Life Sciences IE - Q2 2021

A Mediaplanet campaign focused on

Life Science Innovation

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“Ireland has a chance now to be an adopter of cell and gene therapies, aligning with most other countries in Western Europe.”

Bernard Mallee Director of Communications and Advocacy, IPHA

Q2 2021 | A promotional supplement distributed on behalf of Mediaplanet, which takes sole responsibility for its content

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“I have no doubt that the life sciences sector’s place in Ireland will strengthen in the coming years.”

Simon McKeever CEO, Irish Exporters Association

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IN THIS ISSUE

Cell and gene therapy and vaccine manufacture – the next opportunity for Ireland ~ Matt Moran Director, BiopharmaChem Ireland

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We have a chance to realise the promise of cell and gene therapies In recent years, there has been a steady acceleration in the number of cell and gene therapies in development and authorised for use by patients. They should be available to patients in Ireland and it should be an investment location for these breakthrough treatments, too.

C Making Ireland a global hub for digital health Sinead Keogh Ibec Medtech and Engineering Director, Irish Medtech Association

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Cell and gene therapy: an exciting landscape John Milne PhD Training Director, NIBRT

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ell and gene therapies are a revolution in science.

Cell therapy replaces diseased, broken or missing cells with healthy versions. Gene therapy replaces faulty DNA to cure genetic diseases. These therapies treat, prevent and potentially cure diseases, whether genetic or acquired. With data so far showing transformative results, they are game-changers for patients.

The European Medicines Agency has approved cell and gene therapies for diseases affecting the eyes, for gastroenterology, for spinal muscular atrophy, for metachromatic leukodystrophy and for cancer. In the US, the Food and Drug Administration says it expects to approve between 10 and 20 new cell and gene therapies over the next four years.

Replacing a lifetime of treatment Cell and gene therapies can add months, sometimes years, to a patient’s life, replacing a lifetime of treatment.

In some cases, these treatments can save lives, especially if the intervention happens early. The treatments are expensive because research and development costs are high, with specialised production and logistics operations needed to get them from bench to bedside.

Often, patient populations are small because the conditions they treat are rare. The treatments, usually one-time rather than stretched out across a patient’s life, dramatically reduce the cost of chronic care. That means they make economic, as well as clinical, sense.

Cell and gene therapies can add months, sometimes years, to a patient’s life, replacing a lifetime of treatment. need a re-think when it comes to cell and gene therapies.

The industry recently commissioned PwC to examine ways to integrate the treatments into the care pathway.

Related work is under way, in conjunction with IDA Ireland and NIBRT to understand how we can create centres of manufacturing excellence.

Bringing all this work together requires an initiative led by central Government. Unlocking the potential of cell and gene therapy landscape requires cross-stakeholder dialogue, especially between the State, the industry, doctors and patients. This is urgent.

The pace at which Ireland can translate scientific breakthroughs in cell and gene therapies into better healthcare outcomes and new jobs will depend on how quickly stakeholders can come together in common purpose.

Collectively, let us work towards realising the clinical and economic promise of one of the most radical developments in modern science.

Ireland at the forefront of cell and gene therapy Ireland has a chance now to be an adopter of cell and gene therapies, aligning with most other countries in western Europe. We should look to the investment opportunity in manufacturing, production and supply chains for these treatments. Both the traditional commercial and manufacturing models for medicines

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Bernard Mallee Director of Communications, Advocacy Irish Pharmaceutical Healthcare Association

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Forming alliances and partnerships to advance the life sciences industry How will new collaborations evolve within the life sciences industry and what will the next decade of the sector look like?

T Elaine Daly Life Sciences Industry Lead, Grant Thornton Ireland

Amy Flynn Life Sciences Industry Lead, Grant Thornton US

he life sciences industry is currently facing extensive challenges including regulatory changes, greater global competition, growing pricing pressure and the additional complexities of entering new markets. To assist in overcoming these challenges, the value of effective alliances and partnerships holds increasing importance.

Industry consolidation via M&A has been the traditional pathway for organisations in enhancing technical knowledge, expanding R&D pipelines and growing product portfolios. However, the forging of partnerships is proving to be an increasingly attractive alternative, as organisations seek to boost productivity, leverage data and tap into new sources of innovation. In doing this, organisations not only benefit from the expertise of other industry players but also from reduced capital expenditure, minimised risk and fewer regulatory hurdles.

Innovative partnerships New partnerships are paving the way for innovation and accelerated development. Among life sciences companies, centres for drug discovery have proven to be popular strategic partners. Academic partnerships are a viable alternative in lieu of acquiring intellectual property outright.

Partnerships with technology companies are also helping to bridge the gap of R&D IT. These partnerships enable life science companies to access critical technical capabilities whilst forgoing the cost implications of developing the resources in-house. Notable examples include Apple and Google partnering with life science companies to develop technology resources.

What does the next decade look like?

The COVID-19 pandemic has spurred cross-collaboration between rivals and highlighted the growing need for agility within the life sciences sector over the coming decade. Increasing agility to meet the challenges of the future can be realised via alliances and partnerships, which will form the basis of an integrated healthcare ecosystem. Arising synergies will not only drive innovation and investment, but also improve efficiency via resource sharing and the distribution of costs, risks and benefits among stakeholders.

Regarding key growth areas, science-tech partnerships will unlock new value and drive patient-centric innovations in real word data, precision medicine and the application of AI and machine learning in diagnostics and treatment.

For example, a recent partnership between University College Dublin and IBM Research has led to the creation of a ground-breaking cancer prediction algorithm and motion tracker software. Leveraging AI, cameras and specialised dye, surgeons will have greater precision in the identification and surgical removal of cancerous tissues. The discovery will enable real-time diagnosis, the provision of personalised patient intervention and most importantly, improved patient outcomes.

Such examples of collaboration among stakeholders in life sciences, tech and academia will see healthcare evolve from a one-size-fits-all approach to a model focused on prediction, prevention and personalised treatment. Amidst emerging health trends, the need for alliances and partnerships in research and innovation has never been greater.

UNLOCKING LIFE SCIENCE OPPORTUNITIES IN THE IRISH MARKET Contact:

Kyle Rothwell Executive Director, Head of Investment Properties T: 01 6185502 E: kyle.rothwell@cbre.com

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With 9 of the Top 10 Global Pharma companies located in Ireland, the country is perfectly placed to capitalise on occupier and investor interest in Life Sciences.

Representing and advising leading life science occupiers and investors all over the world, CBRE are subject matter experts and your first point of call for strategic advice.

Paddy Conlon Executive Director, Advisory & Transaction Services T: 01 6185520 E: paddy.conlon@cbre.com

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Supporting the life sciences sector is in our DNA

Cell and gene therapy and vaccine manufacture – the next opportunity for Ireland

The life sciences sector plays a crucial part in the Irish economy. However, we must continue to support the sector navigate the challenges resulting from COVID-19.

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he life science industry’s positive contribution to bolstering economic activity in Ireland has been particularly evident throughout the series of lockdowns that we have experienced.

The sector boasts of annual exports in excess of €45 billion and continues to invest in its workforce and operations.

Importance to our lives The sector will remain a reliable element of the Irish economy’s make-up. Aside from the economic gains, I believe that the general population needs to better understand the importance of innovation within the sector. The quick turnaround in developing effective and safe COVID-19 vaccines to populations must be applauded and credit must be given where credit is certainly due. The work of companies in the sector has given us increased optimism that the lives we all had can resume. We must also recognise the critical work of supply chain actors in transporting vaccines around the globe and ensuring that safety measures are followed in the distribution of the jabs to the world population.

Challenges: supply side shock We understand that a global supply side shock is well underway. Trading shifts mean that sourcing critical supplies, such as polymer, pipettes and precious glass as well as certain metals and packaging is becoming harder. Pharma companies are raising concerns about constraints in the access to components for medicines as these components are prioritised for COVID-19 vaccines.

In terms of distribution, the global shortage in the supply of containers and reefers has been a cause of concern for some time and has been exacerbated in recent months.

The Alliance for Regenerative Medicines (ARM) estimates that there are over 980 companies worldwide working in the advanced therapeutics space. This is the next wave of biopharma innovation and Ireland needs to be involved.

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he advanced therapeutics space ranges from cell and gene therapy (CGT), CAR-T, regenerative medicines to cell based immuno-oncology and mRNA vaccines.

There are currently 1600 clinical trials underway and $10 billion was invested in the sector in 2019. BioPharmaChem Ireland (BPCI) sees two opportunities for Ireland to get involved.

1. Allogeneic manufacture Here products are made in a more traditional manufacturing setting and would represent a shift from traditional biologics manufacture to cell-based platforms. This is an emerging area and the time is right to invest in the necessary infrastructure and skills. To this end, BPCI is working closely with a group led by NIBRT that is exploring this in detail.

Takeda have already established cell-based manufacture at their site in Grangecastle, Dublin and recently announced a further investment of €36 million with the creation of 100 jobs to expand this facility further. UK based biopharma company, MeiraGTx, announced a multimillion euro investment in Shannon where they will manufacture viral vectors and plasmids, creating 100 jobs in the process. Recently Pfizer announced a €40 million investment at its Grangecastle facility into the manufacture of key drug substance for its mRNA COVID-19 vaccine. Maynooth based company Avectas have developed an exciting platform technology in the area.

Recently Pfizer announced a €40 million investment at its Grangecastle facility into the manufacture of key drug substance for its mRNA COVID-19 vaccine.

2. Digitisation of supply of autologous products More suited to a hospital setting, autologous CGT products have complex and sensitive value and supply chains. We are currently working with EY and IDA Ireland to explore opportunities to manage these supply chains out of Ireland, harnessing the capabilities of the technologybased sector in the country.

Given Ireland’s importance as a manufacturer and supplier of biopharma products it seems logical that it enhances this capability by developing a strong CGT and vaccines sector in the country. Present indications point to more investment in this area in the future.

Matt Moran Director, BioPharmaChem Ireland

The future of the sector in Ireland We will continue to work with members, from across sectors, to alleviate challenges as much as possible. I have no doubt that the life sciences sector’s place in Ireland will strengthen in the coming years. I believe that our awareness of the sector’s importance will continue to grow as we meet future challenges head on.

Simon McKeever CEO, Irish Exporters Association

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Ireland’s pharmaceutical knowledge will drive future success The development of COVID-19 vaccines has alerted the public to the importance of biotechnological advances in medicine and their promise for the treatment of many illnesses.

S Tim Farries Principle Consultant, Biopharma Excellence

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imilar to new vaccines, medicines referred to as gene therapies use modified viruses or other genetic material (DNA or RNA) to carry genes for the synthesis of therapeutic proteins in the body where they are needed. Several of these advanced medicines have been approved already, but more are in development for the treatment of genetic diseases, cancers and for tissue repair. Cures for once incurable diseases can now be foreseen.

Managing access to treatment The COVID-19 pandemic has not only highlighted opportunities in these advances, but also the challenges in getting these therapies to patients. This translation of innovative science into commercially viable medicines requires skilled planning to anticipate and mitigate risks throughout their development.

Biological processes used to manufacture these novel therapies commonly suffer inherent variability that necessitates expertise to ensure they are produced with consistent quality and in sufficient volume to meet patient demand. Luckily, Ireland has long been an important hub for biological pharmaceutical manufacturing and the reputation of our workforce in this area is world renowned.

Supply chain issues However, the pandemic has also brought significant challenges to this industry. Companies have experienced

issues with the quality and availability of critical raw materials due to the impact of pandemic control measures on resources and supply chains.

Furthermore, the specialised manufacturing facilities have been appropriated for the COVID-19 vaccine production necessary to bring the world back to normality.

COVID-19 has provided an unprecedented public insight into the pharmaceutical industry and its ability to provide novel medicinal products that are safe and efficacious. This greater awareness demands full transparency regarding clinical data, regulatory approval and interpretation of the risks associated with novel medicinal products.

Seeking regulatory approval The process for obtaining regulatory approval for gene therapies is immensely complicated, and this lengthy journey differs from the hyper-accelerated route made available for pandemic vaccines.

However, the successful delivery of COVID-19 vaccines to large patient populations worldwide demonstrates the feasibility for widespread delivery of gene therapies.

Pharmaceutical innovators are now aware of more efficient regulatory routes of approval and of the wealth of knowledge and experience in the industry available to them, particularly in Ireland. These resources will be a key driver for future success, leading to increased availability of novel therapies to the patients that need them.

Delivering value for life sciences through innovation

Emer Conroy Director, LotusWorks

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It’s always been important to have the ability to work across operations and deliver process improvements in partnership with clients but this was critical during the COVID-19 pandemic.

Ireland is a leading hub for life sciences and manufacturing. Through continuous growth and innovation, it maintains its competitive advantage.

Manufacturing is key to Ireland’s success “Ireland is an international leader in the life science industry and is one of the top three exporters of pharmaceutical products worldwide.

Part of the sector’s success here is reliant on the ability to deliver the most advanced products to the market through efficient manufacturing processes. For our business, having expert technical teams delivering innovation through compliant, high-level performance, tailored solutions, and process improvements ensures our clients continued success and competitiveness in the market” says Emer Conroy, Director of LotusWorks.

Kate Coleman Senior Director and Principal Consultant, PharmaLex

Maintaining competitive advantage For life science manufacturers, remaining competitive while adapting to the latest developments and challenges in today’s marketplace is an essential consideration. The ability to act quickly and increase production in facilities within a short space of time, can not only contribute to market growth but it can also save the lives of millions worldwide.

LotusWorks has been steadily enhancing its ability to deliver and to work across global operations to help resolve complex challenges faced by companies in the sector.

“It’s always been important to have the ability to work across operations

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and deliver process improvements in partnership with clients but this was critical during the COVID-19 pandemic. Our company’s ability to be agile and responsive enabled our clients speedy response to the everevolving challenge the pandemic posed ” says Conroy.

Fostering knowledge-sharing and a culture of continuous improvement is the driving force behind success in the life science sector says Conroy: “We continuously focus on improvement. In the last 18 months, working in partnership with life science manufacturers, we have completed 21 process improvements and contributed cost savings of over €5 million to our clients. These improvements relate to areas such as safety, manufacturing efficiency, calibration optimisation and data management. We understand how important competitiveness is to our life science clients but we never compromise on quality.”

Powered by experience, LotusWorks has been partnering with leading manufacturers in the life science sector since 1989.

For more information visit: lotusworks.com/en-ie/

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The implementation of Industry 4.0 in biopharma While many companies have expressed interest in the potential of Industry 4.0, they have often struggled with the implementation of digital transformation projects.

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he impact of Industry 4.0 on biopharma manufacturing has been a hot topic for the last number of years. However, there is often a challenge in piloting innovative technology in highly used GMP facilities, which are under pressure to deliver commercial production volumes.

Overcoming implementation challenges Firstly, in order to overcome the industry challenges, companies should develop a cohesive strategy and roadmap for digital transformation with a focus on high value use cases. Many companies lack the requisite organisation-wide roadmap, so they face a number of potential problems.

Digital initiatives are often siloed and uncoordinated, which can lead to duplicated efforts, reduced impact and an inability to change the overall course of an organisation.

Secondly, there is a requirement for investment in digital capability.

Ultimately, biomanufacturing employees are needed to implement digital tools and to maximise their value. Too often there is a default to an IT led system-centric approach that prioritises system selection and assumes value will come from implementation alone. A much higher likelihood of success will come from a business and people-centric approach that identifies and builds talent and then empowers operational staff to implement use cases that deliver value.

Help and support available Multiple consultancy firms and vendors offer commercial solutions to assist with 4.0 projects. State agencies have also invested in organisations such as IMR, Confirm, iForm to collaborate with industry.

From a NIBRT perspective we have driven several 4.0 initiatives which enable industry to upskill their staff and to assess emerging technologies: • NIBRT and Siemens Data Champions kick-starter programme enables companies to upskill their staff on the implementation of data analytics projects in biopharma manufacturing.

• Working with BCG, NIBRT have developed suite of Biopharma 4.0 training programmes on how companies can use cutting edge technologies such as Robotics, Artificial Intelligence, Virtual Reality and Augmented Reality to optimise manufacturing operations.

• Partnering with Lonza, PM Group, Novartis and UCD to evaluate deployment of autonomous robots for environmental monitoring.

Killian O’Driscoll Director of Projects, NIBRT

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Making Ireland a global hub for digital health Ireland’s global medtech hub to leverage manufacturing success to become a global leader in R&D and innovation.

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edical technologies are used for diagnosis, prevention, treatment, monitoring or alleviation of disease.

The Irish Medtech Association is the group which represents the sector in Ireland and our vision is for the Ireland to be a global leader in innovative patient-centred medical technology developments, products and solutions.

Ireland already stands out as one of the top five global medtech hubs, with 450 companies here including nine of the world’s top 10 medtech companies. The Irish medtech industry’s role in saving and improving lives across the world has been highlighted by the COVID-19 pandemic with the OECD identifying Ireland as one of the top five producers of COVID related products.

Before the pandemic, R&D spending in 2019 grew 11.5% marking a return to the double-digit growth for the first time since the 2008 financial crisis.

Hub for innovation Ireland performs above the EU average as a ‘strong innovator’ according to the European Innovation Scoreboard. The medtech industry in Ireland has the ambition to leverage its success as a global medtech hub in order to grow the level of R&D in Ireland.

To support this the Irish Medtech Association developed a guidebook ‘Realise your R&D ambition’, with the Irish Medtech Skillnet, to help companies on their innovation journey in seven steps. Our research revealed that in the last five years R&D activity has increased for over 73% of medtech companies, and more than 74% of companies expect their R&D activities to increase over the next three years.

Futureproofing with digital health One of the strategic areas we’ve identified to future-proof the medtech innovation pipeline is digital health. To drive this Ibec has brought together the Irish Medtech Association, Technology Ireland and BioPharmaChem Ireland for a special cross-sectoral campaign, ‘Where Digital Health Thrives’.

The aim is to enable Ireland to become a recognised global hub for digital health, where companies can develop and commercialise products, as well as attract projects and investments. We have identified more than 200 companies working in digital health in Ireland, and have in depth case studies from companies developing innovative digital health solutions such as S3 Connected Health, BlueBridge Technologies, FIRE1, HealthBeacon, Abbott, Novartis, Boston Scientific, IBM, Odyssey VC. As we work to increase the volume and sophistication of R&D led from Ireland for the global market, we will continue to work with business to offer industry foresight, share best practice, and advocate for policies to help companies achieve they potential by lobbying policymakers.

Sinead Keogh Ibec Medtech and Engineering Director, Irish Medtech Association

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The value of robotics in life sciences manufacturing Robotics are set to be the future of the life sciences industry with their innumerable benefits to manufacturing processes.

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obotics play an integral role along production lines in medical device, biologics and pharmaceutical manufacturing. From parts sorting, product assembly and light machine-tending, to quality inspection and packaging. From environmental and product sampling, to seed laboratory automation, kitting logistics, UV-C disinfection and cleaning processes.

Brian Cooney Managing Director, KUKA Robotics Ireland

Neil Mead Area Sales Manager, South East, KUKA Robotics UK and Ireland

Qualitative considerations of adopting robotics Cleanroom space is costly; the use of robotics reduces the overall footprint. Labour content is traditionally high so consider reduced resource pools and rising costs. Robotic technologies also provide the basis for more applications, versus legacy technologies; cobots, vision, mobile robotics and haptic control which all support this growing sector.

Stringent regulations mean medical device manufacturers must reproduce identical products, under rigorous cleanroom conditions, within reduced time frames. Keeping pace with innovation, manufacturing agility and adaptability, aligned with changing product iterations, is essential.

Why life science sector needs automation The clear shift within life sciences is towards robotics.

Traditional, manual operations are being evaluated for automation and greenfield plant designs incorporate automation as standard. Historically medical device design focused on the ‘use case’ with little consideration of successfully manufacturing at scale. Engineers now engage at concept through launch, ensuring products are designed for manufacture and automation. Operatives are increasingly receptive to the benefits delivered by automated manufacturing.

The features and benefits of robot process automation Modular robotics systems are easy to update and efficient in operation; automated quality inspection systems enable 100% parts inspection; machine vision technology can verify serialisation numbers, satisfying compliance and traceability regulations. Robotic cleanroom processes eliminate human contamination risks for processes involving high toxicity ingredients as operator safety is paramount.

Personalised medicines and medical devices are

Robotics are the way forward Pharmaceutical and biologics companies are investing in robotics, many with dedicated teams further exploring automation opportunities. Robots are increasingly being incorporated into applications as technologies evolve and demand increases, such as for new medicines and treatments.

Notably those arising from COVID-19. Robotic automation is integral to sustaining the growth and evolution of life sciences - an important sector for economic growth, which in 2019 generated a turnover in excess of €80 billion.

How patients benefit from 3D printing technology

B WRITTEN BY Mark Nicholls

espoke medical devices are being created by 3D printing to meet clinical needs in a hospital setting.

The devices, that resolve clinical issues and enhance quality of life for patients, are being made to order by a specialist unit run by the University of Limerick, working closely with doctors at the University Hospital Limerick Group.

Professor Leonard O’Sullivan explains that the 3D printing technology is developing rapidly to create devices that would not generally be available. “In our programme of research, we focus initially on how we can advance plastic-based medical devices that are worn outside the body and can be used to advance clinical care for patients,” he says.

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Innovative 3D printing is being used to make personalised medical devices for hospital patients.

Professor Leonard O’Sullivan Director of the Rapid Innovation Unit, School of Design, University of Limerick and Funded Investigator in Confirm Research Centre

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prohibitively expensive. Automation reduces production costs delivering critical, life enhancing treatments as widely as possible. Consider personalised cell and gene therapy, implants and prosthetics - high variety, small batch production requiring highly flexible, robotic manufacturing processes. Operational benefits include productivity; quality; repeatability; waste reduction, traceability; health and safety; cost savings/ROI.

Smart manufacturing The unit, led by Research Lead Kevin O’Sullivan and Technical Lead Dr. Aidan O’Sullivan is advancing 3D printing as a smart manufacturing technology to benefit patients. Two recent examples include delivering solutions for a teenager with cancer and a child with cystic fibrosis.

Professor O’Sullivan, who is Director of the Rapid Innovation Unit at the university’s School of Design and an investigator in CONFIRM - which is the Science Foundation Ireland (SFI) Research Centre for Smart Manufacturing - says there was a need to cover the cancer patient’s protruding eye to keep out light but ensure the eye remained moist. “The clinical care staff had no current solution, so we used 3D scanning to scan the patient’s face to engineer a bespoke eye cover,” he adds.

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3D plastic printed solution With the cystic fibrosis patient, the feeding tube into the child’s abdomen had cracked but clinicians wanted to avoid replacing it under surgery, so a 3D plastic printed solution was designed and fitted to repair the cracked tube and delivered within 24 hours.

Professor O’Sullivan says this shows the value of 3D printing in delivering a rapid response; finding a solution where one was not previously available; and advancing smart manufacturing technology in a hospital to solve a clinical need where there was no previous alternative.

Working with clinicians The bespoke devices also recognise that patients, and their medical conditions, vary in shape and size whereas traditional medical devices are made in set sizes. The team recently moved manufacturing to the hospital site to work more closely with clinical colleagues to understand the day-to-day challenges they face.

Professor O’Sullivan says: “By locating the smart manufacturing technology atthe hospital brings us to the ‘coalface’ so we can interact with our clinical colleagues in exploring opportunities for advancing and applying the technology. Collaboration in design and manufacture is crucial.”

CONFIRM is Ireland’s research centre for cyber-physical, intelligent, networked manufacturing systems and digital supply chains enabling high-impact business transformations. confirm.ie

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Cell and gene therapy: an exciting landscape Cell and gene therapy (CGT) aims to treat, prevent, or potentially cure diseases and has the potential to alleviate the underlying cause of genetic and acquired diseases.

A John Milne PhD Training Director, NIBRT

look at therapies already approved or currently in development in the CGT area clearly demonstrates the interest in these treatments by the wider biopharmaceutical industry.

Cell therapy has been used for many years, for example in bone marrow transplantation. However in the context of CGT, cell therapy refers to cells that have been expanded or modified through exposure to growth conditions outside the body. Cell therapies can be classified as autologous (where a patient is treated with their own cells) or allogeneic (where a patient is treated with cells from another individual).

Gene therapy involves the administration of genetic material to modify or manipulate the expression of a gene product. Genes provide the specific information to produce proteins crucial for life. Gene therapy can replace a gene that causes a medical problem with a healthy copy of the gene, add genes to help the body to fight or treat disease or turn off genes that are causing disease.

Gene therapy involves the administration of genetic material to modify or manipulate the expression of a gene product.

the immune system) are harvested from cancer patients, re-programmed with a specific gene delivered by a viral vector, expanded, tested and infused back into the patient.

The gene modification allows the modified T-cells to detect and kill the cancer cells and have the advantage that they can persist in the patient after the cancer is effectively treated.

Cell therapy refers to cells that have been expanded or modified through exposure to growth conditions outside the body.

Opportunity for Ireland Given Ireland’s tremendous success over recent years in positioning itself as a major international hub for biopharmaceutical manufacturing, there is now great potential to embrace the opportunity that CGT will undoubtedly bring.

Collaboration between stakeholders drawn from government agencies higher education institutes and the wider industry, to provide the necessary workforce of the future, is underway and will be crucial to our success in this area.

Modifying genes for targeted therapy Gene modified cell therapy combines both cell and gene therapies where cells are genetically modified outside the body and infused into the patient. A good example is CAR-T cell treatments, where T-cells (crucial cells in

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Current trends shaping the life sciences industry The rapid development of COVID-19 vaccines has put life sciences in the spotlight, casting a positive glow over the industry’s ability to innovate. Global pandemic aside however, there is continuing progress and innovation across the life sciences industry.

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harleen O’Keeffe and Laura Scott, partners in law firm William Fry, leading advisors to the sector, have been well placed to observe recent trends emerging among life science clients.

Charleen O’Keeffe Partner, William Fry

Laura Scott Partner, William Fry

Digitalisation of the life sciences sector The life sciences sector globally is undergoing a digital transformation. The potential benefits of emerging technologies to the industry are vast.

“By fully embracing digitalisation, life science companies can achieve superior patient outcomes in terms of their products as well as drive efficiencies and costs savings” says O’Keeffe.

There has been a clear move away from the ‘one size fits all’ approach to medicines and medical devices, according to Scott. This has been replaced by an increasing focus on personalised therapies and patient-centricity, enabled in part by digitalisation. Life science companies are harnessing data and analytics to catalyse the development of innovative products and services.

The benefits of digitalisation are also clear from a cost-effectiveness point of view. O’Keeffe points to the example of new drug development “From the analysis of unwieldy volumes of clinical data, to the use of digital communication platforms for improved interactions between patients and doctors and fast and secure data exchange using blockchain technology, digitalisation will have a significant impact on the bottom line for contract research organisations and companies developing new products.”

A move towards disease prevention and early detection Going hand in hand with this is an increase in R&D being dedicated to prevention and early detection. For example, there has been a rapid evolution of smart, wearable technology, as well as the growing development of in-vitro diagnostic medical devices and implantable medical devices.

“We have progressed from pacemakers for arrhythmia patients to implantable cerebellar stimulators for the treatment of movement associated disorders,” Scott says. Similarly, O’Keeffe points to the growing number of indigenous start-ups involved in cutting-edge technologies as evidence of Ireland’s prowess. This acceleration of innovation in the medtech space looks set to continue and Ireland is likely to play a key role in

the industry’s future, spring-boarding from its wellestablished reputation as a manufacturing centre.

Indeed, Ireland is currently Europe’s second-largest exporter of medtech products, with annual export values exceeding €12.6 billion.

As medical devices have developed, so too has the regulatory framework protecting patients.

Last month, the Medical Devices Regulation became fully applicable across the EU, signifying a much anticipated strengthening of the regulatory framework for medical devices in Europe. O’Keeffe says that getting to grips with additional obligations under the new regime has presented challenges for all economic operators across the supply chain.

The future of medicines Looking ahead, both Scott and O’Keeffe again point to the growing importance of personalised medicines and the treatment of rare diseases.

Their clients are increasingly focused on breakthrough treatments, such as advanced therapy medicinal products (ATMPs). These medicines, based on genes, tissues or cells, offer “groundbreaking new opportunities for the treatment of disease and injury and have the potential to make truly personalised medicine a reality.”

Scott is optimistic about Ireland’s role in this future of innovation. “Ireland punches well above its weight in the life sciences industry. We have maintained a track record as a centre of innovation and excellence for manufacturing, from traditional small molecule pharmaceuticals to large molecule biopharmaceutical manufacturing more recently.”

Support institutions like the National Institute for Bioprocessing Research and Training, which offers training and research solutions for the biopharmaceutical manufacturing industry, contribute to maintaining this reputation.

O’Keeffe agrees, adding that with the correct supports, Ireland has an opportunity to remain at the vanguard of the global life sciences sector, and in particular, to become a hub for the global supply, management and manufacture of ATMPs.

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How Ireland is playing a leading role in life science transformation The life sciences sector in Ireland has played a critical role in the COVID-19 pandemic and now with increased industry commitment is set to become a world leader of innovation.

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ore than ever before we have witnessed the significant and important contribution that science, research and innovation play in our daily lives as we have responded to the COVID-19 pandemic.

Here in Ireland, the sector has supported the national and international response throughout the crisis and recently we had the welcome news that Pfizer will establish a vaccine manufacturing facility in Ireland, a further demonstration of the strength of the sector.

Value of life sciences to Irish economy Life sciences remains a critically important sector for the Irish economy. The total life science sector, across medical devices, pharma and bio in Ireland exports more than €45 billion annually and employs over 50,000 people directly, contributing significantly to our economy at national and regional level.

SFI has a goal for Ireland to be a global innovation leader, with this in mind, early this year we launched our new strategy – Shaping Our Future. This has two core ambitions: Delivering Today and Preparing for Tomorrow. Driven by increased investment in research we aim to evolve our collaborative enterprise facing programmes, develop new approaches to investing in emerging areas of science and to provide solutions to the challenges we face as a society.

Professor Mark Ferguson Director General, Science Foundation Ireland and Chief Scientific Advisor to the Government of Ireland

The total life science sector, across medical devices, pharma and bio in Ireland exports more than €45 billion annually and employs over 50,000 people directly, contributing significantly to our economy at national and regional level.

Key aspects of our new strategy include building on the successful collaborative research environment primarily driven through the 16 SFI Research Centres, continuing support for home grown research talent, attracting leading research talent to Ireland, providing a worldclass training environment for young researchers and encouraging a dialogue with the general public.

A leading role in life science innovation With the many new tools now available – synthetic biology, super-computing, genetic technologies, artificial intelligence, advanced imaging and fast communications - the pace of discovery and innovation has rapidly increased. We in Ireland are well positioned to play a leading role and contribute to advances that have the potential to positively transform our society and bring economic prosperity.

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The value of forming a new unique academic-enterprise faculty for Ireland An innovative enterprise-academic partnership has been formed to help meet the economic and social challenges posed by the COVID-19 pandemic.

K Professor Anne Greene Senior Lecturer and Chair of Convene Enterprise Faculty Working Group WRITTEN BY Mark Nicholls

ey employment sectors and two major academic institutions have established a collaborative partnership to help overcome challenges created by the COVID-19 pandemic.

Central to the effort is Convene, a new enterprise-academic partnership that brings together Technological University Dublin (TU Dublin) and University College Dublin (UCD) with 34 founding Enterprise Partners, to deliver the skills and innovation to reinvigorate business, fast-track a resilient economic recovery and renew communities in a sustainable manner.

Shared learning With €17.5 million of government funding, Convene will see the creation of an Enterprise Academy organised around seven employment sectors: tourism, food and drink, creative and cultural, social enterprise, ICT/fintech, medtech and pharma.

The collaboration will combine expertise from the UCD Innovation Academy and TU Dublin’s academic schools and research and innovation centres, with that of the Enterprise Partners, including several from the pharmaceutical and life science sectors.

A new ‘Enterprise Faculty’ - comprised of leaders from business, industry, academia, innovation and research - will facilitate a two-way flow of ideas between the universities and employment sectors.

Professor Anne Greene, Chair of the Convene Enterprise Faculty Working Group, says: “The Enterprise Faculty is charged with developing unique business focused educational models.

“Our Accredited Talent Development model will support companies, professional bodies and other organisations to design, accredit and run their own courses, as well as focusing on new, innovative and agile ways to foster skills training.”

Find out more at convene.ie

Revitalising business Some sectors have adapted or seen growth during the pandemic, but other areas such as tourism, food and drink, and creative and cultural enterprises have struggled. “Some, such as food and drink, have seen their business model flipped and move from the traditional restaurant into the outside space,” she says.

“Convene can work with these sectors in supporting innovative ways of rebooting and revitalising them.” In addition, a face-to-face forum is planned for 2022 to kickstart the tourism and food and drink sectors, while the faculty is working with Screen Skills Ireland to offer support to creative industries.

New expertise can be developed in close collaboration with researchers, industry and professional bodies and regulators for the sector.

Emerging skill needs Support covers enterprises from major industry to start-ups, creating jobs in a sustainable way and anticipating the rapidly emerging skill needs of enterprise. The life sciences/pharma sector has evolved during the pandemic, but Professor Greene suggests that the benefits of this can “trickle down” into the community in terms of jobs and opportunities.

Convene is working with the TU Dublin’s School of Chemical and Pharmaceutical Sciences City Campus to deliver biopharma skills and bring the university to the workplace.

Head of School, Professor Declan McCormack, says: “A workplace-based approach offers many advantages in that graduates from ancillary sectors can be cross-trained into the industry, industry-based employees can be upskilled, while new expertise can be developed in close collaboration with researchers, industry and professional bodies and regulators for the sector.”

Associate Professor John Behan, Head of School of Science & Computing at TU Dublin Tallaght Campus, says: “ Convene is a very welcome and exciting addition to the enterprise-academia landscape, and will offer an ideal mechanism to expand on existing engagements and allow the development of new agile partnerships with the pharmaceutical and life sciences sector.”

Convene was awarded funding of €17.5 million, under the Human Capital Initiative Pillar 3 Fund announced by the Minister for Further and Higher Education, Research, Innovation and Science, Simon Harris TD. In support of shared skills and innovation goals, Convene is harnessing the expertise of the UCD Innovation Academy, 12 TU Dublin academic schools, 10 TU Dublin professional service units, 5 TU Dublin research centres, 3 TU Dublin innovation centres and an ever-expanding number of Enterprise Partners.

Paid for by Convene

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Putting patient safety front and centre for the pharma and biotech industry Vaccines and therapeutics must be subjected to rigorous safety testing before they are used by patients. That’s where the work of outsourced contract service providers plays a critical role.

Paid for by Charles River Laboratories Ireland Limited

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efore a vaccine or therapeutic reaches the market, it must undergo a barrage of validated tests to make sure that it is safe and efficacious for patients to use.

Take the COVID-19 vaccines, which — despite their speedy roll-out — underwent the same strict processes as any other vaccine before they could be approved by the regulators.

“That rigorous regimen is essential and for very obvious reasons,” says Dr Carmen Sweeney, Scientific Director at Charles River Laboratories Ireland Limited. “Ultimately, patient safety is always paramount.”

The staff at Charles River know all about the importance of patient safety. As a contract research organisation (CRO), its products and services help pharma and biotech companies develop novel drugs and therapeutics from early phase discovery through to market.

It’s also imperative for a CRO to have good communication across all of its divisions to manage client expectations. There’s no point in us promising something we can’t deliver.

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The value of outsourcing to a third party Charles River has been helping pharma companies with COVID-19 research from the start of the pandemic. “In Ireland alone we’re involved in the batch release and safety testing of one of the main COVID vaccines, and we’re about to embark on work for another.

The pandemic has been an unprecedented event that has had such a terrible impact around the world, so it’s exciting to know that our services can help put a product onto the market that is going to save lives” says Dr Sweeney.

However, anyone outside the

biotech industry might be surprised to learn that contract research organisations are necessary. Because don’t pharma companies have their own in-house experts and facilities to run vital biologics tests themselves?

Why do they need to outsource them to a third party?

“It depends on the company,” explains Dr Sweeney. “Our clients are varied and include big pharma, mid pharma, virtual biotech startups, universities and government agencies. Not everyone is the same and not everyone has their own in-house capabilities. And the fact is that CROs are experts in their field who do this kind of work, day in, day out.”

Much of the work carried out by the company involves cell and gene therapy products — a promising and evolving area of medicine. “The great thing is that cell and gene therapy products are able to target serious, life-limiting diseases, and can give people more hope and more time,” says Dr Sweeney. “If successful, they can make profound, dramatic and very evident changes.”

Adhering to timelines while following strict procedures The best CROs will always be mindful of clients’ timelines — but never at the expense of patient safety. Even in the middle of global pandemic, corners are never cut, and steps are never missed. “Quality always come first,” says Dr Sweeney. “It’s also imperative for a CRO to have good communication across all of its divisions to manage client expectations. There’s no point in us promising something we can’t deliver. But it is important to do things right first time, on time.”

Being flexible and adaptable is key, too. “In Ireland, our site is very different to how it was three years ago because we’ve extended our capabilities and broadened our service offerings,” says Dr Sweeney.

“We’ve had to adapt in order to meet growing client needs and demands, and as a consequence of Brexit. And most recently we developed the capability to support biosafety level 3 (BSL3) pathogens like SARS-CoV-2 to meet the needs of our customers in the fight against COVID-19.”

Of course, CROs are service providers — they don’t develop their own products. Isn’t that ever a source of frustration for Dr Sweeney and her team? “Not really,” she says. “That’s because we get to work with all kinds of different products. We don’t forget the importance of our work and never lose sight of the bigger picture, which is getting medicines to market that can help patients. COVID has brought that into sharp focus. It really is an honour to do what we do.”

Dr Carmen Sweeney Scientific Director, Charles River Laboratories Ireland Limited WRITTEN BY Tony Greenway

Find out more at criver.com/ Ballina

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