Research Roundup: Barriers to TB immunization, malaria's genetic diversity, and IPM's dapivirine ring

On April 28,  senior leaders from government, the private sector, and the global health community came together in Berlin for a lively discuss on how the G20 can advance global health innovation to drive sustainable development and health security. Here are six key takeaways from that discussion: 1. Global health security can drive economic growth, but health crises destroy economies. While the cost of developing technologies may be significant, the cost of failing to have technologies needed on hand can be far greater. For example, US funding cuts in 2012 stalled development of a promising Ebola vaccine, leaving us without a critical tool needed to stem the 2014 outbreak. The result: Over 11,000 deaths and the collapse of health systems and economies in the three affected West African countries, as well as enormous investment by G20 countries to stem the outbreak. The US government alone spent US$2.4 billion on efforts to combat the disease at its source, in addition to investments at home. On the other hand, investment in global health research and development (R&D) can drive economic growth and job creation. Healthier people lead to healthier economies. 2. Resource mobilization is critical. If there is one message the eclectic group of conference participants can all could agree on, it is that we need additional investment from public- and private-funders to ensure global health security. What was less clear is who will pay for it. Speakers emphasized the vital role governments have to play in funding R&D for poverty-related and neglected diseases (PRNDs) given there isn’t sufficient stand-alone interest from the private industry. German Bundestag member, Stephan Albani, encouraged governments to double their investments in R&D for PRNDs and to continue funding product development partnerships (PDPs), which leverage public- and private-sector contributions to advance health technologies targeting PRDNDs. Other panelists stressed the need to draw in additional support from the private-sector, philanthropy, and other unconventional donors. Tara Hayward from Sabin Vaccine Institute emphasized the need for alternative financing models to stretch investments, while Dr. Kei Katsuno from GHIT Fund discussed his organization’s unique approach to leveraging private and public funds. Katharina Kuss, from the Spanish Foundation for International Cooperation, Health, and Social Affairs, also reminded participants of the need to focus on value-for-money to avoid donor fatigue and continue to engage the private-sector and philanthropy. 3. No one can do this alone; Partnerships are needed. Participants emphasized the need for partnerships in both funding and research. PATH’s Claire Wingfield discussed the unique role of PDPs in drawing together public and private resources and engaging local partners to develop affordable and appropriate technologies for PRNDs, as well as the need to foster an enabling environment for innovation in low- and middle-income countries as they strengthen R&D capacity to address their own health needs. Dr. Peter Jackson from the AMR Centre and Founding Member of CARB-X emphasized the length and high cost of drug development and thus the need for collaboration to bring new antibiotics to market. CEPI’s new CEO, Dr. Richard Hatchett, stressed the need for portfolio partnerships rather than companies working on developing a single vaccine. On the private industry side of our community, Dr. Denis Broun of CEPLA spoke of partnerships with generic companies working on new drug formulations, while Dr. Harald Nusser of Novartis focused on the need for co-creation through multiple partnerships which are less transactional. Professor Helen Rees, Chairperson of the South African Medicines Control Council, raised the issue of medicine affordability for countries as an example of the need for mechanisms of tiered pricing and noted the need for collaboration to ensure tech transfer. 4. We must connect R&D with the overall health system. A new global health technology will only have impact if ultimately reaches the people who need it and is designed for the communities and contexts in which it will be used. Silvia Ferazzi from Medicines for Malaria Venture emphasized that R&D must be viewed as part of broader health systems with product developers and implementers coordinating throughout the R&D process to ensure technologies can be rapidly scaled up at the community level once developed. She also stressed the need for technologies to be designed and adapted to meet the unique constraints of health systems. The need for communities to be engaged at an early stage to inform product design was echoed by both Abdullah Adlahmash of King-Saud University and Dr. Michelle Gayer of International Rescue Committee, while Julie Archer of FIND stressed the need to innovate diagnostics in parallel with drugs and vaccines to enable these tools to be deployed most effectively. 5. Governments DO care, but better coordination is required. Many of the government and multilateral officials in attendance—including German Bundestag member Kordula Schulz-Asche, United Kingdom member of parliament, Jeremy Lefory, and Emanuel Frederico Sotelo from the Embassy of Argentina—highlighted the remarkable gains in global health achieved through new technologies and the stressed their commitment to driving forward global health innovation and strengthening health systems to address longstanding and emerging challenges, including antimicrobial resistance (AMR) and pandemic threats. But attendees also pointed out the need for governments to better coordinate to support new technologies on the journey from lab to bedside. Rob Terry of the World Health Organization (WHO) R&D observatory, discussed his team’s work to create a directory of product profiles to identify priorities and gaps in R&D. Bernhard Schnittger from the European Union (EU) Commission in Germany, stressed the need for alignment between Africa and Europe—in areas of disease surveillance and response, pandemic preparedness, regulatory issues, and capacity building—which H.E. Ajay Bramdeo, AU Permanent Representative to the EU, also reiterated. Ben Alsdurf from TB Alliance focused on the need for streamlined regulatory processes and better coordinated procurement. Discussing the alignment between G20 initiatives and WHO, German B20 Sherpa Dr. Stormy-Annika Mildner noted that the G20 in health can’t divert from the WHO role, but it should set an agenda to streamline initiatives with WHO, and cited five areas where global health is a focus within the G20: Innovation in health, pandemic preparedness, NTDs, AMR, and digital health. 6. These global health challenges impact us all.   Dr. Peter Hotez, Dean of the National School of Tropical Medicine at Baylor College of Medicine, perhaps summed it up best when he shared some surprising new statistics indicating that the majority of cases of certain neglected diseases—including HIV and AIDS, malaria, and tuberculosis—currently exist within the G20 countries, so this is an area which countries of all economic levels cannot afford to ignore. On a positive note, the Millennium Development Goals helped catalyze a 50-80 percent reduction in preventable child diseases. On a more concerning note, new challenges have emerged: Dengue has returned to Southern Europe and malaria cases are on the rise in Greece. Call to action! It’s clear that neglected diseases can no longer be seen as a distant concern only affecting the global south. In this increasingly globalized world where diseases know no borders and our security and economies are intertwined, the leading countries of the world must come together with a coordinated approach to ensuring global health security. That’s why we are calling on all interested parties to sign on to our call to action for G20 leaders to commit investment in research, innovation, and development of innovative health technologies to counter threats posed by AMR, PRNDs, and pandemics. We are working to include global health innovation on the agenda for the B20 meeting, and continue to engage in dialogue with representatives from Argentina and India, the next two G20 hosts and national ministers and heads of government. Join us!

On Monday, Congress struck a deal finalizing government spending legislation for the remainder of fiscal year (FY) 2017. Since October 1, 2016, the government has been operating on a series of continuing resolutions (CR)—maintaining government spending at FY16 levels until a full deal for FY17 could be negotiated. With the omnibus legislation in place, we expect both houses of Congress to pass the final FY17 bill this week.  There was strong bipartisan, bicameral support for advancing FY17 omnibus legislation that reflected priorities, compromises, and negotiations reached during the regular FY17 appropriations process. This means that strong congressional support for protecting medical research and global health in individual FY17 appropriations bills was carried through in the final legislation. While we know there will be more challenges in the FY18 budget and appropriations process, the FY17 omnibus was an encouraging sign that Congress understands the vital role of US global health and medical research programs. US Agency for International Development and State Department While the Trump Administration proposed rescissions for the US Agency for International Development’s (USAID) global health funding for FY17—including cuts to the President’s Emergency Plans for AIDS Relief (PEPFAR), polio, tuberculosis (TB), neglected tropical diseases (NTDs), and eliminating global health security funding—in the final FY17 omnibus, global health programs at USAID saw an 8 percent boost in funding, totaling just over US$3 billion versus $2.83 billion in FY16. Notable increases included $5 million for TB, $81 million for malaria, $40 million for Gavi, the Vaccine Alliance, and $70 million for global health security to create a new Emergency Reserve Fund to respond rapidly to emerging health threats. Other global health accounts within USAID and the State Department received level funding.USAID continues to play a leading role in the US government’s action on global health research and development (R&D), and it is critical that global health programs receive appropriate funding so that investments in R&D will continue to be prioritized among other activities. The combination of increased funding for some key programs and level funding for others in FY17 is a positive sign that Congress shares our priorities and will work to protect these accounts in more challenging budget and appropriations conversations for FY18.National Institutes of Health Strong bipartisan support for the National Institutes of Health (NIH) continued in the FY17 bill. Overall, NIH received a $2 billion increase, raising total funding for FY17 to $34 billion. However, it’s important to note that little of this increase will likely support global health programming. Much of this increase was to fund enactment of the 21st Century Cures Act, but notable increases that could benefit global health R&D included a 6 percent or $277 million increase for the National Institute of Allergy and Infectious Diseases, a $1.76 million increase for the Fogarty International Center, and additional funding for the National Center for Advancing Translational Sciences.While NIH has long enjoyed bipartisan support—and thus it is not surprising to see a funding boost in FY17—it was notable that the Trump Administration proposed over $1.2 billion in rescissions for NIH for FY17 and a 19 percent cut to NIH funding for FY18, including eliminating the Fogarty International Center. NIH leads the world in global health R&D, and its work in basic research is vital to advancing new drugs, vaccines, therapeutics, and other tools for neglected diseases and conditions. It is encouraging to see Congress maintain and increase NIH funding overall and prioritize US leadership in medical research for FY17; however, greater support is needed for NIH programs that advance research for neglected diseases and conditionsCenters for Disease Control and Prevention A laboratory worker wearing a surgical mask works with samples. (Photo: PATH/Mike Wang) The Centers for Disease Control and Prevention’s (CDC) funding for global health was also protected in the final FY17 omnibus. Overall, the CDC Center for Global Health saw an $8 million increase from FY16 funding levels, including targeted increases for global public health protection and global disease protection activities.Funding for polio and measles was increased, while parasitic diseases, malaria, and global HIV and AIDS funding remained level. In addition, the National Center for Emerging and Zoonotic Infectious Diseases received a $5 million increase. CDC plays an important role in detecting, preventing, and responding to infectious disease threats at home and around the world. This work is critical to developing new prevention and diagnosis technologies, particularly those to address endemic and emerging global health threats. Robust funding for CDC’s global health programs is vital to advancing global health R&D and promoting global health security. Department of Defense The Department of Defense’s (DoD) work in infectious disease R&D was also strengthened in the final FY17 omnibus. DoD’s Peer Reviewed Medical Research Program—which conducts research on antimicrobial resistance, diarrheal diseases, emerging infectious diseases, malaria, TB, and vaccine development for infectious diseases—received $300 million in funding. In addition, the bill included strong report language supporting DoD’s critical work in global health R&D and supporting continued and robust investments. The final FY17 spending bill is encouraging news for global health R&D as it protected funding for critical global health and medical research accounts across USAID, NIH, CDC, and DoD. However, this victory may be only temporary, as we know that many of these same accounts will face intense pressures in FY18 budget negotiations, given aggressive action by the Trump Administration to downsize activities and reduce government spending. GHTC will continue to champion strong US leadership in global health R&D and stress the impacts of these important programs in protecting health at home and around the world.