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February 27, 2025

GHTC shares recommendations for South African-led G20

GHTC calls on G20 nations to take embrace cross-collaborative efforts to strengthen R&D globally.

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South Africa’s presidency will be the first time an African country presides over the G20, representing a massive opportunity to shine a light on the needs and capacities of the region, and we welcome their government's focus on science-based innovation. The world remains dangerously unprepared to prevent and respond to emerging diseases and global health threats, and G20 leaders must take action and seize opportunities to ensure every country and community has the tools they need to address poverty-related and neglected diseases as part of universal health coverage and create a pandemic-ready future. This means investing in both new and existing mechanisms that facilitate the development of new health technologies and strengthen the research and development (R&D) ecosystem globally to create a more fit-for-purpose global health architecture.GHTC is calling upon G20 nations to support the Global Coalition for Local and Regional Production, Innovation, and Equitable Access; robustly fund R&D partnerships for pandemic preparedness; establish a global medical countermeasures platform; support investments to strengthen local R&D capacity globally; advance R&D for key priorities like antimicrobial resistance (AMR) and climate resiliency; and improve access to new technologies through regulatory strengthening, specifically prioritizing the R&D needs of underserved populations.1. Pandemic prevention, preparedness, and responseIt is clear that building up robust research and manufacturing capacities in regional science ecosystems is critical to ensuring access to quality and affordable health technologies for the most vulnerable populations, including women and children. Yet the challenge lies in catalyzing more geographically diversified local production of novel health products and building sustainable manufacturing capacity in low- and middle-income countries (LMICs). Cross collaboration is also essential, as these capabilities are not just necessary for strengthening pandemic preparedness and response, but also for combatting endemic diseases. GHTC calls on the G20 to consider the following recommendations: Support the implementation and pilot testing of the Global Coalition for Local and Regional Production, Innovation, and Equitable Access.Ensure civil society and community voices have a seat at the table, including in the decision-making structures of the coalition.Highlight the need to focus on local and regional R&D to fill the gap in health tools for the world’s most neglected communities, including tools addressing historically neglected diseases, such as leishmaniasis, Chagas disease, and dengue, as well as higher-burden, poverty-related diseases such as HIV/AIDS, tuberculosis, and malaria.Boost upstream R&D through the coalition, harnessing and strengthening R&D capacities across G20 countries through both South-South and triangular partnerships. This could include supporting open drug discovery networks, undertaking preclinical and clinical evaluation of prioritized compounds, and initiating clinical trials.Foster regulatory cooperation by collaborating with stakeholders such as the World Health Organization, the Pan American Health Organization, the African Union, the European Union, and others, to share expertise and conduct joint reviews in order to overcome regulatory bottlenecks and facilitate rapid access to products.Strengthen local capacity and ownership through support for R&D hubs that span the product development value chain, from discovery to productive development to distributed manufacturing to clinical trial infrastructure in LMICs. Support regionally led plans for innovation and manufacturing of economically viable vaccines, diagnostics, and therapeutics.Couple manufacturing investments with commitments by private-sector companies and governments to step up support for technology transfer, technical assistance to local manufacturers for quality systems, regulatory authorization, market entry, and workforce development so that new manufacturing hubs have the equipment, expertise, know-how, and power to produce and deliver new quality-assured innovations safely and rapidly at scale.Support preferential procurement policies for regionally manufactured products from global procurers such as Gavi, the Vaccine Alliance; The Global Fund to Fight AIDS, Tuberculosis and Malaria; UNICEF; and Unitaid. Commit to developing globally accessible online prototype libraries of diagnostics, therapeutics, and vaccines for priority viral and bacterial families and for Disease X, in coordination with the World Health Organization’s updated priority viral family list.Accelerate clinical trials aiming to determine product safety and effectiveness and systematically include community engagement plans in clinical study protocols. Establish reference standards for diagnostics early in disease outbreaks and clinical trials.Fully and sustainably finance public-private R&D and access partnerships for strategic health products that will be crucial during a future health emergency or pandemic, including committing $80 million to FIND’s 100 Days Mission framework for diagnostics and $1.5 billion to fulfill the remaining financing needs for the Coalition for Epidemic Preparedness Innovations’s 100 Days Mission strategy for vaccines, as well as supporting Unitaid and others for therapeutics including oxygen therapy.Establish and adopt an end-to-end medical countermeasures platform guided by human rights principles, focusing on the needs of all, particularly those in LMICs, through sustainable financing, addressing R&D needs, and implementing mechanisms for equitable access.Support the coordination of vaccine manufacturing networks to service clinical trials and routine supplies in inter-pandemic and pandemic periods.Facilitate agreement between key stakeholders, countries and funders on how sustainable stockpiles of experimental vaccines, therapeutics, and diagnostics can be created to enable a rapid response to new outbreaks.2. Science and innovation for health and economic growthSouth Africa’s leadership in health research and commitment to science within its G20 health agenda reflects the important role that innovation plays in improving health outcomes and driving economic growth. A resilient product development value chain further fosters innovation of lifesaving products and elevates community expertise. To build on collaboration across G20 health priorities, it is critical to implement an end-to-end research pipeline that carries lessons learned throughout, from clinical trials to manufacturing and surveillance. Furthermore, the evolving threat of AMR underscores the need for crosscutting and sustainable innovation, touching on issues of pandemic preparedness, climate resilience, adaptability, and more. AMR is anticipated to cause 10 million deaths by 2050, with the highest burden in the Global South. While it was promising to see AMR commitments made last year on the global stage, it is imperative that South Africa carries this work forward as G20 lead this year. GHTC calls on G20 countries to consider the following recommendations: Support cross-collaborative approaches for innovation—globally and across G20 health pillars—that foster localized capacity-building and equitable access to products that ensure the specific R&D needs of women, children, and other vulnerable populations are addressed. Establish a comprehensive end-to-end product development pipeline that optimizes global health R&D outputs and maximizes return on investment across G20 priorities. G20 countries should ensure greater cross-sector collaboration—including the pandemic preparedness and science for health pillars—to advance the R&D ecosystem.Engage with local experts, such as primary health care providers, community members, and civil society, to identify specific health technology gaps for underserved populations and take actionable steps to close them, including specifying target product profiles and investing in therapeutics and diagnostic tools for children and pregnant women. Leverage existing political frameworks dedicated to global health R&D, such as the African Union-European Union Innovation Agenda, to develop joint research and innovation agendas to improve the availability and affordability of emerging technologies. Support product development partnerships, which have been a key instrument in the fight against poverty-related and neglected diseases and make further investments in this essential component of the global health architecture. This is particularly critical to ensure that products are developed and distributed with the end user in mind and with characteristics, including affordability, acceptability, and ease of administration, that facilitate their uptake and delivery. Prioritize addressing AMR by investing in the development of novel products and engaging in key partnerships with civil society and multilateral bodies to build on progress made in the fight against AMR.Invest in R&D to develop new antimicrobials and ensure investments align with global and regional push/pull incentives that harness the financial force and prowess of the private sector to bring novel antimicrobial products to market. Contribute to existing global AMR players, such as the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator, or CARB-X, and the Global Antibiotic Research and Development Partnership, or GARDP. Provide ongoing support to the Global AMR R&D Hub in its work providing countries and investors with the latest AMR R&D landscape information, helping to address market gaps. The Hub should also pave the way for efficient deployment of tailor-made incentives for R&D and facilitate global discussions on priorities and opportunities for increasing investments in R&D. With so many tectonic shifts for global health in 2025, GHTC urges G20 members to work with civil society to push for the successful implementation of these key principles, pledges, and initiatives and build a global health architecture with all relevant stakeholders that increases the development of and access to health technologies.

WHO/Pierre Albouy

January 31, 2025

GHTC's statement to the WHO Executive Board on the Global Action Plan on Climate and Health

GHTC's statement on Agenda item 22: Climate and Health at the World Health Organization's (WHO's) Executive Board meeting.

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GHTC's statement on Agenda item 22: Climate and Health at the World Health Organization's (WHO's) Executive Board (EB) meeting.Climate change undermines global health security, and we applaud WHO’s resolution and new Global Action Plan on Climate and Health to address these risks. WHO’s drafted plan accounts for the important role that research will play in addressing climate change, including through regional research capacity-building. We especially applaud the document’s call for member states to promote research and development (R&D) to prevent, detect, treat, and respond to climate-sensitive diseases and health outcomes. However, while the draft includes several strong R&D provisions, it mentions the threat of antimicrobial resistance (AMR) only once. AMR is poised to cause 10 million annual deaths by 2050, and likely more with the growing influence of rising temperatures and evolving zoonotic diseases. Highlighting AMR as a global health threat inextricably linked to climate change and developing actionable guidance will be crucial for holistic and successful global action. With this in mind, we strongly suggest WHO and member states take the following actions: 1. WHO and member states should align the global action plan with last year's World Health Assembly resolution to accelerate global efforts to address antimicrobial resistance. In particular, we urge both WHO and member states to establish a global AMR laboratory network to strengthen worldwide AMR diagnostic capacity. 2. We urge WHO to work jointly with member states to strengthen resilience and adaptation to climate change through increased investments to develop new treatments that keep pace with resistance. We encourage member state investment in R&D to pioneer innovative health technologies, including prioritizing the expansion of access to health tools for those in vulnerable geographies and for the populations most impacted by AMR. 3. We encourage countries to accelerate the development and implementation of national action plans for AMR surveillance and response in addition to prioritizing a comprehensive One Health approach that appraises the needs of those most burdened by AMR. We call on WHO to continue supporting the development, revision, and implementation of AMR national action plans on a routine basis and facilitating regional- and cross-country-level collaboration and integration of national action plans.

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Latest from the Breakthroughs Blog

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

PATH/Gabe Bienczycki

March 31, 2025

Research Roundup: Breakthrough antibiotic discovery, Rapid Hepatitis B test, New drug delivery method

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. A research team has discovered an all-new class of antibiotics that could, if it proves successful down the line, improve our ability to address some of the most drug-resistant bacteria in the world, as antimicrobial resistance continues to rise globally. The new molecule, lariocidin, attacks bacteria distinctly from other antibiotics by inhibiting bacteria’s ability to grow and survive. Lariocidin is also not toxic to human cells, not susceptible to existing mechanisms or antibiotic resistance, and it works well in an animal model of infection, underscoring its potential to be a gamechanger in the global fight against antimicrobial resistance, although years of further research are still needed.Scientists from the Institut Pasteur, in collaboration with Kumamoto University, have assessed a new rapid diagnostic test to identify pregnant women at elevated risk of transmitting Hepatitis B to their babies, which could help eliminate mother-to-child transmission of Hepatitis B during childbirth, especially in low- and middle-income countries. Hepatitis B is a leading cause of death globally and particularly affects resource-limited countries. While vaccination is available, available antiviral therapies do not provide a cure and existing tests can be costly and require specialized equipment that is often unavailable in these settings. The new test is highly effective, inexpensive to produce, easy to use, does not require electricity, can be used in higher temperatures, and provides results in 45 minutes, making it ideal for integration into routine antenatal care in decentralized, resource-limited settings.A recently published paper identified a novel method for delivering drugs in higher doses with less pain that could offer a better way to deliver long-lasting contraception or other drugs that need to be given over extended periods. The project, which began as part of a Gates Foundation-funded effort to expand contraceptive options, particularly in low-resource settings, created a new method of injecting drugs formulated into tiny crystals that can last for months or even years in the body. There are similar drug delivery methods that are already in use, but the new method can last longer and can also be injected through a smaller needle that is easier for patients to tolerate.

PATH/Christopher Nelson

March 25, 2025

PQ Pulse: A malaria product developer’s perspective on breaking down silos

Written by Philip Kenol / GHTC & Lindsey Brown / GHTC

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The World Health Organization’s (WHO’s) prequalification (PQ) program plays a critical role in certifying the quality, safety, and efficacy of medical products to expand access to health technologies in low- and middle-income countries (LMICs). In our PQ Pulse interview series, GHTC speaks with stakeholders involved in the PQ process about persistent challenges within this evolving regulatory ecosystem and potential reforms to promote equitable access to innovative medical products. Our first guest is Pierre Hugo, Vice President of Market Dynamics and Global Supply Security at the Medicines for Malaria Venture (MMV), a nonprofit product development partnership working to advance accessible medicines to treat, prevent, and eliminate malaria. MMV works end-to-end along the research and development pipeline, developing novel products, engaging with regional regulatory bodies, and supporting local manufacturers.In our interview, which has been lightly edited and condensed below, Pierre discusses MMV’s experience navigating WHO PQ and his hopes for the future of the R&D ecosystem.Can you tell us about MMV and the unique role and perspective it brings to product development?We fill the gap and, by and large, are a risk mitigation tool as one of the product development partnerships, or PDPs, within the malaria space to discover, develop, and deliver malaria products. Regarding access, our key ethos is that no drug is a medicine until it's in the hands of the patient. It's all very good and well developing drugs, but if they aren't developed correctly or affordably for the target population and ultimately made available, it's a dead-end game. So, we try to ensure that in the last mile, or the death-mile, drugs are getting to the patients. WHO PQ and organizations like MMV play a very important role.Broadly speaking, how would you describe MMV's experience with engaging in the WHO PQ process? We’ve got a number of products that are now WHO prequalified, working with our pharmaceutical partners. We see the whole PQ process as a critical mechanism to ensure that quality standards are adhered to and, ultimately, to make quality-assured products available in LMICs, where maybe those regulatory pathways are a little bit less mature. I think what's great to see is that the landscape is changing, with a lot more countries achieving WHO maturity-level 3 status [Editor note: a WHO designation for countries with stable, well-functioning regulatory systems]. Yes, there have been challenges. WHO has been very collaborative, the team has been engaging, and we are grateful for the support that WHO PQ provides.Looking forward, it's going to be critical to see how WHO PQ needs to evolve and change to further strengthen and work more closely with countries’ regulatory mechanisms or pathways.How do you see the regulatory landscape evolving in the coming years, including the potential role of the African Medicines Agency (AMA) and other regional bodies? The AMA I think is the future; it's critical that it is a success. There's a fair amount of, I wouldn't say pessimism but [questions about] how long it will take for them to be up and running, simply because they just have so many different countries and regional regulatory systems.By and large, the East African collaborative registration or collaborative processes [The Eastern African collaborative registration process is a regional initiative that aims to facilitate the registration of medicines and medical products through a collaborative process, including joint assessments and mutual recognition of regulatory decisions] have been working to some success. There are other regional harmonization networks, but it takes time, and there is still a lot of work that is needed.How do you view recent reforms made to the PQ program? Overall, we are encouraged to see efforts that enable the fast-tracking of innovative product introduction. The new WHO framework for novel products [a reform implemented in 2024 to initiate parallel, rather than sequential, processes for recommending the use of novel products and evaluating them through PQ] is just entering its pilot phase. The new web portal [an online PQ application platform that will provide real-time information for applicants, regulators, and other stakeholders on the status of products in review] will give us greater transparency. The Coordinated Scientific Advice [a new procedure that allows product developers to engage with WHO early on to better understand the evidence that they will need to generate to support PQ review and generation of policy recommendations] should ensure that later review of the finished product is as streamlined as possible.There also needs to be some thought on how AMA will work with the European Medicines Agency, the US Food and Drug Administration, and WHO PQ to avoid complexity for local manufacturers. If you had a hypothetical magic wand to wave to influence the program, what changes would you make?Something that is critical is to have clarity on timelines and the interaction between PQ and national regulatory bodies and lessons learned. Ultimately, what is the incentive for a manufacturer to go that extra mile to ensure that a product is quality approved [through PQ]? That's where the funders play a critical role in endorsing and supporting the process. Without that support, if you speak to a lot of the manufacturers, they say, “Well, there's no way I'll be going through the WHO PQ process. It's a major investment, and it's an additional long-term commitment that you need to make as a manufacturer.” So, ensuring that there is coordination between normative bodies, funders, procurement partners, and regulators is critical to ensure fast uptake of innovative products.The dream is to have a lot more quality-approved manufacturers in Africa, where over 95 percent of the patient population is. If you look at our new products coming down the line, like single-dose cures or long-acting injectables, greater upfront alignment is key, between WHO PQ and these stringent regulatory authorities, to offer clearer guidance in terms of what those regulatory expectations are for new products. We need to ensure that global procurement agencies, like the Global Fund to Fight AIDS, Tuberculosis and Malaria, the President’s Malaria Initiative, or UNICEF, are working as closely as possible with AMA and with WHO PQ to ensure the rapid uptake of new qualified drugs.I would love to see harmonization between PQ and national regulatory authorities to fast-track important innovation and ensure that new quality-assured drugs get to market faster.Putting on your advocacy hat, where do we, as an advocacy community, need to put our energy in the next couple of years to make some of those improvements become reality? To unleash the potential [of PQ], we need to simplify the processes for manufacturers, ensure procurement commitments for a clear return on investment, and provide continuous and sustained funding to support manufacturers to embark on the lengthy quality assurance process. If I look at the manufacturers, we did an extensive exercise with the Africa Centres for Disease Control and Prevention to identify manufacturers throughout the whole continent that would want to take malaria products forward to be WHO PQ’d. We only had about 50 manufacturers that were interested in taking part in this initiative [out of 400], so that's a very low number. I mean, we're talking small molecules, not vaccines, and you've got to ask yourself why? They obviously don't see a need to have products WHO PQ’d, which is, on the one hand, a problem. The Africa Centres for Disease Control and Prevention and MMV and other partners believe that the African manufacturing sector can take its place long term alongside manufacturers from India and China, who today supply the vast majority of public health medicines for malaria on the continent.Big Pharma, if anything, is disinvesting in Africa. So, having those in-Africa partners is critical within the malaria space and, obviously, not just for malaria, but for HIV and tuberculosis and so forth.So, I'm just thinking that if manufacturers are going down the WHO PQ route, it might be a really nice carrot to say, “Look, if you are applying for the WHO PQ process, this is a financial incentive in place.” That could be a really nice carrot to keep the Big Pharma guys in the game.

PATH/Matthew Dakin

March 24, 2025

Research Roundup: Novel antibody development deal, New fungi-killing compound, Drug discovery platform

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, the Coalition for Epidemic Preparedness Innovations (CEPI) announced a $43.5 million deal with AstraZeneca to further the development of novel antibodies designed to target four pandemic influenza virus strains, which could reduce costs and improve access to monoclonal antibody treatments. The antibodies, called VHH, have unique potential to be a key medical countermeasure in the event of an influenza pandemic, and this investment marks the first time they are being looked at for pandemic flu protection, although they are currently being studied as a potential tool to address chronic diseases, including cancers. If proven effective down the line, VHH antibodies could serve as a stopgap in the case of an influenza pandemic before vaccines can be widely rolled out.A team of Chinese researchers has discovered a bacterial compound that can kill infectious fungi, including antifungal-resistant strains, as antimicrobial resistance, including resistance to antifungals, continues to rise around the world. The compound, mandimycin, was effective against World Health Organization fungal priority pathogens Candida auris, Cryptococcus neoformans, and Aspergillus fumigatus in lab tests and was able to treat an antifungal-resistant Candida auris strain in mice. The compound also seemed less likely than other compounds to lead to the development of resistance in the fungi exposed to it, underscoring its potential as a key tool to address this growing global public health crisis.Last week, the Medicines for Malaria Venture (MMV) and deepmirror announced a new disease-agnostic platform, Drug Design for Global Health, designed to accelerate drug discovery through machine learning and artificial intelligence in low- and middle-income countries. The partners aim to bolster global health security by speeding up the development of new drugs for a variety of significant diseases, including malaria, tuberculosis, and neglected tropical diseases. Specifically, the platform aims to eliminate financial barriers for scientists in low- and middle-income countries and give them access to cutting-edge technology, enabling them to drive innovation in drug discovery research efforts.

PATH/Georgina Goodwin

March 20, 2025