Breakthroughs Blog: NTDs

  Senate supports global health R&D in defense appropriations bill and report. Photo: Ken Kistler Earlier this month, we reported that both the House and Senate Appropriations Committees included language supporting global health research and development (R&D) in their reports concerning funding for the Department of State, foreign operations and related programs. Last week, we heard even more good news for global health R&D out of the Senate Appropriations Committee—this time related to the Department of Defense (DoD). The fiscal year (FY) 2015 defense appropriations bill—which was approved by the Committee last Thursday—includes a $7 million increase for peer-reviewed medical research—from $200 million in FY 2014 to $207 million this year—despite reducing overall DoD funding from FY 2014 levels. In addition, in the accompanying report, the Appropriations Committee includes very strong language recognizing DoD’s substantial contributions to global health R&D and the need to support sustained US investments in this area. The committee report includes language submitted by GHTC recognizing “the critical contribution that the department’s [R&D] portfolio makes in protecting our troops from infectious and neglected diseases they may encounter on missions around the world” and noting “the need to sustain and support US investment in this area by fully funding those R&D programs that carry out this work.” Committee recognizes role of infectious disease research in improving US security The committee report also recognizes the threat that neglected infectious diseases—such as malaria, dengue fever, and Chikungunya—pose to the effectiveness of US forces deployed overseas and expresses concern over reductions in research funding for these disease areas. In the report, the committee notes that it is “concerned with the department’s decisions over recent years to precipitously decrease funding for malaria research” and that it “encourages the department to address diseases of military importance and invest in research for chemoprophylaxis, surveillance, and other countermeasures.” Photo: PATH/Gabe Bienczycki Report calls for DoD to improve coordination across R&D programming The committee report also includes language—submitted by GHTC—which directs each DoD program involved in infectious disease research to submit a report of its R&D activities to the House and Senate Defense Committees outlining the program’s funding and accomplishments from FY 2011 through 2014. As well, the committee urges DoD to partner with other organizations involved in infectious diseases research—including other federal agencies—to mitigate the duplication of research efforts and maximize the use of DoD resources. It is GHTC’s hope that these reports and activities will lead to improved coordination across DoD global health R&D programs, as well as improved coordination across all US agencies involved in global health R&D, which will in turn help fill current gaps in research programming and assure US investments are used most effectively. GHTC is glad to see the Senate recognizing DoD’s critical role in global health R&D, as well as advocating for sustained funding and improved coordination for global health R&D programming at DoD. We are hopeful that the language included in the Senate defense appropriations report will be included in whatever final legislation is passed.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Last week, Deutsche Stiftung Weltbevoelkerung (DSW) attended the seventh European & Developing Countries Clinical Trial Partnership (EDCTP) Forum in Berlin, Germany. Anne Hradský—advocacy coordinator at DSW—writes about the value of EDCTP, the progress it has achieved, and news and insights that came out of this year’s forum. The Lancet has published results for the first-ever large-scale Phase III clinical trial for a vaccine against dengue fever. The results show that the three-dose vaccine could reduce cases of dengue fever by 56.5 percent and dengue hemorrhagic fever—a more severe form of dengue—by up to 88.5 percent. The vaccine is being developed by pharmaceutical company Sanofi Pasteur. A new form of easy-to-use injectable contraceptive Depo-Provera—called Sayana® Press—was introduced in Burkina Faso last week as part of a four-country rollout this year. The new form uses PATH-developed Uniject™—an autodisable injection system involving a plastic bubble with a needle attached and filled with one dose of the contraceptive. The device will be introduced next in Uganda, Senegal, and Niger. The Global Post has published the first article in a special report examining how US-backed public-private partnerships (PPPs) are making an impact on global health and whether there is evidence justifying increased US investment in PPPs, especially by the US Agency for International Development. Leaders of the biopharmaceutical research community called on Congress to improve the clinical research process to accelerate the discovery and development of new medical therapies. The 21st Century Cures Initiative—part of the House Energy & Commerce Committee—asked experts to present “strategies for reducing regulatory oversight, speeding up clinical research processes, and utilizing technology to better understand the potential benefits and risks of promising new treatments.”

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!

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Last week the House Appropriations Committee easily approved the State and Foreign Operations Subcommittee’s (SFOPS) appropriations bill. Both chambers have also released their accompanying reports which provide policy language that gives further clarity on the policymakers’ thinking and intent. The US Food and Drug Administration (FDA) has released a guidance to assist sponsors in drug development for the treatment and prevention of neglected tropical diseases (NTDs) for low- and middle-income countries. The guidance is intended to represented the FDA’s current thinking regarding drug development for NTDs, including clinical trial designs and internal review standards to support approval of drugs. UK Prime Minister David Cameron has called for a global action plan to effectively treat drug-resistant superbugs. Prime Minister Cameron appointed ex-Goldman Sachs Chief Economist Jim O’Neill to lead the analysis on the issue and identify why few new antibiotics are being developed. The O’Neill Commission will also develop a plan for “encouraging and accelerating antibiotic development,” as well as explore incentive mechanisms for drug makers to produce antibiotics even if they are rarely used. Global Health Council (GHC) Executive Director Christine Sow recently wrote about the top ten trends shaping today’s global health outlook. Sow—who was made executive director of the GHC last November—went on a “listening tour” over the last three months to get a better sense of the global health community’s priorities and needs. The All-Party Parliamentary Group on global tuberculosis (TB) in the United Kingdom has released a new report on research and development for global health. The report seeks to explain why diseases that kill so many are neglected in research efforts, and provides a wide range of views and ideas on how to solve the problem.