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In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Yesterday, Senator Patty Murray (D-WA) introduced in the US Senate a significant piece of global health legislation that would strengthen global health research programming within the US Agency for International Development and improve coordination of global health research and development across the US government. The legislation—known as the 21st Century Global Health Technology Act—is companion legislation to the House version of the bill, HR 1515, which was introduced by Representatives Albio Sires (D-NJ) and Mario Diaz-Balart (R-FL) in April 2013. Knight Therapeutics—the developer of a new treatment for the parasitic disease leishmaniasis—is looking to be the first company to auction off the priority review voucher it received from the Food and Drug Administration (FDA). The company received this voucher—which it can redeem to have any drug moved to the front of FDA’s line for product review—following the approval of its leishmaniasis drug Impavido in late March. A Guardian article on the vaccine cold chain discusses the logistical challenges for the global health community in delivering and administering vaccines—which require constant refrigeration for efficacy—in environments with unreliable electricity and infrastructure. It calls for the next generation of vaccines to be developed with the goal of eliminating a burdensome cold chain and notes the success of the MenAfriVac™ vaccine for meningitis which can be used for up to four days outside the cold chain. During the World Health Assembly, UNITAID, the Drugs for Neglected Diseases initiative, and the Medicines Patent Pool launched a new initiative to develop and deliver improved treatments for children suffering from HIV and AIDS. The initiative–known as the Paediatric HIV Treatment Initiative (PHTI)–will focus on three areas: (1) research and development; (2) intellectual property; and (3) market-shaping to ensure availability of treatment regiments for children living with HIV and AIDS. The World Health Organization released a new document on its efforts to find innovative financing for neglected diseases. The documents states there is a $50 million budget line for demonstration projects and the Global Health R&D Observatory over four years, but did not make clear where the observatory would be situated.

The Global Health Technologies Coalition (GHTC) today released the fifth and final paper and a summary of findings paper in its briefing series examining financing, accessibility, regulatory, and capacity issues facing nonprofits engaged in global health research and development (R&D). The five-part series aims to inform policymakers and other stakeholders with an interest in advancing R&D to meet health needs in low- and middle-income countries (LMICs). The series focuses on nonprofit product development organizations (NPPDs), or nongovernmental organizations that partner with the public, philanthropic, and private sectors to develop health products specifically targeting poverty-related and neglected diseases in LMICs.NPPDs play a vital role in bringing together the fragmented resources and expertise of the various sectors involved in neglected disease R&D. The fifth and final paper examines efforts by NPPDs to strengthen the research and manufacturing capacity of academic, nongovernmental, and commercial partners in LMICs. The summary of findings paper provides an overview of the key challenges, lessons, and potential solutions identified by NPPDs in their efforts to advance the development of new vaccines, drugs, diagnostics, microbicides, and other health products for LMICs. The final paper on capacity-strengthening finds that while the mission of NPPDs is developing new health products, rather than capacity-building, many NPPDs have had to actively invest in improving the capacity and infrastructure of their local product development partners. This is because research and manufacturing infrastructure in LMICs remains weak, and many local partners have limited or no experience in conducting research and manufacturing in line with international safety and quality standards. NPPDs are engaged in capacity-strengthening work such as upgrading research and manufacturing facilitates, providing training across many skill sets, and transferring technological knowledge. In the capacity paper, NPPDs offer a set of key lessons that they and their partners have learned in trying to strengthen local research and manufacturing capacity to bring new health technologies to those most in need: There must be a shared commitment among partners to comply with international technical and ethical standards to ensure volunteers’ safety and rights as well as to facilitate access to high-quality products among those in need. Capacity-strengthening investments must weigh accelerating the near-term availability of much-needed products against the potential of lengthier timelines to increase capacity. At times, the need to accelerate access to a product may take precedence over local capacity strengthening. Capacity strengthening should enable home-grown solutions and local product development to be responsive to existing needs and emerging challenges. These efforts should enable local engagement and country ownership of health research, related product development, and manufacturing in endemic countries. Capacity-strengthening investment needs to be sustainable and enable LMICs to leverage the value of this increased capacity for their continued future growth. Because capacity strengthening can be a time-consuming and complex endeavor, donors and governments in endemic countries must commit to financing and enforcing international research and manufacturing standards to ensure an even playing field for the long-term sustainability of these efforts. The summary paper concludes that NPPDs face a number of challenges including insufficient funding, shortcomings in regulatory systems, and limited local research and manufacturing capacity which hinder progress on R&D for poverty-related and neglected diseases in LMICs. However, NPPDs have identified a number of solutions to address these challenges including working toward securing more predictable, stable, and long-term funding across all phases of product development, diversifying funding sources and improving coordination across funders. As well, NPPDs are seeking policy changes and sustainable funding to improve regulatory capacity and pathways and working to strengthen local partners’ research and manufacturing capacities to meet international standards. This fifth and final paper—Briefing Paper, Volume 5: Working with partners to strengthen local research and manufacturing capacity—and the summary of findings paper—Advancing research and development to address poverty-related and neglected diseases and conditions—are part of a series from the GHTC that examines financing, accessibility, regulatory, and capacity issues facing NPPDs. The series aims to inform global policy and financing discussions about R&D for neglected and poverty-related diseases affecting LMICs.

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.