News

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.

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.