Breakthroughs Blog: NIH

Few diseases have shaped global health like the HIV/AIDS pandemic. Since it began, more than 40 million lives have been lost, leaving an enduring impact on families, communities, and health systems worldwide. But HIV has also become one of the clearest examples of what sustained research and development (R&D) can achieve. From antiretroviral therapies (ART) to long-acting prevention tools, decades of scientific innovation have fundamentally changed what is possible in the fight against HIV.This year, HIV innovation stands at a pivotal moment. Shifting funding landscapes and evolving global health priorities have raised important questions about how R&D for HIV will be sustained in the years ahead. As global leaders have reaffirmed the importance of continued R&D investment—such as through the recently adopted United Nations High Level Meeting political declaration on HIV/AIDS—we must also focus on the systems and programs that translate scientific breakthroughs into impact. Few advances better illustrate this balance than lenacapavir, or LEN, an injectable form of HIV prevention requiring only two injections per year, spaced 6 months apart. Unlike daily oral pre-exposure prophylaxis (PrEP), which depends on consistent adherence, LEN offers protection by eliminating daily pill burden for consumers and communities vulnerable to HIV.The journey of LEN reflects the long arc of HIV innovation. Decades of research supported by the US National Institutes of Health helped establish the HIV capsid as a promising drug target, creating the foundation for a new class of HIV medicines. Then, in 2006, researchers at Gilead Sciences began developing capsid inhibitors designed to suppress HIV replication while offering the potential for long-acting treatment. At the time, ART had transformed HIV from a fatal disease into a manageable chronic condition for millions of people, but treatment relied on daily medication, creating ongoing challenges for adherence and access.Following years of research and clinical development, the US Food and Drug Administration (FDA) approved LEN in 2022 as a treatment for adults living with multidrug-resistant HIV whose existing treatment regimens were no longer effective. While this approval marked an important milestone, researchers at Gilead continued exploring the drug's potential as a long-acting option for HIV prevention and found remarkable resultsThe first pivotal late-stage prevention trial of the drug, called PURPOSE 1, conducted among women in South Africa and Uganda—including pregnant and lactating women—found that LEN provided near-complete protection against HIV infection and outperformed daily oral PrEP. PURPOSE 2, a subsequent study, conducted across seven countries and including men and gender-diverse people, confirmed similarly high levels of protection in late 2024. Beyond their clinical success, these studies also represented an important step toward more inclusive HIV research by intentionally enrolling populations that have been historically underrepresented in clinical trials.  Just six months after Gilead submitted LEN for review as an HIV prevention tool, the FDA approved the drug in June 2025 under a priority review designation pathway. Because regulators were able to rely on the extensive safety data generated during the drug's earlier approval for HIV treatment, they could focus their review on its use as a novel preventive intervention. The result was an efficient regulatory process that maintained rigorous standards while accelerating future access to an important new prevention tool. Swift regulatory action extended beyond the United States. In October 2025, the World Health Organization (WHO) prequalified LEN in just 36 days using its abridged prequalification pathway. This expedited process enabled WHO to leverage assessments already completed by the European Medicines Agency’s (EMA) European Union-Medicines for all program, which provides scientific opinions on medicines for use in low- and middle-income countries, while conducting its own review focused on issues relevant to the global procurement and implementation of LEN.  This rapid review mattered because WHO prequalification serves as a critical gateway for procurement by many international organizations and countries, particularly in low- and middle-income countries. Accelerating this process helps ensure that countries are not waiting months or years for access after a product has already demonstrated its safety and effectiveness through other rigorous stringent regulatory approval processes.Accelerated regulatory approval and collaboration continued across multiple regions. Following FDA, EMA, and WHO approval, LEN rapidly advanced through regulatory processes in South Africa, Australia, Brazil, and Canada, and, as of today, it is approved by 17 regulatory bodies, including 12 countries in Africa. In several cases, regulators leveraged reliance mechanisms, such as WHO’s collaborative registration procedure, international collaboration, and priority review pathways to streamline review and accelerate access to this important breakthrough without compromising regulatory rigor. Swift regulatory action was soon matched by commitments from the United States; the Global Fund to Fight AIDS, Tuberculosis and Malaria; and Gilead to rapidly scale up access to LEN and accelerate generic production in high-burden countries.This coordinated approach, supported by political commitment and strategic public-private partnership, created an unusually efficient pathway from scientific discovery to implementation. Compared with earlier HIV prevention technologies, such as oral PrEP and the dapivirine vaginal ring, LEN has progressed through key milestones at a rapid pace. This allowed for accelerated product introduction of lifesaving technologies at the country level, while simultaneously shaping the market and demand for LEN and future prevention options. While every health technology faces unique scientific, regulatory, and access considerations, LEN demonstrates how thoughtful planning, regulatory preparedness, and collaboration between researchers, regulators, countries, multilateral organizations, and communities can significantly shorten the time between discovery and access.As conversations about the future of HIV innovation continue, LEN offers an important blueprint for global health innovation more broadly. It reminds us that sustained investment in R&D produces transformative breakthroughs, inclusive clinical trials generate stronger science, and innovative regulatory pathways can accelerate, rather than compromise, rigorous review. Moreover, the accelerated path from research to rollout illustrates the coordination and collaboration required to advance technologies through regulatory approval while simultaneously shaping markets to enable introduction at scale. The lessons from LEN are already informing the next generation of HIV prevention innovations, with developers pursuing earlier access and licensing strategies for products such as Merck's MK-8527. While the US government, the Global Fund, and Gilead have recently expanded commitments to scale up LEN, the ultimate measure of success will be whether LEN—and the innovations that follow it—reach the people who need them most.  The future of innovations for HIV, as well as tuberculosis, malaria, emerging threats with pandemic potential, and beyond, will require the same integrated approach. Scientific discovery, product development, efficient regulatory pathways, and equitable access cannot be treated as separate objectives; they are mutually reinforcing components. Innovation succeeds not when a product is approved, but when it reaches the communities whose lives it has the power to change. LEN has shown us what’s possible when the entire R&D ecosystem works together. The challenge now is ensuring that this success becomes the standard rather than the exception.

For decades, the United States has led the world in public investment in global health research and development (R&D). Federal support enabled the development of breakthrough technologies that are saving and improving lives in the United States and around the world. US government investment in global health R&D has also generated billions in domestic economic activity, created American jobs, and laid the foundation for future discoveries that will catalyze billions more in economic benefits in the years ahead. America’s leadership in global health R&D reflects the country’s values, entrepreneurial spirit, and commitment to improving lives globally. This year, to mark America’s birthday and celebrate the nation’s extraordinary contributions to advancing lifesaving innovation, GHTC is spotlighting four game-changing global health technologies developed by US innovators with federal support.A DR-TB drug transforming the global fight against TB Tuberculosis (TB) remains the world’s deadliest infectious disease, killing 1.23 million people in 2024 alone, with growing resistance making it even more deadly and difficult to treat.  Historically, treatment for drug-resistant TB (DR-TB) required up to 20 or more pills a day over the course of 18 months or more, and patients often experienced severe side effects, such as hearing loss. Even then, nearly half of patients who were able to access treatment went uncured.Pretomanid, developed by TB Alliance, a New York-based nonprofit product development partnership, represents a major advance in DR-TB therapy. As part of a six-month, all-oral combination regimen, it has drastically reduced treatment duration, complexity, and toxicity for patients.  This innovation was made possible through funding from the US Agency for International Development and the National Institute of Allergy and Infectious Diseases and was advanced in partnership with a broad coalition of American companies, nonprofits, and universities. Since its approval, TB Alliance has strived to make pretomanid-containing regimens more affordable and accessible, improving access to high-quality DR-TB treatment in the places that need it most.A groundbreaking HIV prevention drug poised to revolutionize the fight An estimated 40.8 million people globally are living with HIV/AIDS, and 1.3 million people became newly infected in 2024. Despite decades of progress, momentum toward ending HIV as a public health threat has slowed in recent years, and major gaps remain in our arsenal of prevention tools.  Gilead Sciences, a California-based biopharmaceutical company, developed lenacapavir, a groundbreaking new HIV prevention drug that requires just two injections per year. It offers discreet, long-acting protection, making HIV prevention more accessible and easier to sustain.  Developed using evidence from National Institutes of Health-funded research, lenacapavir is now being scaled up globally through a US Department of State-led partnership, helping ensure this innovation reaches communities in need. A next-generation polio vaccine bringing us closer to eradication The first polio vaccine, introduced in the 1950s, transformed polio from a disease that caused frequent, devastating epidemics into one on the brink of global eradication. However, outbreaks of vaccine-derived poliovirus in under-immunized communities globally have posed a major challenge to vanquishing the disease for good.To address this, PATH, a Washington-based nonprofit developer, partnered with the University of California, San Francisco; the Gates Foundation; and global collaborators to develop nOPV2, a next-generation oral polio vaccine. nOPV2 retains the advantages of the original oral vaccine but has been specifically engineered to reduce the risk of vaccine-derived outbreaks. This breakthrough benefitted from critical development support from the US Centers for Disease Control and Prevention.  More than 1 billion doses of nOPV2 have been administered in countries around the world, with an expanded network of manufacturers helping ensure global access and prevent outbreaks.  First FDA-approved Ebola treatment continuing to offer hope As the current outbreak of the Bundibugyo strain of Ebola in the Democratic Republic of the Congo (DRC) reminds us, Ebola outbreaks can rapidly escalate into international health emergencies. When the 2018-2020 outbreak of Zaire ebolavirus began in the DRC—the world’s second largest Ebola outbreak—there were no approved Ebola treatments. Inmazeb®, a novel antiviral medicine developed by Massachusetts-based Regeneron in collaboration with the Biomedical Advanced Research and Development Authority, was evaluated in a National Institutes of Health-supported trial during the outbreak. The strong results from that trial supported approval by the US Food and Drug Administration (FDA) in 2020, making Inmazeb the first FDA-approved treatment for Ebola, which has since been deployed in Ebola outbreaks in the DRC and Guinea. The most potent antibody in Inmazeb has now been recommended for priority evaluation during the current outbreak after demonstrating broad activity against multiple Ebola strains, including Bundibugyo, for which no approved therapeutics exist—highlighting how US-backed innovation continues to pay off and why sustained investment is needed to stay ahead of future threats.  Ensuring continued US leadership through sustained investment From transforming DR-TB treatment and HIV prevention to accelerating polio eradication and delivering the first Ebola therapy, the United States has long been at the forefront of global health innovation. These successes reflect the best of America: leadership, ingenuity, compassion, and a commitment to improving lives. Sustaining this impact will require continued investment and support in the programs, partnerships, and people that make such breakthroughs possible.

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. 

Earlier this week, the Global Health Technologies Coalition (GHTC) and partners brought more than 25 innovative global health technologies to Capitol Hill to highlight how US government investments in global health research and development (R&D) are saving lives in the United States and around the world. Each technology displayed—whether a vaccine, diagnostic, drug, device, or nutrition solution— demonstrate how these investments not only protect the world’s most vulnerable people but also strengthen America’s own health security, help prevent pandemics, and fuel high-quality US jobs and economic growth. The exhibit offered a snapshot of a larger story of how the United States is doing well by doing good. Between 2007 and 2022, the US government invested just under $46 billion in global health R&D. These investments helped drive the development of 67 new technologies approved since 1999 for neglected and (non-COVID-19) emerging diseases. At the same time, they created 600,000 new US jobs and yielded knowledge expected to generate more than $255 billion in long-term benefits for the American economy—a six-fold return on investment. This exhibit showcased what’s possible when science, purpose, and smart policy align. Explore the exciting US-backed breakthroughs displayed below. VACCINESSingle-dose vaccines for Sudan and Marburg viruses on the rVSV vaccine platform IAVI, a nonprofit based in New York and New Jersey, is advancing single-dose vaccines for the Sudan and Marburg viruses using the proven rVSV vaccine platform, the same technology behind an Ebola vaccine that has helped contain recent outbreaks. Sudan and Marburg viruses continue to spark deadly, Ebola-like outbreaks, yet no approved vaccines or treatments exist, underscoring the urgency of this work. These vaccine candidates are being developed with critical support from the Defense Threat Reduction Agency at the US Department of Defense (DoD) and the Biomedical Advanced Research and Development Authority (BARDA). Novel oral polio type 2 (nOPV2) vaccine PATH, a nonprofit developer based in Washington state with an office in the District of Columbia, alongside the University of California, San Francisco; the Washington-based Gates Foundation; and global partners, developed nOPV2, a next-generation oral polio vaccine. nOPV2 maintains the same advantages of the original oral vaccine but has been specifically engineered to be less likely to seed vaccine-derived polio outbreaks in communities with low immunization coverage. This breakthrough, which is accelerating global efforts to end polio, also benefitted from critical development support from the US Centers for Disease Control and Prevention (CDC).Next-generation malaria vaccines PATH and the University of Oxford are developing next-generation malaria vaccines designed to overcome key limitations of the currently available options and help turn the tide of this longstanding global health challenge. This work has received vital US government support from the US Agency for International Development (USAID), the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH), and the DoD Walter Reed Army Institute of Research and Naval Medical Research Command. Additional US-based partners, including Johns Hopkins University in Maryland, the Scripps Research Institute in California, and the University of Texas at Austin, alongside a constellation of international collaborators, also played a critical role in advancing this research.DRUGSPretomanid, a novel tuberculosis (TB) drugTB Alliance, a New York-based nonprofit, developed pretomanid, a groundbreaking drug for treating highly drug-resistant TB. As part of a six-month combination regimen, it has drastically reduced treatment duration and complexity for patients compared to previous regimens that required up to 20 or more pills a day—as many as 14,000 total over the course of 18 months or more of treatment. This work was backed by US federal funding from USAID and NIAID and advanced in partnership with a broad coalition of American companies, nonprofits, and universities, including AbbVie Inc. in Illinois, Advancing Clinical Therapeutics Globally for HIV and Other Infections in the District of Columbia, the Gates Foundation, Harvard University in Massachusetts, Johns Hopkins University, Johnson & Johnson in New Jersey, RTI International in North Carolina, Texas A&M University, the University of Illinois Chicago, and the University of North Carolina at Chapel Hill.Child-friendly TB medicinesTB continues to infect millions of people worldwide each year, with children facing a heavy burden—an estimated 1.3 million new pediatric cases were reported in 2023. For decades, children with TB were treated with crushed adult pills, a practice that was difficult for caregivers and often led to inconsistent dosing. TB Alliance developed child-friendly TB medicines that are palatable, fast-dissolving in water, and precisely dosed for children, ensuring young patients finally have access to safe, appropriate, and easy-to-administer therapies. This work received vital funding from USAID and was advanced in partnership with other international donors and organizations, as well as US-based partners, including Management Sciences for Health in Virginia and Baylor College of Medicine in Texas.Inhaled oxytocin for the prevention and treatment of postpartum hemorrhage Postpartum hemorrhage, or excessive bleeding after childbirth, is the leading cause of maternal deaths globally. To address this urgent challenge, Monash University has developed an investigational heat-stable, inhaled powder formulation of oxytocin designed to provide the same protection as the injectable gold standard treatment. By eliminating the need for refrigeration and trained providers to administer injections, this innovation could greatly expand access to lifesaving care for mothers in low-resource settings. This work received funding from USAID and support from US-based partners, including the Gates Foundation and Johnson & Johnson, alongside other international collaborators. Monoclonal antibody therapy to prevent and treat Nipah virus (MBP1F5) The Coalition for Epidemic Preparedness Innovations, whose US headquarters are in the District of Columbia, is supporting the development of a monoclonal antibody therapy being advanced by California-based Servare GMP and Mapp Biopharmaceutical to prevent and treat Nipah virus, a highly lethal zoonotic disease with no approved treatments or vaccines. This work received support from the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and Uniformed Services University, as well as USAID.Tafenoquine, a single-dose therapy for relapse prevention of P. vivax malaria & long-acting injectable malaria prophylaxisThe Medicines for Malaria Venture and GSK—whose US headquarters are in Pennsylvania— developed tafenoquine, a single-dose treatment to prevent the difficult-to-treat relapses characteristic of Plasmodium vivax malaria. By replacing multi-day regimens, tafenoquine simplifies care for patients and helps malaria-endemic countries accelerate progress toward elimination. Its development received crucial support from USAID, the DoD Walter Reed Army Institute of Research, and the US Food and Drug Administration through its Priority Review Voucher Program.The Medicines for Malaria Venture, Oregon Health & Science University, and the California-based Calibr-Skaggs Institute for Innovative Medicines are co-developing a long-acting injectable malaria prophylaxis designed to provide combination protection against both Plasmodium falciparum and blood-stage P. vivax malaria. This next-generation approach aims to offer durable, simplified prevention for people in high-risk areas. The work received important support from USAID and the Department of Veterans Affairs.Injectable lenacapavir for HIV prevention Gilead Sciences, a California-based biopharmaceutical company, developed lenacapavir, a groundbreaking new HIV prevention drug requiring twice-yearly injections. In pivotal Phase 3 trials, lenacapavir demonstrated remarkable efficacy across key populations, including historically underserved groups. Developed using evidence from NIH-funded research, it offers discreet, long-acting protection, providing an alternative to daily pills or bimonthly injections and making HIV prevention more accessible and easier to sustain.  DEVICESEllavi Uterine Balloon Tamponade for postpartum hemorrhage As noted earlier, postpartum hemorrhage is the leading cause of maternal deaths worldwide. The Ellavi Uterine Balloon Tamponade is a low-cost, easy-to-use inflatable device placed inside the uterus that uses pressure to rapidly slow or stop bleeding. Designed specifically for use in low-resource settings, it offers a simple, lifesaving intervention where advanced care is not always available. The device was developed by PATH and Sinapi Biomedical, with support from USAID, the Gates Foundation, and other partners.Anne® One continuous wireless vital sign monitoring platform Life-threatening pregnancy risks can too often go undetected in areas with limited resources and health care workforce. The Anne® One continuous, wireless vital-sign monitoring platform, developed by Illinois-based Sibel Health, Inc. and supported by the Gates Foundation and the Steele Foundation for Hope in New Hampshire, helps identify complications in real time, helping improve care for both mothers and babies. The technology can also enhance monitoring and care for patients of all ages, whether at home or in hospital settings. The work received key US government support from the Small Business Innovation Research program and the NIH RADx for Maternal Health Challenge, BARDA, and the DoD Medical Technology Enterprise Consortium.Monthly dapivirine vaginal ring for HIV prevention The dapivirine vaginal ring, originally developed by the Maryland-based International Partnership for Microbicides and now advanced by the Population Council in New York, is a flexible silicone ring that users self-insert, which reduces the risk of HIV infection. The ring provides one month of protection by slowly releasing the antiretroviral drug dapivirine, offering a discreet, user-controlled prevention option. Its development received critical support from NIH, USAID, the Gates Foundation, and other international donors and partners.Microarray needle-free “button” for vaccine and drug delivery Micron Biomedical, based in Georgia, developed a microarray needle-free “button” that could one day be used for delivering vaccines and pharmaceuticals without the need for traditional injections. This innovative, pain-free solution could be self-administered, reducing barriers to vaccination and treatment. It also limits or eliminates the need for refrigerated storage, simplifies transport and storage, and produces no sharps waste, making it especially valuable for low-resource settings. This technology received US funding support from CDC and BARDA (through the New York-based Global Health Investment Corporation) and was developed in partnership with other US-based groups, including the Gates Foundation, PATH, and Emory University in Georgia.Nifty Cup Millions of babies are born each year who are unable to breastfeed because they were born prematurely or have conditions such as cleft lip or palate. In low-resource settings, commonly used feeding tools can be impractical or difficult to keep hygienic. To address this challenge, PATH partnered with Washington-based collaborators, The University of Washington School of Dentistry and Seattle Children’s Hospital, with support from USAID and Laerdal Global Health, to develop the Nifty Cup. This low-cost silicone feeding cup is durable, gentle, easy to disinfect and simple for caregivers to use—a great example of a frugal, high-impact innovation designed specifically for low-resource environments.  HEATmarker™ vaccine vial monitor Most vaccines require continuous refrigeration to remain effective, which can be a significant challenge in remote and low-resource settings worldwide. Breaks in the cold chain can lead health workers to discard perfectly good vaccines because they suspect heat damage or, worse, unknowingly administer doses that have lost potency. To solve this, PATH and New Jersey-based Temptime (later acquired by Illinois-based Zebra Technologies) developed the vaccine vial monitor, a small sticker placed on vaccine vials that changes color when exposed to too much heat, clearly indicating whether a vaccine is still safe to use, preventing waste and saving lives. This simple, low-cost innovation reduces waste, improves safety, and helps ensure lifesaving vaccines reach the people who need them. The work received crucial support from USAID.BD Uniject™ auto-disable prefillable injection system Injectable drugs and vaccines have saved countless lives, yet administering them safely in low-resource settings presents challenges—health workers require appropriate training and if reused, syringes can spread dangerous infections. With funding from USAID, PATH designed the Uniject™ system, now manufactured by New Jersey-based BD. It’s an inexpensive, pre-measured and -filled syringe that automatically disables after a single use. This technology enables health workers with minimal training to safely deliver correctly dosed injections, prevents syringe reuse, reduces product waste, and ultimately saves lives and costs.BD SoloShot™ auto-disable syringeBD and PATH also partnered on the SoloShot™ auto-disable syringe, with support from USAID, which locks after injection, also helping prevent reuse and bloodborne disease transmission. Interceptor® G2 dual-insecticide bednetAs rising insecticide resistance threatens progress against mosquito-borne diseases such as malaria, Zika, and dengue, the Interceptor® G2 dual-insecticide treated bednet represents an important evolution of one of global health’s most essential prevention tools. Developed by BASF, whose agriculture division is based in North Carolina, the Interceptor® G2 uses two insecticides to improve effectiveness against resistant mosquito populations. Its development was supported by the President’s Malaria Initiative, USAID, and CDC, as well as the Gates Foundation, the Innovative Vector Control Consortium, and other international partners.  DIAGNOSTICSLumify AI-assisted handheld ultrasoundLife-threatening risks during pregnancy can go undetected in areas with limited health care resources, leading to deaths, as well as complications for both mothers and their babies. But a portable, artificial-intelligence-powered ultrasound developed by Philips Healthcare, whose North America offices are located in Massachusetts, with support from BARDA and the Gates Foundation, is addressing this challenge head on by helping improve access to screening for pregnant mothers in low-resource settings.Determine™ Antenatal Care Panel; Determine™ HIV Early Detect, Determine™ HBsAg 2, and Determine™ Syphilis TP rapid testsIllinois-based company Abbott developed a rapid panel test capable of simultaneously detecting HIV, hepatitis B virus, and syphilis, three major infections that pose serious risks to maternal and newborn health. The combination platform, which could simplify testing for health systems and patients and improve testing coverage, builds on individual in vitro rapid tests for each virus, which were developed by Abbott and later procured and scaled with support from the US President’s Emergency Plan for AIDS Relief (PEPFAR).OraQuick™ Ebola Rapid Antigen Test, Investigational Marburg rapid antigen test, and OraQuick™ HIV Self-TestOraSure Technologies, a Pennsylvania-based diagnostics company developed the OraQuick™ Ebola Rapid Antigen Test, a point-of-care tool that enables fast, presumptive diagnosis of Ebola virus disease. By providing results in minutes, the test supports health workers in rapidly isolating patients, initiating potentially lifesaving treatment, and ensuring safe and dignified burials that reduce transmission risk. The test was developed with support from BARDA.With support from BARDA, OraSure is also advancing a similar rapid antigen test for Marburg, a related virus to Ebola that also causes sever and often fatal disease.OraSure also has an oral HIV self-test, built on the same platform as its Ebola and Marburg tests. As the first US Food and Drug Administration-approved HIV self-test, it provides discreet, rapid testing for patients at home in as little as 20 minutes. The US government has supported scale-up of this product globally through PEPFAR.Co-Dx PCR Pro™ for on-site PCR testingThe PCR Pro™ molecular diagnostic platform from Utah-based Co-Diagnostics is designed to enable health care professionals to conduct on-site PCR testing, expanding access to fast, accurate testing outside traditional laboratory settings. With test panels available for flu, COVID-19, and RSV as a multiplex test and, separately, HPV and TB, the platform—developed with support from the NIH RADx program, as well as from PATH and the Gates Foundation for specific applications—has the potential to transform decentralized testing globally.NUTRITION INNOVATIONSReady-to-use therapeutic food for the treatment of severe acute malnutrition Nearly one third of children under five worldwide suffer from malnutrition. But a ready-to-use therapeutic food Plumpy’Nut has been a game changer. Developed by scientists at Washington University in St Louis and the French Institut de Recherche pour le Développement, manufactured by Georgia-based Mana and New Hampshire-based Edesia Nutrition, and scaled up with support from USAID and now the Department of State, this essential mix of vitamins, milk, and peanut butter allows severely malnourished children to recover and stay recovered with just a few servings.  Vitamin A biofortified corn Vitamin A deficiency is the leading cause of preventable child blindness worldwide. It impairs growth and immunity, increasing the risk of severe illness from common childhood infections such as diarrhea and measles. Corn biofortified with Vitamin A, developed by the District of Columbia-based Harvest Plus program at the International Food Policy Research institute, with support from USAID’s Feed the Future program, has been a transformative innovation. When consumed regularly, it can provide up to half of daily vitamin A needs for women of reproductive age and children. Thanks to our partners the American Society for Microbiology, the American Society of Tropical Medicine and Hygiene, Research!America, the Innovative Vector Control Consortium, IAVI, Monash University, Philips, Co-Diagnostics, HarvestPlus, Micron Biomedical, BASF, the Medicines for Malaria Venture, TB Alliance, Abbott, Mana, BD, Zebra Technologies, Sibel Health, the Coalition for Epidemic Preparedness Innovations, PATH, Gilead Sciences, OraSure Technologies, and the Global Health Investment Corporation for supporting this event.