Breakthroughs Blog: Women's health innovation

Preeclampsia affects millions of pregnancies around the world, claiming the lives of 42,000 women each year and contributing significantly to fetal and newborn mortality and complications. Early detection and management are crucial to prevent progression to eclampsia, which is characterized by seizures and can be life-threatening.  The burden of preeclampsia is greatest in low- and middle-income countries (LMICs), where workforce shortages, limited laboratory capacity, and procurement challenges undermine the implementation of recommended tools and protocols.  Despite its global impact, preeclampsia remains under-researched and under-represented in the health innovation pipeline compared to conditions with similar prevalence that are not specific to women. These challenges have created critical gaps in screening, diagnosis, and treatment, but new tools in the pipeline could help transform care, particularly in low-resource settings worldwide. Rethinking preeclampsia screening and diagnosis Preeclampsia screening aims to identify high-risk pregnant women before symptoms appear and before they can be formally diagnosed, enabling closer monitoring and preventive care. Screening has traditionally relied on a checklist to evaluate patient history and risk factors. While simple, this approach has shown limited effectiveness and depends heavily on the accuracy of assessment.Newer recommended approaches that combine risk-factor screening with biomarker testing offer improved predictive performance. However, they require medical and laboratory imaging infrastructure that is not widely available in LMICs, limiting their uptake.  Preventive therapies, including low-dose aspirin, calcium supplements, and antihypertensive medications, are recommended for women identified as high risk, but they are not consistently offered to women in LMICs. As a result, many women are diagnosed later in pregnancy, when risks are greater.  The Accelerating Innovation for Mothers project identified 89 preeclampsia risk screening tools in the R&D pipeline but concluded current approaches are unlikely to adequately address the needs of women in LMICs, underscoring the need for greater investment in tools explicitly designed to address their realities.  Artificial intelligence (AI) is emerging as a promising tool to bridge screening and diagnosis gaps. With support from the Gates Foundation, Siemens Healthineers is developing an AI-driven tool that leverages data from blood tests already routinely performed as part of prenatal care to screen for both preeclampsia and anemia. By using existing samples and integrating screening for multiple conditions, this tool could enable more efficient and scalable screening in resource-limited settings. Confirmatory preeclampsia diagnosis relies on detecting elevated blood pressure and the presence of protein in urine, alongside the potential presence of severe symptoms. This requires trained health care workers and access to laboratory equipment, which can hinder accurate, timely diagnosis in resource-challenged environments. Monod Bio, with Gates Foundation support, is developing a rapid, point-of-care diagnostic test that can deliver results in less than 15 minutes. Using an AI-derived algorithm to analyze results, this tool could significantly reduce workforce and equipment needs. Together, these innovations reflect a promising shift toward designing tools specifically to address the needs of low-resource environments, rather than adapting tools used in high-income contexts, a shift essential to closing global gaps in care. Expanding the treatment pipeline There is currently no specific cure for preeclampsia other than early delivery, which can be dangerous for both mother and baby, especially in low-resource settings. Existing treatments focus on managing symptoms, including preventing seizures with magnesium sulfate and controlling blood pressure with antihypertensive medications. A new generation of therapies aims to go further by addressing underlying disease causal pathways, rather than managing symptoms alone.  A research team at the University of Nebraska Medical Center, supported by a Gates Foundation grant, is advancing an innovative treatment based on a naturally occurring compound that reduces the levels of a protein that plays a key role in the development of preeclampsia. In preclinical studies, the compound has improved vascular function, reduced inflammation, and lowered blood pressure. Importantly, it is also stable at room temperature and inexpensive to produce, making it well-suited for settings with limited resources. Another Gates-supported team at the Medical College of Wisconsin has launched a clinical trial evaluating a promising supplement for preeclampsia. The compound, which occurs naturally in foods, has been shown to improve vascular functions in animal models and early human studies. It is also shelf-stable and inexpensive. These novel therapeutics could help transform preeclampsia care by slowing or halting the progression of the condition, rather than simply responding to the presence of symptoms. Their affordability and suitability for austere settings could also help expand access for women who currently lack effective treatment options. Looking ahead Preeclampsia mortality rates remain far too high, reflecting long-standing gaps in research advancing women’s health and a lack of tools suited to low-resource settings. Innovations that leverage emerging technologies like AI and respond to the needs of pregnant women everywhere could help save more mothers and babies worldwide. Solutions designed for LMIC health systems could also strengthen care in underserved or overstretched settings in high-income countries like the United States, where rising health care costs, workforce shortages, and even conflict-related supply chain disruptions are straining health care service delivery.  Turning this potential into impact will require sustained investment to ensure innovations are not only developed but designed for and delivered to the women who need them most. 

IAVI recently announced the start of a first-in-human clinical trial evaluating a combination injection of four broadly neutralizing antibodies, with the aim of eventually developing a tool to prevent HIV transmission in infants during the postnatal period. The combination shot includes four antibodies that target different HIV receptors, including IAVI’s broadly neutralizing antibody ePGT121v1-LS. The current trial is evaluating safety, dosing, pharmacokinetics, durability, and efficacy in 118 adult participants across the United States and Peru, and, if successful, could pave the way for future studies in infants. A research team has identified a bacterium strongly associated with noma, a potentially fatal infection for which the underlying cause is poorly understood. The researchers used metagenomic sequencing and machine learning algorithms to analyze saliva samples from children with acute noma. They identified a bacterial species that may be responsible for the disease, which was detected in the early stages of infection and does not carry known antibiotic resistance genes, suggesting that infection could be effectively treated with existing antibiotics if detected early enough. These findings also pave the way for the development of diagnostic tools that can detect noma early on, when treatment is most effective and before irreversible damage has been done. Last week, Butterfly Network shared that it received regulatory clearance from the US Food and Drug Administration for its artificial intelligence (AI)-powered ultrasound, offering a critical new tool to improve maternal care in low-resource settings with limited access to prenatal imaging. Compared to traditional ultrasounds that rely on expensive technology, the new device is more affordable and provides results in less than two minutes with fewer inputs. The tool has already been deployed in Malawi and Uganda, and this latest approval will enable its widespread rollout in the United States. 

Women’s health remains one of the most underfunded and under-explored areas in health research, despite its profound importance to the lives of women and health outcomes across populations. Today, only about 5 percent of health research and development (R&D) funding worldwide is dedicated to women’s health, and less than one percent of that share supports non-cancer-related conditions, leaving vast gaps in our understanding of conditions that disproportionately or uniquely affect women. These gaps persist globally, including within the United States, where the National Institutes of Health (NIH) plays a central role in shaping biomedical research priorities. While these disparities remain clear today, meaningful progress has been made in women’s health—particularly in expanding women’s inclusion in research and establishing foundational policies that prioritize sex and gender in science. This March, in recognition of Women’s History Month, we look back at key milestones at NIH that have advanced women’s health research. These achievements not only highlight how far the field has come but also help guide where we need to go next. For decades, women were systematically excluded from clinical research, leading to critical gaps in the knowledge needed to adequately understand, diagnose, and treat diseases and other health challenges faced by women. Women’s symptoms were misunderstood, their risks underestimated, and their health needs too often treated as a secondary, niche issue rather than a scientific imperative.  The women’s rights movement of the 1960s ignited a parallel women’s health movement that forced policymakers and scientists to confront systemic disparities. A pivotal turning point came in 1983, when the Public Health Service Task Force on Women’s Health Issues—established by Assistant Secretary for Health Edward Brandt Jr.—became the first federal initiative focused on increasing women’s inclusion in NIH-funded clinical trials. The Congressional Caucus for Women’s Issues echoed that call to action. These were not symbolic gestures, but structural interventions that began reshaping the research enterprise. By 1990, sustained advocacy led to a major advancement: the creation of the NIH Office of Research on Women’s Health (ORWH). For the first time, NIH had a dedicated mechanism and leadership to strengthen, coordinate, and champion women’s health research across the agency. Congress codified and strengthened this progress with the 1993 NIH Revitalization Act, which formally established the ORWH into law and, importantly, mandated that women and minorities be included in all NIH-funded clinical research. The latter change was spurred by a group of female members of Congress who recognized deficiencies in NIH’s prior 1986 internal guidelines that urged but did not require that women be included. These landmark policy changes helped transform women’s health from a peripheral cause into a core component of biomedical science, propelling meaningful scientific progress. With the ORWH fully in force, NIH launched additional efforts to improve women’s health research, including the Specialized Centers of Research on Sex Differences. This initiative aimed to accelerate the translation of discoveries about sex differences from basic science into clinical applications, bridging gaps between laboratory research and women’s clinical care. In 2018, the effort evolved into the Specialized Centers of Research Excellence on Sex Difference—a network of research centers dedicated to advancing translational research on the role of sex differences in the health of women. The 2006 NIH Reform Act, further strengthened ORWH by elevating it into the NIH Office of the Director. This shift gave ORWH greater authority to coordinate across institutes and centers, influence research priorities, and ensure women’s health considerations were integrated at the highest levels of decision-making and across the entire R&D continuum. After two decades of building a scientific and policy foundation for better inclusion, NIH took another pivotal step that reshaped the research enterprise: the NIH Policy on Sex as a Biological Variable (SABV). Implemented in 2016, the policy required researchers to factor sex into the design, analysis, and reporting of basic, preclinical, and clinical studies. For years, basic science relied heavily on male cells and male animal models, embedding blind spots at the earliest stages of discovery. By requiring scientists to examine how sex influences health and disease from the outset, NIH strengthened the rigor, reproducibility, and translational value of federally funded research. The policy helps ensure that differences in disease progression, drug metabolism, immune response, and treatment efficacy are identified early before they become costly failures or missed opportunities in product development. By institutionalizing sex-informed research design, SABV signaled a clear shift in practice. Inclusion is not just about who participates in research, but also about how science is conducted.  In parallel, Congress also passed the 2016 21st Century Cure Act that affirmed and enhanced compliance requirements around SABV and required that people of all ages be included in clinical research unless valid scientific reasons existed for exclusion. The policy also established a task force to advance recommendations, knowledge, and guidance around the safe inclusion of pregnant and lactating individuals in clinical trials.  In 2019, NIH published its first comprehensive strategy to advance the health of women, which outlined the agency’s activities and objectives from 2019 through 2023. Though an updated strategy has since been released, this first plan marked an important first step in translating ORWH’s mission into a unified NIH vision with a structured path forward. With input from technical experts and civil society, NIH published its second women’s health strategy. The current plan prioritizes advancing research on women’s health disparities and underscores the importance of basic and translational research in biomedical discovery and innovation. While it addresses other issues, including actions related to the inclusion of women and girls in clinical trials, much of its focus is on early-stage research. As the strategy concludes in 2028, there is an opportunity to build on this foundation by strengthening support for later-stage R&D and addressing priority gaps in health innovations for women. As we mark International Women’s Day, the question is no longer whether women should be included in research, but whether research is delivering the health products that women need. NIH has built the policy architecture to enhance representation, inclusion, coordination, and strategic priority-setting across the research continuum, correcting historical blind spots and reshaping the research enterprise.  Yet inclusion alone does not guarantee innovation. As we look ahead to the future of women’s health research at NIH, continued collaboration will be essential. We encourage NIH to sustain and deepen its engagement with academia, researchers, industry, and civil society as it shapes the next iteration of its women’s health strategy. Building on this dialogue will help ensure priorities reflect both scientific opportunity and real-world need.  GHTC stands ready to partner in shaping what comes next. NIH has made meaningful progress over the past several decades—now is the moment to build on that momentum and work together to drive even greater impact on women’s health in the years ahead. Beyond this strategy, GHTC wants to continue working with Congress to ensure that the progress made at NIH through various avenues is codified into law. By advancing strong, bipartisan policies that strengthen and sustain women’s health research, Congress can protect recent gains and help ensure they deliver lasting impact for patients and communities around the world. As the agency sets its course, we urge decision makers to maintain a strong commitment to women’s health research, including research that advances the development of new priority health technologies for women. The current strategy’s emphasis on foundational and basic science lays critical groundwork for breakthrough products, but translational and later-stage research are equally vital to move promising discoveries across the finish line and into the hands of patients.  This month, and every month, offers an opportunity to reflect on the progress made, the gaps that remain, and the shared responsibility to accelerate a future where investing in and supporting women’s health research is not the exception, but the standard.