As the global health architecture undergoes reform, four product development partnerships (PDPs) outline the WHO functions that are critical to needs-driven health innovation and explain why these must be protected and strengthened.

WHO and PDPs play distinct but complementary roles. WHO sets global priorities, develops standards and policy guidance, assures quality, and supports countries in adopting and implementing health interventions. PDPs, meanwhile, bring together the scientific, clinical, manufacturing and access partnerships needed to develop health technologies for diseases and populations that markets often overlook. Since 2010, PDPs have helped develop and introduce 79 health technologies.

The paper examines nine WHO functions that underpin the journey from research priority-setting to patient access. These include WHO priority pathogen lists that helped shape GARDP’s Gram-negative portfolio, target product profiles such as the 2026 WHO antibacterial TPPs, the WHO Essential Medicines List, which now includes cefiderocol, prequalification processes, and regulatory reliance pathways that enable national authorities to build on assessments conducted elsewhere.

The paper sets out seven recommendations to protect and strengthen the WHO functions that are essential for needs-driven health innovation and equitable access to health technologies.

Source

Source

GARDP’s feedback on the Plan 

We note several key elements of the new Plan that align with our mission and values. 

• We welcome the Plan’s recognition that addressing AMR requires both stewardship and sustainable access to effective antibiotics. Ensuring patients receive appropriate and timely treatment is essential for better health outcomes and preserving the effectiveness of existing and future antibiotics. We are particularly pleased to see access to Reserve antibiotics singled out. We look forward to working with PAHO, Ministries of Health, and our partners throughout the region to address existing access and stewardship challenges. 

• We commend the emphasis placed on surveillance, laboratory capacity and diagnostics, which are critical for informing treatment decisions, guiding policy and supporting the responsible use of antimicrobials. We recognize that our ability to contribute to sustainable access and stewardship of new and existing antibiotics is built on the foundations of sound public health systems and data. 

• We welcome the strong focus on research and evidence generation, particularly implementation research. Generating evidence on what works in real-world settings is essential to support effective policies and sustainable solutions. We also encourage Member States to consider how they could work with and contribute to product development programmes within GARDP’s current and future pipeline. 

GARDP’s contributions to the Plan 

GARDP will seek to both align its ongoing collaborations and programmes in the region with the Plan, as well as to identify new activities that help to define and advance the framework for action.   

GARDP is already committed via ongoing activities across the region, including the following activities past and present: 

• In September 2022, GARDP and PAHO kicked off a regional surveillance study on carbapenem-resistant organisms in collaboration with all LAC countries through the Latin American Network for Antimicrobial Resistance Surveillance (ReLAVRA+). The study will allow us to better understand the resistance patterns and priority Reserve antibiotics required to treat the patients most in need. Results are pending publication. 

• In June 2023, GARDP and partners published findings from a global observational study on neonatal sepsis, which included Santa Casa de São Paulo School of Medical Sciences and HC de Ribeirão Preto in Brazil.¹ 

• In September 2024, PAHO and GARDP signed a framework agreement with six priority areas for joint action against AMR, including: strengthening the region’s AMR ecosystem; advancing regional access to existing and novel antimicrobials; optimizing antimicrobial portfolios; and leveraging regional mechanisms for improved antibiotic access.  Ongoing projects under the framework agreement include:  

(1) Efforts to validate new and rapid low-complexity laboratory tests to detect cefiderocol resistance to strengthen surveillance and guide clinical use across the region.  

(2) Gathering data on regional access barriers to identify interventions and inform pilot global activities of SECURE, a GARDP and World Health Organization initiative. 

(3) Identifying regional innovation R&D production capacities as well as priorities to foster alignment of future antibiotic development efforts with regional needs and global AMR strategies. 

• In April 2025, GARDP started working with Fiocruz for the implementation of a Brazil cefiderocol introduction research agenda through its units VPPCB Clinical Research Platform and LabSUR, including a research project for characterization and identification of gaps on the appropriate use of Reserve antibiotics, and identification of most appropriate susceptibility diagnostic for use in clinical laboratories, among others. 

• In July 2025, GARDP collaborated with partners in Argentina, to publish research examining the landscape of Reserve antibiotic access across Latin America and the Caribbean, identifying systematic barriers that prevent patients from receiving appropriate treatment, including regulatory approval, manufacturer participation, formulary inclusion, procurement systems and health technology assessment capacity.² 

• In August 2026, GARDP and PAHO organized a training workshop in Bogotá for LAC reference laboratories participating in the ongoing cefiderocol combination study by the University of Liverpool. The results will help identify promising combinations for highly resistant infections, with the leading candidates expected to undergo further evaluation. Beyond the scientific outputs, the initiative is expected to strengthen regional laboratory networks, support knowledge exchange and build sustainable expertise for antimicrobial-resistance research and future public-health action across LAC. 

Looking ahead, GARDP will prioritize expanding our activities across the region and we welcome collaborations and partnerships with Ministries of Health, research institutions, academic centres and non-State actors.

Source

Conversations on antibiotic access have tended to focus on two paradoxical truths: antibiotic overuse drives resistance as bacteria are overexposed to antibiotics, but so does antibiotic underuse as bacteria are either untreated or treated with suboptimal therapeutic options. New research published in The Lancet Public Health goes beyond the over- versus underuse debate to focus instead on optimal use, where the question is whether antibiotic use matches the levels of resistance, disease burden and local context. This webinar will take optimal use as a lens to discuss the challenges surrounding antibiotic access for various populations, including high-burden populations. It will also put forward one potential model to work toward improving access to effective antibiotic treatments: GARDP’s public-private partnership approach, which recently facilitated the approval of a new first-in-class, single-dose oral antibiotic for gonorrhoea infection, zoliflodacin, by the Thai FDA, just six months after it was approved by the US FDA.

Speakers:

• Aislinn Cook, Senior Research Fellow, City St George’s, University of London
• David Paterson, Executive Chair, ADVANCE-ID
• Manica Balasegaram, Executive Director, GARDP
• Pinyo Rattanaumpawan, Professor of Medicine, Mahidol University

Moderator: Regina Osih, Global Access Director, GARDP

Source

Source

Source

Published in the Tagesspiegel Background

By Peter Beyer, Deputy Executive Director, the Global Antibiotic Research & Development Partnership (GARDP) 

Sepsis is often described as a race against time. Every hour that passes before treatment increases the risk of organ failure and death. That is why in Germany, where more people die from sepsis compared with other high-income countries, like the US, Australia and the UK, public health campaigns have rightly focused on a single question: how can we recognise it sooner? 

Yet what is often missing from the discussion is that sepsis itself is becoming harder to treat because of antibiotic resistance. Some of the Gram-negative bacteria responsible for the most severe cases of sepsis are evolving resistance faster than new antibiotics are being developed. Winning the race against time only matters if there is still an effective treatment waiting at the finish line. 

Sepsis occurs when an infection triggers an inflammatory response, which if left untreated can quickly become life-threatening. Globally it is one of the biggest killers, and responsible for more than one fifth of all deaths. In Germany, where every year there are around 230,000 sepsis cases, of which more than 85,000 result in death, efforts to improve awareness and diagnosis are helping more patients receive treatment sooner. But increasingly those treatments are failing. 

The problem is particularly acute for some of the most difficult-to-treat Gram-negative bacteria that frequently cause severe bloodstream infections and sepsis, including Klebsiella pneumoniae, Escherichia coli and Acinetobacter baumannii. These pathogens are increasingly resistant to multiple antibiotics, leaving clinicians with fewer and fewer treatment options. In some cases, the antibiotics that once reliably cured infections are no longer effective. For patients with sepsis, that can mean the difference between recovery and a rapidly deteriorating condition. 

Worryingly, this is a trend that is likely to get worse. Antibiotic resistance is not just on the rise globally but is now believed to have reached a tipping point. With fewer antibiotics being developed, effective new drugs are not being made available to replace those lost to resistance. This is particularly the case for those that target the World Health Organization (WHO) priority pathogens, multidrug-resistant bacteria that pose the greatest public health threat. As a result, drug-resistant infections are now beginning to outpace antibiotic development. With the most difficult-to-treat Gram-negative infections expected to make up an increasing proportion of resistant infections, the number of associated deaths is forecast to rise sharply, increasing by 70% by 2050. 

Germany is not immune from this trend. Like many countries, it faces growing resistance among key pathogens and a pipeline of new antibiotics that remains dangerously thin. What’s more, with a growing population of older people and those living with chronic health conditions, more people in Germany will be at a high risk of sepsis. Yet, despite the remarkable progress of national campaigns like Deutschland Erkennt Sepsis in helping to improve sepsis awareness, and helping more people receive treatment sooner, the rise and spread of antibiotic resistance and the threat it poses remains largely absent from the conversation. The result is an increasingly fragile safety net beneath modern medicine. 

If we are serious about reducing sepsis mortality, we must recognise that the effectiveness of treatment is just as important as the speed with which it is delivered. That means investing not only in diagnostic tools, awareness campaigns and better clinical pathways, but also in the research and development of new antibiotics. 

However, there are reasons for optimism. Through public-private partnerships such as the Global Antibiotic Research & Development Partnership (GARDP), new treatments are being developed for the multidrug-resistant pathogens that cause sepsis. Germany has been a longstanding supporter of these efforts, helping to drive the development of urgently needed antibiotics while promoting responsible access and stewardship. But much more investment and political commitment will be needed if innovation is to keep pace with resistance. 

On Sunday, the theme for this year’s World Sepsis Day is “Invest in sepsis – save lives”. This is an important call to action, but it can only hold true if effective treatments remain available. So, investing in sepsis must mean more than improving awareness and diagnosis. It must also mean investing in the development of new and effective antibiotics. Without them, even the best diagnostics, the fastest response times and the most advanced healthcare systems will struggle to save lives. 

Source

Antimicrobial Resistance (AMR) and neonatal health crises have escalated into critical public health emergencies across Bangladesh, threatening national healthcare infrastructure and standard of living. Driven by the unregulated use of antibiotics, severe diagnostic bottlenecks, poor hospital hygiene, and environmental contamination, multidrug-resistant superbugs are now primary contributors to rising child mortality.

Evaluating sepsis risk scores in paediatric care

Paediatric sepsis remains a leading cause of child mortality across Bangladesh. A separate observational study focused on children admitted with active sepsis to a tertiary hospital in Dhaka revealed an in-hospital mortality rate of approximately 23%. Although this research focused on older paediatric cohorts (aged two months to 18 years), evaluating international organ dysfunction scoring systems like PELOD-2, pSOFA, and the Phoenix Sepsis Score provides vital insights into optimising early critical care management, which can systematically inform and strengthen risk stratification frameworks for vulnerable newborns. The results demonstrated that all three scoring methods had high predictive accuracy. Among them, pSOFA and PELOD-2 provided the most precise discrimination of mortality risk, yielding Area Under the Curve (AUC) values of 0.83 and 0.82, respectively. 

The write-up is a part of Without Borders Media Fellowship by MSF-GARDP Grant on Antimicrobial Resistance, which encourages independent, impartial, and neutral reporting on health and humanitarian crises. 

Source

Sepsis, a severe bloodstream infection, has evolved into a major public health threat. When coupled with Antimicrobial Resistance (AMR), it directly imperils the future of newborns in Bangladesh. The first 28 days of life constitute an exceptionally fragile window. A bacterial infection invading the bloodstream during this period is clinically defined as neonatal sepsis. This condition stands as a major global health crisis. Annually, over 10 million newborns develop this infection worldwide, resulting in approximately 200,000 to 250,000 deaths.

The situation in Bangladesh is uniquely alarming. Nearly 18,000 newborns die from infections here each year. While neonatal sepsis is multifactorial—driven by complex clinical, environmental, and socioeconomic vulnerabilities—AMR significantly complicates treatment and causes a high number of fatalities. Recognising the symptoms of sepsis remains inherently challenging. An infected infant typically feeds less than usual, exhibits severe lethargy, experiences rapid breathing, and suffers from an abnormally high or low body temperature. Because these clinical presentations mimic common, benign illnesses, diagnostic delays are frequent.

The write-up is a part of Without Borders Media Fellowship by MSF-GARDP Grant on Antimicrobial Resistance, which encourages independent, impartial, and neutral reporting on health and humanitarian crises. 

Source