A report from GHTC and Policy Cures Research examines how US federal funding for global health R&D is delivering impact both abroad and at home.

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USAID/Kendra Chittenden
August 5, 2024

GHTC responds to RFI on Next-Generation Cures Bill

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, urging decision-makers to be bold in the legislation and expand the aperture of innovation to include global health technologies for low-resource settings.

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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)
WHO/Pierre Albouy
July 8, 2024

GHTC signs on to letter calling for member states to prioritize civil society involvement in pandemic agreement negotiations.

GHTC signed on to a letter coordinated by the Pandemic Action Network and signed by more than 140 organizations calling for member states to prioritize official involvement of civil society organizations in all remaining negotiations on the pandemic accord.

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Latest from the Breakthroughs Blog

Read stories about bright ideas and bold innovations in global health.

PATH/Georgina Goodwin
June 24, 2024

Research Roundup: Long-acting HIV prevention drug, African vaccine manufacturing project, Novel antifungal funding boost

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week.

Written by Hannah Sachs-Wetstone / GHTC
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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, Gilead Sciences shared results from a late-stage study showing that its long-acting injectable HIV prevention drug, lenacapavir, was more effective at preventing HIV infection in cisgender women and adolescent girls compared to the company’s daily pill, Truvada. The study, which included more than 5,300 cisgender women and adolescent girls, was stopped early by an independent committee because the results exceeded efficacy expectations, with no incidences of HIV infection among participants who received the drug compared to those who were not on any prevention regimen. Truvada is already in wide use for both HIV treatment and prevention, but the twice-a-year lenacapavir injection, which could be approved for HIV prevention regimens by the end of next year, offers an option that could be much easier to adhere to than the daily pill for many people, especially higher-risk individuals.In Paris last week, as part of the replenishment launch for Gavi, the Vaccine Alliance, the African Vaccine Manufacturing Accelerator was launched, a project Gavi will invest $1 billion into over the next decade to help increase Africa’s vaccine manufacturing base to accelerate the rollout of vaccines and improve pandemic preparedness on the continent. This project follows glaring inequities in access to COVID-19 technologies faced by African countries during the pandemic. Specifically, Gavi will provide financial incentives to African vaccine manufacturers once they hit supply and regulatory milestones, using market forces to drive down prices and encourage upstream investment. The project set the goal for Africa countries to produce 60 percent of the vaccines used by the continent by 2040, up from 2 percent currently. It will also explore issues including technology transfer and regulatory harmonization.Elion Therapeutics recently announced the close of an $81 million funding round to advance the development of its next-generation polyene antifungal candidate, SF001, designed to reduce toxicity and address critical challenges associated with currently available antifungal options. The news comes as growing resistance to existing antifungals and increasing fungal infection rates highlight the need for new and improved tools. The promising compound received Qualified Infectious Disease Product and Fast Track designations in 2023 from the US Food and Drug Administration for early antifungal therapy of presumed invasive fungal infection and treatment of invasive aspergillosis. The funding round includes investments from the public-private partnership AMR Action Fund, the fund’s first investment in an antifungal company.
FDA/Michael J. Ermarth
June 17, 2024

Research Roundup: WHO antibacterial R&D report, Broad-spectrum antibiotic partnership, Positive, late-stage results for COVID-flu combo shot

Written by Hannah Sachs-Wetstone / GHTC
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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. On Friday, the World Health Organization (WHO) published a new report detailing the antibacterial agents, including antibiotics, in clinical and preclinical development worldwide, finding that despite improvements, the pipeline remains inadequate to confront the urgent need for new, innovative technologies to address serious infections and replace those becoming ineffective due to rising antimicrobial resistance. According to the report, new products are not being developed at the pace and scale needed to ensure new antibiotics are delivered, given the time required for products to move through the pipeline and the likelihood of failure. Specifically, the report identified gaps in agents for children, agents with more convenient oral formulations, and agents that can address drug-resistant pathogens. The report also stressed that efforts to boost innovation must accompany parallel efforts to ensure equitable access to existing and new products, particularly in low- and middle-income countries, where access gaps can hasten the rise of drug resistance.  Last week, the Global Antibiotic Research & Development Partnership (GARDP) announced an agreement with Bugworks Research to support the further development of a new broad-spectrum antibiotic that targets some of the most difficult-to-treat bacterial pathogens, aiming to enable access simultaneously in Western countries and low- and middle-income countries with a high burden of antimicrobial resistance. GARDP will provide Bugworks up to $20 million in financial and technical support through the approval and commercialization of BWC0977, a compound that has demonstrated in-vitro activity against WHO critical priority pathogens, in return for the manufacturing and commercialization rights to it in 146 primarily low- and middle-income countries. Bugworks previously received more than $12 million from the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator, or CARB-X, for the preclinical development and Phase 1 study of the compound. Moderna recently announced positive late-stage trial results for mRNA-1083, its COVID-flu combination vaccine. The company is the first of several testing a combined COVID-flu vaccine to announce positive late-stage trial results, as experts raise calls for new tools to ensure more people have better protection against both viruses. Trial participants who received the vaccine showed an improved immune response compared with those who got the standalone flu and COVID vaccines that are currently available, even for people 65 years and older, who generally do not mount as robust immune responses to vaccines compared to younger people. The company hopes to have the vaccine approved for the fall of 2025.
USAID/UNICEF/Fauzan Ijazah
June 10, 2024

Research Roundup: Updated COVID-19 vaccines, HIV prevention injection trials, Cholera vaccine research

Written by Hannah Sachs-Wetstone / GHTC
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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 Wednesday, US Food and Drug Administration advisers recommended that next fall’s updated COVID-19 vaccine target the lineage of the JN.1 variant, which became dominant in the United States last winter. There was some debate among experts on whether the vaccine should target the KP.2 subtype of the variant that is now most common in the United States or other offshoot subtypes that may become more dominant over the summer, ultimately deciding to target JN.1 itself, with the hope that the vaccine would offer some cross-protection against other subvariants that might emerge. Moderna, Pfizer, and Novavax say they could have JN.1.-specific shots ready by the fall.Two clinical trials have been launched to test a new, long-acting form of HIV pre-exposure prophylaxis, or PrEP, in cisgender women and people who inject drugs, two populations that have been largely underrepresented in HIV clinical trials. The mid-stage studies, sponsored and funded by Gilead and implemented through the HIV Prevention Trials Network, will test lenacapavir, an injectable antiretroviral drug administered every six months, which is already approved by the US Food and Drug Administration for HIV treatment in combination with other antiretroviral therapy for heavily treatment-experienced individuals and is the first in the capsid inhibitors class of drugs to be FDA approved for HIV treatment. The researchers hope these studies will provide critical data on the use of lenacapavir as HIV PrEP.Last week, the Sabin Vaccine Institute announced a new research project with the Kenya Medical Research Institute aimed at optimizing the use of the oral cholera vaccine in the face of a global resurgence in cholera and acute vaccine shortages, hopefully improving the impact of the vaccine and saving lives. The shortage of the oral cholera vaccine in 2022 led the World Health Organization (WHO) to temporarily modify the two-dose vaccine regimen and recommend a single dose during outbreaks, underscoring the urgent need for research to optimize vaccine use. WHO currently recommends two doses of oral cholera vaccine two weeks apart. The new research will test strategies to extend the time between doses to ensure that more people can receive protection.
WHO/Pierre Albouy
June 7, 2024

Multilateral momentum: World Health Assembly yields progress on key global priorities but falters on pandemic accord

Written by Philip Kenol / GHTC
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Last week, rain clouds gathered over Geneva as delegates from all over the world completed their annual pilgrimage to the World Health Assembly (WHA), the World Health Organization’s (WHO’s) annual forum for the 194 member states. The somber background reflected the mood heading into the meeting, as many were expecting this year’s gathering to be a washout. A visibly weary WHO Director-General Dr. Tedros Adhanom Ghebreyesus expressed his disappointment on the opening day that negotiations on a pandemic accord had not been completed in time for a WHA vote. Representatives also expected contentious fights over sexual and reproductive health and geopolitical conflicts, such as the ones in Ukraine and Gaza, to spill over into the proceedings, freezing debate and derailing possible progress on agenda items ranging from climate and health to universal health coverage. Yet, despite some serious bumps in the road, WHA also showcased that any multilateral system obituary is premature and that multilateralism can still deliver the necessary change we need to advance the global health agenda.   WHA approves new IHR amendments, resets timeline for pandemic agreement negotiationsAll eyes were on whether member states could come together to finalize the negotiations around the pandemic accord, a proposed convention to address some of the shortcomings exposed during the COVID-19 pandemic, as well as amendments to the International Health Regulations (IHR), an existing framework that codifies member state and WHO responsibilities in preparing for and responding to a public health emergency.  Heading into WHA, many stakeholders waited with bated breath to see if member states could bring both these processes across the finish line. Unfortunately, despite two long years of grueling negotiations, countries were unable to forge sufficient consensus to approve the pandemic accord. Instead, countries agreed to extend the mandate of the intergovernmental negotiating body, which coordinates the deliberation process for another year, providing additional time to reach compromises around the most contentious issues (financing, technology transfer—the process by which knowledge is transferred from the originator of a technology to other manufacturers to support the diffusion of health technologies into additional markets—, and a proposed access- and benefit-sharing system, which would pair commitments by countries around the sharing of pathogen samples and sequencing data with commitments from manufacturers to set aside a dedicated portion of their products for equitable distribution during health emergencies).  Nonetheless, member states notched a desperately needed win in reaching consensus on amendments to the IHR, achieving an agreement in the final hours of WHA. The consensus takes on added significance given that country representatives were not only in a race against time but also against fast-eroding trust in multilateralism, which was deeply fractured by the pandemic and subsequent geopolitical conflicts. The amendments to these technical rules, last revised in 2005 following the SARS outbreak, represent the first significant change in international law in the aftermath of the COVID-19 pandemic. While there were many changes to the IHR, one that stands out the most is that the added provisions include a commitment to solidarity and equity on strengthening access to medical products and to financing, including specific text that directs countries to promote research and development (R&D) and strengthen local production of quality, safe, and effective relevant health products. The previous IHR did not include any mention of R&D or the need to ensure equitable access to new tools.   WHA reinvigorates maternal and child health agenda  Progress was also made on a couple of other fronts in Geneva. Alarmed by the stagnation of progress in reducing maternal and child mortality, member states passed a critical resolution committing to specific actions to prevent the deaths of women, babies, and children.The resolution, led by Somalia and other cosponsors, commits countries to tackle the leading causes of maternal and child deaths, particularly in the hardest-hit nations. In it, countries agreed to improve access to maternal health services, including sexual and reproductive services, and comprehensive child health services through stronger primary health care and expanded access to emergency services. It also urges countries to develop and invest in tools that enable access to essential quality medicines for pregnant women, lactating women, mothers, and newborns and calls on WHO to strengthen and expand collaborative efforts, such as those promoted by WHO technical departments and the Global Accelerator for Pediatric formulations, or GAP-f, network, for facilitating better access to medicines for children. The WHA resolution marks WHO’s first significant action on maternal mortality in nearly a decade, following the adoption of the Global Strategy for Women’s, Children’s and Adolescents’ Health in 2015. Antimicrobial resistance in the spotlight  Antimicrobial resistance (AMR) also was in the spotlight in Geneva. With the United Nations High-Level Meeting (UN HLM) on AMR taking place in New York in September and a high-level ministerial meeting in Saudi Arabia in November, this year has been supercharged with attention on the issue, with WHA featuring numerous AMR events, roundtables, and initiatives.  Delegates approved a resolution to accelerate national and global responses on AMR, with many of them highlighting it as a crucial building block for the meetings in the fall. The resolution welcomes WHO’s strategic and operational priorities to address drug-resistant bacterial infections in the human health sector, which include prevention of infections; universal access to affordable, quality diagnosis and appropriate treatment of infections; strategic information, science and innovation; and effective governance and financing of the human health sector response to AMR.  The resolution also calls on member states to support investments in R&D for new tools to combat AMR and replenish the shockingly waning pipeline, to strengthen the capacities and standards of laboratories, and to participate in the WHO’s Global Antimicrobial Resistance and Use Surveillance System, or GLASS.While WHA did ultimately feature some contentious moments, especially around the geopolitics of Ukraine and Gaza, and major pushback on sexual and reproductive health, the latter almost derailing the adoption of several key decisions, the wins on IHR, maternal and child health, and AMR will have reverberations beyond WHA. Delegates hope that these wins will provide the necessary momentum to continue to make progress on the pandemic accord and at the UN HLM on AMR in the fall.  
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Community Webinar: Tests for TB and Drug Resistance

Treatment Action Group

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Jul 22, 2025

Webinar: "Repurposing drugs to address the crisis of antimicrobial resistance"

GARDP

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Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator, the Global Antibiotic Research & Development Partnership, the European Society of Clinical Microbiology and Infectious Diseases, BEAM Alliance, LifeArc, and AMR Solutions

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Treatment Action Group

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