AMR & Infectious Diseases - Q4 2023 by Mediaplanet UK&IE

AMR & Infectious Diseases Q4 2023 | A promotional supplement distributed on behalf of Mediaplanet, which takes sole responsibility for its content

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“We must increase our use of diagnostic tools to ensure valuable new antibiotics remain effective for many years.”

“We no longer have time to stall because pathogens don’t.”

James Anderson, Chair, AMR Industry Alliance

Remko van Leeuwen, Vice President, BEAM Alliance

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Coalescing the global AMR voices for UNGA High-Level Meeting in 2024 The last year has seen several efforts to galvanise the AMR community towards seizing the unique opportunity of the United Nations General Assembly (UNGA) High-Level Meeting (HLM) on AMR scheduled for 2024.

T WRITTEN BY Dr Haileyesus Getahun Director, Global Coordination and Partnership and Quadripartite Joint Secretariat, WHO

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he President of the General Assembly has Overcoming geopolitics will determine outcomes appointed Barbados and Malta as co-facilitators A transformational outcome from the HLM is dependent to present options and modalities for the HLM in on intergovernmental negotiations. The outcomes of collaboration with the quadripartite organisations the high-level meetings on universal health coverage, for AMR (FAO, UNEP, WHO and WOAH) with support from tuberculosis and pandemic prevention, preparedness and the Global Leaders Group (GLG). response that were held in 2023 were heavily criticised for The Quadripartite Joint Secretariat on AMR, which not being ambitious to change the course of action. coordinates the global multisectoral AMR response and AMR is a complex challenge with conflicted interests provides secretariat to the GLG, is working closely with that transcend borders such as trade and geopolitics. the co-facilitators in supporting optimal These are important considerations for the inputs from the human, animal, agri-food global AMR community to overcome. A transformational and environment sectors. Unified and aligned voices are critical outcome from Encouraging efforts to catalyse outcomes at There has been major progress over the last the HLM is the HLM few years to facilitate a unified voice among The GLG suggested seven areas and a the global AMR stakeholders. The global dependent on meeting of civil society organisations consensus on the need to reduce the use of intergovernmental released key messages for UN member antimicrobials in the agrifood system and states to consider. The third Ministerial the Muscat Manifesto targets are cases negotiations. Conference on AMR has resulted in the in point. Muscat Ministerial Manifesto with AMR The AMR Multistakeholder Partnership targets and was endorsed by 47 countries. Platform could offer an opportunity to align voices Efforts are ongoing to propose more targets for ahead of the HLM. The global AMR community has to consideration at the HLM. The Quadripartite, with the coalesce its voice so that the outcome of the HLM will be GLG and other stakeholders, is finalising the investment transformational and not a mere collection of recycled case for AMR across sectors. Disruptive and catalytic commitments. solutions to address the antibiotic pipeline and access crises are being sought to further augment existing push and pull mechanisms with strong emphasis on equitable access. The fourth Ministerial Conference on AMR is now lined up to be held after the HLM to enable stocktaking of the outcomes of the HLM.

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Supporting researchers to find next-generation antimicrobials

breakthroughs to improve patient outcomes. They joined Innovate UK and Medicines Discovery Catapult in the Pathways to Antimicrobial Clinical Efficacy (PACE) project — a £30 million initiative supporting early-stage innovation against AMR. In a first funding call, £10 million is available to support SMEs developing new antimicrobials. “It’s a broad leap from observations in the lab to clinical benefit,” he continues. “But we have to break it down into stepping stones.”

Investment and support of academic research and SMEs could prove a pivotal step in mitigating the global threat of antimicrobial resistance (AMR).

D INTERVIEW WITH Dr Clive Mason Programme Director for AMR, LifeArc WRITTEN BY Mark Nicholls

r Clive Mason — Programme Director for AMR at LifeArc, a self-funded, not-for-profit medical research charity — says better funding can help bridge the gap between research labs and clinics to create new antimicrobials to avert a global AMR crisis.

rather than completely new drugs and approaches.” While pharmaceutical companies have tended to move away from antimicrobials, he believes there is now an opportunity to develop AMR projects from academic labs and SMEs. However, they often lack appropriate resources and support.

Shifting focus from existing to new antimicrobials Antimicrobial productivity slowed in recent decades due to a combination of complex biology and lack of investment due to commercial challenges. “A knock-on effect from this lack of investment means that skills and expertise in this area are being lost,” says Mason. “Additionally, focus has been on new variations of existing antibiotics

Supporting scientists to strengthen their solutions “We need to move good ideas and discoveries out of the lab,” Mason adds. “We must offer better support and advice in the early stages to help scientists pursue their ideas and strengthen the potential of their approach.” LifeArc aims to accelerate healthcare innovation by transforming promising life science ideas into medical

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Investing in early translation With a 10 to 15-year process from discovery to approval for an antimicrobial, Mason warns that AMR will become a major global issue, particularly as antibiotics continue to become less effective for some infections — with low-and-middleincome countries disproportionately impacted. “If AMR thrives in one part of the world, it could impact us all,” he adds. “By investing in early translation, we stand a better chance against AMR.” LifeArc and the wider PACE team have scientists and project managers who can support SMEs and labs or tap into expertise to address specific problems, help generate data and workflows and support translation studies. “We want to ensure we are bringing the additional capabilities to give these projects the best chance of success, maximise the connectivity in what is a relatively small community and apply lessons learned.”

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Optimising antimicrobial use in humans — a global effort Researchers based across five international hubs are working on a unique collaboration they hope will help address the growing threat of antimicrobial resistance.

global network has been established to find new ways of making more effective use of existing antibiotics. The hope is that the Centres for Antimicrobial Optimisation Network (CAMO-Net) will also help combat antimicrobial resistance (AMR).

INTERVIEW WITH Professor Alison Holmes OBE CAMO-Net Lead, University of Liverpool and Imperial College London

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hubs in Brazil, India, South Africa, Uganda and the UK, with shadow sites in Bangladesh, Pakistan and Timor-Leste. “The overarching aim is to develop research to tackle AMR by using antimicrobials more effectively and deliver equitable access to effective and appropriate antimicrobials,” says Holmes. The hubs and shadow centres will be supported Antimicrobial optimisation by technical expertise from centres for diagnostics in Ghana, With limited success in developing new antibiotics, the clinical pharmacology in Thailand and genomics in Malawi. network believes more can be done with the ‘existing Research themes include technology and innovation armoury’ of infection-tackling agents. As (including AI) for optimised prescribing; an international research collaborative, context, culture and behaviours; and We need to ensure the Network will focus on themes such as medicines management. It is underpinned that our treatments technology and innovation for optimised by complementary site-based expertise, prescribing, understanding behaviours, data and infrastructure. are effective and better use of data and improved medicines sustainable in the face of Harnessing local expertise and knowledge management methods to ensure more growing antimicrobial effective use of antibiotics. sharing Network lead, Professor Alison Holmes, Holmes underlines the value of working resistance. says new antibiotics are rare, despite vast collaboratively and globally. Under a amounts of funding to develop them. “More context-specific approach to research can be done in terms of how we can optimise our existing on antimicrobial optimisation, each national hub is agents,” she continues. “Using them more effectively also harnessing local knowledge to address issues and needs means that access to therapy is addressed. It is not just about across communities ranging from highly urbanised centres stewardship, methods and policies — it is about innovation to remote areas. Sites are connected through the Network to and technology. promote shared learning and capacity strengthening. “We need to ensure that our treatments are effective and Holmes hopes this very different way of research sustainable in the face of growing antimicrobial resistance collaboration could become a model for future studies. and to optimise their use to benefit all populations.” CAMO-Net, which is not involved with drug discovery, believes that maximising the efficacy of existing agents will A network approach also facilitate a framework to protect new agents that emerge. Funded by the Wellcome Trust, CAMO-Net has national

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How to translate AMR awareness into decisive strategies and efficient solutions Antimicrobial resistance (AMR) to antibiotics is one of the three most critical threats to patients’ lives, and it continues to grow on a global scale.

P INTERVIEW WITH Elcin Barker Ergun CEO, MENARINI Group

SPREAD WRITTEN BY Angelica O’Toole

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ublished data by the World Health Organization indicates that bacterial AMR is associated with 4.95 million deaths worldwide, with 1.27 million of those deaths directly attributable to AMR. Failure to immediately and decisively act on this devastating threat will lead to a projected USD 2.9 trillion cumulative loss in OECD countries and 10 million deaths globally by 2050. Maintaining resilience against antibiotic resistance Elcin Barker Ergun, CEO of pharmaceutical company MENARINI Group, insists that a decisive pharma contribution must tackle both the need to boost the AMR antibiotics pipeline and increase patient access to such novel antibiotics. “One cannot highlight enough, the criticality of securing patient access to novel antibiotics and the major challenges we are currently facing in achieving this fundamental goal. Only two AMR antibiotics out of the 16 developed and approved during this last decade were accessible to clinicians and patients even in the 14 highest-income countries,” she says. “This has resulted in a continued and large use of older antibiotics as the first treatment option. It was also associated with the bankruptcy of most biotechs involved in the development of those 16 novel AMR antibiotics alongside drastic loss of interest and investment in this therapeutic area.” MENARINI, a global Pharma 50 company headquartered in Italy is one of the few investing in the development and availability of novel antibiotics for clinicians and patients alike. In this challenging context, it strives to maintain a bold and leading role in the fight against AMR. Defining antibiotic access models across Europe Ergun insists that to tackle AMR, all key stakeholders need to collaborate to build a sustainable model, which supports the development of novel antibiotics and ensures patient access. “Successful models that created the right incentives, such as the Orphan Drug Designation, resulted in many orphan drugs being developed, approved and made accessible to clinicians and patients by pharma companies in the last years.” Given the growing threat of AMR and consistent reports highlighting the devastating consequences to humanity, Ergun explains that, within the context of the current revision of the EU legislation, an AMR designation for new antibiotics at a European level, can provide a similar efficient solution. Each country can then adopt complementary and locally fitting models such as the UK-Delinking-2 model, the Swedish procurement model or an orphan diseaseslike model.

Why global antibiotic R&D is broken However, the marketplace for antimicrobial research and development (R&D) has been broken for decades, says Dr Henry Skinner, CEO of the AMR Action Fund, which aims to bring two to four new antibiotics to patients by 2030. “Only a fraction of Phase I and II candidates achieve late-phase development, let alone find their way to the patients who need them,” says Dr Skinner. “The financial equation for antimicrobial development shoulders much of the blame. It can cost more than a billion pounds, accumulated over a decade of effort to bring a drug to market. Yet, annual sales might achieve just a few million pounds. “This poor return on investment is why private investors avoid antibiotics and direct investment goes towards other therapeutic areas such as obesity and cancer, yet antimicrobials — which underpin modern medicine — receive a fraction of the financial lifeblood for a small biotech company.” Driving towards a sustainable market The AMR Action Fund is a public-private partnership with nearly $1 billion in resources, charged with supporting smaller biotech companies through the late-stage development phases. The Fund exists to ensure that vital R&D continues as governments take the critical steps needed to improve market conditions and convince investors to return to the space. “If governments don’t act, and the financial landscape remains unchanged, we are staring down a future with millions of lost lives and billions of pounds spent globally each year in incremental healthcare expenditures due to AMR,” explains Dr Skinner.

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We all need to work towards recognising the devastating consequences of antibiotic resistance.

INTERVIEW WITH Dr Henry Skinner CEO, AMR Action Fund

Value of effective pull incentives for antibiotic R&D “We applaud NHS England for introducing pull incentives in the form of a subscription model that delinks the volume of drugs sold from the rate of reimbursement — vital for preserving the efficacy of next-generation antimicrobials,” says Dr Skinner. He also cites the US’s consideration of its own subscription scheme through the PASTEUR Act, which Congress reintroduced this year. Across Europe, Canada and Japan, governments are exploring these incentive models tailored to their countries’ needs. However, what is essential is its size and timeliness. “A pull incentive will invigorate the market only if it is commensurate with the investment required of new drugs. A pull incentive that is not adequately sized is like building a bridge partway across a ravine. You have advanced, but you’ve not actually gotten anywhere,” he explains. AMR will continue to spread without adequate and decisive solutions When asked why we witness a continuous spread of AMR, Dr. Najy Alsayed — Global Therapeutic Area Head for Infectious Diseases at MENARINI Group — says that there are numerous factors. However, he proposed focusing on two main drivers: (1) The natural ability of bacteria to adapt and develop a mechanism of resistance; and (2) The sub-optimal efficiency of current antibiotics policies based on restricted patient access and low recognition of economical and clinical contributions of the lifesaving capability of novel antibiotics. “Considering the first driver, we can start by stressing the fact that antibiotic resistance occurs when bacteria change so that antibiotic medicines can no longer kill them or stop their growth,” says Dr. Alsayed. “This associated bacterial ability materialises through two main mechanisms. The first one is a mutation in their genes, allowing some bacteria to survive antibiotics. This antibioticprotective genetic mutation is then passed along. The second mechanism is called horizontal gene transfer, involving genetic material moving from antibioticresistant bacteria to other bacteria.” He explains that this is why antibiotics must be continuously developed. We need an appropriate flow of novel antibiotics that addresses the two mechanisms associated with bacterial resistance.

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Reliance on existing antibiotics Dr. Alsayed states that current strategies used to fight AMR are much focused on simply restricting the use of novel antibiotics. However, it is worth noting that this novel antibiotics restricted patient-access has resulted in an increased level of resistance to older antibiotics which continues to be routinely largely used, with clinicians and patients strapped for choice. “This has led to broken development and an unsustainable patient access economic model for antibiotics,” says Dr. Alsayed. “Therefore, the continuous spread of antibiotic resistance — with alarming projections of up to 10 million deaths by 2050 — has prompted the need to consider new approaches and potential solutions.”

INTERVIEW WITH Dr. Najy Alsayed Global Therapeutic Area Head for Infectious Diseases, MENARINI Group

Developing actionable initiatives against AMR The urgent need for new solutions is also made necessary by the dwindling novel antibiotics portfolio alongside a worrisome reduction in the number of pharmaceutical companies and investment funds involved in AMR. “We strongly believe that we all need to work towards recognising the devastating consequences of antibiotic resistance and the imperative for an appropriate and decisive solution,” adds Dr. Alsayed. How can this be done? Ergun says AMR designation can be one way forward, which recognises both the specificity of antibiotic resistance challenges and the life-saving contribution of novel antibiotics. This is particularly essential among vulnerable patients, such as those undergoing transplantation, oncology treatments or major surgery, she explains. “The ongoing UK patient access ‘Delinking 2’ initiative is a very welcomed contribution translating this into a concrete solution adapted to UK needs and constraints. A similar approach was initiated through the Swedish model. This can also be applied at a European level, leveraging the current revision of the EU legislation and building on the successful EU experience, centrally creating the orphan disease designation model and providing guidance to each country,” concludes Ergun. Find out more at menarini.com

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Several governments have rethought the value new antibiotics bring to society and introduced policy reforms to support increased research and development.

Why the UN High-Level Meeting is critical to the fight against AMR Next year, the United Nations will hold a High-Level Meeting (HLM) to discuss the global coordination necessary to tackle antimicrobial resistance (AMR).

he rise of AMR continues to be one of the biggest threats to global health and modern medicine. An estimated 1.2 million people die from antibiotic-resistant bacterial infections every year, and this resistance is rising.

High-Level Meeting on antimicrobial resistance The first HLM on AMR in 2016 proved consequential. It called for concerted action from public and private sectors to address the implications of AMR in a comprehensive manner and implement strategies at a national level — across human health, animal health, agriculture and other factors. The AMR Industry Alliance, which I chair, is a key part of the life sciences industry’s response to that call for action.

WRITTEN BY James Anderson Chair, AMR Industry Alliance

Seizing the moment Much has changed since 2016. Several governments have rethought the value new antibiotics bring to society and introduced policy reforms to support increased research and development. For instance, the UK has debuted pull incentives to spur antibiotic innovation. Without prompt action to bring researchers back into this field, we risk losing valuable expertise that will be impossible to restore in time. Equally, we must increase our use of diagnostic tools to ensure valuable new antibiotics remain effective for many years. The AMR Industry Alliance has also made significant progress and continues to be an engaged partner with public and private stakeholders alike. We introduced a responsible manufacturing certification that works towards reducing the environmental impact of the global antibiotic supply chain; we promoted stewardship activities in low-to-middle-income countries through our annual Stewardship Prize; and we advocated for antibiotic access initiatives, including strengthening the sustainability of off-patent antibiotics. Collaboration to stop the rise of AMR Despite this progress, we must move faster, together, if we’re going to effectively combat the rise of AMR. Leading up to next year’s HLM, the Alliance will step up our work with the UN and its Member States to broaden the collective efforts against AMR, working with various stakeholders to identify and prioritise AMR solutions. Without meaningful change to how we incentivise antibiotic development, deliver them to patients across the world and use diagnostic tools to support rational use, rates of AMR will continue to rise — ushering in what some have called a ‘post-antibiotic’ world. The UN HLM can be a powerful catalyst of change. By working together, we can ensure that momentum continues in this critical fight. 06

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Why a new certification is setting the standard for antibiotic manufacturers the certification is voluntary, our hope is all stakeholders in the healthcare ecosystems adopt it to support the AMR cause.”

There are a number of stages in the production of antibiotics where aquatic waste is created.

How the certification was developed The creation of the Kitemark™ has been years in the making. As manufacturers all have their own criteria to assess the effectiveness of their environmental controls, it was obvious that a standardised approach could bring benefits to people and the planet. BSI facilitated the development of a standard of best practice, on behalf of the AMR Industry Alliance, for the responsible manufacture of antibiotics. “The Antibiotic Manufacturing Standard was published in June 2022,” reveals Soulsby. “Subsequently, we brought a number of stakeholders around a table — including regulators, government policymakers, health system procurers, NGOs and manufacturers — to develop the certification programme that could assess manufacturing controls consistently and at scale, based on the requirements in the Standard.”

Antibiotic manufacturers can be awarded a new certification — if they demonstrate that they are minimising the risk of antibiotic waste entering the environment.

T INTERVIEW WITH Courtney Soulsby Global Healthcare and Life Sciences Director, BSI

INTERVIEW WITH Natasha Bambridge Global Director Consumer Promise Practice, BSI

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he British Standards Institution (BSI) has developed a new certification programme called the ‘BSI Kitemark™ for minimised risk of antimicrobial resistance.’ Potential risks in antibiotic manufacturing It’s been well-publicised that the overuse and misuse of antibiotics are major factors in the spread of antimicrobial resistance (AMR), a global health threat that the World Health Organization says could have catastrophic implications for the treatment and prevention of infections. What may be less publicly known is that the antibiotic manufacturing process itself can also unwittingly facilitate the spread of AMR. The issue can occur when manufacturing waste that includes high levels of antibiotic residues is released into the natural environment — for example, via wastewater. “There are a number of stages in the production of antibiotics where aquatic waste is created,” explains Courtney Soulsby, Global Healthcare and Life Sciences Director at BSI, the

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business improvement and standards company. “For instance, when manufacturing lines are cleaned, when products are distilled or when fermentation processes are used.” If aquatic waste escapes from an antibiotics manufacturing plant and into waste streams, it can ultimately end up in wastewater treatment. Demonstration of effective controls With the Kitemark certification, antibiotics manufacturers are able to show that they have effective controls in place to minimise the concentration of antibiotic waste entering the environment. “This is assessed via a complex engineering calculation — to arrive at the PNEC (predicted no-effect concentration), concentration of antibiotic residue, below which adverse effects (AMR) in the environment are not expected to occur,” reveals Soulsby. “Manufacturers have implemented the AMR Industry Alliance standard and then self-declaring their compliance. From a regulatory point of view, it’s not a requirement; manufacturers want to raise the bar and be independently assessed,” explains Natasha Bambridge, Director of Consumer Promise Practice. “While

Important role of healthcare procurers The new Kitemark™ was rolled out in June 2023, and Bambridge says it is already having an impact. “Four organisations that went through the pilot process and helped us to shape the certification programme now have certified antibiotic products, including Sandoz and Teva,” she says. “Other pharmaceutical organisations are declaring that they are in the process of becoming certified, so they can win new business through healthcare systems’ antibiotic tenders. They know they can differentiate themselves from their competition by having better controls in place and ensuring they have a positive impact on the environment.” The way the Kitemark has been positively welcomed on the healthcare system/procurement side can bring significant benefits to society. “Healthcare systems are starting to reference both the Standard and the certification within their environmental award criteria for antibiotic procurement tenders,” says Bambridge. “That’s gratifying to see. Healthcare procurers can play a central role in driving the certification forward — both for the new innovative antibiotics of the future and, crucially, for the generics representing the large volume of antibiotics on the market today. That represents a critical step forward to address the growing threat of AMR and reduce discharge into the environment.”

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For instance, doctors prefer not to prescribe a new antibiotic as they like to save it for the treatment of a bacterium that is resistant to our standard antibiotics.

The AMR PULL incentive: keep calm but go quick AMR will not be solved without innovation. No innovation is possible without attractive market conditions. This duality is now well understood by the political world, which has already started to work.

he threat of antimicrobial resistance continues to grow. The number of resistant infections is growing by 20% a year in Europe and is causing the deaths of 79,000 people in OECD and EU countries (and many, many more in developing countries).

Flaws stunting innovation New innovative approaches are needed to put a stop to this vicious circle. Over 10 years ago, I founded a startup called Madam Therapeutics to develop a new class of antibiotics. I quickly discovered that it is difficult to make money with a new antibiotic. For instance, doctors prefer not to prescribe a new antibiotic as they like to save it for the treatment of a bacterium that is resistant to our standard antibiotics. It hardly pays to develop antibiotics. Big pharma companies have long since pulled out of the market. Startups and small businesses are struggling. Madam Therapeutics, the company that I founded, survived for over 10 years but was declared bankrupt this summer. Not because we made bad medicines, but because our drugs would not be prescribed. Therefore, investors were not interested. However, new payment models can make the development of an antibiotic attractive again for entrepreneurs like myself.

WRITTEN BY Remko van Leeuwen Vice President, BEAM Alliance

Small steps have been made Over the last 12 months, different countries have put forward concrete proposals for financial incentives to resolve the market failure. Leading the way is the UK, which, on the strength of the experience gathered via a pilot mechanism launched in 2021, is preparing to implement the first permanent subscription instrument. Japan is launching a pilot scheme to parameterise and size its own instrument. Canada is putting together a proposal based on the UK model and is making rapid progress on its implementation. The US has drafted an ambitious bill, the PASTEUR Act, which is still looking for the right legislative vehicle to be passed by Congress. EU looking for a way forward The European Commission has proposed an alternative: the transferable exclusivity extension voucher. The proposal has been heavily criticised, and no other concrete alternative has been put forward. Innovators are gradually going out of business, and the portfolio of products under development is dwindling, hence my call to European politicians: let’s make a move — now. We no longer have time to stall because pathogens don’t.

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The overlooked link between animals, antibiotics and investment risks Blame for antibiotic overuse is usually laid on doctors writing unnecessary prescriptions or patients failing to follow instructions. Little attention has been paid to the world’s single biggest consumer of these vital drugs: intensive animal agriculture.

very year, billions of cows, pigs and poultry are routinely injected with the same antibiotics on which human health relies. In some countries, 80% of antibiotics are sold for use in animals — not to treat disease, but to promote growth and prevent the outbreaks that inevitably occur when large numbers of livestock are packed closely together.

WRITTEN BY Jeremy Coller Founder of FAIRR, Chief Investment Officer and Managing Partner, Coller Capital

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A better approach to antibiotic use At FAIRR, an investor network representing more than 400 investors and more than $70 trillion of assets under management, we provide the data that allows investors to make informed decisions on AMR risk. We’re filling the knowledge gap for investors, highlighting the AMR risks involved in intensive animal agriculture and facilitating dialogue between companies and investors. Why antibiotic use in agriculture is a risk We support an evidence-based holistic approach to tackling Over-using antibiotics in this way makes AMR — not wholesale banning the use them less effective against deadly of drugs but encouraging proper animal There’s also an infections in humans and animals husbandry and reserving antibiotics only for alike. That’s not all. There’s also an treating sick animals. environmental danger environmental danger in the runoff from This change won’t happen by itself. in the runoff from farms with antibiotic-contaminated All the players in the global food system farms with antibioticmanure. Concerns have been raised about and across the supply chain — from dosed-up meat fuelling obesity in humans. food manufacturers to pharmaceutical contaminated manure. There’s a particular risk facing often lowcompanies and farmers to supermarkets paid farm and meat processing workers, and fast food restaurants — need to come given their proximity to animals and meat potentially together to put good antibiotic practices in place. infected with antibiotic-resistant bacteria. At FAIRR, we understand that institutional investors as It all adds up to a huge unnecessary risk to human health. shareholders in all these companies can drive real change. With the global economic costs associated with antimicrobial AMR is a very real risk to our health, but it is also a financial resistance likely to reach $100 trillion by 2050, it also risk to our economy; it’s time for the biggest users of represents a material financial risk to investors’ portfolios, antibiotics to clean up their act. which are often exposed to the leading global protein producers.

the landscape of treatment strategies against AMR. The public also needs a better understanding of the AMR challenge — and of the importance of antibiotics in general. “Antibiotics are THE wonder drug of humankind,” he says. “Giving up on them would be crazy.”

AMR isn’t a silent pandemic — it’s screaming incredibly loudly The world needs to wake up to the threat of AMR, says the Founder and CEO of a biopharma company dedicated to the research and development of novel antibacterial products.

A INTERVIEW WITH Dr Marc Gitzinger Founder and CEO, BioVersys WRITTEN BY Tony Greenway

ntimicrobial resistance (AMR) has been called ‘the silent pandemic.’ This is ironic, notes Dr Marc Gitzinger, Founder and CEO of BioVersys, a biopharmaceutical company focusing on the research and development of novel antibacterial products. “In my view,” he says, “AMR is screaming very loudly indeed.” Need for new antibiotics and lack of investment Dr Gitzinger calls AMR a formidable global threat, which has the potential to unleash a bacterial pandemic — upending the advances made in modern medicine over the last 50 years. To prevent the undermining of our health systems, new antibiotics

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are needed urgently. “Unfortunately, antibiotic development has been incredibly neglected,” he says. “Only smaller players are still innovating in this space while recent analysis showed that in the last five years, around 80% of the people involved in companies that successfully brought antibiotics to market have either retired or gone into other therapeutic areas. That talent loss is worrying.” The problem is financial, says Dr Gitzinger. “We need to change the model, which reimburses pharma companies based on volume and adopt the type of subscription model used in the UK,” he explains. This would make innovations in antimicrobials a more attractive investment area, potentially redefining

Developing innovative assets to combat rising challenges of AMR BioVersys has developed a diverse portfolio of innovative assets to combat antimicrobial resistance. “One is being developed for patients with ventilator-associated bacterial pneumonia and is now at the Phase 2 clinical trial stage,” reveals Dr Gitzinger. Another is in Phase 2a clinical trial and aims to provide an efficacious therapy for tuberculosis patients. As an early-stage biotech, we have decided to focus on areas where there is the highest unmet medical need. We also collaborate with academic partners and, on one of our programmes, a large pharma partner that is one of the few big companies still dedicated to working in this space.” Dr Gitzinger remains optimistic. “If countries change their reimbursement models for novel antibiotics, we will find the solutions to combat AMR,” he says. “Otherwise, antibiotic development will continue to be neglected; and the world will have serious issues as a consequence.”

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Precision antibiotic use to tackle antimicrobial resistance A new study is aiming to help combat antimicrobial resistance by identifying ways to better tailor antibiotic prescribing to individual patients.

ntibiotic prescribing focuses on a ‘one-size-fits-all’ approach and does not account for the differences in antibiotic drug concentration that similar antibiotic doses achieve within individual patients. That, according to Dr Timothy Rawson from Imperial College London (ICL), is a major knowledge gap.

One Health approach: human, animal and environmental health united

Study on precision antibiotic prescribing The DATA-TDM study will use technology and artificial intelligence (AI) techniques to analyse patient data to develop precision prescribing approaches. It can potentially reduce the threat of antimicrobial resistance (AMR) and of antibiotics becoming less effective. Rawson explains that AMR is a global health security issue with around 1.27 million deaths directly caused by drug-resistant infections in 2019. Impact of antibiotic drug concentration DATA-TDM seeks to optimise the use of antibiotics currently available by delivering a better understanding of how antibiotic drug concentration in individual patients impacts treatment outcomes. Rawson says: “It provides a unique dataset to understand the true impact of individual variation in drug concentration on outcome of infection and will support changes in practice to optimise delivery of treatment for patients.” DATA-TDM is now recruiting in a pilot programme at three London hospitals. Optimising antibiotics efficacy With some antibiotics already becoming less effective, Rawson says understanding what happens to an antibiotic in an individual patient and then developing methods of adjusting the dose to optimise treatment is vital. Unsuitable concentrations of drugs can be associated with worse outcomes, lead to side effects and the development of AMR. He explains that optimising antibiotic concentration gives patients the best chance of effective clinical outcomes; helps better understand side effects; and can characterise what may drive antibiotic resistance. Unique dataset for targeted intervention Rawson notes that the DATA-TDM study group is working to create a powerful dataset for the development of tools and novel technologies to directly measure the concentration of antibiotics in patients and lead to targeted interventions. The study will support development of wearable technology for real-time monitoring of antibiotics; AI algorithms to inform individualised prescribing decisions; and computer systems that deliver precise doses based on patient response to treatment. INTERVIEW WITH Dr Timothy Miles Rawson NIHR Academic Clinical Fellow, Imperial College London WRITTEN BY Mark Nicholls

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Antimicrobial resistance (AMR) is a complex public health matter that asks for complex solutions, and it disproportionately impacts marginalised populations across countries.

T WRITTEN BY Madda Henry Magbity Policy Manager, European Public Health Alliance

he pronouncement about the threat of Antimicrobial Resistance (AMR) is real. It continues to put unprecedented pressure on health and care services in Europe, widens health inequities in a post-pandemic society and goes across borders. This calls for coordinated, international and multi-stakeholder action across sectors. Why AMR is an immense global threat AMR presents a threat to humanity as grave as climate change, though its symptoms might not be as visible — yet. The WHO reveals that by 2050, at least 10 million deaths a year will be related to drug-resistant superbugs. AMR gravely impacts marginalised populations within countries due to socioeconomic, ethnic, geographic and other barriers. These communities often have restricted healthcare access, compounding the AMR threat.1 Stewardship: leading by example The European Public Health Alliance (EPHA) AMR Strategy 2023–2025 combines all One Health dimensions — health of humans, animals and the environment — in four pillars: awareness, advocacy, scientific evidence and stewardship. The WHO EURO Roadmap approved at the WHO Regional Committee on 26 October is considered a good example as it sets targets and demands action between sectors and stakeholders.

AMR diplomacy in action in Brussels Co-hosted by EPHA and Health Care Without Harm, the European Parliament Interest Group on AMR and a network of 18 Members of the European Parliament committed to strengthening action on AMR at the EU level. The annual meeting took place in Brussels on 24 October 2023. This year, the event explored issues and impact on human health, animal welfare and ecosystems and discussed practical solutions. With the EU providing strong guidance, it seems Brussels policymakers are ready to take some serious steps towards addressing AMR. The AMR Stakeholder Network unites Recognised as a complex health challenge, inaction is not an option. AMR requires the engagement and coordination of all stakeholders. EPHA is organising the AMR Stakeholder Network, which brings together 60 civil society organisations. The participation of civil society is indispensable to achieving progress. The year 2024 will be a game-changer in the EU elections, and the Alliance aims to ensure that AMR remains at the top of the EU policy agenda. References 1.Adebisi YA, Ogunkola IO. The global antimicrobial resistance response effort must not exclude marginalised populations. Trop Med Health. 2023 Jun 7;51(1):33. doi: 10.1186/s41182-023-00524-w. PMID: 37287083; PMCID: PMC10245439.

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Fighting AMR requires scientific, political and social organisations to closely collaborate AMR is recognised as a major threat to human health, with nearly 5 million people dying each year from infections caused by antimicrobial-resistant bacteria. This is estimated to rise to 10 million by 2050.

he development of resistance is driven by the misuse of antibiotics in humans and animals. Resistant bacteria can then spread through healthcare facilities, within communities and the environment — for example, through food and water.

WRITTEN BY Dr Anna Both Scientist, Institut Pasteur, France

Why AMR is a threat Treating patients with serious infections becomes more difficult because antibiotics that may have been previously effective are no longer reliable. This drives doctors to use antibiotics reserved for treatment of the most resistant bacteria. Bacteria then develop resistance strategies against them — a spiral that will inevitably lead us to untreatable infections in the near future.

Collaboration among global organisations Both national and international governmental and non-governmental organisations — such as WHO, the European Centre for Disease Control (ECDC) and the European Society of Clinical Microbiology and Infectious Disease (ESCMID) — have recognised the urgency of addressing AMR and have established programmes, which monitor the emergence and spread of resistant bacteria and provide training for healthcare workers. ESCMID has made AMR a strategic priority and appointed an AMR Director who will lead a team to improve understanding and combat AMR globally. ESCMID is investing in specific research grants for AMR and developing educational courses with activities supported by a range of study groups that are addressing the AMR crisis. The immediate imperative is to prioritise sufficient funding and actively engage local health and political authorities around the world to protect against the looming spectre of a post-antibiotic era.

Rapid and reliable diagnostics of infections and antimicrobial resistance will help clinicians make smart choices.

Progress in the fight against AMR Fortunately, public health specialists, doctors and scientists have developed a toolbox to combat AMR. In addition to efforts to develop new drugs, we have learned that education and regulation of antibiotic use in human and animal health can have an important impact. Rapid and reliable diagnostics of infections and antimicrobial resistance will help clinicians make smart choices. Improved infection control measures in hospitals and monitoring of wastewater treatment and the food industry are paramount. In a globalised world, resistant bacteria do not respect READ MORE AT GLOBALCAUSE.CO.UK

national borders; what happens at one end of the world will inevitably have a global impact. Therefore, only a global effort, involving both high-income and low and middle-income countries (LMICs), has a chance of success. Adapting existing programmes to LMIC settings has been complex due to gaps in both knowledge and resources. WRITTEN BY Professor Holger Rohde University Medical Center HamburgEppendorf, Director of the ESCMID AMR action committee, European Society for Microbiology and Infectious Diseases (ESCMID), Germany

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A global hub supporting research into antimicrobial resistance The global fight against antimicrobial resistance is being taken to a new level by a ‘neutral broker’ organisation that is providing evidence to help set priorities and maximise the impact of resources and efforts invested into AMR research.

he Global AMR Research and Development (R&D) Hub was launched following a call from G20 Leaders to improve coordination and collaboration in AMR R&D. Aiming to provide an evidence base in support of improving R&D across the One Health spectrum, it is working to support and strengthen the pipelines of new antibiotics and other necessary products to combat AMR.

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Push and pull incentive challenges The Hub, launched in May 2018, is a partnership of Member States and the European Union alongside philanthropic foundations. Hub Secretariat Director, Dr Lesley Ogilvie, says it aims to galvanise support and collaboration across countries,

but challenges remain across the antibiotic ‘push and pull spectrum’ with limited return on investment for companies when new antibiotics are kept in reserve. ‘Push’ incentives aim to support innovation, research and development of new antibiotics, regardless of successful access to the market. ‘Pull’ incentives aim to reward new antibiotics that have proven clinically relevant to patients while ensuring stewardship, access and developers’ financial viability. “The consensus is growing that the most critical products are not getting to the people that need them most — it’s a market failure but most importantly a public health failure,” adds Ogilvie.

Dynamic dashboard capabilities The Hub’s online Dynamic Dashboard platform offers an overview of the global AMR funding landscape across the One Health spectrum — human, animal, plant and environment — and presents information on investments, antibacterial products in the clinical pipeline and push and pull incentives. Hub Secretariat Deputy Director, Dr Ralf Sudbrak, says the dashboard makes global data available to decision-makers, politicians, funders and researchers to identify opportunities and funding gaps. Other Hub outputs include an overview of the progress countries are making on specific initiatives, funding factsheets and reports on data and implementation of research in low and middle-income countries (LMICs). Setting concrete AMR R&D targets A major push is geared towards the United Nations General Assembly (UNGA) 2024 on AMR. “We are trying to get concrete actions and accountability embedded into a UNGA declaration,” says Ogilvie. “We need to come together as a global community to ensure we develop solutions with the most impact.” They aim to keep AMR R&D high on political agendas with a push for actionable commitments and a process for setting R&D targets from UNGA. Sudbrak says the Hub is viewed as a ‘neutral broker’ but warned that the world is running out of tools because of AMR.

WRITTEN BY Dr Lesley Ogilvie Secretariat Director, Global AMR R&D Hub

WRITTEN BY Dr Ralf Sudbrak Secretariat Deputy Director, Global AMR R&D Hub

Find out more at globalamrhub.org

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