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During the past year, leaders from the US Global Leadership Coalition (USGLC)—an advocacy organization promoting diplomacy and development—have traveled across America seeking out innovators and innovations that best demonstrate how strategic US investments in global development can enhance America’s foreign policy and security interests—an approach USGLC calls “smart power” diplomacy. The VVM is a health innovation that is saving lives and money. Photo: Umit Kartoglu Not surprisingly, USGLC leaders discovered that investments in global health innovation are an essential part of America’s “smart power” toolbox. As USGLC leaders traveled from city to city, they discovered numerous examples of how American businesses and nongovernmental organizations (NGOs) are working with the US government to deliver global health innovations that are not only improving lives worldwide, but also creating jobs here in the United States and enhancing America’s global leadership. In fact, nearly half of the 30 programs USGLC identified as “leading American innovators” in its Innovations in Smart Power report—released today—focused on improving global health and nutrition. The report featured two innovations developed by GHTC members, including the PATH-developed Vaccine Vial Monitor (VVM), which indicates whether vaccines have been damaged from exposure to heat. The VVM not only saves lives, but also produces an estimated $14 million annual savings by preventing undamaged vaccines from being discarded. USGLC also featured the Global Health Fellows Program II—led by the Public Health Institute—which brings private sector experts from America to low- and middle-income countries in Africa and Asia—for up to three months—to share their expertise in research and medical technologies with healthcare workers in local communities. Two interns sponsored by the Global Health Fellow Program help build a house for an HIV expectant mother in Uganda. Photo: Global Health Fellows Program II/PHI Other creative global health innovations featured in the report include low-cost toilets to reduce diarrheal disease, fortified peanut paste to combat malnutrition, and an easy squeeze pouch to help HIV-positive mothers deliver antiretroviral drugs to their newborn babies. All of these projects were supported by the US government, and demonstrate how American ingenuity and investments can tackle some of the world’s greatest global health problems. It’s clear that sustained American investment in global health innovation not only supports domestic and international health improvements and economic growth, but also serves as an important diplomatic tool and a demonstration of America’s character. In other worlds, investing in global health innovation=smart power.

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.