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In this guest post, Claire Wingfield—product development policy officer at PATH—writes about a series of papers she developed for the GHTC that outlines key challenges, lessons, and potential solutions in advancing research and development (R&D) to address poverty-related and neglected diseases and conditions. New drugs and vaccines and other health technologies developed over the last few decades have significantly increased life expectancy in most countries. But a wide gap still exists between the health outcomes of the richest and poorest countries. While high-income countries have been able to benefit from recent innovations in health R&D, many of the poorest populations are not able to access these new and improved technologies. For years there has been global debate about how to improve the coordination and increase resources being devoted to R&D targeting poverty-related and neglected diseases and conditions. In order to inform these discussions, the GHTC recently developed a series of briefing papers providing the perspectives of nonprofit product development organizations (NPPDs) on accelerating product development to meet the health needs in low- and middle-income countries (LMICs). Today, GHTC is launching a summary of the findings from the briefing papers which provides an overview of the key challenges, lessons, and potential solutions identified by NPPDs, as well as a final briefing paper describing capacity strengthening activities. New drugs and vaccines and other health technologies developed over the last few decades have significantly increased life expectancy in most countries. But a wide gap still exists between the health outcomes of the richest and poorest countries. Photo credit: PATH/Umit Kartoglu The first paper in this series set the stage by providing examples of how NPPDs approach product development and describing the key challenges that NPPDs and their partners face in developing and introducing technologies that address the health needs of LMICs. The second paper provided the perspectives of NPPDs on the most significant funding challenges and the types of financing mechanisms that support their work. The third paper described how NPPDs and their partners try to ensure access in LMICs to the knowledge and technologies they develop. The fourth paper outlined the most significant regulatory challenges faced by NPPDs and partners throughout the product development process and described how these challenges affect their work. The fifth paper in the series describes NPPDs’ efforts to strengthen the research and manufacturing capacity of academic, nongovernmental, and commercial partners in LMICs, and provides examples of the criteria that NPPDs consider when determining investment in capacity strengthening. NPPDs were created to speed the development and adoption of new technologies targeting the public health needs of the world’s poorest populations. Through partnerships with the public and private sectors, NPPDs bring together the resources and expertise of various groups to advance and increase access to health products that would not otherwise be available for commercial reasons in LMICs. Although many NPPDs have effectively advanced R&D for poverty-related and neglected diseases over the past two decades, progress has been hindered by a number of challenges. The summary paper provides a high-level overview of these challenges which include insufficient funding, lack of consistent regulatory requirements and limited capacities of national regulatory authorities, and limited local capacity for research and manufacturing. Each briefing paper provides a deeper analysis of NPPD perspectives on each of the challenges and how they have worked with partners to address these issues. NPPDs are working toward more predictable, stable, and long-term funding across all phases of product development, as well as diversified funding sources and improved coordination across funders. They are pursuing policy changes and sustainable funding to improve regulatory capacities and pathways for products targeting LMICs. And they are strengthening local partners’ research and manufacturing capacities in line with international standards. Implementing these solutions will further enhance R&D for poverty-related and neglected diseases and conditions and thereby increase access to needed drugs, diagnostics, vaccines, and devices in LMICs. This will not only help to save lives and improve health among vulnerable populations but also contribute to local economic development.

Photo: AVACYesterday, May 18, marked the observance of World AIDS Vaccine Day­­–an annual event to focus attention on the need for a vaccine to prevent HIV infection and AIDS. Although three decades have passed since HIV and AIDS were first identified, more than 1.5 million people still die from AIDS and millions of others contract HIV each year. Despite advances in treatment and prevention, for every three people put on treatment, four others contract HIV. An AIDS vaccine is an important part of a long-term strategy to end the AIDS epidemic. Today, more government institutes, nonprofits, academic research labs, and pharmaceutical and biotechnology companies than ever before are engaged in the global effort to develop a vaccine. The road ahead may prove long and bumpy, but recent breakthroughs in science and technology have boosted confidence that an AIDS vaccine is achievable and on the horizon. Sustained political and financial support is critical to translating this promise into a product. See the infographic below from AVAC for key numbers that indicate the progress that has been made toward the development of an AIDS vaccine.

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.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Joanne Carter—executive director of RESULTS Education Fund—writes about the negative impact the proposed fiscal year (FY) 2015 federal budgets cuts could have on the development of new treatments for tuberculosis (TB). The President’s FY 2015 budget has proposed a $45 million cut—or 19 percent reduction—to the US Agency for International Development’s TB budget. On the occasion of the first meeting on the world’s Global Health Security Agenda this week, Tom Frieden—director of the Centers for Disease Control and Prevention (CDC)—and Andy Weber—assistant secretary of defense—wrote a feature on CNN about why global health security matters to the US. They highlight the $40 million commitment by CDC and the Department of Defense to enable its 12 partner countries to strengthen their ability to prevent, detect, and effectively respond to infectious disease threats worldwide. The International Partnership for Microbicides (IPM) announced this week that it has received the exclusive worldwide rights to dapivirine—a promising HIV prevention medicine—from Janssen R&D Ireland, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. This represents an expansion of IPM’s existing rights to develop, manufacture, and bring to market dapivrine-based products for women in resource-poor countries. The Washington Post Innovations Blog notes five reasons why we should be worried about the future of American innovation. It discusses how unstable and inadequate spending on research and development will stymie the future of scientific research and innovation. This week, the Council of the European Union approved the participation of the European Union in the second program of the European & Developing Countries Clinical Trials Partnership. The second program will support all stages of clinical trials, from Phase I to IV, for HIV and AIDS, TB, malaria and neglected tropical diseases. The Washington Post Editorial Board argues that time is short to address antibiotic resistance in response to the World Health Organization’s warning last week that resistance to antibiotics has become a “major threat to public health.” The article notes that the overuse of antibiotics has bred drug resistance and that few new antibiotics are in the development pipeline to remedy the problem.