Healthcare Innovations & Clinical Trials
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Caitriona Walsh, Chair, IPHA Clinical Research Exchange Group Page 02
“Balancing scientific rigour with recruitment feasibility remains a challenge.”
Prof Gerry Hanna, Vice-Clinical Lead, Cancer Trials Ireland Page 04
Authorities who have a seat at the table need to respond to remediate these issues which are reducing the opportunities for patients to access the latest innovations.
~Dr Muriel O’Byrne, SVP International Regulatory Affairs & European Business Office Head, Regeneron Ireland
WE ARE DRIVING SCIENTIFIC BREAKTHROUGHS, INNOVATIONS AND INSIGHTS TO IMPROVE HEALTH AND WELLBEING.
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Caitriona Walsh Country President and Managing Director, Novartis Ireland & Chair, IPHA Clinical Research Exchange Group
Positive steps towards more clinical trials in Ireland
Including patients in clinical trials is critical in developing new, innovative treatments and improving the nation’s health.
By including patients in clinical trials, their health will improve substantially. Alongside the positive human health impact, clinical trials also enhance the value proposition for innovation in Ireland, with potential to secure future global investment in manufacturing and discovery activity against significant competition.
How Ireland is advancing clinical trials
Both IPHA and the HSE are of the view that Ireland can play a leading role in the provision of clinical trials in Europe, and in recent times, significant steps have been made in this regard. One such step was Ireland’s decision to join the European Clinical Research Infrastructure Network, which has the potential to widen access to clinical research networks in Europe.
Last year, IPHA and the HSE agreed on a standard Contract Research Organisation (model) Clinical Trial Agreement (CRO mCTA) for use between the Site, the CRO and the Sponsor. The key to the success of the CRO-mCTA is that its standardisation will speed up the process by reducing
the administrative and financial burden for the hospitals, CROs and companies. Also, in partnership with the HSE, IPHA launched the updated Bipartite Model Clinical Trial Agreement (CTA) for clinical trials, involving a commercial sponsor and a hospital(s), which supersedes all previous versions of the agreement.
Government backing for clinical trials
From a political level, last July, the Minister for Health established the National Clinical Trial Oversight Group (NCTOG). This group aims to do better for patients by doubling the number of clinical trials taking place in Ireland, and it has already shown a tangible commitment to an improved era for health research. This was followed by the inclusion in the Programme for Government of a commitment to increase the number of clinical trials and examine how to better support clinicians, researchers and support staff to focus on clinical trial activities.
These steps represent a win for all in the Irish healthcare ecosystem, but most significantly, they will increase the speed at which patients can access lifesaving interventions.
Benefits and features of the new clinical trials public portal
Clinical trials are essential to establish how well new treatments work and their safety. They are also important for patients to gain early access to new medicines.
Before they begin, clinical trials are approved by regulatory bodies and ethics committees. This is to ensure they are designed to answer a specific research question and that participants in clinical trials are optimally protected.
Clinical trial regulation in Ireland In Ireland, clinical trials for both medicines and medical devices are assessed and approved by the Health Products Regulatory Authority (HPRA) in collaboration with the National Research Ethics Committees (NREC). For medicines, the process is conducted using a single online platform known as the Clinical Trials Information System (CTIS).
Since 31 January 2025, all ongoing trials have been regulated by the new Clinical Trial Regulation (CTR), which replaced the Clinical Trials Directive (CTD). One benefit of the CTR for patients is the increased transparency of information mandated by the regulation. The CTIS platform also includes a public portal with searchable information for the public.
Clinical trial public portal functionality
The portal’s functionality was improved at the end of 2024. The accessibility of the clinical trial information was enhanced; it is now possible for members of the public to search for clinical trials that are running in Ireland and recruiting.
Users can also filter to search for clinical trials in a certain therapeutic indication and specific eligibility criteria such as gender or age group. If a clinical trial of interest is found, it is possible to view the ‘location and contact points’ to find out the location and Principal Investigators involved (usually a hospital consultant). The new interactive clinical trials map makes it even easier to search for clinical trials in a particular location.
Improving clinical trial accessibility for Irish patients
As of January 2025, 97 clinical trials are recruiting in Ireland, 45 of which relate to the therapeutic area of cancer. Other common therapeutic areas include cardiovascular diseases (10), and musculoskeletal diseases (four).
Clinical trials in Ireland are run in a wide range of hospitals and primary care settings, including Children’s Health Ireland hospitals, Cork University Hospital, St Vincent’s University Hospital and University Hospital Waterford. It is hoped that CTIS’s new features will help improve the accessibility of clinical trials for patients in Ireland.
Advancing science to medicine amid regulatory uncertainty
With an approach driven by science, leading biotechnology company Regeneron proudly invents, develops and commercialises medicines for people with serious diseases. Founded in 1988 and led by physician-scientists, it expanded internationally in 2013 by opening its European Business office in Dublin, acquiring a site in Raheen, Co. Limerick one year later, which has since been transformed into a major bioprocessing campus.
Digital health to transform clinical trials
Muriel O’Byrne, SVP of International Regulatory Affairs, discusses how innovative approaches are improving clinical trial outcomes: “Clinical trial execution continues to evolve significantly, thanks to the potential of advancements like digital health technologies and AI. We are keenly interested in the implementation of AI-driven predictive modelling to enhance patient recruitment, optimise trial design and improve data analysis efficiency while advancements in genetic and biomarkerbased approaches are forming the backbone of personalised medicine.”
The biotech company’s unique ability to repeatedly translate science into medicine has led to a wide array of approved treatments and products, most of which were homegrown in their laboratories. Conducting clinical research in around 50 countries globally, Regeneron leads clinical trials across a vast range of therapeutic areas, including ophthalmology, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, haematologic conditions, infectious diseases and rare diseases.
Legislation intended to enhance clinical trial applications needs improvements to better serve patients, says a biotechnology company committed to conducting trials in Europe.
view, with complex requirements, prolonged setup times and increased administrative burden. These ongoing regulatory hurdles are proving challenging. “Authorities who have a seat at the table need to respond to remediate these issues which are reducing the opportunities for patients to access the latest innovations,” she adds.
As a result of these regulatory changes, many sponsors are reconsidering their trial strategies, with some shifting their focus to non-EU regions with less bureaucratic regulatory landscapes. “Reports indicate that Europe is losing its share of large-scale clinical studies to Asia and the US, due to these heavy administrative processes and extended startup times. This is a concerning trend for the industry, but it is particularly concerning for patients across the EU who need access to innovative therapies,” she explains.
A continued dedication to patients
The biotech company’s unique ability to repeatedly translate science into medicine has led to a wide array of approved treatments and products.
Challenges posed by new EU clinical trial legislation
Thriving within the biotechnology sector in Europe is currently no easy feat, with the implementation of new clinical trial regulations creating serious hurdles and delays. “One example is the EU Clinical Trials Regulation, passed in 2014 and became fully operational this year, which was initially designed to streamline trial applications and position the EU as an attractive location for continued placement of clinical studies. Unfortunately, in its implementation, it has fallen short of its primary objectives,” says O’Byrne.
Although the application process has been streamlined, it is now resource-intensive from a sponsor’s point of
Despite the ongoing regulatory hurdles, Regeneron remains committed to investing in clinical trials in Ireland and Europe, actively engaging in strategies to address regulatory challenges and maintain its competitive edge.
“It is important that we stay nimble. We have excellent clinical research sites here in Ireland, with committed doctors and good patient access,” says O’Byrne.
“We have strong partnerships with major clinical research organisations and institutions and proactively engage to facilitate an attractive EU clinical research ecosystem.”
Ireland’s position as a biopharma innovation hub Ireland maintains a strong presence in the global biopharmaceutical sector, with a well-established research infrastructure and an extremely skilled workforce supporting ongoing clinical innovation, strengthening its position as a hub for research excellence, despite regulatory challenges.
Regeneron’s Limerick facility is one of the largest-scale biopharmaceutical production sites in Ireland, and it has been pivotal in the company’s production capacity for various therapies. The site has seen continuous investment and expansion, reflecting the company’s commitment to Ireland as a strategic location for its operations. Driven by the pursuit of scientific breakthroughs, it continues to ‘follow the science,’ seeking innovative solutions for people living with serious illnesses.
Date of Preparation: March 2025
Dr Muriel O’Byrne
SVP International Regulatory Affairs & European Business Office Head, Regeneron Ireland
Sponsored by Regeneron
Investment in clinical trials: the key to advancing cancer care in Ireland
Investment in clinical trials is vital for improving cancer research in Ireland. A centralised funding model can boost research, patient safety and innovation.
Arobust investment in clinical trial infrastructure is vital for advancing research and enhancing routine patient care. The current system in the HSE relies heavily on piecemeal funding, often supported by charities, for critical roles like clinical trial nurses, research staff and administrative personnel. This lack of permanent funding undermines job security and hinders the appeal of these roles, making it difficult to attract and retain talent.
Clinical trial support requirements
A fundamental, ongoing financial commitment to integrate clinical trial support into routine clinical care is crucial. Such investment is not merely about improving research outcomes. Embedding clinical trial staff into cancer clinics can significantly enhance patient safety and the quality of routine care. Research nurses, for example, often detect overlooked symptoms or treatment side effects, enabling quicker interventions.
International examples, such as the NHS in the UK, demonstrate the effectiveness of a centralised funding approach. The UK’s National Cancer Research Institute has successfully leveraged national investments to develop robust clinical trial infrastructures, attracting early-phase trials and fostering innovation.
Radiotherapy trials as an exemplar In Ireland, radiotherapy clinical trials exemplify the potential of strategic investment. A renewed focus, driven by Cancer Trials Ireland and initiatives like the Irish Radiation Research Oncology Group, has fuelled growth in this area. Investment in clinical fellows and new trial infrastructure at institutions like St. Luke’s has generated innovative, investigatorled projects. Clear, simplified trial designs that target broader patient populations have further contributed to success. However, balancing scientific rigour with recruitment feasibility remains a challenge, particularly for highly specific research questions.
Basic research
Efforts are underway to establish an allIreland translational radiation oncology network, uniting preclinical scientific groups across Ireland. This collaboration aims to strengthen laboratory research linked to clinical trials, focusing on blood tests to predict treatment responses and patient follow-ups. By combining fragmented research into a cohesive centre, Ireland could become a standout European hub for translational oncology, ensuring better integration of lab work and clinical practice while driving innovation in radiation research.
Digitally driven surgery support for lifesaving decision-making
By democratising expertise, digital surgery is revolutionising individualised care and advancing rapidly in the medical field.
While operations carry risks of complications, they can also provide life-saving treatment for injuries, cancer, cardiovascular issues and infectious or inflammatory diseases.
Tech-driven tailored surgery
Each surgery is unique, requiring tailored decisions and actions based on the patient and their condition. Expertise and experience are crucial, but digital surgery can enhance outcomes by analysing the operative scene together with personalised patient factors. Advances like minimally invasive ‘video’ surgery and robotic assistance improve precision while digital surgery can optimise decision-making — guiding the ‘decisions that make the incisions.’
Fluorescence angiography enhances surgery
One real example of where this is becoming widespread is the use of fluorescence angiography during major resectional operations. Here, a proven, safe and approved dye is introduced into the patient’s circulation. Specialised surgical cameras with built-in optical technology then make the dye visible, aiding precision at crucial time-points in the operation. The surgeon gets a real-time indicator of the microperfusion exactly of the area under operation at the exact moment it is needed. This technique effectively supports surgeons’ decisions and reduces some major complications in operations like those for colorectal (‘bowel’) cancer. Artificial intelligence (AI) is further capable of making this technology even more reliable.
Expanding smart surgery applications responsibly
There are numerous other applications that can help make for better decision-checking. Over time, guidance may include common operations like gall bladder and hernia surgery. As hospitals and society become increasingly smart-wired, the capability to generate, analyse and store data is building greatly; although, given the importance of surgery, its implementation here requires careful consideration, safeguards and responsibility, with patient and public interests as a priority.
The UCD Centre for Precision Surgery in Dublin is a leading, networked translational research and education centre that works widely with surgeons, technologists and engineers as well as legal and ethical experts nationally and internationally. With our base in the Mater Misericordiae University Hospital in Dublin and through collaborations like with the Royal College of Surgeons in Ireland, we work for better surgery through the development and deployment of intraoperative smart assistance for surgeons everywhere.
Professor Gerry Hanna Vice-Clinical Lead, Cancer Trials Ireland
Ronan Cahill Director, UCD Centre for Precision Surgery, Consultant General and Colorectal Surgeon, Mater Misericordiae University Hospital
New emergency trial status accelerates major trauma research
Major trauma is a leading cause of critical illness, often requiring intensive care, organ support and mechanical breathing support, with young adults disproportionately affected.
There is a growing need for effective pharmacological and non-pharmacological therapies which can reduce injury impact and improve recovery and patient outcomes following major trauma. Prof Alistair Nichol, Director of the Irish Critical Care-Clinical Trials Network (ICC-CTN), explains: “Trauma is a major cause of death, often affecting younger patients. Advancements in trauma care will provide huge benefits for families across Ireland.”
Improving treatments for critically ill patients
The ICC-CTN delivers a national portfolio of critical care trials seeking to identify treatments that can improve outcomes for critically ill patients, including trauma patients.
“A key focus of our research is on biological sampling. By examining markers in critically ill patients’ blood, we can predict injury severity and recovery, and identify therapeutic targets,” explains Prof Nichol. “These efforts, plus recent changes within the clinical trials landscape are some ways in which we are advancing research in this space.”
New emergency trial status
The new emergency trial status which came into force under the EU Clinical Trials Regulation, means greater access to research than ever before. “Prior to this new regulation, patients who were unconscious were often unable to participate in emergency medication research,
Clinical Research Centre instrumental in support of Ireland’s leading medical experts
RCSI Clinical Research Centre profiles leading investigators in gastroenterology and infectious disease, whose groundbreaking research is improving patient care and advancing therapeutic discoveries.
Instrumental in delivering the WHO Covid-19 Solidarity Trial in Ireland, Dr Eoghan de Barra leads multiple clinical trials and biobanks focused on emerging infectious diseases, antimicrobial resistance and novel therapeutic interventions for viral and bacterial infections.
Advancing infectious disease research
“My primary focus is expanding Ireland’s participation in large clinical trial platforms, improving access and building capacity,” Dr de Barra explains. “We’re building on post-Covid vaccine work, including mpox vaccination and surrogates of protection while working to integrate Ireland into global initiatives like the SNAP trial to advance immunological
but this change opens up new opportunities to advance trauma care for these patients.” Prof Nichol continues: “Our EPO-TRAUMA trial is aiming to enrol 2,500 mechanically ventilated ICU patients following unplanned major trauma and investigate the use of erythropoietin. Where family may not be immediately available to provide agreement to participate, the new regulations allow us to enrol more patients and provide this treatment early, under strict conditions.”
Patient and public involvement
Dr Kate Ainscough, Irish Critical Care-Clinical Trials Network Manager, says: “We know from patient and public involvement (PPI), our public survey and focus groups, that people are generally in support of alternative consent methods. Our PPI representatives have an important role in informing our research strategy, and their feedback improves our research process.”
One PPI representative explains: “My involvement in the PPI group makes it so much clearer to me how important it is to get patients involved in trials. I consider the recent changes for trials involving medicinal products a step forward in the right direction. The most important thing is for patients to be given the best available treatment at the appropriate time.” As part of global collaborative efforts, ICC-CTN partners with like-minded research centres on a national and European level to advance trauma care.
and therapeutics research in infectious diseases. All this can be achieved with partners in our new National Infectious Diseases Clinical Trial Network.”
Revolutionising gastroenterology research
Leading an active clinical and translational research programme focused on improving outcomes for patients with inflammatory bowel disease (IBD) and liver cirrhosis, Prof Karen Boland’s work is improving treatment response with an emphasis on associated lifestyle interventions.
“We’ve found, by measuring muscle mass in patients with IBD, that those with more muscle are more likely to respond to treatment,” Prof Boland explains. “Our work involves exploring
amino acid supplementation, exercise and dietary intervention in IBD and patients with cirrhosis; these data will have a big impact on validating these measures in clinical practice.”
With a large portfolio of work on IBD, Prof Boland also plays a key role in personalising therapeutic interventions. “Although we have treatments for patients with IBD, we don’t have a good understanding of which treatment is best for each patient,” she explains. “We are analysing samples to understand how the microbiome contributes to IBD to identify potential therapeutic targets.”
Clinical research support hub
The RCSI Clinical Research Centre (CRC) provides the facilities and expertise to enable investigators to conduct clinical research to the highest standards, supporting them across a spectrum of clinical areas.
“Having a research centre on-site means I can access clinical space for visits with my dietitian, secure storage for patient samples and administrative support for grants and contracts,” Prof Boland explains. “I don’t have protected research time. I have four kids and a busy workload; I lean on a lot of people around me. Without that additional support, this work wouldn’t be possible.”
Dr de Barra agrees: “As a researcher, you don’t have all the answers. It’s important to be able to reach out to experts, discuss challenges and collaborate.”
ImageprovidedbyRCSI
Prof Alistair Nichol Director of the Irish Critical Care-Clinical Trials Network, University College Dublin and Consultant Intensivist, St Vincent’s University Hospital
Dr Kate Ainscough Irish Critical CareClinical Trials Network Manager
Catherine Guinane Irish Critical Care Patient and Public Involvement Group (ICC-PPI) Representative
Dr Eoghan de Barra Consultant in Infectious Diseases at Beaumont Hospital and RCSI
Professor Karen Boland Consultant Gastroenterologist at Beaumont Hospital and RCSI Read
at iccctn.ie
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Sponsored by RCSI
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Bethany Cooper
WRITTEN BY Bethany Cooper
Process design solution company facilitates complex pharmaceutical production
Engineering consultancy supports the transition from initial research to large-scale manufacturing, delivering high-quality and sustainable technologies.
In medical research and pharmaceutical development, the transition from early-stage research to large-scale manufacturing is a key aspect of ensuring equitable access to innovative treatments and products.
Scaling up pharmaceutical manufacturing
While medical innovation and clinical trial evidence lay the groundwork for developing new therapeutic approaches, scaling up production while maintaining safety, efficacy and regulatory compliance can be challenging.
“The scale-up process is as important as it is complex, and the transition to industrial manufacturing requires extensive input,” explains Aine Dunne, Chief Executive Officer of Process Facilities Group International (PFGi).
“Our team, with backgrounds in research, development and scale-up, work closely with pharmaceutical and life science companies to streamline this process.”
Tailored engineering solutions
PFGi is an engineering consultancy specialising in design solutions for complex processes. They help to facilitate the transition from initial research to largescale manufacturing, supporting pharmaceutical companies, sustainable technology companies, contract research organisations and biotech firms to scale up their production.
“We don’t just size equipment; we collaborate with companies to develop entirely new processes or integrate innovations into existing facilities,” says Dunne. “We don’t expect the client to hand us a fully developed process.
Research delivering novel, patient-centric healthcare to Ireland
Ireland has a world-class research and innovation ecosystem, with strong interconnectivity between academia, industry, government and a highly engaged public that values research.
Ireland hosts leading industry hubs in medical devices, biopharma and technology, underpinned by cutting-edge national research centres, creating fertile ground for healthcare innovation.
Digital healthcare boosts patient empowerment
A key ask from the public through the Creating Our Future national conversation on research (2021) was for a person-centred approach to healthcare, enabled by digital and technological innovations, to promote patient empowerment and better care.
Research Ireland aims to deliver an intensification of interdisciplinary research and a more vibrant research base that showcases Ireland’s global reputation as a research and innovation leader. Our funded researchers are developing novel, patient-centric healthcare
Our collaborative development approach ensures that companies can adapt to the evolving demands of the industry while maintaining efficiency and regulatory compliance.”
With key services such as equipment selection, process mapping and batch manufacturing, the company actively engages in the developmental process, working alongside clients to refine and optimise their production procedures.
Global pharma manufacturing solutions
Working with life science companies globally to commercialise their manufacturing processes, PFGi has offices in Ireland, New Zealand, India, North America and South America. “We have worked with a number of companies in the US and Ireland, commercialising their small-scale laboratory process to reach a wider market,” explains Dunne. “As the industry adapts to develop more niche and high-cost biotech drugs, manufacturing is key. We help companies reduce costs and bring drugs to market faster, minimising capital outlay and providing expert guidance throughout each stage of the process.”
She adds: “Sustainability is a core aspect of engineering in commercial pharma, and our CRP [critical resource planning] and SRP [sustainable resource planning] experts can design efficient systems that minimise water usage, ensure energy systems are appropriately sized and consult on the use of alternative energy sources.” The company prioritises high-quality, safe and efficient design solutions while building lasting, trust-based client relationships for successful project outcomes.
approaches through the merging of data science with clinical science and technology development.
Remote healthcare and AI diagnostics
The Home Health project, led by researchers from the CÚRAM Research Ireland Centre for Medical Devices, together with Cisco and the people of Clare Island, is using technology to improve healthcare for this remote community. Digital technology has enabled remote monitoring of conditions and, combined with video consultations, has empowered the community to monitor their own conditions and engage with healthcare specialists where needed, improving management of patient care across the island.
The specific potential of AI in healthcare is vast. The Lero Research Ireland Centre for Software is collaborating with clinicians to commercialise a novel AI detection
The specific potential of AI in healthcare is vast.
solution for early-stage breast cancer, applying highly accurate machine learning-based technology to spot potential tumours.
Patients providing access to data
The ADAPT and FutureNeuro Research Ireland Centres are developing a novel patient data platform for clinical research in amyotrophic lateral sclerosis (ALS) that will harness AI to interrogate large, diverse data sets and inform development of new, patient-centric treatment approaches.
Such research advances would not be possible without the general public’s involvement, including patients providing access to their data. Public trust and confidence in healthcare research is critical for this. The EMPOWER consortium addresses this by developing a governance framework to ensure the safe use of health data in research.
Dr Siobhan Roche Director, Research for The Economy, Research Ireland
Aine Dunne Chief Executive Officer, Process Facilities Group International (PFGi)
To
Sponsored by Process Facilities Group (PFGi)
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Bethany Cooper
Making digital patient information work better
A leading healthcare expert highlights the need to break down digital barriers to help deliver better outcomes for patients.
Asignificant barrier to sharing healthcare data remains the different coding systems and terminologies used for patient records, says Cathy McCartan, Director of Dedalus Healthcare Ireland, a European healthcare software provider supporting clinical decision-making across Ireland. McCartan emphasises that standardising clinical terminology can enhance healthcare delivery and patient outcomes.
Terminology alignment
With Ireland set to introduce its Digital for Care 2030 plan, terminology alignment and standardised data models are going to play a “major role in its success,” says McCartan. McCartan’s company provides technology for scheduling, predicting health outcomes, managing electronic health records (EHR) and handling diagnostics and lab results, all while prioritising the patient at the core of the process.
Healthcare ecosystem
An important aspect is Dedalus’ Clinical Terminology Services, which provides an effective way of implementing and accessing terminologies and classifications such as SNOMET CT, LOINC and ICD. Clinicians often use a range of terms to describe orthopaedic procedures such as hip replacements, for example, which can be problematic when searching for information on similar topics. “This solution enables different terminologies and coding systems to be aligned so that all the information can be used in a way that enables the healthcare system to operate as an ecosystem,” explains McCartan.
Predictive clinical models
The company has developed its own AI and machine learning solutions to enhance healthcare outcomes, including 19 predictive clinical models used in 388 departments across European hospitals for conditions such as delirium, sepsis, pneumonia and deep vein thrombosis (DVT). Models also manage the flow of patients via natural language tools, support wound management and prioritise night shift tasks. All advancements are trained using European healthcare data and in line with the European AI Act.
Patient focus
Dedalus also supports the National PAS Programme and works with hospitals lacking digital tools, such as providing ordering solutions for lab and radiology test results. “We support healthcare organisations across the continuum of care with applications that follow patients across every stage,” McCartan concludes. “We strive to be a software company that keeps the interests of the patient in mind with everything we do.”
Healthcare Innovations
HPV vaccine innovation reduces pre-cancer cases
Recent modelling work has shown that Ireland is on target to eliminate cervical cancer as a public health problem by 2040.
Cathy
Executive Director, Dedalus Healthcare
Innovations in patient care, like HPV vaccination, are driving significant reductions in cervical pre-cancer cases, marking a new era in women’s health where cervical cancer can be eliminated as a public health problem.
Dr Lucy Jessop Director, National Immunisation Office and Consultant in Public Health Medicine
The introduction of the human papillomavirus (HPV) vaccine in Ireland represents a groundbreaking step in patient-centred care.
Launched in 2010, the programme prioritised early prevention by targeting girls before exposure to the HPV virus, which we know causes the majority of cervical cancers. Despite early challenges, such as vaccine hesitancy driven by misinformation, the programme has significantly reduced the burden of high-grade cervical changes, meaning fewer women require treatment for cervical cancer and pre-cancers.
Shift in screening outcomes
Recent data underscores the vaccine’s transformative effect. Between 2019 and 2022, high-grade cytology rates among vaccinated 25-year-old women dropped to 1.5%, compared to 3.7% in prior unvaccinated cohorts. This decline demonstrates how preventive innovations reduce invasive procedures, improving patient experiences and outcomes.
Addressing barriers to preventive care
The initial HPV vaccine catch-up campaign had variable vaccine uptake (44%–70%). Later, cohorts of girls in the first year of second-level school achieved over 80%, thanks to targeted
public health campaigns. Innovations in outreach, including patient advocacy and education, highlight how addressing misinformation can improve care delivery and public trust. The vaccine programme is now a universal programme offered to both boys and girls in first year, since 2019.
Cervical cancer elimination
Recent modelling work has shown that Ireland is on target to eliminate cervical cancer as a public health problem by 2040. This is due to the combination of high vaccine uptake and cervical screening along with high treatment rates for those identified with cervical pre-cancers and cancers.
Optimising public health strategies
HPV vaccination demonstrates how innovations in preventive care can transform patient outcomes, reducing the need for invasive treatments and optimising public health strategies. Ireland’s success provides a model for integrating vaccination with screening, indicating a future where cervical cancer prevention is more effective and patient-centred. By continuing to innovate, we can ensure that every woman benefits from these advancements, paving the way for a healthier future.
vaccine, visit immunisation.ie
Sponsored by Dedalus
Find out more at dedalus.ie
McCartan
Ireland
Transforming biopharma drug manufacturing through industry-led research
Biopharma is a cornerstone of Ireland’s economy, establishing the country as the EU’s leading net exporter of medicines.
In 2024, biopharma in Ireland produced approximately €100 billion worth of products, with indigenous companies accounting for approximately €3.0 billion of this total. This economic value highlights biopharma’s critical role in national infrastructure, including employment, facility construction, technology and social development.
Biopharma innovation and collaboration
Manufacturing biopharmaceutical products requires highly specialised techniques and analytical capabilities to keep pace with the evolving characteristics of novel drugs.
The sector must also meet numerous stringent regulatory requirements, increasing the need for bespoke technology and data analytics to support drug development, scale-up and lifecycle research.
The Pharmaceutical Manufacturing Technology Centre (PMTC), funded by Enterprise Ireland and IDA Ireland, drives innovation and applied research in the biopharma industry. It fosters collaboration between SMEs and MNCs, providing a platform to introduce, demonstrate and de-risk new technologies and services while showcasing indigenous capabilities and facilitating engagement with local and international partners.
Sustainability and innovation contributions
Central to the organisation’s success is commitment to biopharma community and industry practices, providing targeted solutions for real world needs. Looking ahead, PMTC’s next phase of development will focus on expanding productivity-oriented research for its growing
Understanding HPV: essential knowledge for cancer prevention
Raising awareness about human papillomavirus (HPV) is essential to reduce the prevalence and harm of HPV-related cancers and diseases, ensuring a healthier future for everyone.
In Ireland, over 190 people lose their lives annually because of HPV-related cancers.1 Despite its prevalence, awareness about HPV and its potential to cause various cancers remains low. Research by Ipsos MRBI for MSD Ireland in 2023 showed that a third of Irish people have ‘no awareness’ that vaccines may prevent certain cancers, and three-quarters of people (76%) think it is ‘unlikely’ that they have ever had HPV, despite its commonality.3
Prevalence of HPV-related cancers and diseases
Human papillomavirus (HPV) is a common virus primarily transmitted through intimate skin-to-skin contact, including vaginal, anal or
membership base. This includes enhancing the centre’s capabilities with the delivery of an integrated testbed, including LAB 5.0 for advanced characterisation.
Sustainability is a key focus. All research projects are designed with sustainability in mind, incorporating green processes and waste management solutions while exploring how digitalisation, AI and machine learning can address environmental challenges.
To support the industry’s evolving needs, PMTC has identified priority research areas including digitalisation, advanced data analytics, continuous manufacturing, process optimisation and talent development. In 2025, the centre’s core research will focus on cleaning optimisation; advanced manufacturing with continuous flow reactors; process intensification through digital twin technology; and the expansion of its FoReSight research programme on digitalisation and data analytics.
Digitally driven and research-enabled
As the biopharma sector seeks to integrate digitalisation and data analytics into decision-making, PMTC’s FoReSight research programme plays a pivotal role. A recent white paper, developed in collaboration with a consortium of MNCs and reviewed by the Health Products Regulatory Authority (HPRA), addressed the challenge of improving trust in data analytics for biopharma. Ongoing research aims to publish industry guidelines to harmonise the application of digitalisation and data analytics, paving the way for the adoption of technologies like AI in pharmaceutical manufacturing.
oral sex.4 While most HPV infections resolve on their own within two years, some can persist and lead to serious health issues, including cancers of the cervix, vulva, vagina, anus and penis.4 In Ireland, HPVassociated cancers account for nearly 3% of all invasive cancers, excluding non-melanoma skin cancer.1 This figure rises to 7% among young adults aged 20– 49 years.1 Anogenital warts, caused by HPV types 6 and 11, are another significant concern, with approximately 1,000 cases reported annually in Ireland.2
Cervical cancer elimination
The impact of HPV on cervical cancer is particularly significant, with 99% of cervical cancer cases
attributed to HPV.5 In Ireland alone, there are an estimated 250 new cases of cervical cancer diagnosed each year, resulting in around 80 deaths.1
The World Health Organization (WHO) launched a global initiative in 2020 to eliminate cervical cancer by focusing on prevention through HPV vaccination, screening and treatment of pre-cancerous lesions.6
Ireland has aligned with this global strategy by launching its Cervical Cancer Elimination Action Plan,7 setting a target to eliminate cervical cancer by 2040 by aiming to vaccinate 90% of girls by age 15, screen 80% of eligible individuals with an HPV test every five years and treat 97% of women with cervical disease within one year.7
Need to address remaining challenges
This ambitious plan represents a significant milestone, but challenges remain. Even though Ireland’s vaccination rate is relatively high compared to some other countries, 78.4% for the 2022/2023 academic year,8 the vaccination rate has been declining for the past three years8 and is still far from the 90% target outlined in the plan.7 It is crucial to expand HPV education and awareness, particularly among marginalised or harder-to-reach groups. By focusing on these communities, we can reduce the burden and harm of all HPV-related cancers and pave the way for a healthier future for Ireland.
Dr Rabah Mouras Research Centre Manager, PMTC
Damon Warnock Centre Director, PMTC
Sinead Tuite Vaccines Business Lead, MSD Ireland