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The Global Health Technologies Coalition (GHTC) today released a paper that provides new and comprehensive insights into the challenges facing organizations that advance research and development (R&D) for neglected diseases. The paper—titled Financing and Coordination of Health Research: Perspectives from Nonprofits on Accelerating Product Development and Improving Access for Low- and Middle-Income Countries—also offers concrete solutions to these obstacles. The paper focuses on how nonprofit product development organizations (NPPDs) work to advance R&D for diseases in low- and middle-income countries (LMICs), such as HIV/AIDS, tuberculosis, malaria, neglected tropical diseases, and maternal and reproductive health conditions. NPPDs are nongovernmental organizations that partner with the public, philanthropic, and private sectors to develop health products—including diagnostics, drugs, devices, vaccines, and microbicides—specifically targeted for health needs 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—not only by developing and delivering health products that would not be available otherwise, but also by improving scientific understanding for many of these conditions. For example, the NPPDs included in the paper reported contributing to the development of more than 450 health technologies across neglected and infectious diseases, as well as maternal, newborn, child, reproductive, and sexual health. Despite this progress, NPPDs reported significant gaps in current R&D efforts. These obstacles include: Funding: Numerous NPPDs said that there are too few funders investing too few resources in R&D for neglected and poverty-related diseases. In 2010 and 2011, 12 funders accounted for almost 90 percent of these R&D efforts. This lack of funding threatens to stall or halt progress. Regulatory systems: Navigating weak and disjointed regulatory systems can be a major obstacle for NPPDs. Many cited a lack of consistent regulatory requirements, as well as limited capacity of national regulatory authorities, as the cause of major delays and increased costs. Local capacity: NPPDs also reported that limitations on local research and manufacturing capacity hinder their ability to keep the R&D pipeline filled and successfully deliver new health tools. Fortunately, the paper offers the following solutions, which were identified by NPPDs as necessary to enabling the successful development and delivery of new health tools for LMICs: Sustainable and consistent funding. More predictable, stable, and long-term funding across all phases of product development is needed, as well as diversified funding sources and improved coordination across funders. Better coordination could be achieved through a centralized mechanism tasked with identifying R&D needs, gaps, and priorities. Capacity building for local partners. NPPDs and their partners need sufficient resources to invest in strengthening their local partners’ research and manufacturing capacities. Improving regulatory pathways and capacities. NPPDs noted that policy changes and adequate, sustainable funding are needed to support capacity building and alignment of regulatory requirements. This paper is the first in a series from the GHTC that will examine 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. This first paper provides a high-level overview of the greatest gaps and challenges faced by NPPDs, and further papers will explore these issues in greater detail.

In this guest post, Regina McEnery from IAVI Report writes about the planned closure of the New England Primate Research Center and its effects on the community of HIV researchers who conduct primate studies. As animal facilities go, the New England Primate Research Center (NEPRC) had attained a legendary status on the roster of US biomedical research institutions. A good number of important discoveries have been made within its walls in the half century it has been around. Researchers working there generated some of the earliest evidence that AIDS is a viral disease, and subsequently discovered the simian immunodeficiency virus (SIV), which causes the monkey version of AIDS. It was there, as well, that scientists demonstrated that a vaccine can prevent the transmission of SIV, suggesting that an HIV vaccine is possible. Nor were the NEPRC’s contributions to science confined to HIV and AIDS. The facility has hosted research of profound relevance to everything from cancer to neurological disease and addiction. But lately it had become increasingly clear that this storied institution’s best days were behind it—so far behind it, in fact, that the Harvard Medical School (HMS), which oversees the center, decided it should be shut down. Its decline was slow and fueled largely by management and money problems, rather than the quality of its research. The NEPRC has, for example, been cited at least four times since 2010 by the US Department of Agriculture (USDA) for failure to comply with the requirements of the Animal Control Act. The most recent citation, issued last year, related to a cotton-top tamarin found dehydrated after an employee neglected to provide sufficient water to the squirrel-sized monkey. After examining its recent health history, the NEPRC veterinarian decided to euthanize the monkey, according to the USDA report. The New England Primate Research Center, which had attained a legendary status on the roster of US biomedical research institutions, will be closing. Photo courtesy of IAVI Report. John Harding, acting director of the Division of Comparative Medicine within the Office of Research Infrastructure Programs (ORIP)—the National Institutes of Health arm that provides the core grants for all national primate research centers—notes that it is “ very uncommon to find violations of the sort where animals died.” Still, HMS’s decision to wind down the facility by 2015 has upset the close-knit community of primate researchers. “We were all shocked,” says Ron Veazey, a professor of pathology at the Tulane National Primate Research Center in Louisiana. “Very few people can say, ‘we saw this coming.’ In an ideal world, all those [NEPRC] investigators will be able to transfer projects to other primate centers and everything will go on. But we can’t be sure.” The NEPRC decision to phase out its research also raises serious questions about the future of the approximately 130 projects it hosts—many of which relate to AIDS. Ditto for the 2,000 or so primates housed at the facility in Southborough, MA. The closure is likely to be widely felt throughout the field of HIV research, especially in the areas of vaccine and drug development. “Literally every class of HIV drug, with the exception of protease inhibitors, was first tested in monkeys,” noted Veazey. Louis Picker, a professor of pathology/molecular microbiology and immunology affiliated with the Oregon National Primate Research Center, says he was upset by the decision to shut down the NEPRC—where he did research during his laboratory and pathology medicine residency at Beth Israel Deaconess Medical Center in Boston. But he wasn’t surprised. “You could see the writing on the wall when this first started, two to three years ago, with the mishandling of the animal issues.” Picker says that Harvard’s response to the animal care issues—replacing NEPRC director Ron Desrosiers and two on-site veterinarians—served to drive investigators away rather than fix the problem. HMS, however, did not single out the animal care issues in explaining its decision. In evaluating its long-term needs, HMS says, it concluded that closing NEPRC would be more beneficial and efficient than pouring more resources into maintaining and renewing its supporting grant. “We were surprised,” says Harding. Yet Harvard’s decision, he says, should not be viewed as a signal that interest in funding nonhuman primate research is waning. “In fact, we see a continued need for this.” If anything, says Harding, the recent termination of the large HVTN 505 trial suggests more nonhuman primate research is needed. Still, even researchers personally unaffected by the closure of the NEPRC find its disappearance from the HIV research map hard to take in. “Personally, I see it as a loss for Harvard and for the New England research committee,” said Ana Aldovini, a scientist at Boston Children’s Hospital who once used the NEPRC, but now collaborates with Tulane. “I can’t imagine it not being a loss.” A longer version of this article is available at www.iavireport.org.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. In a continuation of the US Agency for International Development’s (USAID) focus on global health science and technology, GHTC members PATH and Research!America write about the health and economic benefits of US investments in product development. In related news, USAID has released new figures detailing how over the past decade, the agency has been involved in more than 1,600 public-private partnerships with more than 3,000 individual entities The National Institutes of Health published figures detailing how sequestration will impact its 2013 budget. According to the figures, available funds will drop by $1.55 billion from last year. Aeras received at $2.9 million grant from the Bill & Melinda Gates Foundation to work in collaboration with the University of Oxford and biopharmaceutical company Okairos to support the development of vaccines against tuberculosis, HIV, and malaria. PATH has launched a clinical trial in Bangladesh to test a new formulation of oral rehydration solution, a therapy to combat severe dehydration resulting from diarrheal disease.

Last week, Reps. Gerry Connolly (D-VA), Karen Bass (D-CA), and Earl Blumenauer (D-OR) introduced the Global Partnerships Act of 2013. The bill is a welcome step to reform the US government’s foreign assistance programs, including strengthening important aspects of US global health research and development (R&D) efforts. Throughout the bill, research and innovation to improve health worldwide are highlighted as central components of US foreign assistance programs. For instance: Harnessing research, innovation and technology is included as one of the key elements of a new global health sector strategy required by the legislation. In addition to a new overarching Global Development Strategy, the bill would require strategies for all of the major foreign assistance sectors, such as global health, every four years. R&D for new health technologies and solutions is prioritized in the legislation as one of four programmatic health areas the bill would support. The others are: maternal health and child survival; family planning and reproductive health; and combating disease. Research for new technologies is also highlighted as essential to the overall success of US foreign assistance programs. The bill includes strong support for public-private partnerships, such as nonprofit groups that develop global health vaccines, drugs, diagnostics, and other products. Finally, the bill would establish a $50 million per year Innovation Fund at the US Agency for International Development. The fund would support “innovative projects and evidence-based solutions that may be tested, replicated, and scaled up in partner countries to significantly improve development outcomes,” including global public health. The bill provides a promising future for US foreign assistance programs—an effort that reflects former Rep. Howard Berman’s (D-CA) legacy in foreign aid policy (Rep. Berman introduced the same bill before he departed Congress at the end of 2012). The bill rightly places research and innovation at the crux of the global health sector, and provides guidance for needed reforms to the US foreign assistance system. As Rep. Connolly said when releasing the bill, “It is time for a complete overhaul of the way we administer foreign aid. The 21st century requires a foreign aid program that recognizes today’s priorities and streamlines the process in the post-Cold War era.” Congress should unquestionably move this legislation forward and introduce a Senate companion bill. However, given that Congress hasn’t made much traction on most pieces of legislation in the past few years, the Partnership Act’s fate isn’t clear. It’s also possible that sections of this legislation may spin off into their own separate bills and see success. The important thing is to keep the congressional dialogue around foreign aid reform going, and not to lose momentum for urgently needed reforms and improvements. You can read a press release from Rep. Connolly here, and a statement from the Modernizing Foreign Assistance Network here.