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Most of us know what it’s like to be bitten by a mosquito. For those of us in non-malarious countries, the itchy sensation afterward is more annoying than anything, but it eventually goes away. I think it’s probably also safe to say that most people know that malaria is spread by mosquito bites. However, what’s less talked about are the different species of malaria and the need for different treatments depending on the type one has. The most deadly type of malaria is Plasmodium falciparum, and is most common in sub-Saharan Africa. However, another type—Plasmodium vivax (P. vivax)—tends to be the most difficult to cure. P. vivax malaria lives dormant in the liver and can relapse, causing malaria again anywhere between a few weeks and several months after the initial bite. It’s most prevalent in South and South East Asia, Latin America, and the horn of Africa and is responsible for 70-390 million cases of malaria per year. You may be asking yourself, “what’s the point of me telling you all this?” At the tail end of 2013, we heard the news that an investigational antimalarial drug—tafenoquine—for the treatment and radical cure of P. vivax had completed a Phase IIb study. Tafenoquine is being developed by GHTC member Medicines for Malaria Venture (MMV)—a nonprofit working to reduce the burden of malaria by discovering, developing, and facilitating the delivery of new and effective antimalarial drugs—and the pharmaceutical company GlaxoSmithKline (GSK). The results of the Phase IIb study were published in The Lancet last December.   The most deadly type of malaria is Plasmodium falciparum, and is most common in sub-Saharan Africa. However, another type—Plasmodium vivax (P. vivax)—tends to be the most difficult to cure. P. vivax malaria lives dormant in the liver and can relapse, causing malaria again anywhere between a few weeks and several months after the initial bite. Photo: PATH/Evelyn Hockstein Shortly afterwards, in light of the preliminary clinical evidence and in response to GSK’s application, the US Food and Drug Administration (FDA) granted Breakthrough Therapy designation for tafenoquine. Under the designation, the FDA will work closely with the sponsors (GSK and MMV) to provide guidance to expedite the development of tafenoquine. If approved, tafenoquine offers the potential for a single dose option. However, tafenoquine still has to go through more clinical trials, and regulatory review and approval before patients are potentially able to receive treatment for P. vivax malaria. Regardless, both the completion of the Phase IIb clinical trial and it being designated FDA Breakthrough Therapy status are encouraging news that should be told. It’s true there has been much progress in fighting malaria over the years, but hundreds of thousands of people still die each year from P. falciparum and many more suffer the subtle, chronic effects of repeated infection with P. vivax so further research efforts to tackle malaria are still required. Global health research has created lifesaving health tools that have contributed to some of the most astounding public health successes—both domestically and abroad. Research such as that being taken on by MMV and other nonprofit product developers should be supported so that new and much-needed technologies can be developed and eventually accessed by those that need them most. Research in malaria is clearly needed to develop additional tools in the arsenal against a potentially deadly mosquito bite.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. A new report sponsored by the Bill & Melinda Gates Foundation examines the need for post-market surveillance for new drugs and vaccines in low- and middle-income countries. The report is based off the findings from the Safety Surveillance Working Group, and provides recommendations stakeholders should take to strengthen post-market surveillance of global health products. The University of South Florida’s Center for Drug Development and Innovation, and the College of Public Health’s Department of Global Health have been awarded a grant of $2.1 million from the National Institutes of Health. The focus of the research will be to see how parasites, like malaria, grow. At a recent event in Washington, DC, US Agency for International Development (USAID) Administrator Rajiv Shah underscored the agency’s commitment to public-private partnerships. According to Devex, 40 percent of USAID’s resources are programmed through public-private partnerships. New studies show that patients with multidrug-resistant tuberculosis (TB) and HIV and AIDS have a higher chance of living if they take simultaneous treatment for both diseases, as oppose to waiting to take HIV and AIDS treatment. The initial study was small in size, but concurs with three previous major studies of people with regular TB and HIV and AIDS.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The University of Dundee in Scotland has developed a new antimalarial compound in their Drug Discovery Unit that has been selected by GHTC member Medicines for Malaria Venture (MMV) for further preclinical development. According to Dr. Kevin Read, co-project leader at University of Dundee, the compound will now undergo scale-up and further testing with the goal of entering human clinical trials in the next 18 months. In a Q&A, PATH Technology Solutions Program Leader Anurag Mairal writes about product development and distribution challenges in global health. Mairal writes: “The biggest challenge with all of these great innovations is that they’re sometimes disconnected from the realities of what is needed on the ground in low-resource settings. The hurdles that innovative ideas face before they can become a sustainable global health solution are many.” The US government has launched a new initiative to prevent, detect, and respond to infectious disease threats around the world. The initiative aims to improve security at infectious disease laboratories, strengthen immunization programs, and set up emergency response centers to deal with outbreaks. The Lancet writes about the progress made in the tuberculosis drug pipeline, and the implications for future treatments against the disease. The author notes that while recent developments have been very promising, the health of the pipeline rests in nine candidates—all of which are still in preclinical development.

In this guest post, Claire Wingfield—product development policy officer at PATH—writes about a series of dialogues PATH and other partners convened to discuss public-private partnerships for global health product development. PATH recently released a report outlining the key themes and recommendations identified during the three policy dialogues. Last year PATH hosted a series of dialogues in Washington, DC, London, and Brussels to highlight the role that public-private partnerships play in driving the development and introduction of new and innovative global health technologies. The aim of these discussions was to examine how the private, public, philanthropic, and nonprofit sectors are working together to address the health needs of low- and middle-income countries, and how these partnerships can evolve to sustain progress made during the past decade and better leverage limited resources in the future. Participants at the Brussels dialogue (from left to right): Gianpietro van de Goor, European Commission; Cecile Vernant, DSW Head of EU advocacy; Ole Olesen, EDCTP; MEP Maria da Graça Carvahlo; François Bompart, Sanofi; Claire Wingfield, PATH; Maite Suarez, IAVI. Photo credit: DSW Representatives from the US and European governments, nongovernmental organizations, philanthropies, and the private sector shared lessons learned, challenges, and why they see multi-sector partnerships as the most efficient means for accelerating research and development (R&D) targeting poverty-related and neglected diseases and conditions. At the event in DC—co-hosted by PATH and the Clinton Global Health Initiative in March—participants discussed ways to incentivize private-sector contributions to global health R&D, and leverage public-sector investment. The second dialogue took place in London in June and focused on the successes and challenges of public-private partnerships, and the important (and often unique) role that nonprofit product development organizations like PATH play in bridging the gap between partners and managing a complex portfolio. The third and final meeting, co-convened by PATH and Deutsch Stiftung Weltbevoelkerung (DSW)—a German NGO leading R&D advocacy efforts targeting the European Union—was held in Brussels in October, and participants reinforced the need for European governments to strengthen their investments in global health R&D. The key themes of the dialogues were: Innovative partnerships accelerate product development by bringing together the public and private sectors. Multi-sector partnerships can play an important role to address complex global health challenges. The business of health technology development changes quickly, and innovative, flexible models of collaboration for partnership are essential to ensure success. A comprehensive planning model that accounts for regulatory pathways, procurement, and distribution while products are still in development is necessary to speed product uptake. An important first step to a successful public-private partnership is ensuring the goals and strengths of each partner align. At the start of a project, partners must begin planning for both the product’s development and introduction. The markets of low- and middle-income countries represent tremendous growth opportunities and long-term sustainability for the private sector. By tapping into the burgeoning manufacturing capacity and knowledge economies of these and other low- and middle-income countries, public-private partnerships could better contain costs and support the efforts of government donors and funders that are prioritizing broader international development and economic growth over specific health outcomes. Product development for global health works best, fastest, and most efficiently when undertaken as part of a portfolio model in which partners coordinate R&D activities across a range of products at different stages of development. Because the perceived financial risks are often too high relative to the potential economic returns, and the scientific challenges are daunting for many of these diseases and conditions, it is impossible to rely solely on one organization or sector to meet the health needs of low- and middle-income countries. Therefore governments, academic institutions, nonprofit organizations, and private companies in high-, middle-, and low-income countries have—and must continue to) come together to share risk, leverage expertise, and maximize impact. These partnerships are an efficient and sustainable model for conducting global health R&D, and their impact can increase with flexible funding and business models, collaborations with nontraditional partners, and in close collaboration with governments and professionals in low- and middle-income countries.