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V o l . 3 5 I S S U E 2 / 2 6 • J u n e 2 0 2 6 T H E E U R O P E A N F O R U M F O R T H O S E I N T H E B U S I N E S S O F M A K I N G H E A L T H C A R E W O R K From technology to responsibility Artificial intelligence in the OR – tool, or surgeon of tomorrow? Will surgeons be replaced by machines in the future? With the rising impact of artificial intelli- gence and robotics, this concern is on the minds of many medical professionals and patients alike. At the 2026 Congress of the German Society of Surgery, Prof. Dr Jörg-Peter Ritz, President of the German Society for General and Visceral Surgery (DGAV) and Chief Physician and Medical Director at Helios Kliniken Schwerin, painted a more nuanced picture of how AI is already being used in surgery today, what it will be capable of in the near future, and where the limits lie. With over 200 sessions on the sub- ject, the conference itself was proof of just how central this develop- ment has become to the field. Before AI can realise its full poten- tial in surgery, one fundamental prerequisite must be met: the digi- talisation of the healthcare system. Ritz made it clear that Germany still has a considerable amount of catch- ing up to do in this regard. ‘If we don’t have the digital infrastructure in place, then AI won’t arrive, or its arrival will be delayed,’ he said. In many hospitals, digital patient records are still not the norm – paper files and printouts are still part of everyday routine. Only on a solid digital foundation can AI play to its strengths, he said. AI in everyday clinical practice – from admission to the discharge summary Where digitalisation already has a foothold, AI is demonstrating its practical benefits. Automatic speech recognition systems capture patient data during consultations and transfer it directly to the hos- pital information system – without the need for manual input. In some countries, this goes even further: citing a use case from Spain, Ritz explained how, prior to a con- sultation, patients communicate with an AI system that requests relevant data, pre-structures find- ings and coordinates appointments. According to Ritz, this model may still be a long way off for Germany, but it is a realistic prospect that could significantly ease the work- load for clinicians. These benefits are particularly evi- dent in documentation. Initial pilot projects demonstrate how AI can assist in the drafting of discharge summaries and surgical reports – www.healthcare-in-europe.com whilst highlighting gaps that are easily overlooked in day-to-day practice, such as a missing fol- low-up appointment or an undocu- mented medication dose. However, widespread clinical use has yet to take place. This is also true regarding risk stratification: systems that automatically flag critical drug interactions or necessary pre-op- erative measures by analysing cur- rent and past findings are currently under development – and promise to highlight information that would otherwise easily be overlooked in the hectic day-to-day clinical envi- ronment. AI in the OR – VR, robotics and intraoperative assistance In the operating theatre, AI opens up possibilities that go far beyond mere documentation. Virtual reality headsets can be used to project images of tumours and anatomical findings directly onto the surgi- cal site. What was previously a demanding mental exercise – name- ly, translating a two-dimensional X-ray image into the three-dimen- sional reality of the abdominal cavi- ty – can now be supported visually: Tumour boundaries become visible, and critical blood vessel pathways are marked. Ritz assessed the cur- rent state of development: although such systems are already in use, they are predominantly still con- fined to research projects and early clinical applications – widespread clinical use has yet to be achieved. Modern surgical robots are already equipped with computing power far beyond than that of earlier gen- erations – not by chance, but spe- cifically to handle the vast amounts of data required for data and video analysis. This, in turn, offers the potential for sophisticated assis- tance systems, Ritz explained: Much like a collision warning system or lane-change assistant in modern cars, AI systems in the operating theatre could alert surgeons to risky manoeuvres – for example, that a particular surgical approach would be avoided by the majority of expe- rienced colleagues. Such systems are already in their infancy and are set to develop further in the coming years. dreds of kilometres, this technology does not yet play a role in everyday clinical practice, Ritz noted: ‘So far, it has been more about demonstrat- ing what is technically feasible.’ The high demands on data quality and security – particularly with regard to latency, which must be limited to just a few milliseconds – currently pose far too great a risk for every- day clinical practice. On the other hand, telesurgery already offers actual practical bene- fits in surgical training, for example in skills training for specific techni- cal procedures. ‘This means we can observe, and even interact remotely during a minimally invasive proce- dure,’ explained the expert. ‘This is something we can already do; and it works.’ Furthermore, record- ings of these tele-training sessions can even be evaluated using AI, which then automatically provides suggestions for improvement. ‘For example, current systems recognise difficulties at certain stages of a procedure, such as during suturing, and then offer personalised train- ing.’ The aim is to improve surgical technique in a targeted manner and thus enhance patient safety. Telesurgery – technically achievable, but not yet clinically mature Telesurgery is another intriguing and promising field. While there have already been some remarkable procedures, such as a robotic chol- ecystectomy performed across hun- Deskilling and the future of surgical training The convenience that AI assis- tants provide, however, also has a downside, Ritz cautioned: so-called “deskilling” – the gradual loss of basic surgical skills that are no longer practised on a regular basis. The expert illustrated this trend using open cholecystectomy as an example: where previously four people would be at the operating table, today there are only two. In the future, robotic systems could encourage an even further reduc- tion in staff numbers – with the result that young surgeons and assistants would hardly be able to gather any practical experience, and an entire generation of surgical expertise could be lost. ‘That is why we need structured curricula, so that AI and modern technology do not push us out.’ Regarding the titular question of whether AI will replace surgeons, Ritz offered a clear-cut ‘no’. Neither the technical requirements nor the ethical and legal framework – par- ticularly the unresolved issue of accountability – would allow this to happen in the foreseeable future. Additionally, he pointed out an aspect often overlooked in the pub- lic debate: Many patients still mis- understand the concept of robot-as- sisted surgery, believing that the robot performs the operation inde- pendently. In reality, it is always the surgeon who performs the opera- tion – the robot is a precise instru- ment under human control, not an autonomous agent. Addressing this misunderstanding is not merely a matter of providing information, but also of building trust in modern surgical procedures. m o c . e b o d a . k c o t s – n s v r o h i © What AI can and should do is some- thing else entirely: take over routine tasks, simplify documentation, pre- vent errors and support the surgeon in a way that allows them to focus entirely on their most important task – performing surgery. This, says Ritz, would be his most press- ing wish for the near future. With this in mind, he sees AI not as a competitor but as a tool: one that can make surgery safer, more effi- cient and more adaptable – if used wisely. Article: Wolfgang Behrends CONTENTS SURGERY RADIOLOGY WOMEN'S HEALTH LABORATORY ONCOLOGY 1 3 6 8 10 www.healthcare-in-europe.com
2 S U R G E R Y Perioperative pathways Smart waiting lists: From one-size-fits-all to personalised pre-op care Digital solutions that integrate surgical waiting lists with GP records are helping hospitals improve perioperative path- ways and reduce unnecessary appointments. Dr Simon Rang, Consultant Anaesthetist at East Kent Hospitals University NHS Foundation Trust, explains how risk stratification is transform- ing patient care. A UK hospital has demonstrated how digital tools that integrate surgical waiting list data with GP records can improve the patient perioperative pathway. The wait- ing list tool stratifies patients by risk – enabling clinicians to iden- tify low-risk patients who can be booked for surgery with minimal pre-operative preparation whilst directing high-risk patients to a multi-disciplinary pre-op pathway. The tool also means that waiting lists – primarily for orthopaedic procedures – are organised in a way that reduces the likelihood of late cancellations of surgery. By using the technology to mine patient data, East Kent Hospitals in the south-east of England has trans- formed a static waiting list into an active clinical tool. The move has led to reduced consultation times, shorter appointments, improved patient flow, and more efficient use of clinical time. and Lead Matching resources to patient needs Simon Rang, Consultant Dr Anaesthetist for Perioperative Medicine at East Kent Hospitals University NHS Foundation Trust (EKHUFT), says hospitals in the UK are under pres- sure to reduce waiting lists at a time of growing demand in the NHS. 'What we can do as clinicians,' he says, 'is use our resources efficiently to get to a point where our entire perioperative pathway is running as efficiently as possible. But to do that we realised that patients do not all need a generic pre-opera- tive workup; a healthy 25-year-old needing a knee operation is prob- ably going to require less input Publisher mgo fachverlage GmbH & Co. KG E.-C.-Baumann-Str. 5 95326 Kulmbach/Germany Phone +49 (0) 9221 949-311 Fax +49 (0) 9221 949-377 Managing Director: Stephan Behrens Founded by Heinz-Jürgen Witzke ISSN 0942-9085 USA: Cynthia E. Keen (CEK) Correspondents Austria: Michael Krassnitzer (MK) Germany: Cornelia Wels-Maug (CWM) Dr Christina Czeschik (CC) Editor and Production Manager: Wolfgang Behrends (WB) Phone: +49 (0) 9221 949-505 E-Mail: redaktion@european-hospital.com Great Britain: Mark Nicholls (MN) Spain: Mélisande Rouger (MR) than an 80-year-old with medical conditions.' Risk-based triage using shared health records The platform, developed by soft- ware company Graphnet Health, is combined with population health analytics software to triage patients for their medical complexity and perioperative risk. It is under- pinned by a shared healthcare record containing patient data such as medication and medical history from local healthcare organisations such as GPs and neighbourhood hospitals. The software identifies low-risk patients suitable to follow a 'low touch' pre-op workup with a brief nursing assessment by tele- phone – with the aim to pro- gress to 'no-touch' pathways for some patients without any need for pre-op consultations, potentially in areas such as carpal tunnel releases and cataract surgery. Rang says: 'The analytic software allows us to work out which patients are medically complex, or medically simple, and assign them into a RAG (Red, Amber, Green) rat- ing of high, medium and low peri- operative risk. The idea is to make the pre-operative workup more per- sonalised, concentrating efforts on patients that will benefit most.' Significant time savings demonstrated The initial project demonstrated that low-risk patients could be iden- tified in advance and prepared for surgery in a separate pathway involving low-risk nursing clinics with shorter appointment dura- tions. This resulted in a 27% reduc- tion in consultation times – from 30 to 22 minutes. Rang continues: 'For the Trust, that means we can target patients that need our services most and focus on patients that need greater pre- op support. But if many patients do not have to come to a pre-op appointment and fill in unnecessary questionnaires, the experience is much better for them too.' ) e g a m I h s a l F 5 . 2 i n i m e G ( I A f o e s u h t i w d e t a r e n e g e g a m I Mockup of a tablet running a perioperative patient pathway software The improvements in workflow, patient throughput, cost and time efficiencies are significant in ena- bling surgical waiting list co-ordi- nators to book patients into thea- tre slots with the confidence that they are actually ready for surgery. Clearer visibility of a patient's sta- tus via the triage tool helps avoid uncertainty for the different teams involved in perioperative care and minimises late changes to operating lists and cancellations. tion just before surgery, to make the whole pathway smoother and a better experience for patients, and with better outcomes for them,' says Rang. 'The dashboard gives us that early insight – we can see who is low-risk and who needs extra support – and individualise their care. In pre-operative assessment we traditionally have offered the same pre-op workup to everyone; it's now very clear that one size doesn't fit all.' Scaling up towards 'no-touch' path- ways The next step is to scale up the pro- gramme to include more patients on the roll-out of the lowest touch pathway with no pre-op work and to improve digital communication with patients. 'The idea is to organise patients waiting for surgery to reduce last minute assessment and optimisa- The East Kent approach forms part of the wider Combined Intelligence for Population Health Action (CIPHA) programme, which is ena- bling 11 Integrated Care Systems across the NHS to use joined-up data to improve efficiency, reduce inequalities, and deliver better out- comes for patients. By Mark Nicholls Dr Simon Rang Lead is Consultant Dr Simon Rang Anaesthetist for and Perioperative Medicine at East Kent Hospitals University NHS Foundation Trust (EKHUFT), where he provides anaesthetic care and perioperative focus for patients undergoing various surgical procedures. His research interests focus on perioperative medicine, optimising patient care before, during, and after surgery to achieve better outcomes. Subscriptions Simone Sesselmann kundenservice@mgo-fachverlage.de Subscription rate 3 issues: 24 Euro, Single copy: 8 Euro. Publication frequency: 3 times a year Representatives Germany, Austria, Switzerland: Diana Thümmel Phone: +49 9221 949-407 E-Mail: d.thuemmel@mgo-fachverlage.de Europe: Eric Jund Phone: +33 493 58 77 43 E-Mail: jund@european-hospital.com Taiwan: Charles Yang Phone: +886 4 232 236 33 E-Mail: medianet@ms13.hinet.net USA & Canada: Hanna Politis, Media International Phone: +1 301 869 66 10 E-Mail: hanna@media-intl.com All company, brand and product names in this publication are the property of their respective holders. Users must obtain per- mission from those holders before copying or using the owner’s trademarks, product and company names or logos. EUROPEAN HOSPITAL Vol 35 Issue 2/26
R A D I O L O G Y A call for consistency at ECR 2026 The aorta is an organ now – and imaging needs to catch up As the aorta gains recognition as a functioning organ rather than a simple blood conduit, the lack of standardised imaging pro- tocols is becoming an increas- ingly pressing concern. At ECR 2026 in Vienna, Professor Nicola Galea from Sapienza University of Rome made a compelling case for unified imaging approach- es, warning that inconsistency in measurement techniques can lead to flawed clinical decisions. Galea, an Associate Professor in Radiology at the Department of Radiological, Oncological and Pathological Sciences, described the aorta as 'an organism with specific vital function'1 – far more than a passive tube transmitting blood from the heart to the rest of the body. 'There is an increasing emphasis on considering the aorta not as a simple conduit that trans- mits the blood from the heart to the rest of the body, but like a function- al organ,' he told delegates. Yet while the number of papers and guidelines on the aorta con- tinues to grow, most devote little attention to imaging requirements. Session chair Professor Hatem Alkadhi from University Hospital Zurich set the scene by noting that 'there are so many guidelines about the aorta from so many societies' but only a few from radi- ological groups. 'What they all do have in common,' he continued, 'is that they consider the aorta to be an organ, and should be approached like this, which has consequences for both imaging and reporting.' Speaking in the session entitled Approaching the Aorta as an Organ, Galea specifically focused on standardising aortic imaging and assessment, covering appropri- ate approaches for aortic imaging, standardised post-processing and measurement methods, and ways to minimise inter-reader and inter- study variability. When millimetres shape clinical decisions As modern healthcare management becomes increasingly image-driven, guidelines rely more and more on diameter thresholds and indexing measurements. 'That means clinical decisions may depend on small differences, but small differences can have a huge impact in the management of the patient,' Galea explained. 'But the guideline docu- ments do not say how and where to measure, and there is no detail on techniques to apply, how to study a patient, and report.' Aortic imaging, he noted, is 'inher- ently variable' from a technical point of view, in methodology, and in read- er experience – and can be further influenced by the approaches of a specific institution. Artificial intel- ligence may also play a role. 'As a result, lack of standardisation leads to clinical inconsistency,' he said. The consequences can be signifi- cant: 'Comparable studies can give artificial changes in aortic meas- Learn more. Composite figure illustrating modern MRI and CT techniques for aortic assessment urement with false interpretation in the progression and stability of disease and when an assessment is not reproducible that can result in a different therapeutic strategy on the same patient.' This may also lead to physicians losing confi- dence in radiological reports and conducting their own measure- ments and assessments. ESCR consensus document in the works To address this lack of consistency, Galea reported that the European Society of Cardiovascular Radiology (ESCR) is working on a consen- sus document offering recommen- dations on diagnostic definition criteria and standard reporting. Elements covered include guidance on modality selection, scanning protocols, quantitative aortic assess- ment, and reporting standards. Recognising the 'rich toolbox' of imaging modalities available, Galea identified computed tomography angiography (CTA) as the standard for measuring and assessing aortic disease, especially in emergency settings. 'Ultrasound is a first line modality and MRI can be reserved for paediatric patients, young adults, or during pregnancy, and nuclear medicine has a role espe- cially in patients with inflammatory disease, or infective disease.' IMAGINE THERE’S A PERECT WORKFLOW. Introducing a breakthrough for everyday MRI use in intensive care - an innovation clinicians have long been waiting for. The syringe pump is specifically designed for use in the MR environment. It operates directly adjacent to the MRI scanner (up to 3 Tesla), eliminating the need for long and cumbersome tubing. Syriflow® MR streamlines workflows and reduces costs. Its precise infusion pump technology ensures maximum safety and reliability in patient care. www.healthcare-in-europe.com NEW: Syriflow® MR 3 a e l a G . f o r P f o y s e t r u o c e g a m I In the context of aortic imaging with CTA, he stressed that ECG gat- ing is mandatory when evaluating the aortic root. Consistent terminology as a foundation Galea emphasised the importance of an accurate definition of aortic pathology for appropriate clinical management. 'Standardised defini- tions are essential to reduce diag- nostic ambiguity and standardisa- tion reduces variability in clinical decision making,' he concluded. His final message was clear: ded- icated protocols with full aortic coverage are critical; accurate and reproducible techniques should be used to standardise measurements; and consistent terminology must be adopted for aortic pathology. By Mark Nicholls Reference: 1. Czerny M, Grabenwöger M, Berger T et al.: EACTS/ STS Guidelines for diagnosing and treating acute and chronic syndromes of the aortic organ; European Journal of Cardio-Thoracic Surgery 2024; https://doi.org/10.1093/ejcts/ezad426 Professor Nicola Galea, Professor Nicola Galea is a cardiovascular radiologist and Associate Professor in Radiology at Sapienza University of Rome, Italy. He heads the Cardiovascular CT & MR Imaging Unit at the Policlinico Umberto I Hospital. His research focuses on advanced cardiac imaging – particularly cardiac magnetic resonance, 4D Flow aortic imaging, the impact of surgery on aortic morphology and dynamics, as well as imaging biomarkers in cardiomyopathies and inflammatory or ischaemic heart disease.
4 R A D I O L O G Y From threat to essential ally Automation, not replacement: the true promise of AI in radiology Will artificial intelligence (AI) render radiologists obsolete? What seemed a likely scenario only nine years ago, has now given way to a quite differ- ent reality: At RSNA 2025, two experts outlined how AI tools are becoming essential allies – not replacements – for radiolo- gists facing an unprecedented workforce crisis. In 2016, Geoffrey Hinton, PhD, Nobel Laureate and widely known as “the godfather of AI”, told radiol- ogists attending the RSNA Annual Meeting that their jobs would soon be obsolete, replaced by artificial intelligence. Nine years later, radiol- ogists still dominate reading rooms, although AI tools have entered them. The dynamic, however, has changed. AI tools are now desper- ately needed to aid, rather than to replace, radiologists. How did this happen? Nancy Pham, MD, Assistant Professor of Radiology in neuroimaging and neurointerven- tion at Stanford Medicine, offered: “A large and unsustainable imaging vol- ume is outpacing the global baseline radiologist supply.” Speaking in a sci- entific session presentation at RSNA 2025 on AI’s expanding role in image interpretation, she outlined how increasingly heavy workloads and an ageing population of radiologists are driving rising turnover – radiologists leaving their positions or departing the profession entirely – with rates in the United States climbing from 5.3% in 2013 to 8.5% in 2022.1 In Europe, the situation is similarly bleak, with approximately 19% of radiologists retiring within five years.2 Three types of AI in clinical use Dr Pham explained that AI, used intelligently, can help minimize an impending crisis of too many diag- nostic imaging exams and not enough radiologists to read them. She identi- fied three viable applications: 1. Autonomous AI makes clinical decisions without human oversight – making it closest to the type of AI Prof. Hinton was referencing in 2016. Currently, two such products are in clinical use: LumineticsCore, the sole FDA-cleared autono- mous AI product, detects moder- ate-to-severe diabetic retinopathy, and either refers a patient to an eye care professional or advises that a repeat exam should be per- formed in 12 months. CE-marked Oxipit ChestLink reduces workload by identifying normal chest radio- graphs with 99.9% precision, allow- ing radiologists to focus exclusively on complex or abnormal cases. 2. Generative AI interprets free-text notes, laboratory results, vital signs, and a variety of reports. Dr Pham advised that she uses a generative AI tool at Stanford Medicine when a patient has a very complex and lengthy history. This tool rapidly generates well organized, detailed lists and prepares preliminary notes. 3. Augmented, or Assistive, AI serves as a co-pilot and enhances human decision-making. These AI tools handle non-interpretive and tedious tasks such as segmentation, volume measurement, and lesion tracking. Another application is to serve as a second reader acting as a safety net to reduce false positives and negatives. Breast imaging currently offers the strongest evidence of the benefits of AI as a second reader. ‘Noncontrast head CT scans are one of the highest volume exams ordered by emergency department physicians. Often performed daily for minor trauma, headache, or dizziness, the vast majority of these CT exams are normal,’ Dr Pham observed. An AI tool screening nor- mal studies would free radiolo- gists to focus on challenging cases and those with abnormal findings. ‘However,’ she cautioned, ‘the safety bars for such a tool are incredibly high. The brain is unforgiving.’ Tomorrow's highly automated reading room Tara Retson, MD, PhD, Deputy Chief of AI in Breast Imaging at UC San Diego Health, predicted that read- ing rooms will soon become highly automated. Multiple image-specific AI tools will integrate with PACS and electronic medical records, extract- ing information in seconds and gen- erating summaries of prior studies. Radiologists will have a wealth of information at their fingertips in sec- onds, she said. 'Real time alerts, triage, and prioritisation of unread exams is happening now. AI tools are advising which physicians need to be con- tacted immediately, what follow-up is needed, and whether it occurs. AI will standardize BI-RADS reports, do real-time coding, and embed guide- lines into reports.’ AI tools may also Looking back on two decades of education, collaboration and innovation perform control functions, such as performing drift monitoring tasks and audits for transparency. ‘AI fails in ways that we don’t expect’ ‘I believe that the biggest impact AI will have will be automating tasks, not performing activities that will replace radiologists,’ Dr Retson emphasized. ‘AI tools will promote patient centered care, empower radi- ologists to focus on complex imag- ing and cases by liberating them from tedious, time-consuming tasks, and improve workflow efficiency.’ However, vigilance remains crucial: ‘Human oversight is essential. AI must balance key concepts to augment clinical care. AI tools must be sub- jected to rigorous quality control. AI fails in ways that we don’t expect. No system is perfect. AI hallucinations are real,’ she warned. Special Report: Cynthia E. Keen m o c . e b o d a . k c o t s – f f o k n e d o r o G © References: 1. Parikh JR, Drake AR, Rula EY, et al. “Radiologist Turnover in the United States.” J Am Coll Radiol. 2026 Feb 25:S1546-1440(26)00031-1.; https://doi. org/10.1016/j.jacr.2026.01.009 2. Brady AP, Paulo G, Brkljacic B, et. al. “Current status of radiologist staffing, education and training in the 27 EU Member States.” Insights Imaging. 2025 Mar 15;16:59.; https://doi.org/10.1186/s13244-025- 01925-7 Nancy Pham, MD, is an Assistant Professor in neuroimaging and neurointervention at Stanford Medicine in Stanford, CA. Radiology of Tara Retson, MD, PhD, is an Assistant Professor of Radiology at UC San Diego Health. Her research focuses on deep learning applications in medical imaging. ESOR at 20: building a common language for European radiology Past and present leaders of the European School of Radiology (ESOR) reflected on the evolu- tion of radiology education in Europe and the challenges fac- ing the specialty at ECR 2026 to mark the 20th anniversary of the school. Established in 2006, ESOR was created at a time when radiology education across Europe remained highly heterogeneous, with major differences in access to subspecial- ty training, research opportunities, and international mobility. Twenty years later, the school has grown into a broad educational network spanning Europe and beyond. Harmonising education across and beyond Europe For Prof. Nicholas Gourtsoyiannis, founder and former Scientific and Educational Director of ESOR, the school was initially conceived as a response to the need for a more harmonised educational structure within European radiology. ‘ESOR was the fulfilment of a com- mon European dream towards radiological education,’ he recalled during the anniversary discussion at ECR. This international dimension was also highlighted by Prof. Valérie Vilgrain, former Scientific and Educational Director of ESOR, who described the diversity of back- grounds and medical cultures with- in the school as one of its greatest strengths. ‘We work with radiologists not only from Europe, but all over the world,’ she said. ‘This is very different from one country to another, and it is so rich to work with people with a different environment.’ Going digital after Covid Vilgrain also reflected on the impact of the Covid-19 pandemic, which accelerated the development of online learning and hybrid formats, changes that have since become a permanent part of the school’s activities. ‘Now ESOR is probably stronger because we have faced that,’ she noted, explaining how the crisis pushed the organisation to reassess priorities and educational struc- tures. Among the initiatives developed during that period were the online foundation courses covering major radiology subspecialties, which significantly broadened access to high-level radiology education. Prof. Christian Löwe, current Scientific and Educational Director of ESOR, described the combina- tion of online education and onsite interaction as one of the key evo- lutions of the school over recent years. ‘Many things can be done better face to face,’ he said, while acknowl- edging the role digital learning now plays in improving accessibility and international participation. Growing collaborations Partnerships also emerged as a central theme throughout the inter- views. ESOR today collaborates with national radiological societies, academic institutions, subspecialty organisations, and industry part- ners to support fellowships, schol- arships, and educational initiatives. For Löwe, maintaining educational standards increasingly depends on this collaborative approach. ‘We really believe that we can achieve harmonised excellence in education only through partner- ship,’ he explained during a sepa- rate interview focused on coopera- tion between academia and indus- try. The discussions further reflected the broader technological transfor- mation affecting radiology itself. Artificial intelligence, advanced imaging technologies, and data-driv- en medicine are reshaping clinical practice while creating new educa- tional demands for radiologists. of Fulvio Renoldi Bracco, CEO of Bracco Imaging, highlighted the importance collaboration between industry and the medical community as innovation acceler- ates. ‘Without a strong partnership with the physician community, that would not be possible,’ he said. Looking ahead, ESOR’s leadership outlined several priorities for the coming years, including expanding fellowship opportunities, strength- ening cooperation with radiolog- ically under-resourced countries, and developing new educational formats adapted to radiologists at different stages of their careers. Twenty years after its creation, ESOR reflects the broader evolu- tion of radiology itself – a spe- cialty increasingly defined by con- tinuous education, international collaboration, and technological adaptation. By Mélisande Rouger EUROPEAN HOSPITAL Vol 35 Issue 2/26
R A D I O L O G Y ECR 2026 imagines the future of the field Enhanced by AI, but guided by humans: Radiology’s vision for 2050 5 s d n e r h e B / E i H imaging without Diagnostic actual images, but with sleek and shiny scanners; no more radiology and pathology depart- ments, but virtual patient models and AI-enhanced surgical pre- cision: At this year's European Congress of Radiology (ECR) in Vienna, two leading experts envisioned 2050 as a radically different future of medicine – less Grey's Anatomy, more Star Trek. They made it clear that the real question is not whether this future will arrive, but who will be there to shape it. Prof. Regina Beets-Tan and Prof. Pedro Gouveia made their case on the ECR main stage – not through a conventional lecture, but in dia- logue with an AI avatar. And even though the setting was decidedly futuristic, and the tone was gener- ally light-hearted, the underlying issue was clear: radiologists today have to make sure that the technol- ogy of tomorrow will be implement- ed in a way that amplifies their own strengths and benefits their patients. Digital insights to guide real-world actions Beets-Tan – Chairwoman of the Department of Radiology at The Netherlands Cancer Institute in Amsterdam and former ECR Congress President – envisions a discipline transformed at its core. The radiol- ogist of 2050 no longer produces images. Working from raw data, AI reconstructs the patient as a fully navigable three-dimensional model – organs, tumours, lymph nodes visi- ble from every angle, at every depth. ‘Scrolling through images is a thing of the past. We don't look at images. We explore the patients.’ This fundamental change will see radiologists assuming a new role, which Beets-Tan described as “medical information specialist”, interpreting the imaging data, but also managing information from pathology, lab, from endoscopy – all fused by AI into one integrat- ed report. ‘There are no separate departments anymore,’ predicted the expert. ‘We have merged into one big medical information lab, with advanced imaging and lab systems and massive computing power, all in the same place.’ A platinum portal into a not-too-distant future Central to this data-driven vision is the digital twin: a continuously updated virtual patient model inte- grating imaging, genomics, pathol- ogy, lifestyle data, and real-time monitoring. Unlike a static dataset, it learns and adapts – simulating how a patient might respond to different treatments, running out- come scenarios, and identifying the pathway that maximises benefit and minimises harm. Illustrating the imaging suite of the future, the experts presented a sleek, platinum-coated MRI sys- tem – a far cry from the bulky, claustrophobia-inducing machines of the past. With body weight and composition measured seamlessly on entry, and vital signs mon- itored continuously throughout, these scanners essentially become AI-powered digital twin factories. Too futuristic to be feasible? Beets- Tan pondered: ‘I was so lucky to start from conventional imaging and see the evolution into the cur- rent scanners. That was maybe 30 years ago – can you imagine that radiology will stay the same?’ Surgery reinvented: Simulation, pre- cision, and the surgical sixth sense As breast surgeon, Prof. Gouveia from the Champalimaud Foundation in Lisbon offered a different per- spective on these developments: Using a patient’s digital twin enables thorough rehearsal of an operation, he ventured, while an AI performs thousands of surgical simulations to optimise the procedure for safety and outcomes: ‘No more surprises.’ the OR In itself, AI-stabilised smart scalpels respond to tissue in real time – ultrasonically guid- ed, temperature-sensitive, adjust- ing their behaviour based on what they encounter. ‘Just like having a surgical sixth sense,’ the expert described. This advanced instru- ment could further be controlled via a neural interface, allowing the surgeon to activate the scalpel via brain signals instead of tapping for foot pedals. Sounds like more far- fetched science fiction? Driven as much by the gaming industry as by medicine, Gouveia predicted that this type of surgery ‘will come in the near future’. In the 2050 scenario outlined on the ECR stage, surgical training is digi- tally overhauled as well: ‘Cadavers are out – immersive simulation is Enhancing patient safety through efficiency MedicinesComplete significantly minimises research time, and our streamlined access ensures that actionable guidance is instantly available at your fingertips. Research indicates that accessing digital resources through a centralised platform can be up to 21% faster than traditional methods.¹ By centralising access to essential resources, health professionals can reduce the risk of information fatigue and ensure they are always working with the most current, peer-reviewed evidence.² References 1. Westbrook JI, Coiera EW, Gosling AS (2025) Do online information retrieval systems help experienced clinicians answer clinical questions? Available at: https:// pubmed.ncbi.nlm.nih.gov/15684126/. Last accessed: 27 February 2026. 2. Wolfstadt JI, Gurwitz JH, Field TS, Lee M, Mickle T, Kapoor A, et al (2028). The effect of computerized physician order entry with clinical decision support on adverse drug events: a systematic review. Available at: https://pubmed.ncbi.nlm.nih.gov/18373151/. Last accessed: 27 February 2026. Get in touch to start your trial here Available through For more information and to contact us go to PharmaceuticalPress.com What will MRI scanners look like in 2050? At ECR, Prof. Regina Beets-Tan and Prof. Pedro Gouveia envisioned bold changes for radiology. in,’ Gouveia said. Using full-sensory virtual reality with real-time feed- back, haptics, error tracking, and gamification elements, acquiring surgery skills will be more efficient, he predicted, and – in keeping with the tongue-in-cheek tone of the ses- sion – added: ‘Don't worry – we'll still teach them compassion.’ Using technology to make medicine more human again These aspects of humanity and empathy were at the core of the session’s final segment. The ques- tion on the table: what would this high-tech, AI-powered future mean for the individual radiologist? ‘I can assure you, you're not only going to supervise algorithms,’ Beets-Tan stated. Instead, she envisioned her 2050 colleagues to assume the role of “clinical orchestrators”, coordi- nating the insights gathered across the different specialties and creat- ing a harmonised patient journey. But instead of treating patients as a collection of data points, the new technology might even make med- icine more compassionate again, Gouveia pointed out: ‘Currently we already have some problems with keeping being human while we are talking with our patients in appointment rooms. I do spend a lot of time looking into a small screen, typing on a keyboard, and the patient is looking at me.’ Using an AI assistant to prepare relevant data and take over documentation could enable a more dignified doc- tor-patient communication. This aspect of human benefit should serve as guiding principle when adopting new technology, Beets-Tan advised: ‘Do not accept everything. Always ask the AI innovators: how will that improve the workflow that I'm already in?’ She urged her colleagues to take an active part in shaping this evolution to ensure that the future of healthcare is driven by human choices, not technology. While many medical professionals perceive the increasing competence of AI as a threat, Gouveia drew a striking analogy to dissuade that fear: ‘Do you expect to run faster than your car? Obviously not. So you have to really see it as a tool, to help you.’ Used correctly, he argued, AI could be the solution, absorbing the administrative bur- den and restoring an increasingly rare commodity in modern medi- cine: the doctor's time and atten- tion. ‘We need AI to amplify our work,’ he concluded, ‘because our patients need better diagnostics and better treatments. That's the most important thing.’ The Royal College of Pharmacy’s Knowledge Business PharmaceuticalPress.com Article: Wolfgang Behrends www.healthcare-in-europe.com
6 R A D I O L O G Y /W O M E N ' S H E A LT H Choosing the right modality for expectant mothers Abdominal imaging in pregnancy: Balancing diagnostic accuracy with fetal safety Imaging pregnant women with acute abdominal pain remains a significant clinical challenge – not only because of concerns about the impact on the unborn child, but also due to the ana- tomical changes that can obscure diagnosis. At the European Congress of Radiology (ECR) in Vienna, radiologists Vikas Shah and Charis Bourgioti examined the protocols for safe imaging in pregnancy and the manage- ment of abdominal emergencies in expectant mothers. Diagnosing acute abdominal pain in pregnant women is fraught with diffi- culty, explained Vikas Shah, a consult- ant radiologist at University Hospitals of Leicester NHS Trust. 'Many of the normal findings of pregnancy overlap with those features that you find in acute inflammatory disorders such as tachycardia, making a clinical diag- nosis difficult,' he said. 'As the uterus enlarges, there is also displacement and compression of normal anatom- ic structures.' Even when imaging is clearly needed, uncertainty can cause hold-ups, Shah warned: 'There can also be some delays because of hesitancy in knowing how to per- form a study or perhaps lack of local protocols or pathways. Such delays ultimately lead to harm.' Weighing up the imaging options In his ECR presentation, Shah explained that diagnosing acute abdominal pain in pregnant women is fraught with difficulty. While ultrasound is widely availa- ble and low-cost, Shah noted that anatomical changes in pregnancy make it 'very difficult particularly in the second and third trimesters.' CT, though commonly used for abdom- inal emergencies, raises concerns about radiation and contrast expo- sure. Magnetic resonance imag- ing (MRI), however, offers what Shah described as 'the best of both worlds' – radiation-free, multi-pla- Advertorial nar cross-sectional imaging with high sensitivity and specificity. 'It has a high sensitivity and specificity and high inter-observer concord- ance, which means radiologists of varying level of experience can reliably report MRI studies,' he said. Shah discussed the use of 1.5T scanners without intravenous or oral contrast, highlighting the ben- efits of diffusion-weighted imaging (DWI) for detecting inflammatory change and Fast Spin Echo (FSE) T2 sequences for identifying anatomy, masses, and oedema. The critical importance of timely diagnosis Appendicitis is the most common non-obstetric surgical emergency in pregnancy, affecting 1 in 1,500 pregnancies. Shah warned that uncomplicated appendicitis in early pregnancy can lead to fetal loss rates of up to 2% – a figure that rises with diagnostic delay. 'That shows the importance of imaging in both accuracy and time- liness. We need to get the diagnosis right because a negative appendec- tomy will increase fetal loss rate,' he said. 'We also need to scan on time because a delay in making a diagnosis will lead to perforation, abscess formation, and an increase in the fetal loss rate.' Beyond appendicitis, Shah outlined the role of imaging in identifying renal masses, non-haemorrhagic adrenal infarction, ovarian hyper- stimulation, ectopic and heterotopic pregnancies, and fibroid degenera- tion. He stressed that DWI has par- ticular value in leading clinicians to potential abnormalities. 'It is important to use a standard imaging protocols for all cases. The aim is to think beyond the appendix and review other organs carefully. A prompt diagnosis is very important in preventing fetal loss,' he said. Optimising protocols for safe imaging Charis Bourgioti, Assistant Professor of Radiology at the National and Kapodistrian University of Athens, addressed the optimisation of imaging protocols in pregnancy, covering CT and MRI safety issues for mother and fetus, and indi- cations and contraindications for contrast agents. She emphasised the need to con- sider medical, psychological, and legal-ethical dimensions: 'The diag- nostic work-up should be restricted as a general rule to those methods that do not endanger fetal health, and only absolutely necessary radi- ological interventions are justified, especially during the first trimester.' While ultrasound and MRI remain the preferred modalities due to the absence of ionising radiation, Bourgioti maintained that all imag- ing modalities can be used 'if it is clinically indicated'. However, she cautioned that persistent confusion over safety 'results in unnecessary avoidance of useful diagnostic tests.' Balancing benefit and risk Sonography has no known adverse effects on the developing fetus and serves as a primary screening tool, while MRI provides excel- lent soft-tissue contrast. Pregnant patients can be safely imaged at field strengths of up to 3T, though 1.5T is preferred – especially in the first trimester. Bourgioti advised that ionising radi- ation is best avoided in pregnancy, with CT reserved for situations where ultrasound or MRI cannot provide the required information. The use of contrast agents should be limited, she said, as 'their effects on the human embryo or fetus are incompletely understood', and gadolinium should only be admin- istered 'if the potential benefit exceeds the potential risk.' ) 0 . 4 Y B C C ( 4 2 0 2 e n O S O L P , . l a t e Y h s a r a B , D n i k s a R , H n a m f u B Magnetic resonance imaging of a 36-year-old, 32-week pregnant patient who presented with right lower quadrant pain. Coronal fat saturated T2 weighted image showing a distended retrocecal appendix (arrow), a position which makes it difficult to demonstrate on ultrasonography. These findings are consistent with acute appendicitis, which was also confirmed on surgery and pathology. She also noted that, according to new recommendations, abdominal shielding offers limited benefit, as most of the fetal dose comes from internal scatter. References: By Mark Nicholls Dr Vikas Shah Dr Charis Bourgioti Dr Charis Bourgioti is Assistant Professor of Radiology at the National and Kapodistrian University of Athens, Aretaieion Hospital, Greece. She specializes in women's imaging and obstetrical MRI, with a particular focus on placental and maternal pathology. Dr Vikas Shah is a UK-based consultant radiologist at University Hospitals of Leicester NHS Trust, and managing editor of Radiopaedia. He specialises in abdominal, emergency and post- mortem imaging. He is an Honorary Associate Professor at the University of Leicester and the Undergraduate Radiology Lead for the Leicester Medical School. MEDTRON AG presents Syriflow® MR: the syringe pump for MR imaging MEDTRON AG, one of the lead- ing European manufacturers of con- trast media injectors and medical technology “Made in Germany,” is expanding its product portfolio with a groundbreaking innovation: With Syriflow® MR, the company introduc- es a new syringe pump specifically designed for use in MR imaging. With Syriflow® MR, MEDTRON responds to an urgent need in modern intensive care, anaesthesia, and radiology: “We are well aware of the heavy demands in patient care – especially in intensive care units, where every second counts and maximum precision is essen- tial,” says MEDTRON CEO Markus Bappert. “Our new syringe pump for MRI has been designed to sig- nificantly ease the workload of doc- tors, care staff, and technical teams.” Direct placement at the MRI saves time and reduces risks Unlike conventional infusion sys- tems, Syriflow® MR can be placed directly at the MRI (up to 3 Tesla) thanks to its fully non-magnetic design. Long infusion lines and cumbersome workarounds are no longer necessary – this saves time, minimizes the risk of unintentional bolus delivery, and ensures uninter- rupted medication administration, particularly for high-risk patients, e.g. in intensive care. Ensures smooth operation Radiologists benefit from uninterrupt- ed operation: With Syriflow® MR, complex shielding boxes or expen- sive special solutions are unneces- sary – the pump can be seamlessly integrated into existing workflows. Flexible solution for a wide range of applications From precise sedation of new- borns in pediatrics to reliable infu- sion management in anaesthesia: Syriflow® MR covers a broad range of applications. Care staff and radi- ology technologists can operate the pump directly at the scanner with- out additional protective measures or complex training. The intuitive user interface is deliberately mod- eled on established infusion sys- tems – ensuring a smooth start in daily clinical practice. Economical and easy to maintain For hospital management, Syriflow® MR offers clear economic bene- fits: Compatibility with standard syringes prevents follow-up costs for manufacturer-specific consum- ables. At the same time, the robust “Made in Germany” design reduces maintenance and repair require- ments. Technical staff benefit from straightforward servicing and relia- ble performance without the risk of magnetic attraction (up to 3 Tesla). For more information: www.medtron.com/en/syriflow-mr EUROPEAN HOSPITAL Vol 35 Issue 2/26
W O M E N ' S H E A LT H Experts call for joined-up NHS services Reshaping women’s healthcare – from postcode lottery to personalised pathways 7 T T E H © Fragmented care pathways, per- sistent data gaps and a ‘post- code lottery’ of services contin- ue to undermine the quality of healthcare for women across the United Kingdom. At the HETT25 conference in London, a panel of experts from primary and sec- ondary care, research, femtech and digital health innovation dis- cussed how integrated care mod- els and digital tools can reshape outcomes – and why the emerg- ing women’s health hubs may offer a blueprint for the future. Panel chair Dr MaryAnn Ferreux, Chief Medical Officer of Health Innovation Kent Surrey Sussex, said it was important to listen to women when designing new care path- ways. The session – entitled ‘How Innovative, Integrated Care Models Can Reshape Women’s Health Outcomes’ – focused on integrated care pathways and the use of digital resources to enable access to screen- ing and early intervention, particu- larly for underserved populations. GP Dr Aamena Salar from the Modality Partnership in Birmingham painted a stark picture of what women currently experience. ‘They are passed from pillar to post, from primary to secondary care, in a very un-personalised pathway and feel they are not being heard by health- care professionals, or dismissed,’ she said. ‘Watching women through the life course is very limited, we are very much under pressure to see, treat and discharge – that is not what women want.’ Jayprit Serai, an Executive MBA graduate from the University of Cambridge, noted that women often have to ‘repeat themselves over and over again to different physicians’ and that there is a stigma around some treatments. ‘The biggest need is for disaggregated data; we are not understanding that need and are in a big black hole when it comes to women’s health,’ she said. IT systems that fail to disaggregate Femtech consultant Katherine Church echoed these concerns, pointing out that IT health systems often do not enable disaggregation of data. Without such data, understanding the true scale and nature of women’s health needs remains impossible. Amber Vodegel, founder of the Pregnancy+ app and now lead- ing the new 28X Private Period™ app, highlighted the importance of ensuring women have free and safe access to trusted healthcare infor- mation. She stressed the need for platforms that help women learn how to ask doctors the right ques- tions, rather than turning to social media for medical advice. With Pregnancy+ used by 70% of first-time mothers in the UK and two million women a day globally on the platform, Vodegel said there was a need to pitch information at different reading levels to make it more accessible. A postcode lottery of services There was hope that the work of women’s health hubs across the UK would be continued into the new neighbourhood health servic- es unveiled by the government in July as part of its 10 Year Health Plan aimed at bringing care closer to home. However, panellists want- ed to see improved collaboration between primary and secondary care and voluntary organisations, and for health authorities to bet- ter share data, best practice and integrate systems, rather than each being ‘left to their own devices.’ Church said her experience of work- ing with Integrated Care Systems (ICS) was that many were 'doing the same thing but in a slightly dif- ferent way.' She cited an example of one authority offering meno- pause information in nine different languages – an initiative that could be shared, replicated and nuanced to meet local need. 'Every ICS has different population needs but core things should be standardised.' She also pointed out also examples of a 'postcode lottery' where regions offer different services. Upskilled GPs keeping women out of hospital Fragmented provision is frustrating for clinicians as well as patients and often sees women turning up to emergency departments with pain and bleeding because they were not getting support elsewhere. Asked whether there are better ways to address waiting times for women with gynaecological issues, Salar pointed to an initiative in her area where 15,000 women a year are seen by upskilled GPs and nurses, with 90% of women now treated in the community rather than referred to hospital. She also pointed to her team’s research on ovarian cancer pathways showing that women from ethnic minority backgrounds were not coming for- ward soon enough, often present- ing with Stage 4 cancer. ‘Getting under the data’ to reach marginalised groups Ferreux underlined the importance Sex-based prognosis in advanced solid tumour trials Women more likely to survive cancer but suffer more severe side effects Women are more likely to sur- vive cancer than men but face a higher risk of serious and adverse side effects from treat- ment, according to a new inter- national study. Published in JNCI, the research identified consistent differences between male and female can- cer patients in both survival and treatment toxicity. Female patients had a 21% lower risk of death compared with male patients, yet a 12% higher risk of severe tox- icities – findings that held across 12 advanced solid tumour types and multiple treatment modalities including chemotherapy, targeted therapies and immunotherapy. Rather than focusing on how specific cancer treatments affect men and women differently, the study looked at whether sex itself predicts survival and toxic- ity, regardless of treatment type. Lead author Dr Natansh Modi said the study provides some of the clearest evidence yet that biolog- ical sex is a key predictor of out- comes in cancer care. ‘Sex is a fundamental biological factor that influences immune function, drug metabolism, body composition and tumour biology,’ Dr Modi said. ‘Yet despite longstanding recommenda- tions from regulatory and funding bodies to report outcomes by sex, it is still treated as an afterthought in many trials and is rarely factored into baseline risk or used to per- sonalise treatment decisions. ‘The results were clear: women had a 21% lower risk of death compared to men, but they also faced a 12% higher risk of severe side effects. Women demonstrated a survival advantage, but at the cost of increased severe toxicity.’ The study analysed data from more than 20,000 cancer patients across 39 clinical trials supporting US FDA approvals between 2011 and 2021, and spanned 12 advanced solid tumour types, including lung, colorectal, melanoma, and breast cancers. Researchers are now calling for biological sex to be recognised as a core prognostic factor in oncology. ‘This is about improving outcomes for every cancer patient,’ Dr Modi said. ‘If women are living longer but experiencing more severe side effects, we need to acknowledge that and respond to it. At the same time, we need to better understand why male patients appear to have poorer survival.’ Further research is needed to understand the biological mech- anisms driving these differences, including drug exposure, immune regulation, hormonal influences and body composition. Source: Adelaide University www.healthcare-in-europe.com The women’s health expert panel at HETT25: MaryAnn Ferreux, Aamena Salar, Amber Vodegel, Katherine Church, Jayprit Serai, and Sanhita Chakrabati. of disaggregated data to understand who is missing from the data, and putting action plans in place to address that. ‘We need to get under the data to see what is happening and make sure underserved and marginalised groups have the same care as everybody else,’ she added. That not only included obstetrics and gynaecology – which has the largest waiting list for procedures – but also mental health and cardi- ovascular health, which remains the biggest cause of death in women. Huge opportunities in the 10 Year Health Plan Asked what needs to be done over the next five to ten years, panellists felt the 10 Year Health Plan offered ‘huge opportunities’ but underlined the need to nuance models for local needs. A critical point was in women knowing what is available and where to get help. A further element was integrating with the wider community to work with local authorities and the vol- untary sector and ‘empower women to learn about their bodies and understand their presentations.’ Vodegel said there was a need to think differently about care models, having realised that a lot of basic education about pregnancy and women’s health was not standard knowledge, such as not drinking alcohol when pregnant. Sanhita Chakrabarti, an obstetric gynaecologist, public health con- sultant and deputy chief medical officer at Bedfordshire, Luton and Milton Keynes ICB, told delegates: ‘What women are telling us loud and clear is that they want com- passionate provision which is close to home that listens to them at the time that they need their support.’ By Mark Nicholls Dr Aamena Salar is Medical Director of Modality Outpatient Services and a GP partner at Modality Partnership in Birmingham, United Kingdom. She specialises in women’s health with an extended role in gynaecology and has piloted community gynaecology services. She is a member of the national championing women’s health and is setting up the Modality Training Academy. taskforce Jayprit Serai is a strategic Global Regulatory Affairs professional, United Kingdom. She recently completed an Executive MBA from Cambridge Judge Business School, where her individual project focused on closing the women’s health gap. She has extensive experience in the pharmaceutical industry. Amber Vodegel is CEO of 28X Ltd, United Kingdom. She founded Pregnancy+, which became the world’s leading pregnancy app with over 150 million users globally. She is now spearheading 28X, a privacy-first women’s health platform that runs entirely on-device, removing the need for cloud servers or data harvesting. MaryAnn Ferreux is Chief Medical Officer at Health Innovation Kent Surrey Sussex and a Non-Executive Director for Kent and Medway NHS Partnership Trust, United Kingdom. She is an award-winning medical leader with over 20 years’ experience in Australia and the UK, specialising in digital innovation, clinical transformation and population health. public Sanhita Chakrabarti is an obstetric gynaecologist, health consultant and deputy chief medical officer at Bedfordshire, Luton and Milton Keynes ICB, Bedfordshire Hospitals NHS Foundation Trust, United Kingdom. She is the ICB’s women’s health champion and was recently appointed as national speciality adviser for women’s health for NHS England. Katherine Church is a former NHS chief digital officer and an independent femtech consultant, United Kingdom. She works with women’s health founders to create technology that serves the needs of women.
8 L A B O R AT O R Y Avoiding mistakes in design, equipment, validation, and operation Laboratory cleanliness: Breaking the hidden chain of contamination errors Microbiological cleanliness in laboratories demands far more than routine disinfection – it requires a comprehensive con- tamination control strategy from the very first design stage. At the Labs Expo trade fair in Poznan, Poland, industry experts Jerzy Kustra and Piotr Caban outlined the most common mistakes organisations make and how to avoid them. 'Microbiological cleanliness does not begin with disinfection alone, but with the entire contamina- tion control strategy,' said Kustra, CEO of Cleanproject, a Warsaw- based company specialising in cleanrooms and controlled envi- ronments. 'It starts at the design stage, continues through the cor- rect selection of equipment, HVAC (heating, ventilation and air condi- tioning), personnel, clothing and material flows, and must then be maintained through validation, monitoring, training and disci- plined day-to-day operation.' In his presentation, Kustra stressed that contamination risks are typ- ically not the result of one glar- ing error. 'In practice, the biggest problems do not come from one dramatic failure, but from a chain of small mistakes made across design, installation, cleaning, qualification and human behaviour,' he said. A clean zone, he explained, should always be designed around the process, not the other way around. 'The required cleanliness class, microbiological risk, people and material movements, cleaning rou- tines, gowning, servicing access and qualification strategy must all be defined from the beginning in the URS – User Requirements Specification – and then reflected consistently in the project and in operational procedures.' t c e j o r p n a e l C © Advertorial When the foundations are flawed Avoiding mistakes requires what Kustra described as a 'holistic Contamination Control Strategy' – especially important in GMP (good manufacturing practice) environ- ments, 'where microbiological contamination may directly affect product quality, patient safety and research credibility.' These mistakes, he noted, often arise from 'starting too late with the right assumptions.' 'If the URS is weak or incomplete,' he continued, 'the whole project suffers later: wrong zoning, poor people and material flows, insufficient servicing access, underdefined procedures, and equipment that does not truly fit the process.' Further errors can stem from selecting equipment, furniture, gar- ments or routine accessories with- out verifying their suitability for the intended clean class and pro- cess. Inadequate cleaning systems, poorly selected tools, insufficiently trained staff, weak gowning dis- cipline and a lack of structured hygiene plans also contribute. 'In clean zones, "cleaning" is really a controlled process of removing invisible contamination, not simply making surfaces look clean,' Kustra said. Treating cleanliness as a lifecycle issue Cleanproject's contamination con- trol specialist Dr Piotr Caban – who has a particular focus on GMP Annex 1, the rules governing medicinal products in the European Union – outlined practical steps to overcome these challenges. 'The most effective way is to treat microbiological cleanliness as a life- cycle issue. It begins with a well-de- veloped URS based on the real pro- cess, applicable standards and risk level,' he said. 'Then the project, equipment selection, installation, training, qualification and service must all follow the same logic.' deviations and difficulty maintain- ing required cleanroom conditions. 'In more critical environments, this can lead to contamination, batch rejection, invalid research results, regulatory issues and potential risks to health and safety.' A formal contamination control framework is essential, Caban explained. 'This includes defined zoning, flows, gowning rules, clean- ing and disinfection plans, envi- ronmental monitoring, acceptance criteria, documentation, CAPA and continuous improvement.' He emphasised that equipment must be properly qualified, cleaning sys- tems correctly selected, and per- sonnel trained in a structured and repeatable way. 'The human factor is critical, and training is one of the most effective ways to improve stability and compliance,' he added. Direct consequences for patient safety Such processes are particularly important for the healthcare sector. 'The stakes are exceptionally high because microbiological cleanliness is directly connected with patient safety,' Caban said. 'In GMP envi- ronments, contamination may com- promise sterility, product quality and treatment outcomes. This is why strict regulatory requirements apply, and why we at Cleanproject place strong emphasis on fully understanding and implementing GMP Annex 1 requirements in real operational environments.' Beyond healthcare, similar princi- ples apply in industries such as elec- tronics, aerospace and advanced manufacturing. If mistakes are not addressed, Caban warned, the result can be unstable processes, higher operating costs, repeated 'Cleanroom performance,' he con- cluded, 'is never guaranteed by design alone. Even the best facility will fail without proper operation, maintenance and trained personnel. That is why investment in compe- tence and awareness is as impor- tant as investment in technology. By Mark Nicholls Jerzy Kustra and cleanrooms Jerzy Kustra is CEO of Cleanproject, a Warsaw-based company specialising in controlled environments. He has been involved in clean technologies since the early 2000s and has led several clean construction projects, particularly within the space industry sector. Dr Piotr Caban is a contamination control specialist at Cleanproject with over 20 years' experience in cleanroom technologies. He in contamination control and cleanroom operation, with a particular focus on GMP Annex 1 requirements. specialises Early Detection of Invasive Fungal Infections: The β-D-Glucan Test on the LIMUSAVE MT-7500 Invasive fungal diseases are a growing global health challenge. Immunocompromised patients, those in intensive care, and indi- viduals with chronic conditions – particularly lung disease – are at highest risk. These infections are notoriously difficult to diag- nose, yet early detection is crit- ical: delayed treatment signifi- cantly worsens patient outcomes. Traditional methods such as histo- logical analysis and fungal cultures often lack the sensitivity required for timely diagnosis. A Biomarker Hidden in the Cell Wall (13)-β-D-glucan is a structural component of the cell wall of most pathogenic fungi. During active infection, small but detect- able quantities are released into the bloodstream. This makes it a highly specific biomarker for inva- sive mycosis – and the basis of the FUJIFILM Wako β-Glucan Test. The test uses Limulus Amebocyte Lysate (LAL), an extract derived from the blood cells of horseshoe crabs, which reacts selectively with (13)-β-D-glucan. To ensure spec- ificity, the sample is pretreated at 70°C for ten minutes with a solu- tion containing a non-ionic deter- gent and polymyxin B. This step inactivates endotoxin and neutralis- es inhibitory proteins that might otherwise interfere with the result. The pretreated sample is then mixed with the LAL solution, where (13)-β-D-glucan activates Factor G and triggers a cascade reaction. The resulting turbidity change is measured as a transmittance shift, and the time taken to reach a defined threshold – the gelation time (Tg) – is used to calculate the exact glucan concentration from a standard curve. The assay is quan- titative, with a measurement range of 6 to 600 pg/mL and a clinical cut-off value of 7 pg/mL. European Validated Clinical Performance Multiple research groups have published data on the FUJIFILM Wako β-Glucan Test, confirming strong diagnostic per- formance both as a standalone assay and combined with other diagnostic tools. The test is suited for integration into clinical routine, supporting clinicians in making timely and evidence-based treat- ment decisions. Designed for the Clinical Laboratory The LIMUSAVE MT-7500 is the dedicated analyser for the β-Glu- can Test. Compact in size and straightforward to operate, it is built around a simple touchscreen interface and supports random-ac- cess testing. Up to ten samples can be processed simultaneously – expandable to 30 with option- al extension modules. Calibration and patient identification are both handled via barcode scan, mini- mising manual input and potential transcription errors. Results can be printed directly or transferred to a Laboratory Information System (LIS). The reagents are ready to use and supplied as single-test assays, reducing preparation time and the risk of cross-contamination. Quality control materials are available, and within-run precision is excellent, with a maximum coefficient of variation (CV) of 6.6 %. Maximum measurement time is 90 minutes. The FUJIFILM Wako β-Glucan Test on the LIMUSAVE MT-7500 offers laboratories a reliable, sensitive, and workflow-friendly solution for the early diagnosis of invasive fungal infections – at a point in the clinical course where timely intervention can make a decisive difference. EUROPEAN HOSPITAL Vol 35 Issue 2/2026
9 m o c . e b o d a . k c o t s – y l f r e t t u b n e e r g © process from the start of an idea, covers issues of intellectual prop- erty, commercialisation assessment and negotiating licences. 'That is the environment in which I prac- tice – one which encourages inno- vation and is not afraid of working with industry,' he added. Collaborative pathology The expert then outlined the var- ious institutions the university has developed under his lead- ership to advance computational pathology and their key benefits. These focused on the creation of the Division of Computational Pathology & the Computational Pathology and AI Center of Excellence (CPACE); a Digital Pathology Research Center (DPRC); and Office of Collaborative Pathology (OCP). He also pointed Informatics; to the establishment of the AI Data Commons (ADC) Alliance to create a large image and data repository for collaboration with a range of global partners. The various sectors of the Division of Computational Pathology nur- ture talented individuals, support innovation and create an environ- ment to stimulate AIPs, develop and deploy AI tools, and lead AI studies which all help future- proof the department. The DPRC supports internal research and col- laboration with industry partners, vendors and labs, while the OCP streamlines engagement with AIPs and has worked with nearly 40 companies in its first year. By Mark Nicholls L A B O R AT O R Y Computational pathology: Building bridges between labs and business For academia, specifically, they stimulate innovation and transla- tion with a shared risk and path- ways to commercialise products. They are also a way to expand funding opportunities, broaden faculty and trainee experiences, and strengthen institutional repu- tation and competitive advantage. He gave the example of Pittsburgh medical centre securing $10 mil- lion of investment from partnering with information technology firm Leidos over an AI disease detection project. At the other end of the spectrum, industry benefits from working with pathology labs and academ- ia through access to novel tech- nologies, knowledge, and cut- ting-edge science, as well as to experts and a talented pipeline of trainees. 'It is an ethical way for companies to get access to data, get work published, and is a cost- effective way to conduct research. But there are risks associated with it,' Pantanowitz said. These risks can include conflicts of interest, concerns about under- mining academic standards, threats to academic freedom and integrity, a risk of bad publicity when things do not turn out as planned, as well as erosion of trust and arguments over intellectual property and data ownership. Therefore, the expert underlined the importance of dis- closure and conflict of interest at all stages, especially over finance. noted, but in his opinion, the ben- efits outweigh the risks. 'A lot of pathologists do not like working with industry, but I think that is an old-fashioned approach,' he said. 'I encourage faculty and trainees to be entrepreneurial.' Such steps can help them file patents, be part of new AI start- ups, and translate their research into real-world solutions as they take them from the lab to the marketplace. 'A culture of inno- vation is important; it enhances a department's reputation, attracts funding and strategic partnerships, and encourages problem-driven research.' Entrepreneurship encouraged Academia and industry often have different priorities, Pantanowitz Pantanowitz explained that the University of Pittsburgh has an innovation office that handles this Academic-industry partnerships are playing a crucial role in advancing computational pathol- ogy. At the Digital Pathology and AI Congress: Europe in London in December, Liron Pantanowitz outlined the benefits and risks of such collaborations – and why he believes the advantages outweigh the potential pitfalls. Leadership lessons Pantanowitz, who is Professor and Chair of Pathology at the University of Pittsburgh, discussed these academic-industry partner- ships (AIPs) in a keynote speech titled 'Computational Pathology as a Strategic Asset: Leadership Lessons from the Frontlines'. He also presented the creation of a Computational Pathology divi- sion at the university in 2024 and how his Office of Collaborative Pathology serves as a new model for innovation. While he noted that the advent of electronic health records and digi- tal slides make healthcare a 'perfect environment' for AI applications, he said that concerns remain about security, transparency, explaina- bility, reimbursement, regulatory aspects and liability – such as who is responsible when AI makes an error – as well as questions over informed patient consent when AI is involved in care. 'Computational pathology is absolutely essential to every pathology lab and practice but we still do not have guidelines on how to validate AI in clinical practice,' he added. A perfect opportunity for industry AIPs in pathology are important for academic medical centres such as Pittsburgh in encouraging inno- vation and helping get products through regulatory processes. 'Such partnerships are a perfect opportunity for industry to come to medical centres, test their products and get feedback and for training of AI algorithms,' Pantanowitz said. Dr Liron Pantanowitz Dr Liron Pantanowitz is the Maud Menten Professor and Chair of the Department of Pathology at the University of Pittsburgh Medical Center (UPMC) and founder of the university’s Division of Computational Pathology & Informatics. He joined UPMC/Pitt in 2010 as Vice Chair for Pathology Informatics and Director of Cytopathology before moving to the University of Michigan in 2020 as a Professor in the Department of Pathology and Director of Anatomical Pathology. He returned to Pittsburgh in 2023 to Chair the Department of Pathology at UPMC/Pitt. www.healthcare-in-europe.com
1 0 O N C O L O G Y Experts explore often-overlooked patient group in oncology A rising tide: cancer in young adults For a young adult, a cancer diagnosis hits different: a more aggressive disease course, great- er disruptive potential, longer survivorship. Yet most healthcare institutions seem poorly pre- pared for this growing patient group. A plenary session at the National Comprehensive Cancer Network (NCCN) 2026 Annual Conference examined one of the most striking shifts in modern oncology: the rising incidence of cancer in adolescents and young adults (AYA) – a clinically and psychosocially distinct group in need of a dedicated, multidisci- plinary response. Chaired by Dr Christopher H. Lieu, a gastrointestinal medical oncologist at the University of Colorado Anschutz Cancer Center and Vice-Chair of the NCCN Board of Directors, the session brought together Dr Leidy L. Isenalumhe, medical director of the malig- nant haematology programme at Moffitt Cancer Center; Dr Larissa Nekhlyudov, primary care phy- sician at Brigham and Women's Hospital and cancer survivorship physician at Dana-Farber Cancer Institute and professor of medi- cine at Harvard Medical School; Anjali Albanese, social worker at Fox Chase Cancer Center; and Stephanie Samolovitch, founder of Young Adult Survivors United and a 20-year survivor of acute lymph- oblastic leukaemia. A shifting epidemiological landscape Dr Lieu opened with epidemio- logical data that set the tone for the discussion. Drawing on recent analyses of cancer incidence and mortality in individuals aged 20 to 49, he highlighted significant rises across breast, gynaecological, gastrointestinal, and genitourinary cancers. , The sharpest increases are concentrated in the 30–39 age group, and evidence of a birth cohort effect suggests that young- er adults are carrying an elevated cancer risk forward as they age. While these studies focused on the United States, the expert noted, these trends on early-onset cancer reflect a worldwide problem. Most strikingly, colorectal cancer has now become the leading cause of cancer-related death in patients under the age of 50 – a threshold that, until recently, had been pro- jected for 2030 but has already been reached. Different biology, different challenges Exploring the causes for this rise in early-onset cancers, Dr Isenalumhe acknowledged that several factors contribute to this trend. Dietary shifts towards ultra-processed foods, rising obesity rates, and environmental exposures are all implicated, though she stressed that no single factor is sufficient. Crucially, she pointed out distinct changes in tumour biology for AYA patients: ‘Triple-negative breast cancer, melanoma, acute lymph- oblastic leukaemia (ALL) – the genetic mutations that we see in this population are higher risk.’ Treatment tolerability also dif- fers, with AYA patients reacting to chemotherapy with more intense and prolonged neuropathy. These issues are further com- pounded by a diagnostic aware- ness gap that persists at the point of first contact. Dr Isenalumhe noted that many of her patients had been seen by three or four cli- nicians before receiving a correct diagnosis, frequently having been told that they were “too young to have cancer”. This delay in diag- nosis allows the tumours to pick up additional mutations, resulting in higher aggressiveness. Better education at medical school and residency level, she argued, com- bined with dedicated research into the biological mechanisms driv- ing early-onset disease, would be essential to improving outcomes for this population. Falling between the cracks Dr Larissa Nekhlyudov brought a dual perspective as both a primary care physician and a survivorship specialist. She emphasised the role m o c . e b o d a . k c o t s – F k c a J © “Too young to have cancer”? Patients under 50 often find themselves out of place in a system built for older adults. of primary care in closing this awareness gap. She urged clini- cians to maintain a broad differen- tial diagnosis when young patients present with persistent symptoms such as rectal bleeding, abdomi- nal pain, unexplained fatigue, or weight loss: ‘You can't just dismiss it. It can't be haemorrhoids for a year.’ She also highlighted the importance of family history and genetic risk assessment as tools that can prompt earlier, more tar- geted investigation. A cancer diagnosis at 25 or 35 lands at a unique moment in life. Anjali Albanese pointed out the vulnerability of AYA patients: ‘That disruption happens during a life stage where independence is so important, where they're develop- ing their sense of identity, where future planning is such a big part’ – graduation, marriage, maybe starting a family of their own. Cancer changes all of that almost instantly: ‘These people now are thinking, "Do I live to see six months from now?”’ She stressed that meeting these patients' needs requires active outreach to provide them with age-appropriate infor- mation and help them sort out the emotional chaos that a diagnosis brings: ‘It's not their job to come to where we are. We need to figure out how to be where they are.’ Samolovitch highlighted oncofer- tility as one of the most time-sen- sitive and consistently mishandled aspects of AYA care. The urgency of treatment – entirely justified clinically – leaves little room for patients to process questions about family plans they may not yet have fully formed. Diagnosed at 19 and alone in hospital over a weekend, she recalled the oncologist men- tioning the risk of infertility as a passing remark before chemother- apy began two days later. ‘I was like, I don't even know if I'm going to be a mom. So, whatever.’ It was only afterwards, she reflected, that many patients come to understand what was not addressed – or, depending on one's perspective, what was taken from them. Her message to clinicians was direct: anticipate this, and go further. If there is a risk, ask whether it matters to the patient; if they are unsure, keep the conversation open. Dr Nekhlyudov reinforced the point from a survivorship perspec- tive, noting that preferences evolve – a patient who expresses no inter- est in having children at diagnosis may feel very differently a decade or more later. Survivorship: a commitment spanning decades As the experts noted, survivor- ship takes on an entirely different dimension when the time after treatment may span not just ten, but potentially 50 years: In addi- tion to fertility planning, long-term treatment toxicities may profound- ly impact the functional lives of AYA patients, potentially derail- ing their careers. Dr Nekhlyudov therefore argued that survivorship planning must begin at diagnosis, encompassing monitoring for long- term side-effects, reintegration into primary care, and sustained psy- chosocial support. She urged her colleagues to not only focus on attacking the cancer, but also to consider how a given treatment might affect their patients for many years into their lives. However, providing such informed counselling presupposes a body z t u h c s n A U C © Christopher H. Lieu, MD Christopher H. Lieu, MD, is Professor of Medicine and Co-Director of GI Medical Oncology, University of Colorado Anschutz Cancer Center; Associate Director for Clinical Research, University of Colorado School of Medicine. Dr Lieu's research focuses on targeted and immunotherapies for colorectal and GI malignancies, with a particular interest in young-onset colorectal cancer and RAS/BRAF-mutated disease. He serves on the FDA Oncologic Drugs Advisory Committee and the NCCN Board of Directors. r e t n e C r e c n a C e s a h C x o F © Anjali Albanese, MSW, LSW, OSW-C Anjali Albanese, MSW, LSW, OSW-C, is an Oncology Social Worker at Fox Chase Cancer Center, Philadelphia. Ms Albanese specialises in psychosocial support for young adult cancer patients and co-leads the centre's AYA programme, including peer support groups and young adult mixer events designed to reduce isolation and build community among patients. r e t n e C r e c n a C t t i f f o M © Leidy L. Isenalumhe, MD, MS Leidy L. Isenalumhe, MD, MS, is Clinical Medical Director of Malignant Haematology at Moffitt Cancer Center and Research Institute and Co-Medical Director for the Inpatient/ Outpatient service (IPOP). Trained in both paediatric and adult oncology (med-peds), Dr Isenalumhe special- ises in aggressive lymphomas and acute lymphoblastic leukaemia, with a research focus on disparities in the AYA population. of scientific evidence that often does not exist yet. The expert cautioned: ‘They could develop physical effects of their treatment – chemotherapy-related treatment, radiation-induced treatment. We're now using a lot more targeted ther- apy, immunotherapy, but we don't really know what the long-term effects of these regimens will be. It's important that we continue to monitor and to study that.’ The session made a compelling case that AYA oncology has out- grown its status as a subspecialty footnote. Like geriatric oncology before it, the experts argued, AYA cancer care is ready to be recog- nised as a field in its own right – an established discipline with its own evidence base, guidelines, and clinical infrastructure. The biological distinctiveness of ear- ly-onset tumours, the psychosocial complexity of a cancer diagnosis at life's most formative stage, and the decades-long survivorship horizon that follows all demand dedicat- ed research, dedicated training, and dedicated care pathways. The NCCN AYA oncology guidelines are a foundation; what the panel called for, with unmistakable urgency, is the institutional will to build on them. Article: Wolfgang Behrends r e b r a F - a n a D © Larissa Nekhlyudov, MD, MPH Larissa Nekhlyudov, MD, MPH, is Professor of Medicine at Harvard Medical School; practicing primary care physician at Brigham and Women's Hospital; Clinical Director, Internal Medicine for Cancer Survivors at the Dana-Farber Cancer Institute. Dr Nekhlyudov's clinical and research expertise centres on cancer survivorship care and the interplay between primary and oncology care across the full care continuum. U S A Y © Stephanie Samolovitch, MSW Stephanie Samolovitch, MSW, is Founder and Executive Director of Young Adult Survivors United (YASU) as well as an ALL survivor. Ms Samolovitch built a regional young adult cancer community in Western Pennsylvania before launching YASU in 2020, a national organisation pro- viding emotional, social, and financial support to young adults with cancer aged 18–45. She serves as the patient advocate on the NCCN AYA Oncology Guideline Panel. 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O N C O L O G Y 1 1 Gene-editing: from lab to patient Gene-editing technologies show great promise for medical treat- ments and research, with the potential to cure thousands of genetic diseases. At the 2025 World Medical Innovation Forum in Boston, leading experts explored the possibilities and challenges of these rapidly advancing tools. The case of Baby KJ Muldoon – an infant treated with a personalised CRISPR therapy developed in just seven months – illustrates both the transformative power of gene editing and the collabo- rative effort required to bring it to patients. Gene-editing technologies repre- sent a sea change to gene thera- py and biomedical research. The potential of their clinical appli- cations is huge, spanning cancer, hematologic, metabolic, lung, car- diovascular, ocular, neuromuscular, and immunological diseases. 2025 has been an impressive year, with tremendous successes both in academia and industry in terms of developing gene editing drugs for patients. Gene-editing researchers and clinicians are treating rare met- abolic disorders, advancing thera- pies for advanced gastrointestinal cancer, improving CAR-T manufac- turing and targeting, developing cardiovascular disease treatments to reduce LDL cholesterol levels and to lower serum lipid levels, and eliminating viral DNA caus- ing infections. Additionally, major improvements have been made in CRISPR technology and a vari- ety of gene-editing tools. Specific noteworthy achievements include the first human base-edited med- icine and prime-edited medicine therapies. But the most impressive achieve- ment spanning 2024–2025 may be a seven-month-long, high-speed marathon to develop, manufacture, test, obtain FDA approval, and administer a personalised CRISPR gene-editing therapy delivered by lipid nanoparticles to an infant born with neonatal-onset CPS1 (carbamoyl-phosphate synthetase 1) deficiency, a rare, devastating, and potentially deadly genetic mutation affecting one in 1.3 mil- lion infants.1 An exemplary panel of pioneering leaders speaking at a session on gene editing at the 2025 World Medical Innovation Forum held in Boston attracted most of its 2,000+ attendees. The session primarily focused on the collabo- ration of many entities to save the life of Baby KJ Muldoon, and on the hopes and challenges of imple- menting this amazing technology for numerous genetic diseases. Base editing, prime editing, and CRISPR Base editing is a gene-editing tech- nique that directly converts an individual DNA base pair into a different base pair. It makes tar- geted, one-at-a-time changes to the sequence of a piece of DNA, act- ing like a pencil at the site of the mutation to “erase” a specific DNA letter and replace it with a differ- ent one. Prime editing can make insertions, deletions, and substi- tutions up to hundreds of base www.healthcare-in-europe.com Drs. Kiran Musunuru and Rebecca Ahrens-Nicklas, who led the personalized therapy, with Baby KJ. pairs long in the genome. Both techniques were developed in the lab of panellist David Liu, PhD, Professor at the Broad Institute and director of the Merkin Institute for Transformative Technologies in Healthcare in Cambridge, Massachusetts. CRISPR/Cas9 is a gene-editing technology that cuts DNA and harnesses natural DNA repair processes to precisely mod- ify and correct the gene or intro- duce an entirely new one. CRISPR/Cas9 consists of an enzyme that acts as “molecular scissors” to cut DNA at a location specified by a guide RNA, a type of ribonucleic acid that is an essen- tial molecule in cells. Base editing and prime editing can potentially address more than 90% of patho- genic variants in genetic diseases that collectively affect hundreds of millions of people worldwide.2 The goal is to develop therapies that can be safely and cost-effectively manufactured so that gene therapy use in future years will be as com- mon as taking prescription statin medication to lower cholesterol. Baby KJ: first human personalised gene-editing treatment recipient Panel moderator Ben P. Kleinstever, PhD, Associate Professor of Pa thology at Harvard Medical School and an associate investigator at the Center for Genomic Medicine (CGM) in Boston, and participants lauded the historic medical break- through that Baby KJ’s treatment represents: the first successful per- sonalized gene-editing treatment in a human.2 Baby KJ was born with CPS1 defi- ciency. CPS1 is an enzyme that catalyses the first step of the urea cycle, a process in the liver that converts ammonia from the break- down of proteins into urea. The urea is excreted by the kidneys to prevent a buildup of toxic ammo- nia. The CPS1 deficiency is caused by a genetic mutation and has an estimated mortality of 50%. ‘The most impressive fact from the Baby KJ story is that no new sci- ence had to be developed,’ said Dr. Liu. ‘The scope of work from incep- tion would ordinarily take seven years. However, what is impressive is that academic researchers, man- ufacturers, and regulatory agencies worked closely together. This is a remarkable testament to how robust some aspects of the gene editing enterprise for human ther- apeutics are.’ Omar Abudayyeh, PhD, Director of Gene Editing at the Mass General Brigham Gene and Cell Therapy Institute, said that going from con- cept to deployed drug in a person within six months is ‘incredible’, and shows that the systems are in place to do so. ‘To take this technology and get it to work as a therapy is very difficult,’ he said. ‘There is much complexity to make an actual drug product. A gene editing modality is not just a single thing you can inject into some- thing, and it will work. You have to figure out how to express protein components and the piece of guide RNA that targets the protein to get to the right place. Then you have to figure out how to package this together in a way that it will get to the right cell type, such as by using lipid nanoparticles.’ Steve Favaloro, chairman and CEO of Genezen, which develops meth- ods to formulate, manufacture drugs, perform quality control, and maintain the integrity and safety of drugs’ chemical substances, agrees. ‘The underlying science is impres- sive, but then we as CMC manufac- turers (Chemistry, Manufacturing, Steve Favaloro is chairman and CEO of Genezen, a gene and cell therapy Contract Development Manufacturing Organization (CDMO) focused on advancing gene and cell therapies through development and manu- facturing. The Indianapolis, Indiana- headquartered company partners from concept to commercial availabil- ity and scaling to produce life-saving gene and cell therapies. Trevor Martin, PhD, CEO and co- founder of Mammoth Biosciences, started the company with the mission to enable the next generation of ultra- compact CRISPR systems to develop potential long-term curative therapies for patients with life-threatening and debilitating diseases. These include a novel class of ultracompact systems designed to be more specific and ena- ble in vivo gene editing in difficult to reach tissues, utilising both nuclease applications and new editing modal- ities beyond double-stranded breaks. Laura Sepp-Lorenzino, PhD, is Scientific Advisor, Executive Vice President and former Chief Scientific Officer at Intellia Therapeutics. She is an At-Large Director of the American Society of Cell + Gene Therapy (ASGCT). A leader in drug discov- ery and development of small mole- cule and oligonucleotide therapeutics, Dr Sepp-Lorenzino's career has spanned over 30 years in academic and industrial settings. Omar Abudayyeh, PhD, is Director of Gene Editing at the Mass General Brigham Gene and Cell Therapy Institute, an Assistant Professor of Harvard Medical School, and a fac- ulty member of the Department of Stem Cell and Regenerative Biology at Harvard University. He is co-director of the Abudayyeh-Gootenberg Lab, which investigates programmable sys- tems in biology for the development of molecular tools, diagnostics, and therapeutics. a i h p l e d a l i h P f o l a t i p s o H s ' n e r d l i h C © and Control) are challenged with process development that will guarantee safety and repeatability.’ He added, ‘We are getting to a place where gene editing has standard manufacturing process- es that is enabling regulatory agencies to be more comfortable with their approvals. The speed of approval by the U.S. Food and Drug Administration (FDA) would not have been possible for Baby KJ’s treatment if it had not worked with these types of gene editing drugs from pioneers like Verve and Intellia Therapeutics.’ President at Sepp-Lorenzino, Laura PhD, Scientific Advisor and Executive Vice Intellia Therapeutics, a company develop- ing curative genome editing treat- ments, was Chief Science Officer during the time that the clini- cal-stage genome editing company was pioneering the development of novel, potentially curative med- icines using CRISPR-based tech- nologies. In June 2021, the com- pany made global headlines that David R. Liu, PhD, is the Thomas Dudley Cabot Professor of the Natural Sciences at Harvard University, Richard Merkin Professor and director of the Merkin Institute of Transformative Technologies in Healthcare, vice chair of the faculty at the Broad Institute of MIT and Harvard, and a Howard Hughes Medical Institute (HHMI) investigator. His major research inter- ests include the engineering, evolu- tion, and in vivo delivery of genome editing proteins such as base editors and prime editors to study and treat genetic diseases; the evolution of pro- teins with novel therapeutic poten- tial using phage-assisted continuous evolution (PACE); and the discovery of bioactive synthetic small molecules and synthetic polymers using DNA- templated organic synthesis and DNA- encoded libraries.
1 2 O N C O L O G Y The field of gene editing thera- py is moving at a very fast pace, with more than 20 clinical trials currently ongoing. The panellists believe that with a combination of breakthroughs in both research and manufacturing, and the adop- tion of platformization, the costs will be reduced and the feasibility of delivering gene editing therapy will increase. Gene editing tech- nologies are expected to work for most mutation types. Dr Liu hopes that this will motivate a change in investment to devel- op cures for mutational diseases. He pointed out: ‘About 50 million people are living with cancer. The global investment being made to cure cancer is about $10,000 per person per year. It’s about $500 per patient who has HIV/AIDS. Yet only $3 per year is being spent on diseases that affect 400 million people living with rare genetic mutations. We believe that gene editing in the next 5 to 10 years has the potential to be transforma- tional.’ Article: Cynthia E. Keen References: 1. ClinGen Clinical Genome Resource. Pediatric Summary Report. https://actionability.clinicalgenome.org/ac/ Pediatric/ui/stg2SummaryRpt?doc=AC1046 Accessed October 26, 2025. 2. Musunuru K, Granidette SA, Wang X, et al. Patient- Specific In Vivo Gene Editing to Treat a Rare Genetic Disease. N Engl J Med. 2025;392(22):2235-2243. https://doi.org/10.1056/nejmoa2504747 3. Brooks PJ, Ottinger EA, Portero D, et al. The Platform Vector Gene Therapies Project: Increasing the Efficiency of Adeno-Associated Virus Gene Therapy Clinical Trial Startup. Hum Gene Ther. 2020;31(19-20):1034–1042. https://doi.org/10.1089/ hum.2020.259 its CRISPR-based treatment was successfully implemented with the first six patients in the world who had a genetic nerve disorder. Platformization: A key to scalability Dr Sepp-Lorenzino emphasized that because robust precedents were in place, and because pre- clinical data existed to show the safety of gene editing therapy, the Baby KJ collaborators could utilise that. She advocates platformization – a concept where a standardized reproducible technology handles common elements and research- ers can rapidly swap in different therapeutic genes to target various diseases. Platform-based manufac- turing solutions are emerging as a key strategy to reduce R&D risk and cost and enable commercial scalability. ‘There are almost 7,500 known genetic diseases, of which over 4,500 are believed to be caused by a mutation in a single gene,’ commented Trevor Martin, PhD, co-founder and CEO of Mammoth Biosciences of Brisbane, California, a biotech company developing curative therapies based on its ultracompact CRISPR systems. ‘What’s gone largely under the radar is that the FDA has been moving forward with platform des- ignations that have the potential to really accelerate patient access to life-changing medicines.3 There is a lot of promise with gene editing because many of the same building blocks may be used for many of these monogenic muta- tions. This may make the develop- ment of gene editing treatments for smaller disease populations financially feasible and commer- cially scalable.’ Digital pathology m o c . e b o d a . k c o t s – e e y o p m E e v o L © l From single-tumour to pan-cancer AI diagnostics the way cancer Artificial intelligence is trans- forming is diagnosed and treated. Dr Yuri Tolkach, from the University Hospital Cologne in Germany, shared his group's advances in developing AI-based tools for oncological pathology at the 12th Digital Pathology and Artificial Intelligence Europe congress in London in December. tate cancer and tumour detection with good degrees of accuracy, but then switched to multi-segmenta- tion algorithms for colorectal can- cer with better results. 'Annotations are the major problem for colorec- tal cancer,' said Tolkach. 'It took us more than one year to prepare all annotations to train it but now there are different ways we can accelerate the annotations.' During his presentation, Tolkach explained how algorithms for pathology and oncology have evolved over the years – from basic diagnostic levels to more advanced prognostic and predictive models. This evolution now extends to harnessing the capabilities of large language models (LLMs) and mul- ti-modal reasoning with agentic AI integrated into clinical workflows. From years to days: accelerating annotation Four years ago, the Cologne group published its first findings on pros- This breakthrough has significant- ly reduced the annotation time – down to days in some instances – as the group developed a number of precise algorithms for different tumours such as prostate, lung and colorectal cancer. One algorithm for multiple cancers The latest phase of the research has seen a shift towards 'pan-tumor- al algorithms'. Tolkach said: 'The question was, why can't we develop one algorithm for more types of cancers; we have lung, colon and breast AI, but what if we applied these algorithms to another tumour type, why can't we develop one algorithm for all these cancers?' of algorithms and making effective large-scale analysis possible. Multi-modal models are also sup- porting prediction of relapse after cessation of immune checkpoint therapy in malignant melanoma, with mathematical modelling of tumour growth and evolution. 'When we extract all this infor- mation from tumour cells, we can create a model on our computers of tumour growth and see how that tumour grows,' he said. 'That intratumoral heterogeneity is so close to the real-world data.' By Mark Nicholls 'When we applied our five algo- rithms to different tumour types, we saw that the performance was so high to cervical cancers and other cancers and with the same segmentation accuracy.' While the importance of clinical validation cannot be underestimat- ed, the development of the fast- track principle of annotating has been a significant step forward. Extracting data and modelling tumour growth There is great potential for AI in diagnostic tasks, Tolkach explained, particularly with inter- observer variability and aggressiv- ity grading. Advanced algorithms are giving clinicians a very clear understanding of tumours from the outset, with LLMs extracting data from AI parameters for the training Dr Yuri Tolkach Dr Yuri Tolkach is Senior Attending Physician and Research Group Lead at the Institute of Pathology at University Hospital Cologne in Germany. His ‘Digital and computational pathology’ working group has research interests in diagnostic, prognostic, and pre- dictive tools for pathology/oncology, multi-modal data integration (molecu- lar characterisation), intratumoral het- erogeneity and cancer evolution, large language models and reasoning, and quality control in digital pathology. EUROPEAN HOSPITAL Vol 35 Issue 2/26