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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.

This post—written by Sarah Alexander, director of external relations at the Global Alliance to Prevent Prematurity and Stillbirth (GAPPS)—originally appeared in Seattle Children’s On the Pulse blog on March 5th. She shares about a new initiative aimed at developing new strategies to prevent preterm births. Globally, 15 million babies are born preterm each year, and more than 1 million of those do not survive their first month of life. Being born preterm—before 37 weeks gestation—increases the chance of birth complications, developmental disabilities, and lifelong health issues like cerebral palsy, asthma, and vision and hearing problems. Sarah Alexander, director of external relations at GAPPS. Last week, GAPPS—an initiative of Seattle Children’s—announced it is granting a total of $2.8 million to two international pregnancy research sites as part of its Preventing Preterm Birth initiative (PPB). The international sites will mirror similar sites GAPPS has developed in the US, and will enroll women early in pregnancy and collect information and biological specimens during their pregnancies and deliveries. The data and specimens collected will be used to advance innovative research into the causes of preterm birth and identify novel strategies for prevention. Areas of investigation will include studies of infection, inflammation, the microbiome, the immune response, and other pathways leading to increased risk of preterm delivery. Zambia In Lusaka, Zambia, Jeffrey Stringer, MD, an obstetrician and director of the University of North Carolina Global Women’s Health group, will oversee a team of Zambian and US researchers in enrolling 2,000 high-risk pregnant women over a 3-year period. Dr. Stringer, who lived and worked in Zambia for more than a decade, has seen firsthand how the prevalence of infant death impacts families. “There is nothing more devastating than the loss of a child. Whether you live in North America or Zambia, this is a universal truth,” Stringer said. He added, “We will set up a carefully monitored cohort of women and their newborns so we can evaluate the causes of prematurity and figure out ways to prevent it.” Bangladesh In Bangladesh, Anisur Rahman, PhD, head of the Matlab Health Research Centre at the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), will work with his team to enroll 4,700 pregnant women over three years. “We have a very good system for identifying pregnancy, as well as for staying in contact with mothers and babies after pregnancy to collect follow-up data and samples,” Rahman said. “Our center has the potential to contribute a lot to global research, because preterm birth is shared by both developed and developing countries.” Preventing Preterm Birth initiative (PPB) The PPB seeks to discover biological mechanisms that lead to preterm births and develop novel interventions to prevent them. GAPPS has funded seven research projects through the PPB, and those investigators will work in collaboration with these international cohorts of pregnant women, which will allow them to develop interventions to prevent preterm birth. “Increasingly, evidence suggests that poor maternal and fetal health set in motion an irreversible trajectory with serious negative consequences for health in infancy, childhood, and adulthood,” said Eve Lackritz, MD, senior program officer for GAPPS. “Preterm birth research has been hampered by a lack of well-designed pregnancy cohorts in low-resource countries, and developing these two new sites will help to fill that void and lead to broadly-applicable preventive and therapeutic interventions to prevent preterm birth and stillbirth.” For more information, check out these resources: - Preventing Preterm Birth initiative - Grand Challenges

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. This week, the White House released President Obama’s much-anticipated budget request for fiscal year (FY) 2015. The budget request has mixed results for federal agencies that conduct global health research—including the Centers for Disease Control and Prevention, the Department of Defense, the US Food and Drug Administration, the National Institutes of Health, and the US Agency for International Development (USAID). Pharmaceutical company Janssen announced that SIRTURO® (bedaquiline)—a new drug for the treatment of multi-drug resistant tuberculosis (TB)—has been granted conditional approval by the European Commission. The drug was approved for use as part of an appropriate combination regimen for pulmonary multi-drug resistant TB in adult patients. USAID has released its 2013 report to Congress—Health-Related Research and Development Progress Report. The report provides an update on the agency’s global health research and development (R&D) portfolio, specifically highlighting certain technologies and disease areas. The Kaiser Family Foundation has pulled together several news sources reports on research findings presented at the Conference on Retroviruses and Opportunistic Infections taking place in Boston this week.

Yesterday, the White House released President Obama’s much-anticipated budget request for fiscal year (FY) 2015. After hearing that the budget would be released in two phases, we weren’t sure what level of detail or clarity to expect from the top-line numbers. As it turns out, the message is murky—for now. Below are some initial takeaways on the budget proposal’s impact on global health research and development (R&D). State and USAID Global Health Programs While funding for the overall 150 international affairs account remained fairly stagnant compared with FY 2014, funding for the State Department’s global health programs—which fund most global health R&D at the US Agency for International Development (USAID) and the State Department—took a concerning downward shift, falling by 4.6 percent overall. The Maternal & Child Health, Tuberculosis, and Global HIV and AIDS programs that fund research for many new global health tools all saw decreases to varying degrees when compared with the levels that Congress just approved for them in its FY 2014 budget agreement. There were a few ‘winners’—a relative term only; USAID’s Malaria and Family Planning programs saw small increases, and GAVI—which works to scale up currently available vaccines—saw its request increased by $25 million over FY 2014. As many in the community have voiced, the flat-funding of the President’s Emergency Plan for AIDS Relief—coupled with a possible $300 million decrease in the US’s contribution to the Global Fund to Fight AIDS, Tuberculosis, and Malaria—is disappointing, if not unexpected. Funding for the State Department’s global health programs—which fund most global health R&D at the US Agency for International Development (USAID) and the State Department—took a concerning downward shift, falling by 4.6 percent overall. Although these cuts are concerning, the President’s budget request did indicate that the administration is aware of the need for sustained global health R&D programming and recognized the important role that USAID plays in fostering innovation. The President requested $146.3 million for the new Global Development Lab at USAID, which “will consolidate and expand USAID's efforts in science, technology, innovation and partnerships, creating a world-class capability to discover, incubate, test, and scale transformational solutions to the greatest development challenges that we face today.” However, according to the budget justification text, only about $5 million of this funding will go to global health programs.   Global Health R&D at NIH, CDC and FDA The President requested $30.2 billion for funding at the National Institutes of Health (NIH), a slight increase from 2014 appropriations levels of $29.9 billion, but still lower than the President’s request for FY 2014—continuing a troubling decline. It is estimated that NIH’s funding has decreased 15 percent since FY 2004. Within the NIH, the National Institute of Allergy and Infectious Diseases was funded at $4.423 billion, a 3.4 percent decrease from the President’s request for 2014, but a slight increase from the 2014 appropriated budget of $4.359 billion. The National Center for Advancing Translational Science saw a slight cut from FY 2014 appropriations and previous requests, while the National Institute of Child Health and Human Development and the Fogarty International Center were essentially flat-funded. There was potentially better news for global health R&D funding at the Centers for Disease Control and Prevention (CDC). The President requested a total of $464 million for CDC’s Center for Global Health—a significant increase over FY 2014. CDC’s Center for Emerging Zoonotic and Infectious Diseases also received a welcome increase. Both of these CDC centers are involved in the new Global Health Security Agenda programming. While the budget text says that the President requested $45 million for the new initiative, it’s not yet clear where this funding will come from. In more positive news, the President also requested just over $4.7 billion for the US Food and Drug Administration (FDA), allaying fears that the strong FY 2014 funding ($4.3 billion) would not be continued. The funding also assumes $2.612 billion in user fee income. Opportunity, Growth and Security Initiative Adding to the opaque nature of several parts of the global health and science accounts within the President’s budget request is the new $56 billion Opportunity, Growth and Security Initiative. Funds in this category include the $300 million that would go to the Global Fund if other nations are able to increase their own commitments, as well as other funding that would go to NIH and the Science, Technology, Innovation and Partnerships (STIP) in Development program via the new Global Development Lab at USAID. It’s still unclear whether this money will be allocated as stated, and many in the global health community are concerned that it would draw funds away from other health-related programs that have already been flat-funded or seen cuts. While we’re still waiting for more figures for NIH and the Department of Defense’s global health R&D programs, and details from additional budget justification documents—it’s clear that Congress has its work cut out for it in protecting global health R&D programming across the US government. When the appropriations committees from the House and Senate develop their own proposals later this spring, they should work to sustain and protect global health research and product development at USAID, CDC, NIH, FDA and the Defense Department in order to keep up the fight against global health diseases.