Breakthroughs Blog: Malaria

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!

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Two recent announcements occurred regarding US international collaboration on global health research and development (R&D). Earlier this week, the US National Institute of Allergy and Infectious Diseases and the Office of AIDS Research at the National Institutes of Health announced a collaborative project with the Indian Ministry of Science and Technology and Department of Biotechnology to fight tuberculosis in India as part of the Indo-US Vaccine Action Program. On Tuesday, the US Department of Health and Human Services and the European Commission released the first report of the Transatlantic Taskforce on Antimicrobial Resistance (TATFAR), which is a joint commitment by the US and EU to fight antimicrobial resistance. Dr. Lucas Otieno Tina—a physician and researcher at the Kenya Medical Research Institute/US Army Medical Research Unit-Kenya collaboration program—writes in AllAfrica.com about why he has spent his career working to develop a malaria vaccine. He also discusses the promise of the RTS,S malaria vaccine and his involvement in the clinical trials for the vaccine supported by PATH’s Malaria Vaccine Initiative. Last week, the NTD Roundtable—a group of global health partners committed to fighting neglected tropical diseases (NTDs) —hosted briefings in the US House of Representatives and Senate to discuss America’s leadership in the fight against NTDs and the need for greater NTD R&D. The briefings were attended by representatives from key House and Senate committees, the NGO community, and the African diplomatic corps. Among other topics, participants discussed the need for the development of new diagnostic tools and treatments for NTDs. TechCrunch reports about a grant from the Bill & Melinda Gates Foundation to Sure Chill Company in Wales, which has developed a way to store vaccines at a proper temperature without the need for an electrified or gas-powered refrigeration source. The technology reduces problems with vaccine distribution caused by vaccines that lose their efficacy without proper refrigeration.

  As 2014 gets into full swing, the GHTC is looking ahead to many exciting developments on both the global health research and development (R&D) and policy landscapes: A step in the right direction: Policymakers in Congress recently passed both a budget deal for fiscal year (FY) 2014 and FY 2015, as well as a final appropriations package for FY 2014. The package included mixed results for global health research, however the compromise may hallmark a step towards a more “normal” appropriations process for FY 2015. We’ll be watching to see if policymakers boost support for the accounts—like those at the National Institutes of Health—that were hammered by the shutdown and budget sequester. Progress towards new malaria tools: In late 2013, GHTC member Medicines for Malaria Ventures received expedited regulatory approval from the US Food and Drug Administration to move treatment candidate tafenoquine into Phase III trials. And, the most recent clinical trial results of the RTS,S malaria vaccine candidate, released last year by partners PATH Malaria Vaccine Initiative and GlaxoSmithKline (GSK), have spurred excitement that the vaccine may be WHO-approved by 2015. To start the process, GSK announced plans to submit a regulatory application through the European Medicines Agency later this year. 21st Century Global Health Technology Act: Now that Congress has finalized its FY 2014 budget and moved on to other priorities, at the top of our list is the 21st Century Global Health Technology Act. The legislation was introduced in April of 2013 in the House of Representatives by Reps. Albio Sires (D-NJ) and Mario Diaz-Balart (R-FL) and boosts global health R&D programming at the US Agency for International Development. Rumors are a companion Senate version is coming very soon, so stay tuned! Exciting new research is coming up in 2014. Photo: PATH/Evelyn Hockstein R&D takes the stage at WHO: The World Health Organization (WHO) has made some progress in implementing the health R&D resolution it passed in 2013—including reviewing proposals for demonstration projects aimed at promoting R&D for medical products. The World Health Assembly will have eight finalists to choose from at its meeting this May. Horizon 2020 begins: In late 2013, the European Union approved €80 billion in funding for Horizon 2020—the European Parliament’s framework for research and innovation. This represents an increase in funding compared with previous years, and includes an emphasis on public-private partnerships for research. It will be interesting to see how this program affects the global health R&D landscape. State of the Union: This time last year, we were anticipating the start of President Obama’s 2nd term, and what shifts in agency and congressional leadership would mean for US global health research programs. The 2012 and 2013 State of the Union addresses emphasized harnessing innovation to make progress in health, education, and other areas. We’ll be watching this Tuesday night to see how the President plans to build on progress made in the remainder of his term. A new era for the President’s Emergency Plan for AIDS Relief: In other Administration news, Dr. Deborah Birx was recently nominated to be the new US Global AIDS Coordinator. Dr. Birx currently heads the Global HIV and AIDS program at the Centers for Disease Control and Prevention (CDC), and previously ran the Military HIV Research Program (MHRP) at the Department of Defense. We’re excited to see a leader in global health research take the reins of one of the US government’s most important global health programs. Pending her confirmation, it will be intriguing to see where Dr. Birx takes the agency, and how research for new global health tools will play a role. All health is global: Speaking of the CDC, two of the five most pressing health priorities that CDC’s Director Dr. Tom Frieden identified in a recent interview involve big impacts in global health research: eradicating polio and combating disease that originates outside of the United States. Between new research advancements and policy progress, there is clearly a lot we’re excited about for 2014. What new developments in global health R&D are you looking forward to? Ashley Bennett is GHTC's policy officer.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. GHTC member the International Vaccine Institute and the Institute for Translational Vaccinology have agree to collaborate on vaccine research and development and to promote capacity building in low- and middle-income countries. The partnership will focus on improving available technologies, as well as regulatory processes. The House and Senate Committees on Appropriations have released a fiscal year (FY) 2014 omnibus appropriations bill . Funding for global health programs at the US Agency for International Development saw some increases, while the National Institutes of Health remains woefully underfunded—even with an increase of $1 billion over last year’s post-sequestration levels. Results of an early-stage clinical trial show that stem cells taken from patients’ own bone marrow could be used to treat multidrug-resistant and extensively drug-resistant tuberculosis (TB). More tests will be required before this treatment option is validated as a possible alternative to current TB drugs. New research from Washington University in St. Louis School of Medicine has found that a form of malaria attacks red blood cells by “clamping down on cells with a pair of proteins.” This finding may aid scientists in the design of better vaccines and drugs against malaria.