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MATT MORAN Biopharma generates new products, methods and jobs P4
IPHA Action is needed to cut the wait for new medicines P2
IRISH EXPORTERS GDP and changing regulations P10
Life Sciences
IPHA CEO, Oliver O’Connor: “There is little point in investing large sums in R&D if patients must wait years to benefit.” SOURCE: ENTERPRISE IRELAND
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Irish Medtech Association
The digital transformation of manufacturing has arrived. P6
Pharmaceutical Managers Institute
Expert research panel
Science Foundation Ireland, Enterprise Ireland and the Health Research Board on life sciences research in Ireland. P8
Brexit and the effects on pharmaceutical companies. P10
How can we tackle the three year wait for new drugs?
The wait for new medicines to become routinely available in Ireland has got longer, and patients are suffering. Here’s what must be done to address the issue. By Linda Whitney
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ccess to new medicines is vital for patients, but in Ireland, public access typically takes three years from reimbursement – the first application for a medicine to be made available to the public healthcare system. Oliver O’Connor, Chief Executive of the Irish Pharmaceutical Healthcare Association (IPHA) says: “Patients want the best healthcare, based on the latest research and developments in life sciences. There is little point in investing large sums in R&D if patients must wait years to benefit.” It’s not just patients who lose out. A healthcare system that fails to adopt new medicines as they become available falls behind when it comes to delivering care to international standards. “Ireland used to be an early adopter of new medicines and treatments but now we are 12th out of 14 Follow us
European countries when it comes to the time it takes to adopt new medicines,” says O’Connor. “The average time is now three years – and that is after the time taken for a formal Health Technology Assessment.” These are not just medicines for minor ailments – some of them are treatments for serious conditions such as cancer and cardiac conditions. “People with these diseases are not getting the standard of care that is available in other European countries because of these long waiting times,” says O’Connor
The 2008/9 financial crash has caused slowness There are several reasons for the long wait. “Partly it is a question of slow decision-making processes in the health service and the government,” says O’Connor, “but mainly it is because of limitations on spending.” Spending on community health
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Oliver O’Connor Chief Executive, Irish Pharmaceutical Healthcare Association (IPHA)
“One billion packs of medicine flow between the UK and Ireland annually.”
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services has been more or less flat since the crash of 2008/9. This year the state funded new medicines to the tune of €14m, a rise of less than half a percentage point. O’Connor says: “It’s right that medicines be rigorously assessed and must show proven benefits – but most European countries have increased spending by more than half a percentage point. “Furthermore, through our Agreement with the State, savings on €780 million will be provided to the State, which should give some headroom for investment in new medicines”. “Ireland is not in financial crisis anymore, so we need to re-examine the whole question of funding.”
The impact of Brexit One billion packs of medicine flow between the UK and Ireland annually, a supply chain on which many @MediaplanetUK
patients depend. O’Connor says: “A divergence in regulatory standards between the UK and Ireland risks interrupting the flow. We want to see regulatory alignment maintained but, so far, there is no clarity on that.”
Increased prices There have been recent stories about a drug-maker increasing the price of painkillers to thousands of US dollars. “IPHA members would not do that. Through our Agreement with the State, our prices are set at the average of 14 other Western European countries. Furthermore, the Agreement allows for a yearly price reduction,” says O’Connor. “We do not condone these kinds of price increases.” Find out more on businessnews.ie Please recycle
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Focusing on patient outcomes prices drugs on their value SPONSORED
Concerns over rising drug prices is shifting attention away from manufacturing costs to pricing new medicines on the basis of how well they work.
With around two thirds of a government’s budget typically spent on healthcare, it is understandable there is a growing desire to make sure the medicines, devices and services they buy offer value for money and achieve the intended patient outcome. Health services are increasingly concerned that they are being asked to pay inflated prices for the latest drugs and technology. This means medical companies need to develop a pricing structure that is based on the effectiveness of the drugs, treatments, devices and services they are supplying.
Elaine Daly, Partner and Head of Business Consulting, Grant Thornton
Tim Cotter Lead for Life Sciences, Business Consulting, Grant Thornton
Elaine Daly, Partner and Head of Business Consulting at Grant Thornton says, there is a shift in value to focus on efficacy, rather than the cost of manufacturing a medicine or supplying a service. “Value-based pricing shifts the focus from the volume of services provided – clinician visits, procedures, medicines and tests – to the patient outcomes achieved,” she explains. “It is about the regulation of reimbursement, or pricing of pharmaceuticals, on the basis of the therapeutic value the medicine offers. This therapeutic value is a
relative notion as it is measured through a comparison with the clinical benefits of existing drugs and therapies to determine the added health gain. This shares risk between the pharmaceutical company and purchaser because all parties benefit from the right use of the drug.”
How to measure value The issue the supplier and customer then need to agree upon, is how to determine the extra benefit a new drug provides. Here, Tim Cotter, Head of Life Sciences and Business Consulting at Grant Thornton
explains, there are already accepted practices being used and refined. “Health technology assessments (HTAs) are the basis for pharmaceutical pricing and the decision as to whether or not a drug offers an additional value. HTAs also act as a means to support health policies and reimbusement decisions,” he says. “HTAs base their decision-making either on economic evaluations or comparative clinical benefit assessments, including value-based assessment and pricing. “VBP focuses on identifying and modelling the added value that a product or service will provide to a health system in terms of improved patient outcomes, lower costs of treatment and sustainability of care. An economic appraisal or evaluation will weigh the costs of an action against the benefits that it will provide. “A popular form of value measurement is the Quality Adjusted Life Years (QALY) assessment. A QALY integrates the length and quality of life as a single form of indicator and benefits derived from an intervention can be expressed as the gain in
QALYs that it produces.”
VBP driving innovation Value-based pricing is beneficial because it focuses purchaser and supplier strategies on improving patient outcomes. It is an effective way of breaking down siloed reporting because the pricing structure requires a holistic approach to be taken to discover how well treatments have worked and what the true benefit is. It could well encourage medical firms and healthcare authorities to maintain focus on personalised medicines and targeted health technologies that offer the most efficacious benefit for an indvidual. By moving away from cost, strategies for supplying and purchasing medicine, equipment and services can be firmly focused where they should always be – improving patient outcomes.
Find out more on grantthornton.ie
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Life sciences: turning investment into innovation
Ireland’s cutting-edge biopharma industry is generating new products, innovative manufacturing methods, unique training opportunities and thousands of jobs. By Linda Whitney
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nnovations in biopharmaceutical manufacturing are coming thick and fast in Ireland as its burgeoning life sciences sector continues to expand. “In 2003, Ireland had two big biologics plants, but by 2015, that had grown to 15 and two more are in the pipeline. These state-of-the art facilities encourage the development of innovative products, technologies and techniques,” says Matt Moran, Director of Biopharmachem Ireland, the association that represents the biopharma and chemical sectors within business and employer association, Ibec.
Cancer-killing antibodies produced in Ireland Innovative pharmaceuticals now being produced in Ireland include MABs – monoclonal antibodies that are used in the cutting-edge field of cancer immunotherapy in order to trigger the immune system to attack and kill cancer cells. Other new products include orphan drugs, pharmaceutical agents researched and developed specifically to treat rare medical conditions, called orphan diseases.
Less wastage in production methods New methods are also being developed in biopharmaceutical manufacturing. “Companies are now looking at continuous manufacturing, a process more commonly used in petrochemical and polymer plants, but new to pharmaceuticals, where batch manufacture has been standard,” says Moran. “Continuous manufacturing, using the Quality-by-Design (QbD) approach and Process Analytical Technology (PAT), means the processing system can be measured, monitored and tweaked in real time, making it easier to maintain high levels of quality, with less risk of wastage than in batch manufacturing.” Government invested €10bn in the last decade The Irish government, keen to grow the biopharma sector, which accounted for €56bn in exports in 2017, has invested €10bn in the sector in the last decade. Part of the funding went towards the National Institute for Bioprocessing Research and Training (NIBRT), a global centre of excellence for training and research in bioprocessing. NIBRT,
Matt Moran Director, Biopharmachem Ireland
“Collaboration comes easily in a small country where people naturally network among themselves.”
based on an innovative collaboration between University College Dublin, Trinity College Dublin, Dublin City University and the Institute of Technology, Sligo,
was primarily funded by the government of Ireland through Ireland’s inward investment promotion agency, IDA Ireland. About 5,000 people a year receive undergraduate or graduate training or research experience at Dublin-based NIBRT, which is purpose-built to closely replicate a modern bioprocessing plant, including state-of-the-art equipment and research facilities. “It’s a kind of flight simulator for biotech,” says Moran, adding that biotech companies from abroad commonly send staff to NIBRT for training. Science Foundation Ireland, the national foundation for investment in scientific and engineering research has also invested heavily in research, in particular the SFI Strategic Research Clusters (SRCs). These include ten clusters that are dedicated to life sciences, where industry collaborates with research organisations and universities. “Collaboration comes easily in a small country where people naturally network among themselves,” says Moran. “It means the life sciences sector is flexible and, when it spots a trend, it can respond fast.”
8,400 job openings by 2020 The growth of life sciences is fuelling a huge demand for new skills. It is predicted that up to 8,400 job openings will arise in the biopharma sector by 2020, on top of the 28,000+ people employed now. An additional 5,000 staff are expected to be employed in biologics manufacturing in Ireland over the next five years and another 3,400 job openings will arise due to retirements and people leaving the sector. Of the 5,000-strong increase in biologics manufacturing, it is estimated that around 1,000 positions will be for roles such as facility maintenance, supply chain/logistics, human resources, finance, legal and warehousing. The remaining 4,000 roles will require more specific biopharma science and engineering experience. Moran says: “People with qualifications and skills in biotech research, development and manufacturing, such as bioprocessing, bioinformatics, biotech operations, bioprocess engineering and associated digital skills will be in demand.” Read more on: businessnews.ie
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DIT Greenway Hub: A centre for research and innovation in the heart of the DIT Grangegorman Campus
Building and retaining your talent: connecting education with the workplace How integrating the university campus with the biopharma workplace could address the skills and education gap; Professor Declan McCormack gives his views. SPONSORED
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ccording to the Expert Group on Future Skills Needs: ‘The availability of skills and talent is seen by the industry as a key prerequisite for future competitiveness, investment and employment. There is a need for a collaborative approach to ensure the adequacy of the supply of biopharma skills and talent.’ By bringing the university to the workplace, educators can partner with industry to produce a large pool of talent for the sector across all academic grades, from level seven graduates for technician and operator roles, to level nine MSc graduates with Quality Assurance and Validation expertise, right up to level ten PhD students, who are at the forefront of their discipline. DIT has a long history of producing career oriented graduates with skills and competences tailored to the Pharma and BioPharma sectors. Courses have constantly adapted and evolved in response to the ever-changing lifesciences landscape which contributed €67billion in exports in 2017. Over the last decade, €10billion has been committed to the expanding biopharma and medtech sector in Ireland. With many sites now poised to come on-stream and others under construction, it is apparent that a major challenge facing the industry is the development of sufficient numbers of graduates who are literate with scientif-
ic, engineering and problem-solving skills, to meet demand. Last month alone over 1,000 new jobs were announced by Edwards Lifesciences (600), MSD (350) and Takeda (70). Graduates are required across a range of education levels to fill the many roles in production, quality assurance, process engineering, scale up, data analytics, combination devices, validation, drug development and clinical trials. At the recent BioPharma Ambition conference, Dr Dominic Carolan, CEO, NIBRT, forecast 8,400 additional jobs in the industry between now and 2020, requiring skilled professionals.
What are the benefits of workplace-integrated learning? To develop capacity for the sector one of the innovative approaches being undertaken by higher education institutions is to augment traditional college-based students with new cohorts from non-traditional routes. The latter option, incorporating on-line learning, facilitates those wishing to add to their educational awards while gaining industry experience. A key finding in the recent trends in the biopharma manufacturing survey report from NIBRT in December 2017 was that the most effective training was that provided on-the-job (90 per cent). Such 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 thus aiding retention and building corporate knowledge and skills, while new expertise can be developed in close collaboration with researchers, professional and industry bodies, and regulators for the sector.
Professor Declan McCormack Head of School, School of Chemical and Pharmaceutical Sciences, Dublin Institute of Technology
“Creative solutions are required if we are to bridge the education and skills gap.” How can education be embedded in the workplace? In recent years, the Higher Education Authority-funded Springboard initiative has provided direct assistance ‘to help unemployed people to remain as close as possible to the labour market by accessing parttime, flexible higher education and training opportunities to up-skill or re-skill in areas where sustainable employment opportunities may arise as the economy recovers.’ Such funding has provided many opportunities to bring job-seekers into the biopharma and medtech industries, while also helping to embed education in the workplace. In a ground-breaking partner-
ship, DIT and GetReskilled have worked closely with employers and biopharma industry representatives to develop a blended model of learning whereby students can take programmes from their homes or workplaces, supported through their learning experience by academic lecturers, tutors and company-based mentors. In the last five years over 500 graduates equipped with the necessary skills and knowledge to operate in production and quality technical roles have qualified from these programmes. The success of such programmes is evident from employment rates of over 85 per cent. Over 90 per cent of graduates recommended an online programme, most having completed one for the first time. A similar blended model for MSc education, specifically targeted at the skills gap in pharmaceutical validation has also been developed. Johnson and Johnson Campus Ireland, recognising the forecast shortfall in validation and commissioning expertise across their many sites, have partnered with DIT to develop a centre of excellence in validation, connecting the academic institution directly to the workplace. Employees across various divisions such as Vistakon, Janssen Biologics, and DePuy were enrolled in the online MSc in pharmaceutical validation technology programme, supported by management mentors from their respective sites. This model provides career development opportunities for those individuals and encourages sharing of best practice and knowledge across sites through facilitated discussion boards and workshops. The success of the programme is evidenced by its extension to employees from J&J sites in England, Scotland and
The Netherlands.
Workplace-based PhDs Possibly the most exciting development in connecting education with the workplace has been the opportunity for senior personnel and leaders to capture their knowledge and expertise through enrolment on a PhD programme with research outputs disseminated through conferences and peer-reviewed publications. This route to a PhD is particularly synergistic. It brings together the knowledge and industry focus of the individual with the direct academic support and guidance of the institution to tackle major challenges for the sector such as quality risk management, knowledge management and process analytical technology. This model of workplace-based PhDs is one that has really advanced our understanding of the future landscape for the industry while also providing academic endorsement and qualifications to future thought leaders for the sector. An excellent example of how this works is the pharmaceutical regulatory science team at DIT that has enrolled a number of senior biopharma personnel on its PhD register, connected through a growing alumni of industry and regulatory body-based experts in the team. Creative solutions are required if we are to bridge the education and skills gap. The Irish government’s commitment to the establishment of technological universities provides an obvious platform for the growth of such campus workplace models for higher education and will ensure that Ireland can continue to grow successfully in the life sciences sector. Read more on dit.ie/chemistry/
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New thinking in manufacturing
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he Irish economy has moved beyond the recovery phase, with 4.2 per cent growth forecast for 2018. Growth in 2017 was underpinned by business investment in plant, machinery and equipment (excluding IP and aircraft leasing) of almost €1 billion per month, and the quickest real wage growth in Europe at 1.8 per cent. But, as we look to the future, identifying strategic areas for growth will be key to ensure the sustainability of this success. Advanced manufacturing provides a unique opportunity to attract investment, create jobs and drive growth. Manufacturing in Ireland accounts for a whopping 36.7 per cent of GDP, with more than one in ten people in the workforce directly employed by the industry. As the greatest recipient of Shingo
Adrienne McDonnell Senior Executive, Irish Medtech Association
“Per capita, Ireland is world-renowned for manufacturing.”
Prizes for operational excellence, per capita, Ireland is already worldrenowned for manufacturing. Ireland is well-established as a strategic location of choice to expand into Europe’s manufacturing industry, with both a strong base of foreign direct investment and homegrown businesses here. Manufacturing in Europe generates €1,710 billion of value added, with nearly 30 million people employed across more than two million enterprises, according to Eurostat. Ibec’s medtech and engineering sectors have worked with other key stakeholders to advocate for a government-funded, discrete advanced manufacturing centre as a matter of priority to help companies focus on research that is nearer-to-commercialisation of new products and providing greater return on investment for innovation.
The manufacturing sector here currently spends €771 million on R&D annually. But, with Ireland ranked second for technological adoption, ninth for availability of scientists and engineers, and tenth for intellectual property protection globally, our model of substance means we’re well-positioned to be at the forefront of advanced manufacturing. With nine of the top ten medtech companies, ten of the top ten ICT companies and ten of the top ten biopharma companies having a base here, we’re uniquely positioned to capitalise on innovation through strategic collaborations in key areas such as digital. In fewer than ten years, the value of our digital economy has nearly tripled, growing from €4.3 billion to €12.3 billion (2015 figure). Moreover, our digital-related GDP
at six per cent is higher than both the EU’s at 5.7 per cent and G20 at 5.3 per cent averages. These trends reveal the potential to reach €21.4 billion by 2020 and create 56,000 jobs while enhancing productivity. The digital transformation of manufacturing has arrived, and it’s time to embrace it. Creating smart, connected manufacturing with people-centred operations will help drive and strengthen Ireland’s global manufacturing competitiveness. The ‘New thinking in Enterprise Excellence’ manufacturing conference on 7 June 2018, in the Galmont Hotel Galway, hosted by Ibec’s Medtech and engineering sectors, will bring together thought leaders and provide an opportunity for businesses to showcase bestpractice with a special poster competition.
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Helps companies keep ahead of the curve
Medical manufacturing is due a radical shift as a result of digitisation and new technology. Tech expert, Barry Kennedy helps companies keep ahead of the curve. SPONSORED
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By Victoria Briggs
he pace, scale and complexity of technological change can feel almost dizzying at times. How we live, learn, work and interact with each other have all been radically transformed. Nowhere is that more apparent than in manufacturing, where technology is serving to disrupt traditional business models beyond all recognition. According to Barry Kennedy, CEO of Irish Manufacturing Research (the nationwide research organisation that works with companies to solve productivity, efficiency and business model challenges) companies need to ready themselves for further fundamental change. “In today’s world, businesses have to move quickly to stay ahead of competitors in order to gain an economic and global advantage,” he says, citing collaborative robotics, virtual reality, augmented reality, and the industrial internet of things as examples of developments likely to have the same impact on manufacturing at scales as big as – if not bigger than – what Airbnb and Uber had on the hospitality and taxi businesses, where technology underpinned the transformation of both.
‘Customisation will radically change medtech’ Medical technology and biopharmaceuticals are two sectors that Kennedy and his team work with to prepare companies for the big technological challenges that lie ahead.
Barry Kennedy CEO, Irish Manufacturing Research
“We undertake research that allows manufacturers to keep one step ahead.”
“Our role is to demystify and derisk new technologies for manufacturers, and the potential risks and opportunities with new disruptive business models, to ensure Irish industries are resilient to the transformative changes that are coming,” he says. “When it comes to the medtech industry, the advent of customised medical devices means that the way these devices are made will be radically different in the very near future.” At his organisation’s new 3D printing plant in Mullingar, medtech designers work in partnership with medical device companies, orthopaedic surgeons
and clinicians to investigate the future production, for example, bespoke artificial hip and knee joints and implants for patients. “Replacement hips and knees typically come in discrete sizes, which surgeons, today, have to adapt so that they fit inside a patient’s body,” Kennedy explains. “The future of this industry will involve 3D printing at its core, where a surgeon will scan a patient’s joint and send it to be manufactured on one of these ground-breaking systems. This part will be an exact replica of the patient’s original one, which will result in fewer post-surgery recovery problems. IMR, with its partner companies, such as Croom Medical Device or Depuy Synthesis, are at the heart of the development of these breakthroughs. “What’s more, novel organic bone structures can be designed onto these 3D joints, which are known to help promote bone growth. Traditional devices are attached by a screw, but these new designs can allow a patient’s bones to grow into the device, similar to a tree root, which makes for a stronger joint. It’s a game-changer,” he says.
customisation will result in demand for bespoke parts. It means that the way manufacturing plants are set up will have to change and we could see a situation where production of parts will take place in smaller production units nearer to hospitals in a locality,” he says. Bringing companies together with different specialisms for the betterment of both is at the heart of what Kennedy does. Recently, he oversaw a successful collaboration between a technology company and a pharmaceutical company that enabled significant mutual gains to be had by each. “The international medical devices company are global leaders in their field but lacked a depth of knowledge about the digitisation of manufacturing. They were partnered with a global technology company along with our team to test new technology that they were trying to bring to market,” he says. “The partnership helped the medical devices company to get a solution to a very challenging technical issue, while the tech company was able to prove its products worked within that environment, resulting in significant benefits for both communities.”
Technology will drive localised production Digitisation and 3D printing will also require manufactures to make a fundamental shift in strategy, says Kennedy, with technology driving a move away from mass production to more just-in-time mass customisation, ie, building custom-made parts with the same efficiency as mass production. “With 3D printing, we envisage a world that returns to the way manufacturing used to be in terms of localised production. This could happen right across the board. When it comes to medical devices,
Helping manufactures to stay ahead Kennedy describes his organisation’s role as helping to demystify and derisk technology, with the aim of helping members to improve productivity, make energy efficiencies, drive innovation and enhance their manufacturing lines. It is a role that also extends to providing training in such specialised areas as data modelling and data optimisation and testing new technologies. “We undertake research that allows manufacturers to keep one step ahead,” he says. “Advanced technology can be very expensive,
so we have set up pilot lines and test beds for manufacturers to trial out these technologies before investing. We look at whether new systems or machinery are ready for mainstream manufacturing and at what the machines are really capable of. We test if the technology is just hype or if it’s truly a game-changer.” The research centre in Mullingar is a case in point. Home to leading edge 3D printing technology from leading companies such as Carbon 3D (a Silicon Valley-based company whose machines are being used to make for instance next generation customised soles for top-brand sports shoes), it is the only one of its kind available in Europe on an open access basis to industry currently. It is also home to a world first next generation metal 3D printer from Renishaw, with which Irish Manufacturing Reseach are jointly carrying out research for Croom Medical, a leading Irish medical devices company, in partnership with the SFI funded, “I-Form Advanced Manufacturing Research Centre. “Carbon 3D’s system can print extremely fast, using multiple types of plastics that produce parts equivalent to classic manufacturing processes. Manufacturers are able to come along and work with the systems and our research team to test, trial, innovate, design, and deliver working products before investing in their own,” says Kennedy, in what he calls a ‘derisk’ approach. “When it comes to technology, it is vital that manufacturers in Ireland are aware of changes that are happening,” he says. “It’s our job to shine a light on those changes because, together, we can all punch well above our weight.” Read more on imr.ie
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Bridging start-ups, academia and industry
Collaboration brings out the best in research teams
By Sean Hargrave
By Sean Hargrave
Deirdre Glenn Director, Lifesciences and A solid science base of excellent universities and Food Commercialisation and researchers, plus multi-nationals, makes Ireland the perfect Lifesciences Sector Manager location for life science start-ups to start an export drive.
Regardless of economic ups and downs, successive Irish governments have been committed to investing in science and technology, and the country is now reaping the benefits. That is according to Deirdre Glenn, Head of Life Sciences at Enterprise Ireland. Proof comes, she says, from a simple statistic. The science start-ups that the organisation backs are turning over €2bn a year and €1.6bn of this comes from export markets. Underlying this commercial success is a key differentiator in the way Ireland approaches supporting its life science start-ups. Enterprise Ireland not only develops links between these promising small companies and academia, but also with industry. “We’re the only body (that we know of) that gets involved with the best scientists in their country to commercialise research in this way,” she says. “We’ve got very close links in academia so we can help with partnerships in research but then we also have the contacts in industry. The great thing about this dual approach is we have a great insight into what researchers are working on and we also know what has a ready-made commercial market.”
Ireland’s small size is a benefit to getting things done Ireland has a built-in advantage when it comes to exploiting science, Glenn says. Not only does it have excellent universities and a dynamic science base, but its small size – contrary to what some may imagine – is very attractive to investors. “The fact that we’re actually a pretty small nation of just four and half million people or so means we don’t have a cluster but, still, nobody is more than a couple of hours from each other,” she says. “So, we have a strong history of partnership and close links, which makes things so much simpler. When we speak to international colleagues, they are always surprised at how simplified the structure is here in Ireland and how a group like ours is able to develop the links with academia and industry at the same time.”
Research saves lives, but turning research discoveries into real benefits for people’s health and patient care doesn’t happen by itself. The Health Research Board (HRB) supports the people, the infrastructure and the great ideas that help make it happen.
Putting the patient first; whether improving lives, prolonging lives or saving lives, health research must be patient-focused. Recently, we have
Professor Mark Ferguson Director General, Science Foundation Ireland and Chief Scientific Adviser to the Government of Ireland
Ireland is ideally suited to push back the frontiers of science because it has a wide array of excellent researchers working in fine universities across the entire country. The geographic spread of talent in diverse specialities has resulted in a research landscape built on partnerships and collaboration, which are vital for research success, according to Professor Mark Ferguson, Director General of Science Foundation Ireland and Chief Scientific Adviser to the Government of Ireland. “We’re very well positioned with seven fine universities, an Institute of Technology and 17 research centres,” he says. “It means we’re not as centralised as some countries and so there’s a history of collaborating to bring out the best we have to offer.”
Partnership in funding This collaborative approach is evident in how the Science Foundation Ireland’s €172m annual budget is put to best use. Rather than award grants to fully fund certain projects, the foundation will instead cover a third of a team’s cost, so long as the remaining two thirds are supplied by industry and another funding body – often the EU’s Horizon 2020 programme. “We never fully fund a certain project, such as the SFI Research Centres, because we want to make sure the researchers have been able to demonstrate to another funding body, and to industry, that their work will have impact,” Professor Ferguson says. “It’s not always about being the next unicorn, nice though that would be, but by showing their work will improve health, education, the environment or the economy.” Diverse projects with impact This requirement to win over the support of another science funding body and industry underlines a drive towards collaboration for research in Ireland. Science Foundation Ireland always accesses the best minds in science from around Europe to investigate whether a project should be funded. By removing peer review from Ireland, Professor Ferguson believes not only is nepotism avoided, but a more diverse range of ideas is funded. “You can’t get funded just because you know the right people, you have to prove the merit of your work to outside experts,” he says. “That helps us get projects funded that are as diverse as using sensors and the Internet of Things to spot sick cows whose milk may be infected to establish how new flight control systems for drones might be drawn up.” The wide scope of collaborative research programmes, made possible by partnering with industry and funding bodies, has also helped ensure Ireland is well on its way to hitting its Horizon 2020 ambitions. Ferguson reveals the government’s target of securing €1.25bn from the European research fund, which closes in two years, is looking highly achievable, given current rates of grant allocations.
How can we retain our position as a global life sciences hub? Three experts give us their insights.
Export diversity derisks Brexit Another advantage for Ireland’s life science industry is that Enterprise Ireland is devoted to driving export sales. This has meant the start-ups it supports have close ties to markets across the globe and are less reliant on the UK than other parts of Ireland’s economy. “We’re obviously hoping to maintain a very strong trading relationship in the future,” she says. “However, of all the industries in Ireland, we’re probably one of the least affected by Brexit because we have very strong ties with Europe, particularly North Europe and the Nordics, as well as North America.” Much of this appeal with export markets and in encouraging multinationals to choose Ireland can be backed up by what is generically referred to as the ‘Irish Advantage’. Research shows the country is stable and trustworthy and also has the most flexible workers in the world, giving a home to the most innovative SMEs in the EU.
So, why invest in life sciences in Ireland?
Partnership in funding between research bodies and industry prioritises funding teams whose work will have impact, Science Foundation Ireland’s Director General argues.
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invited members of the public to review aspects of the health research proposals we receive. It is the first time something like this has been done in Ireland. Public Patient Involvement (PPI) aims to involve people in the research process, rather than people being the subject of research. The general consensus is that involving members of the public in the review process helps to improve the quality of the research funded by ensuring that the research we support is relevant to the needs of the public. It’s win-win.
Collaboration is key International evidence tells us that
research-active healthcare systems have better outcomes for patients. We have built a network of clinical research facilities and trials in collaboration with the Health Service Executive, health professionals and the research community. This enables the best researchers and health professionals to carry out research that will change people’s lives for the better. Our co-ordination hub, HRB CRCI creates a direct and simple route to this infrastructure, support and regulatory network, helping to attract clinical trials, pharma and
medical device companies to Ireland. HRB CRCI provides consultancy, support and information services to both academic groups and life sciences companies on product development and clinical strategy process from concept to commercialisation.
Investing for the future Creating the capacity to conduct life sciences research is essential. In addition to funding research leaders across every discipline, we support early career researchers to create a sustainable supply of credible leaders for the future. A series of long term investments in PhD training across lots of disciplines, from health services research to clinical academic training, are already creating a large
Dr Mairead O Driscoll Director of Research Strategy and Funding, Health Research Board
number of future leaders across life sciences. This is simply another part of the plan to ensure life sciences can impact positively on people’s health, patient care and health service delivery.
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Fast facts
3
Ireland is the largest net exporter of pharmaceuticals in the world4
years
In Ireland, public access to medicine typically takes three years1
In 2003, Ireland had 2 big biologics plants, but by 2015, that had grown
It is predicted that up
to 8,400 jobs will open in the biopharma sector by 20202
One of the top categories of goods exported to the UK is medical and pharmaceutical products5
2003
2015
9 10 10 10 10 10
top medtech companies top biopharma companies top ICT companies3
Sources: 1 2
Oliver O’Connor Matt Moran
based in Ireland
to 15 plants 2
Adrienne McDonnell 4 Simon McKeever 5 Fiona Durphy 3
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Fiona Dunphy Commercial Manager, Pharmaceutical Managers’ Institute (PMI)
Preparing for new 2020 medical devices regulations
What impact will Brexit have on local Pharma? Following the UK referendum on EU Membership, there was a somewhat surprising result to exit the EU (albeit on a very tight margin - 51.9 per cent ‘leave’ to 48.1 per cent ‘remain’).
Below are some important, upcoming dates: ■ UK scheduled to leave the EU - 29th March 2019 ■ Transition period likely to last until - 31st December 2020 ■ The UK will be able to strike its own trade deals - although they won’t be able to come into force until 1st January 2021. So, what do we know for sure? Well, in all honesty, not a huge amount! Negotiations continue to move very slowly on all sides. We still don’t have visibility on how things will work in the long-term. Discussions concerning future relations between the UK and the EU will start only if and when the transitional phase has been agreed. However, a baby step forward was made on 19th March with The Irish Times reporting that the “backstop” solution for the Border treaty had been agreed. This means that, failing another solution, the guarantees in the draft Brexit document preventing a hard border would stand.1 What we can be certain of, is that the possible impact for the pharmaceutical industry is potentially huge. As an island nation, trade is essential for us; with the UK being our longest-standing trade partner, and one of our most important. According to the CSO2, in 2015 we exported €112.4bn of goods with €15.6bn (13.9 per cent) of these going to the UK. The top categories of goods exported to the UK were meat and meat preparations (€1.9bn), with medical and pharmaceutical products taking the second position (€1.5bn). The main concerns with Brexit are relating to the supply of medicines, and their timely movement around the EU with the additional customs processes now required, along with regulatory alignment. Speaking at a PMI breakfast on February 1, Danny McCoy, CEO with Ibec, said: “Regulatory alignment on non-tariff barriers will be the most significant issue for medicines and products”. We’re now looking at increased customs processes, and we simply don’t have the structure for these here in Ireland. Can the ports cope with these possible new procedures? Is there warehousing available at the ports to cope? With over 45 million packs leaving the UK to EU countries each month, and 70 per cent of EU Investigational Medicinal Products released from the UK it’s easy to see how quickly this will stockpile if there are delays due to possible new customs procedures. There are VAT implications with Brexit too. UK companies will have to pay VAT for products coming in from EU at a rate of 15–20 per cent. But how will this be passed through the supply chain? There will also be VAT implications for creams and injectables of approximately 23 per cent - again these will lead to increased costs – where will this be reflected? Does the manufacture absorb it? The wholesaler/distributor? Or will it be passed onto the end consumer? The questions continue, answers unfortunately are not so easily found! Local concerns regarding Brexit are clear: potential supply chain disruption that might cause delays in medicinal goods getting into and out of UK; a real fear of shortages in the supply of medicinal products (as articulated by Dr. Lorraine Nolan, CEO with the Health Products Regulatory Authority); uncertain VAT implications; transport and customs infrastructure; the impact on the cost of goods – who is paying for this? Just now, the only real certainty is continued uncertainty. The “backstop” agreement this week is a good step in the right direction, and we have to hope that these steps continue. While Brexit is a certainty, the details of the transition period and the ultimate deal remains unclear. The UK is likely to remain a major trading partner of Ireland, so we need to work with the EU to get them the best possible deal – this is in our interests too. 1 irishtimes.com/news/world/europe/brexit-uk-agrees-to-backstop-solution-for-border-in-treaty-text-1.3432512?mode=amp&utm_source=dlvr.it&utm_medium=twitter&__twitter_impr 2 cso.ie/en/media/csoie/releasespublications/documents/statisticalpublications/Brexit.pdf
A key challenge facing medical device manufacturers and distributors is the introduction of the new EU regulations coming into effect starting from May 2020 and preparations need to start now.
I
reland is an incredibly substantial player in the life sciences sector, involved with medical devices, pharmaceutical and biologics. The sector in Ireland exports more than €45 billion annually and employs over 50,000 people, making Ireland the largest net exporter of pharmaceuticals in the world. Ireland has the highest per capita employment of medical technologies personnel across Europe.
Supply chain integrity is key Medical devices are used in many varied situations, including among the general public in their homes, with the most critically ill in hospitals as well as with high-risk surgical procedures and the most vulnerable groups, such as infants and the elderly. The safety and performance of medical devices directly affect patient health and safety. Improper storage along the supply chain therefore can have extremely serious consequences and the specific nature by which these goods must be shipped and the wholesale distribution of medical devices is an important activity in integrated supply chain management. Changes in regulations One of the key challenges facing medtech manufacturers coming down the line is the introduction of the new EU regulations for medical devices. Regulation 2017/745 on medical devices and Regulation 2017/746 for in vitro diagnostic medical devices will replace all preceding directives and will apply with full application in May 2020 and May 2022 respectively. The Health Products Regulatory Authority (HPRA) believe that the new regulations will allow for an effective, consistent and robust regulatory framework for medical devices across Europe and will afford the public appropriate levels
Simon McKeever Chief Executive, Irish Exporters Associaiton
of health protection and access to safe and effective medical devices.
Preparation is key for compliance Manufacturers, distributors and importers have some time to put procedures in place but devoting time now to prepare is imperative so as to ensure compliance when the new regulations come into force. In order to meet the legislative requirements, it is recommended that distributors have a quality system in place that ensures that medical devices that are distributed comply, but also that non-compliant, defective or unsuitable devices can be detected and that traceability is maintained. Personnel involved in distribution need to have sufficient training and expertise. It is recommended that each distribution centre appoint a person to oversee the effectiveness of their quality system and ensure regulatory responsibilities are met. Training and skills development of all personnel involved in the various operations is a key component to ensuring compliant procedures. Security in life sciences supply chains is imperative to ensure that products reach their destination having never been compromised.
Good manufacturing practice and good distribution practice need to work hand-in-hand and vigilance by all concerned in the supply chain is vital to ensure patient safety. The number of subcontracted companies involved in the supply chain for medical devices with different modes of transport and temperature control has increased significantly. Collaboration between all parties, including manufacturers, logistics service providers, ports and airports, is crucial to ensure anti-theft and anti-counterfeit procedures, product integrity and patient safety.
Good distribution practice The Irish Exporters Association has played a pivotal role in ensuring that companies reach and exceed the required compliance standard in ensuring product integrity and patient safety along the supply chain. The IEA GDP Passport ensures compliance under these new regulations and has become the gold standard for Good Distribution Practice in Ireland with all leading logistics service providers in the field now having obtained certification. The IEA have been proactive and launched new courses, which fully cover all changes in medical device regulations with increased emphasis on risk and risk assessment. These courses are fully comprehensive for pharma and also medical devices, cosmetics and falsified products, all of which are areas of risk and concern. Manufacturers can now ensure life sciences products are transported, stored and handled according to GDP regulations by dealing with IEA GDP Passport holders and ensuring patient safety along the supply chain. Read more on: businessnews.ie
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Supporting Irish pharma’s diverse supply chain needs
Twenty-four of the top twenty-five global pharmaceutical and biopharmaceutical companies are based in Ireland. Six of the world’s ten top-selling drugs are produced in the country too, making it the largest net exporter of pharmaceuticals in the EU and a globally-recognised centre of excellence for the sector. SPONSORED
S
upply chain and transportation services are vital within the life sciences sector, particularly in supporting Foreign Direct Investments (FDIs) to establish a manufacturing base in Ireland. This support can exist through pre-construction logistics, capital transfer and bespoke packaging and transportation solutions, including the provision of state-ofthe-art, licensed facilities.
New therapies demand new skillsets Like many industries, the life sciences sector is in the midst of profound change. The industry has always prioritised quality and security in its supply network, and these attributes are still going to be vital. The big, emerging challenge for companies is going to be finding ways to use their supply chains to reduce the cost of healthcare delivery, while improving service to patients and providers. That’s going to require increased emphasis on agility, flexibility and the creation of innovative new offerings, according to Maurice Meade, Managing
Europe and the US. We have full access and integration with GDP-compliant, temperature-controlled transport services by air, road, ocean and express,” adds McCann.
Maurice Meade Managing Director, DHL Global Forwarding, Ireland
Gill McCann Head of Life Sciences, DHL Supply Chain, Ireland
Director of DHL Global Forwarding, Ireland. “To address these challenges, healthcare supply chains are starting to capitalise on the opportunities offered by big data and advanced analytics. Valuable customer insights are being driven from the use of tags, monitoring location and temperature throughout the product journey, enabling better decisions around route, packaging and handling of their valuable cargo.” Scientific advances in medicines and breakthrough therapies will bring new challenges for manufacturing and supply chains; getting sensitive, time-critical medicines to global patients and dealing with the challenges of 3D printing of medicines, personalised medicines and gene therapies. Staying abreast of these advances
- many driven by research organisations and academic collaborations within Ireland - is key. “We support an incredible industry and are proud to be part of the supply chain that gets these critical medicines to patients,” says DHL Supply Chain Ireland’s Life Sciences Head, Gill McCann. “Going forward, our role will be to support industry in developing the means to get these new and complex therapies to patients, often with very short lead times and with stringent security and compliance concerns.”
Connectivity in and out of Ireland “Ireland may be located on the periphery of Europe, but that doesn’t affect our ability to deliver finished goods and clinical trials samples and supplies on a next-day basis to
An integrated global network “Many companies are beginning to recognise the benefits of a more integrated approach to supply chain management,” says Meade. “Traditionally, companies have managed their inbound supply chain at a plant level. By enabling a more holistic view of the inbound supply chains, international delivery networks have reduced complexity, providing visibility from pick up to point of delivery, making them more agile and responsive to market demand. This has allowed us to reduce the amount of inventory sitting in warehouses and release working capital for other needs.” A supply chain for lifesaving/life-sustaining medicines The life sciences supply chain touches the lives of so many people, every day of every week, and this is where global expertise is essential. At the end of runway two at Dublin international airport, customers’ rare medications are stored and packed in a secure, GDP-compliant temperature-controlled, pharma-grade location, then quickly shipped to the four corners of the globe via a guaranteed-integrity end-to-end cold
chain. These include high value drugs for the treatment of chronic and ultra-rare conditions that need to be transported securely, quickly and with full visibility, from Ireland to emerging markets all over the world. Ireland remains ideally placed to manage global and European pharmaceutical and clinical supply chains. Supply chain and transportation services help the industry operate compliantly, safely and efficiently, while ensuring the continued provision of life-sustaining and life-transforming medicines to patients worldwide out of the centre of excellence that is the island of Ireland. About DHL:
DHL supports the life sciences sector across R&D, pharmaceuticals, medical devices and hospitals, and has developed customised Worldwide Medical Express and Thermonet networks which enable end-toend proactive monitoring of temperature-sensitive shipments. DHL has its own airline with over 250 dedicated aircraft connecting over 500 airports and 22 major hubs globally. Read more on logistics.dhl/global-en
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LIFE SCIENCE & TECHNOLOGY SECTOR For over the past 40 years, Mercury Engineering has gained extensive experience in this industry, working on projects large and small for most of the world’s major pharmaceutical companies. Mercury Engineering has a deep understanding of our clients needs & delivering to their high expectations in an innovative & safe manner to the highest quality standards, through our processes and procedures including protocols to deliver first class construction excellence.
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