Breakthroughs Blog: HIV/AIDS

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, US policymakers and global health advocates came together to talk about progress made on preventing maternal and child deaths. The US Agency for International Development (USAID) hosted a high-level forum called Acting on the Call: Ending Preventable Child and Maternal Deaths to both celebrate progress and assess the challenges that remain. The National Institutes of Health has awarded Boston Medical Center $861,000 to train Ugandans basic research for tuberculosis and emerging diseases. Boston Medical Center is one of five institutions to receive similar funding to enhance infectious disease research in low- and middle-income countries. Sabin Vaccine Institute’s Peter Hotez writes in the Huffington Post about the latest developments in hookworm vaccine development and the efforts of HOOKVAC—a global consortium uniting academic, medical, and research partners to find a vaccine to prevent neglected tropical disease hookworm, which currently more than 400 million people suffer from. ASPIRE—one of two late-stage clinical trials for a microbicide to protect women from HIV—has completed enrollment of trial participants, with 2,629 women from 15 trial sites in Malawi, South Africa, Uganda, and Zimbabwe. Now that enrollment is complete, we could potentially find out results from this pivotal trial by late 2015, early 2016. GHTC member Jhpiego has been awarded the US government’s largest project to end preventable maternal and child deaths. The Maternal and Child Survival Program, a 5-year, $500 million agreement supported by the USAID, will accelerate the rapid expansion of innovative, high-impact health approaches in 24 priority countries in order to save the lives of every woman and child in need. At an event last week launching the Pediatric HIV Treatment Initiative, panelists discussed the need for “the right medicines for pediatric HIV”—including the need for simplified treatments, and developing, producing, and distributing these medicines to children in low- and middle-income countries.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. As the DC summer kicks into full swing, Congress has had a busy month moving forward fiscal year (FY) 2015 funding legislation for a variety of government programs including global health research and development (R&D). Last week, both the House and Senate State and Foreign Operations (SFOPs) appropriations subcommittees held mark-ups of their draft bills. Unfortunately, the results were lukewarm for many global health R&D programs. Sens. Cardin (D-MD), Boozman (R-AR), and Coons (D-DE), along with Reps. Castro (D-TX) and McCaul (R-TX) have introduced legislation to authorize the US Agency for International Development’s (USAID) Global Development Lab. The Lab would expand innovative public-private partnerships focused on ending extreme poverty. A group of 35 leading scientists have come together to explore new strategies to accelerate vaccine development for deadly diseases such as malaria, HIV, tuberculosis. The scientists are part of a new initiative—called the Human Vaccines Project—aimed at paving a road map of the human immune system to help researchers speed up the development of vaccines for existing and emerging diseases. SciDev.Net reports that despite the fact that the United Nations World Intellectual Property Organization (WIPO) Re:Search project has brokered at least 60 partnerships to facilitate patent sharing between owners and researchers since 2011, no new drugs or therapies are in development as of today. However, Thomas Bombelles—head of global health at WIPO—says the creation of partnerships is an important first step and that WIPO now has funding to build research capacity in low- and middle-income countries, as well as aid information flow. USAID has released its report to Congress on its global health programs during FY 2013. The report describes the agency’s work to “end extreme poverty through its contributions in global health by ending preventable child and maternal deaths, creating an AIDS-free generation, and protecting communities from infectious diseases.” Pharmaceutical companies GlaxoSmithKline and Johnson & Johnson will collaborate to develop a new HIV treatment that will require only a single pill. If the trials are successful, the new treatment could offer a less toxic alternative to the current therapies available to treat HIV.

In this guest post, Renate Baehr—executive director of Deutsche Stiftung Weltbevoelkerung—writes about the next rendition of the European & Developing Countries Clinical Trials Partnership (EDCTP) and how its expansion will impact more lives in low- and middle-income countries. April 2014 was an important month for European support for global health research and development (R&D). Already the world’s leading contributor of development assistance (as measured by Official Development Assistance), and at the forefront of R&D in the health and pharmaceutical sectors, the European Union (EU) has agreed to significantly increase its budgetary support for global health R&D to tackle poverty-related and neglected diseases. Last month, the European Parliament and EU Member States reached an agreement on the successor to EDCTP —imaginatively entitled—EDCTP2. The EDCTP was established in 2003 and is a partnership of 16 European countries—among which 14 are members of the EU—and 48 sub-Saharan African countries, funded through the EU’s multiannual R&D budget, Horizon 2020. Its original objective when founded was to address the critical need for new and innovative medical products to prevent, diagnose, and treat HIV and AIDS, malaria, and tuberculosis (TB). Following its successful first cycle, both the scope and the budget of EDCTP have now been expanded. With a budget of €683 million, EDCTP2 will spearhead collaborative efforts to support the clinical development of new or improved diagnostics, drugs, vaccines, and microbicides against HIV and AIDS, TB, and malaria. The scope of EDCTP will also expand to include neglected tropical diseases (NTDs) prevalent in sub-Saharan Africa (excluding Chagas disease). Additionally, at a meeting in The Hague at the beginning of this month, the program welcomed eight African countries to join EDCTP. This is the first time in the program’s history that African countries will formally participate, a move which will for the first time enable their full participation in the EDCTP’s governance and decision-making structures through the EDCTP General Assembly. Why is this important? Because poverty-related neglected diseases—namely HIV and AIDS, malaria, TB, and the 17 NTDs listed by the World Health Organization here—affect more than one billion people across the globe. To respond to this challenge, EDCTP2 is directed towards supporting and developing much-needed, affordable, innovative, and quality health products to prevent, diagnose, and treat neglected infectious diseases. Not only is it targeted at having new products developed for market release by the end of the program, but in order to ensure that the successes of the program are sustained, EDCTP2 will also focus on increasing transnational research and developing research capacities in sub-Saharan Africa where they are needed on the ground. Breakthroughs achieved by EDCTP2 over the next 10-years have the potential to transform the lives of millions of people living with the devastating effects of TB, HIV and AIDS, and malaria. Global health R&D can have a direct impact on the health of people living in low- and middle-income countries, lifting a burden of diseases that stifles economic growth and prevents young men and women from reaching their full potential, socially and economically. EDCTP2 is one contribution to ending this, and we call on EU Member States to take this example and follow suit by ramping up their own funding for innovative ways to fight these diseases and advance global health. We look forward with interest as to how it will progress in the coming years. For more information on our work and what we are doing on global health R&D, check out our blog!