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Life Science Innovation
“The ability to innovate will help businesses to build resilience.”
“Digitalisation requires a mindset change towards data-driven decision-making.”
Sinead Keogh, Director Medtech and Engineering, Ibec
Mohamed Noor PhD, Digitalization Manager, NIBRT
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IN THIS ISSUE
“Digital transformation is the key to a successful biopharma operation.” Mohamed Noor PhD Digitalization Manager, NIBRT
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The role of regulatory environments in choosing locations for businesses Decisive action from the EU is needed to ensure new medical devices regulation functions as intended.
“Advanced therapeutics present opportunity for Irish biopharma.” Matt Moran Director General, BioPharmaChem Ireland
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“Ireland is catching the the next wave of biopharma innovation.” Darrin Morrisey CEO, NIBRT
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here are more than 500,000 different types of medical technologies on the market ranging from glasses and wheelchairs to pacemakers and MRI scanners. Medtech is arguably the most innovative sector in Europe with more than 14,200 patent applications filed with the European Patent Office (EPO) in 2020, representing a 2.6% growth compared with the previous year. This is not only due to the diversity of products, but also the short product lifecycle of 18-24 months which is underscored by a commitment to delivering improved medtech for both healthcare professionals and patients. Ensuring regulations support innovation and access To get into the health system, manufacturers must demonstrate that medical technologies meet EU-wide safety and performance requirements. These are assessed by notified bodies who award CE marks. The new EU Medical Device Regulation (MDR), which came into effect 26 May 2021, represents the greatest change for the regulatory system in over 20 years. While the medtech industry is a proven supporter of the EU MDR’s goals, and has invested significantly into the transition process, major challenges still need to be addressed:
The EU has historically been a location of choice for the launch of new medical technologies and Ireland has benefited from this with investments. Competitiveness in changing global landscape The EU has historically been a location of choice for the launch of new medical technologies and Ireland has benefited from this with investments. However, a lack of predictability relating to MDR coupled with an increasingly predictable regulatory environment in other markets, such the US under the Food and Drug Administration (FDA), means that the EU is no longer seen as the most attractive location to develop and launch new medical technologies. This issue risks being further compounded by some investors choosing not to invest in early-stage companies with plans to launch new products in the EU given the lack of business predictability. As the global trading environment becomes more competitive, the ability to innovate will help business to build resilience.
• Tackle certification bottleneck by addressing notified body capacity and facilitating early dialogue for new devices. • Avoid an innovation backlog and retiring legacy devices with appropriate evidence requirements.
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Sinead Keogh Director Medtech and Engineering, Ibec
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Looking to the future: how engaging with industry could improve healthcare for all A leading university calls for industry partnerships to create a real impact in the life and health sciences sector in Ireland.
R Dr Le Roy Dowey Business Development Manager, School of Biomedical Sciences, Ulster University
WRITTEN BY Meredith Jones Russell
anking in the top five UK universities for research power in Allied Health Professions,dentistry, nursing and pharmacy (Times Higher Education), Ulster University has created an environment that supports world-leading and internationally excellent research. Dr Le Roy Dowey, Business Development Manager for Biomedical Sciences at Ulster University is working on how best to combine the university’s research expertise with industry collaborations to improve healthcare for people in Ireland. “REF 2021 has set the stage for the level at which life and health sciences research is at in the university. We’ve got excellent facilities, very exciting projects and a thriving researcher community. “We have the potential to be the go-to development partner for the bio sector. The university creates the perfect environment for us all to exchange ideas and develop innovative solutions that address challenges in the sector.” Recent successes Recent projects have included the development of BloodTrackR which allows blood to be collected by a patient themselves at home, as well as work with the Irish advanced wound care company, Jenarron Therapeutics, on a pain-relieving gel for pain free wound cleaning. Belfast-based SonoTarg, a recent university spin out company, is working on sonodynamic therapy for targeted cancer treatment. The university has also cooperated with Athlas Therapeutics on the development of a novel inhibitor to treat chronic inflammation and long-term conditions without compromising the immune system. “We have fantastic research going on and we’re busy engaging with industry, plus a number of spin-out companies formed as new SMEs,” explains Dowey. “But the challenge we face at this stage is, where do we go to next?”
Paid for by Ulster University
Sector investment Over the next few years, the university is poised to make unprecedented investments in the life and health sciences sector, with two headline projects; the Personalised Medicine Centre and the Centre for Food and Drug Discovery. “We recognise the industry’s needs for expertise and access to cutting edge equipment driven by our academics with years of know-how. Our latest projects open the door to industry partners with access to equipment and academic expertise, allowing us to deliver on projects via a rapid and agile delivery system,” explains Dowey.
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The university creates the perfect environment for us all to exchange ideas and develop innovative solutions that address challenges in the sector. The Personalised Medicine Centre aims to develop treatments and clinical tools that take into account a person’s individual genetic and molecular signatures to create a new generation of treatments and robust diagnostics to inform clinical decision-making across a range of chronic and degenerative diseases. The Centre for Food and Drug Discovery will enable the university to capitalise on a £27 billion market for bioactives, with food playing a central role in preventative health care. “Each project is focused on innovation and industry engagement and is a one-stop-shop, from target and candidate selection to running clinical trials, for everything the industry needs for project delivery,” says Dowey. The university is gearing up to transfer its extensive research knowledge to up-skill companies. Dowey adds: “We’re expanding our course offerings with bespoke CPD courses for organisations on topics such as data analytics, and providing support, particularly to SMEs businesses, to help them meet regulatory conditions.” Creating a network “Engagement across the entire life and health sciences community is vital,” says Dowey. “This investment will allow us not just to signpost industry to solutions, but to introduce the business partners entering the Northern Ireland life and health sciences ecosystem to our very close-knit community.” This will involve helping companies engage with Invest Northern Ireland, Health Innovation Research Alliance Northern Ireland (HIRANI), Ulster University’s partners, such as Catalyst, Queen’s University Belfast, and leading NI industries (Almac, Norbrook, Randox etc.) and the various Health and Social Care Trusts. With its latest investment projects, the university is set to provide unparalleled resources to industry partners in the life and health sciences sector on the island of Ireland.
For information on industry collaboration opportunities please contact Dr Le Roy Dowey lc.dowey@ulster.ac.uk Or scan the QR code to find out more
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Digital transformation is the key to a successful biopharma operation Data analytics is quickly moving from being in the realm of machine learning specialists to being embedded in mainstream graphical tools.
With digitalisation being the next frontier in biotechnology, having access to a skilled workforce will be as critical as having the right infrastructure.
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he COVID-19 pandemic has demonstrated that a combined regulatory and industry cooperation can pave the way towards rapid developments in the face of crisis. Existing manufacturing facilities were rapidly repurposed and additional workforce were hired to meet the demand for COVID-19 vaccine manufacturing, while still meeting patients’ medical requirements for other diseases. At the same time, COVID-19 shows that biopharmaceutical manufacturing can be improved, new modalities should continue to be explored and the learnings from other industries will need to be tapped into.
Mohamed Noor PhD Digitalization Manager, NIBRT
Digitalisation is becoming mainstream In parallel to the emergence of new therapeutics, advances in manufacturing have been made elsewhere across different industries. Digitalised revolution in manufacturing, collectively termed Industry 4.0 and 5.0, continues to provide leaner and sustainable processes, especially for globally distributed manufacturers. Data analytics is quickly moving from being in the realm of machine learning specialists to being embedded in mainstream graphical tools. In the near-term, continued innovation in the digital space will be even more critical for cell and gene therapies where quick and error-free turnaround will be required from sample collection and infusion back into the patient. Investing now for the future Often, a major obstacle in the path towards digitalisation in biotechnology is the perceived difficulties in implementing compliant and holistic computer systems that span from enterprise resource planning to granular system control. With biologic development costing an average of USD 1 billion per molecule, every one-day delay represents increased production cost and competition risk as well as a deferred availability for patients. A streamlined, digitalised clinical manufacturing process will assist the associated trials and regulatory filings. Hence, the upfront expenditure needed for digitalisation should be viewed as an investment within an organisation’s pipeline. Talent development Equally critical is having a skilled workforce with a diversity in their talents and thinking. It requires an agile process with talents that are well familiar with the subtleties of bioprocessing while adhering to regulatory best practices. Importantly, digitalisation encompasses much more than just replacing paper documents with their electronic counterparts. It requires a mindset change towards datadriven decision-making. In this regard, NIBRT continues to develop new programmes to meet industry needs by partnering with our clients and vendors. These programmes will capture the breadth of digitalisation across process development, manufacturing, and supply chain. In the longer term, our initiatives will ensure Ireland remains the location of choice for the biopharmaceutical industry.
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Empowering educational model that keeps pace with new reality of work People in the life sciences sector are increasingly using online learning as the way to keep up with industry trends or make the most of future employment opportunities.
T Professor Neville McClenaghan Head of Department of Life Sciences, ATU Sligo WRITTEN BY Tony Greenway
Paid for by ATU Sligo
here was a time when a student would go based scientist may want to move into a regulatory to college, get a degree or professional role. Facilitating such moves may require new sets of qualifications, find a job — and perhaps never educational attainment and skills.” think much about higher education again. That’s why HEIs such as ATU work closely with industry Those days are long gone, insists Professor Neville to address skill needs with a variety of courses that McClenaghan, Head of Department of Life Sciences at ATU upskill, cross-skill, or even reskill, employees. ATU Sligo’s Sligo, a third level higher education institution (HEI). Bioindustry 4.0 programme is a case in point, developed in Take the life sciences sector, which is forever evolving and collaboration with the National Institute of Bioprocessing diversifying. “We’ve gone from an industry often largely Research and Training (NIBRT) to meet changing needs of associated with biochemicals, to one Ireland’s agile biopharmaceutical sector as visibly encompassing biologics, biomedical it progresses towards greater integration of technologies, and medical devices used in technology and data. an array of contexts,” says McClenaghan. Online higher education is becoming “We’re moving into an exciting era of increasingly popular and powerful, The whole field of life medtech, personalised medicine and notes Mary Butler, Lecturer and Course sciences is changing — so companion diagnostics. The whole field of Lead for Biopharmaceutical/Medtech industry has to equip itself life sciences is changing — so industry has Programmes at ATU Sligo. This is to equip itself with the necessary skillset to evidenced by a strong and growing with the necessary skillset cope with those changes.” portfolio of more than 150 programmes to to cope with those changes. This means higher education is not over 4500 online learners nationally and simply the preserve of school-leavers and internationally. college-based students anymore. In fact, the vast majority “Students want greater accessibility and the opportunity of ATU Sligo’s online part-time cohort are industry-based to study in their own time,” she says. “They may have lifelong learners looking to build qualifications and gain young families, caring responsibilities, be geographicallytransferable skills. remote or travelling with work, needing flexible means of accessing relevant quality education. If so, ATU Sligo Working closely with industry to address skill needs may be the HEI of choice, empowering learners to pursue “These days, people can change jobs multiple times,” rewarding industry careers, enhancing employability, and says McClenaghan. “For example, an engineer may facilitating advancement.” want to transition to a scientific role, or a laboratory-
the region a global investment destination over the next decade in 2030 and beyond. As part of this, The Institute for Research Excellence in advanced Clinical Healthcare (iREACH), based at Queen’s, will be an extension, expansion and integration of current healthcare facilities, committed to establishing research excellence in Advanced Clinical Healthcare in Northern Ireland.
Bringing together life science research and industry excellence Northern Ireland is increasingly emerging as an attractive place for investment in the life and health sciences sector thanks to a combination of factors including skills availability, excellent infrastructure, costeffectiveness and a supportive business environment.
T Professor Emma Flynn Pro-Vice Chancellor for Research and Enterprise, Queen’s University, Belfast
he thriving life sciences industry encompassing pharmaceutical industry, medicines manufacturing and healthcare activity supports 18,000 full-time jobs throughout Northern Ireland. According to the latest Northern Ireland Statistics and Research Agency data, life sciences is now the joint secondbiggest spender on R&D in Northern Ireland alongside the machine industry, investing £74 million in 2018. Research and innovation expertise This is driven by the globally competitive research and innovation expertise offered by the region’s two major universities, Queen’s University Belfast and Ulster University.
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Northern Ireland possesses worldclass expertise in precision medicine, food security, digital and connected health, data analytics, pharmacy and clinical trials. In May 2022, Queen’s ranked first in the United Kingdom for its research in Food and Veterinary Sciences and forth in UK for Health and biomedical Sciences in a major UK wide review of Higher Education research (Research Excellence Framework 2021). Belfast region city deal Queen’s University is leading innovation through the Belfast Region City Deal, an ambitious £1 billion project of transformative co-investment which will deliver more than 20 ambitious projects and programmes, create up to 20,000 new, and better, jobs and help make
Mary Butler Lecturer and Course Lead for Biopharmaceutical/ MedTech Programmes, ATU Sligo
Find out more at atu.ie/sligo-online
Paid for by Queen’s University Belfast
Collaborations for growth By bringing together academic, industry, NHS and government stakeholders, there is a now a once in a generation opportunity to combine the possibilities of major capital investment, world leading medicine and life sciences research, with the priorities and expertise of global life sciences companies, to transform the lives and livelihoods of people, across these islands and across the world. Together, in partnership, this opportunity can be realised.
Queen’s is also successful in translating research into commercial success. In 2019 and 2020 Queen’s ranked #1 for Entrepreneurial Impact in an independent report. Several successful life sciences spinout companies are emerging from Queen’s with the support of QUBIS, the commercialisation arm of the university. These companies are now scaling up their activities, tackling global markets and addressing real-world societal needs. qub.ac.uk
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Advanced therapeutics present opportunity for Irish biopharma Advanced therapeutics are the new frontier to cure and treat medical needs, some unmet to date. Increased investment in the sector will help maintain Ireland’s position as a global life sciences leader.
C Matt Moran Director General, BioPharmaChem Ireland
ell and gene therapies comprise a major part of advanced therapeutics with technologies such as chimeric antigen receptor – T cell or CAR-T able to provide a route to the permanent cure of diseases such as cancer. Recently, Ireland’s first CAR-T therapy was administered out of Trinity St James’s Cancer Institute. The patient was given the treatment for lymphoma. This is a very positive development for the evolution of therapeutics in this country. Exciting therapy advancements Advanced therapeutics do represent a significant opportunity for the Irish biopharma sector. The recent opening of the cell therapy production unit by Takeda at Grangecastle represents another important milestone. This will be Ireland’s first stem cell therapy production facility and heralds a further step in the journey of innovation that the sector has been on since its establishment back in the 1960s.
There lies an opportunity for the sector in Ireland to defend its competitiveness while at the same time meeting its sustainability targets reducing its carbon footprint. This journey has seen the sector evolve from the chemical synthesis of active pharmaceutical ingredients (APIs), through final dosage forms, biotech manufacture right into the exiting new world of advanced therapeutics. The product being made at Grangecastle is designed to treat a side effect of irritable bowel syndrome and is an example of a family of products we know as cell and gene therapies. Achieving green and sustainable production The European Commission has published a policy brief on Factory 5.0 - in their view Industry 5.0 can help to drive this twin transition and involves the interpretation of
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Industry 4.0 Technologies through a human centric lens. This brief emphasises the powerful role that industry can play in achieving societal goals through green and sustainable production. There lies an opportunity for the sector in Ireland to defend its competitiveness while at the same time meeting its sustainability targets reducing its carbon footprint. By embracing the principles of Factory 5.0 Ireland can ensure the long-term future of the sector here.
and a decision by Spear Street Capital to invest in a bioincubator at Cherrywood, South Dublin is welcome. The 30,000 square foot facility will be run by We Are Pioneer Group (WAPG, formerly Biocity), a UK based operator in incubating and accelerating life sciences businesses. It is hoped that initiatives such as this will help to grow out a strong indigenous life sciences sector that can complement the already strong FDI sector.
Building strong investment Ideally Ireland will focus on developing a strong indigenous biotech sector to compliment a very strong multinational industry
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DkIT ignites student’s passion for science
Dr Leanna Morgan started off studying a Level 7 degree and earlier this year was awarded her PhD. She shares her experiences of what inspired her.
A Dr Leanna Morgan PhD Dundalk Institute of Technology
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rriving in Dundalk Institute of Technology You get out what you put in (DkIT) in 2013, a fresh faced Leaving Certificate One of the highlights of this year was the research student, I knew one thing, I wanted to pursue project. I found that the effort you put in you got out and a career in science. Now nine years later, as a I absolutely loved it. It was this experience that sparked recently qualified PhD graduate, the one thing I know my desire to undertake a research PhD. Upon graduation, for certain is DkIT has served me well. I obtained a PhD position on the collaborative BREATH At school, I had a passion for biology and wanted project funded by the European Union’s INTERREG VA to pursue a science qualification, however programme in the Smooth Muscle research I hadn’t studied chemistry or physics at centre here. I completed my PhD in January Leaving Certificate and I was worried that it 2022 and published my first authored paper in may hinder my future. What attracted me to March. The desire to the BSc in Applied Bioscience (Level 7) was The desire to teach originated from the the descriptor of the year one modules in the teach originated positive experiences I have encountered prospectus. throughout my education. I had a number of from the positive remarkable lecturers, who understood that There was a clear emphasis not only on biology but also on the other core sciences teaching goes beyond the ability to deliver experiences I chemistry and physics. I thrived in first year course content. Their encouragement gave as there was a broad introduction to the three have encountered me the confidence to pursue a PhD and their fundamental sciences, biology, chemistry enthusiasm inspired me to follow a career in throughout my and physics. This lay the foundation for teaching, which has led to my current role as the rest of the course and the rest of my an Assistant Lecturer in Biochemistry here in education. academic journey. the School of Health and Science. Completing my Level 7 degree in 2016, I wasn’t ready to conclude my education. Fortunately, Inspiring others to study DkIT offered a number of additional courses that I could I have earned the nickname the ‘eternal student’ but I choose as one year add-ons to achieve a Level 8 degree. I believe that it is a notable achievement for any institution decided on the BSc (Hons) degree in Biopharmaceutical to be able to both inspire undergraduate students to Science. pursue higher levels of education while also facilitating their career ambitions.
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How data science can boost life sciences production Life science manufacturers are being supported by data scientists to analyse the huge amounts of information generated in their production processes to help improve performance.
D Norma Bargary CONFIRM Principal Investigator and Professor of Data Science & Statistical Learning at MACSI in the University of Limerick WRITTEN BY Mark Nicholls
Paid for by Confirm
ata analytics is providing a critical insight into production processes for the life science manufacturing sector. By using adaptable algorithms and statistical models, data scientists are analysing vast amounts of data acquired during production to help manufacturers learn more about their processes as well as make improvements and efficiencies. Cognitive systems Data scientist Norma Bargary explains that advances in technology across life science manufacturing, such as state-of-the-art sensing, robotics, automation and machine connectivity are delivering extensive data from cognitive systems in real time. “This builds a very complete picture of what is going on in the manufacturing process and on the quality of the product,” she says. “Organisations are also striving to become more data driven in this space and utilise that data to make better and faster decisions.” Bridging the gap But Bargary, who is Professor of Data Science & Statistical Learning at MACSI in the University of Limerick, and a Principal Investigator at CONFIRM, the Science Foundation Ireland-funded Research Centre for Smart Manufacturing, says: “There is a huge gap between the advanced technology and the amount of data collected, and the algorithms available. “Our research wants to bridge that gap and develop
models and algorithms to make sense of those big, complicated, data sets.” The statistical models and algorithms can highlight relevant data and facilitate and enhance decision-making to benefit the manufacturing firms and, ultimately, the end consumer. Regulated environment Her work at CONFIRM involves applying research to life sciences manufacturing problems and working with companies to gain an in-depth understanding of their processes and data analytics challenges. The work at the centre also aims to help life science companies understand production issues and processes to make systems more resilient to meet challenges such as Brexit or COVID-19. A further challenge is sustainability, with large amounts of energy required for computing power, storing and analysing vast volumes of data. Clearer understanding CONFIRM has worked with manufacturers to analyse their data and offer a clearer understanding of production processes to identify potential changes that will enhance product yield, understand how products are being used by consumers in the field and model the reliability and lifetime of products. Bargary emphasises the importance of collaboration in research with a range of inter- and trans-disciplinary expertise required, and that the models and algorithms developed also have applications beyond life sciences manufacturing.
ATMPs: Ireland is catching the next wave of biopharma innovation
the first paediatric patient in the world treated with the engineered autologous cell therapy CAR-T for ALL in 2012, and 10 years later is cancer-free and living a normal life.
Ireland’s global leadership in biopharma manufacturing is an excellent foundation on which to build a new leadership position in the development, manufacture, supply and adoption of advanced therapies and vaccines.
O Darrin Morrissey CEO, NIBRT
ver the last 15-20 years, Ireland has established itself as a global leader in biopharmaceutical manufacturing and has had great success in attracting multinational companies to establish manufacturing operations across the country. Biopharma foreign direct investment (FDI) has topped €10 billion over the last decade, with over 40,000 people now directly employed in a sector that contributes over €40 billion in national exports annually . The next wave of growth It is predicted that advanced therapy medicinal products (or ATMPS) will become the main
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driver of biopharma growth over the next decade. They are a biopharma category that comprises a range of highly innovative medicines that includes cell-based therapies, gene-based therapies, engineered regenerative tissues and oligonucleotide-based (e.g. RNA) vaccines and therapies. ATMPs treat diseases at a fundamentally molecular level and represent a potential step-change in the precise personalised nature of treatment and in the capacity to deliver a sustained disease response or even a cure. The power of ATMPs to offer substantial long-term benefits for patients is exemplified in the story of Emily Whitehead, who became
An opportunity for Ireland The manufacture of these highly sophisticated therapies is complex, with the efficient and safe scaledup manufacture of cell-based and gene-based therapies, in particular, presenting unique challenges. Building on our successful trackrecord in monoclonal antibody manufacturing, our existing infrastructure, experienced workforce and new investments, Ireland has a strong role to play in optimising and presenting solutions towards the efficient, cost-effective and safe manufacture of ATMPs. Future investments in ATMPs NIBRT has recently commenced an expansion of its training and research facility in Dublin. The expansion is funded by a capital investment from IDA Ireland / the Government of Ireland of €21 million. It will create dedicated additional space, including an extra five laboratories and two new training suites, for training and research in cell and gene therapy manufacturing. The new facility is scheduled to open in the first half of 2023 and NIBRT is currently hiring additional principal investigators for its research team and additional training staff.
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