Irish Pharmachem 2014

The Industry Buyers Guide 2013/14

Enabling Flexibility in Analytical Operations

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The Industry Buyers Guide 2013/14

CONTENTS 34

3

Minister’s Foreword

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The pharmaceutical and chemical industry has turned a corner after some difficult years, with Ireland well placed to benefit, writes Minister for Jobs, Enterprise and Innovation, Richard Bruton TD.

51

RISK IDENTIFICATION

HAZARDOUS CHEMICALS SECTOR OVERVIEW

5

PharmaChemical Ireland have launched phase three of their strategy for the continued success of Ireland’s pharmaceutical and chemical sector. PCI Director, Matt Moran reports.

24

Ann McGee, MD of McGee Pharma International, advises on how to reduce the human error count and sustain error reduction in your business.

26

Better protection of workers against exposure to hazardous chemicals is good not just for workers, but for companies and society at large.

RECRUITMENT

44

Confidence is high for the Irish PharmaChem sector in 2013, according to The Berkley Group’s latest survey.

CHROMATOGRAPHY

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Ultra Performance Convergence Chromatography, UPC², is fast becoming an essential separations technique for your lab.

MATERIALS HANDLING

48

Enabling Flexibility in Analytical Operations Eurofins Lancaster Laboratories have over 20 years’

Science Foundation Ireland

8

Science Foundation Ireland has played an instrumental role in enhancing Ireland’s international reputation as a prominent force in the pharmaceutical arena.

Pharmaceutical Manufacturing Technology Centre 12 Nessa Fennelly, Senior Executive, PharmaChemical Ireland, reports on the development of the Pharmaceutical Manufacturing Technology Centre.

Irish Pharmachem Cover12.indd 1

Bioprocessing

16

20

Irish PharmaChem companies using certain hazardous substances must act now or face disruption to their supply chains, as the REACH Regulation now requires a licence for the supply and use of certain substances.

packaging solutions

experience in offering out-sourced or in-sourced QC Testing personnel to global pharma and biopharma companies.

IDA IRELAND

30

Ireland remains a key location for life sciences investments, and with very good reason, writes Antoinette Tyrrell, IDA Ireland.

PRODUCT IDENTIFICATION

32

For 40 years, GS1 has been bringing industries together to revolutionise the way they do business.

Nanotechnology & Advanced Manufacturing

Michael Gillen, Director, Irish BioIndustry Association, reports on four Irish biotech companies at the forefront of innovation.

REACH DIRECTIVE

28

14

Killian O'Driscoll, Projects Director, explains the unique work of the National Institute for Bioprocessing Research and Training (NIBRT).

BIOTECHNOLOGY

COVER STORY

34

40

B. Braun Original Equipment Manufacturer offers expertise which exceeds customers’ expectations in infusion therapy and contract manufacturing.

22

SteriPack’s facility in Malaysia ensures that the group can offer state of the art blister packaging services all over the globe.

PACKAGING MACHINERY

42

Goliath Packaging Systems is a one-stop-shop for packaging machinery, materials handling systems and industrial washing equipment.

1

51

The life science industry is focusing on global customs and trade compliance as its supply chains become increasingly more complex and far-reaching.

GDP Guidelines

56

Embracing and adopting the new EU GDP Guidelines is vital to ensure Ireland remains a driving global force in life sciences.

30/05/2012 14:57

Chemical Suppliers General Suppliers Company Listings Useful References

58 60 70 80

38

The proposed European Clinical Trial Regulation could significantly boost research activity throughout Europe, writes Fionnuala Gibbons, Clinical Trial Liaison Officer, MMI/ICRIN.

CONTRACT MANUFACTURING

Customs & Trade Compliance

Listings Section

Why nanoscience is at the forefront of pharmaceutical, medical device and even diagnosis development,

by Dr Colm Faulkner, CRANN.

CLINICAL TRIALS DIRECTIVE

Henley Forklift Group Ltd are celebrating 40 years supplying the materials handling industry.

Irish PharmaChem is published by: Tara Publishing Ltd. 14 Upper Fitzwilliam Street, Dublin 2.

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MINISTER’S FOREWORD

CREATING THE RIGHT ENVIRONMENT FOR SUCCESS The Pharmaceutical and Chemical Industry has turned a corner after some difficult years, with Ireland well placed to benefit, writes Minister for Jobs, Enterprise and Innovation, Richard Bruton TD.

A

s Minister for Jobs, Enterprise and Innovation, I am very pleased to provide this foreword for the Irish PharmaChem Yearbook and Diary 2013.

From the Government’s point of view, we will continue to work with the Pharma sector to ensure that we maintain: • Strong local management and a solid reputation for industryacademia collaboration; • A 12.5% corporate tax rate and a 25% Research and Development (R&D) tax credit; • No stamp duty on intellectual property transfer in Ireland; • Leading edge industry infrastructure, with IDA Ireland linking companies with excellent pre planned sites, a developed sub-supply and world class design consultants.

industry. Our record is very impressive: nine of the top 10 pharmaceutical companies in the world have a base in Ireland, as do eight of the top 10 medtech companies. In addition, there are a large number of companies outside of the top ten who manufacture and successfully export from Ireland. The life sciences sector in Ireland accounts for over 50,000 jobs and €50 billion worth of exports.

The Government has been working for many years to diversify the pharmaceutical base here in Ireland.

Patents on several blockbuster drugs expired over the last decade and, notwithstanding these developments, there has been continued growth in the sector.

In growing the pharmaceutical sector, our strategy has been to win leading company investment and to diversify the breadth of operations over multi-product sites, including associated services and development of new compounds.

THE NEXT WAVE OF OPPORTUNITY While the Government will continue to enhance Ireland’s offering in

IMPRESSIVE TRACK RECORD The Irish pharmaceutical industry is an enormously important and highly valued sector in Ireland. The government and IDA Ireland have played our part in ensuring we became the location of choice for these and other players in the

Richard Bruton TD, Minister for Jobs, Enterprise and Innovation.

the pharmaceutical sector, we will also continue to focus on biopharmaceuticals, which represent the next wave of opportunity in the industry. Indeed, we have successfully attracted and developed globally

Ireland is in position to be the location of choice for development and manufacture of a number of next generation drugs.

3

MINISTER’S FOREWORD

leading programmes from companies such as Allergan, Amgen, Centocor, Eli Lilly, Genzyme, Merck, and Pfizer, with the result that Ireland now has a globally leading biopharmaceutical cluster in the next generation of pharmaceutical products.

Ireland retains an exemplary global record in this regard, with an excellent regulator in the Irish Medicines Board and with much improved competitiveness through wage reduction and restraint, which is helping Ireland to compete with lower cost locations.

In addition, the Government, through its agencies, are continuing to invest in research and training to help the academic system support industry. IDA Ireland, through its overseas network, remains committed to maintaining and growing relationships with key decision makers in the pharmaceutical industry and IDA Ireland can offer assistance to companies to support new investment and enhancement of technical capability.

The overall export performance of the sector, therefore, is multifactorial and whilst there are challenges with regard to patent expiration, IDA Ireland will continue to support continuous improvement and transformation in its existing client base, while seeking to win new FDI opportunities in the pharmaceutical sector.

Priority Areas A key cross-Government initiative is implementation of the recommendations in the report of the Research Prioritisation Steering Group, which seeks to maximise the impact of our spend by focusing the majority of public competitive research funding on 14

priority areas.

The priority areas were identified on the basis of existing strengths of the public research base and the enterprise base, opportunities that exist in terms of the global marketplace and those which are most likely to deliver economic and societal impact.

The PharmaChem sector has been performing well in Ireland,

In with â‚Ź1.1 billion of new investment announced in 2012 from five February 2012, major IDA client companies, which will result in 1,200 jobs. the Government agreed to implement the by funding Departments and Agencies recommendations of this report as in order to re-align the majority of a whole of Government policy goal competitive public research funding and the Prioritisation Action Group around the priority areas.

(PAG) was established, under the

This new approach is driving chairmanship and political leadership new behaviours, resulting in a more of the Minister for Research and holistic approach to funding research Innovation, tasked with driving across relevant Departments and implementation. The PAG comprises funding Agencies. representatives of all relevant Government Departments and State TURNING THE CORNER Agencies funding research.

While the industry has been faced

Key to delivering on with some difficult years due to patent implementation is collaboration across expiration and competitiveness the funding Agencies and Departments, challenges, it is starting to see an and the PAG, which has held eight increase in R&D productivity, with plenary meetings since its inception, is the advent of more targeted biotech the opportune forum for dialogue which therapies and personalised medicines. can facilitate this collaboration. Action 2012 saw the highest number of new plans for each of the priority areas are drugs, 39, approved by the United being developed, and represent the States Food and Drug Administration detailed blueprint for actions to be taken in 16 years and the predictions are that the industry has turned a corner.

Ireland is in position to be the location of choice for development and manufacture of a number of these next generation drugs and the sector has been performing well in Ireland, with â‚Ź1.1 billion of new investment announced in 2012 from five major IDA client companies, which will result in 1,200 jobs.

I wish Irish PharmaChem every success in the year ahead.

The Government has been working for many years to diversify the pharmaceutical base here in Ireland.

4

Richard Bruton TD, Minister for Jobs, Enterprise and Innovation

SECTOR OVERVIEW

ADAPTING TO MEET THE CHALLENGES OF THE FUTURE PharmaChemical Ireland have launched phase three of their strategy for the continued success of Ireland's Pharmaceutical and Chemical sector. PCI Director, Matt Moran, reports.

sector. What this meant, in effect, was companies investing in product and process development activities close to existing manufacturing operations.

Such investments would facilitate further development of existing manufacturing operations from a quality and cost perspective, as well as attracting the development and launch of new entities or products.

P

harmaChemical Ireland launched Phase 3 of their strategy, ‘Strategy in Action’ in Brussels in December of 2012.

The launch took place at the Offices of The European Commission where the completed document was presented to the EU Commissioner for Research, Máire Geoghegan Quinn.

The document is phase three of the initial strategy plan, ‘Innovation and Excellence’ that PharmaChemical Ireland launched at the Drugs, Chemicals and Allied Technologies (DCAT) meeting in New York City. This represented the beginning of a journey when PharmaChemical Ireland and its member companies undertook to lead the transformation of the sector in Ireland.

Prevailing global trends in the sector, such as the patent cliff, rising drug development costs, and falling approvals of new medicines drove this desire to transform. The industry concluded that the existing model of manufacturing only was unlikely to deliver a long term future for the sector in Ireland.

The industry would need to expand its mandate, as well as sharpening up existing operations from a cost and efficiency perspective.

DEVELOPLMENT PLUS MANUFACTURING The concept of development plus manufacturing or ‘D&M’ was adopted by the

The Pharmaceutical Challenges at a Glance

a manufacturing unit by employing best practices in operational excellence. It also needs to maintain a close to perfect record of compliance across the entire regulatory spectrum.

Where possible, operations need to be environmentally and economically sustainable. For multinational companies, on site process or product development capabilities are vital, if the site is to position itself as a location of choice for new investments. Indigenous sites need to base their own business models on significant investment in innovation.

In June of 2011, PCI launched phase two of its strategy, ‘Ireland a Location for Scientific Investment’. This report documented real progress by the industry as it moved towards a more integrated model. The report also contained a series of compelling testimonies by global and local CEOs, describing why Ireland remained a location in which they were prepared to invest: see graph below.

Against this global backdrop the sector in Ireland faces particular challenges: (see graph above).

• Costs need to continue to decline, in particular labour waste and energy charges; • The skills gaps need to continue to be addressed; • We need to address the fragmentation in Ireland’s supporting infrastructures for clinical R&D and innovation; • The lack of engagement by the CURRENT SITUATION healthcare system with industry, par- Current Situation global industry now entered the post environment. Major ticularly in relation to research,The cliniThe has global industry haspatent nowcliffentered drugs are currently coming off patent. Prevailing healthcare policies in cal trials and the development blockbuster and the post patent cliff environment. Major Ireland, and indeed across the developed world, continue to apply downwards pressure on prices.

However, as global supply continues tocoming circumnavigate the globe related manufacturing of innovative blockbuster drugs are currently as the sector strives to reduce costs, a worrying trend has emerged within the sector. healthcare products and services. off patent. Prevailing healthcare policies in Ireland, and indeed across the devel(Insert FDA Tables from Page 7 of attached PDF – COMP F-A 2012 GB OPERATIONAL EXCELLENCE DIGITAL) oped world, continue to apply downwards In summary, for a site to be fit for purpressure on prices. However, as global Trends evident from the FDA (see tables) point to a reduction in quality standards pose, it needs to achieve excellence as This supply continues the globally. contrasts with experienceto in circumnavigate Ireland, where quality standards remain 5

very high. PharmaChemical Ireland member companies have prioritised compliance as part of their strategy. This should help to enhance the attractiveness of the country as a location for the continued supply of pharmaceutical and chemical products.

STRATEGY IN ACTION

SECTOR OVERVIEW

globe as the sector strives to reduce Warning Letters by FDA Center Fiscal Year 2011 1,200

1,040

1,000 800 600 400 200 0

324 175

108

8

CDRH CDER CFSAN CBER

65 CVM

CTP

Total Recall Events by FDA Center Fiscal Year 2011 2,000 1,380

1,500 1,271 1,000 500 0

419

511

CDRH CDER CFSAN CBER

59

0

CVM

CTP

The global industry has now entered the post-patent cliff environment. Major blockbuster drugs are currently coming off patent. Prevailing healthcare policies in Ireland, and indeed across the developed world, are continuing to apply downward pressure on prices.

However, as supply continues to circumnavigate the globe as efforts to reduce costs continue, a worrying trend has emerged within the sector in relation to quality standards. Trends evident from Fig 2.2 point to a reduction in quality standards globally. This contrasts with experience in Ireland, where quality standards remain very high. PharmaChemical Ireland member companies have prioritised compliance as part of their strategy. This should help to enhance the attractiveness of the country as a location for the continued supply of pharmaceutical and chemical products.

Fig 2.2 costs, a worrying trend has emerged within the sector.

Trends evident from the FDA (see tables) point to a reduction in quality standards globally. This contrasts with experience in Ireland, where quality standards remain very high. PharmaChemical Ireland member companies have prioritised compliance as part of their strategy.

This should help to enhance the attractiveness of the country as a location for the continued supply of pharmaceutical and chemical products.

Strategy in Action Since the launch of Phase 1 of the strategy in early 2010, a great number of PCI member companies have been implementing many elements of it. In fact, in many cases, Irish sites have undergone significant transformation since they first established in this country. This has helped Ireland to move from the status of being a sourcing location, primarily for Active Pharmaceutical Ingredients, to many sites becoming fully integrated operations, offering a range of activities beyond pure manufacturing, including process development, product development, manufacture for clinical trials, shared services etc.

Phase three of the PCI Strategy contains 12 compelling case studies outlining how Irish sites have evolved and transformed since establishing in Ireland.

These cases are examples of the PCI strategy in action.

A wide range of examples of how best practice is being applied

Pictured at the launch of Phase 3 of PharmaChemical Ireland’s ‘Strategy in Action’ in Brussels are Padraig Somers of Helsinn Birex Pharmaceuticals, Matt Moran, Director, PharmaChemical Ireland, and EU Commissioner for Research, Maire Geoghegan Quinn (© European Union, 2013).

comprise the main body of the report.

There are compelling stories of how companies such as Sanofi Genzyme, Bristol Myers Squibb, GE Healthcare and GSK have led the way in lean manufacturing and Six Sigma, making breakthrough progress in site productivity and efficiency. We also find out how Eli Lilly, Janssen and Allergan have developed capacity and expertise in biotechnol7 ogy, where they continue to invest significantly in new facilities. We examine how Helsinn Birex, Henkel Loctite and MSD have invested hugely in developing on-site process and product development, co-located with manufacturing, as well as how Pfizer have kept to the fore in the whole field of Process Analytical Technology and Quality by Design.

PCI plans to add further case studies: for example, Novartis are developing one at the moment. All of these case studies can be found at www.pharmachemicalireland.ie.

Conclusion Undoubtedly, the world of pharmaceutical and chemical manufacturing will remain very challenging. However, the cases outlined in Phase 3 of the PCI Strategy point to a sector that is flexible, adaptable and agile; a sector which is secure in this country for the long term; a sector capable of transforming to meet the challenges of the future.

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The Pharmaceutical Industry at a Glance

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Nine of the top 10 leading multinational companies are based in Ireland; The industry contributes total tax receipts of €3 billion annually to the Irish economy; Ireland is the world’s largest net exporter of pharmaceuticals, with exports valued at €55 billion, accounting for over 50% of the total Irish exports; Strong local management and solid reputation for industryacademia collaboration; The sector employs over 24,000 people directly and further 25,000 indirectly in businesses that supply goods and services to the sector; Over 50% of the employees are third-level graduates; An inherent ability to comply with tough and demanding international regulation; A proven track record; A 12.5% corporate tax rate and a 25% R&D tax credit; No stamp duty on Intellectual Property transfer in Ireland; Leading edge industry infrastructure, with IDA Ireland linking companies with excellent pre-planned sites, a developed sub supply and world class design consultants.

Swords Laboratories, Watery Lane, Swords, Co. Dublin 01 8139000 www.bms.com

Science Foundation Ireland

Excellence with Impact Science Foundation Ireland (SFI) has played an instrumental role in enhancing Ireland’s international reputation as a prominent force in the pharmaceutical arena. This has been achieved by strategically investing in research teams who generate new knowledge, leading-edge technologies and competitive enterprises in the fields of science and engineering.

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stablished as the Government’s science agency in 2000, SFI has assisted the development of our pharmaceutical credentials to a point where today, Ireland is considered to be an emergent international hub for pharmaceuticals.

Since its establishment, SFI has invested over €1.677 billion in scientific research carried out over almost 3524 awards. The total number of life science awards approved by SFI to date is now 1,490, with a total value of €719m. There are currently 374 active life science awards with a value funded of €337m.

The importance and impact of the life sciences sector in Ireland is evident across the public and private sectors. Nine of the top 10 pharmaceutical companies in the world have a base in Ireland, as do eight of the top 10 medtech companies. The life sciences sector

in Ireland accounts for over 50,000 jobs and €50 billion worth of exports. Also, the life sciences sector is supported and complemented by world class research institutions and health professionals working in our hospitals.

SFI’s remit has been extended to fund applied research in addition to its current remit to fund oriented basic research. In addition, new function has been added to enable SFI to promote and support awareness and understanding of STEM subjects. SFI can also now participate in, and contribute funding to, international research projects which relate to strategic areas of opportunity for Ireland.

POLICY DEVELOPMENTS There have also been a number of important developments in Irish scientific research policy in the past year, including

Since its establishment, SFI has invested over €1.677 billion in scientific research carried out over almost 3524 awards.

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SFI has assisted the development of our pharmaceutical credentials to a point where today, Ireland is considered to be an emergent international hub for pharmaceuticals.

publication of the report of the National Research Prioritisation Strategy Group, a new national framework, guidelines and protocols for IP protection and exploitation, ‘Putting Public Research to Work for Ireland’, the Government’s Action Plan for Jobs 2013, SFI’s new strategic policy ‘Agenda 2020’, SFI’s Annual Plan 2013, and SFI’s achievements summary ‘Discovery to Delivery’.

Public investment in research through SFI and other government agencies is making an impact: • Ireland is now in the top 20 countries in scientific global rankings from a position of 36th in 2003 (Source: Thomson Reuters Essential Scientific Indicators).

• Ireland is third in the world for the quality of its research in Immunology

Science Foundation Ireland

goals, the strategies for achieving them, and the performance indicators that will be used to measure SFI’s progress.

SFI’s four goals are: 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.

4. To represent the ideal modern public service organisation, staffed in a lean and flexible manner, with efficient and effective management.

In the Agenda 2020 The total number of life science awards approved by SFI to document, each of these date is now 1,490, with a total value of €719m. objectives is elaborated upon by setting out the reasons why it is important, the actions that will be taken to and eighth in the world for the quality achieve it and the KPIs that will be used of its research in Materials Science. to measure progress. Each year, SFI will • SFI supported research published publish both an audit of progress and an over 6,000 papers in 2012 (up 16% annual plan. on 2011): one third of these are coauthored with internationally based Economic and societal impact researchers.

The Irish Government is committed to • Over the past decade, SFI has funding excellent science that creates built a community of approx. 3,000 economic and societal impact. researchers in Ireland’s higher edu The Government is taking cation institutes, led by approx. 400 on this challenge and in early 2013 scientists. announced the largest ever state/industry • Over 700 companies are taking co-funded research investment in Ireland. part in over 1,000 collaborations Over €300m (€200m from Government with SFI research groups, ranging and €100m from industry) is to be investfrom informal connections to coled in seven new Science Foundation laborations that involve significant Ireland Research Centres. These centres financial sponsorship. The goal of will focus on a broad range of topics, these relationships is to make those including, pharmaceutical manufacturing, companies more competitive, via drug synthesis, connected health, and transferring technology and trained neonatal care. people out of the labs and into the

The Alimentary Pharmabiotic companies.

Centre or APC, one of these seven SFI • Irish science has a global reach: SFI funded research centres, is dedicated researchers engaged in approxito investigating the close links between mately 1,800 academic collaborathe gut microbiota, a complex community tions, spanning 68 countries. of trillions of microbes unique to every individual’s gut, and health status linking The SFI Strategy – Agenda 2020 directly to healthy ageing as well as optiAgenda 2020, SFI’s ambitious sevenmal brain function. year strategic plan, lays out four key

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Academically, Ireland’s international ranking for the quality of its research remains impressive, and, in the last two years, we have consolidated our position within the Top 20 countries for overall scientific performance.

Furthermore, with the trend of Ireland’s particular excellence in specific disciplines, such as molecular genetics and genomics, probiotics and immunology continuing, our status in academia complements our commercial prowess and helps in converting excellent research into viable businesses and pharmaceutical products that generate both employment opportunities and health benefits.

Recent SFI Related Investments – SFI Research Centres: Some of the most significant SFI pharmarelated investments include: •

The Alimentary Pharmabiotic Centre (APC) led by Prof. Fergus Shanahan, at APC and with coinvestigators in UCC, Teagasc Moorepark Food Research Centre, Mercy University Hospital, Cork University Hospital and Cork Institute of Technology, investigates the close links between diet, the microbiota and health status. The Centre aims to provide the necessary scientific basis for the selection of health-promoting bacteria and food constituents for incorporation into ‘functional foods’ for improved health, and which can support the development of novel bioactives to treat intestinal and infectious diseases. The research undertaken by the APC will address important societal issues such as disease prevention, improved cognition and healthy ageing and is supported by food, biotechnology, pharmaceutical and diagnostic industries.

•

INFANT, Irish Centre for Fetal and Neonatal Translational Research, is led by Prof. Louise Kenny, Prof.

Geraldine Boylan at UCC, with co-PIs based in Tyndall National Institute at UCC, Royal College of Surgeons (RCSI). The INFANT team is a diverse group of doctors and scientists who are supported by strong industry partners, international collaborators and business and regulatory advisors. Over the last five years, the team has col-

Science Foundation Ireland

of 19 individual projects will be carried out, which all fall under one of three main themes: 1. New Frontiers in Pharmaceutical Synthesis: efficient synthetic routes and processes for molecules that are precursors to potential pharmaceutically relevant materials; 2. Crystal Growth and Design: studying the physical characteristics of crystalline materials and their interactions to understand how to utilise them most effectively as active pharmaceutical ingredients;

SFI’s remit has been extended to fund applied research in addition to its current remit to fund oriented basic research.

laborated to develop screening and diagnostic tests and novel methods of monitoring pregnancy and newborns and the team members have become international leaders in this area. INFANT will focus on fasttracking discoveries to the bedside by serving as a hub for innovation, spanning three of the major priority areas outlined in the Research Prioritisation Report: Diagnostics, Medical Devices and Connected Health. These areas are associated with large global markets that have a strong Irish base.

•

The Synthesis & Solid State Pharmaceutical Centre (SSPC) is led by Prof. B.K. Hodnett. The overarching aim of the SSPC2 Centre will be to better understand mechanisms, control processes and predict outcomes for the efficient and environmentally sustainable production of safe medicines.

This will be achieved by utilising a “molecule-to-medicine” approach that encompasses chemical synthesis, crystal engineering, and drug production and manufacture. A total

3. Drug Product Formulation and Manufacture: using science- and engineeringbased knowledge to optimise solid state pharmaceutics and produce new and improved drug formulations.

Technology Innovation Development Award Funding As part of SFI’s Technology Innovation Development Award (TIDA) programme for 2013, the following pharmaceuticaloriented projects received funding: •

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• •

•

Dr Warren Thomas, Royal College of Surgeons in Ireland. Title: Development of novel anti-tumour peptides for the treatment of malignant pleural mesothelioma; Prof. Dr Mathias O. Senge, TCD. Title: Phosphorous porphyrins as simple and efficient imaging and treatment dyes for photodynamic cancer therapy; Prof. Tia Keyes, DCU. Title: Peptide directed metal complex probes for intra-cell sensing; Dr Adolfo Lopez-Noriega, Royal College of Surgeons in Ireland.

Title: Collagen-based scaffolds as a platform for the controlled release of bioactive molecules; Dr Celine Marmion, Royal College of Surgeons in Ireland. Title: An In Vivo

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•

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study of novel multi-functional metallodrug candidates as anti-cancer agents: a crucial step in their commercialisation; Dr Catherine Greene, Royal College of Surgeons in Ireland. Title: Capture affinity technology to isolate messenger RNA-specific microRNAs (miR-CATCH); Prof. Jochen Prehn, Royal College of Surgeons in Ireland. Title: Circulating microRNAs in HNF1AMODY carriers: Evaluation as novel biomarkers and therapeutic targets; Dr Eva Szegezdi, NUIG. Title: Development of Ex Vivo Diagnostic Multivariate Index Assay for Prediction of Treatment Efficacy in Acute Leukemias; Prof. Marina Lynch, TCD. Title: Development of a blood-based marker for early detection of cognitive dysfunction; Prof. Robert Forster, DCU. Title: GeneSys: A high sensitivity and selectivity DNA detection platform; Prof. Paul Murphy, NUIG Title: New macrocyclic peptidomimetics with potential in cancer therapy); Prof. Seamas Donnelly, UCD. Title: Development novel anti-inflammatory compounds targeting Macrophage Migration Inhibitory Factor’s (MIF) tautomerase enzymatic activity; Dr Keith Murphy, UCD. Title: Characterisation of a novel biomarker panel for clinical and preclinical neurotherapeutics; Dr Gerard McGlacken, UCC. Title: Optimised detection of key biomarkers of Pseudomonas aeruginosa towards a clinical application; Dr Anne Moore, UCC. Title: Dermal Drug Delivery for Lymphatic Targeting.

The Future for Research The 2013 capital allocation of €156m to SFI will ensure that the current cohort of 3,000 researchers (who collaborate with over 500 companies) and seven large research centres are supported, as part of an overall cohesive plan to return Ireland to economic growth.

For more information about SFI-supported research and details of upcoming calls, go to www.sfi.ie.

Global. DiversiďŹ ed. Transformative.

Alkermes plc is a fully integrated, global biopharmaceutical company that applies its scientiďŹ c expertise and proprietary technologies to develop innovative medicines that improve patient outcomes. Headquartered in Dublin, Ireland, Alkermes has its principal solid oral pharmaceutical development and manufacturing facilities in Athlone. Located on a 40 acre site, capabilities include formulation development, analytical development, tech transfer, product scale-up, product registration and commercial manufacturing.

www.alkermes.com

Award Winner 2012

Pharmaceutical Manufacturing Technology Centre

FUNDING THE FUTURE OF RESEARCH Nessa Fennelly, Senior Executive, Pharmachemical Ireland, reports on the development of the Pharmaceutical Manufacturing Technology Centre and what it means to Ireland.

E

nterprise Ireland and the IDA have approved the funding of a €5m “industry led, industry driven research programme” called the Pharmaceutical Manufacturing Technology Centre (PMTC). The programme was launched in February 2012 and a deadline of June 29 was issued for submissions from academia.

In September 2012, the successful academic submissions were chosen and contracts were signed. In October, industry and academia met to review the overall plan and establish working teams.

Five thematic areas have been prioritised over the five year term of the centre: 1. Advanced rapid micro-biological techniques – IT Tallaght / IT Waterford / UCC; 2. Enabling and control of continuous processing – UCC / CIT / WIT / UL; 3. Soft sensor modelling – UL; 4. API real time release PAT – NUIG / Tyndall / CIT; 5. Pharmaceutical packaging technologies – DIT / UL / IT Tralee.

BECOMING THE SITE OF CHOICE The mission is to have one centre for the sector consisting of FDI’s & SME’s harnessing all of the resources available in the HEIs. A pharmaceutical technology centre will assist Irish pharma and biopharma sites to become or maintain their position as the “site of choice” within their global site portfolio.

The vision of the Pharmaceutical Manufacturing Technology Centre is to support and develop the Irish pharmaceutical industry (small and large molecule) by improving manufacturing competitiveness, enhancing the research and development mandate and activity of Irish pharmaceutical manufacturing sites and companies. The centre will conduct and coordinate research in advanced pharmaceutical manufacturing technologies which have a wide application across the Irish pharmaceutical industry.

RESEARCH FACILITIES The PMTC will assist with coordination and be an easy access point for the Irish pharmaceutical industry to pharma-related research facilities in Ireland, including HEI facilities, Institutes and other research centres.

It will work closely with all Irish research centres and academic institutions to source additional funding for pharmaceutical manufacturing related research, through company specific projects, IDA research funding and EU framework programmes.

It can serve as a one stop shop to showcase advanced pharmaceutical manufacturing expertise and support academic/industry collaboration in relation to advanced pharmaceutical manufacturing technologies and know-how for manufacturing industry and related service providers.

12

ADDRESSING THE CHALLENGES AHEAD The pharma industry in Ireland is under threat due to a number of factors, which include: • • • • •

Expiration of many patents, leading to a significant fall in revenue; A diminished volume emerging from research pipelines to replace the major blockbuster drugs; The erosion of competitiveness, with increasing competition from new low cost overseas locations; The cost of manufacturing in a highly regulated environment; Global consolidation.

To counteract these threats, the PMTC infrastructure will play to Ireland’s key strengths, which include: • A unique concentration of world leading manufacturing; • World class facilities in universities and ITs; • A critical volume of talented PI’s and Post Docs in our HEA facilities; • A good volume of SMEs with an excellent track record; • A strong willingness to work together across companies, academia & Government.

With such an infrastructure, we will best position the Irish (Bio) pharmaceutical industry for the challenges ahead and maximise success for the future.

Bioprocessing

NIBRT: A National Treasure Killian O'Driscoll, Projects Director, National Institute for Bioprocessing Research and Training (NIBRT) explains the unique work of NIBRT.

T

he National Institute for Bioprocessing Research and Training (NIBRT) is a worldclass institute that provides training and research solutions for the bioprocessing industry. Our mission is to support the bioprocessing industry by providing a unique learning experience for trainees in an environment that replicates the most modern industrial bioprocessing facility. In parallel, we also undertake leading edge research in key areas of bioprocessing in collaboration with industry.

NIBRT is based on an innovative collaboration between University College Dublin, Trinity College Dublin, Dublin City University and the Institute of Technology, Sligo. NIBRT was primarily funded by IDA Ireland (Industrial Development Agency), to assist with the attraction and development of biopharma foreign investment in Ireland.

NIBRT offers a quality training and research experience not previously possible anywhere in the world.

PHARMACEUTICAL MANUFACTURING The life sciences manufacturing industry is a critical component of the Irish economy, generating exports of €55 billion in 2011 (50% of national total), €3 billion in taxes and with a total employment of 60,000 (Source: PharmaChemical Ireland: Ireland – the location of choice for scientific investment, 2011). However, this “jewel in the crown” of the Irish economy is facing unprecedented challenges.

The pharmachem sector (“small molecule”), in particular, is under pressure from a diverse range of challenges, including the advent of the “patent cliff”, excess global manufacturing capacity, limited product pipelines, with a consequent modest global growth target of 6% to 2016¹. These challenges have contributed to a period of consolidation and cost optimisation in the industry.

The NIBRT Control Room and Upstream Pilot Plant.

At the same time, there is significant opportunity for growth in the related biopharma sector (“large molecule”). The world market for biopharmaceuticals in 2012 is now greater than $140 billion; growing at 15-18% annually² and by 2016 seven of the top 10 blockbusters drugs will be biopharmaceuticals³.

It is now estimated that 50% of medicines in the global pipeline are derived from biotechnology, with 700 biosimilars/biobetters in the development pipeline⁴. It is predicted that job losses in the traditional small molecule pharmachem sector from 2010-2015 will be offset by job gains in the biopharma sector⁵.

Following extensive consultation with industry and academia, the Irish Government decided to address these challenges and opportunities by establishing NIBRT, which officially opened in Dublin in June 2011.

FACILITIES The NIBRT building is a purpose-built, multi-functional facility which replicates the most modern industrial bioprocessing facilities. Located on the grounds of the UCD Campus, the total building area is approximately 6,500 m². At the heart of the NIBRT building is the bioprocess14

ing pilot plant, consisting of extensive upstream, downstream, fill-finish and the associated analytical facilities. These facilities are all operated in a realistic GMP simulated, operational manufacturing environment.

The facility also provides extensive research laboratory areas with ample capacity for PMTC research teams and for client companies. The labs include the Waters Centre of Innovation, which provide access to the most upto-date analytical equipment as part of NIBRT’s strategic partnership with Waters⁶.

In 2012, the NIBRT facility was awarded the ISPE/Interphex Facility of the Year Award for Novel Collaboration.

This is the international pharmaceutical industry’s premier awards program dedicated to celebrating innovation and accomplishments in facility design, construction, and operation⁷.

TRAINING NIBRT provides a broad range of training and education programs to a wide variety of companies, including Merck Sharp Dohme, Amgen, Lilly, Johnson and Johnson, Pfizer, Elanco, Genzyme, and Allergan. NIBRT training is based on a 5

Bioprocessing

C’s model, where the C’s represent: • Competency-based learning, • Customised courses, • Certified programs, • Continuous professional development • Cost effective.

Working with its academic partners, NIBRT also provides comprehensive education programmes for undergraduates, MSc students and for those who are looking to cross-skill for the biopharma industry.

The NIBRT building is located on the grounds of the UCD campus in Dublin.

RESEARCH NIBRT research is based on a foundation of scientific excellence and is focused on delivering practical solutions to the biopharma industry. Research solutions are tailored to meet specific client requirements. These solutions include contract research, consultancy and collaborative research projects.

Key research themes include: Advanced Manufacturing Competitiveness: This focuses on the development and application of science and technology to improve the quality and efficiency of advanced manufacturing processes and products. It is a broadly defined theme which provides considerable scope for interdisciplinary research to support Irish based industry to develop/win new projects by fostering academic research collaborations.

The theme encompasses future industrial trends to enable Irish based industries to develop pioneering processes and products, as well as attracting foreign direct investment.

By way of example, through its interactions with its pharmaceutical client base, NIBRT has identified the requirement for a critical research mass focused on the development and modification of streamlined mammalian production systems for the realisation of maximum specific productivity and associated quality, in both the traditional innovator and biosimilar production arenas.

A key feature of this program is the relationship between bioengineering, biomaterials, bioanalytics and systems biology multi-omics methodology with process analytical technology and associated ICT supporting platforms for data management, mining and knowledge driven decision making.

Production of Novel Therapeutics: This research theme focuses on devel-

Trainees in the Upstream Pilot Plant at the NIBRT building in Dublin.

oping and aligning the existing research competence in Ireland to build an industry leading position in supporting the development and production of novel therapeutics.

It encompasses targeted research projects from a broad range of life sciences and ICT competencies.

Projects include topics from the development, characterisation, process optimisation, process monitoring and data management required for novel therapeutics.

NIBRT’s strong track record of managing collaborations between industry, academia and Government institutions was recognised in 2012 when NIBRT was awarded the Manufacturing Collaboration of the Decade Award by Bioprocess International.

SUMMARY The National Institute for Bioprocessing Research and Training (NIBRT) is a world-class institute that provides training and research solutions for the bioprocessing industry. Our mission is to support the bioprocessing industry by providing a unique learning experience for trainees in an environment that replicates the most modern industrial 15

bioprocessing facility. In parallel, we also undertake leading edge research in key areas of bioprocessing in collaboration with industry.

References 1. http://files.pharmaventures.com/ api_manufacturing_white_paper. pdf (mainly based on growth in BRIC countries).

2. Rader, R.A., Biopharmaceutical Products in the U.S. and European Markets (database), BioPlan Associates, www.bioplanassociates. com/publications/pub_bpuseu.htm 3. http://www.marketsandmarkets.com/ Market-Reports/biopharmaceutical323.html 4. What Europe has to offer biotech companies? Ernst and Young http:// www.europabio.org 5. http://www.forfas.ie/publication/ search.jsp?ft=/publications/2010/ title,6970,en.php 6. http://www.waters.com/waters/ en_US/Professor-Pauline-Rudd%2CNIBRT%2C-Dublin%2C-Ireland/nav. htm?locale=en_US&cid=134671201 7. http://www.facilityoftheyear.org/home2

BIOTECHNOLOGY

Irish BIOTECH SMEs Lead the Way

I

Michael Gillen, Director, Irish BioIndustry Association, reports on four Irish biotech companies that are at the forefront of innovation.

nnovation continues to flourish amongst biotechnology companies in Ireland and this article will look at some of the advances being made by four indigenous companies.

Innovation at Megazyme Megazyme International is a global leader in the development, manufacture and supply of innovative diagnostic technology for the food, feed, fermentation, dairy, wine and biofuels industries.

Based in Bray, Co. Wicklow, the company employs 34 staff and continues to invest in research to facilitate the development of novel and innovative analytical methods. Some of the new analytical developments include: •

Endo-Cellulase Assay Kit: a novel test method that employs patented technology for the measurement of endo-cellulase activity. EndoCellulase is the most important enzyme in biomass utilisation. This is a simple method to replace traditional, more laborious methods.

•

Fructan Assay Kit: a modification to the standard analytical method for the measurement of fructan has been developed to enable the measurement of “prebiotics” (fructooligosaccharides) in baby formula.

•

Enzymatic Yeast β-Glucan Kit: a novel test method employing highly pure enzymes to measure yeast beta-glucan in feeds. Yeast betaglucan is used in the supplementation of chicken feed to act as an immuno-stimulant, replacing the use of antibiotics.

•

Wine Analysis Test Kits: liquid formulations of co-factors used in Megazyme test kits have been developed to provide extended stability in solution. This provides ease

of use to the “end user”, removing the requirement to aliquot and freeze / thaw co-factor solutions.

Megazyme has applied innovation not only in the conception of new products but also in methodology used in the manufacturing processes. For example, the introduction of a eukaryotic protein expression system at Megazyme has enabled the production of ultra-pure enzymes that would otherwise be unavailable. In conjunction with a purpose built fermentation facility, more enzymes will be produced via this expression system and such enzymes have already been used in novel analytical methods.

Megazyme International Ireland won the Overall SFA National Small Business Award in 2013.

Opsona: leaders in innate immune drug development Opsona Therapeutics is one of Europe's most innovative and dynamic drug development companies. At the forefront of drug development in immunology research, they have consistently validated and developed a series of exciting new drug candidates and strategies which modulate the human innate immune system since their foundation in 2004.

Opsona is a spin-out from Trinity College Dublin. Recognised as key opinion leaders, the founders of the company are Professor Luke O'Neill, Professor Kingston Mills and Professor Dermot Kelleher.

Ireland is ranked one of the leading countries in the field of immunology research, and the three founders have made a number of key discoveries in this area.

The objective of the company is to deliver tomorrow's treatments from today's cutting edge research. They continue to develop a unique and advanced range of drugs to treat and prevent autoimmune and inflammatory diseases, 16

Michael Gillen, Director, Irish BioIndustry Association and Senior Executive, PharmaChemical Ireland.

as well as technology for cancers and infectious diseases. Their lead product, OPN-305, is an antibody to reduce proinflammatory cytokine production. In April of this year, Opsona raised €33m (USD $43m) in oversubscribed Series C equity financing to advance clinical development of this lead product

The participants in this Series C financing include existing investors, Novartis Venture Fund, Fountain Healthcare Partners, Roche Venture Fund and Seroba Kernel Life Sciences.

The new investors joining the consortium are BB Biotech Ventures, Sunstone Capital, Baxter Ventures, Amgen Ventures, and EMBL Ventures. BB Biotech Ventures and Novartis Venture Fund led the Series C financing round.

BB Biotech Ventures, Sunstone Capital and Baxter Ventures will be joining the board of directors.

Opsona is developing new treatments for inflammatory diseases and will use the proceeds to conduct a

BIOTECHNOLOGY

two-part multi-centred, double blinded and placebo controlled clinical study to evaluate the safety, tolerability and efficacy of its lead product OPN-305 in renal transplant patients at high risk of Delayed Graft Function (DGF).

This is the first clinical indication for OPN-305, a fully human monoclonal IgG4 antibody targeting Toll-likereceptor-2 (TLR2).

Opsona recently completed a successful Phase I clinical trial in healthy human volunteers and has also demonstrated activity in preclinical animal models and ex-vivo studies.

This first-in-class inhibitor of TLR2 has the advantage of inhibiting multiple cytokines, leading to the pathogenesis of the complex inflammatory response in various diseases (ischemia/reperfusion injuries, rheumatoid arthritis, diabetes, lupus, nephritis and various cancers) and has, therefore, a potentially broad application potential Luxcel Biosciences – illuminating discovery Luxcel Biosciences was founded in 2002 in Co. Cork, Ireland, to commercialise cutting-edge, porphyrin-based, phosphorescent, oxygen-sensing probes and oxygen sensors, with initial applications targeted at the pharmaceutical, food safety and packaging industries. Their aim is to produce fluorescence and phosphorescence-based tools that will provide direct benefits for customers.

These benefits include increased speed and accuracy, reduced research and development (R&D) costs for manufacturers and safer products for consumers.

In April 2013, Luxcel officially launched their MitoImage™ O2 IMAGING SERIES of real-time Live Cell O2 Imaging Probes at Experimental Biology 2013, Boston. These new cellpenetrating Nanoparticle Formulations, MitoImage™ MM2, MitoImage™ NanO2 and MitoImage™ NanO2 IR, are configured for use on Standard Fluorescent Microscopes (wide field, confocal and two-photon), and are ideal for O2 localisation and quantitation, in-vitro, in-vivo and for 3D culture.

In conjunction with academic partners from the Department of Obstetrics & Gynaecology, University of Oxford, Luxcel Biosciences also presented a paper entitled, ‘Monitoring the interplay between oxygen availability and metabolism in tumour biology’ at the Boston Conference.

IdentiGEN – leaders in DNA-based solutions IdentiGEN is a leading provider of DNA-based solutions to the agri-food industry, currently operating in Ireland, UK, USA and Canada. They apply their core expertise in genetic identification to develop and market a range of products designed to improve the safety, quality and integrity of the food supply.

Their principal product, DNA TraceBack®, provides food retailers, processors and producers with the capability to identify and trace the source of meat products through the entire supply chain.

IdentiGEN was founded in 1996 as a spin-out from world class research conducted at Trinity College Dublin. The founders, including Professor Paddy Cunningham, were a team of scientists from the Institute of Genetics, Trinity College Dublin, respected worldwide for their contributions to the field of livestock population and quantitative genetics. IdentiGEN’s incorporation in Ireland in 1996 was coincident with the UK’s BSE (or “mad cow” disease) crisis. The company’s founders were among the first to apply molecular genetic techniques to sourceverify meat products.

Acquiring enabling technology from Trinity College Dublin, IdentiGEN pursued the technology further, into proof-of-concept testing and commercial deployment. The company pioneered the commercial-scale integration of sophisticated genetic technologies with industrial-scale meat processing and retailing. IdentiGEN became the first company anywhere to deliver and implement an operational and scalable DNA traceability solution for 100% of the fresh beef distributed by a national food retailer, and the first anywhere to leverage this technology into consumer markets.

17

IdentiGEN is a leading provider of DNA-based solutions to the agri-food industry, currently operating in Ireland, UK, USA and Canada.

Today, technology innovation is key to driving breakthroughs in the agri-food business sector. IdentiGEN is committed to technology innovation, and the company’s core genetic analysis technology is protected by a number of patents developed internally or through exclusive world-wide licenses from its technology development partners. Their intellectual property strategy blends focused internal R&D efforts and the strategic in-sourcing of intellectual property rights that can help support future growth.

The company maintains its focus on the growing international demand for greater integrity in the food chain. The next generation of products being developed by IdentiGEN will harness the potential of the expanding repository of data on the genetics and performance traits of livestock to deliver high-value management systems, enabling customers to maximise the quality, nutrition content and economic value of their food products.

CONCLUSION These four companies are representative of the biotechnologies being commercialised in Ireland. In the past, we have spoken of the need to develop businesses in a sustainable manner that will drive Ireland forward towards its economic, environmental and social goals. The indigenous companies are representative of those businesses that will continue to ensure that Ireland is well positioned to be at the centre of this innovative, knowledge-based and sustainable economy.

REACH DIRECTIVE

Authorisation – the ‘A’ in REACH Irish PharmaChem companies using certain hazardous substances must act now or face disruption to their supply chains, as the REACH Regulation now requires a licence for the supply and use of certain substances, writes Dr Majella Cosgrave, Manager of the HSA’s Chemicals Helpdesk.

U

nder the REACH Regulation, the supply and use of some hazardous substances is now subject to a licensing system, in a process known as authorisation.

Once a substance is included on the ‘authorisation list’, then companies must apply to the European Chemicals Agency (ECHA) to continue to use it.

Under the process, the use of a substance can continue once the risks associated with it are adequately controlled, or the socio-economic benefits of the use of the substance outweigh the risks, and an authorisation has been granted to the user.

Authorisation List Substances are subject to authorisation once they are included on the authorisation list, also known as Annex XIV of REACH. Before a substance can be added to the authorisation list, it must firstly be identified as a substance of very high concern (SVHC) (e.g.

CMRs, PBTs, ‘substances of equivalent concern’ e.g. endocrine disruptors) and included on ECHA’s candidate list.

Periodically, ECHA examines substances on the candidate list and

recommends some of them for inclusion in the authorisation list, if they meet certain criteria. This recommendation of ECHA is subject to a three-month public consultation, during which stakeholders can submit comments. The final decision on inclusion of a substance in the authorisation list is taken by the European Commission, in collaboration with the member states. This means that the list is added to on a regular basis (currently yearly) and companies are recommended to check it regularly for updates. Both the candidate list and the up-to-date authorisation list can be found on ECHA’s website, www.echa.europa.eu.

Latest application dates and sunset dates Within the authorisation list, there are two dates specified for each substance: •

The sunset date is the date after which the placing on the market and the use of a substance is prohibited unless an authorisation is granted to the user; • The latest application date (LAD) is the date by which the authorisation application must be received by ECHA if the applicant wishes to continue to use the substance beyond the sunset date.

To ensure timely processing of the applications and to manage the workload, ECHA has Chemical suppliers should consider whether a substance on the established specific authorisation list can be substituted with a less hazardous one. submission windows for substances with 18

Majella Cosgrave, Manager of the HSA’s Chemicals Helpdesk.

the same LADs and these submissions dates can be found on ECHA’s website.

Advice for suppliers • Consider whether a substance on the authorisation list can be substituted with a less hazardous one; • If not, then consider whether to apply for an authorisation to cover your own use and uses in your supply chain (this will also apply to companies manufacturing or importing for their own use).

Advice for Downstream users • Consider if you can use a different substance to the one that is on the authorisation list; • If this is not possible, then an authorisation must be in place for

TEVA PHARMACEUTICALS IRELAND, WATERFORD, IRELAND

Teva’s Respiratory Centre of Excellence R&D and Operations in Partnership +353 51 331331 email: jane.obrien@teva.ie

REACH DIRECTIVE

Under the REACH Regulation, the supply and use of some hazardous substances is now subject to a licensing system, in a process known as authorisation.

• •

• •

•

your specific use; Speak to your supplier to find out if he intends to apply for an authorisation and if he will cover your use; Provide information to your supplier so your use can be covered in his application; If your current supplier does not intend to apply for an authorisation, or will not cover your specific use, then try to find an alternative supplier willing to do it; Alternatively, consider submitting your own application, which would allow a company immediately above you in the supply chain to supply you with the substance (without the supplier needing to have an authorisation in place himself).

The consequences Many Irish business sectors are potentially affected by this system, and this includes the PharmaChem sector.

The application process is likely to require the investment of considerable time and resources and this, combined with the overall uncertainty of a new system, should make companies consider if this is the best course of action for them, or whether an alternative chemical or process is more suitable than the authorisation process.

However, it needs to be remembered that authorisation is not a ban on a substance: it is a licensing system to allow the continued use of certain hazardous chemicals, where their use needs to continue as there is no alternative available and where the control of risk can be demonstrated.

It is recognised that for some activities within the pharmaceutical manufacturing business, it is very difficult to substitute a substance within

a process for a different one. Therefore, Irish PharmaChem companies using critical substances that are on the candidate list and therefore, likely to make it into the authorisation list (e.g. a number of aprotic solvents) should now plan for authorisation.

The authorisation application An authorisation application is significant, and companies should refer to the ECHA website for details of what needs to be in it and how to prepare it. In brief, the application will need to specify: •

The use(s) for which authorisation is sought; • A chemical safety report (CSR) covering the risks related to the properties that led to identification as an SVHC (unless already submitted as part of a registration dossier by the applicant); • An assessment of alternatives; • A substitution plan, if the conclusion is that there is a feasible alternative; • For the socio-economic route, a socio economic analysis, along with information that there are no alternatives available.

There is a fee for each application for authorisation. The size of the fee will depend on a number of factors, including whether the submitting company is an SME (reduced fees) and the number of uses, substance and applicants covered by the application.

Companies can use ECHA’s Fee Calculator, which is available on ECHA’s website, to estimate the fee before submission.

Granting of authorisations Companies must submit their authorisation applications to ECHA. Decisions on whether to grant the 20

About the Author Dr Majella Cosgrave is a senior inspector with the Health and Safety Authority, where she has worked for the past 13 years.

During that time, she has been involved in the enforcement of chemicals legislation in Ireland and in the development of EU chemicals policy through her involvement in various EU committees.

She was heavily involved in the implementation of the EU REACH Regulation in Ireland.

Presently, she works within the Chemicals Business Services Division of the HSA, with responsibility in areas such as the identification and evaluation of hazardous chemicals.

Dr Cosgrave manages the Chemicals Helpdesk within the Authority, a service set up to assist Irish companies to meet their regulatory obligations. She works closely with the European Chemicals Agency (ECHA) and is Ireland’s representative on ECHA’s Member State Committee.

authorisation or not will be taken by the European Commission, and agreed

by Member States, and will take into account opinions from ECHA’s Risk Assessment Committee (RAC) and Socio-Economic Committee (SEAC).

The ECHA website contains information on applications for authorisation in a dedicated support section.

In addition, companies intending to submit an application can request a pre-submission information session with an ECHA representative, which will allow them to ask casespecific questions regarding the regulatory and procedural aspects of the process. Pre-submission information sessions should be held the latest about six months before the submission of the application.

Companies with specific questions or concerns should contact the HSA’s Chemicals Helpdesk by email: chemicals@hsa.ie or by calling 1890 289389.

UTILITIES MANAGEMENT

DALKIA: THE ENERGY EXPERTS

D

alkia is the number one energy and utilities management expert for pharmaceuticals in Ireland. A multinational company that operates in over 35 countries throughout the world, Dalkia turns over â‚Ź8 billion annually. One of the major hallmarks in Ireland for the company has been the development of their combined heat-and-power plant (CHP) offering.

Indeed, there are a number of CHP plants installed in the country that Dalkia not only designed, built, and operate, but also helped to finance, allowing clients to benefit significantly from reduced energy costs by controlling their own consumption on-site.

They also tailor-make energy management contracts for clients on the utilities side. Dalkia provide guarantees on conversion efficiency and distribu-

tion efficiency for various utilities, and in some cases, even forecast usage: they guarantee that they can reduce levels in these categories.

Dalkia make commitments to their partners for the long-term. They give firm commitments not just on energy, but also on availability and reliability, with great emphasis placed on quality and safety.

UNDERSTANDING THE CLIENT “It is important in every sector, particularly pharmaceuticals, that we understand the way the client operates,� notes Colm Flanagan, Commercial Director. “We have to understand standards like GMP, GDP, and GLP. Integrating our company into the client’s management systems, and yet still being responsible for our delivery, is a very important

aspect of servicing the pharmaceutical market. We fully recognise that we need to be a part of the plant solution.�

So what makes Dalkia a partner of choice? “First of all, our ability to deliver, which is second to none, as is our competence in the area of energy.

Our third competitive advantage is our ability to automate,� says Flanagan. “This area is another emerging trend in the industry that is making things quite interesting.�

For more information, see www.dalkia.ie, email info@dalkia.ie or call Colm Flanagan, Commercial Director at 01 8701200.

Creating Utilities & Energy Progress Expert energy services for Pharmaceutical industries ‡

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21

packaging solutions

SteriPack Drives Pharma Packaging Growth SteriPack’s facility in Malaysia ensures that the group can offer state of the art blister packaging services all over the globe.

S

teriPack is a worldwide packaging solutions provider, serving the medical device and pharmaceutical industries. Since its foundation in 1994, the company has invested significantly by building its processes and quality systems to extremely high standards throughout its facilities located in Ireland, Poland, Malaysia, and the US.

In recent times, SteriPack’s facility in Asia has specialised in pharmaceutical opportunities, with pharma now accounting for 50% of its business exports to over 52 countries. The facility, which is located in Klang, Selangor, Malaysia, has been extended in recent months, expanding its pharmaceutical packaging services within its new purpose built cGMP compliant Grade D facility, assisting pharmaceutical and allied healthcare companies who require outsourced blister packaging services.

COST REDUCTION “Companies from the pharmaceutical and healthcare sector have to comply with very strict safety rules,” explains John Ward, Managing Director SteriPack Malaysia. “As well as ensuring the best protection of the drugs and allowing full traceability, the contribution of the packaging to greater efficiency and cost reduction has become a major factor.”

The SteriPack Malaysia MD believes that “the days of air freighting finished product all over the world are starting to end”. This is where SteriPack have a huge advantage: “The ability to be able to offer state of the art packing facilities in Asia is a major attraction for our global customers.”

For SteriPack, demand for

Blister Contract Packaging continues to grow amongst their pharmaceutical client base. “We have plans to expand our pharmaceutical packaging service offerings in 2013 to allow for bulk bottle filling, powder filling and liquid filling, all within a cGMP environment,” Ward notes. “This extra facility will be fully operational by January 2014.”

SteriPack also provide a wide range of cleanroom manufactured barrier foil packaging solutions to the pharmaceutical industry. SteriPack’s focus is to provide customers with a responsive, can-do attitude to almost any pharmaceutical packaging request.

COMPANY HISTORY SteriPack are recognised globally as an industry leader in providing medical packaging solutions and contract services. Since its inception 19 years ago, the group has grown steadily, with manufacturing facilities now located in Ireland, Poland, Malaysia and the USA.

Their ISO Class 8 cleanroom production facilities house all manufacturing capabilities, ensuring that SteriPack remain at the very highest levels of quality and service at all times.

SteriPack prides itself on its commitment towards: • working with dedication and innovation, with total focus on the customer; • integrity, honesty and sincerity by following ethical and moral standards; • promoting a work culture that provides individual growth, team spirit and creativity to overcome challenges and attain goals;

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John Ward, Managing Director SteriPack Malaysia.

•

achieving growth along with their customers, staff and suppliers.

The group’s head office is located in Clara, Co. Offaly, while the US business, specialising in flexible medical packaging and contract manufacturing service solutions, is based in Lakeland, Florida.

SteriPack Poland was established in 2006 to serve customers in central and eastern Europe. Specialising in contract manufacturing services, the company is located in Jelcz-Laskowice, Poland. SteriPack Asia was established in 2008 and operates a 8,500 square metre facility in Malaysia.

For more information, please email info@steripackgroup.com or visit www.steripackgroup.com.

RISK IDENTIFICATION

The High Cost of Human Error Ann McGee, MD of McGee Pharma International, advises on how to reduce the human error count and sustain error reduction in your business.

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uman error frequently occurs in pharmaceutical manufacturing, even when the organisation considers that they have done everything to prevent its occurrence. Documentation appears accurate, personnel are fully trained and equipment operates as designed; but errors continue to be made. In many organisations, ‘Human Error’ is assigned as the root cause of the event, with reasons assigned such as ‘Lack of Attention to Detail’ or ‘Failure to Follow Procedure'. Corrective action will involve re-training or disciplinary action. Such approaches do not seek to understand why the error(s) occurred and they certainly cannot be expected to prevent re-occurrence.

In this article, we look at the common causes of human error in pharmaceutical manufacturing and outline an approach to reducing these errors, with an objective to offer you an insight into the common causes of human error in the area of pharmaceutical manufacturing and to provide you with a defined approach to investigating risk influencing factors and root cause, reducing human error and sustaining error reduction within your own company.

DEFINING HUMAN ERROR So what is human error and why is its impact so important for pharmaceutical manufacture?

An ‘error' is a deviation from accuracy or correctness. ‘Human Error’ is a mistake made by a person rather

than a machine (Source: Oxford English Dictionary).

According to Dr Kevin O’Donnell, IMB, Dec 2009, “Human Error is frequently cited as a primary cause of Quality Defect issues that have led to batch recalls”.

Indeed, as highlighted by Kevin O’Donnell at the Pharmachem Skillsnet & PharmaChemical Ireland Conference in Cork, on December 2, 2009, the Irish Medicines Board has reported that 25% of all Quality Defects, such as deviations, laboratory errors, complaints and inspection issues, are attributed to human error, e.g.

• Failing to follow procedures correctly; • Using technical dossiers to support batch release that do not correctly reflect the contents of the Marketing Authorisation (MA); • Poor line clearance, resulting in rogues being left on a processing line; • Failing to implement Variations following their approval by the Competent Authority.

In the same presentation, O’Donnell also outlined that the IMB has reported that 90% of recalls relating to

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packaging and labelling are attributed to human error and that quality defects are often attributed to human error without scientific evidence.

John Evans, Managing Director, HEB, and leading expert on human error, identifies two main types of Risk Influencing Factors (RIFs) for human error. These are Stressor RIF’s (pressure causing a feeling of stress) and Structural RIFs (inherent weakness in activity). RIFs can be grouped into ‘families’ of issues that might affect the risk of Human Error e.g. Process, Information, Resource, Competence, Organisation, Stressors (PIRCOS).

Stressor RIFs increase the probability of human error. They are often temporary but may re-occur, i.e. if they are caused by fatigue or very tight work deadlines, and therefore, are subjective, as they depend on the person within the team making an error. They do, however, also expose structural vulnerability of activity, which will need further investigation.

Structural RIFs are relatively persistent in nature but are not often immediately obvious, unless triggered by stressors. Structural RIFs occur across a company and can be caused in

RISK IDENTIFICATION

About the Author

Ann McGee, Managing Director, McGee Pharma International, has over 30 years work experience, divided between the pharmaceutical industry, as a regulator and a Pharmaceutical Consultant. Ann’s industrial experience spans the areas of Clinical Trials, Regulatory Affairs, Product Development, Compliance, Technical Management and as a Qualified Person.

As a regulator, Ann worked as a Senior Inspector with the Irish Medicines Board and inspected nationally and internationally on behalf of the EMEA for GxP compliance. Ann also acted as Registrar and Secretary (CEO) of the Pharmaceutical Society of Ireland, the statutory body governing the profession of pharmacy in Ireland.

Ann was a winner in the Services category, Small Firms Association National Awards 2013, as well as being named the Enterprise Ireland Women Means Business Female Entrepreneur of the Year 2012. any one of a number of areas: for example, processes where several concurrent activities are competing for attention; information giving (poor layout of batch manufacturing record); resource characteristics such as environmental conditions causing distraction; organisational planning, including when shift arrangements undermine vigilance.

It is important that realistic demands are placed on employees as work overload/concurrent conduct of tasks leads to mistakes. Other factors to take into consideration when identifying RIFs include an individual’s physical and mental capacity and the effect of sleep deprivation/stress/emotional upset.

Leadership & Team Work To ensure a true understanding of human error and its contributory factors, a strategic approach should be taken. It is extremely important to create aware-

ness and understanding of risks in your organisation by analysing your processes and understanding your human error risks.

To do this, we recommend you apply a QRM (Quality Risk Management) approach (Risk Assessment, Risk Control, Risk, Review, Risk Communication) that includes routine tracking, evaluation and analysis of human error metrics.

While it is advisable to proactively assess potential risks, situations occur where retrospective analysis is necessary. We outline below key activities that should be undertaken in each situation.

RISK IDENTIFICATION For prospective Risk Identification, you will need to identify ‘How & Where’ in the process human error is likely to occur through the use of a Scientific Approach: • Review process flow and information flow; • Identify the RIFs; • Identify the issues with which RIFs are commonly associated (PIRCOS); • Plan your processes to minimise and control these risks.

For retrospective analysis, you will need to capture the event in real time, taking note of environmental and other factors that may be relevant to a thorough evaluation of the issue. You will also need to consider the level of the RIF effect: 1. Individual - affects single individual; 2. Local - within limited physical area, relevant to specific activity, affects finite number of people; 3. Generic - common - risks shared across numerous instances of a common problem (e.g. mis-read a table in a document used widely in the company) or independent – several risks in different parts of organisation (e.g. mis-read typeface used in numerous documents only used locally).

Then you should analyse whether your non-compliances associated with human error can provide further insight (e.g. from QMS, Deviations and Complaints Management System, CAPA).

There are a number of Root Cause Analysis (RCA) Tools/ Techniques that can be used such as brainstorming sessions; fishbone diagram; five whys and fault tree analysis.

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enhancing human reliability In order to design and manage your operations with human error in mind, an open communication environment is essential. It is important to include the following key factors to support all of the team to achieve a reduction in human error: •

Don’t assume the cause of a Quality Defect is human error!

• Shift from a retrospective and superficial evaluation of human error to a prospective risk based evaluation of your critical processes and procedures.

• Investigate and identify true contributory causes: - Use a team based approach.

- Use a science based approach.

• Motivate your people to embrace human error identification through recognition and support.

• Be aware of limitations: risk factors can be outside of conscious control.

• Create an atmosphere of accountability by displacement of blame.

• Give and take feedback.

• Empower personnel to address their own RIFs. • Continuous Improvement process: - Involve staff at all levels; - Introduce a core risk reduction team who develop body of knowledge.

• Support innovation and understanding.

In summary, be clear as to what constitutes human error. Use a risk based approach to identify the RIFs for your critical processes and design to minimise human error potential. Apply a QRM approach to sustaining low levels of human error and to promoting a working environment that supports a proactive approach to minimising the potential for human error.

references

Human Error & Re-training – Issues to consider during deviation and complaint investigations Kevin O’Donnell Ph.D., Market Compliance Manager, Irish Medicines Board (December 2009) Human Error Seminar

By Ann McGee and John Evans (May 2010)

HAZARDOUS CHEMICALS

PROTECTING YOUR INVESTMENT Barbara Nolan, Head of the European Commission Representation in Dublin, explains how better protection of workers against exposure to hazardous chemicals is good not just for workers, but for companies and society at large.

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very day, millions of EU workers are potentially exposed to hazardous chemicals in a wide range of employment sectors, including manufacturing and service industries, agriculture, health care and education.

Hazardous chemicals are substances which may be as simple as cleaning fluids, containing elements that might harm health.

Although not all accidents in work are related to chemicals, data shows that around 6.9m workers have had an accident at work and approximately 23m are dealing with a work-related health-problem (EU-27, data from 2007, Eurostat, 2010). With the EU’s proposal of February 2013 to improve the classification, labelling and packaging of chemicals, workers would be better informed about the risks, and employers would be better equipped to protect their workers' health.

Levels of accidents at work are at a historically low level, thanks to the EU’s occupational safety and health policy, but there is a continuous need to improve the workplace environment by investing more in the prevention of accidents, diseases and ill health. New

challenges are constantly arising which need to be tackled.

COUNTING THE COST The economic cost of work-related accidents and diseases to industry and society in general is enormous.

We all have an interest in reducing that cost to a minimum by applying effective preventive policy.

Investing more in preventing accidents and disease in the workplace helps improve a firm’s economic performance and bolsters the sustainability of our social security systems. A report published by the Department of Enterprise, Trade and Employment in 2006 suggests that the cost to the Irish economy could be between €3.3 and €3.6 billion per year.

Of course, it is not just a question of reducing costs. Better health and safety also contributes to company performance by improving staff well-being, reducing absenteeism and staff turnover, and improving job satisfaction. There is no doubt that a good working environment is a big factor in competitiveness and can play a crucial role in increasing the workforce’s potential.

IDENTIFYING CORE PROPERTIES One of the ways the EU is trying to make the workplace safer is through EU law which requires manufacturers and suppliers of chemical substances and mixtures to identify the core properties

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of the substances.

For example, if you work in a dry cleaners and the cleaning agent that you are using to remove marks from clothing is likely to burn your hands if you touch it, because of the addition of a certain ingredients, this information must be clearly communicated. This can be via the packaging label or safety data sheets, which will inform users of the possible risks that may arise from the use of the substance.

Employers then use this information when carrying out workplace risk assessments. This allows them to put in place appropriate risk management measures to protect you and other workers' health and safety, such as process enclosure, ventilation systems and the use of personal protective equipment.

Improving working conditions is obviously good for workers, but good health and safety at work is also good for companies, for our social welfare systems and for society as a whole.

Good health is good business – for everyone.

For more information, see the European Chemical Agency at http://echa.europa.eu, or check out the European Commission press release at http://europa.eu/rapid/ press-release_IP-13-158_en.htm.

Questions about how the EU protects workers or other EU policy areas?

Check out our website: www.euireland.ie

Or drop in and visit us here; European Commission Representation in Ireland European Union House, 18 Dawson Street, Dublin 2 E-mail: eu-ie-info-request@ec.europa.eu www.facebook.com/EUIreland www.twitter.com/eurireland For up to date information on how the EU is working in the area of Employment, Social Affairs and Inclusion; http://ec.europa.eu/social/home

COVER STORY

SOURCING YOUR ANALYTICAL QC SOLUTIONS Eurofins Lancaster Laboratories have over 20 years' experience in offering out-sourced or in-sourced QC testing personnel to Global Pharma and Biopharma companies.

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n recent years, the impact of the global economy, emerging lower cost market players, patent cliffs and post-merger rationalisation have heightened the need for increasingly flexible operating models within biopharmaceutical commercialisation and supply chain activities.

Representatives of the global industry in Ireland have led the way in terms of reform and functional flexibility as they compete with their global counterparts for a long term role in corporate strategy. With their cultural affinity with the US, tax structures and an educational system supporting an already established investment footprint within the global drug supply chain, Ireland is again reasserting itself as the market to support high value manufacturing operations.

However, global organisations increasingly take a more risk based approach to resourcing activities, which are dependent on future product development and commercialisation.

CONTRACT SERVICE ORGANISATIONS Contract service organisations are evolving to meet these needs by allowing access to scientific expertise and capacity without long term commitment to fixed costs, either in terms of additional permanent headcount or capital investment.

GMP QC testing operations have been an operational area that has undergone change from traditional internally resourced models to those which utilise external outsourced service providers, or utilise in-sourced skilled headcount through contingent workforce solutions.

The context of the use of these variable cost model solutions varies but are all largely driven by the increased pressures of operational facilities within large biopharma to achieve ever greater

Eurofins Lancaster Laboratories have over 20 years’ experience in making a long lasting positive impact on their clients’ testing operations.

levels of responsiveness and therefore, competitiveness to meet the needs of their global organisations and supply chains.

Eurofins Lancaster Laboratories has developed a number of variable cost service models to enhance their clients’ performance within the analytical QC space. Historically, the most commonly used approach has been ‘Fee For Service’ procurement of analytical testing. Specific tests or testing based projects like method validations or stability studies are undertaken.

Samples are sent to the contractor site and results reported within pre-agreed timelines.

FULL TIME EQUIVALENT When the duration and complexity of projects increase, it can be more operationally and cost effective to adopt an FTE (Full Time Equivalent) approach.

This model involves the utilisation of a number of analysts to undertake a program of work over several weeks or months. A scope of work will be determined and an appropriate number of FTEs assigned to that work. Workload is reviewed periodically and resource allo28

cation is adjusted accordingly.

Large method remediation and validation projects are often well suited to this service model. The flexibility of having resource dedicated to a project enables changes in scope to be easily and quickly accommodated. A high level of familiarity with client methods and individual reporting requirements is achieved quickly. The purchase order/ invoicing commercial interface is also greatly simplified and all these factors achieve a reduced level of management resource on the client side.

Professional Scientific Staffing Often, work must be performed within the client facility and quality system.

In these instances Eurofins Lancaster Laboratories deploy their Professional Scientific Staffing (PSS) service model.

This involves agreeing a scope of work within the client’s environment, often in a dedicated area of the facility. Technical staff are selected and trained before initiating laboratory testing activities at the client location. The model offers more compressed start-up times, compared to their clients sourcing temporary

COVER STORY

contract staff and Eurofins Lancaster Laboratories’ track record demonstrates that the stability and technical expertise realised allows them to achieve higher levels of performance. Alignment of an objective metrics-led performance and continual improvement process with the needs of the client is a critical success factor. This enables effective ongoing dialogue, in addition to the execution of the technical scope of work.

“As the work is undertaken within the client’s facilities, the model can be very cost effective compared to other outsourced models,” explains Mark Glass, Business Development Director at Eurofins Lancaster Laboratories.

PSS uses a site-led approach, where a team leader is installed to be the client’s point of contact for all operational, quality and service discussions.

This means that Eurofins Lancaster Laboratories’ team members are clearly dedicated to the project activities and mitigates restrictions imposed by some employment law. As Eurofins Lancaster Laboratories’ staff are full-time, permanent employees, they can access a wide range of career development opportunities, both within the client teams and at their own facilities.

As a dedicated laboratory service company, all employees can pursue careers not only in laboratory operations, but also project management, quality and business development, amongst others. Eurofins Lancaster Laboratories work for hundreds of companies globally, so the technical experience their staff can be exposed to is extremely varied. Often, training and development will involve secondments to other locations.

Changing marketplace Jon S. Kauffman PhD has worked for Eurofins Lancaster Laboratories for over 20 years and is currently leading the laboratory located in Dungarvan, Co. Waterford. He sees the change within the market place positively.

“Market dynamics have changed in recent years,” he explains.

“Companies strive to be flexible and Eurofins Lancaster Laboratories have developed these service models to meet those needs. What we have also created is an exciting environment for our employees.

“We see a closer relationship merging between central development functions, often based in the US and our manufacturing facilities in Ireland,”

he continues.

“These sites are being asked to take products in development and scale up the manufacturing process earlier in the development process than previously. They need to be able to react to these variable demands, and Eurofins Lancaster Laboratories has developed a number of Eurofins Lancaster variable cost service models to enhance their clients’ performance Laboratories can within the analytical QC space. support many aspects of these powerful facilitating tool and allows commercialisation projects, such as their clients to operate in a similar way process validation support, release to dealing with their own QC and LIMS and stability studies. They are also environment. “We are very proud of Lab approaching risk assessment and conAccess. The challenge has been getting tinuity of supply more comprehensively. our clients to utilise all the functionality!”

This involves establishing testing capaGlass smiles. bilities to serve as back-up, should any interruption to internal testing operations occur and ensuring they can accommodate peaks in demand.”

MAKING A POSITIVE IMPACT With industry-wide headcount restrictions, organisations often want to refocus their internal headcount on high value activities, often relating to proprietary methods. In those instances, Eurofins Lancaster Laboratories are deployed to absorb more routine monographed testing activities or less technical activities, such as water and environmental sample analysis. Eurofins Lancaster Laboratories have over 20 years’ experience in these areas and often make a long lasting positive impact on their clients’ testing operations.

Eurofins Lancaster Laboratories invest not only in laboratory technology and capacity, but also in the ability to interact with their clients effectively. “We have the expertise and tools to understand and meet clients’ needs and expectations, and also make our service to clients as seamless as possible,” reveals Mark Glass. “Outsourcing will take up resources on both sides if the communication tools and experience are not in place to manage the relationship between the two organisations.”

LAB ACCESS SYSTEM Eurofins Lancaster Laboratories’ Lab Access system allows 24/7 web based access to all raw data, results, operational and commercial information relating to their clients’ projects. This is a 29

As Eurofins Lancaster Laboratories’ staff are full-time, permanent employees, they can access a wide range of career development opportunities, both within the client teams and at their own facilities.

“Our staff have real industry experience,” he concludes. “Understanding the client context is crucial, so we can design the right approach to meet their needs. Our client facing teams combine project management expertise with a technical science background, developed in industry. This allows us to consult, be that on how to design a method validation protocol or support our clients’ on site EM activities, It’s all about understanding our clients’ needs.”

To learn more about Eurofins Lancaster Laboratories service models, contact Mark Glass. Email: mglass@LancasterLabs.com Tel: 058 48300 Web: www.LancasterLabsPharma.com

IDA IRELAND

IRELAND’S ALLURE CONTINUES

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Ireland remains a key location for life sciences investments, and with very good reason, writes Antoinette Tyrrell, IDA Ireland.

reland has made its mark on the global life sciences stage as a result of its commitment to a robust science, technology and innovation strategy.

Significant investments in both attracting the life sciences industry to the country and growing its existing resources have resulted in an economy that supports innovation and scientific advancement.

Despite a difficult economic environment, Ireland’s exports have shown significant resilience; Ireland’s pharmaceutical sector plays a significant part in this.

The pharmaceutical industry in Ireland consists of approximately 120 companies, employing some 24,500 people directly and a further 24,000-plus people indirectly. The sector generates circa. €55 billion in exports;Ireland is home to nine of the top 10 pharmaceutical companies in the world; and is the eighth largest producer of pharmaceuticals in the world.

Pharmaceutical companies with key operations in Ireland include Novartis, Abbott, Sanofi, Johnson & Johnson, Lilly, Merck, Allergen, Genzyme and GSK. YOUNG, SKILLED WORKFORCE One of Ireland’s key advantages is its young, skilled and educated workforce.

Some 50% of the population is under 35 years of age and the shared population of 25-34 year-olds in Ireland with a thirdlevel qualification is higher than in the US or the UK and above the OECD average.

Ireland’s favourable employee demographic will continue for the foreseeable future, especially with a high birth and replacement rate over the past decade.

Because developing and maintaining a skilled life sciences workforce is a major priority for the Government, companies establishing roots in Ireland can count on long-term commitment and an increasingly talented workforce who are innovative and adaptable. Ireland’s competitive position has greatly improved

since the start of the global economic down-turn, with steep falls in operating costs in construction, energy, utilities and consistent falls in wage costs in the economy.

BUSINESS FRIENDLY ENVIRONMENT Companies investing in Ireland recognise its business friendly environment, with strong Ireland is now the number one location outside the US for significant pharmaceutical and development and manufacturing in Biologics. biotechnology expertise. Government policy designed to deliver a substantial trained makers and enterprise agencies work workforce with the highest levels of skills closely together to ensure that Ireland across the spectrum of bioprocessing provides for the requirements of potential activity to local industry. Ireland’s efforts overseas investors. Ireland’s universal are paying off, as it is now the number corporate tax rate of 12.5% is highly one location outside the US for significompetitive and integrated in internationcant development and manufacturing in al tax agreements across the world. This Biologics. favourable economic and fiscal environment is highly supportive of the pharmaIDA SUPPORT ceutical sector, with one of the strongest Ireland’s efforts to build a strong acainfrastructures supporting intellectual demic foundation in science and its property development and management, encouragement of strong business and as well as state funded 25% tax credit on academic collaborations have made eligible R&D spending.

Ireland a global competitor for invest Ireland also has a strong comment from multinational companies. mitment to Research, Development and Ireland’s dynamic RD&I sector is driven Innovation (RD&I) funding. The Irish by an exceptional level of collaboration Government provides funding and supbetween industry, academia, government port to fuel innovation across industry, agencies and regulatory authorities. research and education, comprising a

For companies wishing to locate commitment to €8 billion investment that in Ireland, IDA Ireland is available to prois doubling the number of PhD graduates vide support, and is particularly supportand supporting greater commercialisaive of companies that focus on research tion of ideas, increasing translational and development, high end manufacturresearch activity and supporting entering and global service activities. With a prise R&D. For example, recognising that pro-business environment, a robust R&D biopharma is restricted by skills shortculture, supportive government and a ages and technical bio-processing chalyoung educated workforce, Ireland is lenges worldwide, the Irish Government well-positioned to support the life sciencestablished a National Bioprocessing es industry, whether it is a development Research, Education, Training and stage life sciences business or a leading Service Institute (NIBRT). NIBRT is multinational company.

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Telephone +353-1 603 4000

Email: idaireland@ida.ie

IDA IRELAND Wilton Park House Wilton Place, DUBLIN 2

Website: www.idaireland.com @IDAIRELAND

www.linkedin.com/company/ida-ireland

PRODUCT IDENTIFICATION

GS1: 40 YEARS OF SETTING STANDARDS

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For 40 years, GS1 has been bringing industries together to revolutionise the way they do business.

n 1973, industry leaders came together to select a single standard for product identification – the barcode. What started as a way to speed grocery store checkout has become the global language of business – a common way for trading partners around the world to identify, capture, and share information about products, locations and more.

Today, GS1 is helping diverse industries drive efficiency, safety and growth through the adoption and use of standards. From retail to healthcare to fresh foods to foodservice to transportation, GS1 Standards continue to transform our lives.

Preventing medical errors, enabling traceability and recall and combating counterfeiting are top-of-mind concerns facing the healthcare sector, and GS1 standards are helping to solve these issues.

GS1 Ireland has been working with the Irish healthcare sector for a number of years with the primary aim being to “drive the adoption of supply chain solutions in the healthcare sector based on GS1 standards in order to reduce both risk and costs”.

The key benefits in adopting GS1 standards for healthcare can be summarised as follows:

SUPPLY CHAIN ACCURACY Healthcare systems around the globe are facing challenges that affect the entire supply chain. The entire sector is concerned primarily with two main issues: patient safety and greater supply chain efficiency and accuracy. The facility to identify things uniquely and accurately is essential, be it a medication, an item of clinical equipment or even a patient. The regulatory landscape continues to evolve in healthcare globally. New regulations in the EU, the US and elsewhere will have a major direct impact on the healthcare supply chain.

Use of GS1 standards enables traceability and promotes a safe and secure supply chain by providing greater visibility, accuracy and efficiency for the benefit of all parties involved.

• • • • • • • • • • •

Improving patient safety; Lowering costs through increased efficiency; Reducing medication errors; Enabling supply chain visibility; Facilitating effective product recalls; Tracking of pharmaceutical products/medical devices; Reducing introduction of counterfeit products; Enhancing inventory management; Linking critical product data to the patient record; Supporting regulatory compliance; Optimising order, invoice, sales reporting, and chargeback/rebate processes.

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Ensuring regulatory compliance Product serialisation, compliance with EU, FDA and other international drug pedigree requirements and establishing anti-counterfeiting solutions are top of mind for the pharmaceutical industry.

The proposed European and US FDA Unique Device Identification (UDI) regulations are at the forefront in the medical device arena, as companies need to transform disparate medical identification methods into a standardised UDI system.

On both fronts, the industry is leveraging GS1 Standards and the support of GS1 experts to prepare for these new requirements and ensure regulatory compliance.

Get involved! Go to www.gs1ie.org/healthcare About GS1: GS1 is an international, neutral, not-for-profit organisation, with operations in more than 110 countries around the world, including Ireland. The GS1 System of Standards is the most widelyused system of supply chain standards, serving more than 2m companies worldwide. It is recognised by organisations such as the International Organisation for Standardisation (ISO), and the European Committee for Standardisation (CEN). For more information, contact: Siobháin Duggan, Healthcare Sector Director, on (01) 2080660 or visit www.gs1ie.org.

TEMPERATURE CONTROL

Temperature Controlled Storage Solutions from CRS

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he pharmaceutical industry is only too acutely aware that failure to store pharmaceutical products at the correct temperature ranges can possibly result in subpotent products and potentially, therapeutic failure.

The team at CRS Pharma Solutions are experts in the storage of temperature sensitive pharmaceutical products and have been working alongside the pharmaceutical industry for 25 years, advising on the more technical aspects of temperature controlled storage and providing customised solutions for many projects.

CRS Pharma Solutions provide a full range of temperature controlled storage, from Cold Stores to Hotboxes, 10/06/2013 Freezers 8701_CRS_ADVERT_ART.pdf to Incubators. Also, new to their product range is a full range of flat

pack Cold Rooms, which can be installed within any existing facility.

Commissioning and Validation CRS Pharma Solutions have an expert in-house Commissioning and Validation Team. Their validation proccess is comprehensive and is executed efficiently and in compliance with regulatory requirements, including current GMP and DGP best practice guidelines. The validation team is fully versed in all the challenges faced by the QP and RP with regard to audits and regulatory compliance.

They will ensure that all equipment is calibrated to exact specifications and that all quality and regulatory requirements are met, providing full 15:20:35 Installation, Operational and Performance Qualification (IQ, OQ & PQ), including

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empty and full state thermal mapping studies and complete documentation detailing the process.

AFTER SALES SERVICE At CRS Pharma Solutions after sales service and customer care is key! They can also provide you with fully validated and calibrated contingency storage if necessary and will provide a 24-hour emergency call out service to ensure the critical care of your product.

CRS Pharma Solutions have the expertise, experience and dedication and have worked with many clients in the pharmaceutical industry over many years. They can offer many testimonials from existing customers and would be delighted to meet with you to discuss your project: call 1890 929 824 for more information.

Nanotechnology and Advanced Manufacturing

Nanoscience: Macro Benefits Why nanoscience is at the forefront of pharmaceutical, medical device and even diagnosis development, by Dr Colm Faulkner, Commercialisation / Industry Business Development Executive, CRANN.

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he ability to control and engineer materials at the nanoscale, and to control biological responses to nanomaterials, is important for the pharmaceutical, biotechnology, chemical and medical device manufacturing industries.

Nanotechnology is defined as a key enabling technology (KET), by the European Union, as it impacts multiple sectors. Ireland is currently globally ranked 6th and 8th in nanoscience¹ and materials science² respectively.

A nanoscale material is defined as, “a material with one or more dimensions of <100 nm,” ³, which is about 100 times smaller than the diameter of a blood cell.

In the world of nanoscience, as surface area increases relative to volume, materials can take on intriguing new properties. Insulators can become conductive, soft materials can display incredible strength and coloured materials can become transparent.

These remarkable changes provide exciting opportunities for traditional businesses to develop improved devices or processes and for new enterprises to develop revolutionary products.

The possibilities in the field of nanoscience are immense and nanotechnology touches almost all areas of human endeavour, from medical devices with enhanced functionality, to new ways to treat and diagnose disease, to radical new materials awaiting vertical integration into the advanced manufacturing supply chain.

Advanced Manufacturing Ireland is recognised as a world leader in high-volume advanced manufacturing, hosting operations of nine of the top 10 multinational companies (MNCs) in the medical technology and pharmaceutical sectors and seven of the

The Centre for Research on Adaptive Nanostructures and Nanodevices, CRANN, unites researchers with expertise in materials, medicine, immunology and pharmacy to work on interdisciplinary problems related to next generation materials and devices.

world’s top 10 companies in ICT. These companies account for over 70% of Irish exports⁴ and directly employ more than 250,000 staff⁵. In 2010, chemicals accounted for €22.8 billion or 25% of Irish manufacturing output, pharmaceuticals €30 billion or 33% of total, and medical devices €4.3 billion or 4.8% of total.

Multinational companies based in Ireland should have a deep understanding of nanotechnology and nano/ new materials in order to compete for corporate research investment from overseas. Research in nanotechnology in Ireland offers industry a number of benefits, including: • Improved materials and processes to reduce manufacturing costs; • Development of new materials with enhanced properties; • Product improvement; • New products or technology development; • Advanced materials analysis and testing capabilities; 34

•

A stream of highly qualified numerate lab skilled graduates, and post graduates.

Research Trends Nanotechnology underpins much interdisciplinary research activity around healthcare and materials. For example, lab on chip technologies afford the prospect of cost effective or disposable, minimally invasive testing for multiple ailments at the point of care, often using nanotechnology. Implants and medical devices can now incorporate targeted drug delivery systems – materials can be made more biocompatible and engineered to trigger the appropriate immune response. Materials can be controlled at the nanoscale to control properties as wide as drug elution rates, lubricity, fluorescence, mechanical strength, cell adhesion etc.

Research in nano particles offers benefits such as new drug delivery mechanisms with reduced drug dosages, highly localised drug dosages,

Advanced control and I N G R E D I E N T S optimisation for the life sciences industry?

YOUR SUPPLY PARTNER:

%

Absolutely.

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38

Nanotechnology and Advanced Manufacturing

wishing to tackle either large scale, long improved term, grand challenges or shorter term mechanical, more routine materials testing and charmagnetic, optiacterisation. cal or electrical

A dedicated CRANN comproperties for mercialisation team supports the develapplication opment and exploitation of new techin electronic, nologies, in areas including sensors & medical devicdiagnostics, drug delivery, drug release, es, sensors or diagnostics/point of care [POC], antinew drug delivmicrobial coatings. Some of CRANN’s ery systems. research programs with industry have For examthe explicit aim of new technology develple, Prof. Ann opment, IP management/protection, and Marie Healy, The possibilities in the field of nanoscience are immense, from medical devices technology transfer.

TCD School with enhanced functionality, to new ways to treat and diagnose disease. of Pharmacy, CRANN – Materials Analysis is developing new applications/markets for existing and Testing porous nano-materials for pulmonary drugs [lowering the high cost and risks The CRANN central equipment facildrug delivery: imagine tiny sponges associated with drug discovery], new ity [CEF] is an integrated microscopy, loaded with drugs accessing difficult to therapies and treatments. reach outreaches of the lungs. Her team metrology, photonics, nanobio and

Many nanoparticles are polymer processing facility, suited to also investigates new materials for drug designed with multiple applications, for materials testing, modification and protopackaging. example therapy and diagnostics, leadtyping for industry as well as academics.

Prof. Marek Radomski and ing to the field of ‘theranostics’, and This facility is staffed by core staff with his researchers investigate the nanocan be made responsive to external a blend of industry and research experiparticle mediated agglomeration of stimuli such as magnetic fields or light. blood platelets: leading to understanding ence, which can be accessed directly by New advances in medical imaging have industry or researchers. essential for blood clotting and wound resulted.

For more information, please contact healing⁶. With researchers in UCD, they

Improved nano-engineered Mary Colclough research how nanoparticle-corona sysmaterials such as plastics offer (colcloum@tcd.ie), or Dr Chris Keely tems are attracted to and interact with additional functionality: they can be (ckeely@tcd.ie). cell membranes, leading to internalisastronger, lighter, more conductive tion of nanoparticles⁷. and with improved barrier properties.

Dr. Ed Lavelle of Nanoparticles can be used to enhance Immunology works to undermaterials as wide ranging as antistand the role of adjuvants microbial surfaces to engineered tissue and delivery systems to creand bone materials used in regenerative ate better vaccines. medicine. Nanotechnology researchers improve our understanding of existCRANN – Industry/ ing materials and discover and create Commercialisation new ones. They explore novel ways to A dedicated CRANN project deposit, pattern, structure, package or management team supports Prof. Ann Marie Healy, TCD School of Pharmacy, is developing deliver these materials. the needs of industry, both porous nano-materials for pulmonary drug delivery: imagine tiny multi-nationals and small to sponges loaded with drugs accessing difficult to reach outreaches Research in CRANN/Trinity of the lungs. medium size enterprises, College Dublin Ireland has deep expertise in nanoteReferences chnology across all the Dublin universi[1] http://www.irishexporters.ie/section/ [5] http://www.timeshighereducation. ties, NUIG, and UCC. The Centre for IEARevealIrelandsTop250Exporters co.uk/story.asp?storycode=413239.

Research on Adaptive Nanostructures 8th in the world ranking in Times Multinational Companies Account for and Nanodevices, CRANN, is TCD’s Bulk of Irish Exports (2011).

Higher Education. (2010). largest research institute, with links to [2] http://www.djei.ie/ [6] MJ Santos-Martinez, I InkielewiczUCC, the RCSI, and the Trinity Centre press/2012/20120105c.htmIDA Ireland Stepniak, C Medina, K Rahme, for Bioengineering [TCBE]. CRANN End of Year Statement 2011.

DM D’Arcy, D Fox, JD Holmes, HZ unites researchers with expertise in Zhang, MW Radomski, Int. Journal of [3] ISO/TC229 Documentary standmaterials, medicine, immunology and ards for nanotechnology, Nanomedicine, 7, 243 (2012) pharmacy to work on interdisciplinary TR ISO, (2008).

[7] A Lesniak, A Salvati, MJ Santosproblems related to next generation Martinez, MW Radomski, KA Dawson, [4] SFI carried out independent validamaterials and devices. CRANN unites tion of this number in 2008. Nature C Åberg, J. Am. Chem. Soc., 135, academics, business and clinicians.

Nanotechnology, (2006).

1438 (2013)

CRANN’s scientific challenge is to develop new nanomaterials with 36

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CLINICAL TRIALS DIRECTIVE

THE EVOLUTION OF EUROPEAN CLINICAL TRIALS The proposed European Clinical Trial Regulation could significantly boost research activity throughout Europe, writes Fionnuala Gibbons, Clinical Trial Liaison Officer, MMI/ICRIN.

C

linical trials represent an essential component of evidence based medical research. Prior to 2001, each European member state had its own national clinical trials regulations and approval systems (e.g. Clinical Trials Act 1987 and 1990 in Ireland).

This increased the complexity of multinational European clinical research, primarily due to differing requirements and approval mechanisms between countries. In an attempt to standardise and harmonise clinical trial approvals amongst member states, the European Commission introduced the first European Clinical Trials Directive EC 2001/20 (CTD).

The CTD on “the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use” has ensured a high level of patient safety. However, divergence in its transposition into national law and interpretation has “led to an unfavourable regulatory framework for clinical research in Europe” ¹, contributing to a 25% decline in the annual number of clinical trial applications across the EU, with a corresponding doubling of administrative costs.²

The absence of a consistent pan-European regulatory framework is one of the key reasons for this. The decline is of great concern to those who directly benefit from, or work in, clinical trials: namely patients, clinicians, academia and the pharmaceutical industry.

RESOLVING CURRENT ISSUES In July 2012, the European Commission

(EC) adopted a proposal for a Clinical Trials Regulation.

The proposed Regulation aims to resolve a number of issues identified with the current legislation on clinical trials and, once passed, will replace the current Clinical Trials Directive in regulating the clinical trials of medicinal products in patients across Fionnuala Gibbons, Clinical Trial Liaison Officer, Molecular Medicine Europe.

Ireland (MMI)/Irish Clinical Research Infrastructure Network (ICRIN).

The Irish Clinical Research John Dalli, European Commissioner Infrastructure for Health and Consumer Policy, the Network (ICRIN), with the Irish proposed new regulation could save up Medicines Board (IMB) and Health to €800m each year in regulatory costs, Information & Quality Authority (HIQA), whilst simultaneously boosting research held a stakeholder seminar in March activity throughout the European in the Mansion House, Dublin, to Union. “Patients in Europe should have inform and initiate discussions on how access to the most innovative clinical Ireland could effectively implement the research,” he commented.

European Commission draft regulation

The new Regulation, as proon clinical trials. The seminar focused posed by the Commission in consultaon identifying the changes required tion with various stakeholders, such nationally to ensure Ireland can comply as patients, academia and industry with all the legal requirements of the representatives, will apply directly to all proposed Regulation without significant 27 Member States, and effect harmonidisruption to clinical trial activity during sation of the legislation for conducting the changeover period. clinical trials across Europe. It should

Clinical research accounts result in simplifying the rules for healthfor greater than €20 billion per annum care research across Europe and there of investment in the EU. According to 38

CLINICAL TRIALS DIRECTIVE

Benefits Of The Regulation Under the new Regulation: 1.

A “single portal” system will allow applicants seeking to conduct trials in multiple geographies to submit a single application. It will ensure a swift and comprehensive assessment with a single decision.

2.

Simplified reporting procedures will reduce the burden of submitting largely identical information separately to various bodies.

3.

The Commission will introduce mechanisms to ensure the rules are enforced consistently in each Member State.

4.

There will be a greater focus on patient safety and protection through the conSiobhan Gaynor, Programme Manager- Clinical sideration of varying levels of and Translational Research, Molecular Medicine Ireland (MMI)/ Irish Clinical Research Infrastructure Network (ICRIN). risk to subjects participating in clinical trials by the introduction of the concept of a fore, encourage faster development of low and high risk trial. new medicines, as well as review and 5. Introduction of proportionate improvement of authorised medicines. approaches to trial management will be introduced: for example, INCREASING NUMBER OF TRIALS frequency of on-site monitoring and The proposed Regulation aims to independent monitoring of data and increase the number of trials conducted patient safety to dynamically adapt in the EU, by directly addressing the key risk management plans for clinical criticisms of the EC 2001/20 (CTD). The trials. resulting new legislation will apply the 6. Introduction of increased transparsame rules equally in all 27 countries for ency will be introduced into clinical carrying out clinical trials across the EU research. From May 2011, clinical and will be transposed, without interpretrials approved in the EU have been tation into national legalisation. published in an official register,

While the Commission's legand the move towards increasing islative proposal appears to be a big transparency of clinical research step forward, it is not expected to be continues under the new regulation. enacted until 2016.The Regulation will Patients will be able to find clinical replace directive EC 2001/20 (CTD), trials that they may be interested in but must first be jointly agreed by both participating in and will be able to the European Parliament and European easily assess clinical trial results, Council. The proposed legislation aims both positive and negative, thereby to streamline the process of applying reducing publication bias. and gaining authorisation to conduct clinical trials in Europe and simultaneThe Challenges Ahead ously assuring data quality and protectThere is uniform support for a revision ing patient safety³. of the current Directive for drug clinical

The Regulation sets clear trials. However, some challenges remain objectives and timelines for the assesswith respect to compliance with the short ment and decision on clinical trials timelines indicated and the alignment

by Member States, while respecting of the ethics and competent authority international guidelines such as Good systems in order to produce a single Clinical Practice (ICH-GCP) and the national opinion.

World Medical Association’s ethical

By streamlining authorisation standard, the ‘Declaration of Helsinki’.

39

Susan Lennon, Clinical Research Manager, Molecular Medicine Ireland (MMI)/Irish Clinical Research Infrastructure Network (ICRIN).

and reporting processes, the new regulation will decrease the level of onerous and often duplicated paperwork, whilst facilitating timely start-up of multinational clinical trials. With this new regulation, the commission hopes to re-establish the EU as a key location of choice for the conduct of clinical studies with a direct focus on the patient.

1.

2.

3.

European Commission, Fostering EU’s attractiveness in clinical research: Commission proposes to revamp rules on trials with medicines, 2012, visit: http://europa.eu European Commission, Proposal for a Clinical Trials Regulation – Questions and Answers, 2012, visit: http://europa.eu http://www.ecrin.org/ fileadmin/user_upload/ public_documents/The%20 EU%20Clinical%20Trials%20 Regulation%20joint%20 statement%20logos%20 FINAL.pdf

CONTRACT MANUFACTURING

THE BRAINS OF B. BRAUN oem B. Braun Original Equipment Manufacturer (OEM) offers expertise which exceeds customers’ expectations in infusion therapy and contract manufacturing.

B

. Braun is an outsourcing provider for all your infusion therapy needs and contract manufacturing services. B. Braun offers standard and customised products, innovative technologies, indepth knowledge of applications and markets, as well as a process-orientated service to implement your project quickly and efficiently.

“Choose from more than 30,000 market-proven medical and pharmaceutical products and teams of specialists for the implementation of your project,” explains Gary Glennon, Business Unit Manager. “Partnering with B. Braun can speed results in the market and help you to increase your profit. Challenge us and we will provide you with your individual system-built solutions.”

B. Braun OEM – The Safety Expert B. Braun is an international healthcare provider with long-term expertise in the production of pharmaceutical and medical products. Based on this expertise, the OEM Division supplies system-built solutions to the pharmaceutical and medical device industry.

Their product portfolio includes pharmaceutical solutions, infusion solutions, electrolyte solutions, volume replacement solutions, injectables, anaesthetics, irrigation solutions and

parenteral nutrition according to your requirements.

Their medical devices – such as syringes, needles, infusion lines, IV administration sets, infusion accessories, spikes, stopcocks, infusion filters, irrigation accessories, central venous catheters, peripheral venipuncture sets, pumps, systems and disposables, can be cusWith many years experience of the medical devices and pharma tomised or combined in pro- products, B. Braun’s local support provides customer-focused solutions to everyday issues. cedure sets that can meet virtually any medical need.

B. Braun also have B. Braun OEM Ireland a complete range of products for disinWith many years experience of the medifection and hygiene. Whether provided cal devices and pharma products, B. as standard or customised products, Braun’s local support provides customerthe B. Braun portfolio spans the whole focused solutions to everyday issues. healthcare value chain and provides high “Medical device and pharmaceutical quality and product safety. companies need the security of supply

B. Braun OEM has the experfrom a global, leading, fully regulated tise in medical sciences, pharmacy, and validated supplier: B. Braun is that product development, production, law, partner,” stresses Gary, “thanks to our packaging and logistics. This provides experience in providing pharmaceutical complete outsourcing knowledge to companies with solutions for the reconcustomers. The OEM project managestitution and administration challenges of ment teams are the experts for individual their preparations, particularly focusing customer ideas. The principal activities on providing a convenient patient friendly within customer projects are product all in one delivery system.” variation and combination, pharmaceuti B. Braun has successfully cal contract manufacturing and common partnered with many major international development. Along with the additional pharmaceutical companies to develop support like analytical services, regulaand supply own brand kits, which may tory support and a professional customer include devices such as syringes, reconand logistic service, B. Braun OEM is stitution devices, solutions and adminisable to provide system-built solutions. tration systems, including filters, cannula,

“Companies in the healthcare dressings and more. market have a special responsibility for

“Our project management ensuring the best possible patient care services provide a step by step procand for supporting those who interact ess, through all the relevant design and with patients,” notes Gary. “With the regulatory issues associated with such expertise of B. Braun, the pharmaceutical undertakings,” notes Gary. industry can provide, not only the drug, but the complete system to apply the For more information, call Gary drug exactly and safely: therapy safety Glennon, your local contact, on from bottle to body.”

(01) 7091834.

40

536 Grants Crescent, Greenogue Business Park, Rathcoole, Co. Dublin Tel : + 353 1 4019800 Sales Office : + 353 1 4019817 E mail : pharma.sales@univareurope.com www.univareurope.com

Univar is Ireland’s leading source of high quality ingredients to the pharmaceutical sector. Our purpose built site has been designed to meet the regulatory compliance demands of our pharmaceutical customers.

We are serious about safety and we are committed to making a positive impact on environmental issues in handling fine chemicals.

Univar is the partner of choice for many of the world’s leading pharmaceutical ingredient manufacturers.

Whether you are looking for API’S, EXCIPIENTS, PROCESS CHEMICALS, SOLVENTS, OR INTERMEDIATES we can provide technical and regulatory support.

To discuss your specific needs please contact our sales office at +353 1 4019817 22

Tel: +353 21 421 7500 Fax: +353 21 421 7598

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PACKAGING

GOLIATH: THE PACKAGING GIANT Goliath Packaging Systems is a one-stopshop for packaging machinery, materials handling systems and industrial washing equipment.

G

oliath Packaging Systems Ltd, in business since 2007, sources, supplies, installs and after-sales services a comprehensive range of end-of-line packaging, materials handling and industrial washing equipment to the Irish pharmaceutical and chemical sectors.

With experience gained through many years of successful project delivery for discerning blue-chip customers throughout Ireland, the expertise of its international partners / suppliers and the skills of its factory trained staff, Goliath is perfectly positioned to meet the demands of its customer base.

The company recognises the importance of the pharmaceutical and chemical industry to the Irish economy and concentrates on this critical market segment via its trading division, Goliath Pharma, with projects successfully delivered during the past 12 months to companies such as Norbrook Labs, Medentech, Servier, Essilor, Terumo BCT and Allergan, amongst others.

IMPRESSIVE PRODUCT RANGE The Goliath Pharma product range consists of the following distinct items: • • • • •

Liquid Filling Systems; Shrink Wrapping, Banding & Over Wrapping; Tablet Presses, Milling, Blending & Drying; Blistering / Cartoning; Case Erecting, Case Packing & Bagin-Box Systems;

• • • • • • • • • • • • • •

Manual & High Speed Labelling Systems (bottles, tubes, vials, cases etc); Case Sealing; Cotton & Desiccant Insertion; Conveying Systems; Pallet Inverting & Exchange (Fixed, Mobile & Automatic In-line); Pallet Stacking / Handling; Scissors & Vacuum Lifting Systems; Materials Handling Systems (Reel, Drum & Product Manipulators); Pallet Elevating Systems; Palletising Systems (Gantry, Articulated Arm & Layer); Stretch Wrapping; Strapping Systems (Case & Pallet); Washing Systems (Bottle, Jar, Box, Tray, Drum, Pallet, Keg & IBC etc); AGV Transport.

In addition, the following complementary, ancillary items are provided

by Goliath in order to offer a fully integrated turn-key service: • Weighing Systems; • Labelling / PharmaCode Reading; • X-Ray / Metal Detection.

Goliath also offers a Project Management / Packaging Consultancy Service to assist in the early determination of customers’ particular packaging equipment requirements, while full validation packages (IQ, OQ, PQ, FAT & SAT etc) are available as required to meet URS demands.

Goliath serves the following segments of the Irish PharmaChem sector; • Pharmaceutical; • BioTech; • Chemical; • Healthcare;

• •

Medical Devices; Contract Packing.

SPECIALIST PACKAGING EQUIPMENT SUPPLIERS Goliath works with a number of internationally known specialist packaging equipment suppliers, including the following: • Filamatic; • Pester Pac Automation; • Soco System; • Newsmith; • Toppy; • MJ Maillis; • JBT.

Goliath understands the specific needs of the pharmaceutical and chemical sector. From liquid filling, shrink wrapping / banding, case-packing, labelling/ coding, palletising, pallet inverting and high speed washing, via partnerships with the above international companies, Goliath has positioned itself as a major provider of packaging equipment to the Irish PharmaChem sector.

Centrally located in Nenagh, Co. Tipperary, Goliath is less than two hours from all major markets, while trained engineers maintain spare parts and service all equipment installed with annual service contracts (reactive / preventative) available as preferred.

To discuss your particular packaging equipment needs, please contact George O’Leary, Director, Goliath Packaging Systems Ltd, 92 Silver St., Nenagh, Co. Tipperary.

Tel: 067 37893 Fax: 067 34794 Mobile: 087 1222816 E-mail: info@goliath.ie Web: www.goliath.ie

Via partnerships with internationally known suppliers such as Soco System, Goliath has positioned itself as a major provider of packaging machinery, materials handling systems and washing equipment to the Irish PharmaChem sector.

42

Shrink Wrapping

Bag-In-Box

Banding

Case Sealing

Liquid Filling

Conveying

Case Erecting

Labelling Systems

Case Packing

Check Weighing

Leaflet Dispensing Metal/X-Ray Detection

sales

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T: 067 37893 F: 067 34794 M: 087 1222816 info@goliath.ie www.goliath.ie BEECHWOOD, NENAGH, CO. TIPPERARY Pallet Inverting

Palletising

Scissors Lifting

Stretch Wrapping

Vacuum Lifting

Strapping

Reel Handling

AGV Transport

Drum Handling

Washing Systems

Pallet Elevation

Warehousing

sales

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RECRUITMENT

Bright Future for Pharma Sector Confidence is high for the Irish PharmaChem sector in 2013, according to The Berkley Group’s latest survey. Jean O'Keeffe, Berkley Recruitment, reports.

H

aving come through a major rationalisation in the pharmaceutical industry in recent years, the 2012 patent cliff and many more M&A and alliances, the Berkley Group has a look at some of the fall-out changes in the market from a sentiment and talent perspective. With our expertise in recruitment, talent management and software solutions, we can see key observations and trends in the market and more importantly, sign-posts of things to come.

The first half of 2013 has started with well founded and positive sentiment across the work force, with 81% of the respondents to the Berkley survey stating their company was performing the same or better compared to the previous 12 months. 66% of those surveyed claimed that they were not worried or less worried about job security than the previous 12 months.

So what brings this confidence to the Pharma sector?

In 2012/2013, we have started to see a huge change in the landscape of this sector in Ireland. We have seen a major shift towards Biotech/Biologics, with just two main sites a decade ago, compared to the 10 sites we have today.

Amgen are here, Biomarin are soon ramping up, existing sites are expanding and over the next few months, a wave of further investments will be announced by the IDA. the talent ecosystem As the eighth largest producers of pharmaceuticals in the world, employing approximately 24,500 people directly and contributing €55 billion in exports – there is now a huge focus on how the sector nurtures and maintains the talent ecosystem over the next five years.

There is a lot of common ground in pharmaceutical organisations

regarding talent. Some key things we can see happening in 2013 are more advanced talent attraction strategies, the application and usage of contract staff reviewed with a drive on knowledge retention and efficiencies, closer links to universities and audiences with upskilling properties, and most importantly, global mapping for key skills sets critical to an organisation. While the local market can provide the majority of the staff required, there is the occasional need to look to international waters for additional skills when ramping up in scale.

Skills such as BioProcess, Technical Services, Engineering, Quality and Regulatory, for Biologics in particular, have risen in the last 6-9 months and this is set to escalate rapidly in the next three years. We are finding that organisations are now forced to develop competitive and comprehensive strategies for attracting talent to their company.

44

THE RISE OF MANUFACTURING According to a recent survey conducted

by Irish Jobs, the real high flyer in Irish industry at the moment is manufacturing, up 17% from the same quarter last year.

Irish manufacturing has consistently outperformed the euro zone average over the past 12 months. The survey reached a 15-month high of 53.9 in July last year.

As mentioned above, the manufacturing increase over the period in the IrishJobs.ie report is well in line with the NCB Manufacturing Purchasing Managers’ Index, which has unfortunately fallen somewhat in the latest data, to 48.6 in March from 51.5 in February 2013. Manufacturing is hiring and candidates have a choice again.

ROBUST RECRUITMENT STRATEGY Organisations are now constructing Employee Value Propositions (EVP) with

When compared to results from the previous survey, the percentage of pessimist seen on a global scale. Only 20% felt that their organisation was doing worse, an company performance has improved compared to this time last year. However, i especially well.

RECRUITMENT

Interestingly, respondents from India were particularly positive, with 75% answe huge 45% from the previous survey, reflecting substantial growth in the job mark the mindful recognition that a brand and an online advert is no longer sufficient in the market today.

With time to hire reducing in the first half of 2013, it is now critical for organisations to have a robust recruitment strategy in place that allows depth of screening but also allows for speed to make a hiring decision. Internal systems are critical to producing the right culture for career development to retain and grow talent for an organisation.

In our survey, there was a comparable trend in Ireland, with 61% of respondents saying that the recruitment process took two months or less. This indicates that companies are acting fast to acquire the best talent.

CONSISTENCY AND EFFECTIVENESS Recruitment strategies internally or via third parties have evolved dramatically in the last 12 months: attraction, engagement and retention have been brought closer together in one solution to retain consistency and effectiveness when bringing new talent into an organisation.

Succession planning at a site, region or global level is allowing for more comprehensive headhunt campaigns: looking for talent on an ongoing basis, not just matching against the job spec of the headcount here and now.

Relating back to the Berkley survey, we can confirm that up to 50% of those surveyed plan to move roles in the next six months and 20% felt their chances for promotion had improved from this time last year.

The linkage of innovation, vertical expertise and RPO has led the marketplace away from traditional global roll-outs of recruitment process services. The ‘one size fits all’ model has entered turbulent times due to its rigid nature, mainly in the fields of skill delicacy, speed, feedback and regional nuances.

Organisations are engaging high end talent management experts to conduct a phase of audit and discovery before designing flexible and responsive solutions to best meet the needs of talent attraction and ensure line management time is not hindered by recruitment, which is often the condition of busy times. Organisations we discussed this topic with are adamant that having a solid delivery model in house with a robust ‘Plan B’ system is key for the future of RPO.

Job Creation

70.0%

In your own company, estimate the percentage of jobs that have been cut/created in the past 12 months

30.0%

Job Market Opportunities

50.0%

40.0%

20.0%

Over half (53%) of Irish respondents said they had seen some form of job cuts in the past year, wh though it seems that the number of jobs being created in Ireland is improving – albeit slowly – up 10.0% increased by 8%.

Some countries did see a rise in the number of job cuts though, for instance France’s results were 0.0% UK, the percentage of those seeing job cuts had decreased by 7%.

How is your company performing compared to this time last year? (Source: Global Workplace Survey, Ireland Report, Berkley Group)

Market Sentiment Report 2013 the | 10current job market?

How would youH1 describe

About the Authors Berkley Group is a wholly owned subsidiary of Rethink Group plc, which is quoted on the London Stock Exchange AIM market. Berkley comprises of two groups, specialist Recruitment Group and Talent Management Solutions Group. With nine offices globally, Berkley’s Irish operation includes offices in Cork and Dublin.

60.0%

45.0% 40.0% 35.0%

The latest statistics from Ireland’s National Recruitment Federation (NRF) sugg 30.0% staffing market has been demonstrating signs of robust growth. Despite this th 25.0% to fully recover, with almost half of Irish respondents (44%) feeling pessimistic 20.0% – 41% of respondents worldwide believed the local jobs market was weak.

15.0%

10.0%of r However, professionals in the UK appeared more optimistic with only 34% 5.0% steady – 16% more than in Ireland.

0.0%

When compared with data from the previous sentiment survey in Q3 of 2012, instance, the percentage of Irish respondents arguing that it was weak with lim worldwide.

Are you more or less worried about job security than 12 months ago? (Source: Global Market Survey, Sentiment 2013 |9 Workplace IrelandReport Report, H1 Berkley Group)

How would you describe the current job market? (Source: Global Workplace Survey, Ireland Report, Berkley Group)

Market Sentiment Report H1 2013 | 6 45

CHROMATOGRAPHY

Making the Case for UPC² Ultra Performance Convergence Chromatography, UPC², is fast becoming an essential separations technique for your laboratory, which can hugely simplify your workflow.

U

ltra Performance Convergence Chromatography™ (UPC²®) is a broad-based, complementary analytical platform that is taking its place alongside of LC and GC as one of the three essential separation technologies for modern laboratory analysis.

There are three main forms of chromatography: GC, LC, and now convergence chromatography (CC). While all three use a stationary phase to interact with compounds of interest and a mobile phase to move compounds through the stationary phase and achieve separation, the techniques differ mainly by the mobile phases used.

GC is defined by using a gas as its mobile phase, LC is defined by using liquids as its mobile phase, and CC is defined by using both gas and liquids. It is this convergence of mobile phases in combination with a far greater choice of stationary phases that makes CC a powerful additional choice for laboratory scientists.

normal-phase chromatography. Among the advantages that reversed-phase chromatography offers are ruggedness and reliability, as well as the power of gradient elution for rapid method development: these capabilities significantly improve workflow and were not possible with normal-phase LC.

Reversed-phase LC, however requires sample injection in a water-compatible solvent, which can mean hours (sometimes days) worth of repeated extractions and dry-down processes. As the diversity of samples increased, so too did the time to do sample prep. All the workflow benefits of reversed-phase chromatography were being eroded.

Because UPC² can receive samples in organic solvents, it significantly simplifies the requirements for sample preparation, while maintaining all the advantages of RPLC.

Orthogonality you can rely on A major concern of scientists in regulated industries is that impurity, degradation peaks, or structurally similar compounds may be overlooked. Orthogonal methods that provide different elution orders of peaks are needed to ensure full characterisation and that nothing is overlooked.

Having a second technology platform that can routinely provide reliable orthogonal data is proving to be a strong driver for UPC² adoption.

Simplified workflow When reversed-phase chromatography was introduced, scientists moved quickly away from

The greatest business impact we can deliver to any customer is to simplify their workflow. With the ACQUITY® UPC² System, the impact on workflow starts with the time saved in sample preparation; add in the time saved in analysis and data interpretation, and you have a complete measurement for a faster route to answers.

That’s why the ACQUITY UPC² System is taking its place alongside LC and GC in analytical laboratories.

Because UPC² can receive samples in organic solvents, it significantly simplifies the requirements for sample preparation, while maintaining all the advantages of RPLC.

46

For more information please contact: Waters Chromatography Ireland Unit 3.1 Woodford Business Park Santry, Dublin 9 Tel: (01) 4481500 E-mail: ireland@waters.com Web: www.waters.com

BEYOND LC. BEYOND GC. BEYOND SFC.

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Pharmaceutical & Life Sciences | Food | Environmental | Clinical | Chemical Materials ©2013 Waters Corporation. Waters, UPLC, ACQUITY UPC,2 UPC,2 UltraPerformance Convergence Chromatography and The Science of What’s Possible are trademarks of Waters Corporation.

MATERIALS HANDLING

Henley Celebrates 40th Birthday Henley Forklift Group Ltd are celebrating 40 years supplying the materials handling industry!

H

enley Forklift Group Ltd and Henley Hire Services Ltd are celebrating 40 years in business. Since 1973, the Irish owned company has been at the forefront of the materials handling industry in Ireland, and is the sole Irish distributor for leading brands like Mitsubishi, Atlet, Terex, Sichelschmidt and Ulma.

With a significant primary operating centre in Dublin, Henley service their extensive nationwide customer base through strategically placed, locally managed regional offices in Cork, Limerick, Galway, Waterford, Kerry and Belfast.

“Each of our regional offices carry significant volumes of hire trucks, spare parts, new and second hand forklifts, so that we can provide our customers with the best local service possible,” explains Mark Kenny, Hire & Service Director. “We have been the distributor for Mitsubishi forklift trucks for the last 35 years and we enjoy long relationships with all our suppliers and our customers.”

ONE STOP SHOP Henley deliver a one-stop-shop for all your materials handling needs, according to Mark. “Our relationship with our customers doesn’t end when they take delivery of their order,” he explains. “We offer

our customers a complete range of materials handling services, including sales, service, hire, parts and driver training.”

The company recently delivered 12 trucks on contract hire to Pinewood Healthcare in Clonmel, Co. Tipperary, one of Ireland’s leading pharmaceutical manufacturers. Pinewood Healthcare was established in 1976 and is a widely diversified pharmaceutical group, presently marketing its products in over 30 countries worldwide.

The relationship with Pinewood Healthcare is a perfect example of what Henley can offer pharmaceutical and chemical companies. “We can meet all their materials handling needs and with a presence all over the country, we are never far away from our customers,” Mark notes. “We can help our customers to manage and control the running costs of their forklift fleet. We offer various fleet management packages to suit every need.”

FAST & RELIABLE Henley Forklift Group provides a nationwide back-up service, ensuring downtime is kept to an absolute minimum. “We have built a reputation for fast and reliable breakdown response with the aim of being on site within four hours of an initial call,” Mark explains.

Indeed, Henley offer tailored service packages to suit every need, including competitive prices on fixed price servicing and spare parts, with over 35 factory trained mobile service engineers who repair and service not only their own products, but every forklift on the market and have ready access to spare parts for all types of forklifts across all brands..

Meanwhile, the Henley Forklift Training Centre was established in 1999 to provide certified operator training in accordance with the Safety, Health & Welfare at Work Act 2005. “The fact remains that 90% of forklift operators are unaware of the basic lifting capacity of their forklift trucks and every year, people are injured unnecessarily in accidents that should not have happened,” explains Mark. “Our driver training helps to pre-

48

Henley recently delivered 12 trucks on contract hire to Pinewood Healthcare in Clonmel, Co. Tipperary, one of Ireland’s leading pharmaceutical manufacturers.

vent accidents by the habitual use of safe working methods, as well as improving the skill and technique of the drivers.”

To help celebrate their 40th anniversary, Henley have launched a new website, www.henley.ie, and you can also follow them on Facebook (www.facebook.com/ HenleyForkliftGroupLtd), Twitter (https:// twitter.com/henleyforklift/), LinkedIn (http://www.linkedin.com/company/ henley-forklift-group-ltd/) and YouTube (http://www.youtube.com/user/henleyforkliftgroup/).

The relationship with Pinewood Healthcare is a perfect example of what Henley can offer pharmaceutical and chemical companies.

Celebrating 40 years supporting the Irish Material Handling Industry!

ᅛ Service ᅛ Sales

ᅛ Hire

ᅛ Parts

ᅛ Thorough Examinations ᅛ Fleet Management ᅛ Driver Training

New and Used Equipment Nationwide Service Service packages to suit all types of applications Full range of material handling equipment Long and short term hire available Nationwide parts facilitates parts supplied for all makes and models Courses to suit all requirements Help you to comply with current legislation Help to control your forklift running costs Provide detailed reporting

VISIT OUR WEBSITE

www.henley.ie

TEMPORARY OFFICE ACCOMMODATION

Portakabin Allspace Have You Covered

P

ortakabin Allspace are Ireland’s leading supplier of quality temporary office accommodation, having provided exceptional facilities for a range of offices and training rooms throughout the country, including a large number of pharmaceutical and chemical companies.

“Our commitment to providing the highest quality working environments is reflected in the organisations we work with,” says Mike Sheedy, National Hire Manager. “Our customer portfolio includes businesses from the largest blue-chip organisations, including companies like Eli Lilly, Pfizer, Genzyme, Microsoft, Apple, Boston Scientific, Medtronic, Glanbia, DHL, Port of Dublin, Intel, Dublin Airport, IBM, and HP, to mention a few.

“We can meet the varied 114664_AS8002_Pharmachem_ad_Layout 1 modu11/04/2012 lar buildings requirements of customers

in a range of market sectors.”

Recent projects in the life sciences sector include the development of a fully serviced two-storey office complex, integrated with existing buildings, for medical device innovators, Boston Scientific, with the 12,500 square feet of office space completed in just six weeks. Another project saw the creation of office accommodation for 100 engineers at world-leading biotech company, Genzyme, as well as a hygienic ‘gowning room’ for staff entering the sterile, cleanroom area of the main building.

Portakabin Allspace engages in the development and manufacture of relocatable and modular accommodation building systems.

The company offers building systems for offices, classrooms, nurseries and children's centres, surgeries 12:49 Page 1 and clinics, marketing suites, toilets and

showers, events, and storage, as well as gatehouses, call centres, and shops.

In addition, it offers modular ramps and steps for buildings of all sizes and uses; and interiors, such as workstations, seating, storage solutions, lighting, and tables.

Not only that, but Portakabin Allspace also provides building works, construction design and management, planning applications and building control approval, as well as project consultancy and management services. Portakabin Allspace also provides project management, as well as refurbishment, relocation, reconfiguration, repairs, maintenance, and parts replacement services. With operations in Dublin, Cork and Galway, Portakabin Allspace has a nationwide presence to ensure all clients’ needs are met quickly and efficiently. For more information, see www.allspace.ie.

Did you know that you could have high-quality bespoke buildings in days?

Yes, you can have the specialist working environments you need – fast.

If you need extra office space, forensic labs, control labs, pharmaceutical labs or any other facilities at short notice, Portakabin Allspace has the experience to supply the buildings you need.

So that you don’t have to worry about time or cost overruns you can rely on the Customer Charter promise that your buildings will be delivered on time and on budget.

In fact, in the unlikely event that we ever fail to meet your contract start date we’ll give hire customers a week’s free hire for every day we’re late or sales customers a free additional 12 months product warranty.*

Interim solutions can be delivered in days or even hours while permanent solutions can be installed up to 50% faster than traditional buildings.

To learn more about our high-quality buildings

visit www.allspace.ie or call us today on 01 808 5055

For your complete peace of mind, all our new Portakabin Allspace buildings come with a unique 30-year structural and 5-year product warranty package. Portakabin is the only modular building manufacturer to offer such a comprehensive warranty package.

Portakabin Allspace, Head Office: Roseville Business Park Turvey Avenue Donabate Co Dublin

What’s more all our buildings are manufactured to ISO 14001 for environmental standards and have been awarded the CE mark for quality.

* Terms and Conditions apply. A copy is available on request.

50

Porta, Portakabin and Portakabin Allspace are registered trade marks. © Portakabin Allspace 2012.

Customs & Trade Compliance

The Changing Face of Cross Border Trade The life sciences industry is focusing on global customs and trade compliance as its supply chains become increasingly more complex and far-reaching, writes Colin Doolin, Senior Manager, Ernst & Young Global Strategic International Trade Team, Dublin.

L

ife sciences companies ship thousands of finished products, raw materials, ingredients and intermediates to hundreds of countries around the world every day.

Like all global industries, the life science sector increasingly relies on fast and cost-effective international movement of its key products.

These cross-border movements are subject to international customs and trade rules, including the formalities associated with the correct declaration of the goods and their liability to duties and taxes under the rules of each of the countries involved. Failure to properly comply with these rules can result in significant business costs, resulting in interruptions to the supply chain, monetary costs in terms of duties, taxes and fines, as well as potential damage to reputation with customs or other national authorities.

Historically, the trade function within such companies had operated mainly in reactive mode – dealing with the day-to-day operational and logistics requirements, as well as dealing with problems when they arose. However, significant changes happening in the industry and in the global trade envi-

ronment have led to a change in this approach.

A DIFFERENT ENVIRONMENT On the industry side, global life sciences companies’ main business focus was previously in developed markets, where no customs duty applies to finished pharmaceutical, biotech, medical device and many consumer health products and the World Trade Organisation’s Pharmaceutical Agreement eliminated duty from most API’s and intermediates.

In addition, unlike today, the majority of clinical trials were also held in developed markets.

However, the industry has fundamentally changed over the last 10 years with the “patent cliff” significantly reducing blockbuster revenues, supply chains being reengineered to deal with diversified portfolios such as vaccines, animal health and generics and very

51

significant current and future growth of emerging markets (currently 12-15% annually).

This means that companies now have to deal with markets levying import duties on their products of up to 27% and their first experience of such markets is usually for clinical trial projects, with their related difficult valuation issues, very urgent timelines and irrecoverable duty and VAT issues.

CUSTOMS SECURITY PROGRAMMES On the global customs environment side, the growth in customs security programmes all over the world such as AEO (EU Authorised Economic Operator) and C-TPAT (US Customs –Trade Partnership Against Terrorism), coupled with a boom in Free Trade Agreements, as well as an increased focus on compliance from the US Sarbanes Oxley Act to Foreign Corrupt

Customs & Trade Compliance

Practices Act (FCPA) and increased scrutiny and enforcement by customs authorities have only served to reinforce this need.

Many companies are now moving to reposition the customs and trade role to where it is more pro-active and provides significant input to key business decisions across the enterprise, from cost reduction to strategic planning.

These key trends were discussed in depth at Ernst & Youngâ&#x20AC;&#x2122;s sixth Global Life Sciences Strategic Trade Forum, which attracted global trade leaders from 25 of the largest US, European and Asian pharmaceutical, medical device, biotech and consumer health companies to Dublin.

Key Areas of Focus The following topics were highlighted by the delegates during the course of this two-day forum, as representing the key customs duty and import VAT risk or opportunity areas for life science companies affecting their supply chains: Cost Reduction: Significant cost reductions have been achieved through the reduction or elimination of duty and irrecoverable VAT costs on APIâ&#x20AC;&#x2122;s, raw materials (intermediates, chemicals, packaging) and finished products, as well as clinical trial APIâ&#x20AC;&#x2122;s and dosage materials in developed and emerging markets.

Global Trade Compliance / Supply Chain Facilitation: Global customs risk has increased significantly in the last 10 years, with companies dealing with new authorities in emerging territories who can take a very aggressive approach to enforcement.

These factors, coupled with increased focus on compliance, both internally and externally, have driven a need for a more enterprise wide approach to risk and compliance in the international trade arena.

Strategies have included adopting standardised procedures and policies, tailored to local legislation, training and awareness programmes, both virtual and in-person, as well auditing and monitoring programmes to reduce risk and improve compliance in the global life sciences business.

This provides a strong framework for global trade compliance in key areas such as valuation, classification, special programs, documentation, pre

The challenge for any global corporation is how best to manage diverse jurisdictions in remote locations to a globally consistent standard.

and post entry processes, as well as special areas of focus such as clinical trials, and are designed to comply with key moves by Customs authorities to facilitate trade for compliant traders, such as the Authorised Economic Operator programme in Europe. On the emerging markets side, they can also be critical in any FCPA / UK Anti-Bribery Act management strategy, as it relates to customs authorities and the import function.

Strategic Trade Planning: The evolving life sciences supply chain is being reengineered to deal with a fundamental shift in the industry dynamics, as companies evolve beyond from the old blockbuster model, diversifying into other key areas of health, to be ready for not only the significant future growth in emerging markets but also a digital age of health care with a more patientcentric approach and new partnerships and market entrants reinventing the healthcare landscape.

The global trade function in a major life sciences company will play a key role in this evolution to ensure the core objective of getting products to patients is met.

MANAGING DIVERSE JURISDICTIONS The challenge for any global corporation is how best to manage diverse jurisdictions in remote locations to a globally consistent standard in order to protect the company's position and reputation, manage risk and ensure operational effi-

52

ciency and minimal delays on customs issues in the supply chain.

These factors have led global life science companies to analyse how best to manage the increasingly complex issue of cross border trade by developing globally consistent policies and standards for managing customs compliance and tailoring them to the company's business and local markets.

The increasing need for a more global approach to international trade to cater for the evolution in the industry led to the creation of the above mentioned Ernst & Young Global Life Sciences Strategic Trade Forum a number of years ago, where key industry players gather from around the world to discuss these issues and share ideas and strategies The most recent outing in Dublin in March attracted the largest audience to date, giving a clear indication that the topic of global customs and trade compliance is high on the agenda for the life sciences industry.

For further details, and information on topics covered during the Forum, please contact: Colin Doolin, Senior Manager, Ernst & Young, Global Strategic International Trade Team, Dublin.

Email: colin.doolin@ie.ey.com.

Alternatively, contact Aidan Meagher, Director, Ernst & Young, International Tax Services. Email: aidan.meagher@ie.ey.com.

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WASTE MANAGEMENT

INDAVER: YOUR WASTE MANAGEMENT PARTNER

I

ndaver’s Total Waste Management service is designed to meet the needs of large international industrial companies, primarily from the pharmaceutical and chemical sectors. Indaver manages all waste streams generated on the customer’s site in accordance with the EU waste hierarchy. Regular reviews ensure waste management services are optimised in a cycle of continuous improvement. ISO accredited for over a decade, Indaver provides full compliance with Irish, UK, EU, Environmental and Health & Safety legislation and all relevant ADR and IMDG transport legislation.

European Network A leading European waste management company, Indaver has been established in Ireland since 1977. Their core business is running specialised

facilities and managing intelligent waste management systems, focusing on sustainable material and energy management. With over 30 years’ experience, Indaver has the expertise to provide sustainable, cost effective and tailored total waste management solutions to offer customers the lowest total cost of ownership.

Indaver’s European network of hazardous waste processing facilities and strong data management systems ensures the flexibility to meet customers’ needs and the ability to provide full traceability from the point of collection to final disposal. Customers also have secure access to their own online reports.

Assets in Ireland Indaver’s facilities in Ireland include the EPA licensed Dublin Port Hazardous Waste Facility, incorporating a transfer

station, a laboratory and a state-ofthe-art solvent recovery facility. For non-hazardous waste, Indaver’s €140m waste-to-energy facility in Duleek, Co. Meath, has been operating since August 2011, and is helping Ireland meet its EU and national objectives by diverting municipal solid waste away from landfill and up the waste hierarchy to recovery every year.

The company recently received planning permission, allowing for an additional 10% capacity to treat hazardous waste. This brings to 220,000 tonnes the amount of waste that will be turned into energy for the equivalent of 25,000 homes. The wasteto-energy facility in Meath, which will take in hazardous waste, is the first of its kind in Ireland. Indaver is committed to providing Irish industry with secure, cost-effective and sustainable waste solutions.

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54

R&D

New Web Resource Targets R&D FUNDING OPPORTUNITIES

A

n important new web resource for business detailing R&D funding opportunities and jobs was launched recently, as an extension of the www.euraxess.ie portal.

The portal brings together a number of important resources that companies can access directly: • •

Advertise vacancies; Search an online database of researcher CVs; • Access the fast track research visas system; • Search for funding support opportunities.

The new R&D funding search facility allows businesses to search in real-time for all national and European funding supports for their business and research activities. This will address a common industry concern that this infor-

mation is both fragmented and difficult to access.

BOOSTING R&D “This great new resource will give a boost to research and development and clearly demonstrates that when it comes to innovation, Ireland is open for business,” said Minister for Research and Innovation, Sean Sherlock TD, at its launch.

“Businesses have specifically asked for a one-stop shop for these queries and that is exactly what this new portal does.”

The portal has been developed by the Irish Universities Association EURAXESS office, which is supported by the Department of Jobs, Enterprise and Innovation and the European Commission. It is the first of its kind in the wider European EURAXESS network of over 200 EURAXESS mobility centres in 40 countries across Europe.

Pictured are EU Commissioner Maire Geoghegan-Quinn; Minister Sean Sherlock TD; Jennifer Cleary, EURAXESS Ireland; Anthony McCauley, Fujitsu; and David Prendergast, Intel.

The European Commissioner for Research and Innovation, Máire Geoghegan-Quinn, underlined the importance of this new service: “This new Industry User Interface will make EURAXESS Ireland more attractive to industry. We will be exploring the possibility of rolling this out to other countries, so that business users across Europe will have a tailored interface including both job and funding opportunities.”

www.euraxess.ie/business PROVIDING SOLUTIONS FOR INDUSTRY R&D One click access to a tailored web resource to support your R&D activities.

The www.euraxess.ie/business interface provides a number of important free resources: FUNDING SEARCH

FAST TRACK IMMIGRATION

Comprehensive search for Irish and European funding opportunities supporting R&D, recruitment and general business development for companies.

Free and fast processing service for overseas R&D personnel.

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CV DATABASE

ADVERTISE A JOB

Helping you find R&D Candidates.

Enabling companies to freely advertise research positions on EURAXESS Ireland, EURAXESS Europe and Nature Jobs.

READ MORE

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For more information contact: Jennifer Cleary, EURAXESS Ireland Manager, Phone: 01 6764948 | Email: jennifer.cleary@iua.ie

55

GDP Guidelines

New Guidelines “Long Overdue” Embracing and adopting the new EU GDP Guidelines is vital to ensure Ireland remains a driving global force in life sciences, writes Michael O’Kane, Business Development Manager, with World Courier Ireland.

I

reland has been a driving force in global life science research & development and manufacturing for over 40 years, and like in many other countries, it is widely acknowledged that the life science landscape and the global needs of its inhabitants are constantly evolving.

Being able to remain competitive and bringing value to both existing and new product life cycles is critical to continued success.

In essence, it means being able to guarantee complete compliance with all new regulatory requirements, ensuring that your business organisation takes the correct steps to making sure that all is in place.

High on the agenda of all pharmaceutical companies, CROs and investigators are the EU GDP Guidelines, published on March 7, 2013.

Distributors and logistics providers must all ensure compliance and this article provides an insight into how World Courier perceives

the new legislation and how you can incorporate it into your own business model.

LONG OVERDUE After almost two years of review, an updated GDP guideline for EU distribution of medicinal products for human use was published in the Official Journal of the European Union in March. This new guideline replaces the existing directive (94/C 63/03) that has been in effect since 1994.

Compliance with the 2013 EU Guideline (2013/C 68/01) becomes mandatory six months after date of publication, or on September 7, 2013.

“This new guideline is long overdue,” says Dr Ruediger Lomb, Global Director of Quality and Technical Compliance for World Courier Group.

“The globalisation of the industry over the past two decades has increased risk exponentially for pharmaceutical companies, medical professionals and patients.

“The tendency to outsource

production to locations around the world has led to quantum changes in storage and transportation requirements, in the number of parties now involved in the supply chain, in the competency and qualification of these suppliers, and in the oversight required,” he continues. “Factor into this the stringent temperature requirements of many of today’s biological products and the spike in counterfeit drugs and we can readily see the importance of introducing regulatory change that better reflects our current distribution realities.”

CONCRETE REGULATIONS According to Dr Lomb, the vague generalities associated with the earlier directive have been replaced with concrete regulations in 2013. “The prevalent themes of responsibility, quality management and process control will go a long way towards actualising the EU’s objective of improving product quality and safety,” he says.

Pictured are (l-r): Declan Fortune, Customer Service; Gerry Maher, Country Manager; Martin Keoghan, Specialist Driver; and Michael O’Kane, Business Development Manager, World Courier Ireland.

56

GDP Guidelines

Key themes of the new GDP Guidelines include: Assigning Broad-Based Responsibility: Based on many of the principles that exist within current industry Good Manufacturing Practice (GMP) standards, the new guideline is much more extensive than its predecessor.

It holds the wholesale drug distributor – as well as any and all individuals or agents who perform services on its behalf – to the same standards as the manufacturer, calling for appropriate facilities, the availability of competent and sufficient personnel, documented processes, and appropriate quality management. By nature of the manufacturing authorisation, any manufacturer that distributes its own product is similarly required to comply with all GDP requirements.

Documented Quality Management Systems: Under the new guidelines, distributors will be required to maintain quality systems that clearly define and document all responsibilities, processes and risk management policies. The quality system must extend to the control and review of any outsourced activities related to the procurement, storage, supply, transport and import/ export of medicinal products, putting clear emphasis on the need for valid third-party vendor qualification.

About World Courier:

World Courier is the largest, most experienced specialty logistics provider in the world, operating a company-owned network of 152 ISO 9001-certified offices in over 50 countries, including 13 GMP-compliant investigational drug storage facilities in key emerging and strategic locations. With a fully GxP-compliant transport and supply chain system in place network-wide, World Courier meets the most demanding industry and regulatory requirements for managing time- and temperature-sensitive pharmaceutical shipments. World Courier was acquired in 2012 by AmerisourceBergen, one of the world's largest pharmaceutical services companies, ranked 29 on the Fortune 500 list.

World Courier considers itself to be fully compliant with the regulations set out in the 2013 EU Guideline. For more information on World Courier, Ireland, please contact: Michael O’Kane, Business Development Manager on 01 8624001, email mokane@worldcourier.ie or visit www.worldcourier.com.

and specialised handling for sensitive products such as temperature-controlled products, investigational medicinal products and commercial medications.

Call To Action Two logistical activities that come under scrutiny in the guideline, but to which no specific regulations have been associated, include the need for distributors/suppliers to establish: • Provisions that minimise the duration of temporary storage during transit; • Risk assessment of delivery routes to determine where temperature controls are required.

“While all of the details may not

Focus on Transportation: Addressing the complexity of physical distribution within today’s supply chain, regulations concerning transportation have been expanded considerably in the new guideline. Specific topics addressed include regulation of storage conditions during transit; the existence of appropriate and qualified vehicles and equipment by the transport supplier; documenting and reporting of temperature deviations; security precautions for deliveries; appropriate use of containers, packaging and labelling;

yet have been worked out and some of the specifics give distributors latitude in complying” says Dr Lomb, “this new EU guideline brings GDP to the next level. It is the current ‘gold standard’ in pharmaceutical regulation. The FDA has nothing comparable and while the USP (United States Pharmacopoeia) issued a long awaited update some months ago, this one has a different focus.

The EU guideline pretty much makes GMP rules mandatory for distribution.

Based on this, my recommendation for pharmaceutical distributors is to partner with a supplier such as World Courier Ireland, who have a proven, GxPcompliant track record in their area of specialty.”

World Courier Ireland’s Declan Fortune and Martin Keoghan are pictured loading up another delivery at their Irish headquarters in Santry, Dublin.

57

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Irish PharmaChem 2013/14

Chemical Suppliers Acids & alkalis

chiral compounds

Associated Chemicals Ltd Brenntag Ireland Camida Ltd Chemco Ireland Ltd Chemsource Industrial Division Corcoran Chemicals Limited Fisher Scientific Ireland Ltd Goulding Chemicals Ltd Heterochem Dist Ltd National Chemical Company Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin Solv-Echem Ireland Ltd Univar B.V.

Associated Chemicals Ltd Camida Ltd National Chemical Company

Activated carbons

fine chemicals

Associated Chemicals Ltd

Associated Chemicals Ltd Betco Marketing Ltd Brenntag Ireland Camida Ltd Chemco Ireland Ltd Chemsource Industrial Division Fisher Scientific Ireland Ltd Heterochem Dist Ltd National Chemical Company Ocon Chemicals Ltd P.K. Chemicals Ltd Solv-Echem Ireland Ltd Univar B.V.

biochemicals Associated Chemicals Ltd Brenntag Ireland Camida Ltd Fisher Scientific Ireland Ltd Ocon Chemicals Ltd

biocides Associated Chemicals Ltd Brenntag Ireland Camida Ltd Corcoran Chemicals Limited Heterochem Dist Ltd National Chemical Company P.K. Chemicals Ltd Univar B.V.

catalysts Associated Chemicals Ltd Brenntag Ireland Camida Ltd Corcoran Chemicals Limited Fisher Scientific Ireland Ltd Heterochem Dist Ltd National Chemical Company P.K. Chemicals Ltd

excipients Associated Chemicals Ltd Betco Marketing Ltd Brenntag Ireland Camida Ltd Corcoran Chemicals Limited Heterochem Dist Ltd National Chemical Company P.K. Chemicals Ltd Univar B.V.

gases Corcoran Chemicals Limited National Chemical Company

heterocyclics Associated Chemicals Ltd Camida Ltd National Chemical Company

inorganic chemicals Associated Chemicals Ltd Brenntag Ireland Camida Ltd Chemco Ireland Ltd Chemsource Industrial Division Fisher Scientific Ireland Ltd Heterochem Dist Ltd

58

Langanbach Services Ltd National Chemical Company P.K. Chemicals Ltd SciChem - Cork SciChem - Dublin Solv-Echem Ireland Ltd Univar B.V.

laboratory reagents Brenntag Ireland Corcoran Chemicals Limited Fisher Scientific Ireland Ltd gs1 Ireland National Chemical Company Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin Solv-Echem Ireland Ltd Water Chromatography Ireland

Misc. chemicals Associated Chemicals Ltd Brenntag Ireland Camida Ltd Chemsource Industrial Division Corcoran Chemicals Limited Fisher Scientific Ireland Ltd Heterochem Dist Ltd National Chemical Company Ocon Chemicals Ltd P.K. Chemicals Ltd SciChem - Cork SciChem - Dublin Solv-Echem Ireland Ltd Univar B.V.

oils, fats and waxes Associated Chemicals Ltd Brenntag Ireland Corcoran Chemicals Limited gs1 Ireland Heterochem Dist Ltd National Chemical Company P.K. Chemicals Ltd Univar B.V.

organic intermediates Associated Chemicals Ltd Brenntag Ireland Camida Ltd

Chemco Ireland Ltd Corcoran Chemicals Limited Fisher Scientific Ireland Ltd National Chemical Company Univar B.V.

SciChem - Cork SciChem - Dublin Water Chromatography Ireland

organometallics

Associiated Chemicals Ltd Brenntag Ireland Camida Ltd Fisher Scientific Ireland Ltd Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin Univar B.V.

Associated Chemicals Ltd Camida Ltd Corcoran Chemicals Limited National Chemical Company

reagents Associated Chemicals Ltd Brenntag Ireland Camida Ltd Corcoran Chemicals Limited Fisher Scientific Ireland Ltd gs1 Ireland National Chemical Company Ocon Chemicals Ltd

silanes

solvents Betco Marketing Ltd Brenntag Ireland Camida Ltd Chemco Ireland Ltd Chemsource Industrial Division Corcoran Chemicals Limited

Fisher Scientific Ireland Ltd gs1 Ireland Heterochem Dist Ltd National Chemical Company Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin Solv-Echem Ireland Ltd teva Pharmaceuticals Ireland Univar B.V. Water Chromatography Ireland

surfactants Associated Chemicals Ltd Brenntag Ireland Camida Ltd Corcoran Chemicals Limited Heterochem Dist Ltd Langanbach Services Ltd National Chemical Company Univar B.V.

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Johnson & Johnson Ireland Ltd. Airton Road, Tallaght, Dublin 24 PH: 01 4665200 Fax: 01 4665340 59

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General Suppliers Actuators

AUTOMATION

BLISTERING / DE-BLISTERING

Tyco Valves & Controls Ireland Ltd WrenTech Ltd

ABB Ltd Callaghan Engineering Goliath Packaging Systems Ltd gs1 Ireland LABPLAN O'Flynn Medical Ltd PJ Boner & Co. Ltd Weber Packaging Solutions Ltd

Catalent Pharma Solutions Goliath Packaging Systems Ltd SteriPack

BALANCES

BPRV BS&B Safety Systems Ltd

air filtration / monitoring / pollution control

Fisher Scientific Ireland Ltd Ocon Chemicals Ltd PJ Boner & Co. Ltd SciChem - Cork SciChem - Dublin

SciChem - Cork SciChem - Dublin

BARCODING / LABELLING TRACEABILITY

ALARMS

ALUMINIUM PRODUCTS

Goliath Packaging Systems Ltd gs1 Ireland Indaver Ireland Millmount Healthcare Weber Packaging Solutions Ltd

ProSys Containment and Sampling Technology Sartorius Mechatronics Weber Packaging Solutions Ltd

SteriPack

BIOpharmaceuticals

CAD

ANALYSIS SERVICES

Alkermes Pharma Ireland Limited

Callaghan Engineering

Anecto Catalent Pharma Solutions Indaver Ireland Lancaster Laboratories

BIOTECHNOLOGY

CALIBRATION

ABB Ltd Callaghan Engineering Catalent Pharma Solutions Labplan Ocon Chemicals Ltd Particular Sciences Ltd SciChem - Cork SciChem - Dublin

Dalkia Limited Endress & Hauser (Ireland) Ltd Labplan Ocon Chemicals Ltd PJ Boner & Co. Ltd Sartorius Mechatronics Water Chromatography Ireland

aerators WrenTech Ltd

agitators CPI Technology Ltd Quitmann O'Neill WrenTech Ltd

PJ Boner & Co. Ltd

ANALYTICAL EQUIPMENT ABB Ltd Fisher Scientific Ireland Ltd LABPLAN PJ Boner & Co. Ltd SciChem - Cork SciChem - Dublin

AUTOCLAVES Fisher Scientific Ireland Ltd Goliath Packaging Systems Ltd GS1 Ireland Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin WrenTech Ltd

BLENDERS Fisher Scientific Ireland Ltd Goliath Packaging Systems Ltd SciChem - Cork SciChem - Dublin WrenTech Ltd

BLOWERs CPI Technology Ltd Flexachem Manufacturing Ltd

BURSTING / RUPTURE DISCS BS&B Safety Systems Ltd CPI Technology Ltd Flexachem Manufacturing Ltd

CABINETS

CENTRIFUGES CPI Technology Ltd Fisher Scientific Ireland Ltd Labplan Ocon Chemicals Ltd Sartorius Mechatronics SciChem - Cork SciChem - Dublin

CHEMICAL CONSULTANTS Callaghan Engineering

60

CHROMATOGRAPHY Fisher Scientific Ireland Ltd Labplan Ocon Chemicals Ltd Particular Sciences Ltd SciChem - Cork SciChem - Dublin Water Chromatography Ireland

CLEANROOMS Callaghan Engineering Dalkia Limited Millmount Healthcare Ocon Chemicals Ltd

CLeaning SERVICES / EQUIPMENT Goliath Packaging Systems Ltd gs1 Ireland WrenTech Ltd

COLD CHAIN PACKAGING Catalent Pharma Solutions CRS Pharma Solutions gs1 Ireland Millmount Healthcare

COMPRESSED AIR / COMPRESSORS Dalkia Limited Festo Ltd Idex Pump Technologies (Ireland) Ltd

COMPUTER SYSTEMS gs1 Ireland Premier Validation Weber Packaging Solutions Ltd

CONDENSORS CPI Technology Ltd Cross Technical Solutions Flexachem Manufacturing Ltd Graham Hart (Process Technology) Ltd

CONract Pharma Services Alkermes Pharma Ireland Limited

CONVEYORS Goliath Packaging Systems Ltd Weber Packaging Solutions Ltd WrenTech Ltd

COOLING SYSTEMS CPI Technology Ltd Cross Technical Solutions Dalkia Limited Goliath Packaging Systems Ltd

DATA ACQUISITION ABB Ltd Endress & Hauser (Ireland) Ltd Labplan PJ Boner & Co. Ltd Weber Packaging Solutions Ltd

DESIGN Callaghan Engineering Cross Technical Solutions Graham Hart (Process Technology) Ltd Pilz Ireland SteriPack

DiSPERSERS Fisher Scientific Ireland Ltd Ocon Chemicals Ltd WrenTech Ltd

DISTILLATION CPI Technology Ltd Fisher Scientific Ireland Ltd Graham Hart (Process Technology) Ltd Labplan Ocon Chemicals Ltd Soltec (Ireland) Ltd

DRIERS

CONDITION MONITORING

CPI Technology Ltd

Dalkia Limited Flexachem Manufacturing Ltd PJ Boner & Co. Ltd

DRUMS / CONTAINERS

CONSTRUCTION MANAGEMENT Callaghan Engineering Portakabin Allspace

Carbon Group Chemco Ireland Ltd Complas Packaging Ltd Indaver Ireland Industrial Packaging Ltd Ocon Chemicals Ltd Quitmann O'Neill WrenTech Ltd 61

EDUCATION & TRAINING CPI Technology Ltd Euraxess gs1 Ireland HRB Clinic Research Facility McGee Pharma International Pilz Ireland Science Foundation Ireland (SFI) Water Chromatography Ireland

EFFLUENT MONITORING / TREATMENT TREATMENT Carbon Group Endress & Hauser (Ireland) Ltd Flexachem Manufacturing Ltd Lancaster Laboratories PJ Boner & Co. Ltd

ELECTRICAL Callaghan Engineering PJ Boner & Co. Ltd

ELECTRONIC COMPONENTS Pilz Ireland

ENERGY EFFICIENCY / MANAGEMENT Berkley Group Callaghan Engineering Dalkia Limited Endress & Hauser (Ireland) Ltd Sustainable Energy Authority of Ireland

ENGINEERING SERVICES Berkley Group Callaghan Engineering Cross Technical Solutions Dalkia Limited Henley Forklift Group Limited Pilz Ireland PJ Boner & Co. Ltd

eNVIRONMENTAL CONSULTING ABB Ltd Callaghan Engineering Pilz Ireland

ENVIRONMENTAL SERVICES/ EQUIPMENT ABB Ltd Indaver Ireland Pilz Ireland PJ Boner & Co. Ltd Quitmann O'Neill

g en eral S U PPL IER S

Irish PharmaChem 2013/14

g e n eral S U PPL IER S

Irish PharmaChem 2013/14 EVAPORATORS Cross Technical Solutions Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd Graham Hart (Process Technology) Ltd Labplan

Endress & Hauser (Ireland) Ltd Flexachem Manufacturing Ltd Tyco Valves & Controls Ireland Ltd

FLUID HANDLING

Clip Ltd Ireland

CPI Technology Ltd Idex Pump Technologies (Ireland) Ltd Labplan SciChem - Cork SciChem - Dublin WrenTech Ltd

EXPLOSION PROOFING

FUME CUPBOARDS

Henley Forklift Group Limited Pilz Ireland Sartorius Mechatronics

Fisher Scientific Ireland Ltd Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin

EXHIBITION DESIGN & DISPLAY

EXPLOSION PROTECTION / PANELS

FURNACES

BS&B Safety Systems Ltd CPI Technology Ltd Henley Forklift Group Limited Pilz Ireland

SciChem - Cork SciChem - Dublin

FACILITY DESIGN

Cross Technical Solutions Fisher Scientific Ireland Ltd SciChem - Cork SciChem - Dublin

Callaghan Engineering

FACILITIES MANAGEMENT

GAS DETECTION

GAUGES

Goliath Packaging Systems Ltd gs1 Ireland Hochtief Facility Managemen Portakabin Allspace

Fisher Scientific Ireland Ltd Ocon Chemicals Ltd PJ Boner & Co. Ltd

FILLING EQUIPMENT

GLASSWARE

Goliath Packaging Systems Ltd Quitmann O'Neill WrenTech Ltd

Associated Chemicals Ltd CPI Technology Ltd Fisher Scientific Ireland Ltd Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin

FILTERS CPI Technology Ltd Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd Ocon Chemicals Ltd

FILTRATION Associated Chemicals Ltd CPI Technology Ltd Flexachem Manufacturing Ltd Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin

FLOW CONTROL

GRINDING CPI Technology Ltd

HAZARDOUS WASTE DISPOSAL / TREATMENT gs1 Ireland Idex Pump Technologies (Ireland) Ltd Indaver Ireland Ocon Chemicals Ltd Quitmann O'Neill Soltec (Ireland) Ltd

CPI Technology Ltd

62

HEALTH & SAFETY / FIRST AID Ocon Chemicals Ltd Pilz Ireland

HEAT EXCHANGERS CPI Technology Ltd Graham Hart (Process Technology) Ltd Labplan ProSys Containment and Sampling Technology

HOMOGENISERS CPI Technology Ltd Fisher Scientific Ireland Ltd SciChem - Cork SciChem - Dublin WrenTech Ltd

HOSES CPI Technology Ltd

HYDRAULICS Henley Forklift Group Limited WrenTech Ltd

INCINERATION Indaver Ireland Tyco Valves & Controls Ireland Ltd

INCUBATORS Fisher Scientific Ireland Ltd Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin

INJECTION MOULDING Allstop Europe Ltd

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SciChem - Cork SciChem - Dublin Tyco Valves & Controls Ireland Ltd

IT Callaghan Engineering gs1 Ireland Weber Packaging Solutions Ltd

INVESTMENT

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manafacture Portakabin Allspace Sartorius Mechatronics

materials handling / forklifts / pallet trucks

Ocon Chemicals Ltd

meters CPI Technology Ltd Dalkia Limited Fisher Scientific Ireland Ltd Ocon Chemicals Ltd

microscopes

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Fisher Scientific Ireland Ltd Ocon Chemicals Ltd SciChem - Cork SciChem - Dublin

lab equipment / supplies

mechanical engineering services

Carbon Group Goliath Packaging Systems Ltd gs1 Ireland Labplan Ocon Chemicals Ltd PJ Boner & Co. Ltd Solv-Echem Ireland Ltd SciChem - Cork SciChem - Dublin WrenTech Ltd

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legal / financial / insurance

mechanical & process engineering

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logistics C&G Logistics Group gs1 Ireland KWE (Ireland) Ltd Solv-Echem Ireland Ltd Weber Packaging Solutions Ltd

lifts & hoists Goliath Packaging Systems Ltd Henley Forklift Group Limited WrenTech Ltd

machine tools Lister Machine Tools Ltd Soltec (Ireland) Ltd

maintenance CPI Technology Ltd Dalkia Limited gs1 Ireland Hochtief Facility Management Sartorius Mechatronics UK Ltd

medical device manufacture

milling

mixers CPI Technology Ltd Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd Goliath Packaging Systems Ltd SciChem - Cork SciChem - Dublin Tyco Valves & Controls Ireland Ltd WrenTech Ltd

noise / odour control Associated Chemicals Ltd Flexachem Manufacturing Ltd

oem manufacturing

membrane filtration systems

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Anecto Catalent Pharma Solutions Complas Packaging Ltd gs1 Ireland Industrial Packaging Ltd Quitmann O'Neill SteriPack Weber Packaging Solutions Ltd

packaging / machinery Goliath Packaging Systems Ltd gs1 Ireland

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Irish PharmaChem 2013/14 Interpac Millmount Healthcare NPP Group Ltd Quitmann O'Neill Smurfit Kappa Ireland Weber Packaging Solutions Ltd WrenTech Ltd

pallets Goliath Packaging Systems Ltd gs1 Ireland Quitmann O'Neill

pharmaceuTical fabrication gs1 Ireland Tyco Valves & Controls Ireland Ltd

pipes / cores CPI Technology Ltd Flexachem Manufacturing Ltd Industrial Packaging Ltd Smurfit Kappa Ireland

plastic containers Carbon Group Fisher Scientific Ireland Ltd Industrial Packaging Ltd Measom Freer Medisize Ireland Ltd Ocon Chemicals Ltd PrimePac Ltd SciChem - Cork SciChem - Dublin

plastIC CORES / TUBES Industrial Packaging Ltd Ocon Chemicals Ltd Smurfit Kappa Ireland

pneumatics Flexachem Manufacturing Ltd PJ Boner & Co. Ltd

pollution control Callaghan Engineering

powDer handling Carbon Group CPI Technology Ltd Goliath Packaging Systems Ltd Idex Pump Technologies (Ireland) Ltd ProSys Containment and Sampling Technology Quitmann O'Neill

Tyco Valves & Controls Ireland Ltd WrenTech Ltd

protective clothing / apparatus

pressure measurements / switches / vessels

Fisher Scientific Ireland Ltd Ocon Chemicals Ltd

BS&B Safety Systems Ltd Flexachem Manufacturing Ltd

pumps

pressure relief BS&B Safety Systems Ltd CPI Technology Ltd Flexachem Manufacturing Ltd Pilz Ireland Tyco Valves & Controls Ireland Ltd

pressure vessels CPI Technology Ltd Flexachem Manufacturing Ltd Graham Hart (Process Technology) Ltd

print packaging Contego Packaging Group gs1 Ireland SteriPack Weber Packaging Solutions Ltd

process control ABB Ltd Callaghan Engineering Endress & Hauser (Ireland) Ltd Pilz Ireland PJ Boner & Co. Ltd Sartorius Mechatronics Tyco Valves & Controls Ireland Ltd

process design ABB Ltd Callaghan Engineering gs1 Ireland Pilz Ireland Tyco Valves & Controls Ireland Ltd

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r&d Euraxess Ireland Fisher Scientific Ireland Ltd Lancaster Laboratories SciChem - Cork SciChem - Dublin TopChem Pharmaceuticals Ltd Tyco Valves & Controls Ireland Ltd

REACTORS CPI Technology Ltd Flexachem Manufacturing Ltd Tyco Valves & Controls Ireland Ltd

recruitment Berkley Group Brightwater ICDS Recruitment Consultants Lancaster Laboratories

refrigeration / freezing

Pilz Ireland Tyco Valves & Controls Ireland Ltd

Cross Technical Solutions CRS Pharma Solutions Dalkia Limited Fisher Scientific Ireland Ltd Langanbach Services Ltd SciChem - Cork SciChem - Dublin

project management

renewable energy

ABB Ltd Callaghan Engineering Goliath Packaging Systems Ltd gs1 Ireland Pilz Ireland

ABB Ltd Callaghan Engineering Dalkia Limited Sustainable Energy Authority of Ireland

process & mechanical engineering contractors

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RESPIRATORY PHARMACEUTICALS Teva Pharmaceuticals Ireland

robotics Goliath Packaging Systems Ltd gs1 Ireland Labplan

sanitary tubing CPI Technology Ltd Flexachem Manufacturing Ltd

scada / dcs / mis ABB Ltd Callaghan Engineering PJ Boner & Co. Ltd

scrubbers Flexachem Manufacturing Ltd Graham Hart (Process Technology) Ltd

seals & gaskets Flexachem Manufacturing Ltd Quitmann O'Neill Tyco Valves & Controls Ireland Ltd

sieving Fisher Scientific Ireland Ltd Ocon Chemicals Ltd Particular Sciences Ltd WrenTech Ltd

software gs1 Ireland Sartorius Mechatronics

solvent recovery / services Carbon Group CPI Technology Ltd Soltec (Ireland) Ltd

stainless steel / fitting / products CPI Technology Ltd Idex Pump Technologies (Ireland) Ltd National Chemical Company Quitmann O'Neill Tyco Valves & Controls Ireland Ltd WrenTech Ltd Weber Packaging Solutions Ltd

stEAM EQUIPMENT

transport & logistics

CPI Technology Ltd Flexachem Manufacturing Ltd Tyco Valves & Controls Ireland Ltd

C&G Logistics Group Celtic Forwarding Ltd gs1 Ireland Henley Forklift Group Limited KWE (Ireland) Ltd National Chemical Company Quitmann O'Neill Weber Packaging Solutions Ltd

storage / bunding CRS Pharma Solutions Goliath Packaging Systems Ltd gs1 Ireland SciChem - Cork SciChem - Dublin

tube sets / disposables

storage of hazardous materials

Fisher Scientific Ireland Ltd Langanbach Services Ltd Ocon Chemicals Ltd

C&G Logistics Group

vacum systems

supply chain management

CPI Technology Ltd Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd WrenTech Ltd

C&G Logistics Group Catalent Pharma Solutions gs1 Ireland KWE (Ireland) Ltd National Chemical Company Solv-Echem Ireland Ltd

tableting equipment Flexachem Manufacturing Ltd Goliath Packaging Systems Ltd WrenTech Ltd

tanks Celtic Forwarding Ltd Complas Packaging Ltd Flexachem Manufacturing Ltd Quitmann O'Neill

temperature control Endress & Hauser (Ireland) Ltd Flexachem Manufacturing Ltd gs1 Ireland Ocon Chemicals Ltd PJ Boner & Co. Ltd Tyco Valves & Controls Ireland Ltd

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validation ABB Ltd Callaghan Engineering Cross Technical Solutions Pilz Ireland McGee Pharma International Lancaster Laboratories

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vision systems Weber Packaging Solutions Ltd

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C/O Irish Universities Association, 48 Merrion Square Dublin 2.

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maclachlan & donaldson Address:

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47 Merrion Square, Dublin 2.

(01) 676 3465 (01) 661 2083 mail@maclachlan.ie www.maclachlan.ie Intellectual Property Attorneys.

Dr. Yvonne McKeown

McGee Pharma International Address:

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Web: Business:

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Suite 2, Stafford House, Strand Road, Portmarnock, Co. Dublin.

(01) 846 4742 (01) 846 4898 info@mcgeepharma.com www.mcgeepharma.com Pharmaceutical Quality, Technical & Compliance Specialist Consultancy.

Jane Lyons

measom freer Address:

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37-41 Charwell Drive, Wigston, Leicester, LE18 2FL, UK. (0044) 1162 881588 (0044) 1162 813000 sales@measomfreer.co.uk www.measomfreer.co.uk Manufacturer.

Sales Director: Mark Freer

medisize ireland ltd Address:

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High Road, Letterkenny, Co. Donegal.

(074) 918 8549 info@medisize.com www.medisize.com Contract manufacturer of primary pharmaceutical packaging and medical and diagnostic devices.

merck millipore Address: Tullagreen,

Carrigtwohill,

Co. Cork.

Tel: (021) 488 3666 Fax: (021) 488 3048 Email: liz.henderson@merckgroup.com Web: www.merckmillipore.com Business: Life Science.

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Liz Henderson

millmount heathcare Address:

Tel: Fax: Email: Web: Business:

Contact:

Block 7, CityNorth Business Campus, Stamullen, Co. Meath.

(01) 841 8300 (01) 841 8039 info@millmount.com www.millmounthealthcare.ie Full-service contract packaging service provider for the pharmaceutical industry.

Fully licensed for primary/ secondary packaging, warehousing and EU batch releases.

Managing Director: Pascal Keogh

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NATIONAL CHEMICAL COMPANY Address:

Tel: Fax: Email:

Web: Business:

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NCC House, 42 Lower Leeson St., Dublin 2.

(01) 613 1400 (01) 634 0132 sales@ncc.ie www.ncc.ie Supply Chain PartnerLife Sciences Industry Sales Director: Christy Smith

npp group ltd Address:

Unit 509, Mitchelstown Road,

73

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Web: Business:

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Northwest Business Park, Ballycoolin, Blanchardstown, Dublin 15.

(01) 880 9299 sales@npp.ie bmcmahon@npp.ie www.npp.ie Flexible packaging suppliers & distributors.

Sales Director: Eoin McDonagh

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o'flynn medical ltd Address:

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Contact:

Westend, Millstreet, Co Cork.

(029) 21 799 (029) 70 191 info@oflynnmedical.com www.oflynnmedical.com Distributor of Scrubex "Automated Protective Clothing Distributor".

Managing Director: Tadhg O'Flynn

OCON CHEMICALS LTD Address:

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Web: Contact:

Unit 5, South Cork Industrial Estate, Vicars Road, Pouladuff, Co. Cork.

(021) 431 8555 (021) 431 8560 info@oconchemicals.com www.oconchemicals.ie Managing Director: Frank Mulcahy

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particular sciences ltd Address:

Tel: Fax: Email: Web: Business:

2 Birch House, Rosemount Business Park, Ballycoolin Road, Dublin 11.

(01) 820 5395 (01) 822 8813 info@particular.ie www.particular.ie Scientific instruments, sales and support, material characterisation.

pilz ireland Address:

Tel: Fax:

Cork Business & Technology Park, Model Farm Road, Co. Cork.

(021) 434 6535 (021) 480 4994

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C o mpa n y lis t i n g s

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sales@pilz.ie www.pilz.ie Process and machinery safety engineering services and training.

Sales Manager: Andrew Donnelly MD: John McAuliffe

P.k. chemicals ltd Address:

Tel: Fax: Email: Business: Contact:

Unit 23, Sandyford Office Park, Blackthorn Avenue, Foxrock, Dublin 18.

(01) 295 6977 (01) 295 8338 debbie@pkchemicals.com Chemical Distributor.

Purchasing and Sales Manager: Sarah Murphy

Premier Validation Address:

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Tyone, Nenagh, Co. Tipperary.

(01) 443 4016 (0906) 460 301 graham.okeeffe@ premiervalidation.com www.premiervalidation.com Validation and regulatory compliance specialist.

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SARTORIUS MECHATRONICS UK LTD Address:

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Prime Pac Ltd Address:

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Unit 2, Newpark Industrial Estate, Antrim, BT41 2DU. (0044) 2894 428 188 (0044) 2894 428 177 sales@primepacltd.com www.primepacltd.com Manufacturer & supplier of plastic containers.

Director: John McGahon

SCICHEM - CORK Address:

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ProSys Containment And Sampling Technology PORTAKABIN ALLSPACE Address: Roseville Business Park,

Turvey Avenue,

Donabate, Co. Dublin.

Tel: (01) 808 5055 Fax: (01) 808 5150 Email: msheedy@portakabinallspace.ie Web: www.allspace.ie Business: Modular and portable

buildings supply and

manufacture.

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Mike Sheedy

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Building C, Athlone Business & Technology Park, Garrycastle, Athlone, Co. Westmeath.

(0906) 460 300 (0906) 460 301 susan.neenan@ppdi.com www.ppdi.com Contract Research Organisation.

Director, GMP Labs, Europe: Susan Neenan

UIDA Business Park, Carrigtohill, Co. Cork.

(021) 485 3900 (021) 485 3866 mmcl@prosys.ie www.prosys.ie

Address:

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Quintiles Ireland Ltd Address:

Tel: Fax: Web: Business:

Contact:

Eastpoint Business Park, Fairview, Dublin 3.

(01) 819 5100 (01) 809 9500 www.quintiles.com Clinical Research and Development.

Managing Director: John Kiernan

Quitmann Oâ&#x20AC;&#x2122;Neill Packaging Ltd Address:

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St. Brendanâ&#x20AC;&#x2122;s Road, Portuma, Co. Galway.

(090) 974 1148/9 (090) 974 1459 sales@quitmannoneill.com www.qonpack.com Packaging stockist & distributers.

General Manager: David Oâ&#x20AC;&#x2122;Neill

Unit 14, Barryscourt Business Park, Carrigtwohill, Co. Cork.

(021) 488 2388 (021) 488 2389 cork@scichem.com www.scichem.com Laboratory Suppliers.

Branch Manager: John Molloy

SCICHEM â&#x20AC;&#x201C; DUBLIN

COMPANY LISTINGS

PPD, Inc.

Address:

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Unit 41, The Business Centre, Stadium Business Park, Ballycoolin Road, Dublin 11.

(01) 808 3050 (01) 808 9388 info.ireland@sartorius.com www.sartorius.com Laboratory & Process technology provider.

Sales & service of laboratory & process weighing equipment.

Nick Parsons

Greenhills Industrial Estate, Walkinstown, Dublin 12.

(01) 450 4077 (01) 450 4328 dublin@scichem.com www.scichem.com Laboratory Suppliers.

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Ballymount Road, $GGUHVV %DOO\PRXQW 5RDG

Walkinstown, :DONLQVWRZQ

Dublin 12.

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Zone A, Mullingar Business Park, Mullingar, Co. Westmeath.

(044) 933 5133 info@soltec.ie www.soltec.ie Soltec is Ireland’s only commercially operated solvent recycling plant.

Solid hazardous waste collections also provided.

Business Development Manager: Michael Corcoran

SOLV-ECHEM IRELAND LTD Address:

Tel: Email: Web: Business:

Contact:

Great Island Industrial Park, Ballincollig, Co. Cork.

(021) 487 7066 tony@solvechem.com www.solvechem.com Chemical distribution, chemicals, solvents, water treatment, warehousing.

Director: Tony Murray

Science foundation ireland (SFI) Address:

Tel: Fax: Email:

Web: Business:

Contact:

Wilton Park House, Wilton Place, Dublin 2.

(01) 607 3200 (01) 607 3201 info@sfi.ie www.sfi.ie Government funding agency for research.

Director - Programmes, Enterprise & International Affairs: Dr. Ruth Freeman

SUSTAINABLE ENERGY AUTHORITY OF IRELAND Address: Tel: Fax: Email: Web: Business:

Glasnevin, Dublin 9.

(01) 836 9080 (01) 837 2848 info@sei.ie www.sei.ie Energy advice & information.

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TEDAC LTD Address:

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31 Cleeve Lodge Road, Downend, Bristol, England, BS16 6AF. 004417 910 4821 0044751 566 0775 info@tedac.co.uk www.tedac.co.uk Temperature and humidity mapping services.

Director: Chris Bell

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Tel: Fax: Email:

Web: Business:

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Kilbeggan Road, Clara, Co. Offaly.

(057) 933 1888 (057) 933 1887 info@steripackgroup.com www.steripackgroup.com Contract Manufacturing Services, Medical And Pharmaceutical Packaging, Test Laboratory Services.

Sales Manager: Colm Flood

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Tel: Fax: Business:

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Killeen Road, Dublin 12.

(01) 419 0200 (01) 419 0325 Forklift and Warehouse Supplies.

Terry O’ Reilly

TYCO VALVES & CONTROLS IRELAND LIMITED Address:

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Victoria House, Beaumont Avenue, Churchtown, Dublin 14.

(01) 295 1101 tkilbane@tyco-valves.com www.tycoflowcontrol-eu.com Industrial valves & controls.

General Manager: Tony Kilbane

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teva pharmaceuticals ireland Address:

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Unit 301, IDA Industrial Park, Waterford.

(051) 331 331 www.teva.ie Respiratory Pharmaceutical R&D and Manufacture.

Managing Director: Andy Crowley

TOPCHEM PHARMACEITICALS LTD STERIPACK

Toyota Material Handling Ireland Ltd

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Ballymote Business Park, Carrownanty, Ballynote, Co. Sligo.

(071) 918 9685 (071) 919 7864 donal@topchempharma.com www.topchempharma.com Development and manufacture of pharmaceutical active ingredients.

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Univar B.V. Address: 536 Grants Crescent,

Greenogue Business Park,

Rathcoole,

Co. Dublin.

Tel: (01) 401 9800 Fax: (01) 401 9142 Email: pharma.sales@univareurope.com Business: Ingredients: pharma

industry including API’s,

xcipients, process chems,

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John McCluskey

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Weber Packaging :(%(5 $%(//,1* &2012 2',1* Solutions Ltd IRISH P / HARMA C HEM

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smurray@wrentech.ie &RQWDFW 6DOHV $GPLQLVWUDWRU Web: www.wrentech.ie Sales Administrator: Contact: 6LREKDQ 0XUUD\

$GGUHVV .LOFDQQRQ ,QG (VW Address: Kilcannon Industrial Estate, Old Dublin Road,

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F E B

St. OZe^gmbg^ l Day

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St. IZmkb\d l Day

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20 Easter Sunday

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Fhma^k l Day

Public Holiday

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Summer Time Begins

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Easter Monday

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Lm'Lm^ia^g l Day

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Irish I R I SPharmaChem HPharmaChem P H A R M A C H E2013/14 M2013 2012 Irish

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Products, Project Management and Services for the Healthcare Industry As one of the leading companies in the healthcare market, B. Braun is your professional and reliable outsourcing partner for pharmaceutical contract manufacturing and customized product variation and combination.

Rely on our expertise in infusion therapy and project management and contact us for your system-built outsourcing solution.

Products

Pharmaceutical solutions Medical devices Disinfection & hygiene

Project Managament

Product variation and combination Pharmaceutical contract manufacturing

Services

Analytical services Regulatory support Customer service

Contact us today to discuss your individual product and manufacturing requirements.

B. Braun Medical Ltd. | OEM Division | 3 Naas Road Industrial Park I Dublin 12 gary.glennon@bbraun.com I www.bbraunoem.com

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