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GHTC shared a statement ahead of the first part of Senate Committee on Appropriations' hearing on "Biomedical Research: Keeping America's Edge in Innovation," emphasizing how the US government contributes to developing lifesaving technologies that help Americans and people around the world, as well as generate significant economic benefits for the United States and urging appropriators to continue to support this work.Statement for the RecordSubmitted by Dr. Kristie Mikus, Executive Director, Global Health Technologies Coalition April 29, 2025 Introduction The Global Health Technologies Coalition (GHTC) thanks the committee for allowing the submission of statements for the record for such a crucial hearing. The title “Biomedical Research: Keeping America’s Edge in Innovation” underscores what a critical moment we are in as a nation as we watch various branches of the US-supported biomedical innovation ecosystem come to a halt after decades of meaningful and methodical progress. Over the past ~100 days, the scientific community has faced challenges on an unprecedented scale and has been forced to reckon with an uncertain future where the United States may start to fall behind the rest of the world. As GHTC—a group of 50 nonprofit organizations, academic institutions, and aligned businesses advancing policies to accelerate the creation of new drugs, vaccines, diagnostics, and other health tools to bring healthy lives within reach for all people—we encourage the committee to not lose sight of or backpaddle in support of key biomedical innovation programs that have been written into bipartisan appropriations bills for decades. Our coalition focuses on the challenge of conducting research and development (R&D) for neglected diseases, emerging infectious diseases (EIDs), antimicrobial resistance (AMR), and other global health priorities for which there is a lack of commercial incentive to spur large private sector R&D investments. Because of this market gap, the US government created the funding structures and capacity for R&D to develop lifesaving technologies that mitigate the progression of diseases like HIV/AIDS, malaria, tuberculosis (TB), Ebola, Zika, and, most recently, COVID-19. These efforts by the US government have saved millions of lives and improved the well-being of an even greater share of people around the world afflicted with illnesses that have plagued humanity for centuries. The challenge and way forward through R&D Unfortunately, we are still without essential technologies to achieve a future where pandemics are prevented and health is within reach for all. Additionally, diseases are evolving and beginning to outpace our ability to respond effectively. In 2022, 1.3 million people were killed by TB, 1.3 million people were newly diagnosed with HIV, and 249 million people were infected by malaria. In 2021, at least 1.14 million people were killed by bacterial resistance, and 4.71 million deaths were associated with bacterial resistance. More than 1 billion people worldwide are affected by neglected tropical diseases (NTDs), a group of 21 diseases caused by a variety of pathogens. Given these growing challenges, new medical products are needed to overcome neglected diseases, stay ahead of the deadly growth of drug and insecticide resistance, replace outdated and toxic treatments, prepare for future pandemics, and better reach low-resource and remote communities in the United States and globally. The United States has a proven track record of success. US government support has led to the development of 67 approved global health technologies (excluding COVID-19-related technologies), representing over a quarter of all approved global health technologies created worldwide since 1999. Looking ahead and toward new challenges, there are 579 global health technologies in late-stage development worldwide, with the US government supporting 261 (45 percent) of them through US agency collaborations. However, canceling grants, halting future investments, and firing key staff will be debilitating setbacks for these late-stage products. In addition to building the innovation ecosystem that helps to protect Americans’ health and security, investing in global health innovation also yields significant domestic economic benefits. Such benefits include remarkable job creation, economic gains, and a flourishing technology sector propelled by US dollars and expertise. After analyzing the data, GHTC and our partners at Impact Global Health released a report quantifying the return on investment of US government funding for global health R&D over the past 16-plus years. Highlights of this analysis include:  More than 600,000 new jobs created in the United States. A direct influx of more than $104 billion into the US economy. A separate and additional $102 billion into the economy from basic-science-related global health research. And, finally, an estimated $251 billion that will be infused into the economy from future innovations underpinned by the past 16 years of investment and invention.Broadly, the US government agency network that supports global health R&D includes the Department of State; the US Agency for International Development (USAID); the Department of Health and Human Services (HHS), including the Centers for Disease Control and Prevention, the National Institutes of Health (NIH), the Advanced Research Projects Agency for Health, and the Biomedical Advanced Research and Development Authority (BARDA); and the Department of Defense. Each of these agencies’ work on global health R&D has in some capacity been jeopardized, frozen, or eliminated in the past 100 days. While we appreciate the need for thoughtful reviews of federal funding and the pursuit of an effective executive branch, the cuts to and eliminations of key global health programs will damage the legacy of US leadership in the innovation space. Luckily, there is time to reverse these decisions, change course, and reestablish the United States as a powerhouse of biomedical R&D, as well as a trusted and well-funded research partner to the world. Below we intend to highlight a few areas where the global health R&D community finds itself at a critical juncture. Understanding that a significant amount of funding has hit a standstill, we want to present not only an update to the committee of where the work stands but also what the future could look like if these lifesaving and cost-effective programs, projects, and functions are fully operational. USAID Over the past several months, the critical R&D work conducted through USAID funding has hit a standstill. Many of our members have had their programs terminated, putting an indefinite hold on progress toward tackling some of the world’s most pressing challenges. As a key implementer of US global health programs, USAID, while not perfect, has been wellpositioned to identify pressing gaps and needs in innovations. The agency applies a unique business mindset, focusing on the late-stage R&D of technologies that are affordable, appropriate for last-mile settings, and primed for widespread adoption—thus maximizing the impact of US taxpayer investment. The benefit of these investments for Americans is also substantial: these investments not only save and improve lives worldwide, but they also strengthen the US economy, support our innovation sector, and keep Americans safe. Following a brief foreign assistance review, nearly all global health R&D awards were terminated. Projects terminated include efforts to advance: Promising HIV vaccines. Two early-stage trials of promising HIV vaccines were stopped from proceeding after patient enrollment had begun. Researchers now face a ticking clock to find alternative funding to continue the trials before the doses expire and efforts to train staff and recruit patients are for naught. An HIV vaccine is a priority to end the epidemic in the United States and globally. Next-generation malaria vaccines with improved efficacy. A clinical trial of two experimental vaccines in the United Kingdom was shut down mid-trial after some patients had already received doses, leaving them without appropriate follow-up care, and an award to the Walter Reed Army Institute of Research was ended. Advancing improved malaria vaccines is a priority for global health and protecting US military personnel. Shorter treatment and preventative regimens for TB, including drug-resistant forms, which could reduce treatment time by several months and improve adherence. Three significant treatment trials were halted, including two that were set to begin this year, and one with children, which was stopped mid-trial after some kids had received partial treatment. A trial that was set to start this spring to advance a one-month preventative therapy to stop people exposed to DR-TB from developing active TB is now on hold, and its future is unclear. Efforts to strengthen laboratory and surveillance systems across dozens of countries, which is critical to detect and prevent the spread of EIDs. If these efforts are resumed, the decades-long fights to tackle these diseases could reach a tipping point after years of dedicated work by the brightest minds in the American research enterprise. NIH NIH excels at basic and early-stage biomedical research, unlocking scientific discoveries that can later be translated into lifesaving global health technologies by the private sector, nonprofits, and other US agencies. While NIH primarily facilitates basic research on global health challenges through intramural programs and external grants to universities, nonprofits, and other organizations across the United States, its ongoing investments in clinical trials for HIV/AIDS— and, increasingly, trials for malaria and TB—also makes it one of the biggest global funders of clinical development in each of these disease areas. Two key NIH institutes and centers, the Fogarty International Center (FIC) and the National Institute of Allergy and Infectious Diseases (NIAID), contribute the lion’s share to global health R&D that directly benefits US citizens. Both FIC and NIAID are at risk of elimination and/or reprioritization and have absorbed some of the deepest cuts after the recent HHS reorganization. Both institute directors were reassigned to the Indian Health Service, and grants that focus on, among other issues, international collaboration, HIV/AIDS, and pandemic prevention have been terminated or indefinitely frozen. We write today to encourage the appropriations committee to think strategically about these vital resources at NIH and their contributions to our national and global health security through the pursuit of innovation. FIC plays an important role in accelerating science, partnerships, and technical assistance to advance new technologies for some of the world’s most pressing health challenges. With less than one-fifth of one percent of the total NIH budget, the center delivers significant scientific returns for global and American health, forging international partnerships to facilitate truly global research. Many FIC-trained scientists now hold high-ranking academic and government positions around the world and have made critical contributions to long-standing global public health challenges such as HIV/AIDS and emerging threats like COVID-19, Zika, and Ebola. Ultimately, FIC investments abroad improve public health in the United States. FIC’s investments in scientific capacity globally improve our ability to detect emerging and novel disease threats sooner. The center also creates a platform for partnerships between scientists in the United States and around the world. When FIC investments lead to new tools or interventions designed for low-resource settings, these innovations can be deployed back in the United States, where they can drive down costs and improve access to health care in rural settings—an exchange known as reciprocal innovation. For over six decades, most NIH funding for neglected disease R&D has flowed through NIAID, which conducts research across a range of global infectious disease threats, including HIV/AIDS, malaria, TB, NTDs, influenza, Zika, Ebola, and COVID-19. NIAID scientists, in partnership with Moderna, developed one of first COVID-19 vaccines, mRNA-1273, to reach Americans, and advanced the vaccine to human clinical trials just 65 days after the genome of the virus was shared—far quicker than any previous vaccine development timeline. Beyond COVID-19, NIAID has recently contributed to several major global health innovations: NIAID supported, through a public-private partnership, the development of an innovative, automated diagnostic for TB—the Cepheid Xpert® MTB/RIF test—which is simple to use and provides results in less than two hours. In comparison, older diagnostic methods can take several weeks. NIAID supported clinical research demonstrating that a combination of two newer drugs, bedaquiline and delamanid, could be safely taken together to treat drug-resistant TB in HIV-positive and HIV-negative individuals. NIAID supported preclinical research that contributed to the development of pretomanid, a new drug approved in 2019 by the US Food and Drug Administration for use as part of a combination therapy for highly drug-resistant forms of TB. NIAID developed an Ebola treatment, mAb114, which was found to dramatically improve the survival rate of infected patients in a clinical trial carried out amid the 2019- 2019 outbreak in the Democratic Republic of the Congo. The technology underpinning this treatment has also been used in research on therapeutics for COVID-19—illustrating how continued investment in a range of global health challenges helps prime our research infrastructure and scientific knowledge base for emerging threats. We have seen the NIH research partnerships supported by FIC and the technologies accelerated by NIAID scientists transform our global health security toolbox and take center stage in the fights against the most significant health-related disasters in recent memory. These institutes and centers have saved American lives while powering the biomedical innovation engine that makes the United States’ leadership on these issues second to none. Sustaining support for these research entities will help maintain our edge on innovation and keep us all safe. BARDA BARDA supports the advanced development of vaccines, drugs, and other medical countermeasures to protect Americans against threats to public health, including EIDs, AMR, and pandemic influenza. BARDA works with industry to bridge the “valley of death” between basic research and product development—so called because many potential medical innovations stall after public funding for basic research drops off but before other public, private, or nonprofit R&D funders pick up later-stage product development efforts. Through unique contracting and incentive mechanisms, BARDA’s partnerships ensure promising research is translated into urgently needed medical products by creating commercial incentives for private-sector partners to invest in R&D. Through emergency supplemental appropriations, BARDA has made a significant impact during global health emergencies. Between 2015 and 2017, BARDA helped advance at least three Ebola vaccine candidates, at least six diagnostics for Zika, and at least five Zika vaccine candidates, leading to 11 US Food and Drug Administration-approved products for filoviruses like Ebola and Zika. BARDA has also supported development of broad-spectrum antiviral called galidesivir, which has the potential to treat a variety of pathogens, including Ebola, Marburg, yellow fever, and Zika. In response to COVID-19, BARDA has supported at least 127 products, including vaccines, diagnostics, therapeutics, and devices, and devices through $25 billion in emergency supplemental funding appropriated through COVID-19 relief bills, which is more than 43 times its base fiscal year 2020 appropriation. As we have all now seen firsthand, the delay between the emergence of a health threat and the development of appropriate tools to combat it costs lives and disrupts the most fundamental functioning of our global society. BARDA has also already made significant contributions to the global effort to curb AMR, including through the founding of the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), as directed by the U.S. National Action Plan for Combating Antibiotic-Resistant Bacteria. Since 2017, CARB-X has supported 113 R&D projects in 14 countries. Of these, 18 projects have already advanced into or completed clinical trials; 12 remain active in clinical development, including late-stage clinical trials; and three diagnostic products have reached the market. Indeed, BARDA is a leader across three critical stages of R&D through three programs: preclinical research supported by CARB-X, clinical research funded through the Broad Spectrum Antimicrobials Program, and post-approval funding from the Project BioShield Special Reserve Fund. Conclusion Global health research that improves the lives of people around the world while at the same time supporting US interests, creating jobs, and spurring economic growth at home is a win-win investment. The traditional distinction between “domestic” and “global” can create vulnerabilities to Americans’ health and well-being. Many diseases that may not be common in the United States now still pose significant domestic health concern or threats to Americans. The incidence and burden of these health challenges globally represent a reservoir for continued spread, risking the emergence of dangerous genetic mutations, and they are also a source of significant human and economic loss. Millions of people die every year, and our vulnerability to disease increases because we lack the necessary technological innovations. The United States, as a biomedical research powerhouse, can change history and save lives through relatively small public investments while meeting necessary domestic health security requirements. It also makes good business sense for America to invest in biomedical innovation for global health considering the economic benefits to the United States aforementioned, including several hundred thousands of jobs created for the US economy. The challenges the R&D community faces today are hard to ignore, but by regaining lost ground on issues like funding biomedical innovation, reengaging with international research collaborations, and strengthening the capacity for research universities and research organizations, we can pull ahead and reclaim our strategic edge.

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. A new study published in The Lancet Infectious Diseases ahead of World Malaria Day last week found that adding a low dose of the widely available antimalarial drug primaquine to artemisinin-based combination therapy is safe and effective at blocking Plasmodium falciparum malaria transmission in young children in areas of low- and moderate-to-high transmission. The new study fills a gap in knowledge of the safety and efficacy of this approach for young children, who face the highest burden of clinical malaria and are particularly at risk of artemisinin-resistant strains but could face adverse complications from adult formulations of primaquine. The findings highlight the need for child-friendly formulations of primaquine and support the expanded use of the drug in regions with a moderate-to-high transmission rate and the threat of artemisinin partial resistance.The Drugs for Neglected Diseases initiative, the National Health Service University Hospitals of Liverpool Group, and the University of Liverpool have initiated a clinical trial in Liverpool, United Kingdom to test an oral drug for visceral leishmaniasis, one of the world’s deadliest parasitic diseases. Current treatments for visceral leishmaniasis, which is almost always fatal if left untreated, include daily injections for up to 17 days, which can cause immediate pain, as well as nausea, vomiting, and more serious complications. The new oral drug, DNDI-6899, is easier to store, transport, and administer than current treatments. If proven successful, the drug could help make treatment more accessible to those who need it most.DioSynVax and ACM BioLabs have signed a new deal to jointly develop a next-generation avian flu vaccine with the potential for mucosal vaccine delivery, as the virus continues its worrying spread. The mRNA vaccine targets all major clades of the H5 avian flu subtype and could be scaled for rapid distribution globally in the case of a pandemic. The vaccine is also designed to be delivered via nasal spray, which could help increase uptake; to induce mucosal immunity, which helps fight the pathogen before it starts circulating the body; and to be temperature stable, enabling rollout in lower-resource settings.

In 2001, I traveled to Ghana as a graduate student working on a US Agency for International Development-funded decentralization program. I arrived armed with materials on local governance best practices. But the mayors I met were focused on urgent public health issues: clean water, HIV/AIDS, tuberculosis, and malaria. That trip, meant to be an early lesson in governance, became my first and most personal education in global health. It also nearly killed me. I was taking mefloquine weekly to prevent malaria. Toward the end of our stay, my partner and I set off to explore the country. Somewhere along the way, I developed what I believed to be giardia. That infection likely compromised the absorption of the mefloquine and left me dangerously vulnerable. One night in the village of Kokrobite, I woke with a high fever and chills so intense I could barely stand. A local man saw me and immediately recognized it as malaria. He arranged for a taxi to take me back to Accra. Before I left, he handed me a small, crumpled packet labeled in Chinese characters. Inside was a blister pack of pills. The only word written in English on the package was artesunate. He told me it would help, and, in that moment, sick, scared, and weak, I took it. At the hospital, a blood smear confirmed that I had cerebral malaria caused by Plasmodium falciparum, the deadliest strain. Cerebral malaria can cause brain swelling, coma, and death. I drifted in and out of consciousness for days. At one point, hospital staff told my partner that there was nothing more they could do. I should “go home” and be “as comfortable as possible.”My partner worked relentlessly to get me on one of the next flights back to the United States. I was so sick that the airline nearly refused to let me board. Once we arrived home, I was seen right away by an infectious disease doctor at Johns Hopkins Hospital. After reviewing my labs and the herbal remedy package, he said plainly: this saved your life. The artesunate had bought me enough time to survive the journey and begin treatment. At the time, the World Health Organization had not yet formally endorsed artemisinin-based combination therapies (ACTs) as the global standard for P. falciparum malaria. That came in 2006. But the effectiveness of artesunate alone was already well known in many parts of the world. That medicine saved my life.I missed several weeks of school but made a full recovery. Without that drug and the help of my partner (now my husband) and friends in Accra, I wouldn’t be here today. More than two decades have passed, and we've made tremendous progress. Insecticide-treated bed nets, rapid diagnostic tests, and ACTs have saved millions of lives. Two malaria vaccines, RTS,S and R21/Matrix-M, have been approved. Long-acting monoclonal antibodies are showing promise as seasonal protection for children. Newer insecticide-treated nets help counter resistance. And researchers are exploring RNA-based therapeutics and single-dose cures.Many of these breakthroughs are being developed by members of the Global Health Technologies Coalition, where I now serve as Executive Director. These tools represent our best chance not just to control malaria but to end it.But progress is not guaranteed. Cuts to foreign assistance and global health research and development are already slowing the progress of innovations in the pipeline. Some promising tools may be delayed or abandoned. That means more children at risk, more untreated infections, and more drug-resistant strains emerging. The parasite has evolved before. It will do so again if we let it. And malaria is no longer a disease that happens mostly outside of the United States. In the past two years, locally acquired cases have been reported in Florida, Texas, and Maryland. Climate change, global travel, and changing mosquito habitats are making malaria a threat we can no longer treat as distant. I know how thin the line is between surviving this disease and not. For me, it’s not abstract. It’s the memory of a fevered body, the generosity of strangers, and a medicine in the right place at the right time. This World Malaria Day, I urge leaders and policymakers to stay the course. The science is moving forward. But science alone isn’t enough. If we don’t finish what we’ve started, we risk letting malaria surge back and take more lives with it. Science has given us the tools. The question now is whether we will act in time or let the disease outpace us once again. 

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. The Sabin Vaccine Institute has launched a multi-site Phase 2 clinical trial, supported by the Biomedical Advanced Research and Development Authority, in the United States to test its Marburg vaccine candidate, as outbreaks of the virus, for which there is no approved vaccine, grow in frequency. This trial builds on previous Phase 2 testing in Kenya and Uganda, as well as an open-label Phase 2 trial in Rwanda during the country’s outbreak last year. These trials in the African regions where Marburg and other similar viruses are most common or endemic are key to ensuring the vaccine is effective in the populations currently facing the highest risk of outbreaks. In addition, this new trial in the United States provides key safety and immune response data in non-endemic populations, helping prepare us for the possibility of outbreaks outside of the virus's typical range.Researchers have discovered a small antibody fragment that can block fertilization by targeting a key protein on the egg's surface, potentially paving the way for a nonhormonal contraceptive method. The fragment was found to be effective in mice, and it could potentially have fewer side effects due to its small size. Currently available hormonal contraceptive methods can cause side effects, like mood changes, headaches, or increased risk of blood clots, leading researchers to look for nonhormonal options for people who do not want to or cannot use hormonal methods. The researchers will next develop a similar antibody for human targets and test it in IVF experiments.The Drugs for Neglected Diseases initiative (DNDi) and partners initiated Phase 2 clinical trials in Malawi and Tanzania testing a new, easier-to-administer, and patient-friendly formulation of flucytosine, a medicine used to treat cryptococcal meningitis, which is a major health threat to people with weakened immune systems, including those with advanced HIV disease. Currently, flucytosine can be difficult to administer in resource-limited settings, and many countries face limited supply. As a result, access to timely treatment is limited in Africa, where the disease kills up to 70 percent of those who get it. The new formulation reduces dosing frequency from four times a day to just twice daily, is easier to take with water or through a nasogastric tube, and is suitable for outpatient self-administration.