Healthcare is evolving due to patient expectations, digital transformation and scientific research. New delivery models, such as personalised medicine through genomics, could enhance cost efficiencies, diagnoses and predictability in care.

By studying an individual’s complete set of genetic material (genome), researchers can determine why people have varying disease risks and why medicines affect them differently. With this information, the right therapeutic strategy can be tailored for the right person at the right time.

Moving Ireland’s genomic strategy forward

In 2022, the HSE published its National Strategy for Accelerating Genetic and Genomic Medicine in Ireland. However, research based on genomic data generated in Ireland is relatively underdeveloped, with factors contingent on its optimal delivery, such as access to personalised health information.

Impending regulations could be catalysers for change. The European Parliament recently passed a framework to enable cross-border sharing of digital health information, the European Health Data Space. Ireland’s Department of Health published its roadmap to implement a patient app and shared care records as part of ‘Digital for Care: A Digital Health Framework for Ireland 2024 – 2030.’

System and infrastructure changes are required nationally to drive the genomic strategy. With system overhauls already underway in several European countries to advance genomic innovation, local policymakers and researchers need only look to our neighbours for inspiration and collaboration opportunities.

Personalised medicine in practice

In Estonia, the passing of the Human Genes Research Act led to the establishment of a Genome Centre. The centre draws data from cancer registries, causes of death registries, electronic health records, health insurance funds, hospital databases and research projects. Over a 20+ year biobanking journey, 20% of Estonia’s adult population has now had their genetic material genotyped.

System and infrastructure changes are required nationally to drive the genomic strategy.

Analyses of gene variants in the genome have contributed to 830+ peer-reviewed papers, leading to advances in scientific research and early disease detection. Today, the Estonian Biobank boasts a 70%+ public approval rating.

Transitioning to a healthcare landscape tailored to individual needs

The European Genomic Data Infrastructure project, backed by €40 million in funding from the European Commission, brings together 54 partners from across 20 countries, including Ireland, to create technical capacity for accessing genomic data in Europe.

The new European Partnership for Personalised Medicine (EP PerMed), launched under Horizon Europe, has a budget of €375 million over 10 years. It aims to ensure that the long-term vision of personalised medicine is translated into roadmaps with funding and supporting activities.

Researchers in Ireland can leverage these well-funded European projects to draw on a wider pool of actionable genetic information. International collaboration in genomic research will be pivotal to the discovery of innovative treatments and, ultimately, enhance patient care.

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Irish life sciences facilities nationwide create jobs, impact capital expenditure and are a source of materials and services. Irish-based companies supplying the industry amplify this impact.

Home to 13 of the world’s top 15 pharma companies and 14 of the largest 15 medtech companies, Ireland is one of the world’s leading locations for life sciences. Employing about 100,000 people, the sector exports over €100 billion annually.

Advancing Ireland life sciences

From small molecule API to biologics and cell/gene therapy, Ireland’s biopharma industry is enabling more complex manufacturing and advanced therapeutics.

A €12 billion biologics investment has been secured over the past decade from leading companies. The National Institute for Bioprocessing Research and Training (NIBRT) is driving talent development, recently opening a new CONCEPT lab, providing state-of-the-art solutions for next-generation therapeutic research, including biologics, cell, gene and RNA therapies.

Technology driving competitiveness

Ireland boasts Europe’s highest number of medtech jobs per capita and a broad talent pool. This is borne out by continuous glucose monitoring manufacturers building new facilities in Galway and Kilkenny, highlighting Ireland’s technical capability enabling the transition towards connected, ‘smarter’ devices.

Launched in 2023, Digital Manufacturing Ireland (DMI) is helping manufacturers to adopt new technologies like AI, automation and digitalisation to optimise operations, transform value chains and drive competitiveness. DMI is also leading on the skills and training needs associated with the adoption of these advanced manufacturing technologies.

Ireland’s strategic investments

Foundations are strong, but the sector faces ongoing disruption. Accelerated by technology and geopolitical uncertainty, agility and resilience across manufacturing supply chains remain critical. AI and Industry 5.0 are potential game-changers for productivity, sustainable work practices and faster collaboration across the entire value chain, for both drug development and device innovation. Ireland is responding through investment in NIBRT and DMI.

IDA Ireland is supporting industry transformation through upskilling and talent development, R&D and sustainability incentives. Ireland’s talent pool and industry’s capacity to innovate, deliver and commercialise products in a dynamic global environment remain key success factors. Ireland offers a talented, innovative business environment focused on partnership for success. This, combined with Ireland’s stability, is critical to securing next-generation life sciences investment. 

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Medicines allow people to live longer, healthier lives. They prevent chronic illnesses, improve survival rates for many diseases, combat obesity and improve mental health.

Medicines bring additional health benefits by releasing other healthcare resources, which helps with hospital waiting lists and overcrowded GP clinics. However, for this to happen, a medicine needs to travel a long road — from bench to bedside.

Medicines R&D requirements

The research, development and approval process takes between 10 and 15 years, costing about €2.13 billion. For innovation and medicines development to flourish, predictability and stability within the biopharmaceutical research environment are required.

Central to this is intellectual property (IP) rights, which protect innovative companies’ investment and incentivise the development of new medicines. One such incentive is Regulatory Data Protection (RDP), currently the source of much debate arising from the European Commission’s proposal to cut the current baseline period of RDP from eight years to six years, with conditions on how to achieve the further two years.

RDP enables pharmaceutical innovation

Industry shares the goals of the European Commission, as outlined in the EU Pharmaceutical Legislative package, of providing equitable access to medicines throughout EU Member States while ensuring that Europe can be a world leader in medical innovation. However, cutting the period of RDP has the potential to cause a loss of competitiveness and lead to fewer new medicines being available to Europeans.

R&D is already leaving European shores. In the 1990s, half of all new treatments originated in Europe, that figure is now just one in five. In 2002, the US spent €2 billion more than Europe on pharmaceutical R&D. Today, the US is spending €25 billion more. This means fewer opportunities to participate in clinical trials; longer delays in accessing innovative medicines; and a loss of know-how.

Stable and appropriate RDP is key to long-term investment in medicines development. A robust and innovative EU pharmaceutical industry is essential for Europe’s ambitions to combat cancer, address public health challenges (like antimicrobial resistance and Alzheimer’s) and prepare for future pandemics.

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A report underscores the significant impact of the Covid-19 pandemic, escalating geopolitical tensions and increasing international competition, which collectively stress the need for Ireland to enhance its competitiveness

At the BioPharmaChem Ireland (BPCI) Impact 2024 Conference held in Cork, in May this year, Minister for Finance, Michael McGrath TD, was among the keynote speakers addressing an assembly of industry leaders and experts.

Unveiling sector policy priorities

The conference served as a platform for the biopharmachem sector to unveil its policy document, ‘Global Impact; The Importance of the Irish BioPharmaChem Industry.’ It delineates the key policy priorities for the Government, aiming to futureproof the sector.

The biopharmachem sector employs 80,000 people directly and indirectly, contributing €116 billion in exports annually. The sector has articulated its policy priorities across three pivotal areas: (1) talent and innovation; (2) sustainability support; and (3) collaboration.

Growth underscored by talent and innovation

Ireland’s biopharmachem sector thrives due to its highly skilled workforce, robust research ecosystem and favourable business environment. Leveraging the surplus in the National Training Fund to invest in digital, green, management and employability skills will be crucial for the sector’s resilience. This surplus offers a chance to support lifelong learning initiatives, addressing growing interest from employers.

Traditionally, the sector recruits PhD graduates, enabling Ireland to move up the value chain towards early-stage development and clinical manufacturing. To maintain this trajectory, investment in Higher Education Institutes (HEIs) is essential. This includes support for undergraduate education, innovative delivery models and state-of-the-art research infrastructure.

Infrastructure and support for sustainability

BPCI member companies annually report their environmental performance, akin to EPA requirements, in our Annual Responsible Care Report. The sector has improved energy efficiency, with a 0.4% decrease in energy consumption despite a 48.2% increase in production volume; companies are adopting cleaner technologies and energy-efficient practices, driving innovation and operational efficiency – but there is more to do.

The Government must develop a comprehensive national energy strategy, integrating renewable energy sources into the grid while enhancing financial and advisory supports for firms adopting sustainability best practices.

Strategic coordination through an ‘Office of Life Sciences’

Approximately 700 companies operate in Ireland’s biopharma, medtech and digital health sectors. These industries are converging through drug-device combination products, digital therapeutics and personalised medicines.

We’re advocating for the development of a national health technology and life sciences strategy. This strategy, spearheaded by the Department of Enterprise, Trade and Employment, should be adequately resourced for effective implementation. The proposed ‘Office of LifeSciences’ aims to adopt industrial policies that prioritise resources and promote clustering, enabling strategic cross-sectoral cooperation.

By addressing these strategic priorities, the sector seeks to maintain its leadership position and continue its vital contributions to the Irish and global economies.

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Dr Paul Leonard

Industry and Commercialisation Liaison, Life Sciences Institute, DCU

Robbie Sinnott

DCU Research Infrastructure Manager

A new life sciences institute at Dublin City University harnesses diverse expertise, cutting-edge facilities and the power of collaboration to tackle global health challenges.

Dublin City University’s (DCU) new Life Sciences Institute (LSI) brings together world-class multi-disciplinary expertise from across eight schools to deliver on its mission to ‘transform challenges into impact.’ The Institute tackles global challenges across health, therapeutics, agriculture, the environment and the bioeconomy.

Collaborative solutions for global challenges

LSI Director Professor Anne Parle-McDermott says the centre is a virtual entity that brings life science research activity together under a single umbrella. LSI researchers work with partners to identify and address “global challenges that really matter and impact all our lives.” It invites partners with scientific or industrial challenges to collaborate on developing solutions.

She explains: “Our approach is to work with industry, charities and state bodies to identify key challenges within health, food and the environment. “We build a team within and beyond LSI to brainstorm and design a solution-focused project. We involve stakeholders from day one to ensure our research is focused on real-world problems.”

Diverse scientific themes

The centre is working, for example, with Science Foundation Ireland and Teagasc on issues such as potato blight monitoring, while specialist cancer experts work with hospitals and pharmaceutical companies to advance knowledge in clinical areas.

Meanwhile, the expertise of immunologists, neuroscientists, biologists, chemists, physicists, psychologists, sports scientists and engineers focus on other challenges, providing a supportive, multi-disciplinary environment that allows innovation and creativity to flourish.

DCU’s LSI has three broad themes of health, biodetection and pure research, along with specific subgroups. “We are diverse and can bring a variety of expertise together to fit each challenge,” adds Prof Parle-McDermott. 

Innovative research for industry impact

LSI Industry and Commercialisation Liaison Lead, Dr Paul Leonard, says industry often has to work at a fast pace and, therefore, does not possess the extra resources or the time required to fully address some of its challenges. “We have a valuable resource in this new research institute and want to harness that to work with industry partners to find solutions that will then be taken into companies and commercialised. Our goal is to have impact via real-world implementation,” he says.

“But we don’t want industry to think they can only come to us when they have a problem; we also work together to enhance current processes or come up with something new.” Recently funded collaborations include nucleic acid therapeutics, novel therapies for chronic pain and improving protein production in cells used by the biopharma industry.

Our approach is to work with industry, charities
and state bodies to identify key challenges
within health, food and the environment.

World-class infrastructure

Dr Leonard emphasises that it is not possible to conduct world-class science without world-class infrastructure. “You can have great ideas,” he continues, “but if you do not have the equipment, facilities, ecosystem and structure around that, you cannot transform those ideas into innovations. That is where DCU Core Technologies comes in.”

It offers the LSI access to state-of-the-art equipment and resources needed to facilitate effective research. Research Infrastructure Manager Robbie Sinnott explains that the Core Technologies are supported by a multidisciplinary team of technical officers with expertise in microscopy, flow cytometry, cell culture, high-throughput screening, genomics, materials analysis and additive manufacturing.

Highest verifiable standards

The unit has over 50 high-end scientific systems to ensure LSI research outputs are of the highest verifiable standards. These instruments are available for use by all national and international academic researchers as well as industry and commercial entities.

One example system is the cutting-edge robotically controlled AUTOPILOT system, which can handle thousands of samples to increase the speed, reproducibility and complexity of the experiments that can be carried out. Sinnott also sees Core Technologies’ role as taking away the responsibility of equipment management from researchers or industry partners, enabling them to fully focus on research.

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Bioresorbable polymers are critical to patient care, enabling long-acting injectables that provide extended-release of medication. These help boost therapy compliance, enhance therapeutic efficacy and reduce dosing frequency requirements.

Ashland Viatel^TM bioresorbable polymers play a crucial role in the fabrication of degradable medical devices, including sutures, orthopaedic implants and biodegradable ‘scaffolds’ for cell growth to regenerate tissue.

Emerging centre for bioresorbable polymers

Ashland, a global additives and specialty ingredients company, has launched seven innovative technology platforms including this bioresorbable polymers platform. The company is supporting substantial market growth via the recently expanded facility located in Mullingar’s National Science Park, a biomedical hub.

“Our scientists carefully tune bioresorbable polymers for desired performance in terms of degradation and physical properties, creating huge application potential across the medical field from enhancing treatment of chronic diseases to supporting a new age of tissue regeneration. The Mullingar site is pivotal for developing and manufacturing these materials,” says Seán McMahon, Ph.D., global business manager.

Our scientists carefully tune bioresorbable
polymers for desired performance in terms
of degradation and physical properties.

Long-acting function

McMahon explains: “One way our pharma customers use our bioresorbable polymers is to incorporate a drug compound into the polymer to form a long-acting drug depot. The depot is injected into patients and safely biodegrades while slowly releasing the drug over a programmed duration, such as one to six months.”

This is particularly relevant to serious chronic illnesses that remain the leading cause of death in many countries. These depots reduce injection frequency and help patients stay in compliance to realise greater treatment benefits.

Embracing diversity

Focusing on precision chemistry, the solvers in Mullingar produce, purify and test polymers helping ensure quality and control. These chemistries offer great potential to solve some of medicine’s most complex delivery needs, including new routes of administration, tissue targeting and cellular delivery. “Custom polymer synthesis is probably the site’s most strategic capability because drug formulators are facing new excipient needs,” concludes McMahon.

Ashland has expanded its team by tapping into Ireland’s biomedical talent pool, and the Mullingar location is central to achieving the expansion. The facility has a fantastic workplace culture driven by a dynamic diverse team of people recruited globally.

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Contract development and manufacturing organisations drive pharma innovation by offering specialised drug development, particle engineering and scalable manufacturing solutions for the drugs of the future.

Over the past few years, contract development and manufacturing organisations (CDMOs) have played an increasingly important role in supporting pharmaceutical companies to bring innovative new drugs to market.

Particle engineering addressing solubility challenges

Industry specialist Dr Paul Downing explains that the molecules for new drugs are becoming harder to manufacture as they become more potent with smaller amounts of drug per dose.

“Some molecules have a solubility challenge,” he explains, “which necessitates advanced formulation to enhance the bioavailability and effectiveness of the drug. As manufacturing techniques get more specialised, we are seeing big pharma innovator companies outsourcing their chemistry business to CDMOs.”

CDMOs provide comprehensive services to pharmaceutical and biotechnology companies, including product development, formulation, manufacturing, packaging and distribution. Their role is growing as the drug development landscape evolves.

Customised molecule scale-up and production

Downing, having spent his entire career in the pharmaceutical sector, is general manager of Hovione, a CDMO based in Cork. With foundations in the antibiotics field when it was founded 65 years ago, it has moved to custom synthesis of active pharmaceutical ingredients (API), particle engineering (modifying particles into a defined shape and composition), continuous tabletting and inhalation.

It works with specific molecules developed by pharmaceutical partners and is a world leader in resolving technical challenges around particle engineering by offering spray drying (forming a dry powder from a liquid) services and a route towards production at commercial volume.

“We take their molecule, scale it up, adjust the synthesis to make it more effective and then offer a commercial supply,” he says. The company employs 2,400 people globally with headquarters in Portugal and manufacturing sites in Ireland, the United States and Macau, with chemists, engineers, pharmacists, data scientists and project management at the core.

CDMOs provide comprehensive services to
pharmaceutical and biotechnology companies.

Evolving CDMO–pharma collaborations

As drugs grow more complex, the company believes the future of drug development lies in stronger CDMO–pharmaceutical collaborations. Downing also acknowledges the sector must continue to evolve. “We are constantly looking at how the landscape changes with new modalities and drugs getting more sophisticated with more personalised medicine,” Downing says.

As an innovative, customer-focused organisation, Hovione is dedicated to responding to client needs to help develop the drugs of the future [WF(H3] That could involve improving the bioavailability of drugs, so they better enter the patient’s system; adopting advanced manufacturing techniques; and exploiting their global reach. “We are nimble, flexible and responsive,” he adds.

Strategic relationships and sustainability

Recruiting specialised talent and listening to the market are critical, insists Downing. He also emphasises the importance of strategic client relationships for upcoming innovations and strong academic partnerships worldwide.

“Together, these provide a fuller understanding of the problems we need to solve for customers, as well as the access to the latest technical solutions and talent to bring into our R&D team,” he adds. Hovione has a strong regulatory record, backed by Ireland’s recognised regulatory frameworks. “That allows us to operate at the highest standard and lowest risk and that translates across the whole group because we share our best practices,” explains Downing.

Additionally, the company adopts sustainable practices, reducing the Cork site’s carbon footprint by 40%. Full electrification via wind turbines is being evaluated, aiming for net zero by 2030.

Ireland as a major hub

Downing further underlines the value of a presence in Ireland as a major pharmaceutical hub with over 40 chemical biopharmaceutical companies; a talent pool that feeds from academic institutions and enables the company to hire for global roles; a supply network; and an ecosystem of pharmaceutical industries that attracts candidates from across the globe.

“Plus, the customer intimacy relationship that Ireland brings makes it an ideal place for us to be.”

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The medtech industry in Ireland is constantly evolving and is now perfectly equipped to advance our position as a global leader.

Ireland is recognised as a global medtech hub, with 450 companies employing 48,000 people to deliver €13 billion in medtech exports, enabling life-changing innovation.

Research and growth in global medtech

The average medtech worldwide research and investment rate is approximately 8% in the sector. Medtech is an innovation leader in Europe with 15,985 patent applications filed with the European Patent Office (EPO) in 2023, representing a 1.3% growth compared with the previous year.

Additionally, continued indigenous R&D investment will ensure Ireland is well-positioned to lead the latest megatrends, with its ecosystem spanning medtech leaders, world-class manufacturers, disruptive startups and internationally recognised research facilities.

The average medtech worldwide research and investment rate is approximately 8% in the sector.

Medtech industry trends

Some ‘game-changers’ impacting the industry include:

• Health with ageing demographics and the rise of chronic diseases driving demands and costs
• Customers with changing behaviours, more personalised healthcare and greater access to insights from data
• Healthtech and convergence with greater multi-stakeholder convergence seeing new technologies developed, along with new business strategies to deliver and protect them (eg. cybersecurity)
• Sustainability with smart manufacturing and connecting devices helping drive efficiencies to reduce the sector’s carbon footprint along with measures to support the circular economy

While industry has invested heavily in R&D to shape the future of healthcare in the face of change with new technologies and continuous professional development, more needs to be done at a government level. Irish medtech is advocating for the formation of an industrial life sciences and national health technology strategy to address the growing healthcare pressures through innovation and collaboration.

National healthtech strategy

The development of a national health technology strategy, led by the Department of Enterprise, Trade and Employment, will enable the adoption of industrial policies that promote clustering so that Ireland can realise more strategic cross-sectoral cooperation. This would help us support growth by leveraging the best of the medtech, biopharma and tech sectors — which have an envious presence here — and support cutting-edge innovation to create a new era in transformative healthcare

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Learn how artificial intelligence (AI) can tackle some of the biggest challenges when it comes to tasks such as drug discovery and data analysis.

Ireland is one of the many countries embracing the pace of change delivered by the advances in AI technology, and the Irish Government is investing 47 million euros over the next five years to fund the Enterprise Ireland Technology Gateway Programme to harvest innovation across the country.^[1]

AI revolutionising drug research

Ireland published a National AI Strategy three years ago and has a strong tech and digital ecosystem due to the significant number of tech companies that are located here. Novartis is prioritising AI to understand disease and drug targets better. The technology is expected to help scientists save valuable research time that would have previously taken days or weeks to extract and summarise information in documents such as patents, scientific publications and trial data.

Paul McGettigan, who leads the company’s data science AI programme in Dublin, reflects on how the advent of AI changed his outlook and ambitions as he celebrates 30 years as a scientist. “Throughout my career, I’ve tried to stay close to where the action is — at least in areas where I feel I can make a productive contribution. It was exciting to be part of the internet revolution in the dot-com days. I would say it is even more thrilling to see where AI will take us as this opportunity could change our industry significantly,” he says.

Accelerating drug discovery and delivery

There are opportunities to apply AI, machine learning and data science techniques across the entire care pathway — from early drug discovery to development, manufacturing and supply chain. The industry is witnessing increasing applications of AI to gain insights from real-world data that can inform future research and development.^[2]

McGettigan adds: “The process of taking a drug from hypothesis to clinical trials is a very long one, so it is still too early to detect the full impact of AI on this process. From the projects my teammates and I participate in, I can see that AI has great potential in the research space. AI techniques will help our teams identify novel targets and higher quality molecules more rapidly, for example, and ultimately increase the likelihood of success in later stages of a project.”

There are opportunities to apply AI, machine
learning and data science techniques
across the entire care pathway.

Augmenting the workforce

The addition of AI-enhanced production does not mean the displacement of human workers. Instead, it enhances teams’ abilities to perform their roles. Employees are equipped with advanced tools that augment their capabilities, improving their decision-making and allowing them to focus on more complex and creative aspects of their work. This shift promotes a culture of continuous learning and development.

This is not a process that can be done alone. Novartis is collaborating with Ireland-based Deciphex, allowing the utilisation of AI to develop tools to better detect and measure tissue lesions more accurately, which can enhance the drug discovery and development processes.

AI transforming pharmaceutical operations

AI is a tool and a catalyst for transformation in the pharmaceutical industry. At Novartis in Ireland, it is driving efficiency, precision and speed improvements, enhancing the company’s ability to serve patients better. As McGettigan aptly puts it, the advent of AI has been an industry-changing opportunity paving the way for a future where advanced technology and human ingenuity work hand in hand to achieve remarkable outcomes.

References
[1] https://technologygateway.ie/
[2] AI for social good in sustainable development goals | McKinsey

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Demand for STEM skills is projected to increase by around 8% over the next 18 months, compared to an average 3% growth forecast for all occupations.

Employment within STEM-related sectors is also expected to grow by around 6.5% over the same period. Science Foundation Ireland (SFI), through various campaigns, fosters awareness and appreciation of science careers.

Fostering STEM passion and understanding

Science Week (10–17 November 2024) sees hundreds of events hosted nationwide. Its momentum complements collaborations with the Department of Education, helping young people and teachers interact with — and better understand — science. As well as a curriculum subject, science is a pastime and a prospective profession. Igniting the spark of scientific interest during one’s formative years can be life-defining.

Supporting postgraduates

In 2023, Ireland ranked 15th globally for university-industry R&D collaboration; our organisation supported 2,476 postgraduate research students, and 30% of PhD graduates and postdoctoral staff departing SFI teams entered industry as a first destination. Moreover, since January 2024, the tax-free stipend for SFI and Irish Research Council-supported PhD researchers has increased by €3,000 (to €22,000).

Responding to increased demand and rapidly evolving needs for a highly-skilled, adaptable workforce, Centres for Research Training (CRTs) bring together the higher education sector and industry to deliver innovative programmes, undertaken by cohorts of postgraduates, developing critical capacity in data and ICT skills. The growing role of technology and data in today’s world provides strong career opportunities for those with analytical and problem-solving skills.

In 2023, Ireland ranked 15th globally for
university-industry R&D collaboration.

Academic-industry collaboration

Our Industry RD&I (research, development and innovation) Fellowship Programmesupports mutually beneficial academia-industry interactions by addressing industry-informed challenges. Researchers at faculty and postdoctoral levels can spend up to a year full-time (or two years part-time) in industry worldwide.

Public service secondments

Our Public Service Fellowship Programme offers researchers secondments to government departments and agencies. This year’s programme — co-funded with Environmental Protection Agency, Geological Survey Ireland and Sustainable Energy Authority of Ireland — provided 14 awards, spanning 11 departments and agencies.  

Agency in-house placement

For postdoctoral researchers seeking career development within a funding agency, our Fellowship Programme provides fulfilling, in-house placements, where comprehensive training plans and mentorship help enrich both organisation and participating fellows.

Alumni of our funded research teams are in high demand, nationally and internationally. Around 61% of researchers have taken up positions outside academia after working in SFI-funded teams.

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