Breakthroughs Blog

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. Recently published research found that vaccinating infants for measles earlier could help close a crucial gap in protection in those early months of life and warrants further study, especially as measles cases surge globally, underscoring the need for new and innovative approaches. The systematic review looked at 34 journal articles with data from 8,000 babies under nine months old in low- and middle-income countries, finding that maternal measles antibody rates were highest at birth before decreasing rapidly, leaving infants with low antibody rates for months before their first recommended measles vaccine dose at 9-12 months, followed by a second at 15-18 months. An earlier first dose, achieved either by giving the first dose sooner or adding a third dose before the routine two-dose schedule, could help close that critical gap in immunity.Last week, Roche announced that it is launching a Phase 3 trial of its novel antibiotic candidate, zosurabalpin, in patients with carbapenem-resistant Acinetobacter baumannii (CRAB) infections, considered one of the most dangerous and deadly antibiotic-resistant pathogens and a priority for antibiotic development. The study, expected to start at the end of 2025 or early 2026, will compare the safety and efficacy of zosurabalpin with standard-of-care antibiotics in around 400 patients with CRAB infections at sites across Europe, North and South America, and Asia. Zosurabalpin was previously shown to demonstrate high efficacy in lab tests against human clinical CRAB isolates and in mice with lung and thigh infections caused by pan–drug-resistant A baumannii.The Coalition for Epidemic Preparedness (CEPI) announced last week that it has signed a new agreement with the US Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense to enable collaboration on several projects to boost global preparedness against future disease outbreaks, including through the development of medical countermeasures. The first project will support the development of a monoclonal antibody for the Nipah virus, a deadly zoonotic disease with no approved tools to defend against it. The department will transfer doses of a Nipah monoclonal antibody, which is currently undergoing Phase 1 testing in the United States, to CEPI for a Phase 1b/2a clinical trial in India and Bangladesh, two countries that see almost annual Nipah outbreaks. These trials aim to provide critical data that could enable access to the monoclonal antibody to protect vulnerable populations during an outbreak in Nipah-affected regions and the US joint forces in a potential emergency.

For decades, strong US government investment in biomedical innovation has fueled the development of new vaccines, treatments, and other breakthrough global health technologies that have saved and improved millions of lives around the world and here at home. Unfortunately, in recent months, we have seen these investments decline significantly, as the US government has shrunk its foreign assistance footprint and ended hundreds of medical research grants. With the majority of global health research programs at the US Agency for International Development (USAID) and many other key US agency programs facing an uncertain future, past progress and future gains in global health innovation are now at risk. These disruptions threaten to undermine the United States’ longstanding role as a global leader in biomedical innovation, compromise the return on previous investments, and heighten health risks for people in the United States and around the world.The current US administration has signaled its priority to make America safer, stronger, and more prosperous—a goal which is directly aligned with the outcomes of global health research and development (R&D). By embracing ongoing commitments and continuing to invest in global health R&D, US policymakers can safeguard the well-being, resilience, and economic prosperity of the American people—advancing the agenda of the US administration while simultaneously saving and improving lives around the world. Global health R&D protects Americans from disease threats and promotes international stabilityDisease threats know no borders. Americans are increasingly at risk of emerging and neglected diseases, as underscored by the recent domestic outbreaks of H5N1, measles, mpox, and tuberculosis. Right now, health technologies developed with US funding are protecting Americans and ensuring that the United States is equipped with the proper tools to mitigate disease threats. The 2025 outbreak of Sudan virus, which can cause Ebola disease in humans, in Uganda was the latest Ebola outbreak that endangered the well-being of citizens worldwide. In addition to providing critical monetary and technical assistance contributions to Uganda to combat this outbreak, the US government also donated courses of an experimental monoclonal antibody treatment that was developed with US funding and 500 rapid detection test kits to support ongoing surveillance and prevention of future outbreaks. Additionally, other global partners launched two major clinical trials testing an experimental vaccine and therapeutics, including the monoclonal antibody therapy and an antiviral treatment, all of which were developed with past US government support. Collectively, these interventions and the rapid response effort helped stop the virus from spreading beyond Ugandan borders, ultimately protecting lives around the world and quelling the potential threat to Americans. Thanks to sustained US investment in Ebola research and outbreak response since 2011, the United States had the knowledge, infrastructure, and tools needed to respond quickly and effectively to the recent outbreak—minimizing the threat to regional stability and American public health.Beyond Ebola, the US government has also advanced other global health breakthroughs that have directly benefited Americans, including new drug-resistant tuberculosis treatments, long-acting HIV prevention and treatment options, and vaccines for mpox.Global health R&D strengthens US global influence, while also protecting military personnelGlobal health R&D has historically been a powerful diplomatic tool for the United States in strengthening its partnerships and ties around the world. By drawing back its investments, the United States risks ceding leadership in the foreign policy and medical research space to other countries—including its geopolitical rivals—who could step up to fill part of the vacuum left behind. Take China for example: in recent years, it has continued to grow its R&D investments, diminishing the gap between American and Chinese investments. Additionally, at the 2024 Forum on China Africa Cooperation, the Chinese government announced plans to encourage Chinese businesses to invest in the production of medicines and vaccines in Africa as part of its 2025-2027 action plan. As other global actors expand their influence in global health, including through increased investment in medical innovation and manufacturing, the United States must remain engaged to preserve its leadership, uphold its values, and continue delivering lifesaving impact around the world. Diminished leadership in global health innovation could also increase the vulnerability of US military personnel stationed around the world. Infectious diseases are the single largest cause of hospitalizations of US servicemembers during conflicts, representing an average of nearly 60 percent of casualties in recent conflicts. Global health technologies advanced through foreign assistance dollars and non-defense spending have helped keep US warfighters healthy and safe. For example, the US Centers for Disease Control and Prevention helped create a test to ensure US military uniforms treated with malaria-targeting insecticides remain effective, and USAID supported the development of tafenoquine, a single-dose medicine used to treat Plasmodium vivax malaria, as well as the only US Food and Drug Administration-approved treatment for leishmaniasis, a parasitic disease common in the Middle East. Without continued investments in research, challenges like growing antibiotic resistance could put the US military in an increasingly vulnerable position.Global health R&D drives American innovation and prosperityBetween 2007 and 2022, the US government invested just under $46 billion in R&D for neglected diseases, emerging infectious diseases, and sexual and reproductive health issues (To put this amount in context, in 2022 alone, the US government spent $751 billion on defense and $1.34 trillion on Medicare and Medicaid). This relatively modest investment helped contribute to the development of 67 new technologies approved since 1999 for neglected and emerging diseases (excluding COVID-19) and fueled a burgeoning pipeline of 261 promising products in late-stage development, which could further reduce the human and economic toll of these diseases.Beyond its health impact, this investment has also delivered substantial economic benefits to the US economy. Between 2007 and 2022, at least 86 percent of all funding that the US government directed to global health R&D was reinvested in American companies and institutions. This investment has created an estimated 600,000 new American jobs, spurred $104 billion in direct economic activity, and yielded scientific knowledge to inspire further innovations, which will ultimately generate $255 billion in long-term benefits to the American economy.These investments have also proven their potential to create cost savings, by driving down health care costs or preventing costly care down the line. For example, switching all patients with drug-resistant tuberculosis to regimens incorporating a new drug, pretomanid, which was developed with support from USAID and the National Institutes of Health, could generate global cost savings of $740 million annually. Even modest investments in scientific research can yield significant economic returns for the United States. The good we do makes us great Investment in global health R&D makes up just a small portion of the federal budget—around 0.8 percent in fiscal year 2022—but it has a priceless impact on the lives and livelihoods of Americans and people in need around the world. When the United States invests in global health research, we create opportunities and benefit the health of people in our nation and around the world. We fuel innovation at home. We create jobs. We make friends and allies. We make the world safer, and we make our world safer too. It’s the good we do, in part, that makes us great. As the US government reimagines its foreign assistance architecture and makes future research funding decisions, global health R&D efforts must be prioritized to preserve the progress we’ve made and deliver the bold breakthroughs of tomorrow. Sustaining the US government’s commitment to global health R&D will yield strategic and cost-effective benefits, bringing us closer to a safer, stronger, and more prosperous America and world—but only if we are able to meet the moment we are in.

Every year, delegates from around the world descend on Geneva, Switzerland for the annual World Health Assembly (WHA), a convening of key donors, decision-makers, and advocates who are seeking to drive the collective health agenda forward. But while this year offered many of the same lengthy debates, geopolitical outbursts, panel discussions, and late-night receptions, it was clear to all that we are not in normal times.   Global health is facing a moment of profound uncertainty. The financial strain on the World Health Organization (WHO) is just one signal of a wider set of systemic pressures—from donor fatigue to the imperative for countries to mobilize more domestic resources. This year’s forum arrived at a moment when expectations are high, but so too is the risk of backsliding without renewed commitments and smarter, more sustainable strategies. Despite this backdrop, delegates should rightfully celebrate some of the wins that WHO and member states notched this year on behalf of the global community.   Pandemic Agreement is adopted by delegatesIn what was the most anticipated moment of this year’s WHA, member states came together to adopt the Pandemic Agreement—an achievement met with standing ovations and thunderous applause. The moment marked not only a significant step forward for global health but also a rare and much-needed boost for multilateralism.  Deliberations had stretched on for three long years, and until the final moments, it remained uncertain whether negotiators would reach any substantive agreement. But they persisted, driven by the sense that this was a once-in-a-generation chance to ensure the mistakes of the COVID-19 pandemic are not repeated and to lay the foundation for a new architecture and obligations to drive greater equity in the development of and access to medical countermeasures.Notably, this agreement commits countries to develop policies attaching public interest conditions to research and development (R&D) funding—an unprecedented move with the potential to transform how treatments, tests, and vaccines are developed and delivered during health crises.  Additionally, it introduces a new global coordinating mechanism for supply chains and logistics, mandates national policies to ensure post-trial access to products for both trial participants and at-risk groups, and sets out guiding principles for a new Pathogen Access and Benefit-Sharing (PABS) system. Under this system, participating manufacturers would allocate 20 percent of their medical countermeasure production during a health emergency to WHO—supporting more equitable access and distribution around the globe.While delegates celebrated this historic milestone, the process is far from over. Global leaders must still finalize negotiations on the PABS system, which is widely seen by many low- and middle-income countries (LMICs) as the linchpin for ensuring equitable operationalization of the agreement.   More decisions will also have to be made around implementation, especially on financing capacity-strengthening efforts to ensure that countries can meet the new obligations enshrined in the agreement. But for now, many in the community are breathing a major sigh of relief and raising a glass to the successful completion of this arduous phase.   Financing at the forefrontGlobal health is facing a funding crisis as several major donors retreat, leaving many to wonder whether shared global goals and targets can still be achieved. Many major institutions are hindered by a lack of resources, and WHO itself faces an almost catastrophic budget shortfall.   At WHO’s Executive Board meeting in February, member states made the difficult decision to reduce the organization’s budget from $5.3 billion to $4.9 billion for the 2026-2027 period. Subsequently, the secretariat called for an even further reduced budget of $4.2 billion due to the anticipated decline in official development assistance.   During WHA deliberations, member states shared strong views about how the organization’s resources should be allocated. The regions of Africa, the Americas, and the Eastern Mediterranean called for the preservation of in-country work and greater alignment of budget allocations with public health need. In contrast, several donor countries, such as Australia, Canada, Switzerland, and the United Kingdom emphasized the need to safeguard WHO’s normative work, which has predominately been performed at its headquarters in Geneva.   In late April, the secretariat presented member states with a proposal to restructure WHO staff and activities. It recommends that work in Geneva be based around three technical divisions: Health Promotion and Disease Prevention and Control; Health Systems; and Health Emergency Preparedness and Response. The office of the Chief Scientist and the division of Business Operations would provide cross-cutting support. There have also been proposals to reduce the senior leadership team at headquarters from 12 to 7 and consolidate the number of departments from 76 to 34. WHO’s regional offices are finalizing their restructuring efforts as well, aiming to align more closely with the new model for headquarters.  While this plan has been relatively well received thus far, with many country representatives praising WHO for its consultative process, the devil will be in the details. Specifically, it remains to be seen how programs vital to health R&D and infectious disease response will be affected. So far, it is encouraging that WHO is retaining some of its key R&D functions, like the prequalification program and the office of the Chief Scientist. But the impact of the restructuring on disease-specific programs, like tuberculosis, malaria, HIV/AIDS, and neglected tropical diseases, is still unclear.United States makes surprising appearanceFor the first time since 1948, WHA convened without the United States. This absence was acutely felt—not only in the lack of a US delegation in diplomatic deliberations, but also in the ripple effects created across an already strained global health landscape. Nowhere was this more apparent than in the budget negotiations, where the vacuum left by US withdrawal and funding cuts loomed large, injecting uncertainty and apprehension into an already difficult process. Leaders were also thrown for a loop when they received a surprise video message from the new US Department of Health and Human Services Secretary Robert F. Kennedy Jr. In his remarks, which echoed many of the current administration’s previously shared concerns about WHO, Kennedy appeared to extend a bit of an olive branch, calling for “a new era of international health cooperation, free from political influence and corporate bias.” Yet, despite a sprinkling of conciliatory language and even praise for some of WHO’s efforts, he did not give any indication of a shift in policy, nor did he suggest that the United States would consider rejoining the organization at this time.  Secretary Kennedy did acknowledge, however, that infectious disease and pandemic preparedness need to remain national and global priorities, though how the US government intends to forge that cooperation outside of WHO, the Pandemic Agreement, and the International Health Regulations remains unclear.   As we approach the official US withdrawal from WHO in January, it will be interesting to see how the United States will seek to engage in global health dialogues and coordinate with multilateral institutions. The question remains whether the US government will stop the withdrawal or move toward some new framework that allows for limited technical collaboration.   Research takes a back seatAlongside the high-profile discussions on the budget and the Pandemic Agreement, this year’s WHA saw delegates tackle some 75 agenda items during the marathon nine-day session. Yet, R&D—typically a staple of WHA conversations—took a noticeable back seat. Few agenda items beyond the Pandemic Agreement addressed access issues, and virtually none focused on specific product types or infectious diseases. While this may not signal a troubling shift just yet, the innovation community cannot take for granted the need for continued and sustained advocacy to elevate health research as a priority. Even so, the week was not without its bright spots, with new commitments advanced to tackle antimicrobial resistance (AMR) and the impacts of climate change on health and to improve maternal and child health—offering concrete examples of where global health priorities are still gaining ground. Member states unanimously agreed to update WHO’s global action plan on AMR for discussion at next year’s WHA, with several nations underscoring the importance of developing new and effective medicines to keep pace with evolving drug-resistant pathogens. Many countries also offered support for WHO’s Global Strategy for Women’s, Children’s, and Adolescent’s Health, which is aimed at helping reach Sustainable Development Goals 3.1 and 3.2 to reduce maternal, newborn, and under-five mortality rates. Additionally, a new action plan on climate and health was also adopted, which includes R&D-enabling efforts to create stronger links between researchers and policymakers, expand access to financing and technical support, and promote greater cross-border collaboration.   This year’s WHA reflected both hard-won progress and tough realities—and it also set the stage for what comes next. The adoption of the Pandemic Agreement is more than a milestone; it's a mandate to turn consensus into action that advances equity and preparedness. As WHO confronts a reduced budget and undertakes a major restructuring, there's a chance for the organization to streamline, refocus, and emerge as a more agile, effective force in global health. If leaders can build on WHA’s momentum and commit to smarter, more inclusive cooperation, this moment of disruption could mark the start of a leaner and more resilient era in global health.  

The recent staffing cuts at the U.S. Food and Drug Administration (FDA), which affected roughly 20 percent of its workforce, have prompted concerns about the agency’s ability to fulfill its mission. The cuts would severely impact US companies and US global leadership in the biomedical space.  The global implications would be even more grievous—particularly for low- and middle-income countries (LMICs) that depend on the FDA’s regulatory leadership. Many LMICs and other countries rely on the FDA’s assessments, approvals, and post-market surveillance data to inform their own regulatory decisions. These programs, often referred to as “reliance programs,” streamline national approval processes by referencing trusted decisions from agencies like the FDA. As the agency grapples with significant staffing reductions, there could be ripple effects on these international structures.What are reliance programs?Reliance programs allow regulatory authorities in one country to draw on the evaluations, inspections, and approvals of trusted agencies—known as Stringent Regulatory Authorities (SRAs)—such as the FDA. Many LMICs use FDA decisions to streamline access to essential medicines and vaccines, avoiding duplicative reviews and accelerating timelines. This model is especially valuable where regulatory resources are limited, allowing local agencies to focus on post-market surveillance and health care delivery. The FDA’s assessments serve as a de facto quality mark, reinforcing confidence in products worldwide.One example is the World Health Organization’s (WHO’s) Collaborative Registration Procedure (CRP), which enables countries to fast-track the registration of WHO-prequalified medicines by leveraging FDA and other SRA reviews. Between 2015 and 2021, the CRP facilitated 59 approvals for 16 medicines across 23 countries, demonstrating its impact on timely access to quality-assured medicines for patients.Implications for the United StatesIf the FDA’s reduced capacity compromises its ability to effectively conduct timely reviews, update guidance documents, or perform inspections, the most immediate impacts will be felt in the United States. The United States could lose influence in setting international safety, efficacy, and quality standards if other regulatory authorities begin supplanting the FDA's role in global reliance networks. Over time, this erosion of regulatory leadership could diminish the FDA’s status as the gold standard globally—a position that has long bolstered American soft power in global health and trade. Manufacturers based in the United States that are developing products for diseases endemic in LMICs may also find their innovations at a disadvantage if the FDA lags behind other regulators in review speed or capacity or if the WHO prequalification program, which allows US manufacturers to leverage mechanisms that streamline and accelerate the deployment of their innovations in LMICs,  no longer recognizes the validity of FDA review. In 2024, for example, WHO prequalified a Hepatitis C self-test manufactured by Bethlehem, Pennsylvania-based OraSure Technologies. An innovative mpox point-of-care molecular test developed by Sunnyvale, California-based Cepheid became the first such diagnostic ever approved by WHO for emergency use. These FDA-WHO collaborations are vital for the purchase and procurement of American products. If the FDA retreats from this space, it could reduce the competitiveness of American firms in emerging markets and make the United States a less attractive regulatory partner for international collaboration. Preserving the FDA’s global standing is, therefore, not only a matter of public health but also of economic and geopolitical significance.Potential impacts on LMICsHowever, the secondary consequences could be more acute for countries relying on the FDA’s efficiency to inform their regulatory decisions. Delays in product approvals may extend the time before essential medicines reach patients in LMICs—where the burden of disease is often highest and timely access is critical. The loss of experienced personnel and institutional knowledge may also weaken confidence in the consistency and rigor of FDA assessments, prompting some regulators to reevaluate the extent of their reliance. The FDA should build its internal capacity to address neglected diseases rather than reduce staff, providing training opportunities and ensuring their workforce has the prerequisite expertise.Looking aheadTo help safeguard both domestic and global health outcomes, it will be important for the FDA to maintain its capacity to carry out timely, science-based evaluations. One upcoming opportunity to support this effort is the Prescription Drug User Fee Act (PDUFA) reauthorization, which allows the FDA to collect fees from pharmaceutical companies to help fund its drug review programs. PDUFA has long been a bipartisan priority and is key in supporting the agency’s scientific workforce and review capabilities. Ensuring the continuity of this program will help the FDA meet its responsibilities at home and abroad. As global reliance on the FDA remains high—particularly among countries with limited regulatory resources—continued investment in the agency’s capacity will be necessary both for US innovation and global health systems that depend on its leadership.Now more than ever, we must protect the FDA’s ability to lead. A weakened FDA puts American innovation and jobs at risk, slows access to breakthrough products, and opens the door for other countries to set the standards we once defined. The world looks to the FDA, not just for safety and science, but for leadership. With PDUFA reauthorization on the horizon, Congress has a critical opportunity to invest in the FDA’s workforce and secure the United States’ role as the global leader in health and biomedical innovation.