Research Roundup: SFOPS, new FDA guidance, top trends in global health, new report on global health R&D, and more

Earlier this week, Anne Hradský—advocacy coordinator for Global Health Research and Development (R&D), Katharina Scheffler—advocacy officer—and others from Deutsche Stiftung Weltbevoelkerung (DSW)—joined other European and African stakeholders for the Seventh European & Developing Countries Clinical Trials Partnerships (EDCTP) Forum in Berlin, Germany. EDCTP—which was established in 2003 and renewed in 2014—is a partnership of 16 European countries—among which 14 are members of the European Union (EU)—and 48 sub-Saharan African countries to accelerate the development of new or improved drugs, vaccines, microbicides, and diagnostics for HIV and AIDS, tuberculosis (TB), malaria, and neglected tropical diseases (NTDs). Upon her return from the forum, Ms. Hradsky answered a few questions about the value of EDCTP, the progress it has achieved, and news and insights that came out of this year’s forum. Anne Hradský—advocacy coordinator for Global Health R&D at DSW— answers our questions. Photo: DSW Anne Hradský—advocacy coordinator for Global Health R&D at DSW— answers our questions. Photo: DSW Q: From your perspective as a coordinator for an international development and advocacy organization, could you explain why EDCTP is such a valuable mechanism for advancing global health R&D? EDCTP is an incredibly important tool in EU policy for stimulating investment and research into HIV and AIDS, malaria, and TB. Furthermore, it is an important European-African partnership, which is directed towards supporting and developing much-needed, affordable, innovative, and quality health products to prevent, diagnose, and treat neglected infectious diseases. This is fundamentally important for global health as diseases such as HIV and AIDS, malaria, and TB affect more than one billion people across the globe. What is more, this burden falls disproportionately on young women, depriving them of their full potential. Specifically, the EDCTP boosts the development of new or improved health technologies by supporting multi-center and multinational projects that combine clinical trials, capacity building, and networking activities. It works to strengthen scientific capacity for clinical trials and clinical research in endemic countries—largely in sub-Saharan Africa—and by promoting collaboration between the medical sector, like-minded organizations, product development partners, research funders, and development cooperation agencies. You can read in more detail about the set-up of the EDCTP in the recently-published EDCTP in a nutshell. EDCTP Countries. Graphic: DSW Q: Now in its 11th year, what has EDCTP achieved and what’s ahead next for the partnership? The first phase of EDCTP has been a success in many ways. Simply, its establishment is an achievement in and of itself. As a result of the approximately 100 clinical trials EDCTP has supported so far, it has succeeded in finding eight improved medical treatments. Additionally, it has improved research capacity in sub-Saharan Africa. One intangible achievement of the program is to demonstrate the importance that EU policymakers have placed on supporting investment into innovative global health activities. What the last eleven years and what the next program hopes to achieve is to demonstrate that investment in global health R&D can have a direct impact on the health of people living in low- and middle-income countries. New medical interventions—like, for example, vaccines for malaria and HIV and AIDS or more effective and accessible contraceptives—can be utilized to lift a burden of diseases that stifle economic growth and prevent young men and women from reaching their full potential—physically, economically, and socially. Practically speaking, for EDCTP’s second phase starting in 2014, it aims to be even more ambitious. The budget has been nearly tripled, and a number of African countries graduated to full membership status—giving them equal powers in EDCTP’s general assembly. Furthermore, the scope of EDCTP will expand to cover NTDs, as well as Phase I and IV clinical trials. EDCTP2 is expected to have an even stronger coordinating role in national research programs and to succeed in bringing together large funds also from third parties to run resource intensive Phase III clinical trials. Q: What are the most exciting results, news, or outcomes that came out of this year’s forum? The forum gathered 320 participants from 42 different countries. An overall majority of these participants were young and confident African researchers who presented the tremendous research they have conducted in EDCTP-funded projects in the past several years. New interventions that have been incubated with the support of EDCTP were also showcased at the forum. Among these scientific achievements were: the identification of a new treatment regimen that may significantly shorten the duration of TB therapy; the successful Phase II trial of an HIV vaccine in Kenya; and, the conduction of first studies of controlled human malaria infection (CHMI) in African populations. What these innovations show is that investment in global health R&D can have real and potentially immediate returns on donor and private sector investment—developing treatments that are needed now for young men and women living in some the world’s poorest countries. The forum also succeeded in bringing together major funders of global health R&D such as the Bill & Melinda Gates Foundation, the Wellcome Trust, the German Ministry for Research and Education, and the Research Council of Norway. In the context of the partners’ session, DSW was delighted to have been given the opportunity to present its collaboration with EDCTP. DSW—in its mission to support increased funding for research into HIV and AIDS, TB , and malaria—has been a long standing advocate for EDCTP’s mission. As part of this support, we followed the formal session of the forum with a dedicated roundtable event on the benefits of EDCTP in the German parliament. At this event, we stressed the importance of a so-called political “buy-in” to the EDCTP process and the broader international fight against poverty-related and neglected diseases. Hopefully, the German members of Parliament in attendance left the meeting with a clear message to bring to their government colleagues: European governments need to step up their financial support and match the EU’s efforts in global health!

While lawmakers battled it out on the field last week during the annual Congressional Baseball Game (Democrats won for the sixth year in a row!), they found something they could join together on as the House Appropriations Committee easily approved the State and Foreign Operations Subcommittee’s (SFOPS) appropriations bill on Tuesday afternoon. Since GHTC reported two weeks ago on initial funding levels between the bills, both chambers have also released their accompanying reports which provide policy language that gives further clarity on the policymakers’ thinking and intent. What’s new? House and Senate appropriation reports included language supporting global health R&D. Photo: PATH/Patrick McKern We think the House Committee hit a home run in their inclusion of language submitted by the GHTC on the need for coordination across the US government on global health research and development (R&D). The language in the report directs the US Agency for International Development (USAID) to coordinate across the government with the other agencies involved in global health R&D. As it currently stands, there is no cross-US government global health R&D strategy, which leads to gaps in research, inefficiencies, and missed opportunities. This is a no-cost fix which will help leverage taxpayer dollars, fill gaps, and ensure that the ball is not dropped when valuable research needs to be shared across agencies. We’re glad to see policymakers are recognizing the need for improved coordination, and we are hopeful this language will be included in whatever final legislation is passed—whether in a continuing resolution, conference, or omnibus bill.   New to this year’s Senate report was the inclusion of a ‘Research and Development’ line within the Global Health section of the report which noted “the Committee supports investments in new global health technologies to address ongoing global health challenges.” This is another score for R&D advocates and one we hope will be included in final law. Also new for both chambers’ reports was the inclusion of language supporting the Global Development Lab. Both versions express support for the lab, as well as instructions to keep Congress informed on its progress. Continued support for R&D Similar to last year’s report, the House included language encouraging USAID to continue supporting research around the need for new drugs to address neglected tropical diseases (NTDs). Also like last year, the Senate language was a bit more enigmatic—noting the contributions of the private sector in R&D for NTDs, but not specifically mentioning USAID’s role in the process. Again, we’re hoping the House language will be included in the final bill. Similarly, the House provides strong language around continued support for microbicide development. R&D for malaria continued to have strong support, particularly from the Senate bill, which, similar to previous years, included language about the need for new insecticides, diagnostic, and vector control tools, alternatives to arteminisin combination therapies and counter resistance, and pediatric formulations. While this isn’t new, it’s encouraging to see this remains a priority for policymakers. As in previous years, the Senate bill provides strong support for the acceleration of research for contraceptives that are “effective, affordable, and easier to deliver.” Both reports included language about efforts to develop a malaria vaccine and language around the need for continued research for a vaccine to combat AIDS. Next steps Now that both chambers’ appropriations committees have approved their respective SFOPS bills, it will be up to policymakers to work out the differences, both in funding levels and policy. We’re hoping lawmakers can figure out a way to keep the ball rolling, but whatever happens, we’ll be watching the situation closely.