getting new HIV-prevention methods into the hands of women worldwide. Continuing to involve women in additional research on the ring and its possible introduction must continue if we are to realize its potential and pave the way for other technologies in the pipeline such as a three-month dapivirine-only ring and a multipurpose dapivirine-contraceptive ring. We’re currently pursuing regulatory approval for the dapivirine ring and looking to two open-label extension studies—DREAM and HOPE—currently underway, to gain insight into when, why, and how women use the ring now that its safety and efficacy are known, and to collect extended safety data.Expanding the toolkit of HIV prevention options available to young women would lower HIV infection rates, allow healthy women to pursue employment, and help sustain strong and productive workforces.The sooner we reduce the heavy HIV burden young women bear, the sooner we can empower a new generation to lead healthy and productive lives. Sharyn Tenn is the senior director for external affairs at the International Partnership for Microbicides.