Volume 1, Issue 1
Giving Ireland a scientific and competitive edge in global markets
Research & Innovation Website:
www.researchandinnovation.ie
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- 3 C OVER S TORY
- 24, 25 & 26 C LEANROOMS
Giving Ireland a scientific and competitive edge in global markets.
The role and importance of clean rooms in research and innovation in Ireland.
- 10, 12, 13 & 14 R ESEARCH & D EVELOPMENT UCC aims to become leading research university in Ireland. New Abbott test may help doctors more accurately evaluate heart attacks.
Cleanzone – The international trade fair and congress for cleanroom technology. PAGE 3
Professor Mark Ferguson, Director General, Science Foundation Ireland.
IRDG – Fostering industry innovation and competitiveness in Ireland.
Cash refunds for engineering activity.
- 29 R ENEWABLE E NERGY
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David Graham, BVD Programme Manager, Animal Health Ireland.
OpenHydro and Alderney Renewable Energy to develop major European tidal array.
Research and innovation at DCU - Ireland’s university of enterprise.
- 17 & 21 R&D TAX C REDITS
Cleanroom cleaning – An arduous task?
- 31 E NTERPRISE S UPPORT PAGE 10
Working it out - A step at a time.
Professor Anita Maguire, UCC.
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- 32 C LINICAL T RIALS
R&D tax credits – Onwards and upwards.
Outsourcing Clinical Trials Series.
Mary Rose Burke, Director of Business Representation, Ibec.
- 19 & 20 F UNDING & I NVESTMENT NDRC - Making ventures happen. InterTradeIreland launches 12th annual all-island Seedcorn Investor Readiness Competition.
Managing Director: Colin Murphy Editor: Mike Rohan
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Denis Hayes, Managing Director, IRDG.
Group Operations Manager: Sylvia McCarthy Advertising: Adrian Murphy Production Manager: Sylvia McCarthy
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- 22 & 23 I NNOVATION
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APC wins Bioscience Innovation Award. All-island programme to eradicate BVD virus. PAGE 17
Ian Collins, Head of R&D Tax Services, Ernst & Young.
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RESEARCH & INNOVATION, VOLUME 1, ISSUE 1
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COVER STORY
Giving Ireland a Scientific and Competitive Edge in Global Markets Established 13 years ago, Science Foundation Ireland (SFI) is the State organisation entrusted with funding excellent and impactful scientific research in Ireland and promoting the role of science in society.
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FI’s mission is to ‘build and strengthen scientific and engineering research and its infrastructure in the areas of greatest strategic value to Ireland’s long-term competitiveness and development.’ SFI’s Agenda 2020 is an ambitious plan to position Ireland as a global knowledge leader in the fields of scientific and engineering research, to drive economic, social and cultural development. The aim is to build on the considerable achievements in Ireland’s scientific and enterprise communities. Four Key Objectives The Agenda 2020 strategy has established four primary objectives for SFI: 1. To be the best science funding agency in the world at creating impact from excellent research and demonstrating clear value for money invested; 2. To be the exemplar in building partnerships that fund excellent science and drive it out into the market and society; 3. To have the most engaged and scientifically informed public; and
Pictured are Dr William Finlay, Director of Global Biotherapeutics Technologies, Pfizer; Dr Paul Duffy, Vice President, Pfizer; Professor, Mark Ferguson, Director General, SFI; and Sean Sherlock, TD, Minister for Research and Innovation, launching the new collaborative SFI and Pfizer biomedical research funding programme.
4. To represent the ideal modern public service organisation, staffed in a lean and flexible manner, with efficient and effective management.
Professor Mark Ferguson, Director General of Science Foundation Ireland and Chief Scientific Adviser to the Government of Ireland.
Investment SFI spends about Eur150 million annually in funding research in Ireland. The investment is targeted at academic researchers and research teams who are most likely to generate new knowledge, leading edge technologies and competitive enterprises in the fields of science, technology, engineering and maths. The Foundation also promotes and supports the study of, education in, and engagement with STEM and promotes an awareness and understanding of the value of STEM to society and, in particular, to the growth of the economy. So how does the Irish Government’s budget for investment in scientific research and development compare internationally? “In terms of budget as a percentage of GDP, there are figures that suggest that any country should be investing between 0.8% and 1% of GDP. We invest probably closer to 0.6%, so we have still some ways to go after a good start,” explains Professor Mark Ferguson, who became Director General of Science Foundation Ireland in January 2012 and has also been Chief Scientific
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aimed at achieving high scientific excellence of economic importance, is a central element of this activity. Last year, SFI invested over Eur200 million in seven Research Centres of excellence with an additional Eur100 million in funding from more than 150 companies. The seven new world-class SFI Research Centres – AMBER, APC, Insight, I-PIC, Infant, MaREI and SSPC - mark a new collaborative approach and bring together multi-disciplinary teams comprising 800 scientists from across Ireland’s leading higher education and research institutions and interacting with 156 industry partners (see Panel). The seven new SFI Research Centres are focused on areas such as marine renewable energy, functional foods, nanotechnology, phototonics and drug synthesis crystallization. “So at a time of extreme public austerity, this is the largest single investment by the State in scientific projects and it is the largest ever public/private Pictured: Dr Joseph Roche, Trinity College Dublin, showcasing quantum locking with the partnership,” he points out. SFI expects to President of Ireland, Michael D. Higgins, Prof Michael John Gorman, CEO of Science Gallery announce at least two new Research Centres during International, and Prof Mark Ferguson, Director General of SFI. 2014. Indeed, yet further Research Centres are planned Adviser to the Government of Ireland since October 2012. in the long-term with Professor Mark Ferguson envisaging that The SFI’s budget has not surprisingly been impacted by the eco- between 15 and 20 are required. “The scientific community nomic downturn. “It was planned at one point to go to 1.2% of understands that siloed approaches don’t always work but actualGDP in the good times of the ‘Celtic Tiger’ but this never ly joining of excellence across the system is a good thing to do occurred. However, successive Irish Governments have pretty and there is good data to support that,” he remarks. much kept faith with science in the sense that although there have been cuts to SFI’s budget, they have not necessarily been as severe Supporting Business as cuts to other parts of the public service, nor as severe as cuts to SFI is also supporting enterprise in Ireland through its newly science budgets in some other European countries that are also fac- launched Industry Fellowship Scheme, which promotes the ing economic austerity.” Professor Ferguson adds: “The scientific importance of research across the full industrial spectrum from community here has to show on a daily basis that they are doing SMEs to multinationals. The programme allows the exchange of excellent and relevant work.” people at all levels between academia in Ireland and industry in Indeed, scientific excellence and relevance are the two key criteria Ireland and abroad. used when assessing the suitability of any projects for funding by SFI. In 2013, SFI invested Eur9.1 million in 81 applied research projects focusing on the early stages of commercialisation of new Working With Enterprise research findings through SFI’s TIDA (Technology Innovation Working with Irish enterprise is a central element of SFI’s activi- Development Award) programme - which also trained approxities. Over 30% of SFI funded researchers have established collabo- mately 100 researchers in entrepreneurship. rations with industry. SFI funded researchers have 1067 collaborations with 702 Professor Ferguson comments: “SFI technically cannot fund any companies - 540 collaborations with 274 multinational compaindustry. We can only fund into a higher education institute in nies and 527 collaborations with 428 SMEs. SFI researchers have Ireland. So our sister agency Enterprise Ireland typically funds 1,821 international collaborations in over 60 countries. indigenous industry and IDA attracts multinational companies. SFI In 2014, SFI will continue to focus on the development of focuses on research in higher educational institutions but many of careers for researchers in industry and academia through a broad these programmes are increasingly collaborative with industry.” range of career development schemes. New programmes such as For example, SFI’s Research Centres Programme requires indus- the SFI Industry Fellowship, the SFI Advance Fellowship, SFI try to contribute 30% of the Spokes and SFI Partnership are funding, with a minimum cash commencing in 2014. Full component of 10%. details of all SFI programmes “You can receive funding from are available on the SFI webindustry by way of donation of site. consumables, people’s time, equipment and so on but, for Economic Impact me, cash is an important metric Government support for scienbecause it indicates how importific endeavour in Ireland is tant it is for the company conshowing results. With regard cerned,” he says. to scientific citations, Ireland ranked below Bangladesh in Research Centres 2000 but has since climbed Programme into the top 20 nations globalSFI seeks to identify priority ly. The economic impact is areas where Ireland can attain also evident. meaningful impact in a global For example, 72% of the economy. Its recently launched The inaugural SFI St Patrick’s Day Medal being presented by An Taoiseach Enda jobs that the IDA attracted to Research Centres programme, Kenny to Dr Garret FitzGerald. Ireland in 2013 had a prior RESEARCH & INNOVATION, VOLUME 1, ISSUE 1
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€300 Million Investment in Seven World Class Research Centres The seven new world-class SFI Research Centres are in the following areas: * INISGHT - Data Analytics – with the explosion of internet based information through this centre we will see the development of breakthrough data analytics technologies to make Ireland a global leader in this rapidly expanding area. * MaREI - Marine renewable energy – Ireland is one of the best locations in the world in terms of marine renewable energy resources. This centre will look to generate energy technologies for industry from wave, tidal and floating wind devices. * AMBER - Nanotechnology/engineered materials – will deliver worldleading research across a number of key enterprise sectors, most notably ICT, industrial technology and medical devices and delivery systems. Ireland is currently ranked 6th globally in nanotechnology and 8th in materials science. * Alimentary Pharmabiotic Centre (APC) - Food for health/functional
foods - the centre will address important issues such as disease prevention, healthy ageing and improved population health in general. Ireland is currently ranked 2nd in the world in probiotics research. * I-PIC - Photonics – which is the generation, manipulation and utilization of light, is an important enabling technology that underpins many areas such as future networks, communications systems and medical devices. * INFANT - Perinatal Translational Research – which will focus on fasttracking discoveries relating to most complications of pregnancy and newborn babies and service a huge societal and economic need globally. * SSPC - Drug synthesis/crystallization – this centre will develop new mechanisms and better control processes to produce new and improved drug formulations and safe medicines. This centre is of major importance to Ireland’s pharmaceutical sector, a sector which generated over Eur56 billion in exports in 2012.
linkage with an SFI funded very effective organisaresearch group. “It shows tion. The scientific and that we are an important technical staff within SFI, part of the ‘ecosystem’,” he unlike many other areas points out. “The factors of the public service, are that influence overseas on five year contracts and business in establishing a will leave during that time presence in Ireland, such as period – so it is very custhe availability of a well tomer-focused,” he says. educated, English speaking “Their careers will be in labour pool, tax incentives industry or academia and and entry to the EU marthis keeps the science ket, are all well known but dynamic. It ensures an an increasingly important influx of folks who are reason is the ability to colhighly motivated and laborate with the research effective and who then go system.” on to careers in either Now head of SFI for industry or academia.” over two years, Professor Ferguson praises his predeInternational cessors for their work in Prof Mark Ferguson, Director General of SFI, pictured with Minister of State for Research and Benchmarking building up the capacity of Innovation, Sean Sherlock TD; maths educator and TV and radio presenter Aoibhinn Ní Ireland compares favthe science system in Shúilleabháin; and pupils from Gardiner Street, Primary School, Dublin on the occasion of the ourably on an internationIreland. “However, we launch of the Discover Primary Science and Maths (DPSM) Awards of Science and Maths al basis with regard to its need to do a better job of Excellence. scientific capabilities. articulating what we do Ireland hold a top 20 and we can also do better,” he says. place globally in all fields of science but ranks first in molecular genetics, second in gut microbe interactions (functional foods), Lean and Mean third in immunology and eighth in material sciences, according SFI is staffed by about 50 people. “So it is mean and lean. It is a to SFI. However, while Ireland is strong in certain fields of science it is weak in others. In a recent EU study, Ireland ranked in the top three countries in Europe in terms of innovation and some global surveys place Ireland in the top ten. “However, we should not be complacent because other countries investing more in their science base, such as China, India and Korea, are rapidly catching up,” he remarks.
Pictured at the launch of the Science Foundation Ireland Smart Futures three year strategy: Minister for Jobs, Enterprise and Innovation Richard Bruton TD, with Shane O'Donnell, Smart Futures STEM Ambassador/County Clare Hurling Hero, and Dr Ruth Freeman, Director of Strategy and Communications in SFI.
Optimism The Director General of SFI is optimistic about Irish industrial, commercial and economic development over the next five years. “I am very positive about Ireland’s outlook. I think the enterprise agencies work well together – IDA, Enterprise Ireland and ourselves. The universities are increasingly in tune that excellence is absolutely paramount but so is relevance and so is impact. It is also very important politically that you can demonstrate clearly to people that investing in scientific research is as important as investing in other walks of life, such as doctors, police etc,” Professor Mark Ferguson concludes. I
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RESEARCH & DEVELOPMENT
UCC Aims to Become Leading Research University in Ireland With research and innovation high on the political agenda for the reversal of Ireland’s economic fortunes, University College Cork has never been better positioned to fulfill the ambition of its Vice President for Research and Innovation Professor Anita Maguire to become the leading research university in Ireland.
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University College Cork is at a very exciting phase in terms of its research environment. Over the past 15 years, Ireland has invested extensively in the development of the research infrastructure. Over this time, UCC has been very successful in attracting competitive support, both nationally and internationally, for the development of a broad range of interdisciplinary research centres which form a very significant component of the research landscape in the university,” she comments. Ranked in the top two per cent of universities worldwide by Thomp- Professor Anita Maguire. son Reuters based on the quality of its research output and peer esteem, ond in the world for probiotics research. UCC is Ireland’s first five-star university (according to the QS World University Research Investment Rankings) with internationally recognised Despite adverse economic conditions, research in science, food, engineering, UCC’s research investment reached medicine, business, law, social sciences almost Eur80 million in 2011/2012, with and the humanities. non-exchequer funding accounting for Of Ireland’s most highly cited 25% of research income. researchers, 62% are from UCC and The university has experienced great based on citations, UCC is ranked as sec- success in competing for EU research
awards to date. It performed particularly strongly in the 7th Framework Programme for Research (FP7) receiving more than Eur67 million from over 190 awards. This success in winning EU grants is reflected in UCC's position as the most successful university in Ireland in FP7 success rates (23.7%). International Collaboration As Dr Maguire points out, UCC researchers now collaborate with almost 700 of the world’s top universities across 110 countries and are ideally placed to leverage these collaborations for success in future exchequer and non-exchequer funding programmes. Last February, Science Foundation Ireland (SFI) announced the largest joint State/industry research investment (Eur300 million) in Irish history. Of the seven successful research centres, UCC will lead four, co-lead a fifth and partner the remaining two (see Panel). Dr Maguire says: “2013 was a very exciting year for research in UCC as the
UCC’s Recent Success in Securing SFI Funding Of the seven successful research centres to attract funding from Science Foundation Ireland’s (SFI) Eur300 million investment announced last year, UCC will lead four, co-lead a fifth and partner the remaining two. The SFI research centres led by UCC include: * Irish Photonic Integration Research Centre (IPIC) led by Professor Paul Townsend, at the Tyndall National Institute, Ireland’s leading research institution, which will address the grand challenge of photonic integration. * Alimentary Pharmabiotic Centre (APC) led by Professor Fergus Shanahan, which has pioneered research into food, the gastrointestinal bacterial community, and health.
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* Irish Centre for Fetal and Neonatal Translational Research (INFANT) led by Professors Louise Kenny and Geraldine Boylan, which specialises in perinatal health. * Marine Renewable Energy Ireland (MaREI) which focuses on developing the science and technologies required by the marine renewable energy sector. * Ireland’s Big Data and Analytics Research Centre (Insight) which focuses on addressing broad-ranging data analytic technologies and challenges. It is a national research centre that is co-hosted by UCC, UCD, DCU, and NUIG, with lead principal investigators at each site. The co-leading principal investigator of Insight at UCC is Professor Barry O’Sullivan.
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CASE STUDY
Advanced Materials For Marine Renewable Energy Devices
Composite materials are synonymous with aerospace, with the Boeing 787 Dreamliner sporting a revolutionary carbon-fibre wing and fuselage to save weight and fuel. The massive wind turbine blades that are now generating up to 20% of Ireland’s electricity are made of glass-fibre reinforced polymers, another composite material. These applications of composites reduce costs and improve durability and performance in an energy-hungry world. Prof. Conchúr Ó Brádaigh, Director of the SFI MaREI Centre is working to apply the same composite materials to marine renewable energy devices such as tidal turbine blades, wave energy devices and offshore wind turbines. “Composite materials are a natural fit for highly-stressed ocean energy components such as
blades, which will have to rotate many tens of millions of times while immersed in seawater, without corroding, in order to produce the electricity of the future,” says Prof. Ó Brádaigh. Composite materials are already being used for prototype tidal turbine blades for instance, but the manufacturing processes being used are more suitable to low-volume production of aircraft, than to the thousands of structures that will be required to supply the multi-MW tidal farms that are being planned in Scottish, Irish and Canadian waters in the next five years. The key barrier to commercialisation of marine renewable energy, says Prof Ó Brádaigh was to reduce the Levelised Cost of Electricity (LCOE) to a level competitive with that of conventional sources of electricity, such as fossil-fuel plants, and even onshore wind. “One of the most important factors in calculating the LCOE is being able to predict the operations and maintenance cost of this technology. The superior fatigue performance of composite materials compared to metals,
of the research come to fruition contributing to knowledge and to economic growth.”
SFI centres – APC, Infant, MaREI, IPIC in addition to Insight which is co-led by UCC – became established within the university, developing their collaborations with the enterprise and university partners and attracting leading researchers from all over the world to participate in cutting-edge programmes. The impact of this investment will be seen over the coming years as the results
Horizon 2020 She points out that the SFI-funded centres are ideally placed to exploit the opportunities offered by Horizon 2020, the biggest EU research and innovation programme yet with a budget of nearly Eur80 billion over seven years. “Horizon 2020 offers opportunities to research teams across a very broad range of disciplines from science and engineering to humanities and the social sciences, and indeed trans-disciplinary engagement is particularly encouraged. We hope to build on our success in the last EU programme (FP7) with even more successful bids for projects which will give us access to non-exchequer funds at a time when funding at national level for higher education is diminishing,” Dr Maguire adds.
and the fact that they don’t corrode in seawater, means that these fibre-reinforced structures don’t have to be inspected as often, and can be fitted with embedded sensors that will report back to base on their structural health during operation,” he explains. Conchúr Ó Brádaigh joined UCC as Director of the SFI MaREI centre in February of this year, from NUI Galway, where he was a senior lecturer. A Key Performance Indicator of the SFI centres is their ability to have an economic impact on the country, and ultimately to help create jobs. Prof Ó Brádaigh has a track record in this area, having co-founded the successful NUI Galway spinout ÉireComposites Teo, which employs over 70 people in Connemara, producing and testing composite structures mainly for the aerospace and wind energy markets.
research, explains Dr Maguire. The Tyndall National Institute as Ireland’s largest research institute accounts for some 30% of the research activity in the university. While the institution has proved very successful in developing interdisciplinary research centres, a substantial proportion of the research activity is undertaken within the departments and schools of the university. Dr Maguire says: “Such activity is central to the development of new clusters of research focus and the seeding of future centres and institutes. The focus of current and emergent research strengths is closely aligned with key Government and European Commission policies.” I
Centres of Excellence The university’s research strategy is focused on creating major centres of excellence for world-class RESEARCH & INNOVATION, VOLUME 1, ISSUE 1
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RESEARCH & DEVELOPMENT
New Abbott Test May Help Doctors More Accurately Evaluate Heart Attacks Abbott, the global healthcare company, has developed a new diagnostic test to help doctors evaluate if a person is having a heart attack (1). he ARCHITECT STAT High Sensitive Troponin-I (hsTnl) assay could allow doctors to reduce the time to diagnosis and treatment by several hours when compared to standard troponin tests. Abbott’s diagnostic manufacturing facility in Longford supported the development of the test and now manufactures it for worldwide use. Abbott’s new hsTnI test can measure very low levels of the protein, which allows doctors to evaluate whether or not patients are having a heart attack within two to four hours (2). This faster evaluation could allow doctors to reduce the time to diagnosis and treatment by several hours when compared to standard troponin tests.
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Preliminary data suggests ARCHITECT STAT High Sensitive Troponin-I assay may help doctors more accurately identify heart attacks in women. Abbott Diagnostics
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development of the test and now manufactures it for worldwide use. Pictured with the test are Stefan Molitor, Site Director, Abbott Diagnostics Longford and Mairead Dalton, Abbott Diagnostics employee.
Early Diagnosis Cardiac troponin, a protein found in the heart muscle, is the preferred biomarker used to identify suspected heart attacks (3). Many patients who visit the emergency room with a suspected heart attack currently have blood samples drawn with troponin tests upon admission, after six hours, and then potentially 12 hours later, before a diagnosis may be made (4). For patients who are having a heart attack, early diagnosis is crucial. Once the heart stops receiving blood, heart muscle cells start to die and could lead to parts of the heart being irreversibly damaged. "Use of this test could speed up the process whereby patients with suspected acute coronary syndromes are evaluated. What this could means is that high-risk patients may be identified and treated at the earliest opportunity, but also that low-risk patients can be reassured and discharged. This has obvious benefits for both patient care and resource utilisation," says Dr Niall Mahon, Consultant Cardiologist, Mater Misericordiae University and Mater Private Hospitals, Dublin. The new hsTnI test could be particularly beneficial for women, who are often underdiagnosed or under-treated (5), as women 12
has played an integral role in supporting R&D colleagues in the United States to bring this innovative diagnostic test to the market by working on the development phase of this test. In addition, Abbott Longford manufactures ARCHITECT STAT hsTnI assays for worldwide use. "Abbott Longford was chosen to manufacture this innovative product because of our strong record of compliance, emphasis on quality, ability to bring products to market efficiently, the security of our manufacturing environment and the quality of our technical and operational staff," says Stefan Molitor, Site Director, Abbott Diagnostics Longford.
Picture Conor McCabe Photography.
often show different symptoms from men when it comes to heart attacks. Preliminary Findings Promising preliminary findings from a study of 1,126 patients presenting with symptoms of a heart attack presented at the European Society of Cardiology (ESC) Congress 2013 suggest that Abbott's hsTnI test may help doctors improve the diagnosis and prognosis of patients presenting with symptoms of a heart attack (6). "Using this high-sensitive troponin assay allows optimal diagnostic performance in early identification of patients with evolving myocardial injury. The high-sensitive assay may help physicians to rule in and rule out acute myocardial injury. While Abbott’s high-sensitive troponin test benefits both men and women, the sensitivity of this assay is unique in that it has the potential for earlier diagnosis in women," says Dr Maria Fitzgibbon, Consultant and Head of the Biochemistry and Diagnostic Endocrinology Department at the Mater Misericordiae University and Mater Private Hospitals, Dublin. Abbott’s diagnostics facility in Longford RESEARCH & INNOVATION, VOLUME 1, ISSUE 1
Routine Use The ARCHITECT STAT hsTnI test will be in routine diagnostic use at the Mater Misericordiae University and Mater Private Hospitals, Dublin, shortly and it is anticipated it will also be adopted by other key cardiology centres throughout Ireland. The ARCHITECT STAT hsTnI assay is commercially available in several countries in Europe, as well as Canada, Australia, New Zealand, and Brazil and runs on Abbott's fully automated ARCHITECT family of analyzers. The test is currently for researchuse only in the United States. I (1) Abbott ARCHITECT STAT High Sensitive Troponin-I Product Insert (PI), January 2013. (2) Abbott ARCHITECT STAT High Sensitive Troponin-I Product Insert (PI), January 2013. (3) Thygesen K, Alpert JS, Jaffe AS et al. Third universal definition of myocardial infarction. European Heart Journal. 2012; 33:2551-2567. (4) Thygesen K, Alpert JS, White HD et al. Universal definition of myocardial infarction. European Heart Journal. 2007; 28:2525-38. (5) Pope JH, Aufderheide TP, Ruthazer R, et al. Missed diagnoses of acute cardiac ischemia in the emergency department. New England Journal of Medicine. 2000; 342:1163-1170. (6) Anoop S, Mills N, Griffiths M, et. al. High-sensitivity cardiac troponin and the underdiagnosis.
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Research and Innovation at DCU – Ireland’s University of Enterprise Research at Dublin City University not only creates new knowledge but also translates such knowledge into benefits for society and for the economy. o ease this translation, DCU has four Research and Enterprise Hubs which are focused in key areas of societal importance and which are set up to make it easier to engage with researchers in DCU. The Research and Enterprise Hubs are: • health technologies, and the healthy and ageing society • information technology and the digital society • sustainable economies and societies • democratic and secure societies. Each of the Hubs brings together expertise from different disciplines, enabling more productive interactions with partners in commercial, social and cultural enterprises. Through their business development and engagement teams, the Hubs accelerate the translation of discoveries and inventions into innovations that can benefit people’s lives.
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Activities in the health technologies and the healthy and ageing society hub include: bioengineering and medical devices, diagnostics, pharmaceuticals and therapeutic proteins, food for health, connected health and assistive technologies, and supportive care in dementia. The information technology and the digital society hub is engaged in research and innovation in networks and communications, the sensor web and the internet of
things, smart grids, language technologies, and software optimisation. Within the sustainable economies and societies hub, research activities include work on energy generation and efficiency, novel materials, green chemistry, sensors, water quality, and sustainability. The democratic and secure societies hub encompasses activities addressing conflict resolution and reconstruction, innovative government, digital media, communications, intercultural studies, applied ethics, and responsible research and innovation. Further expertise and facilities in DCU is provided by three cross-cutting platforms: • The Science and Technology Enhancement Platform, which provides key infrastructure and knowledge in core science and engineering disciplines such as: sensor research, plasma science, materials science, cloud computing, mathematical and computational modeling, data analytics, biotechnology, and mechanical and electronic engineering • The Societal Impact Platform helps to incorporate societal perspectives into our research and to increase public engagement • The Business Innovation Platform provides expertise in particular areas of business processes as required by enterprise partners (such as marketing, human resource development, and leadership development) and supports the Hubs in bridging the gap between research and innovation. As shown in the diagram, the Hubs and Platforms are arranged in a matrix. From the core of academic excellence, the four research and enterprise hubs reach out to enterprise and society, while the cross-cutting platforms provide additional expertise to deepen and reinforce research and innovation activities. DCU has a strong track record of engagement, collaboration and delivery with a wide
variety of partners from academia, SMEs, large national and international corporations, social enterprises, public bodies and charities. We are continually striving to lower the barriers for enterprises to engage with DCU to access expertise, research and facilities. Whether the engagement is via consultancy, contract or collaborative research, or by licensing of our technologies, we are open and ready for business. For more information, see the websites www.dcu.ie/research, www.dcu/invent or contact: DCU Research – Dr Ana Terres, Director of Research Support, Tel: +353-1-700 8000, Email: research@dcu.ie; DCU Innovation – Mr Richard Stokes, Director of Innovation, Tel: +353-1-700 7777, Email: info@invent.dcu.ie. I
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DCU’s research and innovation matrix: from the core of academic excellence, the four research and enterprise hubs develop research that can have an impact on important areas for the economy and society. These activities are reinforced by additional expertise in three crosscutting platforms (science and technology enhancement, business innovation, and societal impact.
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RESEARCH & DEVELOPMENT
IRDG – Fostering Industry Innovation and Competitiveness in Ireland By Denis Hayes, Managing Director of IRDG
IRDG is an Innovation Network, led by industry, for R&D performing companies and third level colleges throughout Ireland.
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s a non-profit body, we work together with our members to drive excellence in Innovation within Ireland’s industry to create growth, jobs and prosperity. IRDG is a vibrant and growing organisation. Our membership has more than doubled in the last two years. These members come from all sectors of industry including Engineering, Healthcare, Food and Beverage, Software & ICT, Financial Services and Education. Ultimately everything we do is connected with R&D and Innovation. Whether you are a start-up or a multinational, the IRDG is a go-to organisation and network for you. Members range from some of the biggest Irish and Multinational companies in the country with several thousand employees, to home grown Irish start-up companies with just 2 employees. We also have 10 of the leading third level research institutes amongst the membership. The common thread that links all of them together is R&D and Innovation. They are all actively part of IRDG because they know R&D and Innovation is strategically vital to their business success. They want to ensure they are best informed, advised and connected to make the very most of every opportunity.
needs at any point in time. Everything we do is focused on our Member’s needs. We respond to the areas of interest to them, but also work hard to bring new thinking, new ideas and new opportunities.
Denis Hayes, Managing Director of IRDG.
Galway to Dublin and Belfast. Our long established relationships with key state agencies including Enterprise Ireland, IDA, Department of Finance, Revenue and others means we are a well-respected voice of the R&D performing community when it comes to policy and programme decisions. Add to that our knowledge and long list of contacts in the R&D area, and you soon find IRDG to be a truly nationwide, crosssectoral Innovation Network.
“IRDG brings the R&D teams from every sector in the country together under one roof ” – Paul Bouchier, Dairygold.
“To have an organisation like IRDG that’s an advocate purely in the Research and Innovation agenda is super important” – Terry Landers, Microsoft.
Our network beyond the members is equally extensive. Annually more than 500 companies and organisations attend seminars and workshops right across the country, from Waterford to Cork to Limerick to
Some companies join as they have very specific R&D needs they are working to address. Others join to be part of the Innovation Network. Either way, all members are entitled to the same levels of support and service depending upon their
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“IRDG were key for us in putting together our new biocompatibility application for R&D Funding” – Evelyn O’Toole, Complete Laboratory Solutions. Ultimately, everything we do is connected with R&D and Innovation. We break it down under 5 Pillars of Activity: * Representation * Funding & Support * Innovation Networking * Collaboration * Learning. Representation IRDG is the Representative Group for Manufacturing and Services companies involved in Research, Development and Innovation in Ireland. We relay the views and experiences of our member companies to State bodies with a view to improving the incentives and environment for industry to conduct its Innovation and R&D activities.
“A voice for industry led R&D in Ireland, helping to secure funding for industrial R&D, a crucial element in Ireland’s competitiveness” – Máire Geoghegan-Quinn, EU Commissioner. IRDG members at Alltech for Innovation Practice Group visit.
Funding for R&D and Innovation IRDG identifies the sources of funding for industry R&D within Ireland and the wider EU. We keep our membership up-to-date on developments and assist and support them on an individual basis to avail of State and EU financial incentives and programmes. Innovation Networking IRDG operates an Innovation Network which encompasses companies, institutes and organisations across the island of Ireland. The sharing and support that members can avail of from their fellow network members is a huge resource. Ireland is fortunate to have a significant number of MNC’s and Irish companies, an entrepreneurial culture, a good infrastructure of HEI’s and excellent government and EU incentives in a relatively small geographical area. The potential for leveraging this network to create new connections and innovative development is tremendous.
“IRDG were able to put us in contact with a number of likeminded companies who had already established a formal innovation programme” – Siobhán Camplisson, Allergan. Collaboration IRDG facilitates collaboration between member companies and the third-level sector via seminars and individual consultation. We have developed great networks into the Universities and Institutes of Technology. In so doing, we can help our members to expand their research, and develop great products and services into the future.
Nationwide seminars on a variety of topics related to R&D and Innovation.
Learning Learning is all about best practice in Innovation. IRDG promotes learning among its members by: * Bringing expert speakers to deliver workshops and seminars on such topics as Lean in Innovation and Product Development, Horizon 2020, Systematic Innovation, Design Thinking and more. * Organising member companies to host Innovation Practice Groups where they share their Innovation practices with other members companies.
“It has taken away the myth that R&D is the domain of the people in the white coats” – Hugh Henry, Bord na Móna. No better time for R&D and Innovation Many would argue there has never been a more challenging time in Ireland to do business. Yet there has never been a better time to do R&D and Innovation. Now more than ever we need Research and Innovation in Ireland to drive economic recovery. The financial supports, the quality of research expertise available in the third level sector, and the willingness and openness of those involved in Innovation to support each other and promote knowledge and capability, has never been stronger. Companies are clearly recognising that there is a need to reach out and embrace a more open approach to Innovation. In doing so they are becoming more enRESEARCH & INNOVATION, VOLUME 1, ISSUE 1
gaged with other Innovation Leaders across the island, maximising their potential and improving their competitiveness.
“The Industry Research & Development Group, working with Irish Agencies, has done tremendous work with companies both small and big, in helping them to develop their products, to develop their services, and to transform our economy” – An Taoiseach, Enda Kenny. If your organisation is active in R&D, you need to be part of this growing Innovation Network. www.irdg.ie or 01 - 2374671 I
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I R&D TAX CREDITS
Cash Refunds For Engineering Activity By Ian Collins, Head of R&D Tax Services, Ernst & Young
Have you considered whether your engineering activities qualify for Irish research and development (“R&D”) tax credits or cash refunds? Have you ruled this out? ne of the most common mistakes we hear companies make is disregarding potential eligibility for R&D activities. Work undertaken by companies that is considered R&D for the purposes of the Irish tax regime can often be much broader than people think; it is not just limited to scientists in white coats working in labs. Qualifying R&D extends far beyond the typical “blue sky” research activity and can include a broad range of activities including large elements of new product and process development, evolution, and continuous improvement. This is something a lot of companies tend to overlook and as a result are missing out on valuable cash refunds! It’s important that you do not automatically rule out claiming for this benefit until you have fully explored the activities within your business. Eligibility for R&D tax credits can include producing new, or improving existing, materials, products, devices, processes, systems or services. These areas, which are typically embedded within the wider operations of businesses, tend to get overlooked. As a result, a little investigative work could produce serious tangible results in the form of extra cash for you!
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Eligibility for R&D tax credits can include producing new, or improving existing, materials, products, devices, processes, systems or services. These areas, which are typically embedded within the wider operations of businesses, tend to get overlooked
Overview The regime provides for effective tax relief of up to 37.5% for R&D expenditure falling within the scope of this scheme, equating to €37.50 of every €100 spent. This coupled with the availability of grant support can help companies halve the cost of doing R&D in Ireland, as illustrated by the attached example. A qualifying project in receipt of 20% grant funding
What is R&D? Our experience shows that the definition of R&D for tax purposes can include activities that occur in the wider business areas, such as manufacturing operations and assembly processes, regulatory certification and business services. Examples of areas which may qualify for R&D eligibility include: • Design, construction, and testing of systems, devices or processes, such as new hardware or software components, digital interface and control systems • Integration of legacy and new systems, for example following corporate mergers or acquisitions, or adoption of an Enterprise Architecture. This type of integration often occurs after an M&A transaction or JV/strategic alliance. • Data intensive activities, including, collection, storage and analysis, distribution and retrieval; defining or working with new or emerging data models and metadata standards, integration with third party content • Advances in network management and RESEARCH & INNOVATION, VOLUME 1, ISSUE 1
Ian Collins, Head of R&D Tax Services, Ernst & Young.
operational tools, development of wired and wireless technologies, designing mobile and interactive services, evolution of next generation network switching and control systems • Adoption of new technologies such as RFID tagging, mobile and smart card applications, developments of the ‘digital home’, biometric and security applications, thermal and optical imagery • Modification to existing processes or systems to improve throughout or increase efficiencies; establishing capacity, performance, scalability, availability, security Common Pitfalls Below are some of the most common pitfalls to watch out for when making a claim to Irish Revenue: • The most common mistake companies make is underclaiming their R&D benefits by simply focusing on their R&D departments and ignoring other areas of their business. This has resulted in significant sums being left behind. • Lack of documentation to support a claim filed with Revenue. Remember to expect that Revenue will look for evidence in the form of supporting documentation to back-up your claim. • Capturing the correct expenditure items. The tax rules are quite complex and Revenue’s attitudes during audits are hardening, therefore it will be important to make sure your claim is prepared in compliance with the relevant tax legislation. I 17
I
FUNDING & INVESTMENT
NDRC – Making Ventures Happen The Dublin-based company NDRC is an early stage investor in innovation, investing directly into innovative start-ups and indirectly to improve the environment in which ventures can grow. ver the last five years, NDRC has been working to build the best model for supporting early stage technologies, working with some of the brightest and best researchers, technologists and entrepreneurs to turn great ideas into successful ventures. NDRC’s core purpose is to bridge the gap between research and venture in the digital space by harnessing the dynamic entrepreneurship within Ireland’s knowledge economy. The core principles of NDRC are engineered into the DNA of NDRC’s two investment programmes: NDRC LaunchPad and NDRC VentureLab. These programmes are designed to address the specific challenges encountered in the creation of high impact viable new ventures.
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NDRC LaunchPad NDRC LaunchPad is Ireland’s first and leading digital accelerator, specifically designed to enable entrepreneurs to transform solid ideas into high impact ventures. As a pre-seed investment programme, the focus of this highly regarded initiative is to create commercially viable startups. The emphasis is to harness the inherent dynamism of indigenous and international entrepreneurialism through intensive mentoring and the high touch approach that exemplifies the NDRC method. Over an intensive 12-week period, participants receive help with every aspect of their business as well as a fast track to
attracting follow on investment. NDRC LaunchPad is recognised as a leading and much emulated accelerator in Europe. NDRC LaunchPad provides emerging startup promoters with: * Unparalleled expertise across relevant disciplines with hands-on mentoring * 12 weeks working alongside a broad spectrum of startups, innovators and investors * Peer-to-peer experiential environment * Weekly workshops and networking with acknowledged thought leaders * Micro-seed investment of up to €20k * The opportunity to pitch to investors at the end of programme Lift Off event. The next call for applications to NDRC LaunchPad will open in May with a deadline in early July for a programme that will start in September 2014. For more information visit www.ndrc.ie/launchpad. NDRC VentureLab NDRC VentureLab, a tailored science and technology accelerator, is dedicated to commercialising novel tech and engineering advances to create high specialism ventures. Building upon cumulative knowledge garnered over a five year period, NDRC VentureLab is targeted at supporting ventures where the nature of the ‘problem’ necessitates a greater depth of science, tech or intellectual RESEARCH & INNOVATION, VOLUME 1, ISSUE 1
property. The NDRC team initially spends 3-4 months delving deep into propositions with the promoters prior to entry. Validated propositions then engage with NDRC for a 6 month programme offering the following: * Hands-on ‘sleeves rolled up’ approach rom some of the best commercialisation experts in the ecosystem, mentoring and access to our networks * 6 month intensive, deeply experiential and focused accelerator programme * Peer to peer learning * Access to multiple areas of expertise within the commercialisation process * €100k convertible loan investment * Opportunity to develop a great new ‘investor ready’ venture. In January 2014, NDRC announced that it had surpassed its projected results for 2013, with its portfolio of start-up ventures having secured a cumulative Eur40 million in commercial follow on investment from angel and VC investors, with a combined market value of approximately Eur120 million. NDRC was also recently ranked the top University-Business Incubator for IT in the World by UBI Index, the world’s first global index to benchmark performance and best practices in University Business Incubators across the world. I
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I FUNDING & INVESTMENT
InterTradeIreland Launches 12th Annual All-island Seedcorn Investor Readiness Competition is calling on new startIthenterTradeIreland ups and early stage companies to enter InterTradeIreland all-island Seedcorn Investor Readiness Competition. With a total cash prize fund of Eur280,000 with no equity stake, it aims to transform equity raising businesses into first-class investor ready companies. Now in its 12th year, the competition has supported 1,949 enterprising companies, with the companies that have made it through to the regional finals successfully raising Eur179 million in new funds. It is considered among the investment and business communities in Ireland as one of the most important barometers for new and emerging companies. With nine cash prizes on offer; entrepreneurs compete against each other regionally before competing for the all-island ‘Best Early Stage’ and ‘Best New Start’ company titles. The Seedcorn competition imitates the real-life investment process; every business idea is reviewed by investment
experts and leading industry experts before companies are given individual feedback. Initial applications will be shortlisted with successful companies being invited to submit their full business plan. Companies will have the opportunity to attend one of a number of Seedcorn workshops in the coming weeks, designed to guide those considering entering the competition. Details can be found on the InterTradeIreland website www.intertradeireland.com/seedcorn. Companies must register their interest and complete the initial application form for the competition by Friday 30th May with the final business plan due by Friday 5th September 2014. If shortlisted, the company will be invited to deliver an investment pitch in front of the judging panel of experts. Companies can get involved with InterTradeIreland’s Seedcorn competition by registering at www.intertradeireland.com/seedcorn. Regional winners will be announced in
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mid November before going on to compete in the all-island grand final which takes place in Belfast on the 26th November 2014. I
I R&D TAX CREDITS
R&D Tax Credits – Onwards and Upwards By James Hughes, Tax Manager, Mazars
The Research & Development Tax Credit was introduced from 2003 as a means of incentivising innovative companies. t the time, the credit was computed as 20% of the qualifying R&D expenditure and could be offset against a company’s Corporation Tax liability. A de minimus limit applied at the time, generally referred to as the 2003 base year threshold, meaning only the expenditure incurred over and above the comparable 2003 expenditure amount would be available for the credit. In many instances, uptake of the credit was low. As a result, the credit was substantially overhauled from the end of 2008. The credit was increased to 25% of qualifying R&D expenditure and a refundable credit was introduced. Whereas previously, only profitable companies could attain a cash value for the credit, the amendments enabled loss making companies to get cash refunds of the credit by reference to corporation or payroll taxes paid.
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Austerity Budgets In the time since 2008, a number of austerity budgets have been presented, tax rates have increased and numerous tax reliefs have been curtailed and or abolished. The notable exception from the executioners block has been the R&D Tax Credit. All budgets from 2009 to present have sought to incrementally improve the R&D Tax Credit and how it applies to qualifying companies, large or small, multinational or indigenous. Notable amendments include: • The introduction of a ‘volume basis’ to the 2003 base year threshold. From
All budgets from 2009 to present have sought to incrementally improve the R&D Tax Credit and how it applies to qualifying companies
James Hughes.
2012, the first €100,000 of expenditure qualified for the credit, notwithstanding the 2003 amount. This has since been amended to €200,000 in 2013 and €300,000 in 2014. • Introduction of a ‘key employee’ element, such that companies can elect to surrender part of the credit to a key employee in a tax free scenario. • Amendment of the expenditure limits applicable to R&D activities carried out for a company by subcontractors or universities. The original 10% and 5% respective limits of internal expenditure were restrictive to small companies lacking particular expertise. Therefore a €100,000 de minimus limit was introduced for each class. The 10% subcontractor limit has also recently been increased to 15%. Horizon 2020 The next round of the EU Framework Programme for Research and Innovation, Horizon 2020 signals the continued commitment of the EU to innovation and technological development. In conjunction RESEARCH & INNOVATION, VOLUME 1, ISSUE 1
with this, the EU has set Ireland a target for R&D expenditures of 2.5% of GDP by 2020. The Department of Finance Review of Ireland’s Research & Development Tax Credit 2013 confirms that the equivalent proportion was 1.17% of GDP in 2011. As such, there is an onus on Ireland to further increase expenditure on R&D activities in the period to 2020. Hopefully the R&D Tax Credit will remain central to this commitment by Ireland and will continue to form one of the key methods by which the exchequer can support and incentivise research, innovation and development. A word of warning however. Whilst the fiscal policy suggests that the R&D Tax Credit is here to stay, a degree of control and structure is of course required. The Revenue Commissioners are challenged with patrolling this tax measure and ensuring a level playing field for all. From our experiences, the Revenue approach to R&D reviews and audits is twofold. In the first instance, claims are subjected to a science test, based on technological advancements and uncertainties. It would appear that the substantial majority of all claims audited are satisfying this science test. The second test, the financial test relates to the amount of expenditures claimed by companies. Based on audit results and feedback from Revenue, it would appear that the majority of claims are deemed somewhat excessive by Revenue and are resulting in a partial clawback of the credit claimed. Any company that is developing a new product that involves some form of experimentation, or is doing existing things in a new way should consider the opportunity to claim the credit. I James Hughes is a Tax Manager, heading up the Research & Development Tax Practice in Mazars. Phone: 01 449 6476 Email: jhughes@mazars.ie.
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I INNOVATION
APC Wins Bioscience Innovation Award PC Ltd -The Applied Process A Company – is the proud winner of the 2014 Bioscience Irish Times
and cheaper way. APC has built strategic-based partnerships with 8 of the Top Ten InterTradeIreland Innovation Award. global pharma and 5 of the Top Ten APC is a Chemical Engineering biopharma. These companies are spread Research & Technologies company across Ireland, Europe, USA, Asia and which was spun-out from the UCD Australasia. APC also engages and School of Chemical & Bioprocess supports emerging biotech firms in Engineering in 2011 by Dr Mark delivering their first medicines and Barrett and Prof Brian Glennon. products to the market place. APC has developed proprietary APC now employs 35 highly qualified engineering platform technologies, chemical engineers and research ACHIEVETM and BioACHIEVETM scientists. In 2013 APC opened a US which they incorporate into the design APC’s process and technology development team (from office to support this exceptional market and manufacture of pharmaceutical left): Dr Gary Morris, Dr Colin Byrne, Prof Brian Glennon driven growth, which unusually has (co-founder and director), Dr Anna Przyby., Dr Mark been achieved without any venture medicines. These technologies reduce the time, Barrett (co-founder and CEO), Dr Mark Hanlon, Dr Miriam capital investment. cost and associated risk for the Kennedy (front row). CEO and Co-Founder, Dr Mark development and supply of new and Barrett comments: “We are delighted existing medicines. APC’s technological engineering solutions are not bound by that APC is recognised for our innovations are incorporated from when a the type of medicine, the type of innovation, it has been an incredibly drug is initially discovered and progressed treatment, or the phase in its exciting journey for our team to through clinical development, to when it development, but by the necessity for conceptualise, develop and commercialise is marketed and taken by patients across companies to deliver their medicines to new innovative pharmaceutical the world. Uniquely APC’s chemical their patients in a quicker, more reliable engineering technologies.” I
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I INNOVATION
All-island Programme to Eradicate BVD Virus Dr David Graham, BVD Programme Manager
Bovine viral diarrhoea virus (BVDV) is an infectious disease of cattle which is widespread in beef and dairy herds in Northern Ireland and the Republic of Ireland where it is estimated to cost farmers €125 million each year. hese losses accrue primarily from out breaks of pneumonia and diarrhoea in calves and a range of reproductive losses in adults. The primary source of infection is calves which are born persistently infected (PI) with BVD virus as a result of infection in early pregnancy. These PI calves typically do not survive beyond 18 months of age, but in the interim excrete high levels of the virus throughout their lifetimes. It is recognised that the key to eradicating BVD virus at herd, regional or national level is the identification and removal of PI animals coupled with appropriate biosecurity meas ures to prevent spread of infection between herds.
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North-South Collaboration Animal Health Ireland (AHI) and Animal Health and Welfare NI (AHWNI) are sister organisations established in the Republic of Ireland and Northern Ireland to give leadership in addressing non-regulated diseases of cattle including BVD. Based on the outputs of a shared Technical Working Group consisting of experts from across the island, AHI and AHWNI are currently working jointly through cross-industry imp lementation groups to deliver
Pictured left to right: David Graham, BVD Programme Manager Animal Health Ireland; Joe O’Flaherty, CEO, Animal Health Ireland; and Mike Magan, Chairman of Animal Health Ireland.
Animal Health Ireland recently received an Irish Times/Intertrade Ireland Innovation Award for the Bovine viral diarrhoea virus eradication programme. The award, which was presented by An Taoiseach, Enda Kenny, was for North-South Collaborative Innovation. Pictured left to right: Thomas Hunter McGowan of InterTradeIreland; Mike Magan, Chairman of Animal Health Ireland; Taoiseach Enda Kenny; David Graham, BVD Programme Manager Animal Health Ireland; and Joe O’Flaherty, CEO, Animal Health Ireland.
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an all-island BVD eradication programme over a six year period. All calves are required by law to be uniquely identified shortly after birth, with this identification number dis played on officially-approved ear tags. A key component of the programme is the testing of ear tissue samples collected during routine identity tagging using official identity tags that have been modified for this purpose. These tissue tag samples are then submitted by farmers to one of a series of designated testing laboratories where they are screened for virus. Results are then transmitted electronically to programme databases which then issue results by SMS message to the farmers’ mobile phones with follow up letters as required. The programme in ROI is now in the second year of compulsory testing with some 2.1M calves tagged and tested in 2013, of which 0.67% was found to be PI. The programme in Northern Ire land is currently in the second year of a voluntary programme with the intro duction of legislation to move the programme to a com pulsory basis anticipated later in 2014. For further details see www.animal healthireland.ie or www.animalhealthni.com. I 23
I CLEAN ROOMS
The Role and Importance of Cleanrooms in Research and Innovation in Ireland By Conor Murray, Chairman, Irish Cleanroom Society
Cleanrooms in Research and Innovation is a good news story and so very important to our personal and economic wellbeing in Ireland today and in the future. leanrooms exist in all areas of Life Sciences and Healthcare in this country and in particular in Research and Innovation. Medical Devices, along with Pharmaceutical and Biopharmaceutical manufacturing are a key part of Life Sciences and Good Manufacturing Practice (GMP) is the cornerstone of Regulatory Compliance as it focuses on product quality and patient safety. We all know about the importance and contribution of the Life Science industry to the economy. A key underlying reason for the continued existence and growth is down to the quality of our people as we are seen as a ‘safe pair of hands’, from a regulatory perspective. The good news story is about sustaining our livelihood as most of us involved in Research and Innovation are directly or indirectly involved in serving this industry.
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The opening of the CCMI in January 2014.
Life Science Innovation Ireland is very much among a core of countries at the centre of Life Science innovation in research, manufacturing and quality. This is a result of a targeted and concentrated partnership of all the people involved – in the Life Science companies, State Bodies including IDA, Enterprise Ireland, Science Foundation of Ireland, 24
Health Research Board, Universities and 3rd level institutions, National Standards Authority of Ireland and the Irish Medicines Board as well as industry bodies including the Irish Medical Device Association and PharmaChemical Ireland, part of IBEC. Our English language skills, high level of education, work ethos and flexibility all contribute to Ireland’s success. And even though Ireland is a small country its focus on attention to detail and flexibility delivers excellence in product quality and regulatory compliance. The very size of this country and compact industry groupings, relative to other larger countries has been turned to our advantage.
SMEs which often have difficulty in procuring cleanroom space. The first clinical trial using CCMI-manufactured stem cells is being funded by the Health Research Board and Science Foundation Ireland. Another example is the Clinical Research Facility at St James Hospital in Dublin, which is due to open shortly and provides for the preparation of novel therapeutics and the running of clinical trials. This is being funded by the Welcome Trust and the Health Research Board and is a collaboration between the hospital and TCD. The facility will include a state of the art cleanroom for sterile intravenous and cytotoxic drug preparations.
Cleanrooms Cleanrooms are being used for research and innovation right across the country in our universities, multinational companies, research institutions and hospitals. They range from manufacturing to clinical research to Nanotechology cleanrooms and all the way across the technology spectrum to Biosafety Cleanroom Laboratories where the needs of product protection and personnel protection need to be carefully balanced. A recent example of cleanroom technology being directly applied in research and innovation is in the area of Regenerative Medicine and Stem Cell therapies. The Centre for Cell Manufacturing Ireland (CCMI) at NUI Galway opened for business on January 27 of this year. This is the country's first facility to receive a licence from the Irish Medicines Board to manufacture culture-expanded stem cells for human use. In addition to stem cell manufacture, the CCMI will offer a custom advanced therapeutic medicinal product (ATMP) manufacturing service to industry and also a cleanroom leasing service to Irish
Safe Pair of Hands Ireland is seen as a safe pair of hands because we understand the importance of product quality, constant vigilance and individual responsibility and contribution to patient safety. This is because we ourselves are the patient. This Life Science industry is for us, not for someone else or them, either now or in the future. And even if we are not the patient now, we are close to someone we love who is or will be the beneficiary of one of these life saving therapies, treatments and medical devices. This is about our wellbeing. The Irish Cleanroom Society was formed in 1999 in response to the significant growth of cleanrooms within the island of Ireland in the 80s and 90s. Driven by research and innovation Ireland has evolved in Life Sciences from bulk Chemicals and bulk Active Pharmaceutical Ingredients to finished Pharmaceuticals and Biophar maceuticals and Medical Devices. The Irish Cleanroom Society has made its contribution to supporting the cleanroom industry and research and innovation in Ireland. I
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I CLEANROOMS
Cleanzone – The International Trade Fair and Congress For Cleanroom Technology On 21 and 22 October 2014, Cleanzone – the international trade fair and congress for cleanroom technology – will take place for the third time in Frankfurt am Main, Germany. leanzone is the new international indusC try meeting place for cleanroom technology, and is aimed at all sectors where pro-
directly related to specific presentations from the congress taking place at the same time.
duction, assembly, packaging or work is carried out under cleanroom conditions. Exhibitors at the trade fair present the entire range of what is on offer, from the planning, construction and operation of cleanrooms to consumables and training. The congress taking place at the same time tackles current topics in the cleanroom industry, offering opportunities for interdisciplinary and international exchange at a professional level. Cleanzone is intended for international visitors from all areas of application for life sciences (pharmaceuticals, cosmetics, food, biotechnology and pharmacy industries) and micro-technology (micro-
Cleanzone Congress - Call for Papers The Cleanzone Congress taking place alongside the trade fair will be much more flexible in 2014: four modules covering the themes “Design and Construction of Cleanrooms” (Basics + Advanced) and “Operating Cleanrooms” (Basics + Advanced) can be booked separately. ReinraumAkademie (Leipzig) will be continuing its sterling work
electronics, micro-system technology, semiconductor, plastics and surface technology, aerospace, optics and laser technology, automotive, electronics and precision engineering industries). Cleanzone Plaza Promotes Interdisciplinary Exchange In 2014 one of the drivers of in-depth interdisciplinary exchange is the Cleanzone Plaza event stage, which not only hosts numerous events like the presentation of the Cleanroom Award by ReinraumAkademie, but is also a forum for exhibitors to share experience from across the cleanroom spectrum. Among the newcomers to this year's Cleanzone Plaza are four panel discussions
as content partner to the Cleanzone Congress, and has opened its call for papers – visit www.cleanzone-callforpapers.com. Interested exhibitors can now register online and select their preferred stand location in the hall plan - visit www.cleanzone.messefrankfurt.com. I
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I CLEANROOMS
Cleanroom Cleaning – An Arduous Task? By Edward Becker, Hydroflex OHG
Many cleanroom operators understand the importance of cleanroom cleaning. In every cleanroom contamination is permanently being generated by personnel and equipment. uch contamination will subsequently either be filtered out of the air (airborne particles) or settle on surfaces. These contaminated surfaces must then be cleaned regularly (floors usually daily) by means of wiping or mopping. Contamination and tiny, invisible particles can only be reliably removed from surfaces with the manual process of wiping with special mops. The process of cleaning therefore has a direct effect on the cleanliness and thus on the status of the cleanroom. However, cleanroom cleaning is often regarded as time-consuming, inconvenient or troublesome, which is understandable if outdated techniques or equipment are being utilised. There are no short cuts to a cleaned cleanroom as this process needs to be carried out very carefully and precisely and internal SOPs need be complied with. With the PurQuip® ERGO system, Hydroflex has now developed a completely new cleaning concept which has the potential to revolutionize many aspects of cleanroom cleaning and create new perspectives. Efficiency, Safety and Ergonomics are seen as important aspects in cleanroom cleaning. In the following some of the important aspects are addressed:
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Time Requirement That time is directly linked to costs is especially true in cleanrooms. Cleanroom operators and users are primarily responsible for the production of their products. As manual cleaning usually takes place at the end of each working day / production process and it is often the case (especially in aseptic cleanrooms) that no additional staff is provided for this purpose. The process needs to be carried out as efficiently as possible, while at the same time ensuring that the quality is not reduced. Exertion The greatest source of contamination in any cleanroom is the human. At every movement we release vast amounts of particles and germs from the surface of the skin into the environment. Thus all movements in the controlled environment need to be reduced to a minimum. During the cleaning procedure, mechanical processes need to be carried out that require exertion by the user. Cleaning processes that require a large amount of effort, result in more particle generation and can lead to the demotivation of the users and result in user error. User Error Strict adherence to the operating procedures and instructions validated internally by the company is essential for an effective cleaning process. Incorrect procedures or incorrect handling of the mop or trolley 26
system can quickly lead to an insufficiently wetted floor or to ineffective cleaning. This often means that a safe disinfection is not achieved. In order to avoid this kind of incorrect use the user needs to be trained and the cleaning process designed as simple as possible without potential sources of error. Reproducibility The effectiveness of the cleaning process must be tested and validated before a new cleaning system can be implemented. The efficiency of the cleaning and disinfection needs to be monitored regularly, even if a system has already been in use for long period of time. All work steps and components of the cleaning system need be designed to be as reproducible as possible in order to ensure that the cleaning process can be validated. If there are variables, for example in the process of wetting the mop, then it can no longer be guaranteed that the disinfection is equally effective in each process. Cross Contamination The mop head is the central part of every mopping system as it both distributes previously absorbed liquid on a surface as well as picks-up and retains tiny particles by means of its material structure and fine microfibres. These particles, which are usually microbially contaminated, must be removed in order to prevent further bacterial growth or transmission by people and equipment. As the mop is contaminated with bacteria after the wiping process, it must be moved out of the clean room without coming into further contact with the fresh liquid, the equipment or the user. Only in this way cross contamination can be prevented. Suitability Equipment that is brought into the cleanroom must be compatible with the relevant cleanroom class in accordance with applicable regulations such as GMP and ISO 14644. This ensures safety through compliance. According to these regulations, customary or industrial versions of cleaning equipments should not be used in cleanroom areas. Cleaning equipment should be robust, abrasion-free and easy to clean and also needs to withstand the process of disinfection and sterilization (GMP areas). Complicated structures with cracks and difficultly cleanable areas should be avoided. The PurQuip® ERGO Cleaning Principle Hydroflex has launched an innovative cleaning concept which perfectly combines ergonomics, efficiency and safety. This is enabled by a completely new development which was designed to meet all of the previously mentioned aspects. The PurQuip® ERGO system is the first cleaning trolley to implement a simple 3-step principle (i.e. 3 buckets) with a special mop
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wetting unit. The aim of the system is to achieve a simple, effective and ergonomically perfect cleaning process: Bucket 1: Pick-up of a fresh mop Bucket 2: Simple wetting of the mop with mop wetting device
Step 1.
Step 2.
Bucket 3: (After cleaning) discarding of the used mop Special innovation: the system allows all steps (mop pick-up, mop wetting, mop discarding) to be performed without hand contact! Saves time: With the ERGO principle it is now possible to carry out cleaning processes substantially quicker, as neither set-up time (e.g. mop box systems) nor several wetting steps (e.g. press systems) are necessary. Each mop can be attached and wetted in just a few seconds. Also, as only the exactly required number of mops are wetted, excess is avoided. Reduces effort: The handling of boxes or the strenuous wringing of wet mops is no longer required. Mop wetting is performed in a single easy step, thereby reducing user exertion to a bare minimum. Avoids user error: The logical set-up of the 3-step system minimises the possibility of user error. As the process is very simple and uncomplicated, it is easy to learn and repeat. Reproducibility: The special mop wetting device is at the core of the system. It applies the same amount of liquid out of the bucket onto the mop at every activation and thus guarantees an exact wetting level and absolute reproducibility. Avoids cross contamination: As the first touchless system, this method not only completely prevents hand contact with the mop but also with the mop frame and buckets. Cross contamination is thus virtually ruled out Suitability: The ERGO system has an electropolished stainless steel frame and robust plastic buckets. The components can be dismantled, are easy to clean and completely autoclavable. Light components were selected in order to further improve the ergonomics. The system is particularly suited for use with PurQuip速 plastic accessories. Training information and videos are available in order to better understand this new cleaning method. The importance of training for cleaning personnel should also be noted at this point. Summary Cleanroom cleaning is a process that always demands time and precise execution. With
the correct equipment it is, however, possible to achieve significant savings in time and effort without restricting safety and efficiency. Selection of a suitable system and implementation of the correct cleaning method requires a high level of expertise. Specialized man-
Step 3.
facturers offer support and extensive advice right through to staff training. For further information visis www.cleanroom-hygiene.com. I
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RENEWABLE ENERGY
OpenHydro and Alderney Renewable Energy to Develop Major European Tidal Array Irish tidal technology company OpenHydro and Alderney Renewable Energy (ARE) have signed a joint venture which will see the two companies combine their expertise and resources to develop a 300MW tidal array in Alderney waters. he island of Alderney is located in the Channel Islands and its territorial waters contain one of the world’s largest tidal energy resources, which once fully developed is estimated to power 1.5 million homes. Once completed, the array developed by OpenHydro and ARE is expected to consist of 150 turbines (2.0MW each) which will produce enough power for over 150,000 homes. ARE has a long established relationship with OpenHydro (OpenHydro holds a 31% shareholding in ARE) with both companies bringing their Thierry Kalanquin and Nick Horler. complementary expertise to this project. In 2008, ARE secured a 65 year Industry Firsts license from the States of Alderney OpenHydro has achieved a number of permitting ARE to develop marine industry firsts including being the first to renewable energy projects in Alderney’s deploy a tidal turbine at the European waters. OpenHydro will provide the Marine Energy Centre (EMEC), the first to turbines, which will be manufactured in connect to and generate electricity from Cherbourg (France) in an industrial site tidal streams onto the UK National Grid which will also support future tidal energy and the first to successfully demonstrate a farms off the French coast. method of safely and economically OpenHydro specialises in the design, deploying and recovering turbines directly manufacture and installation of marine on the seabed. The deployment and turbines generating renewable energy from recovery method delivers a step change in tidal streams. The company vision is to the economics of tidal energy. deploy marine turbine farms under the OpenHydro has a project portfolio surface of the oceans to produce energy spanning the USA, Canada, France, silently, invisibly and with no impact on Ireland, Scotland and the Channel Islands the environment. with utility partners including Emera, EDF, Bord Gáis, SnoPUD and SSE. OpenHydro has won a number of awards for its innovations in the field of renewable energy technology. OpenHydro is part of the DCNS group, a world leader in naval defence and an innovator in the energy sector. Future Developments FAB Link, a joint venture between
ARE and Transmission Investment LLP is developing a power interconnector between France, Alderney and Britain. This link will enable the tidal power generated in Alderney’s waters to be exported to European markets, as well as allowing energy to be traded between France and Britain. Development of the FAB project is progressing in conjunction with French Grid operator RTE. The 300MW tidal array in Alderney waters is expected to reach full scale deployment from 2020 which will coincide with the commissioning of the FAB interconnector. Thierry Kalanquin, chairman of OpenHydro and DCNS senior vice president energies and marine infrastructure, comments: “We are very excited about this next phase in the development of tidal energy in Alderney waters. Our initial agreement with ARE which dates back to 2007 has been a strategic part of our site development business plan.” Nick Horler, executive chairman of ARE, says: “The economic development of Alderney’s tidal power projects will provide Europe with a new source of predictable, clean, renewable energy and improve the security of our energy supplies. The joint venture partnership that we now have in place with OpenHydro is a critical piece in the jigsaw as we move to now make significant progress towards creating one of the largest renewable energy projects in European coastal waters.” OpenHydro and Bord Gais have been awarded exclusive rights to develop a 100MW tidal energy farm off Torr Head on the north coast of Antrim. The project, potentially the first of its kind in the island of Ireland, is expected to be completed by the year 2020. I
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ENTERPRISE SUPPORT
Work It Out – A Step at a Time By Mary Rose Burke, Director of Business Representation, Ibec
New jobs, strong inward investment, surging exports and record low government borrowing costs is enabling Irish firms to win new business, drive growth and put people back to work. e are on the way back, stronger, wiser and more competitive than before. But major challenges remain. Across a range of important areas the country is not working as it should and the government needs to act. To secure the next phase of Ireland’s economic revival, we need to make the right choices. That is why Ibec has launched a new campaign, entitled ‘An Ireland that works’, which sets out the views of business on the way forward. It identifies key economic and policy issues on the national agenda that will have a major impact on Ireland’s success into the future, including: tax, regulation, investment, entrepreneurship and Ireland’s place in the world.
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Better Government The need for better government is a central priority. Poorly designed policy, legislation and regulation add to the cost of doing business and are an obstacle to growth and job creation. For example, Government needs to simplify and reform enterprise support structures, particularly innovation funding. Government’s focus on innovation policy has led to the development of a range of national innovation-support programmes by national and regional innovation support agencies targeted specifically at industry. These include both direct, such as grants, and indirect supports, such as tax incentives. However, there is a lack of clear information on the wide range of assistance available and a perception that it is difficult to access these supports, this problem is particularly acute for people starting a new business. Ireland needs a central website that provides information on all national and local enterprise and innovation supports. R&D Investment The R&D tax credit is a key way to boost the innovation activity of companies in Ireland. R&D is an increasingly mobile investment for firms; which face increasingly competitive incentives for their R&D activity from a range of countries.
While Ireland’s tax incentives for R&D activity have improved considerably over the past decade, the offerings of our main competitors have also been enhanced. Government must continue to monitor Ireland’s R&D competitors in terms of incentives offered in order to underpin Ireland’s attractiveness for mobile investment and ensure our R&D tax credit model is world-class. The objective must be to join the ranks of European innovation leaders. Our innovation investment target for 2020 is 2.5% GNP (equal to 2.0% of GDP). This will be achieved by both public and industry direct contributions, and it also assumes that industry’s total investment will represent approximately two-thirds of total expenditure. This will require more support to facilitate the emergence of technologicallybased local firms and encouraging innovative activities in less intensive sectors. More must be done to help Irish companies scale up.
Mary
Rose
Burke,
Director
of
Business
Representation, Ibec.
effectively commercialised and scientific talent transfers to industry.
Strategy for Science, Technology and Innovation Since the launch of the Strategy for Science, Technology and Innovation in 2006, the focus of Government has been on imbedding high-value activity in Ireland and improving the chances of successful commercialisation of R&D conducted in Ireland. The national research prioritisation exercise has established a clear business case for investing in fourteen targeted areas and stressed the importance of maintaining public investment, albeit in a more efficient and targeted manner. The national research prioritisation exercise is in essence Ireland’s national smart specialisation strategy, which further enhances the links between business and higher education. Other improvements currently underway include measures to improve the availability of skills and people, as well as regulatory reforms in areas such as intellectual property and technology transfer. Government must continue monitor the impact of public R&D investment ensuring that research is
Horizon 2020 For one of the world’s most open economies, we can extend Ireland’s global reach by effective participation in Horizon 2020, the new EU framework programme for research and innovation funding. Government, academia and business needs to take advantage of the opportunities that the programme presents. We now need to ensure that the high level of participation this programme seeks to encourage by companies, particularly SMEs is quickly realised and developed over its lifetime. Now is the time to secure the recovery by putting in place the conditions for the next phase of our economic development. We have the potential to grow at twice the EU average in the years ahead, but government needs to make the right choices. If the conditions are right, business will deliver a new phase of strong growth and prosperity for all our citizens. For more information, log on to www.ibec.ie/irelandworks or on Twitter:@ibec¬_irl I
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CLINICAL TRIALS
Outsourcing Clinical Trials Series The flagship Outsourcing Clinical Trials series has grown into one of the industry’s most established pharmaceutical events series on offer to both big pharma and small to mid-sized companies. he free to attend series for all CLevel, VP & Director level delegates from the Pharma, biotech and medical device companies helps bring together local clinical-stage biotechs with local and international CROs and service providers.
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Outsourcing in Clinical Trials UK and Ireland Outsourcing in Clinical Trials UK and Ireland comes to London on the 25th and 26th of June following the worldwide success of Arena International’s Outsourcing in Clinical Trials global series. London has been added to the calendar to bring industry insight, case study led presentations and a fantastic selection of global and local service providers to the doorstep of the UK pharmaceutical, biotech and medical device industry. The programme at the event reflects view points from both large and small companies who are in the clinical phases of drug development so that attendees can better harmonise their outsourcing strategies and get an overview of the current state of the UK’s clinical drug development industry. Considering an estimated $133 billion is spent on clinical trials worldwide, with outsourcing making up a large chunk of the budget at approximately 62%, it has never been more crucial to understand and optimise outsourcing policies. With billions of dollars on the line, the Outsourcing Clinical Trials series has been helping shape
the industry and aid decision making with a unique platform for discussion amongst only the highest level delegation available. Ultimately it is these decision makers that dictate spending, and with so much at stake it remains imperative to get these critical decisions correct. Outsourcing Large Pharmaceutical companies are faced with the constant challenge to cut costs; and outsourcing is the key decision many make in order to achieve efficiencies. Many of these companies have outsourcing strategies in place so look to the Outsourcing Clinical Trials Series to introduce them to new and innovative strategies that can make the process more efficient. For the smaller companies, many of which are on the complete opposite of the spectrum, the need is to shape their ‘outsourcing identity’. Discovering which model is most effective for them is vital to their overall success and aids in increasing their chances of bringing a new drug to market. Companies represented on the speaking faculty include multinationals like Astra Zeneca, Takeda, Eli Lilly, Biogen Idec and
Eisai as well as a good selection of young biotech companies who are sharing their knowledge of sourcing the right vendors, running trials domestically and internationally and strengthening their clinical partnerships. Agenda highlights include Chris Bailey from Immbio LTD who is looking at sourcing vendors for international trials from a smaller biotech perspective, David Webber from Biogen Idec who is considering risk sharing agreements when partnering up with CROs and also panel discussions which look at strategic partnership management and also sourcing the best vendor from a smaller company perspective. Key Benefit The key draw of outsourcing clinical trials is that CROs often make the process cheaper and more efficient ultimately allowing the pharmaceutical companies to invest more time and resource into development of new drugs, cures and devices that can help shape health for years to come. To find out more about any of the events taking place in the Outsourcing Clinical trials roadshow please contact events@arena-international.com. To register for your place at any of the upcoming events you can register online at your chosen event simply by clicking on any of the listed event sites and submitting your details on the registration page and referencing I&E to guarantee your place. I
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