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Researchers at the Durham University in the United Kingdom have received a US$100,000 grant from the Bill & Melinda Gates Foundation to test the feasibility of training dogs to detect malaria. Dogs have been trained to use their keen sense of smell to detect other diseases, including certain cancers, and studies suggest that malaria infection causes a distinct odor, and that unique chemicals can be found on the breath of patients. The team plans to recruit 400 children in the Gambia, including many who are currently infected with malaria. The children will wear nylon socks for 24 hours, which will then be used to train the dogs to identify malaria based on odors in the sweat and skin. If successful, this approach to malaria testing would be quick and cheap, and would not require any equipment or a laboratory setting. A new, commercially-available diagnostic can predict premature births, a critical tool as half of all preterm births occur in women without known risk factors. Between 2011 and 2013, the Utah-based Sera Prognostics enrolled more than 5,500 pregnant women at 11 sites across the United States, and confirmed that the quantity of two proteins in the blood can indicate risk for preterm birth. The test can be administered at 19 or 20 weeks into the pregnancy; pregnancy normally lasts 40 weeks and delivery before 37 weeks is considered preterm. The test—PreTRM®—tells a woman her percentage risk, and currently costs $945, however, Sera Prognostics is working with the Bill & Melinda Gates Foundation to develop tools more suitable for low-income countries. Startup NextGen Jane is developing a “smart tampon” that would collect menstrual blood each month and test for a range of diseases and conditions, including sexually transmitted infections, endometriosis, polycystic ovarian syndrome, uterine fibroids, cervical cancer, and more. Many of these conditions are asymptomatic, and consequently go undetected until significant damage has been done. The team at NextGen Jane has a working prototype—a device that siphons menstrual blood from tampons—and is conducting clinical trials for several of the diagnostics themselves, which identify biomarkers for different conditions in menstrual blood. The tool will connect to a database, allowing women to analyze the data and track their reproductive health over time. The team anticipates having a complete product—combined diagnostics and the delivery mechanism—within the next year, which will be commercially available within three to four years.

US Navy Lt. Kimberly Edgel, left, and Christian Baldeviano examine a positive malaria blood smear at Naval Medical Research Unit (NAMRU) 6 in Callao, Peru.This afternoon, the US Senate voted to protect critical medical research programs at the Department of Defense (DoD). In a vote of 66 to 32, the Senate approved Senator Durbin’s (D-IL) Amendment 4369 to the Fiscal Year 2017 National Defense Authorization Act (FY17 NDAA), which strikes sections 898 and 756 in the underlying bill, designed to enact enough restrictions and red tape on DoD medical research to effectively end all existing programs. With this vote, the majority of the Senate signified that medical research is a critical function of the DoD, and must continue to be a priority. Infectious disease and other medical research at DoD plays a vital role in serving the Department’s overarching mission: supporting our military men and women. Not only does DoD infectious disease research directly benefit service members overseas—who experience neglected infectious diseases alongside local communities—but it also plays a key role in domestic health preparedness initiatives that prevent, detect, and respond to infectious diseases that threaten the health of American civilians at home. Beyond threat reduction to Americans, DoD research can often be translated for other contexts, and serves as an important component of US global health efforts to address HIV and AIDS, tuberculosis, malaria, and neglected tropical diseases in low-income countries.For example, malaria, which threatens the lives of nearly 3.2 billion people in tropical and poor regions of the world, is also a significant threat to the operational readiness of the US military. More person-days were lost among US military personnel due to malaria than to bullets during every military campaign fought in malaria-endemic regions during the 20th century. Thanks to ongoing research at DoD, nearly all of the most effective and widely used antimalarials—used to protect our service members overseas and adapted for widespread use in endemic regions—were developed in part by US military researchers. DoD medical research is also critical to medical advances that directly benefit US civilians at home: One of every four vaccines approved by the US Food and Drug Administration in the last century was developed with the participation of DoD. The 2014 Ebola epidemic in West Africa offers yet another example: the Department’s quick work to advance the development of Ebola countermeasures and safety protocols during troop deployment to West Africa was vital to protecting lives of service members and civilians in the region and remains vital to ongoing response efforts.On May 25th, GHTC sent a letter to members of the Senate, urging them to uphold the DoD’s critical medical research programs and oppose provisions in Sections 756 and 898 of the FY17 NDAA, which would limit our nation’s ability to develop medical countermeasures necessary to protect our troops and save lives around the world.GHTC commends Senator Durbin’s leadership on a bipartisan effort to remove these troubling provisions and extend our thanks to the co-sponsors of Amendment 4369: Cochran (R-MS), Reid (D-NV), Blunt (R-MO), Mikulski (R-AK), Murkowski (D-MD), Murray (D-WA), Collins (R-ME), Feinstein (D-CA), Shelby (R-AL), Casey (D-PA), Gillibrand (D-NY), Baldwin (D-WI), Bennet (D-CO), Markey (D-MA), Brown (D-OH), Leahy (D-VT), Hirono (D-HI), Reed (D-RI), Menendez (D-NJ), Tester (D-MT), Coons (D-DE), Kirk (R-IL), Klobuchar (D-MN), Udall (D-NM), Boxer (D-CA), Schatz (D-HI), Moran (R-KS), Sanders (D-VT), Warren (D-MA), Cardin (D-MD), Schumer (D-NY).

As happens every May, the World Health Organization’s (WHO) highest governing body, the World Health Assembly (WHA), met last week for its 69th annual meeting in Geneva, Switzerland. The agenda was the most packed in recent memory, consisting of more than 70 discussion items, many of which were controversial. As a result, the agenda did not conclude until the eleventh hour on Saturday, May 28. Despite the lengthy agenda and difficult conversations, the WHA made two key decisions impacting global health research and development (R&D). This post will focus on those agenda items then GHTC will publish a full report covering the entire WHA R&D debate the week of June 6.   In the meantime, you can watch a recording of the panel discussion and webinar hosted by GHTC and the Geneva Centre for Security Policy on May 23, which provides a broad overview of many of the R&D issues discussed at WHA. Framework of engagement with non-State actors (FENSA) Discussions around revising WHO’s policies and procedures for engaging with non-State actors (any group other than a member state) have been highly contentious. Advocates for the proposed framework have argued that WHO needs to insulate its normative functions from undue influence by outside groups, while others have argued that the unintended consequences of the pre-WHA draft framework could be dramatic for some of WHO’s partners by inappropriately categorizing some partnerships as commercial entities. The intensive negotiation process at WHA resulted in a compromise decision that addresses concerns previously discussed by GHTC regarding FENSA’s impact on product development partnerships, while also maintaining some of the more stringent restrictions on how WHO engages with for-profit companies. As such, FENSA will move forward into implementation with the following key adjustments:   Assessments of any proposed engagement with non-State actors will be guided by an implementation guide prepared by the WHO Director-General, which lays out clear criteria and guidelines. Evaluation of new engagements will be conducted by a specialized risk assessment staff to remove as much of the burden as possible from program staff. Ongoing or repetitive engagements can be classified as low-risk and subjected to a streamlined evaluation process, so long as a full risk assessment has been conducted on a substantively similar project in the past. The private sector is prohibited from providing staff secondments to WHO and is dramatically restricted in how it can provide in-kind or financial contributions.  Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) The CEWG is a continuation of the Expert Working Group (EWG), which was convened more than a decade ago to chart how WHO could better support R&D for neglected diseases. This WHA marked an opportunity for the global health community to approve the plan set forth by the WHO Special Programme for Research and Training in Tropical Diseases (TDR) to create a pooled fund to support R&D and a global health R&D observatory to develop and recommend global research priorities. After extensive negotiations, the WHA’s decision calls on the WHO to:    Expedite the further development of a global health R&D observatory. Develop terms of reference and a costed work plan for the observatory for consideration at the 70th WHA. Develop an operational plan for a voluntary pooled fund for consideration at the 70th WHA. Advocate for sustainable funding for the new mechanisms. Convene a series of expert working groups to inform the new mechanisms’ policies and procedures. In combination, these directives make clear the concern that many member states shared regarding TDR’s ability to raise the additional funding needed to support its ambitious proposals, as well as a desire to better understand how the observatory would prioritize research project recommendations across the global health R&D portfolio. Given the debate regarding these two items, the WHA declined to give it the green light at this year’s assembly, preferring instead to ask for more detailed operational proposals for consideration next year.   Given all of the unanswered questions on both CEWG and FENSA heading into WHA, it was important to see compromises come out of the discussion; both processes will go forward, but in a measured fashion to allow the development of concrete workplans and guidelines to shape their implementation. GHTC will continue following both processes closely, and looks forward to helping ensure that the concerns of the global health R&D community are front and center in both initiatives.

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.