Life Sciences campaign 2017

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Life Sciences RESURGENCE

Barry Heavey on how increased investment is leading to new job opportunities p2

HEALTHCARE

Oliver O’Connor discusses balancing patient care and innovation. p6

SECTOR GROWTH

Deidre Glenn shows how Ireland are performing on a global scale p6

The research landscape How is R&D advancing life sciences in Ireland and how can we secure further investment? p10 PHOTO: ENTERPRISE IRELAND

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iN THIS ISSUE

What is being done to bridge the skills gap?

Matt Moran, Director, Biopharmachem Ireland explores P4

Regulatory change is coming, are you ready?

Dr Áine Fox Senior Executive, Irish Medtech Association offers her advice P8

Extended Q&A on post Brexit opportunities With Simon McKeever, Chief Executive, Irish Exporters Association ONLINE

Investing in our future

Over the last number of years, Ireland has made its mark as a thriving research environment, one with a unique combination of large-scale strategic and technical manufacturing.

W

e’ve seen a very strong resurgence in the Life Sciences sector, primarily driven by new drug approvals in the pharmaceutical industry. Many of those new drugs will be manufactured in Ireland, and that has led to increased investment and, additionally, thousands of new jobs.

A lot of the growth has been in biologic drugs or biopharmaceuticals, which are more complex drugs and difficult to manufacture. There has been a shortage in capacity for manufacturing these new drugs globally, but Ireland has won a lot of new investment to support manufacturing capacity for these new complex drugs. In terms of attracting foreign direct investment in advanced manFollow us

ufacture in the Life Sciences, Ireland are probably number one globally – we’ve won close to €5 billion in the last five years of new investment. We have a very strong track record in advanced manufacturing and getting large projects up and running in a timely and cost-effective way.

Filling the skills gap Finding people with the right skills to support large investments is a number one challenge the industry faces globally and Ireland certainly isn’t immune to that. We need to grow our skills base, and get more people excited about the Life Sciences and the career prospects it holds. We invested €70 million in creating a dedicated training centre for the industry called NIBRT (National Institute for Bioprocessing Research and Train-

@MediaplanetIE

Barry Heavey Head of Life Sciences, Engineering and Industrial Tech, IDA Ireland

“We’re watching the next generation therapy space very closely” @MediaplanetIE

ing) in collaboration with many universities around the country which has been a success. Equally, SFI (Science Foundation Ireland) funded SSPC (The Synthesis and Solid State Pharmaceutical Centre), to support the small-molecule industry, focused on the development and manufacture of chemical-based drugs.

We need to ensure the pipeline of graduates coming from college really understand what the challenges are in industries now and in the next few years.We see the potential for not only industry-academic collaboration, but also business-to-business collaboration. There are many companies who have similar challenges in the manufacturing process and are considering similar investments, while other companies are developing solutions and may have solutions for others. @MediaplanetUK

In the next few years, we’re going to potentially see a big growth in next-generation drugs and therapies, such as cells therapy – using cells to treat diseases like cancer especially – and gene therapy also to treat diseases previously proved difficult to treat, along with combinations of both. So, we’re watching the next generation therapy space very closely. The other area of real opportunity is in convergence – the convergence of the biopharmaceutical industry with the medical device industry in areas like advanced drug delivery, and also convergence with the tech sector – in order to provide better outcomes for patients. Given Ireland has strength in all these areas – biotech, medtech and tech – we could really make it in that space.

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Commercial feature

Creating a valuable team for innovation

NUI Galway is home to with Ireland’s only licenced s Research and development: NUI Galway is home to Ireland’s only licenced stem cell manufacturing centre and its Bioscience Research Building has over 8,000 metres of lab space. Photo NUI Galway.

By Clodagh Dooley

World-class research universities should be designed to take a longerterm view, invest more, look ahead to the future, and hone the competitiveness of companies and universities.

Professor Lokesh Joshi, Vice President for Research at NUI Galway, explains.

lenge, we need interdisciplinary or transdisciplinary teams, in which experts from distinct scientific disciplines can bring us closer to a solution. Sometimes you will have that in Ireland, but sometimes you won’t, so one needs to look across the globe and find both industry and university partners worldwide as well.”

Education in Life Sciences increases our understanding of the nature of life and disease, which is important in itself. But, Life Sciences has a greater potential – that of representing a platform for new industry in Ireland, with new jobs, products and services for the benefit of society, especially in the health sector.

“For such a small country, Ireland is so vibrant and very adaptable to the health needs within the global market,” says Prof Joshi, whose own research background is in biosciences. “Irish universities are playing an essential role in advancing and supporting the Life Sciences industry today – not only in terms of coming up with creative ideas, but also in helping industries to refine or test ideas.

“This is always the power of collaboration, because research is now moving away from the individual, and his or her expertise or single approach, to resolving global challenges. And, to find an innovative solution for a chal-

Making priorities And where groundbreaking research happens, investment will follow. “I feel that Ireland is doing far better in terms of investment than many other economies in small countries, even in the advanced world,” says Prof Joshi.

“There are more funding opportunities for anything from small projects to large projects, and the chances of success are higher here in Ireland.

“There is a realisation within the university community, research community, and within the country as a whole that because we are a small country, Ireland has to prioritise investment in research. This strategic investment, and the quality of our academic research, can be further used to attract and retain MNCs. “Ireland has become known as the largest MedTech employer across Europe, so businesses know there is local, skilled talent ready for their new venture. This has been helped by the close links that the industry has formed with

Professor Lokesh Joshi Vice President for Research, NUI Galway

“We need to be very aware of the needs for the next generation of technologies – where is technology moving globally” education centres in Ireland and initiatives such as the BioInnovate Ireland training programme.

“MedTech’s strength was also boosted by the formation of CÚRAM, based here in our University, representing an investment of over €40 million from Science Foundation Ireland and industry.

“Ireland is a hub of MedTech activity, as a result of three full decades of investment and strategic thinking, planning and de-

livery of that. We have created an ecosystem whereby industries and universities work together often supported by our agencies, such as Enterprise Ireland, IDA Ireland, Science Foundation Ireland and the Health Research Board – so that has made a very rich ecosystem of MedTech research and industrial clustering in Ireland. That’s how you make a successful cluster – you have the right partner – in academia, in government, and in industry.”

Looking to the future Prof Joshi feels that by continuing to have a strong record in teaching biomedical sciences, in developing new courses, and in encouraging a sharp focus on standardised and systematic views of managing innovation, the future of university research should remain bright.

“We need to be very aware of the needs for the next generation of technologies – where is technology moving globally, because we are part of a globally competitive environment. People will only work with us if we are the best, so we need to be fully aware of where the needs are, and if we have the capacity, the best ideas, and the best way of delivering these ideas.

“We’re in an age of acceleration and I think we will see transformation in relation to what can be done in Life Sciences. For ex-

ample, we have Ireland’s only licenced stem cell manufacturing facility, which is used to manufacture cultured stem cells for human use. In the next couple of years, we should see these manufacturing technologies widely used by industry as they engage with us. With the translational research facilities available as well, there is really a full offering available for the sector.

“There’s a tremendous enthusiasm and participation in Ireland to find solutions and to make a contribution to the Life Sciences industry, so this is a very exciting era that we are living in. When you want to solve problems, you need people with complementary skills and those that are aligned. Industries can bring expertise of business models – they know exactly what they want, they know how to manufacture, and they understand the market needs. Universities can provide the academic rigour, proper design of studies, and complementary research expertise.

Such collaborations can create synergies to enhance the impact - on health and on society - of our research. www.nuigalway.ie/medtech @researchatNUIG

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STATS

Employment in the sector has grown from

5,200

28,000

in 1988 to

in 2016.

Over half of which are third-level graduates compared to the national average of

24 per cent

In addition 28,000 people are employed providing services to the sector.

Employment in Biologics manufacturing accounts for around

6,000 employees

Given the recent investment announcements, we should consider the future scenario whereby an additional 5000 staff could gain employment in Biologics manufacturing over the next five years increasing overall employment to

11,000

The sector has benefited from the increased output of PhD researchers, employing approximately

25%

of all PhD researchers currently employed in Irish industry Source: BioPharmachem Ireland

Working together: Collaboration between universities and industry are key to growth. Photo: Thinkstock

The potential for growth

By Clodagh Dooley

Matt Moran, Director at BioPharmachem Ireland, speaks about the expansion of opportunities within the biopharmachem sector, and how both industry and academics can take advantage.

The Irish biopharma industry is going through a significant cycle of investment at the moment,” says Moran.

“Capital investment projects, valued at approximately €4-5 billion, have been completed or are currently in progress around Ireland today.

In Dublin and in other parts of Ireland, there are many large companies who are completing, or have completed, biotech manufacturing plants which will create some new jobs by the end of this year.

“Most of the investment taking place now is in biotech, which would currently be the cutting edge of pharmaceutical manufacturing. So, we are very much in expansionary mode.”

Along with expansion comes opportunity, and Moran says that while Ireland’s talent pool is a key global competitive advantage, it is vital to ensure that highly-trained people are available for the biopharma industry.

“The Expert Group on Future Skills Needs (EGFSN), a government-sponsored body, conducted a study on the industry to identify what the talent opportunities will be in the future. Last August, they published an interesting report where they identified over 8,000 job opportunities, both through new investment and through replacement of existing staff, as they retire between now and 2020. There’s a need for filling roles across the range of science

Matt Moran Director, BioPharmachem Ireland

disciplines, engineering disciplines, manufacturing, development, analytical support, and so forth.

“So, as an industry association, this has become a priority for us. We have a very active skills group and a programme of initiatives to try and ensure that those opportunities are filled. We support graduate fairs, graduate development, meet third level institutes to ensure that courses meet the needs of industry, and promote careers in the industry.

We’re also have our Biopharma Ambition event, to showcase the ambition of the industry in providing future health solutions.”

‘Partnerships are vital’ With one of the key advantages of Ireland’s biopharma sector being the productive collaboration between industry, academia and the Government, Moran stresses the importance of further enhancing this relationship – both by continued investment in education and in showcasing the skills of academics that are best suited to the workplace.

“Partnerships between universities and industry for work placement is vital. We ran a Job Seek-

er programme in collaboration with Skillsnet, the Department of Social Protection, the IDA, Tallaght Institute of Technology and various partner companies. Over 30 graduates were given threemonth placements and most of them were then offered full-time positions. NIBRT (National Institute for Bioprocessing Research and Training) are also continuously developing its training offering to supply highly-educated people for companies.”

Moran says career and industry days are also essential in helping to bridge the gap between third level education and the current skills demand of the industry.

“It’s about building good communication between companies and institutes. The institutes can find out more about the companies, and the companies can find out more about the institutes – thereby ensuring that the graduates have suitable skills to work in the industry.

“If you look at the EGFSN report, there’s approximately 5,000 Life Sciences graduates released every year, which is a significant amount – there’s probably enough graduates to fill the opportunities in the industry.

“We are seeing expansion in large-molecule manufacturing in Ireland. It’s a well-embedded industry and more development-type activity is happening. We’re also seeing more specialised shares services taking place and more supply chain management being run out of Ireland. The industry will continue to grow. Ireland is one of the main global manufacturing hubs and the biopharma sector is very important for our country – we just need to ensure our research, innovation and manufacturing excellence is maintained.”

Commercial feature

Evolving with an emerging industry

By Clodagh Dooley

Worth over €30 million in exports, today’s biopharmaceutical industry is booming.

For companies in this climate of high innovation and constant changes, the ability to act rapidly and flexibly is of vital importance.

“The biggest change we have seen in the biopharma industry since the 1960’s has been the emergence of biologics,” says Mr. Greg Beattie of Charles River Laboratories. “Biologics are very large, complex molecules produced from live cells and require very different approaches for development than traditional ‘small molecule’ drugs that are developed using more standard synthetic chemistry methods. “ Producing and developing new biologics is a difficult and lengthy process. In turn, the biopharma industry has gradually become more willing to look to CROs (Contract Research Organisations) and embrace the concept of outsourcing and insourcing, as they search for new sources of discovery and innovation.

“Companies are designing more complex, large molecule drugs now, which are more difficult and challenging to test and manufacture,” says Mr. Beattie. “One of the biggest restraints for biopharma companies is the cost associated with bringing a product from concept through

to market. So, many companies are looking to outsource more, particularly some of the virtual companies emerging today.”

“For CROs, it’s about partnering with clients by understanding and assisting with everything from early identification of a target and preclinical development of that product, through to commercialization efforts including ongoing batch release and potency testing.” By involving CROs in their development efforts, companies are given an opportunity to enlist the efforts of scientists that have worked on many similar products. This increases the efficiency and speed at which a product moves through the development process and allows pharma and biotech companies to focus on their core competencies.

“CROs that help from the early stages, right through to manufacturing and release of product, are strategically placed to help large companies. It is much easier to move relevant assays and product knowledge within one company rather than transfer them between different CROs. Likewise, they are better placed with smaller companies who don’t have the resources or in-house capabilities to bring their concept through to market.”

Quality Mr. Beattie says that because Ireland has strict regulatory

Greg Beattie Corporate Vice President, Global Biologics Testing Solutions, Charles River

requirements, companies can rest assured that the level of testing CROs are doing is of a high quality standard.

“Ireland is strictly monitored and the regulatory environment is overseen by the most stringent and respected authorities, the HPRA (Health Products Regulatory Authority) and the FDA (The United States Food and Drug Administration). There’s a strict set of guidelines and standards we must follow, and they’re very heavily enforced.”

“With testing performed at CROs, clients can get a result and be assured that the assay has been executed to the best and highest possible standard in a relatively short turnaround. The client doesn’t have to oversee it or check that each test is done correctly and in compliance.” According to Mr. Beattie, Ire-

land is a top location for pharmaceutical investment.

“It’s amazing that for a country of its size, Ireland is one of the major players in terms of the pharmaceutical market and I’d go as far to say that it is a centre for excellence, a growing hub for research and development in particular. There is a huge influx of money and investment in Ireland, both from a government standpoint and also from the major pharma companies. Some of the biggest pharma and medical device companies are headquartered in Ireland.”

“There’s been great investment from the Industrial Development Authority Ireland and Science Foundation Ireland, to name but a few, because they recognise the potential in Ireland. This is because of the nature of the education and the high-quality of students that emerge from higher education in Ireland.”

Growth Mr. Beattie says that as the industry continues to evolve, we need to ensure we are evolving with it.

“I expect that we will see continued growth in the development of biological therapies, including monoclonal antibody, hormone, vaccine and cell and gene therapy products.

There’s a lot of new and emerging diseases and a wealth of therapeutic and prophylactic products yet to be discovered. The human body is com-

plex and as we continue to learn more, we will discover more target areas and ways to treat emerging diseases.”

“It’s an exciting time. We’ve come through a very lean few years, but now we’re seeing more movement, growth and investment. Everyday we’re hearing about new jobs and more companies rooting themselves in Ireland. We need to make sure that we’re best placed and aligned to meet the growing demands and growing needs of clients. And, that’s incumbent on all CROs, and ourselves – to ensure we are able to meet that growing need and demand and ultimately help to deliver therapies to the patients that need them.”

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Q&A

Deirdre Glenn Head of Life Sciences, Enterprise Ireland

The only way is innovation Deirdre Glenn, Head of Life Sciences at Enterprise Ireland, speaks about the role of Irish-owned organisations within the Life Sciences sector.

How is Ireland’s Life Sciences sector performing on a global level?

Foreign investment laid the groundwork for developing the modern Irish economy. Today, a significant part of Ireland’s economic, industrial and export growth comes from Irishowned enterprise. Ireland has developed a powerful base of world-class exporting companies focused on innovation and internationalisation.

Ireland’s Life Sciences sector is of key importance to the Irish economy and has continued to grow year-on-year, despite the recent global recession and the challenges facing Ireland. The sector has evolved into one of the leading global clusters and now exports more than €50 billion annually, with direct employment of 50,000 people in MNC and indigenous industry. The cluster is becoming increasingly integrated, including world-class researchers, innovative start-ups and established indigenous companies supported

by Enterprise Ireland (EI); leading global multinationals supported by the IDA; private investors and VCs; clinical specialists; and important ancillary service providers.

What constitutes a successful Irish company?

The indigenous sector is an important component of this Life Sciences cluster with over 250 EI client companies employing over 6,500 people, with annual sales and exports more than €1.5 billion and €1.2 billion respectively. The indigenous company base has extensive capabilities across the Life Sciences supply chain, including design and development; the manufacture of medical sub-supply components; diagnostics and medical devices; digital health; the manufacture of active pharmaceutical ingredients; the manufacture of human and veterinary finished products; the provision of pharma/biopharma services including clinical trials management, regulation, engineering and construction; and drug discovery/development/delivery.

What will make Irish businesses stand out in the competitive Life Sciences sector?

Research, Development and Innovation (RDI) is well recognised as a key economic differentiator. As a small open economy, Irish firms must innovate and make products that are cheaper or better than those in foreign markets. EI’s role in this regard is to de-risk such RDI so that companies will develop new and improved technologies, products and services. We operate a range of supports to help companies drive their own internal RDI capacity and to help them engage with third level researchers and the clinical community, to undertake collaborative market-led research for the benefit of the company and deliver innovative products in a cost-effective manner.

Innovations: The Applied Optics Group at NUI Galway are pictured working with adaptive optics. Photo: NUIG

Within reach: Accessing valued treatment

By Clodagh Dooley

Oliver O’Connor, Chief Executive of the Irish Pharmaceutical Healthcare Association (IPHA), discusses the standards that can help to ensure the healthcare needs of Irish patients are met with valued, innovative medicines.

In Ireland, pharmaceutical pricing can be an issue,” says O’Connor. “However, the IPHA have entered into a binding Agreement on the Supply and Pricing of Medicines to the Health Services with the Government. The Agreement provides a reliable framework for the process of bringing new medicines into the health services, and the pricing at which new drugs are offered and how this is changed every year.

“Under the Agreement, the pricing of community and hospital prices in Ireland is set to an average of ex-wholesaler price from 14 EU Member States and this is adjusted every year, downwards only. We have provided €12 million per month in savings since the 1st of August last year.”

As well as having a predictable pricing framework to enable patients access to the medicines best suited to their needs as quickly as possible, O’Connor says it is vital that the reimbursement process is also predictable and administered efficiently.

“An important part of this is ‘horizon scanning’ – reviewing new medicines that are to be offered into Ireland. This means that companies will show the HSE what they are intending to bring forward next year, so that the HSE will be able to provide adequate budgeting as well as plan the process properly, to ensure there is equity among all patients and one type of medicine doesn’t jump ahead

Oliver O’Connor Chief Executive, Irish Pharmaceutical Healthcare Association (IPHA)

of the queue. “If companies don’t go through a horizon scan, they may find themselves in a position where this new medicine has come up, patients need it, but the HSE hasn’t budget availability for it.”

Having a global outlook Before medicines are granted a license in Ireland, they must go through several stages of clinical trials. O’Connor says although the industry is continuing to invest in new research and development in universities and hospitals, Ireland still has some distance to go to get to the level of clinical trials seen in other countries. “Countries like Denmark have good patient registries which makes it easier to set up a trial because you know the number of patients, their medical history, and so on. We don’t have that across the board in Ireland – in some areas, it is good but in others, it’s not. It’s a broader issue, but building patient registries does require more investment in IT in the health service.”

Another challenge which may hinder patients’ access to fast and

effective treatment by health services is the increasing threat of counterfeit medicines. However, with the upcoming introduction of the Falsified Medicines Directive, O’Connor says patients will feel more reassured.

“This major project, which has been in discussion around Europe for several years, will help to minimise the chances of counterfeit medicines entering into the medicines supply chain. Pharmacists (the IPU), manufacturers, wholesalers, importers and everyone who supplies medicines to patients, will put in place a system to verify the authenticity of a product. By February 2019, every medicine will be checked to ensure it’s the real thing – this will happen over 100 million times, in less than one third of a second every time”.

“Each pack will be barcoded, which will be authenticated before dispensing, so it’s a huge procedure to coordinate all the data and organise the barcodes on an entire European basis. Very soon, we will have a National Medicine’s Verification Organisation set up here, which will work to ensure this verification system is in place in two years’ time.”

And, with Ireland also in a bid to bring the European Medicines Agency (EMA) from London to Dublin post-Brexit, the protection of human health can only strengthen in Ireland.

“The re-location of EMA to Dublin would highlight Ireland as an area of significance for the pharmaceutical industry in Europe and globally. It would show that we are a highly-regulated country with high-skilled people, both in terms of the regulation of medicines and Life Sciences, and we take our standards and regulations very seriously.”

COMMERCIAL FEATURE

The changing face of Ireland’s healthcare industry

By Tony Greenway

The healthcare industry in Ireland has become far more patient-focussed in recent years — which means that pharma companies are having to re-think their operations and their strategies.

In the last few years, the international life sciences landscape has changed dramatically. In Ireland, the industry is still as important as ever to the economy, of course, because it’s home to 18 of the world’s top 20 pharma companies, directly employs over 50,000 people and has the largest cluster of medical device companies in Europe. “For a small country, we punch well beyond our weight,” says Tim Cotter, Head of Life Sciences, Business Consulting Grant Thornton.

The difference now is that the pharmaceutical industry is rapidly moving towards patient centricity as a business model - a change that has been dictated by the healthcare payer and the patient, who are looking for a more concentrated focus on value and

more positive outcomes. “There has been what is termed a ‘value versus volume’ revolution,” says Elaine Daly, Partner, Head of Business Consulting, Grant Thornton. “Previously, the emphasis in the industry was simply on the production of drugs. Now it has to consider the whole of the patient’s health. This means that companies need to focus on early intervention and integrated care. They have to be more connected in terms of the way they design and develop products, such as apps which can make an individual’s health information easier to access and promote self-monitoring. Organisations now have to be more agile in responding to changing market conditions and patient demands - whether that’s at research stage or at a development stage - to make sure they are fulfilling patient needs at all times.”

Cultural shift To do this effectively, pharma companies need to make a complete cultural shift in terms of their structure.

Elaine Daly Partner, Head of Business Consulting, Grant Thornton

“At an operation level, they have to assess how they attract the right talent and the right leadership in order to motivate their salesforce and embed this new patient-focussed emphasis into their organisational culture,” says Daly. “This means having people on board who can understand the patients’ needs from a drug perspective and also from a non-drugs perspective.” On a strategic level, it’s important to put systems in place to manage change and

Tim Cotter Head of Life Sciences, Business Consulting, Grant Thornton

implement the required strategy to ensure your organisation can succeed in its shift toward patient centricity.

“This is a hyper-competitive industry,” says Cotter. “Any company that doesn’t embrace changing trends and changing models is going to get left behind.” Grant Thornton are ideally positioned to assist organisations in the Life Sciences sector to cope with such changes as they possess international expertise which can be leveraged to the

national market across a broad range of service lines to shape a new culture including changing business models and structures and adopting new approaches to patient centered leadership and service delivery.

This isn’t going to switch any time soon, either. “In the next three to five years, the industry trend will continue further towards patient-centred outcomes,” says Cotter. “I also think we’ll see significant development in the area of connected solutions and value add wraparound services for patients, particularly in terms of medical devices and tracking applications through the use of mobile technology such as smart phones and tablets.This means patients are going to become more involved in remedies and solutions regarding their own healthcare, in conjunction with their healthcare provider. It’s a very exciting time.”

Translating Life Science Breakthroughs into Life Saving Treatments www.breakthroughcancerresearch.ie Breakthrough Cancer Research funds research into poor prognosis cancers CHY 19801

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Simon McKeever Chief Executive, Irish Exporters Association

What mechanisms best encourage growth in Irish Life Sciences exports?

Ireland, as a small open economy, really punches above its weight globally in the Life Sciences industry. We are home to 9 of the top 10 world’s pharmaceutical companies and we exported nearly €32bn in medical and pharmaceutical products in 2016.

Our booming Life Sciences industry is largely due to our high number of educated graduates, access to the EU and undoubtedly our low corporate tax rate. Ireland’s universities in the fields of Engineering, Chemistry, Bio Chemistry and Bio Technology have strong cooperative links with industry in the sector. Irish third level institutions saw a gap in the education market for courses that produced highly skilled graduates in these developing technologies and there is now a close link between the industry and colleges in this country, ensuring that the skills needed in the sector are steadily met.

What kind of opportunities do you see Brexit affording Irish exporters in the life sciences industry?

Ireland has always been a powerful player in the pharmaceutical industry, attracting a significant level of FDI. Ireland has an excellent reputation globally as a centre of excellence in the Life Sciences industry and Brexit could result in increased FDI for companies wanting to move operations or business lines to Ireland in order to retain access to the EU market while still remaining in an English speaking nation.

Brexit may also create huge opportunities for service providers within the Life Sciences supply chain. Irish pharma companies currently use the UK as a land bridge / airbridge to ship finished products to mainland Europe and storage facilities in the UK are used for onward delivery within the EU. There is currently a serious lack of facilities of the scale required within Ireland so opportunities exist to build warehousing facilities here dedicated to Life Sciences, specialising in temperature controlled logistics with the resulting development of Ireland as a pharma distribution centre for the rest of the EU. This would of course need to be supported with the strategic development of sufficient air transport.

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Medtech: New technology is bringing new regulations concerning medical devices and patient safety. Photo: Thinkstock

Skill up now to survive regulatory change

By Linda Whitney

The medtech sector in Europe faces the most meaningful regulatory change in two decades. A new breed of upskilled talent is urgently required to help it succeed.

Ireland’s medtech sector, along with the rest of Europe, is facing one of the most meaningful regulatory change in two decades. How companies cope with implementation of these changes will be critical and could be the difference between success and failure.

Medtech companies are experienced in dealing with regulatory change - but the current changes bring unprecedented challenges to Ireland’s 450 medtech companies What’s needed, is a cadre of skilled regulatory talent that can help companies successfully navigate the new global regulatory territory successfully – and in close collaboration with industry, the association aims to help create them. Ireland’s medtech sector has a proud history of success with as many as 18 of the world’s top 25 medtech businesses having a base here and strong indigenous companies making a global mark and combined annual exports of E12.6 billion.

“The medtech sector is now experiencing global regulatory change at an unprecedented and relentless pace,” says Dr. Áine Fox, Senior Executive of the Irish Medtech Association. “New regulatory requirements - sometimes with stringent implementation timelines - are emerging from multiple global jurisdictions. However, the cumulative impact on medtech manufacturers with products in multiple global markets is not always considered.”

“To help meet this demand for professionals with this important expertise, the Irish Medtech Association Skillnet has specialist programmes in the area of regulatory

Dr. Áine Fox Senior Executive, Irish Medtech Association

affairs, including a fundamentals in regulatory affairs programme, and a Masters in Medical Technology Regulatory Affairs” Fox points out: “The revision of ISO13485:2016, designed to ensure medical device manufacturers’ quality management systems (QMS) comply with the regulations in the EU, Canada, Japan and Australia, has effectively created new QMS requirements for medical device manufacturers in markets outside the US.”

Ongoing challenges While there are welcome moves towards global regulatory harmonisation, this will take time. Fox says: “In the meantime, key regulatory differences across markets present a continuing challenge to manufacturers.”

At the same time, many regulators are increasingly asserting their mandate to protect public health with new proposals and changes. Fox points out: “The US Food and Drugs Administration (FDA) and other global regulatory bodies are showing significantly increased expectations for robust, high-quality human factors studies to

support medical product and combination product regulatory submissions.”

Regulators are also increasingly focusing on a risk-based regulatory approach to health IT and cybersecurity as new eHealth technologies and solutions are developed.

Aware that patients are playing a more active role in their own healthcare, regulators are also examining how device manufacturers can share data with patients.

New technology is also bringing new regulation: draft regulatory guidance has recently been issued on technical considerations for manufacturing 3D printed devices.

At European level, new regulations concerning medical devices and in-vitro diagnostic medical devices contain significantly more detail than the current Directives.

Secondary legislation - still to be developed - will fundamentally determine how effectively and smoothly industry can adapt to the new EU regulatory framework.

Fox says: “We will continue advocacy with key stakeholders in conjunction with MedTech Europe as secondary legislative acts are developed and become ‘live’.”

Faced with this blizzard of regulatory change medtech companies will need to upskill. Fox says: “Expertise and skills in interpreting and complying with existing and emerging regulations will be critical in the face of increasing regulatory workloads.

Companies will need to invest time and money to improve their upskilling strategies for their regulatory affairs professionals.”

She adds: “Medtech companies need to be fully aware of emerging guidance and trends in order to prepare for the future.

Regulatory affairs is increasingly recognised as a having a whole-business impact for organisations, so demand for regulatory talent who can understand the implications of the changing global regulatory landscape is increasing.”

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PANEL OF EXPERTS

We asked three experts in the Life Sciences sector to offer their insight into how research and development is aiding innovation, and why further investment is imperative to the future of the indstry.

Investment is key to innovation and development How is R&D advancing the Life Sciences industry in Ireland?

W

Professor Mark Ferguson Director General of Science Foundation Ireland (SFI) and Chief Scientific Adviser to the Government of Ireland

e are now the most R&D efficient country in Europe, 10th in the world for academic paper citations and attracting top international researchers. SFI’s 12 Research Centres have attracted €40 million in committed cash from 394 industry contracts. By investing in world-class researchers, we are generating new knowledge, transferring it to the marketplace and creating a global competitive advantage.

T Colm Galligan Medical Director, MSD Ireland

he sector in Ireland has grown from very humble beginnings in the 1960s to reach global significance. MSD’s pipeline of activities is being driven in particular by new discoveries. Our wider sector is reaping the rewards of years of research in exciting areas of science such as genomics, proteomics and metabolomics as well as harnessing the body’s own immune system in novel ways to fight diseases.

C

Prof. Joe Eustace Director, Health Research Board (HRB) Clinical Research Facility

linical research promotes a successful robust healthcare system. It ensures access to effective new therapies, it supports professional development and thus staff retention, it is conducted to a higher quality standard than routine care and thereby enhances overall patient outcomes. It provides Irish SMEs access to clinical experts and employs an increasing workforce in Pharma, CROs and academia.

Why is increased investment into Ireland’s research and innovation landscape so important?

How can Ireland attract further significant investment in the Life Sciences industry?

The State’s investment in R&D through SFI is bringing the sector into maturity. Increased investment under the Government’s strategy ‘Innovation 2020’ will facilitate more research, collaborations and EU-funded projects, generating economic growth. It will maximise Brexit-related opportunities to attract excellent research talent here and further develop joint international research programmes.

By catalysing our research teams to lead and win major awards from the European funding programme Horizon 2020, we will continue attracting investment to Ireland. We will launch a new collaborative programme with the UK shortly, further strengthening links there. Under ‘Innovation 2020’, we will also seek funding to develop new programmes to maintain our international competitiveness.

Government initiatives have encouraged MSD to position its sites here, developing and manufacturing many of our pipeline products. However, Ireland is facing growing competition from its European neighbours and beyond, as other countries compete in this sector.

Increased R&D spending is crucial for Ireland’s future business success, allowing us to push the envelope on innovation and invest in solutions that can meet patients’ unmet medical needs.

Creating policies that encourage the best and brightest talent from across the world to take up careers here will be important, as will ensuring education evolves to keep pace with the technological advancements of our time.

With the Government’s clear ambition to make the pharma sector a cornerstone of economic growth, more could also be done to encourage clinical research in Ireland. Through the creation of a more centralised research process for example, clinical trials could get off the ground early and progress.

Most Pharma companies route their Irish Clinical Trials through their UK offices but with Brexit it will likely either establish a separate Irish office – to Ireland’s benefit - or route research via another EU country - which will marginalize Ireland. Investing in Ireland’s clinical trial infrastructure over the next 2-3 years will impact on these decisions and our success in the next 2-3 decades.

To optimize Ireland’s success in large European funded multinational projects, we must join ERIC-ECRIN, a decision under review with the Department of Health. To attract more Industry research we need to build on the work of the HRB/EI funded CRCI which provides a single national access point and sign posting service; and which is working with IPHA to standardize trial CDAs, contracts, and budgets.

Read more expert insight at businessnews.ie

COMMERCIAL FEATURE

A joined up approach to academic-industry collaboration

By Tony Greenway

Academic and research institutions are increasingly collaborating with industry say senior staff at Dublin City University (DCU) — but the trick is doing so effectively.

“There’s a scientific revolution taking place in Ireland,” notes Richard Stokes, CEO of Invent DCU and Director of Innovation at Dublin City University (DCU). “Researchers rarely work in isolation these days.

In fact, national science policy — as set out in the Government’s Research and Innovation Strategy Innovation 2020 — actively encourages university-industry collaboration. And universities have changed a great deal in the last 15 years. They are now hubs of innovation and there are exciting things happening throughout the Irish university system. We’re proud to be among the leaders in the area of translational research in Ireland with a strong track record of industrial collaboration and licensing.”

Many of their graduates have gone on to become senior managers in biotech and pharma companies in Ireland. Yet fostering effective collaboration between academic organisations and enterprise isn’t a simple process. To do it well, you first need to create an ecosystem that allows mutually beneficial relationships to flourish.

To engage more effectively with industry the university set up DCU

Invent as a commercialisation company to support and encourage the translation of innovative research, inspired where possible, by industrial partners. Invent is staffed by a team of experienced business development managers who complement the research expertise of the researchers and who talk the language of business.

“This center-ofexcellence proposes to bring together experts from most of the universities and is supported by 27 industrial partners”

Innovation campus Invent also houses an incubation centre offering laboratory and office facilities for start-ups; and, more recently, it opened a new innovation campus (DCU Alpha) where more established businesses can locate innovation arms and easily tap into research expertise. “We find that, particularly in the pharma and biotechnology sectors, companies want to be close to the university’s researchers and resources,” says Stokes.

“For example, a specialty pharma start-up Sigmoid Biopharma based in our Invent Centre has now expanded into our new Nanobioanalytical Research Facility (NRF).

pen at all, efficient operational organisation is critical. “One of the challenges facing companies that want to work closely with a university is accessibility,” she says. “They want to know: ‘Where do we go and who do we contact?’ Our answer was to set up central units called Research and Enterprise Hubs in areas which reflect both the expertise at DCU but also those of strategic importance to the university, these Hubs, along with Invent, act as points of contact for any company that is interested in working with us.

The university has also developed a connected infrastructure network, which includes research centres such as its National Institute for Cellular Biotechnology (NICB) and the Nanobioanalytical Research Facility (NRF), along with a number of others. “We’ve organised these into core facilities with centrally managed access, fully supported by an experienced technical team,” says Loscher.

“This means we can either do the

Industry expertise Professor Christine Loscher, Director, Health Technologies Research & Enterprise Hub at DCU, says that any innovative company that wants to grow and develop can benefit hugely from embedding itself in a research environment. She also points out that, for this to hap-

research work for a company — or they can do it here themselves with their own people, or they can locate some of their activities on campus in a space that has been specifically allocated to them. It’s a ‘joined up’ approach that is working very well for us. Companies can avail of the breadth of expertise necessary for their business in one place, such as cell engineering, advanced analytics and protein characterization.”

Describing the long history of interaction that the NICB has with the Biopharmaceutical industry in Ireland Dr. Niall Barron the Director of NICB explained “We have worked with many of the big multinationals to help them increase the efficiency of the cell lines they use to produce modern Biotherapeutics. We apply techniques such as transcriptomics and proteomics to understand the genetics of these valuable cell lines and then use advanced gene engineering techniques to improve Biopharmaceutical production by these cells.” This expertise will also form part of an ambitious proposal led by the National Institute for Bioprocessing Research and Training (NIBRT) to create a new SFI Centre focused on addressing the challenges faced by the Biopharma industry. “This center-of-excellence proposes to bring together experts from most of the universities and is supported by 27 industrial partners. The ambition is that not only will this

initiative demonstrate Ireland’s strong commitment to supporting, strengthening and embedding the Biomanufacturing industry here, but to also send a strong message globally as to the importance we place on the continued success of the industry in Ireland. Hopefully that will have a positive impact on future FDI in this area”.

Long-term investment However, Loscher warns that it’s not that we want to be simply ‘a service provider’ to industry.

“Rather, we want to work with companies to solve their problems, but also use our relationship with them to better understand the big challenges that they will be facing in the future,” she says “That way DCU can develop research programmes that will be really important to them in the long-term. And companies are getting the message that while the research they want done in the short term is important, there is also a need for investment in fundamental research in order to give them a competitive edge in the longer-term.”

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