Research & innovation vol 1, issue 2 2014

Volume 1, Issue 2

Moving progressively forward at AMBER

Research & Innovation Website:

www.researchandinnovation.ie

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- 3 C OVER S TORY

- 21 C ONTRACT L ABORATORIES

Moving progressively forward at AMBER.

BioClin offers an unmatched range of services to industry.

- 11 & 12 C ONTRACT R ESEARCH O RGANISATIONS

- 22 O VENS & F URNACES

Atlantia Food Clinical Trials delivers comprehensive end-to-end solutions.

Venn Life Sciences teams up with Golden Jubilee Hospital on international heart study.

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Professor Jonathan Coleman, AMBER.

Scientific data goes digital.

SLCLAB – Helping laboratories to improve their day-to-day operation.

$450,000 worth of Fulbright Awards now open for applications.

Call for improvements to Ireland’s R&D regime.

Michael Hayes, Managing Director, IRDG.

- 23-27 LIMS

- 13 S TUDY & R ESEARCH

- 14 R&D TAX C REDITS

Versatile high-temp furnace ensures high-purity processing.

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A total quality data management solution.

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Scientific data goes digital.

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Professor Michael Coey, AMBER.

- 15 C LEANROOMS

- 28 R ESEARCH & I NNOVATION Mayo Clinic and NUI Galway formalise collaboration.

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UCC device to help coronary disease.

Professor Noel Caplice, UCC.

Cleanzone Congress with “Basic” and “Advanced” sessions.

Managing Director: Colin Murphy Editor: Mike Rohan

- 16 R ESEARCH & D EVELOPMENT IRDG: All about R&D and innovation in industry.

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Dr Garry Duffy, RCSI & AMBER.

Group Operations Manager: Sylvia McCarthy Advertising: Adrian Murphy Production Manager: Sylvia McCarthy

Research & Innovation is published by Premier Publishing Limited, 51 Parkwest Enterprise Centre, Nangor Road, Dublin 12.

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- 19 I NTELLECTUAL P ROPERTY

Premier Publishing Limited can accept no responsibility for the accuracy of contributors’ articles or statements appearing in this magazine. Any views or opinions expressed are not necessarily those of Premier Publishing and its Directors. No responsibility for loss or distress occasioned to any person acting or refraining from acting as a result of the material in this publication can be accepted by the authors, contributors, editor and publisher. A reader should access separate advice when acting on specific editorial in this publication!

Proposals to extend R&D protection against patent infringement for companies in the pharmaceutical sector.

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Ian Collins, Head of R&D Tax Services, EY.

Design, Origination and Separations by Fullpoint Design (057) 8680873. (086) 1573510 Printed by W&G Baird.

Annual Subscription (UK and Ireland) £95 Overseas Subscription £115

RESEARCH & INNOVATION, VOLUME 1, ISSUE 2

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COVER STORY

Moving Progressively Forward at AMBER Tasked with working to translate science into new discoveries and devices for a range of sectors, particularly ICT, medical devices and industrial technologies, AMBER (Advanced Materials and Bio-Engineering Research Centre) has achieved a number of ‘world firsts’ since being established a year ago.

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pecialising in nanotechnology and engineered materials, AMBER is an academia-industry research consortium funded by the Department of Jobs, Enterprise and Innovation through Science Foundation Ireland (SFI) to the tune of Eur35million. This funding is supported with an additional Eur23 million investment from industry partners.

Nanoscience and materials science are areas where Ireland was

Pictured at the launch of the Advanced Materials and Bio-Engineering Research Centre (AMBER) are: Professor Mark Ferguson, Director General of SFI; Richard Bruton TD, Minister for Jobs, Enterprise and Innovation; and Professor Stefano Sanvito of AMBER.

already ranked inside the top ten globally for research and the creation of AMBER is further enhancing this position. Indeed, nanoscience - the study of materials on the nanoscale or 100,000 times smaller than a single human hair - helps to support Eur15 billion or 10% of Irish exports and 250,000 jobs in sectors like technology, biomedicine, pharmaceuticals and energy. As a national centre responsible for driving future materials science research, AMBER plays a central role in growing and retaining existing companies, providing world-leading research, increasing the level of foreign direct investment and supporting job creation in Ireland.

AMBER brings together internationally leading researchers from three leading academic institutes - Trinity College Dublin (CRANN and the Trinity Centre for Bioengineering), Royal College of Surgeons in Ireland and University College Cork. Indeed, AMBER provides a focal point for Ireland’s leading material science researchers working across the disciplines of Physics, Chemistry, Bioengineering and Medicine. AMBER is headquartered in the CRANN Institute, Trinity College Dublin.

Working Closely With Industry AMBER collaborates closely with industry, providing access to world-class research infrastructure and expertise. AMBER’s research programmes are designed to tackle significant industrial challenges and include the development of novel data processing and memory applications, thermoelectric devices, food and pharmaceutical packaging, medical implant coatings, diagnostics and drug delivery systems, and regenerative tissue engineering.

AMBER is currently working with twenty companies, ranging in scale from large multinationals to indigenous SMEs, each co-funding a defined research project to meet their specific needs. The industry partners are generally from four key sectors - ICT, medical devices, pharmaceuticals and industrial technologies.

AMBER is also well placed to identify potential funding opportunities for new and existing partner companies through Science Foundation Ireland (SFI), Enterprise Ireland, the IDA and European funding.

During its first year of operation, AMBER has been successful in creating new knowledge and intellectual property and transferring this knowledge to industry through staff exchange, licensing agreements and enterprise spin-outs.

Strategic Partnerships For example, AMBER has formed a strategic partnership with Bell Labs, the research arm of Alcatel-Lucent, to embark on joint energy research projects in the fields of energy harvesting, energy efficiency and energy storage. The two organisations will seek ways to make data networks in communications and ICT more energy efficient in the face of exponential growth in traffic. This collaboration creates a mutually beneficial research partnership where Bell Labs provides scientific and industry expertise around thermal science and energy efficiency and AMBER provides deep fundamental materials science expertise and world leading characterisation facilities.

AMBER is working with Intel on the development of novel materials to pattern, create and contact Professor Jonathan Coleman.

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nanometre scale devices. The associated learnings will assist in the development of the next generation Intel technologies. “The research being done at AMBER is world-class. It is providing the kind of answers for us in Intel that we need as a company at the leading edge of our industry,” says Leonard Hobbs, Research and New Business Director, Intel Ireland Within the pharmaceutical sector, AMBER is working with Sigmoid Pharma on advanced characterisation of the SmPill® oral drug delivery technology. “AMBER is not just a national centre of excellence, it is an international centre of excellence,” points out Ivan Coulter, CEO Sigmoid Pharma.

Similarly, within the medical and diagnostic devices sector, Merck Millipore is collaborating with AMBER to develop new membrane technologies.

Research Centres Programme AMBER is part of Science Foundation Ireland’s Research Centres Programme, which is the largest ever state/industry co-funded research investment of its kind in Ireland. The programme entails Eur200 million of Irish exchequer investment matched by Eur100 million in support from industry in seven world class research centres of scale.

As a national centre, AMBER is playing a key role in Ireland’s economic and industrial development. AMBER also provides a gateway to access significant European funding, linking Irish industry to universities and industry in Europe.

Professor Mark Ferguson, Director General of Science Foundation Ireland and Chief Scientific Adviser to the Govern ment of Ireland, says: “Science Foundation Ireland is committed to funding impactful research which will lead to new products and services of the future. Just over a year since it was established as an SFI Professor Michael Coey.

Research Centre, AMBER’s researchers are working to address the big issues facing modern society – across healthcare, energy, transport and other areas. It is this type of research that has led to Ireland’s international position as third for nanoscience and sixth for materials science.”

World Firsts AMBER has scored a number of ‘world firsts’ in the last twelve months. An AMBER research team headed by Professor Jonathan Coleman, Professor of Chemical Physics at Trinity College and AMBER, has discovered a new research method to produce industrial quantities of high quality graphene. Graphene is a single-atom thick sheet of carbon, which is extremely light and stronger than steel, while being highly flexible and extremely electrically conductive.

The AMBER discovery is expected to change the way many consumer and industrial products are manufactured. The materials have a multitude of potential applications including advanced food packaging; high strength plastics; foldable touch screens for mobile

phones and laptops; super-protective coatings for wind turbines and ships; faster broadband and batteries with significantly higher capacity.

Thomas Swan Ltd, which has collaborated with the AMBER research team, has signed a license agreement to scale up production and make the high quality graphene available for industrial Professor John Boland. applications.

“This shows how industry and academic collaboration can lead to research of the highest calibre, with real commercial applications,” says Professor Jonathan Coleman. “Graphene has been identified as a life changing material and to be involved at this stage of development is a wonderful achievement.”

New Material Discovery In another major breakthrough, AMBER scientists have discovered a completely new material, which could revolutionise information technology, computer processes and data storage. The world-first discovery was led by one of Ireland’s most highly-cited researchers Professor Michael Coey, a Principal Investigator at AMBER from Trinity’s School of Physics.

The AMBER research has created a completely new alloy of manganese, ruthenium and gallium, known as MRG. MRG is a new type of magnet, technically known as a ‘zero-moment half metal’.

The world first discovery will initiate a completely new line of materials research and could open up numerous possibilities for electronics and information technology.

Professor Michael Coey comments: “Magnetic materials are what make reading and storing data – either on personal devices or on large scale servers in data centres – possible. Magnets are at the heart of every electronic device we use – from computers and laptops to tablets, smartphones and digital cameras. Given its unique insensitivity to magnetic fields, and the tenacity of its internal magnetic properties, MRG could now revolutionise how data is stored, which could have major implications for the future development of electronics, information technology and a host of other applications.”

Measuring Poisson’s Ratio on the Nanoscale Another world first has been achieved by an AMBER team led by Professor John Boland, Research Professor in Trinity’s School of Chemistry. They have become the first researchers in the world to measure Poisson’s Ratio on the nanoscale. Poisson’s Ratio describes the fundamental elasticity of any solid and is a basic principle of engineering that dates back to 1811.

Professor Boland explains: “The Poisson’s Ratio is crucial to construction and engineering, ensuring that all load-bearing structures such as buildings and bridges are made of the correct materials and ultimately are safe and sturdy. It has been a hugely effective guide for large scale structures, but it has until now, been unavailable to assist in the design of nanoscale structures that are so important for today’s technologies. By translating this basic mechanical concept to the nanoscale, essentially measuring the elasticity of materials that are just a few hundred atoms across, it will open up huge opportunities for electronics and ICT. As we move to an age of wearable technology, it is crucial that scientists understand how materials respond at their very basic level.”

World’s First Graphene-rubber Sensors The AMBER research team led by Professor Jonathan Coleman has

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recently followed up on its earlier discovery that occurs during a heart attack, with new by producing the world’s first graphenehealthy cells derived from stem cells that rubber sensors. They have discovered a come from the patient’s own bone marmethod of creating wearable sensors by row. AMBER will lead specific tasks in the adding graphene to shop-bought rubber consortium, tackling surgical device bands. design, nanotechnology safety and drug The addition of graphene allows the rubdelivery. ber to conduct electricity without compro“Regenerative medicine and stem cell mising its mechanical properties. Tests therapies have the potential to revolushowed that, any electrical current flowing tionise the treatment of patients who have through the graphene-infused rubber suffered a heart attack, and through bands was very strongly affected if the AMCARE we will develop new technoloband was stretched. Consequently, if the gies to enhance stem cell therapies for band is incorporated into clothing, it is AMBER has launched new NanoWOW Lesson Plans for these patients by increasing targeting and sensitive to small movements such as primary school students in Ireland. ease of delivery using advanced biomateribreathing and pulse. als,” says Dr Garry Duffy, Department of According to AMBER, the discovery opens up a host of possibili- Anatomy and Tissue Engineering Research Group, RCSI and ties for the development of wearable sensors made from rubber, AMBER Investigator, who is co-ordinating AMCARE. which could be used to monitor blood pressure, joint movement and respiration. Other applications include the automotive industry - to Educational Role develop sensitive airbags; in robotics, in medical device development AMBER also has an important role at all levels of the education sys- to monitor bodily motion - or as early warning systems for cot tem in Ireland from primary school to fourth level, in order to death in babies or sleep apnoea in adults. Alternatively the rubber- ensure a pipeline of graduates who receive training in world-class graphene sensors could be woven into clothing to monitor the move- R&D infrastructure and are equipped to work to industry standards. ment of athletes or patients undergoing physical rehabilitation.

For example, AMBER has launched new NanoWOW Lesson Professor Jonathan Coleman comments: “Sensors are becoming Plans for primary school students in Ireland. The lesson plans are extremely important in medicine, wellness and exercise, medical designed to introduce device manufacturing, car manufacturing and robotics, among other 5th and 6th class areas. Biosensors, which are worn on or implanted into the skin, pupils to the world of must be made of durable, flexible and stretchable materials that nanoscience and materespond to the motion of the wearer. By implanting graphene into rials science. rubber, a flexible natural material, we are able to completely change Professor Stefano its properties to make it electrically conductive, to develop a com- Sanvito of AMBER pletely new type of sensor. Because rubber is available widely and remarks: “The new cheaply, this unique discovery will open up major possibilities in NanoWOW lesson sensor manufacturing worldwide.” plans are designed to engage school children Advances in Medical Science in a creative way that In the area of medical science, AMBER along with the Royal College fosters their curiosity of Surgeons in Ireland (RCSI) is leading an EU consortium to devel- in nanoscience. We op materials to regenerate cardiac tissue following heart attacks, the also want to develop leading cause of death globally. The consortium - Advanced their interest and Dr Garry Duffy.

Materials for Cardiac Regeneration (AMCARE) – is receiving EU understanding so they funding of Eur8.7 million and comprises ten European industry and are aware of nanoscience as part of their everyday lives and the academic partners. potential future career options that would be open to them.”

AMCARE conducts research to develop natural materials and new Professor Sanvito adds: “With Nanoscience linked to Eur15 bilsurgical devices to enhance the delivery of the body’s own stem cells lion or 10% of Irish exports and 250,000 jobs in sectors like techto the heart to promote healing after a heart attack (myocardial nology, biomedicine, pharmaceuticals, energy and more, the imporinfarction) and prevent premature death. The therapies being devel- tance of making nanoscience relevant amongst school pupils is obvioped will replace heart cells that die due to the reduced blood flow ous for future development.” I

follow us on Twitter @BellLabs or visit us at www.bell-labs.com for more information

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Henkel Ireland Operations & Research Ltd I Global Centre of excellence for development and manufacture of cyanoacrylate and acrylic adhesive technologies I Years of experience in design and development of monomers, resins, adhesives, sealants and coatings I Process technology and manufacturing know-how I Application knowledge in key sectors including automotive, aerospace, electronics and medical devices I Opportunities for collaborative research with industrial and academic partners

I RESEARCH & DEVELOPMENT

Henkel Adhesive Technologies Developing Innovative Products and More Efficient Manufacturing Processes Henkel operates worldwide with leading brands and technologies in three business areas: Laundry & Home Care, Beauty Care and Adhesive Technologies. ounded in 1876, Henkel holds globally leading market positions both in the consumer and industrial businesses with well-known brands such as Persil, Schwarzkopf and Loctite. Henkel employs about 47,000 people and reported sales of Eur16.4 billion and adjusted operating profit of Eur2.5 billion in fiscal 2013.

Henkel’s preferred shares are listed in the German stock index DAX.

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Henkel Adhesive Technologies Adhesives, sealants and surface treatments from Henkel Adhesives Technologies are everywhere – at home, at school, in the office, on the building site and in the factory. They can be found in many objects that are manufactured, which touch our lives every day: cars, books and magazines, computers, aircraft, refrigerators, cell phones, furniture, shoes, textiles, packaging, and many more. Without Henkel products and technologies such items would look different, not last as long, cost more to produce or simply be manufactured using traditional methods.

Familiar with the complexity of the requirements of its customers, the services

Henkel offers range from design and consultancy, product development and dispensing equipment through to process expertise. When it comes to developing innovative products and more efficient manufacturing processes, Henkel is the partner of choice for many leading companies.

Henkel Adhesive Technologies is divided in five Strategic Business Units, each following its own business model and targeting different markets and customers: • Craftsmen, Consumers and Building Adhesives • Packaging, Consumer Goods and Construction Adhesives • General Industry • Transport and Metal • Electronics.

Adhesive Technology Research & Development Henkel Adhesive Technologies has concentrated all of its adhesive expertise in a total of eight technology platforms. To achieve useful results in innovation, everybody needs to be deeply familiar with all of the know-how that Henkel has in a specific area. A platform devoted specifically to one technology can assure this. In order to create the greatest possible scope for future development in each technology, Henkel Adhesive Technologies has carved out the technologies and chemistries from the Strategic Business Units (SBUs).

The relationship between the SBUs and the technology platforms could be described as that of customer and supplier.

Based on their own customer insights as well as market analysis and monitoring, the SBUs request the platforms to carry out research for them in directions which they consider will have a lasting impact on their markets. The platforms provide the necessary resources for this research. Ideas are collected and coordinated by the innovation manager appointed within each SBU. The eight technology platforms are focused on the following chemistries: RESEARCH & INNOVATION, VOLUME 1, ISSUE 2

• • • • • • •

Acrylates Hotmelts Polyurethanes Silicones & Sealants Surface Treatment Thermosets Water-based Adhesives.

Henkel Ireland Operations & Research Ltd Henkel Ireland Operations & Research Ltd, located in Tallaght, Dublin is the centre of excellence for cyanoacrylate and (meth)acrylate adhesive technologies. New innovative adhesives, sealants and coatings are developed and manufactured, primarily for the General Industry, Automotive, Electronics and Consumer SBUs. The Dublin Research, Development & Engineering Centre is one of the primary locations of the Global Acrylics Technology Platform with a focus on fundamental and applied research in cyanoacrylate and acrylic technologies. With years of experience and knowledge in the design, development and manufacture of new monomers and resin systems there is huge potential for collaboration with universities and academic research institutes in many areas including composites, nanotechnologies and advanced materials. I 9

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COMMUNICATIONS

Bell Labs Shaping the Networking and Communications Industry lcatel-Lucent is at the forefront of global communications, providA ing products and innovations in IP and cloud networking, as well as ultra-broadband fixed and wireless access to service providers and their customers, and to enterprises and institutions throughout the world.

Underpinning Alcatel-Lucent in driving the industrial transformation from voice telephony to high-speed digital delivery of data, video and information is Bell Labs, an integral part of the group and one of the world’s foremost technology research institutes, responsible for countless breakthroughs that have shaped the networking and communications industry.

In June of this year, Bell Labs in Ireland announced a new strategic partnership with AMBER to seek ways to make the hardware within data networks more energy efficient in the face of exponential growth

Pictured at the announcement of AMBER’s partnership with Bell Labs are Marcus Weldon (left), Bell Labs President & Corporate CTO, with Professor Jonathan Coleman from AMBER.

in traffic. This collaboration creates a mutually beneficial research partnership where Bell Labs provides scientific and industry expertise around thermal science and AMBER provides deep fundamental materials science expertise and world leading characterisation facilities.

Dr Domhnaill Hernon, Bell Labs Research Department Head based in Dublin, says: “The collaboration with AMBER is critical to the long-term ability of our group to provide game changing technologies within the telecommunications industry. We leverage AMBER’s expertise in nano science to create new thermal designs that can more efficiently remove heat. Some of these research areas are novel thermoelectric materials for cooling and waste heat recovery; thermally optimized photonics devices for improved transmission of high speed data over long distances; and energy storage to enable off-grid deployment of small cell products.” I

Pictured (left to right): Bell Labs President & Corporate CTO Marcus Weldon with Prof John Donegan from AMBER.

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I CONTRACT RESEARCH ORGANISATIONS

Atlantia Food Clinical Trials Delivers Comprehensive End-to-end Solutions Atlantia Food Clinical Trials Ltd (www.atlantiafoodclinicaltrials.com) is a world class dynamic company providing clinical studies expertise for the food, beverage and supplements sector. tlantia delivers a comprehensive end-to-end solution for human intervention studies in functional ingredients in foods & beverages, nutraceuticals, medical foods, dietary supplements and infant formula. The Atlantia team has over 10 years of experience providing clinical trials and research in the area of food for health.

Atlantia can provide all the expertise required to design and conduct a clinical trial in accordance with ICH GCP Guidelines, including clinical study design, statistical powering, regulatory approval, data capture, subject screening and recruitment, informed consent, external monitoring, medically trained research staff, including Principal Investigators who are qualified doctors, secure investigative product storage with temperature logging, biological sample collection and storage (blood, urine, faeces, saliva), sample analysis, data collection (paper or EDC), statistical report, and preparation of publications for peerreviewed journals.

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Atlantia Executive Team.

Europe’s Leading Scientists Atlantia works with some of Europe’s leading scientists across a variety of partner institutions and provides clients with a range of options based on their clinical

research and validation needs. Atlantia can manage all aspects of your trials or simply provide you with specific elements of a trial that your company may require.

• Alimentary Pharmabiotic Centre http://apc.ucc.ie. A world leading research centre in the areas of Gut health and probiotics.

• Teagasc Food research centre www.teagasc.ie. As the dairy research arm of the Ireland’s food industry Atlantia works with many world leading researchers on a host of health areas.

• Mardyke Arena Cork http://www. mardykearena.com/. The Mardyke Arena is Atlantia’s sports partner where it does studies with world class facilities and exceptional staff.

Highly Flexible Atlantia has a highly flexible structure, with capabilities right across the spectrum of functional food and beverage categories , such as dairy, probiotic, proteins , infant-specific foods, vitamins/minerals and medical foods. The Atlantia clinical research team has wide experience in clinical trials in a number of health areas, including gastrointestinal health (constipation, digestive discomfort, gut transit, diarrhoea, IBS, digestive aids, change in intestinal microbiota, GI infections), cardiovascular health (blood pressure, cholesterol, triglycerides, fatty acids), mental health (cognitive function, psychological stress), physical performance (muscle mass in a resistance training trial, RESEARCH & INNOVATION, VOLUME 1, ISSUE 2

sarcopaenia in an elderly population, lower body function in an older population, osteoarthritis), uptake of nutrients (e.g. iron, amino acids, vitamin supplementation) and other studies such as oral health.

Atlantia’s clients include multinational organisations as well as small national companies, research institutions and government agencies. Atlantia has a long list of completed work and many client testimonials on the care and level of professional service received by each. Your project will be assigned with a dedicated team of professional who will work tirelessly to ensure that we bring your results in on time and on budget.

Atlantia’s website contains a lot more information on Atlantia and the team that deliver your results and welcome all enquiries at any time. I

Atlantia’s clients include multinational organisations as well as small national companies, research institutions and government agencies.

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I

CONTRACT RESEARCH ORGANISATIONS

Venn Life Sciences Teams Up With Golden Jubilee Hospital on International Heart Study enn Life Sciences, a European Clinical Research Organisation with headquarters V in Dublin, have teamed up with the Golden Jubilee Hospital in Scotland to conduct an international clinical trial into an innovative new heart treatment.

The study sees Venn working alongside Professor Keith Oldroyd of the Golden Jubilee National Hospital in Scotland, and aims to determine whether the use of Percutaneous Coronary Intervention (PCI) with a new stent with a bio-absorbable coating could be used as an effective method for treating patients with disease in the left-main coronary artery in their heart. The left-main coronary artery is one of the most important arteries in the human

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body, providing the major blood supply to the heart muscle. This latest trial aims to test the effectiveness of a newly designed stent with a bioabsorbable coating, which has the potential to speed up healing of the artery and additional, long term, benefits for patients.

The study will be conducted in five European countries over a two year period with Prof Oldroyd and Prof Robert-Jan van Guens from the prestigious Erasmus University in Rotterdam, Holland, serving as the co-principal investigators.

Venn CEO, Tony Richardson states: “We are delighted to be part of this important study as it is an area of the business that we have focused on expanding in recent years. Our recent expansions and service additions allow us to supply the complete envelope of services for these studies whether they are single site or multi-country site studies.”

Professor Keith Oldroyd, one of the Principal Investigators, Consultant Cardiologist and Director of Research at the Golden Jubilee, says: “The developments in

RESEARCH & INNOVATION, VOLUME 1, ISSUE 2

PCI and stenting over the past 20 years have been absolutely incredible. The new stent we will be using in this trial has an innovative coating, which delivers a drug to prevent renarrowing and over a period of three to four months, dissolves into two harmless components (carbon dioxide and water). This should dramatically improve the healing of the artery and will reduce the length of time a patient has to rely on blood thinning medication.”

For more information on Venn Life Sciences visit www.vennlifesciences.com. I

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STUDY & RESEARCH

$450,000 Worth of Fulbright Awards Now Open For Applications The Fulbright Commission in Ireland has opened its competition for $450,000 worth of Fulbright Awards for the 2015-2016 academic year. ulbright grants are for Irish or EU citizens to study, research, or teach in the US. The awards include a monetary grant, accident and emergency insurance, cultural and professional programming and visa administration.

Applications are due by Wednesday, November 12th, 2014 and more information can be found on www.fulbright.ie.

EPA, the Marine Institute, Teagasc and the Department of Arts, Heritage and the Gaeltacht. I am delighted that there is such a breadth of disciplines and opportunities available for Ireland’s leading students and researchers. I would encourage all applicants who are interested in learning more about their discipline, sharing new experiences and crossing cultural boundaries, to apply to become a ‘Fulbrighter.’”

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New Awards This year sees the launch of six new awards.

The Fulbright Commission has partnered with Tulane University, the University of Notre Dame and University of Pennsylvania on LL.M. Student Awards.

These awards offer exceptional opportunities for prospective postgraduate students to study law at top US universities. In addition, the Commission is collaborating with the National University of Ireland to offer a Visiting Researcher Award for prospective or registered PhD candidates who hold an honours degree from a National University of Ireland Constituent University or other NUI member institution to complete study or research in the US. For Scholars, there is a Fulbright Visiting Lecturer in Irish History Award on offer at

the University of Montana, and the Commission has partnered with the University of Notre Dame to supplement its Fulbright TechImpact Awards with two awards in Language Technology. The Fulbright TechImpact Awards offer early career scholars or professionals the opportunity to explore how technology contributes to a larger social value through undertaking short-term, non-commercial projects and research in the US. Colleen Dube, Executive Director of the Fulbright Commission, comments: “For 2015-2016 we have an unprecedented number of partners and awards on offer for students, scholars, professionals and Irish language teachers. Our new awards complement the existing awards we have forged with CRH plc, Enterprise Ireland, the

The Fulbright Awards are presented on an annual basis to Irish students, scholars, and professionals to undertake postgraduate study and research at higher education, cultural, and related institutions in the United States and for Americans to do the same in Ireland.

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Other Awards In addition to the discipline-specific sponsored awards the Commission also has on offer:

For 2015-2016 we have an unprecedented number of partners and awards on offer for students, scholars, professionals and Irish language teachers. * Fulbright Irish Student Awards which are for Irish citizens or EU citizens resident in the Republic of Ireland for three or more years to complete postgraduate research or study over the course of one year in the United States. * Fulbright Irish Scholar Awards which are for Irish citizens or E.U. citizens resident in the Republic of Ireland for three or more years to complete postdoctoral or professional research or lecturing over the course of one year in the United States. * Fulbright Foreign Language Teaching Assistantship (FLTA) awards for Irish citizens or EU citizens resident in the Republic of Ireland for three or more years with fluency in Irish to teach Irish and take courses at a US college over the course of ten months in the United States.

Applications are encouraged in all disciplines, including the arts. Please see www.fulbright.ie for further details. I 13

I R&D TAX CREDITS

Call For Improvements to Ireland’s R&D Regime in the Budget

By Ian Collins, Head of R&D Tax Services – EY The R&D tax credit scheme has become a key part of Ireland’s corporate tax incentive package in attracting R&D investment to Ireland and retaining that investment. he scheme has enabled a multitude of companies to reduce their payroll costs year on year, increase their cash flow, provide that extra budget required to recruit targeted hires, increase margins on qualifying R&D projects, and has also enabled multinationals to attract further R&D investment to Ireland.

There have been numerous announcements recently to support this – SAP is expanding its R&D investment in predictive analytics, HP is constructing a new state-of-the-art R&D facility in Galway, and Microsoft continues to expand its data centre in Ireland, to name but a few. All of these are continuing to contribute to job growth in high value added areas.

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The global R&D arena is extremely competitive and this reinforces the need for Ireland to continue

R&D tax credit regime last year, the results of which identified that the Irish regime is considered among the best in class internationally. On foot of this review there were measures introduced in last year’s budget to the Irish R&D regime which were very much welcomed, however we cannot become complacent with further measures required to stay ahead of competing jurisdictions.

Improvements Needed R&D projects are extremely mobile in this day and age. As a result, many of our international competitors are enhancing their R&D incentive packages in an effort to attract high value added R&D investment to their shores. The global R&D arena is extremely competitive and this reinforces the need for Ireland to continue to enhance its overall offering. The following recommendations should be considered in the context of next month’s budget in October: • Introduce more certainty in order to enhance the overall effectiveness of the R&D scheme and to ensure greater consistency both on audits and assessing qualifying criteria. There should be a specialist dedicated unit within Revenue to deal with specific R&D tax matters, as well as handling technical appeals in a

to enhance its overall offering.

As a nation, government and industry do not articulate the benefits that typically accrue from participation in the R&D regime, such as employment growth and retention, attracting future investment to Ireland, and improvement of general internal R&D processes within participating companies, all of which leads to an improved R&D environment. These spillover benefits are vital to help companies compete and win future R&D investments.

Readers may recall that the Department of Finance carried out a review of Ireland’s 14

R&D projects are extremely mobile in this day and age.

As a result, many of our international competitors are enhancing their R&D incentive packages in an effort to attract high value added R&D investment to their shores.

RESEARCH & INNOVATION, VOLUME 1, ISSUE 2

Ian Collins, Head of R&D Tax Services - EY

more streamlined manner.

• Introduce a simplified R&D regime for the SME sector. There are many SME’s not availing of these R&D cash benefits due to administrative complexity. Many of our international competitor jurisdictions offer a simplified regime for SME’s to tackle this issue.

• Improve the employee reward scheme: the rules as they currently stand are too restrictive and should be broadened to enable loss making companies avail of the relief. Due to the cash refundable nature of the R&D regime, there should be no loss to the Exchequer by broadening the relief to enable loss making companies pass on the benefit of their R&D credits to their key R&D employees.

• Align with grant aid: in order to help attract additional R&D investment into Ireland, a pre-approval mechanism should be put in place to enable companies the ability to pre-agree the percentage of an R&D grant-aided project that qualifies for the R&D tax credit. This would afford companies the ability to factor in the benefits of both grant aid and R&D tax relief into their pricing model when competing with their international affiliates for R&D projects. I

I CLEANROOMS

New: Cleanzone Congress With “Basic” and “Advanced” Sessions he third Cleanzone Congress on 21 and 22 October 2014 will be focusing more T closely on the varied requirements of its participants. On both mornings of the event, informative 'Basic' sessions will explore the key questions pertaining to planning, operating and working in cleanrooms. The 'Advanced' sessions taking place in the afternoon, on the other hand, are targeted at professionals who are looking to expand their expertise regarding key product developments, market trends and innovations. The Cleanzone Congress will be covering the following three fields: cleanroom construction and planning ('Basic'), new cleanroom applications ('Advanced') and the operation of cleanrooms (both 'Basic' and 'Advanced').

In the 'Basic' sessions, presentations by experts will be providing in-depth knowledge on cleanroom standards, exploring current questions of cleanroom use with examples from medical technology, detail-

ing cleanroom air handling concepts and investigating issues of systems classification.

In addition, topics such as clothing concepts, employee training, monitoring systems and cleaning agents will be addressed by experts.

The 'Advanced' sessions are aimed at participants who want – and need – to remain abreast of the very latest developments. At the first day, specialists have a look at the special requirements entailed by organic LEDs and MEMS for cleanroom production. Other topics that will be covered in the first session include energy efficiency in accordance with the TC-209 standard and the future challenges to aerospace medicine.

The presentations on the second day of the congress include the application of the disinfectant hydrogen peroxide, procedures for putting on cleanroom clothing, energy efficiency, compliance and facility management.

All four congress modules can be booked

separately. Prices start at €125.00 for one module, with two modules available for €225.00, three modules for €300.00 and a ticket to the entire event for €350.00.

For further information on the Congress and the trade fair, visit www.cleanzone. messefrankfurt.com. I

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I RESEARCH & DEVELOPMENT

IRDG: All About R&D and Innovation in Industry

By Denis Hayes, Managing Director of IRDG IRDG is a non-profit, business-led Innovation Network of member companies and third level colleges working together to drive excellence in Innovation within Ireland’s industry. ust as our members are doing many interesting and exciting things in R&D and Innovation across all parts of Ireland, so too are we within IRDG. With a level of activity this year that is unprecedented, and a variety which includes new and international best practice, indigenous and multinational companies of all sectors and sizes are joining IRDG to become part of the action.

Driving IRDG’s focus and efforts are our 5 Pillars – Representation, Funding & Support, Innovation Networking, Collaboration and Learning. Coupled with our determination to deliver value and interest, these Pillars ensure real benefit for our growing and diverse membership, regardless of their stage in the R&D life cycle.

Design Thinking, Lean Product Development, R&D Tax Credits and Intellectual Property are all key focus areas within IRDG this Autumn, with major events to support each one. As always with IRDG events, the focus will be on industry experience, and how such thinking has been applied to improve processes around Innovation. We will also be collaborating with the German Irish Chamber of Industry & Commerce during October to expose industry to new R&D opportunities.

We’ve said it before - there’s no better time for R&D and Innovation in Ireland. The financial supports, the quality of research expertise, along with the openness to share and learn within industry, is all serving to promote and improve this vital part of our economy. As the IRDG Innovation Network, we are right

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there at the heart of it, bringing it all to you. All you’ve got to do is join in! For further information visit www.irdg.ie.

Lean Product Development (LPD) LPD is an approach to Product Development and Innovation which uses Lean Principles to drive efficiency, reduce costs and improve speed to market. Developed and implemented worldwide

by Ron Mascitelli (USA), IRDG has now secured the licence to rollout Ron’s techniques in Ireland. IRDG brought Ron to Ireland in 2013 and 2014, for IRDG’s Lean Innovation Conference and to deliver nationwide workshops. Ron’s common-sense, practical approach was welcomed by comapnies, and many are already on the journey of implementing Lean Product Development.

Briefings on LPD and how IRDG can assist companies will take place around the country throughout the Autumn.

Pictured at the official launch of IRDG’s Lean Product Development Licence were Sean McNulty (Dolmen), Ron Mascitelli, Mary Byrne (IRDG), Pat Lawlor

We’ve said it before - there’s no better time for R&D and Innovation in Ireland. The financial supports, the quality of research expertise, along with the openness to share and learn within industry, is all serving to promote and improve this vital part of our economy.

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(CIRCA), Shane Hughes (Lean Unlimited) and Denis Hayes (IRDG). Ron has trained this entire team to implement his LPD techniques in Ireland.

LPD is an approach to Product Development and Innovation which uses Lean Principles to drive efficiency, reduce costs and improve speed to market.

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R&D Tax Credits Over 150 delegates gathered in Cork for our R&D Tax Credit event on September 2nd. The main focus of discussion was centred on Audit approach and experience as well as the areas of clarification that will be contained in the imminent Guidelines update from Revenue. Further information on the R&D Tax Credit scheme is available through IRDG.

light this valuable resource to companies. The event showcased each of the Gateways, and included industry presentations from IRDG members Openet and Nypro. I

John Adams, Nypro; Denis Hayes, MD, IRDG; Damien English TD, Minister for Skills, Research & Innovation; Mary Byrne, IRDG; Alan McNamee, Openet.

Guest Speakers – Back: Brian Walsh, FMC; Bill Kearney, IBM. Front: Ken Hardy, KPMG; Denis Hayes, MD of IRDG; Brian Boyle, Revenue Commissioners.

Technology Gateways The nationwide network of Technology Gateways acts as off-site ‘R&D departments’ for participating companies using funding of Eur23million provided by the Department of Jobs, Enterprise and Innovation. IRDG, working together with Enterprise Ireland, gathered together a large industry audience in Dublin recently to high-

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Driving IRDG’s focus and efforts are our 5 Pillars – Representation, Funding & Support, Innovation Networking, Collaboration and Learning.

RESEARCH & INNOVATION, VOLUME 1, ISSUE 2

I INTELLECTURAL PROPERTY

Proposals to Extend R&D Protection Against Patent Infringement For Companies in the Pharmaceutical Sector

By Gerard Kelly, Partner, Mason Hayes & Curran On 31 July 2014, the Irish legislature published the Intellectual Property (Miscellaneous Provisions) Bill 2014.

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his Bill will, among other things, provide research companies in Ireland with greater legal protection against infringing existing patents when they take steps necessary to obtain regulatory approval for the marketing of human and veterinary medicinal products.

The Bill, when enacted, will amend Section 42 of the Patents Act 1992, by expanding the scope of the Bolar-type research exemption currently provided for under Irish law.

It will bring Ireland into line with other EU countries with more expansive protections such as Germany.

The current Bolar-type exemption in Section 42 creates a defence to patent infringement claims for studies, tests and trials conducted by pharmaceutical companies with a view to obtaining market authorisation for a medicinal product for human or veterinary use. The exemption was implemented into Irish law in 2006 by the European Communities (Limitation of Effect of Patent) Regulations 2006 on foot of an EU Directive (2004/27/EC). At the time, each Member State was left to interpret and implement the Directive as it saw fit. The Irish legislature, like its counterpart

The proposed legislative change will ensure that existing patent rights do not hamper research and innovation in Ireland and encourage companies engaged in such activity to carry out activities here without the fear of patent litigation.

in the UK, provided for literal interpretation of the Directive’s exemption provision, which seems to be narrow in its effect. It is thought that the current wording places certain pharmaceutical companies carrying out R&D in Ireland at a competitive disadvantage and this may impact on Ireland’s ability to attract foreign direct investment from companies involved in such R&D. Regulatory Impact As highlighted by the Department of Jobs, Enterprise and Innovation in its Regulatory Impact Analysis (April 2013) concerning the proposed expansion of the defence under Irish law, the exemption only extends to studies and trials needed for filing applications for a marketing authorisation in the EU only. The proposed amendment under the Bill will effectively expand the current patent infringement defence for “studies, tests and trials” to include all “studies, tests, experiments and trials (including clinical trials and field trials)” and will cover acts done in Ireland relating to the acquisition of a marketing authorisation outside the EU. The Department’s Regulatory Impact Analysis considered the costs, benefits and impacts of the proposed amendment. It concluded that there were limited costs to its implementation, it would not negatively impact consumers or competition, and would most likely add to national competitiveness by enhancing the attractiveness of Ireland as a location to undertake research and development activities in the generic pharmaceutical sector. At the same time, it recognised the balancing of the rights of innovative companies to recoup their original R&D investment in obtaining the existing patent rights involved.

Greater Certainty This amendment will provide greater cer-

tainty for pharmaceutical companies engaged in R&D in relation to the type of research activities which do and do not constitute patent infringement under Irish law. It will also move Ireland towards a more harmonised approach in the law between Ireland, the US and other EU Member States. The proposed legislative change will ensure that existing patent rights do not hamper research and innovation in Ireland and encourage companies engaged in such activity to carry out activities here without the fear of patent litigation.

The Bill is only in draft form at present and must pass further stages in both the Dáil and the Seanad before enactment into law. But in light of the conclusions of the Department summarised above, and the importance of R&D activities to the Irish economy, it is likely that this more liberal amendment will make its way into law shortly.

The contents of this publication are to assist access to information and do not constitute legal or other advice. Specific advice should be sought in relation to specific cases. I

RESEARCH & INNOVATION, VOLUME 1, ISSUE 2

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www.calorgas.ie 1850 812 450 E: info@calorgas.ie

Calor are proud energy suppliers of Bioclin Research Laboratories

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CONTRACT LABORATORIES

BioClin Offers an Unmatched Range of Services to Industry Based at the IDA Technology and Business Park, Garrycastle, Athlone, BioClin Laboratories is Ireland’s leading GLP certified (INAB), cGMP certified (IMB) and FDA registered contract laboratory. ioClin offers an extensive range of services to the pharmaceutical, biotechnology, veterinary and nutraceutical industries. The analytical services include method development and validation, method transfer and optimisation and high-throughput analysis for a range of compounds from small molecules to proteins and peptides. In addition, project management services and pharmacokinetic services are available enabling clients to allow BioClin to manage its development support services.

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Internationally Recognised BioClin is internationally recognised for providing expert analytical services and rapid reporting of data to support drug development and product release. Its breadth of scientific experience and knowledge across a wide range of techniques enables it to develop optimal methods that can be relied upon to run efficiently and meet regulatory requirements.

BioClin incorporates a 14,000 sq ft fully equipped modern laboratory. The laboratory is an independent analytical laboratory providing confidential analytical services including cGMP Chemistry/Microbiology Testing and Bioanalysis. It is the policy of the laboratory to operate to a high standard of quality in accordance with guidelines set out by organisations such as the Food and Drug Administration (FDA) in the USA, the Irish Medicine’s Board (IMB) and the Irish National Accreditation Board (INAB).

The laboratory consists of cGMP Analytical Laboratory, cGMP Raw Material Laboratory, cGMP Microbiology Laboratory, Water Laboratory, GLP Bioanalysis Laboratory, Stability Storage Room, RIA Laboratory as well as sample

receipt, archives and administration.

Key Strengths BioClin’s key strengths are its versatility and capacity to integrate its exceptional technical expertise and quality management with a range of related services, enabling it to offer a complete range of development services to its clients. Bioclin was established in 2003 and has an excellent track record, with services including: * GLP/GCP/CMP analytical support for drug substance and drug product development;

* GMP analytical support for process development and manufacturing; * GMP support for supply chain, vendor qualification, raw materials and QC testing; * GLP bioanalysis to support preclinical and clinical trials; * Environmental analysis.

BioClin joined Intertek Plc, a leading provider of quality and safety services to a wide range of industries around the world, in 2008 but became independent again in 2013, following a management buyout.

Invaluable Asset BioClin is an invaluable asset for two of

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Ireland’s biggest industrial sectors – pharmaceuticals and medical devices. BioClin’s solutions to meet the needs of the pharmaceuticals industry include: * Analytical research & development; * Cleaning validations; * Comparator studies; * Impurity ID and Quantification; * Elemental and trace metals analysis; * Extractables & leachables; * Physical characterization techniques; * QC testing services; * ICH Stability and storage testing; * Investigative Analysis; * Challenge Testing.

BioClin also offers a comprehensive range of services for the medical devices industry including: * Characterization – API’s in device, bioanalysis, identification and quantitation of impurities, degradation pathways, residual solvents (OVI’s); * Storage, stability, batch release testing; * Supply chain management; * Materials integrity and compatibility, surface morphology, microstructure, mechanical testing, imaging and phase distribution of drug components; * Fracture, failure & contamination analysis; * Metallurgy, corrosion, chemical resistance; * Plastics, polymers, raw materials testing.

For further information contact BioClin Laboratories on Tel +353 (0) 90 646 0200, Fax +353 (0)90 6460210, Email enquiries@bioclinlabs.com or visit www.bioclinlabs.com. I 21

I OVENS & FURNACES

Versatile High-temp Furnace Ensures High-purity Processing he Gero HBO top-hat furnace now T available from Carbolite provides a wide variety of thermal processing conditions from high-vacuum to over-pressure, with or without gases, at temperatures up to 3000ºC and without risk of contamination from heating elements.

The high-purity performance is achieved by using a tungsten radiation plate as the heat source instead of heating elements with fibre insulation, which risk contaminating samples. The radiation plate lining in the HBO furnace also prevents samples being contaminated with dust from outside. The high heat transfer performance of the radiation plate allows the furnace to be used for particularly dynamic thermal processing programmes.

The furnace is available in several cham-

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ber sizes from 200mm to 400mm diameter and 300mm to 500mm high. All incorporate a versatile tungsten sample carrier that is convenient to load, and all components are easy to access and maintain. A wide variety of gases can be used. A sophisticated control system allows fully automatic operation and includes state-of-the-art visualisation, remote control, remote maintenance and data logging.

Typical processes for which the HBO furnace has been designed include: • High-vacuum operation up to 2x10 -6 mbar with fast, stable heating, including during heat-up.

• High-vacuum partial pressure operation from 5x10 -5 to 1 x 10 -4 mbar for all installed gases using mass flow control (MFC)

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• Partial pressure operation using hydrogen and inert gases from 1 mbar to 1000 mbar (absolute).

• Atmospheric pressure operation with flowing gases at 20-50 mbar.

• Atmospheric pressure operation using hydrogen with a static atmosphere.

Over-pressure operation up to a predefined value. I

I LIMS

Scientific Data Goes Digital A new digital lab notebook proves that digitalization of scientific data opens up new horizons for scientific data processing. Developed by scientists turned entrepreneurs from Berlin, the lab management tool labfolder simplifies documentation and archiving procedures of scientific results, with an immense effect on the overall efficiency of laboratory research. he advantages are obvious: Digital platforms like labfolder offer well organized, maximum protected data in one place, accessible anytime, from anywhere. Scientists can effortlessly manage and share their scientific data online, a move that saves valuable research time and money.

Nonetheless, most research institutes, universities and research driven enterprises still struggle to implement the benefits of digital research tools into their everyday work environments. As a result, piles of paper, scattered notes and vast collections of different digital storage locations continue to pose challenges to scientists on a global scale.

can be retrieved anywhere - directly at the lab bench, at a conference or outside in the field.

The integration of reference managers and academic social networks like Mendeley and Figshare also allow for the linking of scientific literature and experimental raw data. The good news: labfolder is absolutely free for individual scientists and small groups; advanced packages for the management of larger groups and enterprises are available for a monthly fee.

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Labfolder – A Free and Secure Digital Lab Notebook As a viable alternative to conventional paper laboratory notebooks, the cloudbased online platform labfolder allows scientists to document, archive and share their research data in a digital format. With an interface similar to a page in a conventional paper lab book, the electronic lab notebook provides tools like protocol templates, an image editor and a sketching pad that accelerate lab work to a great extent. At the

same time labfolder promotes communication and collaboration between scientists, offering extended team editions with tailormade group functions, knowledge management and access control.

Another big bonus of labfolder are the free mobile apps, available for all portable devices operating under Android and iOS. Within seconds scientists can turn their smartphones, tablets and ipads into digital lab notebooks with unlimited access to scientific data, anytime and anywhere. Once recorded with the labfolder app, all scribbled notes, sketches and photos of experiments are seamlessly transferred into the digital lab notebook. In turn, archived research data

Data security – Maximum Protection 24/7 In terms of data security, labfolder incorporates state-of-the-art enterprise security procedures for maximum data protection. Daily backups, redundant servers and encrypted data communication give maximum data safety and security. Being compliant to the rules of Good Laboratory Practice, all entries are also provided with a full audit trail, timestamps and digital signatures.

Developed from scientists for scientists, the Berlin-based labfolder GmbH is continuously improving its product and strongly encourages customer feedback to boost the overall lab experience for researchers worldwide. I

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I LIMS

SLCLAB – Helping Laboratories to Improve Their Day-to-day Operation SLCLAB is a team of professionals where the value of experience and the passion and energy of youth have set a goal: to be attentive to the Information management needs of laboratories, innovating constantly and willing to provide the service that customers deserve.

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ue to the fact SLCLAB were founded in a laboratory and have more than 15 years of experience with over 250 clients including laboratories that work in the field of research and innovation, SLCLAB have the added benefit of understanding the requirements and problems that can arise.

SLCLAB’s powerful and dynamic Laboratory Information Management System (LIMS), ALFA21 is the perfect tool for laboratories that are looking to improve the day-to-day operation of their laboratory.

Technical Expertise Over the years, SLCLAB have developed a high level of technical expertise when it comes to connecting all types of analysers to their software. This feature of a LIMS gives you benefits in data accuracy and in the speed of data entry, again aiding with compliance and improving the performance of the lab. Also reducing the number of retests required saving the laboratory both time and money.

Another important aspect of the program is traceability which provides various levels of security and audit trails to enable you to trace activity and provide accountability.

It also allows you to access to historic data using inbuilt searching facilities and reporting tools provide far greater possibilities to perform analysis on your data and use this information to improve pro-

ductivity.

ALFA21 will help you certify or accredit your laboratory according to ISO standards. The users can register preventive actions, non-conformities or corrective actions related with whatever anomalous situation that can occur in the laboratory, as well as leaving notifications to other users.

Various Versions SLCLAB’s program comes in various versions including; ALFA21 – Clinical and Genome analysis; ALFA21 FQM – Food & Water/Physicochemical and Environ mental Analysis; ALFA21 APT – Anatomic Pathology.

ALFA21 is fully scalable from single site to multisite installations utilizing a single database for all sites and disciplines to allow a true fully integrated, multidisciplinary LIMS. SLCLAB have an innovative business model when it comes to expanding their client base, offering the possibility to request a Demo version and also buy the program online, which is not very common.

Four Basic Pillars The way SLCLAB work is based on four basic pillars: RESEARCH & INNOVATION, VOLUME 1, ISSUE 2

• Listen to your needs. Each laboratory has its own characteristics and way of working. SLCLAB’s objective is to listen to your needs.

• Customised installation. The installation of ALFA21 is performed by qualified technicians.

During the installation process SLCLAB will propose how you can make the most of ALFA21 to carry out your work.

• Support after the installation. It is very important that the installation is executed perfectly, but more important is that the laboratory is supported afterwards. At your disposal there is a dedicated support department, comprised of qualified professionals.

• Your ALFA21 always up-to-date.

SLCLAB guarantee that with your annual maintenance, you will always have the most up-to-date version of ALFA21.

For more information please visit www.slclab.com/en. I

SLCLAB’s powerful and dynamic Laboratory Information Management System (LIMS), ALFA21 is the perfect tool for laboratories that are looking to improve the day-to-day operation of their laboratory.

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I

LIMS

A Total Quality Data Management Solution SoftTrace LIMS is a flexible, fully scalable, industrial strength laboratory system purpose built on proven technology to meet the specific analysis and data integration demands of Pharmaceutical and Food manufacturers. ith an emphasis on regulatory compliance, SoftTrace LIMS supports customers in maximising efficiency while meeting their regulatory and accreditation needs by maintaining full data and instrument traceability. It ensures the highest standards of integrity and quality, in conformance with regulatory requirements for audit trails, security via multiple levels of permissions, data integrity, sample identification and tracking, corrective actions, control methodologies, access to SOPs, and data archiving. This includes compliance with 21 CFR Part 11 requirements for integrated security features, electronic records and signatures.

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Features: • User defined database of tests, specifications, sample stages and parameterised worksheets.

• Automatic test / sample creation and frequency control.

• Create and store sampling schedules and workflow plans.

• Flexible data input routines, with realtime validation.

• Full audit history on all results.

• Real-time alerts and quality incident monitoring.

• Instrument interfacing and data capture library.

• Certificates of analysis / conformance documentation.

• Full system and data access security.

• Usage audit trail to operator and instrument level and internal chain of custody.

• Interface to manufacturing and business systems.

• Full support for the generation and use of barcode labels.

• Instrument calibration and event management tool.

damental aspect of SoftTrace LIMS that quickly delivers significant productivity gains. It saves analyst time, increases sample throughput, and eliminates transcription errors while maintaining quality data integrity and security. Instrument level auditing, traceability and calibration scheduling increases the efficient use of laboratory resources and guarantees demonstrable regulatory compliance.

Integrate all Operational Areas Automatic, real-time data transfer to and from analytical instruments and third party ERP, process and control systems is a fun-

Integrated Quality Management at FMC FMC has deployed SoftTrace LIMS at manufacturing facilities in Ireland and US for more than a decade. FMC chose SoftTrace as an integrated quality management solution to meet the challenges of achieving enhanced product quality management while, at the same time, driving down costs. The decision to deploy SoftTrace was based on its specific focus on FMC’s production planning, cost control, product quality management and batch process requirements.

At FMC SoftTrace provides real-time access to all quality and traceability data. It facilitates chemical and micro-packaging analysis on a seven day continuous basis and monitors all laboratory results against predetermined target and upper limits and specifications. SoftTrace highlights out-ofspecification packing process results and automatically determines the disposition of all finished products. This data is then used to determine the profile of the SAP inventory.

For further information contact SoftTrace on Tel +353 21 4533781, E-mail info@soft-trace.com or visit www.softtrace.com. I

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• Attach SOPs, quality documentation, standard and free text comments.

• Generate certificates of analysis, compliance documentation and barcode labels.

• Flexible reporting and graphing (SPC) options.

Benefits: • Real-time monitoring and validation of all quality analysis data from raw material to shipped finished product.

• A flexible and responsive testing protocol.

• Significant cost reductions and increased operational efficiency.

• Guaranteed data integrity.

• Increased security with a usage and amendment audit trail to operator and instrument level.

• Immediate access to all quality management data, statistics and graphs.

• Demonstrable traceability and regulatory compliance.

• Production value maximisation.

I RESEARCH & INNOVATION

Mayo Clinic and NUI Galway Formalise Collaboration he National University Ireland T Galway has signed an agreement to formalise collaborative ties with

which is to realize the potential of regenerative medicine. Here in Galway we have Ireland’s only facilthe Mayo Clinic Centre for ity licenced to produce stem cells for Regenerative Medicine in the US. human use, while the new clinical The agreement follows many years and translational research facility for of close cooperation, and paves the conducting clinical trials with way for joint collaborations in clinipatients will be complete in early cal trials using regenerative thera2015.” pies.

NUI Galway’s Regenerative Collaborative research projects Medicine Institute (REMEDI) and will focus on a number of key stratethe Network of Excellence for gic areas of importance for both Functional Biomaterials (NFB), institutes, including adult stem cell both of which are supported by therapy, gene therapy, biomaterials Science Foundation Ireland, are and biomedical engineering. working together specifically to Further-more, the agreement facili- Pictured at the signing of the MOU are: Professor Lokesh Joshi, Vice- develop joint clinical trial protates ongoing student and staff President for Research, NUI Galway; Dr Jim Browne, President, NUI grammes in the area of regenerative exchange between Galway and the Galway; Professor Tony Windebank, Deputy Director for Discovery, medicine.

Centre for Regenerative Medicine at Mayo Clinic; and Professor Tim US. The signing of the MOU comes The Memorandum of Under- O’Brien, Director of REMEDI NUI Galway. on top of the recent announcement standing (MOU) puts the emphasis of a new $16 million agreement on regulatory science to facilitate global licensed for use by the respective national between Mayo Clinic and Enterprise Ireland translation of regenerative medicine thera- medical authorities. where up to 20 novel medical technologies pies to the clinic. Both the National National University of Ireland Galway’s will be commercialised in Ireland over the University Ireland Galway and the Mayo President, Dr Jim Browne says: next five years with the aim of creating sevClinic Centre for Regenerative Medicine “Formalising our longstanding links paves eral high value medical technology spin-out have GMP cell manufacturing facilities, the way for advancing our common agenda companies. I

UCC Device to Help Coronary Disease n what promises to be a major step forIUCC’s ward in the treatment of coronary disease, Centre for Research in Vascular Biology has developed a new device that promotes the bypass of arterial obstructions, potentially removing the need for major surgery.

Worldwide, there are approximately three million open heart coronary bypass and peripheral artery bypass operations each year. These procedures involve major surgery with inherent risks of anaesthesia, ventilation, surgical trauma and potential complications such as kidney failure and wound infection. Around 20% of all patients requiring surgery are unable to undergo such bypass procedures because of the poor status of their arteries or co-existing illness that would make the risk of surgery too great.

Publishing in the prestigious journal Biomaterials, the research project (led by Professor Noel Caplice in UCC with col28

laborators in the Mayo Clinic, USA) has developed a vascular cell delivery device and tested it successfully in a large animal model with similar sized arteries to humans. The device is inserted via a keyhole procedure through the artery to the site of obstruction and promotes micro-bypass of this obstruction over a four week period. This results in the return of normal heart function and a recovery of full exercise capacity.

Professor Noel Caplice, Professor Noel Caplice, UCC, with the medical device.

Director of the Centre for Research in Vascular Biology at UCC and has the potential to reduce costs and time Chair of Cardiovascular Sciences says: “If spent in hospital.” reproduced in humans this device would Plans are now in place to test this technoloffer an alternative to open surgical bypass ogy over the coming years in patients who operations with implications for treatment of require bypass surgery but would otherwise patients who are currently inoperable. It also be deemed unfit for surgical intervention. I RESEARCH & INNOVATION, VOLUME 1, ISSUE 2