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
• Pierre Daram, Associate Director STI Portfolio, GARDP
• David Paterson, Executive Chair, ADVANCE-ID
• Pinyo Rattanaumpawan, Professor of Medicine, Mahidol University

Moderator: Regina Osih, Global Access Director, GARDP

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In 2019, GARDP launched “5 BY 25”, an initiative to develop five new antibiotic treatments during the period 2020-2025. Part of a broader strategy, 5 BY 25 signaled GARDP’s ambition to develop its R&D and access portfolio and expand its role in global efforts to counter antibiotic resistance. This webinar will take stock of what GARDP has accomplished and learned over the past five years, and how it is now leveraging progress to advance sustainable antibiotic R&D and access focused on public health needs.

Speakers:

• Anand Anandkumar – Bugworks
• Manica Balasegaram – GARDP
• Glenda Gray – SAMRC & Wits University
• David Paterson – ADVANCE-ID

Moderator: Herman Goossens – University of Antwerp

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In June 2022, Shionogi, GARDP and CHAI launched a project to improve access to a Reserve antibiotic, cefiderocol. Now, more than two years down the line, what is the status of this project? How much closer are the project partners to making the antibiotic cefiderocol accessible in the GARDP territory? What challenges have the project partners encountered, and what can the broader global health community learn from them? This webinar asked project partners to respond to such questions and to evaluate the implications for antibiotic access more generally.

Speakers:

• Manish Dhanuka – Orchid Pharma
• Rahul Dwivedi – GARDP
• Monika Schneider – Shionogi Inc.
• Melynda Watkins – CHAI

Moderator: Peter Beyer – GARDP

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As 2024 comes to a close, the AMR-CC and GARDP are hosting a 60-minute webinar to debrief the successes and challenges of a busy year and weigh near-term and mid-term priorities of the AMR community and consider how to translate a year of ambition into sustained action.

Program:

Welcome: Dr. Cecilia Mundaca Shah, Associate Vice President, Global Health, UN Foundation

Opening remarks: Mr. Jeremy Knox, Head of Policy, Infectious Disease, Wellcome Trust

Panel Discussion: Unpacking 2024’s milestone moments

• Dr. Rohit Malpani, Advisor, GARDP
• Helle Aagard, Deputy Director, ReAct Europe
• Arshnee Moodley, CGIAR Antimicrobial Resistance Hub Leader, International Livestock Research Institute
• Sabiha Essack, Professor in the School of Pharmaceutical Sciences at the University of KwaZulu-Natal

Moderated by Dr. Cecilia Mundaca Shah, Associate Vice President, Global Health, UN Foundation

Q&A with discussants (15 min)

Fireside Chat: Key messages that landed in 2024

• Dr. Malin Grape, AMR Ambassador, Sweden (to be confirmed)
• Dr. Sujith Chandy, Executive Director, ICARS

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World AMR Awareness Week (WAAW), which takes place every 18-24 November, is a global campaign to draw attention to this critical issue. This year’s theme is “Educate. Advocate. Act now.”

We invite you to join us in raising awareness, including by participating in GARDP’s #PowerofAntibiotics campaign—see below!

ACTIVITIES 

The race is on to protect the #PowerOfAntibiotics 

Discover how you can get involved to help us raise awareness about the spread of drug-resistant infections. Visit PowerOfAntibiotics.org, a living platform for sharing stories and mobilizing action and discover the stories of Nour, Tori, Jeremy, Bhakti and others.

Take action

World Children’s Day— “Listen to the future. Stand up for children’s rights.”, 20 November

Children and newborns are especially vulnerable to growing antibiotic resistance. 1 in 5 deaths caused by antibiotic resistance occur in children under the age of five, and up to 3 million newborns get serious infections that lead to sepsis every year.

Discover GARDP’s work to identify and develop new treatments and provide data to inform treatment guidelines specifically for children and newborns.

Read our policy paper

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On September 25th, join GARDP and Foreign Policy at UNGA79 in New York City for a critical examination of these pressing issues. The Health Forum will bring together world leaders, policymakers, industry experts, and civil society to explore strategies for expanding healthcare access and improving system resilience. This forum features three sessions focused on turning insights into action, and culminates in a special session on antimicrobial resistance, setting the stage for the UN High-Level Meeting on AMR the next day.

Global Solutions to Emerging Global Threats
5:00 p.m. – 7:30 p.m. EDT
Cross-sector collaboration and sustained financing is crucial for addressing emerging global health threats like infectious diseases, pandemics, and antimicrobial resistance (AMR). Ahead of the High-Level Meeting on AMR, this session will focus on turning goals and agreements into action by delving into the role of data and innovation in health security, the investment needed for research and development, and the global cooperation needed to mitigate and effectively respond to evolving global health threats.

More information about GARDP

• GARDP’s strategy
• Investment case

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Nearly five million deaths are associated with antimicrobial resistance (AMR). Children and newborns are especially vulnerable to drug-resistant bacteria. 1 in 5 deaths caused by antibiotic resistance occur in children under the age of five, and up to 3 million newborns get serious infections that lead to life-threatening conditions every year. Very few innovative new antibiotics have come to the market in the past years and resistance against these new agents develops faster than ever. There are many bottlenecks and challenges to the development, access and stewardship of new antibiotics to address the growing burden of drug-resistant infections, and especially those priority pathogens identified by the World Health Organization (WHO).
The symposium will serve to identify several of the bottlenecks to development, access, and stewardship and examine how partnerships that bring together the resources, expertise, and cooperation of the public, private, and not-for-profit sectors can best overcome these challenges and ensure the right antibiotic at the right time can reach patients in need.
You are cordially invited to participate in the Antimicrobial Resistance (AMR) Symposium hosted by the Charité Center for Global Health, the Charité Antimicrobial Stewardship initiative and GARDP.

Program: 
You can find the full program here.

Live stream

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ESCMID Global is the premier congress in the field of infectious diseases, bringing together more than 15,000 experts from all over the world. These findings represent some of the progress GARDP is making in accelerating the development of, and access to, new antibiotic treatments, and reaching its goal of developing five new antibiotic treatments by 2025.

Below are summaries of the work presented. Please click on the abstracts to learn more:

SEXUALLY TRANSMITTED INFECTIONS

There are more than 82 million new gonorrhoea infections occurring globally each year, making it the second most common bacterial STI. Its resistance to antibiotics is on the rise and rapidly spreading. With only one remaining treatment option for this disease, GARDP is developing zoliflodacin, a new single-dose oral treatment for gonorrhoea.

Previous in vitro studies have shown zoliflodacin to be active against multidrug-resistant strains of Neisseria gonorrhoeae, including those resistant to ceftriaxone and azithromycin, with no cross-resistance with other antibiotics. In an oral presentation at ESCMID Global 2024, Alison Luckey, Senior Medical Lead for GARDP’s STI team, shared the positive phase 3 clinical trial results for zoliflodacin.

With a total 930 participants, including women, adolescents and people living with HIV, this was the largest clinical trial ever conducted for a new treatment against gonorrhoea. The trial included 16 trial sites in five countries, including Belgium, the Netherlands, South Africa, Thailand, and the US. A single oral 3g dose of zoliflodacin was shown to be effective at treating gonorrhoea infection and had a favourable safety profile compared with the current standard of care.

In addition to these topline results, GARDP also presented several posters on zoliflodacin, including one which looked at adverse events occurring during the phase 3 trial, and found them to be similar in frequency, profile and severity compared with the standard of care for gonorrhoea, with no new safety concerns.

Another poster looking at antimicrobial susceptibility to several antibiotics showed that bacterial isolates, responsible for gonorrhoea infection obtained from participants in the phase 3 trial, displayed globally high levels of resistance to ciprofloxacin and tetracycline, and continued good levels of activity for zoliflodacin.

Finally, a poster was also presented on the results of a phase 1 study examining the possible interactions between zoliflodacin and itraconazole, which is known to affect metabolism in the liver in ways that could impact the levels of zoliflodacin in the blood. The study found a relatively small effect in healthy adults, suggesting that with zoliflodacin such drug-drug interactions will be of no concern in the treatment of patients.

Read now:

• Pharmacokinetics of zoliflodacin in healthy participants in the presence of itraconazole suggest no clinically meaningful CYP3A4-mediated drug-drug interactions
• Oral zoliflodacin is non-inferior to a combination of ceftriaxone and azithromycin for treatment of uncomplicated urogenital gonorrhoea: results of a large global Phase 3 randomised controlled trial
• Safety profile of oral zoliflodacin for uncomplicated gonorrhoea in a Phase 3 trial
• Antimicrobial susceptibility of baseline Neisseria gonorrhoeae isolates from participants recruited in the global zoliflodacin Phase 3 randomised controlled trial

NEONATAL SEPSIS

Children and newborns are especially vulnerable to drug-resistant bacteria, with 1 in 5 deaths caused by antibiotic resistance occurring in children under the age of five, and up to 3 million newborns getting serious infections that lead to sepsis every year. GARDP is working to identify and develop new treatments for children, with special attention to newborns with sepsis, and provide data to inform treatment guidelines for this vulnerable group.

The rise and spread of antimicrobial resistance threatens to undermine the effectiveness of WHO-recommended antibiotics, particularly in low- and middle-income countries, where the burden of disease is the greatest. In a study involving more than 3,000 neonatal patients, GARDP researchers sought to examine the link between the susceptibility of bacteria to available antibiotics and mortality. In an oral presentation they found that while there was no conclusive evidence of an association between antibiotic coverage and mortality, mortality reductions were greater where there was reduced susceptibility to the antibiotic colistin.

Read now:

• Antibiotic coverage and association with mortality in neonates with sepsis in LMIC

ACCESS

GARDP aims to improve access to essential antibiotic treatments that are effective against multidrug-resistant priority pathogens, particularly in low- and middle-income countries (LIMCs) where the burden of disease is high. Through its use of licensing agreements, for example, it is expanding access to cefiderocol, in order to make it available to people in up to 135 LMICs. Cefiderocol is a relatively new antibiotic that has been approved for use against complicated urinary tract infections (cUTIs), hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP) and serious infections caused by Gram-negative bacteria.

However, a key part of this entails assessing cefiderocol to see if it is active against multidrug-resistant bacterial strains that are common in these regions. In three in vitro studies, GARDP compared cefiderocol against isolates of multidrug-resistant (MDR) bacteria – carbapenem-resistant Acinetobacter baumannii (CRAB), carbapenem-resistant Pseudomonas aeruginosa (CRPA) and carbapenem-resistant Enterobacterales (CRE) – obtained from regions with a high burden of disease. Cefiderocol demonstrated good activity against all MDR isolates, suggesting that it could indeed be potentially considered as a therapeutic option in countries with a high burden of CRAB, CRPA and CRE infections.

In addition to the poster presentations detailing these results, Jennifer Cohn, Global Access Director for GARDP, discussed these findings and broader access issues in her presentation, “Access to reserve antibiotics in LMICs,” part of a 2-hour symposium, “Introduction of newer antibiotics in LMICs,” co-chaired by Manica Balasegaram, GARDP’s Executive Director.

Read now:

• Access to reserve antibiotics in LMICs
• In vitro activity of cefiderocol against carbapenem-resistant Acinetobacter baumannii (CRAB) clinical isolates from countries with high CRAB incidence, 2019-2022
• In vitro activity of cefiderocol against carbapenem-resistant Enterobacterales (CREs) clinical isolates from countries with high CRE incidence, 2019-2022
• In vitro activity of cefiderocol against carbapenem-resistant Pseudomonas aeruginosa (CRPA) clinical isolates from countries with high CRPA incidence, 2019-2022

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The webinar will feature a presentation on SECURE as well as a panel discussion to discuss how SECURE could work in countries and highlight the impact it could have on access to antibiotics in LMICs.

Alongside other interventions, the analysis on SECURE has explored pooled procurement, stockpiling and catalytic financing support for countries to ensure a consistent and affordable supply of antibiotics to address drug-resistant infections. The goal is to create market efficiencies, predictability of supply and cost savings.

Speakers:

• Kim Faure, Project Lead for SECURE

• Alexandra Cameron, Senior Expert in the WHO’s AMR Division

• Yewande Alimi, AMR and One Health Unit Lead at the Africa CDC

• Joël Denis, Director General of Canada’s Antimicrobial Resistance Task Force at the Public Health Agency of Canada.

Moderation by Javier Guzman, Director of Global Health Policy at the Centre for Global Development.

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The webinar will be an opportunity to not only present GARDP’s new five-year strategy, but also highlight our achievements over the past five years in developing new and improved treatments for drug-resistant infections, including neonatal sepsis, serious bacterial infections and gonorrhoea, and ensure that they reach the people who need them most, including children, women and the elderly.

Over the past five years, through our partnership model, GARDP has successfully developed a comprehensive portfolio of antibiotic treatments and we are well on our way of reaching our goal of delivering five treatments by 2025 (with four treatments in our current portfolio). We are also pioneering new access models with our innovator, manufacturing and distribution partners.

Our unique not-for-profit antibiotic R&D model focuses on integrating R&D and access, negotiating public-private collaboration and licensing agreements, and working in partnership with all key stakeholders—including scientists, clinicians, industry, manufacturers, regulators, donors and civil society—to coordinate efforts in the antibiotic pipeline of drug development and access with the goal of addressing public health needs.

Our new five-year strategy outlines how GARDP is a global solution to AMR, working with partners to create a new global antibiotic pipeline that is driven by public health need rather than profit.

Speakers:

• Manica Balasegaram, Executive Director, GARDP
• Angela Dramowski, Professor of Paediatric Infectious Diseases at Tygerberg Hospital, Stellenbosch University; Principal Investigator of the neonatal sepsis observational study
• Ramanan Laxminarayan, One Health Trust Founder and Director; GARDP Board Chair
• Veronika von Messling, Director-General for Life Sciences at the German Federal Ministry of Education and Research; GARDP Board Member
• Jasper Claessen, Senior Advisor at the Department of Pharmaceutical Affairs, Dutch Ministry of Healt

Moderator: Laura Piddock, Scientific Director, GARDP

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