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. Last week, the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) announced that it is awarding $729,000 to Immunartes to develop a monoclonal antibody designed to prevent infections caused by Staphylococcus aureus, a leading cause of bloodstream infections that is responsible for more than 1 million deaths every year. Methicillin-resistant S. aureus, or MRSA, is of particular concern; it is one of the five leading contributors to deaths from antimicrobial resistance. The antibody is designed to neutralize the bacterium’s abilities to evade the immune system and, if successful, could be a promising solution to protect high-risk populations from infection.  A recent study has suggested it might be feasible to develop a vaccine offering lifelong protection against the Nipah virus, one of the world’s deadliest pathogens for which there are no vaccines. The research team tracked 25 survivors from the original 1998 outbreak in humans of the virus in southern Malaysia, finding that 72 percent of the survivors still had detectable levels of virus-neutralizing antibodies in their blood that could help protect them from being infected again. These results suggest that there is an enduring immune response to the virus, and they can be used to ensure that the candidate vaccines in development are targeting the correct parts of the virus, as well as to help develop monoclonal antibodies to treat Nipah infections. The Coalition for Epidemic Preparedness Innovations is funding two promising vaccine candidates for Nipah virus, which have completed Phase 1 trials.A new European Union project called Comparative Signature of Marburg Virus Cell Activation as a Blueprint for the Identification of Antiviral Targets against Newly Emerging Viruses, or COMBINE, aims to better our understanding of how viruses enter cells to create tools that will improve our ability to combat emerging infectious diseases, as viral disease emergence is expected to accelerate in the coming years. The project will use the Marburg virus as a model to create a blueprint for identifying new targets for antiviral strategies. This blueprint will be used to establish the preclinical basis for the continued development of drugs and vaccines for Marburg and also to develop an innovative, experimental pipeline of countermeasures that can be rapidly applied to other emerging viruses, strengthening global readiness for future outbreaks of pathogens with pandemic potential.

As 2025 kicks off, we are poised for a year of political uncertainty. There are questions aplenty around the future of US leadership in global health and how priorities will change as the Trump Administration takes office. Canadian Prime Minister Justin Trudeau's resignation and the upcoming elections in Germany may also lead to further policy changes in donor countries historically committed to global health and development. This reshaping of global political dynamics and the lasting impact of emerging infectious disease threats present challenges and opportunities for multilateral collaboration and innovation for global health research and development (R&D) in 2025. As we look ahead at the global health landscape in this pivotal year, here are some of the key issues we are watching. 1. Will the United States fully withdraw from WHO this time?In his very first day in office, President Donald Trump signed an executive order withdrawing the United States from the World Health Organization (WHO), a move that many global health experts agree will make the United States and other countries less safe from infectious diseases and other public health threats. President Trump had previously initiated the process to pull US support from the organization in 2020, but the clock ran out before the end of his term, and President Joe Biden later reversed the decision at the start of his presidency. In the executive order, President Trump outlined his administration’s reasoning for pulling out of the global health agency, decrying “unfairly onerous” payments from the United States compared to other member states and the organization’s “inappropriate political influence.”  The departure from WHO will have dire consequences for global public health, as well as US security, diplomacy, and influence. There are a number of US institutions that collaborate closely with WHO on important work that remains vital to US interests, including polio eradication, cancer prevention, and global health security. US agencies, pharmaceutical companies, and laboratories rely on the WHO Pandemic Influenza Preparedness Framework to gain access to new influenza virus samples for R&D. Severing ties with WHO will impede US access to crucial tools for developing biological countermeasures to influenza.   And WHO’s work extends far beyond influenza. WHO has tremendous reach, working with 150 countries and 70 research institutions in the United States alone. WHO supports the global tracking of infectious diseases, updating networks for polio, measles, and other diseases to provide real-time data for member state officials to guide public health responses. The organization helps facilitate global access to a variety of health products and provides an accelerated path for the procurement of safe, effective, and reliable health innovations. WHO’s prequalification program expands global markets for US producers, offering an accelerated path for approval and uptake of American health innovations in low- and middle-income countries. For example, in 2024, WHO prequalified a Hepatitis self-test manufactured by Pennsylvania-based OraSure Technologies. Lastly, there are concerns about how the US withdrawal will diminish its influence in such a critical global institution. While no major organization is perfect, WHO has chartered a path of reform in recent years, due in large part to US leadership pushing for more effective and efficient governance structures. US concerns will only continue to be addressed if we remain a member state, working with WHO officials and other countries on improvements to the organization. The executive order also calls for broad reassessment and reassignment of American WHO personnel, many of whom play a pivotal role in supporting and directing the organization’s essential work around the world—from responding to disease outbreaks and training local health care workers to classifying disease variants and chairing the WHO Science Council. In fact, there are more Americans in leadership positions at WHO than from any other country. Pulling out of the organization only jeopardizes the United States’ ability to continue to be the most important player in the global health space. 2. Is there enough time to successfully conclude the Pandemic Accord negotiations?A Pandemic Accord could be a game changer in strengthening R&D capacity and creating new frameworks for the development of and access to new medical countermeasures. Reaching a position of solidarity is undoubtedly challenging in an increasingly fragmented world, but if the agreement fails, it will represent a massive failure for global health.   In 2024, countries tried and failed to finalize this proposed international agreement to strengthen pandemic prevention, preparedness, and response (PPPR). Negotiations proved too contentious and the timeline too short to deliver on a new framework. In 2025, countries have one last chance to get it across the finish line. While significant progress was made on reaching consensus on several articles at the end of last year, pain points persist on technology- and knowledge-sharing mandates and the inclusion and operational details of the proposed Pathogen Access and Benefit Sharing system—a mechanism that would facilitate the sharing of pathogen samples and genetic data needed for product development in exchange for benefits like free or discounted contributions of health products.  The Pandemic Accord negotiators held five meetings in 2024, adding up to a total of twelve negotiating sessions held since 2022. And though member states are closer to reaching a finalized text, late last year, negotiators again pushed back their deadline to the 78th World Health Assembly in May 2025. The Executive Order signed by President Trump on January 21 demands that the Secretary of State cease negotiations on the Pandemic Accord and recall and reassign American staff working with WHO; these actions will further disrupt the negotiating process, leaving the United States notably absent from any further discussions.3. How will the G20 and G7 continue the momentum in 2025?  South Africa assumed the G20 presidency late last year, and the question now is how they will build on the momentum of global health progress made under previous G20 presidencies. At the end of last year, South Africa outlined its health priorities, which include accelerating Universal Health Coverage through primary care, strengthening health workforces, combating noncommunicable diseases, and advancing PPPR. South Africa also introduced a science and innovation arm to its global health agenda, committing to review, strengthen, and leverage member state science, research, and innovation sectors.  It will be worth watching whether South Africa builds upon and facilitates the implementation of Brazil’s signature initiative from their presidency last year, the Coalition for Local and Regional Production, Innovation, and Equitable Access, which seeks to strengthen local production to enable more equitable access to safe, affordable, high-quality, and effective health products for neglected diseases.  While South Africa has established an ambitious global health agenda, there is a broader concern that the G20 might succumb to the current tumultuous political climate—France is resettling after elections of its National Assembly last year, the United States has swapped party leadership across the White House and Congress, and Germany has federal elections scheduled for February. With several G20 members undergoing political shake-ups and heavy domestic issues underpinning global conversations, finding member state synergy will be critical this year. And the G7 does not appear to be in a better position after Prime Minister Trudeau’s resignation in early January, as leadership transitions and operational delays will likely sidetrack G7 responsibilities and hamper ambition.  4. Will the financing drum beat fade?This year will also be significant for global health financing. 2025 wraps the seventh three-year replenishment fundraising cycle of The Global Fund to Fight AIDS, Tuberculosis and Malaria. The new WHO Investment Round continues as well, and the World Bank Pandemic Fund announced that its third funding cycle will begin later this spring, shifting from the last two rounds of financing PPPR-related projects to now emphasize support for national and regional health institutions.  Yet, despite the continued need to increase investment in key global health institutions and priority areas, many governments find themselves in constrained resource environments, and around the globe, leaders are pulling back their commitments to provide the necessary funds to address critical challenges like emerging infectious diseases. Mobilizing new funds will be vital for delivering on the Sustainable Development Goals, and 2025 may represent a crossroads on whether countries can sustainably and adequately finance programs, research, and initiatives that boost PPPR.  It is undoubtedly a year marked by change and challenge in global health. As we move into 2025, policymakers, experts, and advocates must navigate an increasingly complex space. The road ahead will require all of us to foster collaboration, embrace creativity, and strengthen advocacy efforts within the global health community. But most of all, it may be the year for the global health community to showcase resilience and forge innovative pathways and partnerships that drive meaningful progress in global health R&D.  

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. Researchers at Penn State have discovered a new storage technique that can keep protein-based drugs and vaccines stable without requiring a cold chain. This method could make these products easier and cheaper to store and distribute, enabling greater access and generating cost savings. Currently, most biologic drugs and vaccines require temperature-controlled conditions throughout the supply chain, from production to administration to patients. Products preserved with this new method, which involves an oil-based solution and a molecule to coat the surface of the protein, were found in mice to be just as effective as refrigerated versions, and there were no signs of adverse health effects. The researchers are planning to test their method with additional proteins and are also working to secure patent rights and partner with pharmaceutical companies.The first patients have been enrolled in a pivotal clinical trial, supported by the Africa Centres for Disease Control and Prevention (Africa-CDC), the Institut National de la Recherche Biomédicale, and PANTHER, testing promising mpox therapeutic options. Mpox continues to pose a significant global health threat with no approved therapeutics specifically for the virus. The first drug being tested is brincidofovir, an antiviral from Emergent BioSolutions. The trial, which aims to bolster our ability to respond to mpox, also demonstrates Africa’s proactive role in partnering to tackle this ongoing challenge that has caused numerous outbreaks across the continent.The Global Antibiotic Research and Development Partnership (GARDP) and Debiopharm have signed a memorandum of understanding to develop Debio 1453, a novel compound representing a new antibiotic class that targets the Neisseria gonorrhoeae bacteria, as multidrug-resistant strains of N. gonorrhoeae emerging around the world make infections harder to treat. The partnership aims to develop Debio 1453 for regulatory approval and scale-up. The compound, with ongoing support from the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), previously demonstrated efficacy in preclinical studies against N. gonorrhoeae strains resistant to ceftriaxone, the last available recommended treatment globally, and other multidrug- resistant strains.

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, the World Health Organization (WHO) announced that it had prequalified a point-of-care assay that can help guide the treatment of Plasmodium vivax malaria. The assay, developed by SD Biosensor and PATH, detects glucose-6-phosphate dehydrogenase deficiency, which can lead to severe anemia in patients taking certain drugs to treat P. vivax malaria. This designation aims to improve access to the diagnostic in countries facing a high burden of malaria, enabling improved treatment for patients. The announcement arrives shortly after WHO prequalified two drugs for the treatment of P. vivax malaria last month.Researchers at the University of Minnesota and the Midwest Antiviral Drug Discovery Center have developed the first nanobody-based inhibitors targeting the Ebola virus, a deadly pathogen with a fatality rate of about 50 percent. Nanobodies are small antibodies derived from animals that can penetrate areas of viruses and human tissues that larger antibodies cannot reach, providing protection against infection. The team, which previously developed nanobodies to target COVID-19, found promising results for their nanobodies in lab tests in Ebola-infected mice. If this research continues to be successful, it could pave the way for treatments not only for Ebola but also for other viruses in the same family, including Sudan ebolavirus and Marburg virus.Last week, the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) announced $2.6 million in funding to Clarametyx Biosciences to develop an anti-biofilm vaccine that could help prevent serious bacterial infections and mitigate the rise of antibiotic resistance. Specifically, the funding will support the further development of the company’s pathogen-agnostic vaccine candidate designed to prevent the formulation of bacterial biofilms, which are protective layers that bacteria use to shield themselves from antibiotics and the immune system, therefore allowing the body’s immune system to clear infections without the use of antibiotics. Hard-to-treat bacterial infections associated with biofilms are estimated to be responsible for up to 80 percent of bacterial infections and are known to contribute to the emergence of antibiotic resistance.