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GHTC responded to a request for information (RFI) from Representatives Larry Bucshon (IN-08) and Diana DeGette (CO-01) on what Congress can do to bring about a next generation of treatments through the Next-Generation Cures Bill with the below response, urging decision-makers to be bold in the legislation and expand the aperture of innovation to include global health technologies for low-resource settings.To the attention of:Representatives Larry Bucshon and Diana DeGetteWe write to you today representing the Global Health Technologies Coalition (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. Thank you for the opportunity to contribute GHTC’s thoughts and perspectives to the Next-Generation Cures Bill. The 21st Century Cures Act’s legacy and the ideas-turned-legislation from the Cures 2.0 bill have accelerated the global health research and development (R&D) community’s success and provided the United States and the world with critical biomedical innovations. According to a recent report published by GHTC and our partners at Policy Cures Research, US investments in global health R&D have a remarkable return on investment and, over the past 16 years, have generated $104 billion in the economy and added more than 600,000 jobs to the US workforce. We strongly urge you and your fellow members of Congress to ensure that any legislation that tackles biomedical research should include reference to and encourage funding for global health R&D to mitigate health threats of the past, present, and future.Today, we recommend the following key priority areas for consideration for the Next-Generation Cures Act and offer ourselves as a resource as you develop this future landmark legislation:1. Strengthening ARPA-H’s mandate for global health.The Advanced Research Projects Agency for Health (ARPA-H) is a crowning achievement of the push for Cures 2.0 and one that GHTC is a vocal supporter of. GHTC would like to see the Office of International Affairs at ARPA-H empowered to address global health challenges like neglected diseases, emerging infectious diseases, antimicrobial resistance (AMR), and other health threats using the same novel approach ARPA-H is known for. High-risk, high-reward or fail-fast innovation in global health R&D is necessary to create new technologies for low-resourced communities worldwide. Innovation for low-resourced communities in global health could provide benefits for low-resourced settings in the United States. 2. Including PASTEUR (Sec. 105 of Cures 2.0) into the Next-Generation Cures Act.The Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act would create a program in the Department of Health and Human Services to incentivize the development of new drugs to address AMR through a subscription-based payment model.Since this was a past priority of Cures 2.0, it should be included in the Next-Generation Cures Act. 3. Including other bills with no clear paths to passage into the legislation.The bipartisan Supporting Innovative Global Health Technologies (SIGHT) Act is a piece of legislation that could use a powerful vehicle like the Next-Generation Cures Act to get it across the finish line. The SIGHT Act would create a distinct program and budget line for health R&D at the US Agency for International Development, establish a new leadership role and advisory council to guide investments, grant the agency authority to provide research awards, and mandate annual reporting on health R&D investments and results. This bill would transform our global health toolbox of the future and is worth considering for Next-Generation Cures.4. Prioritize transparency and authorize loan authorities at BARDA.The Biomedical Advanced Research and Development Authority (BARDA) is a critical federal agency for biomedical innovation, and greater transparency will assist innovators in understanding what has already been developed and what is still needed. Previously, BARDA has responded to requests to publicly report on its investments, providing valuable information to innovators and stakeholders that engage with the agency and invest in medical countermeasure development. This reporting should be used for all BARDA investments, including chemical, biological, radiological, and nuclear; emerging infectious disease; and AMR countermeasures. This transparency is important for oversight, reduces duplication, and promotes collaboration and coordination with other federal agencies and external partners engaged in global health security research. Additionally, BARDA needs a mechanism to support the finance of large-scale projects that could better prepare the United States and the world for future biological threats. With loan authorities, BARDA would be capable of supporting projects like innovative biomanufacturing facilities, such as microneedle patch vaccines.5. Prioritize deliverability and applicability of all global health technologies for use in low-resource settings.The deliverability and administration of new medical countermeasures are often blocked by the constraints of low-resource settings in the United States and abroad, where there is limited or inconsistent access to refrigeration, sanitation, electricity, highly trained health care workers, laboratories, and/or other resources. These constraints impeded the global deliverability of first-generation COVID-19 vaccines and therapeutics. Operation Warp Speed was successful at quickly developing safe and effective vaccines, but its leadership told GHTC that deliverability for low-resource settings was not being considered in vaccine portfolio decisions. We should learn from our past mistakes and, across the innovation ecosystem, ensure technologies that can be used for global health challenges are designed for low-resource settings.6. Encourage growth and strengthening of global health innovation at CDC.The Centers for Disease Control and Prevention (CDC), through their work in the National Center for Emerging and Zoonotic Infectious Diseases and the Global Health Center, are on the front lines of the next pandemic. By strengthening their mandates for innovation and R&D, the Next-Generation Cures Bill would be an investment in our global health security because of the important work these institutes conduct in surveillance, diagnostics, and delivery. Investments in strengthening the coordination that the Global Health Center conducts are integral to our pandemic preparedness.Investing and bolstering our global health R&D ecosystem across the US government leads to lives saved, jobs created, and economies strengthened. The global health security of the United States depends on other countries' capacity to fight against endemic diseases and quickly respond to outbreaks. The technologies we pioneer and fund with US dollars fortify our global defenses in preparation for those threats of yesterday, today, and tomorrow. By being bold in the Next-Generation Cures Bill and expanding the aperture of innovation to include global health technologies for low-resource settings, we can fight the world’s most pressing health challenges, maintain US leadership in global health diplomacy, and keep our country safe.Sincerely,Alex LongPolicy and Advocacy OfficerGlobal Health Technologies Coalition (GHTC)

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. Last week, Valneva and LimmaTech Biologics AG announced a new strategic partnership and exclusive licensing agreement for the development, manufacturing, and commercialization of Shigella4V, a tetravalent bioconjugate vaccine candidate against shigellosis. Shigellosis is caused by Shigella bacteria and is the second leading cause of fatal diarrheal disease globally, particularly in low- and middle-income countries. There are currently no approved vaccines for Shigella. Under the agreement, LimmaTech will receive support for conducting Phase 2 clinical trials of the vaccine candidate in low- and middle-income countries, which are expected to begin later this year. Then, Valneva will be responsible for the further development of the vaccine candidate through potential regulatory approval and commercialization if approved.The Biological Pest Control Centre in Valencia, Spain is releasing thousands of sterilized tiger mosquitoes, one of the species whose females transmit dengue to humans, to reduce the spread of dengue and other vector-borne diseases in Europe, as climate change has led to an expanding population of tiger mosquitoes across the continent and rising dengue rates globally. The lab employs an electron accelerator that uses radiation to sterilize the males, releasing an estimated 45,000 male mosquitos every week, who then unsuccessfully mate with the disease-spreading females, leading to an eventual reduction in the overall mosquito population. Similar sterilization techniques have been previously used to address disease vectors, but the Spanish lab is pioneering its use on the tiger mosquito.Last week, Indian company Biological E announced that the World Health Organization (WHO) has prequalified its novel oral poliovirus type 2 vaccine, a next-generation live attenuated oral vaccine, which can hopefully help reduce the incidence of vaccine-derived poliovirus, along with Indonesia PT Bio Farma's vaccine that was prequalified earlier this year. Cases of vaccine-derived poliovirus have increased in recent years in areas with low immunization rates. The new vaccine has improved genetic stability and carries a lower chance of starting new outbreaks of vaccine-derived virus compared to currently available poliovirus type 2 vaccines. Biological E said its manufacturing facilities can produce more than 500 million doses each year, with Indian regulators already having cleared the vaccine for export purposes.

How we got hereSince the earliest days of the House Republicans’ current position in the majority, health agencies like the US Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) have been called to testify multiple times before the House Committee on Energy and Commerce (E&C). E&C has used its power as the authorizing committee for domestic health agencies to hold hearings, issue subpoenas, and file reports on what Republican lawmakers perceive as failures of—and a lack of transparency of—public health agencies. More recently, in the committee, there has been a crescendo of opposition to NIH’s status quo—often focused on the work of the National Institute of Allergy and Infectious Diseases (NIAID) and its staff.With that in mind, GHTC and the global health community were prepared for either new legislation or reform plans targeting NIH. Sure enough, E&C, under the leadership of Chair Cathy McMorris Rodgers (R-WA), released a proposal in June to overhaul NIH by restructuring the agency and redirecting the mission of the institutes back to what House Republicans believe should be NIH’s focus. The proposal was outlined in a report and further explained in an op-ed coauthored by E&C Chair Rodgers and Robert Aderholdt (R-AL), Chair of the Labor, Health and Human Services, Education and Related Agencies (LHHS) Appropriations Subcommittee, which oversees NIH funding, signaling Chair Aderholdt’s support of the proposed framework.Later that month, the House’s fiscal year 2025 (FY25) LHHS bill was released, incorporating the newly proposed NIH framework. Rather than go through the typical process of advancing authorizing legislation, House Republicans attempted to put into effect a new NIH structure through the appropriations process. This process signaled House Republicans’ serious intent to reform NIH, even though there is little likelihood that these currently partisan priorities would ever be enacted in the final version of the LHHS bill since the Democrat-controlled Senate and White House must pass it.The frameworkThe proposed framework takes several key Republican talking points and applies them to NIH’s structure, mission, and processes. These broad buckets of change have implications across the entire NIH system, notwithstanding other new rules concerning how many grants a principal investigator can hold and how much overhead research organizations can claim. Here is a quick walk-through:Structure: The framework takes the 27 institutes of NIH and the (currently independent) Advanced Research Projects Agency for Health (ARPA-H) and consolidates them into 15 new institutes. This consolidation reflects a key Republican talking point that health agencies have gotten too large and cumbersome to effectively collaborate internally, which takes them further away from the core missions of the institution.Mission: The framework proposal persistently condemns demographic- and disease-based research and urges a focus on “the whole individual and all populations across the entire lifespan” instead.  Processes: One issue E&C Republicans have been laser focused on is accountability and transparency concerning what and who NIH funds. The framework proposes a heightened degree of oversight on grants and a stricter set of rules for NIH leadership.Of course, proposals to reform and make a more efficient agency are not without merit, but the context in which they were proposed has left some in the advocacy community with many questions. For example, before the pandemic, on the Hill, NIH generally received bipartisan support for its work and typically unquestioned budgetary increases to maintain its status as the global leader in biomedical research. However, since the pandemic, these issues of NIH consolidation, reconsidering demographic-based research, and heightened transparency have been targeted for what is seen by the advocacy community as a political issue, fueled by the fallout from COVID-19.Global health and the frameworkWhen it comes to the global health implications of the proposal, the issues are vast but also technically speculative, solely based on what we know from E&C and House Republicans’ past comments on the future of NIH and their stance on infectious disease research in the wake of the COVID-19 pandemic. The potential implications are as follows:NIAIDOne of the most intriguing developments is the splitting of NIAID, the world’s largest funder of global health research and development (R&D), into the National Institute of Infectious Diseases (NIID) and the National Institute of the Immune System and Arthritis. This fracturing of NIAID is seen as a direct response to the scrutiny that NIAID and its previous director, Dr. Anthony Fauci, have faced for the institute’s infectious disease work. While there may be good arguments for having an institute expressly focused on infectious diseases, this move also has the appearance of utilizing legislative powers and abilities to purposefully single out a critical line of work in global health at NIH, thus making it more susceptible to political pressures and perhaps more vulnerable to cuts in appropriations. This raises natural questions around process—why use this process at this time versus a more vetted and strategic process and why now.Additionally, the schism may disrupt the immunity and infectious disease research conducted at NIAID. Research into pathogens with pandemic potential, neglected diseases, vaccines, antimicrobial resistance, and even long COVID are all issues that intertwine with infectious disease work and work on the immune system. This break in the institute might disrupt or complicate ongoing efforts to combat important disease threats at home and abroad.If this piece of the framework were to be enacted in any way, NIAID advocates would have to take a closer look at the division of resources at the two new institutes to better understand how the work will be distributed and how the research will be financially impacted. From there, advocates will have to work with congressional colleagues to ensure that the infectious disease work at NIID remains independent but is conducted safely through consultation with researchers and advocacy organizations.FICIn the restructuring proposal, the Fogarty International Center (FIC) is lumped together with unrelated and domestic-facing institutes into the National Institute on Health Sciences Research. FIC acts as the global health focal point at NIH and has trained a vast network of around 8,500 professionals from 132 countries in public health threat response, many of whom have gone on to hold high-ranking academic and government positions. By placing FIC with unrelated institutes under the umbrella of “Health Sciences Research,” Congress would minimize its position in global health leadership and would mischaracterize FIC’s core mission and value added to the NIH ecosystem.If these changes were enacted, the onus would be on the advocacy community to make sure FIC is seen as an integral player in the US global health apparatus and to US global health security. In the 2018 President’s Budget Request and the FY25 House LHHS appropriations amendments process, there have been proposals to zero out FIC, leaving advocates understandably on alert for this potential restructuring.ARPA-HAs was alluded to before, in the framework, ARPA-H is moved under NIH’s leadership and merged with other institutes into a new National Institute on Innovation and Advanced Research rather than serving as an independent incubator for next-generation research. If ARPA-H begins operating under NIH’s topline appropriation, this would likely lead to a shrinking budget for ARPA-H—as was seen in the House’s FY25 LHHS bill.These cuts should be a warning sign to any research that exists outside the US-facing work ARPA-H is set to conduct. ARPA-H’s recently built-out Office of International Affairs and potential for global reach will likely be diminished as available resources dry up because of NIH’s primarily domestic mandate and competition for budgets.If the framework were to be enacted and ARPA-H did fall under NIH’s jurisdiction, global health advocates would need to strengthen their messages on ARPA-H's potential for global health research and needed funding. The next-generation innovation the advocacy community hopes to see out of this new agency is only possible if the appropriators sustain past funding levels, even if it rests within a restructured NIH.Going forwardGHTC wants to see a strengthened and streamlined NIH and agrees that improvements can be made to structures and systems, provided that the ultimate goal is to have an empowered, strategically structured, and well-resourced NIH. That way, the institutes can take on the global health R&D demands and challenges of the future that will result in greater innovation for vaccines, therapeutics, and diagnostics.In the wake of the release of this proposal, GHTC is focused on advocating for strengthening NIH’s global health R&D capacity and working with congressional colleagues on a path forward for NIH that reforms what can be improved and doubles down on what is already working. The global health impacts of NIH’s work are expansive, but in the framework, they are less obvious and require a closer look at the current political landscape and how global health-related issues are divided up at NIH.GHTC is hopeful that our colleagues on and off the Hill will work together to strengthen NIH’s global health impact.

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 results of a new study presented at the 2024 International AIDS Conference showed that long-acting injectable cabotegravir was safe and well tolerated as an HIV pre-exposure prophylaxis method in cisgender women before and during pregnancy. These exciting results come from an extension study of the efficacy trials among cisgender women that analyzed the outcomes of more than 300 pregnancies and infants. There has been limited data on the safety of long-acting injectable cabotegravir during pregnancy, so hopefully, these findings can fill that knowledge gap and lead to greater access to this highly effective HIV prevention option for this population, who may experience biological changes and social dynamics that can increase their likelihood of acquiring HIV during and after pregnancy.Last week, the Administration for Strategic Preparedness and Response at the US Department of Health and Human Services announced $25 million in funding to Walgreens to support a decentralized clinical trial testing COVID-19 vaccines. The study specifically aims to identify vaccine correlates of protection, or measurable immunity markers that correlate with protection against disease, using licensed or authorized COVID-19 vaccines to help assess immunity duration and streamline future clinical trials. This decentralized approach, which will include about 20 Walgreens pharmacies in urban, suburban, and rural communities, allows for a more diverse pool of study participants by bringing the study closer to where participants live. The funding comes through Project NextGen, a US government-led program to accelerate the development of next-generation COVID-19 technologies, including vaccines.  New data shows that Merck & Co.’s monoclonal antibody is safe and effective at reducing the incidence of respiratory syncytial virus (RSV)-related infections in infants. The Phase 2b/3 trial tested clesrovimab, also known as MK-1654, in healthy pre-term and full-term infants, finding that the antibody reduced the incidence of RSV-related infections over 150 days when compared to a placebo and hit key safety measures. The company announced that detailed findings will soon be presented to the scientific community and filed with global regulators. Hopefully, the antibody will eventually serve as an additional tool in the growing toolkit of new vaccines and monoclonal antibodies to address the burden of RSV in infants and older adults.