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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. More detailed information about the President’s fiscal year (FY) 2015 budget requests to Congress was released this week, resulting in a mixed bag for global health research and development. The Congressional Budget Justifications—annual presentations to Congress to justify requests for funding—help shed more light on the administration’s priorities for FY 2015. The results of a Phase III clinical trial for a rotavirus vaccine were released this week and published in The Lancet. The vaccine candidate—which was tested in India—was found to be safe and have modest efficacy of 53.6 percent against severe rotavirus gastroenteritis. New data shows that the number of principle investigators with National Institutes of Health (NIH) funding dropped significantly last year—between 500 and 1000 researchers. While NIH funding has been on the decline over the last several years, the most significant drop in researchers was due to last year’s sequestration. GHTC member Seattle BioMed has a received a $9.8 million grant from the National Institute of Allergy and Infectious Diseases to develop two new vaccines against HIV and AIDS. Seattle BioMed will lead a consortium of academic institutions working together on the project, including Rockefeller University, the University of Washington, Seattle Children’s Hospital, and the Fred Hutchinson Cancer Research Center.

As more detailed information about the President’s fiscal year (FY) 2015 budget requests to Congress is released, the results continue to be a mixed bag for global health research and development (R&D). The Congressional Budget Justifications—annual presentations to Congress to justify requests for funding—help shed a light into the administration’s priorities for FY 2015. National Institutes of Health (NIH) While the President made a modest request for overall NIH funding, the release of the NIH congressional budget justifications gives us a better sense of how the President hopes to fund specific institutes and programs at the agency. The National Institute of Infectious Diseases (NIAID) did include increases of $5.76 million for Biodefense and Emerging Infectious Diseases, $6.95 million for infectious and immunologic diseases, and $23.4 million for HIV and AIDS research compared with funding for FY 2014. The President’s request for the Office of AIDS Research—which covers all HIV and AIDS activities within all of the centers at NIH—was $3.004 billion. While this is nearly a $20 million increase from 2014 enacted levels, this number is still below enacted numbers for 2011 and 2012. Within this request was a decrease of 0.4 percent from 2014 funding for microbicides, an increase of 0.8 percent for vaccine research and a decrease of 1.4 percent for therapeutics research. Centers for Disease Control and Prevention (CDC) Historically, research at the CDC has led to major advances against devastating diseases, including the eradication of smallpox and advances in AIDS research. With a disappointing funding request for NIH, we were glad to see a much stronger request for the global health budget within the CDC. The President’s request included $445.29 million for Emerging and Zoonotic Infectious diseases, a $54.85 million increase from FY 2014 levels. Included in this was the $30 million requested for the Advanced Molecular Detection Initiative. The $30 million will go towards investments in advanced molecular detection technologies to help speed up outbreak detection and increase response efficacy. We’re glad to see the Administration acknowledging the need for the CDC to be cutting-edge in an increasingly global arena. US Food and Drug Administration (FDA) Amongst the government agencies involved in various stages of the development pipeline, the FDA has a vital role to play in accelerating the review of new global health products and strengthening the global regulatory system. Despite the tough budgetary times we currently face, Congress has been asking the FDA to do more with less. That said, we were pleased to see the President acknowledge that increased authority should also mean increased funding, with a robust request of $4.7 billion for the FDA, an 8.1 percent increase from Congress’ appropriation for 2014. The FDA’s Congressional Budget Justification acknowledged the unique role of the agency as an important international collaborator for global health through research and information sharing. The language specifically highlights the Biologics Program and its work to promote research and information sharing to facilitate access to vaccines and other products, harmonize regulatory standards, and establish and maintain standards for biologics. Another highlight is the news that FDA is in the process of drafting a proposed rule to add to their current list of neglected diseases for which they can allow accelerated reviews, and is specifically considering adding Chagas disease. US Agency for International Development (USAID) As we reported in our first blog post, while funding for global health at USAID and the Department of State was fairly disappointing, we were pleased to see an increase in the President’s request for malaria. Notable in this request was acknowledgement of the need for continued funding for R&D to support “the development of new malaria vaccine candidates, antimalarial drugs, new insecticides, and other malaria related research with multilateral donors.” Also in the USAID request was $153 million in central funding to accelerate science, technology innovation, and partnership. USAID describes this aim to “develop and scale breakthrough solutions and accelerate the transformation of the United States’ development enterprise by leveraging outside resources and improving the sustainability of development programs by attracting private-sector, market driven resources.” Department of Defense (DoD) DoD is the only US agency that funds global health research and product development from discovery to introduction. While we’re still sifting through all of the details in the Defense budget justifications, R&D at the agency—including health R&D—increased overall by 1.7 percent over FY 2014 enacted levels. Much of the global health research at DoD is funded through the Army’s Research, Development Testing and Evaluation (RDT&E) division as well as the Defense Health Program—including research on HIV and AIDS, malaria, and leishmaniasis. While we’re grateful the administration is continuing to recognize the need for sustained, robust support for global health R&D across several agencies, the decline of global health research funding in some key accounts remains concerning. We’ll look to Congress to equip these agencies with the necessary resources to carry out their essential role in developing new global health tools.

In this guest post, Claire Wingfield—product development policy officer at PATH—writes about a new paper she developed for the GHTC that outlines key regulatory challenges encountered by nonprofit product developers. The regulatory landscape for health products targeting the needs of low- and middle-income countries encompasses many stakeholders, mechanisms, and levels of oversight on the global, regional, and national levels. And at every step of the product development process there are regulatory milestones to be met, no matter the type of health technology, the health condition being addressed, or the geography. Subsequently, developers often engage a number of regulatory stakeholders throughout a product’s lifecycle, and encounter any number of challenges along the way. Costs for product developers and manufacturers to comply with regulatory requirements are a large—and growing—component of research and development (R&D) expenditures, and regulatory challenges can delay timely access to technologies for patients. Despite this, until recently policymakers and donors have paid little attention to regulatory reform in discussions on improving financing and coordination of global health R&D. The GHTC has launched a paper outlining the most significant challenges that nonprofit product developers (NPPDs) and partners encounter throughout the R&D continuum to demonstrate how regulatory challenges impede their ability to accelerate R&D and increase the costs of product development. The GHTC has launched a paper outlining the most significant challenges that nonprofit product developers (NPPDs) and partners encounter throughout the R&D continuum to demonstrate how regulatory challenges impede their ability to accelerate R&D and increase the costs of product development. Photo credit: PATH/Umit Kartoglu Regulatory processes and obstacles can vary widely by product platform, as well as geography. However, representatives from all of the NPPDs contributing to the paper agreed on three thematic challenges that increase the costs of product development, cause delays in product introduction, complicate an already difficult process, and—ultimately—can result in fewer lives saved: Complex global regulatory environment. Weak regulatory capacity in low- and middle-income countries. The need for increased investment in regulatory capacity within NPPDs. Competing and misaligned requirements across regulatory authorities in high-, middle-, and low-income countries have created a confusing landscape for NPPDs. Because of the complexity of the regulatory environment, many NPPDs and partners face unclear signals about which regulatory body to approach first, what the requirements are for each review, and when these reviews can take place. Unfortunately, because many national regulatory authorities in low- and middle-income countries are often poorly funded, understaffed, and overburdened, they lack the resources to provide adequate guidance to developers, as well as proper oversight over many of the products being studied, introduced, and used in their countries. This lack of capacity and resources can be a significant hurdle and lead to considerable, costly delays in product development and introduction, and could mean reduced protection for patients. As their innovation pipelines grow, NPPDs are taking over more aspects of product development programs and recognizing the need to work more directly with regulators. Based on their experiences in navigating the regulatory pathways of health products to address poverty-related and neglected diseases, respondents had some recommendations to strengthen regulatory processes: Best practice is to develop a regulatory strategy at the beginning of the development cycle that outlines activities through product registration. All regulatory bodies should possess a foundational level of core competencies. Regulatory harmonization and capacity strengthening should encourage collaboration of poorly resourced regulatory bodies with better-resourced and more experienced regulatory authorities. It is critical to educate non-regulatory stakeholders on the impact of regulatory delays on increasing the cost and length of product development and introduction to make the case for increased investment. Increased development of health products targeting the health needs of low- and middle-income countries is highlighting the need for stronger regulatory systems and increased collaboration among stakeholders—including developers, manufacturers, regulators, and policymakers—to ensure that the innovation pipeline is filled with technologies that are being developed to maximize health impact.

The Global Health Technologies Coalition (GHTC) today released a new paper providing unique insight into the regulatory barriers incurred by nonprofits in global health research and development (R&D). The paper examines the most significant challenges organizations face in navigating the regulatory landscape to advance the development of new vaccines, drugs, diagnostics, microbicides, and devices for low- and middle-income countries (LMICs). The paper focuses on nonprofit product development organizations (NPPDs), or nongovernmental organizations that partner with the public, philanthropic, and private sectors to develop health products specifically targeted for HIV/AIDS, tuberculosis, malaria, neglected tropical diseases, maternal health, and other needs in LMICs. Previous research has found that NPPDs play a vital role in bringing together the fragmented resources and expertise of the various sectors involved in neglected disease R&D. The new paper finds that regulatory processes and obstacles can vary widely depending on product and geography. Each of these challenges has a significant impact on the ability for NPPDs and their partners to ensure new technologies are available for patients in LMICs. NPPDs identified three key regulatory challenges, including: Complex global regulatory environment: the regulatory landscape for products targeting the health needs of LMICs is difficult to navigate because of the different levels of regulatory oversight across a spectrum of experience and expertise. Weak regulatory capacity in LMICs: regulatory authorities in LMICs lack sufficient resources to reliably evaluate and monitor the safety, efficacy, and quality of all types of health products. The need for increased investment in regulatory capacity within NPPDs: the robust pipelines and increasing product responsibilities necessitate strengthening internal regulatory capacity of the NPPDs. While the regulatory landscape for the R&D of health products addressing poverty-related and neglected diseases and conditions is complex, NPPDs and their partners continue to grow their pipelines. Therefore, NPPDs contributing to this paper outlined a set of key recommendations to strengthen regulatory processes: Best practice is to develop a regulatory strategy at the beginning of the development cycle that outlines activities through product registration. All regulatory bodies should possess a foundational level of core competencies. Regulatory harmonization and capacity strengthening should encourage collaboration of poorly resourced regulatory bodies with better-resourced and more experienced regulatory authorities. It is critical to educate non-regulatory stakeholders on the impact of regulatory delays on increasing the cost and length of product development and introduction to make the case for increased investment. This paper—Briefing Paper, Volume 4: Addressing regulatory challenges throughout the product development process—is the fourth in 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.