Irish Pharmachem 2015

The Industry Buyers Guide 2015

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The Industry Buyers Guide 2015

CONTENTS 20

2

MINISTER’S FOREWORD

2 Ireland is in a strong position to benefit from new trends in the pharmaceutical and biopharmaceutical industry as the connectedness between companies and researchers increases, writes Richard Bruton TD, Minister for Jobs, Enterprise and Innovation.

44

Trials on medicinal products for human use is intended to set the global gold standard for clinical trials, writes Fionnuala Gibbons, Clinical Industry Liaison Officer, Molecular Medicine Ireland/Irish Clinical Research Infrastructure Network.

SUPPLY CHAIN SECTOR OVERVIEW

4

While the Patent Cliff had a significant impact on pharma exports, particularly last year, the signs in 2014 are that its worst effects are behind us and Ireland can look to the future with confidence, writes Matt Moran, Director, PharmaChemical Ireland.

26

Ann McGee, MD of McGee Pharma International, examines the Falsified Medicines Directive and the MA Holder’s responsibilities in ensuring the integrity of the pharmaceutical supply chain.

of the water-energy-waste nexus and finding ways to reduce the environmental and economic impact of this vital interdependency.

NEW PRODUCT DEVELOPMENT

42

Pfizer’s New Products Technology Laboratory is a hotbed for innovation in low volume, small molecule API manufacture.

RESEARCH & DEVELOPMENT 44 Enabling Flexibility in Analytical Operations The Synthesis and Solid State Pharmaceutical Centre

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 by strategically investing in research teams who generate new knowledge, leading-edge technologies and competitive enterprises in the fields of science and engineering.

10

Ireland is well positioned at the forefront of the development of orphan medicinal products, writes Jenny Loughney, Director, Irish BioIndustry Association, PharmaChemical Ireland.

INVESTMENT & DEVELOPMENT

14

Following a couple of challenging years, the Irish PharmaChem sector is in rude health again and a host of key investments mean that its future prospects look extremely bright, writes Barry Heavey, Head of IDA Life Sciences Division.

TRACEABILITY

18

The regulatory landscape for traceability of medicines continues to evolve globally, including the advent of the Falsified Medicines Directive, writes Siobhán Duggan, Healthcare Sector Director, GS1 Ireland.

CLINICAL TRIALS

20

The new Regulation No 536/2014 of the European Parliament and the Council of April 16 on Clinical

30

Horizon 2020, the EU programme for research and innovation, brings a wealth of opportunities for Ireland’s PharmaChem industry.

CHROMATOGRAPHY

34

Waters’ ACQUITY® QDa™ Detector is the culmination of their committed experience in mass spectrometry, resulting in an instrument with real innovation.

CONTRACT MANUFACTURING

Irish Pharmachem Cover12.indd 1

BIOTECHNOLOGY

HORIZON 2020

36

When it comes to contract manufacturing, B. Braun OEM, the B2B division of B. Braun, offers tailormade solutions for the healthcare industry.

CALIBRATION

37

at UL has a broadened remit, which should lead to more breakthroughs from molecule to medicine.

RECRUITMENT

49

When it comes to the pharma sector, Ireland’s tight talent pool is attracted to companies with strong employer branding, writes Steve Greenwood of Berkley Recruitment.

Listings Section 30/05/2012 14:57

Chemical Suppliers General Suppliers Company Listings Useful References

52 54 60 72

It is crucial that companies avoid the mistake of thinking that calibration is simply a regulatory requirement to be satisfied; it is much more valuable than that.

MATERIALS HANDLING

38

The Toyota Traigo 80 counterbalanced range is being extended up to 5.0 tons, bringing a host of benefits to users.

TEMPERATURE CONTROL

40

The team at CRS Pharma Solutions are experts in the storage of temperature sensitive pharmaceutical products.

ENERGY MANAGEMENT

41

Veolia’s core expertise is rooted in its understanding

1

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MINISTER’S FOREWORD

Bright Future for BioPharma in Ireland Ireland is in a strong position to benefit from new trends in the pharmaceutical and biopharmaceutical industry as the connectedness between companies and researchers increases, writes Richard Bruton TD, Minister for Jobs, Enterprise and Innovation.

F

ew people close to the industry need reminding of the key role that the pharma sector plays in the Irish economy:

• •

• •

Ireland is the world’s largest net exporter of pharmaceuticals, with exports valued at €56 billion.

Nine of the top 10 Pharmaceutical and 17 of the top 25 Medical Technology companies have significant operations in Ireland.

The industry contributes total tax receipts of €3 billion annually to the Irish economy.

50,000 people are directly employed in life sciences in Ireland, with an equivalent number employed in service provision to the industry.

Ireland has remained at the forefront of the pharma sector globally over recent decades and has proven to be a key location for many companies in this area.

A notable aspect of recent investments in this area has been the arrival of a number of exciting new companies investing in Ireland for the first time and looking to develop and

manufacture innovative new products in Ireland. These companies have made extremely significant investments in the construction of high tech facilities, creating employment in the specialised process engineering industry and the construction industry and bringing vibrancy, diversity and growth to the sector.

In the drive to make Ireland the location of choice, my Department and IDA Ireland are also working to ensure the availability of suitable property solutions through the provision of advance facilities.

Companies such as Regeneron, Alexion, Ethicon and Biomarin, have all cited the Government’s flagship National Institute for Bioprocess Research and Training (NIBRT) as a key determinant in their choice of Ireland as a location for investment.

Our indigenous life sciences sector has also performed strongly, now consisting of over 250 companies, supported by my Department through Enterprise Ireland. In 2013, this sector contributed over €1billion in sales, €760m in exports and employed over 6,000 people.

Research Prioritisation In February 2012, the Government

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

adopted the recommendations in the Report of the Research Prioritisation Steering Group as part of an overarching strategy aimed at accelerating the economic returns from public investment in research and innovation. The Research Prioritisation Steering Group has reported on excellent progress being made for the 14 identified Priority Areas, of which

Ireland has remained at the forefront of the pharma sector globally over recent decades and has proven to be a key location for many companies in this area.

2

MINISTER’S FOREWORD

a number are of relevance to PharmaChem, including: • • • • •

Connected Health and Independent Living; Medical Devices; Diagnostics; Therapeutics – Synthesis, Formulation, Processing and Drug Delivery; Manufacturing Competitiveness.

Collaboration Between Indigenous and Multinational Companies Ireland is developing a strong cluster of internationally recognised indigenous companies, providing high-end services and products for the pharmaceutiIreland is in a strong position to be a hub for convergence in bio-pharmaceuticals and medical devices. cal industry. These companies have benefited from having Future Trends ing and connected health solutions in a strong customer base in Emerging from the economic crisis with chronic disease.

Ireland and are now exporting to biostrong growth in the technology sectors,

ICT technology is also increaspharmaceutical manufacturing sites Ireland is in a strong position to benefit ingly part of the vision for next generation globally. Research centres such as manufacturing and the digital factory.

NIBRT and the Synthesis and Solid State from new trends in the industry as the connectedness between companies and Companies such as Intel are collaboratPharmaceutical Centre (SSPC) can researchers increases. Areas to watch in ing with bio-pharmaceutical companies serve as hubs to support collaboration life sciences include the convergence of like Amgen and Pfizer on addressing between innovative Irish companies and chemistry and biotechnology. Ireland is common issues in advanced manufacturmajor multinationals. extremely well positioned to be a location ing through research in the Irish Centre of choice for development and manufacfor Manufacturing Research (ICMR).

Collaboration with the turing of next-generation drugs.

Science Foundation Ireland has Clinical Community A similar area of interest is the recently provided significant expansion Arising from actions identified in the 2013 convergence of bio-pharmaceuticals and of their funding for the Synthesis and Action Plan for Jobs, the Government medical devices. Bio-pharmaceutical Solid State Pharmaceuticals Centre, led announced in July of this year that a companies are increasingly looking at

by University of Limerick, to support the National Health Innovation Hub, with the advanced medical devices to improve research in chemistry and formulation potential to support hundreds of new the efficacy and safety of drug delivery. relevant to the pharmaceutical induscompanies and thousands of new jobs, Again, Ireland is in a strong position to be try. In addition, Enterprise Ireland and will be established in 2014, following the a hub for convergence in this space, due IDA Ireland have funded the creation success of a Demonstrator project in to our very significant cluster in medical of the Pharmaceutical Manufacturing Cork and an independent evaluation of devices.

Technology Centre (PMTC) as an indusits role.

The diagnosis and monitoring try-led centre to support applied research

The National Health Innovation of disease, as well as decision-making on manufacturing in the pharmaceutical Hub will be a win-win for businesses, the in relation to disease treatment, has industry. health system and most importantly, for increasingly becoming a “big data” issue. job-creation: Ireland’s very strong cluster of ICT and Conclusion • Innovative Irish healthcare compa“born on the internet” companies creates I have no doubt that by working together nies will for the first time be able a significant opportunity for Ireland to in a collaborative way, we can build on to easily gain access to the health be a location of choice for collaboration our achievements to date to ensure that system to test their products and across the life sciences and ICT sectors. the life science sector can continue to be services, increasing the chances of

The Tyndall institute in Cork is a major success story for our country. developing commercial ideas and already very active in advanced materials I wish the Irish PharmaChem creating jobs; and microelectronic technology for use in Yearbook and PharmaChemical Ireland • The health system will be able to areas such as drug delivery devices, and every success in the year ahead. gain easy access to innovative comthe technology centre ARCH (Applied panies who can provide solutions to Research in Connected Health) is bringRichard Bruton TD, the problems that it faces, making it ing companies together to explore oppor- Minister for Jobs, Enterprise and cheaper and easier to deliver better tunities in technology for patient monitorInnovation health-care to more patients.

3

Sector overview

Worst Effects of Patent Cliff Behind Us While the Patent Cliff had a significant impact on pharma exports, particularly last year, the signs in 2014 are that its worst effects are behind us and Ireland can look to the future with confidence, writes Matt Moran, Director, PharmaChemical Ireland.

!"##"$%&'

M

uch has been written around the Patent Cliff and its impact on the sector here and the consequent impact on national Gross Domestic Product (GDP) numbers. A brief analysis of the export figures tell us that the worst effects of this were seen in 2013, when the total exports from the sector fell by around €5 billion to just over €50 billion in that year. This represented a fall of over 8% from 2012.

The number had fallen by just under 2% in 2012 over 2011, as the impacts of the cliff were starting to manifest themselves. The reasons for this have been well rehearsed at this stage, so there is no need to go over this ground again: a number of high profile blockbuster drugs coming to the end of their patent life.

With medicinal and pharmaceutical products accounting for over 50% of the national exports of goods that leave this country, much attention has been directed towards this number. However, a look at the first six months of this year gives cause for cautious optimism - see Table 1.

Chart 1

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-./01/4*12"3"

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Chart 1

The first category addressed in the table covers finished products – or the pack as seen by the consumer. The second category is the total number and includes Active Pharmaceutical Ingredients (APIs) as well as non-pharmaceutical chemicals.

Chart 1 shows that for both categories, the volume of exports is trending upwards again. This has positive effects on the annual growth rates, which can be seen in Table 1. For chemicals and allied products exports, the annual growth rates in May and June increased strongly by

Month

% Change: Medicinal Products

% Change: Chemicals and Allied Products

January

0.7

5.8

February

-2.2

1.5

March

-10.2

-11.0

April

-18.2

-10.0

May

12.5

12.3

June

-6.8

11.2

Matt Moran, Director, PharmaChemical Ireland.

Table 1 – Monthly comparisons Year on Year 2014/2013- Exports

4

Sector overview

12.3% and 11.2% respectively. All in all, the chart and table tells us that the drag on exports has slowed. Moreover, the drag should continue to slow and diminish as exports benefit from a strengthening of global demand.

This is reason to be optimistic

likely that this will result in the creation of over 2,000 new direct jobs in the sector, not to mention the additional indirect employment that will be created, as well as the construction jobs created during the development of these facilities.

It is worth sitting back and viewEuro millions

Projected Employment

Allergan- Biotech Manufacturing and Development

350

200

MSD Ballydine- R&D

100

100

Abbvie Sligo- R&D/Manufacturing

85

175

Pfizer Biotech- Development and Manufacturing

200

Biomarin- purchase of Pfizer Biotech site

40

Genzyme- Biotech Manufacturing

200

Eli Lilly- Biotech Manufacturing

330

200

Amgen- Biotech Manufacturing

150

100

Mylan

380

500

MSD Brinny

29

70

Regeneron- greenfield site

220

300

Pfizer- Ringaskiddy-Chemical Synthesis

22

Jazz Pharmaceuticals- greenfield site

50

50

Alexion- establishment of aseptic fill finish Athlone

N/A

50

Alexion- supply chain/laboratory/packaging- Dublin

75

250

Total

2231

2145

150

Table 2: Recent investment in the industry- 2011-2014

about the medium to long term future of the sector. But this is only half the story.

Another impact of the cliff and general overcapacity in the sector has been a number of high profile mergers, which have undoubtedly had impact in this country, with a corresponding number of high profile plant closures. Balanced against this has been a more or less continuous stream of new investments over the past couple of years. In the main, these investments are in biopharmaceutical manufacturing or high end chemical synthesis or product and process development. Table 2 lists a number of these.

As one can see from the table, just under €2.25 billion in new capital investment is in the process of being invested in the country as I write. It is

ing these investments a little more closely. They fall into two broad categories.

1.Expansion of Existing Operations.

These are investments made by existing companies who have operated successfully in this country for some time. These tend to fall into two further categories: product or process development and advanced or biopharmaceutical manufacture. Advanced manufacture would include high potency synthesis with options for continuous or plug and play operations, such as the new synthesis plant recently opened by Pfizer at their Ringaskiddy facility, which is actually a retrofit of an older, phased out plant.

This is an excellent example of a plant

5

moving in tandem with cutting edge developments in the space at a global level. MSD at Ballydine have established a state-of-the-art product development facility, co-located with their chemical synthesis plant. This is concentrating on drug development and chemical synthesis. Abbvie in Sligo have completed investment in pharmaceutical manufacture to the tune of over €85m. Mylan are investing €75m per annum over a five year period to 2016 in developing their pharmaceutical capabilities in Dublin and Galway.

Biopharmaceutical manufacturing that incorporates all aspects of utilising genetic engineering techniques to produce, purify, formulate and package large molecules, such as monoclonal antibodies, is recognised as a very important emerging technology for the future of the pharmaceutical industry.

It is vital that Ireland is a major player in this arena. The recent explosion of investment in this field in this country has pushed Ireland to second place behind the USA as a centre for the manufacture and development of such products.

There have been a number of high profile investments in this space; Eli Lilly will invest €330m in a second biomanufacturing facility at their Kinsale campus. What makes the Eli Lilly investment even more interesting is that fact that it is co-located with existing chemical manufacture, making this site unique in Ireland and Europe. Eli Lilly continue to invest in product and process development at the Co. Cork site, making them a living example of the development plus manufacturing strategy espoused in the PharmaChemical Ireland series of strategic plans, discussed at length in previous articles here.

Allergan continue on their journey of being the primary manufacturing and development location for the California based corporation by investing €350m in a new biologics facility in Westport. They intend to employ an additional 200 in this, bringing their total headcount well over the 1,000 mark, making them a vital part of the local economy in Co. Mayo.

The Pfizer Biopharmaceutical manufacturing site at Grangecastle in Dublin continues to be central to the future development of their biotech portfolio, leading the company to invest a further €200m at that site.

Meanwhile, companies like MSD at Brinny, Genzyme-Sanofi in

Sector overview

Waterford, and Amgen in Dublin continue to invest in their biotech operations.

2. New Greenfield Investments Making up the rest the capital being invested by the industry in the country are a number of new companies. These are generally emerging biotech companies, who tend to specialise in the rare or orphan disease space, similar to Genzyme, who established in Ireland a number of years ago. These are very high value products aimed at diseases of unmet therapeutic need in the main.

The value of these products means that they can achieve blockbuster or close to blockbuster status relatively quickly and from a national perspective can replace revenues lost as a result of the patent cliff.

A prime example of this would be Alexion, founded in 1992, whose drug, Soliris has been developed to treat paroxysmal nocturnal hemoglobinuria (PNH) and atypical haemolytic uremic syndrome (aHUS). Alexion have embarked on a three-phase investment in Ireland. They purchased part of the original Elan plant in Athlone to establish aseptic filling operations in the country.

This has been followed by a €75m investment at two locations in Dublin to establish supply chain, warehousing, laboratory and packaging operations. They plan to employ 300 in the country by 2016.

Regeneron, established in New York in 1988, has purchased the original Dell facility in Limerick and will bring a much needed investment of €220m to that city, creating 300 jobs in the process.

Regeneron, who already have offices in Dublin, will build a brand new biopharmaceutical manufacturing plant there.

Regeneron are also part of the new wave of US based biotech companies.

Biomarin purchased the existing Pfizer biotechnology campus in Rinkaskiddy, Co. Cork, and will create 100 jobs there. Biomarin are based in California and specialise in enzyme replacement therapies.

Jazz Pharmaceuticals plan to invest €50m, creating 50 new jobs, at a manufacturing site in Athlone. Jazz specialise in narcolepsy, hemotology, oncology and psychiatry.

Conclusion It is possible to conclude, therefore, that the biopharmaceutical and chemical sectors remain strong in Ireland.

New capital investment in Ireland's pharma sector culd lead to the creation of 2000 new jobs.

The Patent Cliff did impact exports, as PharmaChemical Ireland predicted a number of years ago. However, the strategic response of the sector, which PharmaChemical Ireland has led, through publication and execution on its strategic plan, appears to be bearing fruit.

The sharp fall-off in exports experienced between 2011 and 2013 seems to be tapering off quickly and the

significant level of investment in new cutting edge manufacture, bolstered by a much greater emphasis on product and process development here, will result in a boost to economic activity in the sector in the medium term.

The renewed emphasis on development will result in the generation of more local know-how and intellectual capital, which can only bode well for the long term future of the sector.

The fall-off in pharma exports in 2011 and 2013 seems to be tapering off quickly.

6

At Roche we focus on developing medicines and diagnostics that will help patients live longer, better lives.

For further information please contact Roche Ireland Limited Clarecastle Co. Clare Tel: (065) 686 7200

Science Foundation Ireland

Excellence with Impact

I

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.

reland is building a reputation as a world leader in scientific research capability, continuously climbing the international citation and innovation rankings to be in the top 20 countries overall for citations, while achieving rankings of 1st, 3rd and 4th in Immunology, Nanoscience and Computer Science research respectively. 2013 saw Ireland receive a special mention from leading scientific journal, Nature Magazine, as one of five ‘Up and Coming’ destinations for high level research based on the quality and quantity of scientific research being carried out in our Higher Education Institutes.

Ireland is committed to funding excellent and impactful research. SFI supports over 450 leading researchers who are involved in 2,000 national and international collaborations across 48 countries.

There have also been a number of key highlights for SFI over the past year. 2013 was an outstanding and productive year for the organisation and the research community it supports. SFI succeeded in meeting all of its targets under the Government’s Action Plan for Jobs, while its remit was further expanded under the Industrial Development (Science Foundation Ireland) (Amendment) Act. Some of the key highlights are listed below: •

•

Seven new world leading research centres delivered through €300m investment from SFI and over 150 companies – the largest collaborative research programme in the history of Ireland.

SFI invested €152m in 307 new research awards to 20 institutions in Ireland.

• •

•

2,656 researchers supported through SFI programmes in 2013.

54 patents registered, 27 technologies licensed and four spin-off companies created.

SFI awards directly supported over 900 collaborations with industry.

THE SFI STRATEGY – AGENDA 2020 Agenda 2020, SFI’s ambitious seven-year strategic plan, lays out four key 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 SFI supports over 450 leading researchers in 2,000 national and demonstrating clear and international collaborations. value for money invested. publish both an audit of progress and an 2. To be the exemplar in building partnerships that fund excel- annual plan. lent science and drive it out into the SFI’s priorities for 2014 are as follows: market and society.

3. To have the most engaged and sci• Empower Irish researchers to lead entifically informed public. and win in the EU Horizon 2020 pro4. To represent the ideal modern public gramme. service organisation, staffed in a • Launch Advance Fellowship scheme lean and flexible manner, with effito maximise the number of women cient and effective management. employed in STEM industries and research.

In the Agenda 2020 document, • Assess and fund new Spokes each of these objectives is elaborated projects, jointly with industry, to upon by setting out the reasons why it is existing SFI Research Centres. important, the actions that will be taken to • Assess and fund new SFI Research achieve it and the KPIs that will be used Centres, jointly with industry. to measure progress. Each year, SFI will

8

Science Foundation Ireland

• •

• • •

•

Fund, jointly with DEL, collaborative research of excellence and impact on an all island basis.

In partnership with the HEI’s, target recruitment of outstanding researchers in areas of key strategic importance and priority for Ireland.

Develop new funding schemes for ‘applied’ research in areas of strategic national importance.

Support the development of early and mid‐career researchers.

Provide funding in significant partnership with industry or major research entities, in areas of strategic national importance.

Provide funding to promote the study of, education in and awareness of science, technology, engineering and mathematics (STEM).

RECENT SFI RELATED INVESTMENTS – SFI RESEARCH CENTRES: Some of the most significant SFI pharma-related 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 collaborated 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 achieve by utilising a “molecule-to-medicine” approach that encompasses chemical synthesis, crystal engineering, and drug production and manufacture. A total 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; 3. Drug Product Formulation and Manufacture: using science- and engineering-based knowledge to optimise solid state pharmaceutics and produce new and improved drug formulations.

SFI INDUSTRY FELLOWSHIP PROGRAMME Earlier this year, SFI announced funding of €1.7m to support 20 new industryacademia partnerships through the SFI Industry Fellowship Programme. The

9

The next 12 months will see SFI continue to build industry partnership.

funding will provide researchers from academic institutions with the opportunity to gain important first-hand experience in an industry research environment, while also providing industry with access to highly specialised trained researchers from academic institutions.

The aim of the programme is to increase levels of collaboration between industry and academia. SFI covers the salary costs of the Industry Fellows and the Fellowships can be awarded to academic researchers wishing to spend time in industry anywhere in the world and to individuals from industry worldwide wishing to spend time in an eligible Irish research body.

Of the 20 partnerships receiving funding, examples include Dr Mark Tangney of UCC, who is taking part in a programme with Perkin Elmer Inc., and Dr Annette Byrne of the Royal College of Surgeons in Ireland (RCSI), who will be seconded to Bayer Healthcare Pharmaceuticals’ Global Medical Affairs (GMA) Oncology Division in the US. THE FUTURE FOR RESEARCH The next 12 months will see SFI continue to build industry partnerships that fund excellent scientific research that will drive both economic and societal benefits, not least of which is further job creation in areas of strategic importance for Ireland.

SFI will also begin to leverage the enormous potential that ‘Horizon 2020’ offers and build partnerships that will make it possible for Ireland to maximize success under the programme.

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

Biotechnology

Ireland: A Home for Orphan Medicinal Products Ireland is well positioned at the forefront of the development of orphan medicinal products, writes Jenny Loughney, Director, Irish BioIndustry Association, PharmaChemical Ireland.

O

rphan medicinal products are an important and growing category of health care biotechnology. The international rare disease research community is making a significant effort to work collaboratively to support the development of orphan products in the diagnosis, cure and management of rare diseases.

The International Rare Disease Research Consortium (IRDiRC), initiated by the European Commission and the US National Institutes for Health, was launched in April 2011. This consortium aims to deliver 200 new therapies for rare disease by 2020, as well as the means to diagnose most rare diseases.

The European Medicines Agency (EMA) is the decision-making body for market authorisation of orphan medicines in Europe. The European Medicines Agency Committee for Orphan Medicinal Products (COMP) reviews applications for products seeking ‘orphan medicinal product designation’. To qualify for orphan designation, a medicine must be intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting no more than 5 in 10,000 people in the EU at the time of submission of the designation application. The US Food and Drug Administration (FDA) run a similar designation scheme.

Stimulating Research and Development The designation of Orphan Medicinal Product status from these bodies stimulates research and development of orphan drugs through incentives that include scientific advice and market exclusivity for a given period post author-

isation. This designation process brings hope to some 30m Europeans and their families affected by one of many rare diseases.

In response to a recommendation by The European Council, in 2014 The Department of Health published its National Rare Disease Plan for Ireland 2014-2018. To ensure continuity, efforts were made to integrate elements of European and global best practice as set out by key lead agencies at European level, including EURORDIS and EUROCERD. Below are some of initial recommendations made under the National Rare Disease Plan for Ireland: •

The establishment of a national clinical program for rare diseases; • Designation of centres of expertise; • Establishment of a national office for rare diseases; • Conduction of a coherent system to conduct broad epidemiological surveillance of rare disease in Ireland; • Exploration into the potential for industry collaboration in research relevant to rare diseases, particularly with regard to research relevant to the diagnosis, treatment and management of rare disease; • Early dialogue between the Health Service Executive (HSE) and companies who are running clinical trials in Ireland with Irish patients where license approval is imminent; • Potential to offer sponsors an incentive to run trials in Ireland, increasing access to innovation for Irish patients.

At present, orphan drugs and technologies exist for only a fraction of known rare diseases. Many rare disease

10

Jenny Loughney, Director, Irish BioIndustry Association, PharmaChemical Ireland.

patients find themselves in the position that there is no licensed treatment available for their condition anywhere in the world. Enhancing the development of new orphan drugs and technologies forms a distinct goal for rare disease strategies. Below are examples of three leading innovation companies active in this space in Ireland.

Opsona Therapeutics 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

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

Biotechnology

immune system, since their foundation in 2004.

In April 2013, Opsona were successful in raising €33m in Series C equity financing. Furthermore, in October of the same year, Opsona Therapeutics raised an additional €3m from Omnes Capital in Series C extension, resulting in a total financing round of €36m.

The proceeds of this Series C financing will supplement funding 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) as the first clinical indication for the development of OPN-305. Opsona's lead product, OPN305 is a humanised monoclonal IgG4 antibody targeting Toll-like-receptor-2 (TLR2). There are no other treatments for DGF and this gives the compound the potential to have a significant effect on the quality of life in the relevant patient group. In 2014, OPN-305 was granted EMA and FDA orphan drug status.

Developed since 2005, studies have confirmed that it works in animals and an initial clinical trial in healthy humans has shown it is safe. Now, as part of the EU-funded project MABSOT, the drug will be tested on a number of patients. This will be a proof-of-concept clinical trial. For this trial, OPN-305 will be given to organ recipients along with the existing standard treatment.

Altogether, 50 medical centres in the US and Europe will be involved in this Phase II trial, with 270 patients opting to be involved.

BioMarin In 2014, Ireland welcomed the launch by global biotechnology company BioMarin of the next phase of its investment at its manufacturing operations in Shanbally, Co. Cork. In addition to moves already underway to create 100 new jobs, the company plans to create a further 40 positions by 2015. The Cork site will manufacture products to treat rare genetic diseases.

The California based company specialises in enzyme replacement therapies and in 2014, BioMarin received approval from the FDA and The European Commission for VIMIZIM® (elosulfase alfa), an enzyme replacement therapy for the treatment of patients with the lysosomal storage disorder Morquio A syndrome, which is an ultrarare, severely debilitating disease that

affects an estimated 3,000 patients in the developed world. The disease occurs as a result of a deficiency of activity in an enzyme involved in glycosaminoglycan (GAG) metabolism. The accumulation of GAGs leads to significant morbidities and multisystemic clinical impairments, resulting in diminished functional capacity, impaired quality of life and early mortality. VIMIZIM® addresses the condition at the cellular level, fulfilling a large unmet need, and represents an advance for Morquio A patients and their families.

As a result of this approval, BioMarin has also expanded its Dublin Global Commercial Operations Hub. The Dublin operation has responsibility for international supply chain, logistics and high level commercial decision making, which includes price, distribution and third party contracts for the launch of VIMIZIM®. This expansion complements the growth in BioMarin’s biopharmaceutical manufacturing facility in Shanbally, Co. Cork, with an expected combined total employment of approximately 200 people in Ireland by the end of 2017.

Genable Technologies Genable Technologies is a privately held, venture-capital backed, Dublin based biopharmaceutical company. The company is developing new gene therapies to treat dominant genetic diseases and has been successful in receiving significant support and investment form Fountain Healthcare Partners, Delta Partners, Fighting Blindness Ireland, Foundation Fighting Blindness Clinical Research Institute (US) and Enterprise Ireland.

In 2014, Spark Therapeutics

12

and Genable Technologies announced a collaboration agreement for Genable's lead therapeutic, GT038, to treat rhodopsin-linked autosomal dominant retinitis pigmentosa (RHO adRP). The parties have entered into a broad agreement in which Spark will be the exclusive manufacturer of the product and provide development advice and expertise to Genable to help in the ongoing development of GT038. More recently, Genable confirmed that following on from a Pre-IND meeting with the FDA, GT038 has now moved from research to development.

GT038 is a potential treatment for rhodopsin (RHO)-linked autosomal dominant retinitis pigmentosa (adRP), an inherited retinal dystrophy that leads to blindness in most cases. There is currently no approved pharmacologic treatment for adRP, which affects an estimated 30,000 patients worldwide.

GT038 utilizes AAV vectors with an established safety and efficacy profile to deliver RNA interference (RNAi) molecules to suppress the expression of faulty and normal copies of RHO and restore normal gene expression. GT038 has been granted orphan drug designation in both the US and Europe.

Conclusion The above examples represent just some of the impressive biotechnology sector in Ireland in relation to orphan medicinal products. Along with recent investments from multiple biopharmaceutical companies such as Alexion, Regeneron and Sanofi Genzyme in Ireland, we are now well positioned to be at the centre of this innovative global community.

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Investment & Development

Investing in Ireland Inc. Following a couple of challenging years, the Irish PharmaChem sector is in rude health again and a host of key investments mean that its future prospects look extremely bright, writes Barry Heavey, Head of IDA Life Sciences Division.

D

espite a number of global industry challenges, the Irish pharmaceutical sector is in a healthy condition at present, supporting almost 25,000 direct jobs and 25,000 indirect roles.

Ireland, like other countries, has been grappling with the twin challenges of patent expiry and mergers and acquisition (M&A) activity, but the sector here has weathered these storms well and the industry is actually going through a period of innovation and positive change.

It should be noted there was a fall-off in employment, starting in 2008 due to the patent cliff and M&A activity, but employment growth resumed in 2012 and the lost jobs have now been

replaced. This job creation has also had a strong regional balance, with recent investments in Sligo, Westport, Galway, Limerick, Waterford, Carlow and Athlone, in addition to traditional hubs of Dublin and Cork.

Drivers of Employment Growth The driver for employment growth has been in the sub-sectors of biopharmaceuticals (Regeneron, Alexion, Lilly, Biomarin, Merck, Amgen) and speciality pharma (Allergan, Mylan, Jazz, Alkermes).

A good example of how Irish plants have dealt with the loss of patent protection is Eli Lilly in Kinsale, Co. Cork.

It lost patent protection for a key drug in

Barry Heavey, Head of Life Sciences Division, IDA.

14

Telephone +353-1 603 4000

Email: idaireland@ida.ie

IDA IRELAND Wilton Park House Wilton Place, DUBLIN 2

Website: www.idaireland.com @IDAIRELAND

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Investment & Development

2011 (peak sales were close to $6 billion) but the company has invested over €600m in establishing bio-pharmaceutical manufacturing on that site and at the time of writing, it had over 100 positions open in biopharma manufacturing.

More widely, Ireland is set to benefit from the exciting progress in the development of new drugs (precision medicines) for treating cancer: • MSD are manufacturing exciting bio-pharmaceutical MK3475 in Ireland for ongoing clinical trials and if this drug is approved, it will be produced commercially in MSD’s sites in Carlow and Brinny, Co. Cork.

• Pfizer have invested in a specialised new product development lab in their Ringaskiddy site to handle development of a number of pipeline anticancer drugs.

The Biotech Revolution Bio-technology generally is driving great change in the Irish pharma industry. For example, Regeneron, one of the exciting biotech players in the US, have recently announced plans to invest $300m in a new facility in Limerick.

More recently, J&J who already have a very successful biotech facility in Cork, announced the intention to build another biotech facility in Limerick. A subsidiary called Ethicon Biosurgery has announced plans to invest $100m in a new facility in Limerick, employing 270 people. This new facility will produce a combination of a medical device with a biopharmaceutical for wound healing: a biopharmaceutical drug placed onto a biomaterial pad.

Another big investment came from Alexion, who are going to introduce a supply chain management team and a packaging and release testing facility to Dublin, and they have acquired a biologic sterile full finish facility in Athlone. Their investment in Ireland will soon approach $100m.

We've also had a big investment by Mylan ($500m). This is an interesting one because they invested in Dublin to bring in a combination product for respiratory disease and are planning to expand their injectables facility near Galway. Their respiratory investment is focused on the development of a device for better inhalation of certain drugs.

Mylan acquired that technology from Pfizer and moved it to Ireland because they felt that Ireland was a good place to develop that drug-device combina-

The medical device industry continues to be an area of strength for Ireland.

tion, given the country’s expertise in the development and manufacturing of medical devices and bio-pharmaceuticals.

Exciting Investments In February 2013, Sanofi Genzyme announced the $44m expansion of their facility in Waterford. That was an exciting investment because they were bringing in one of their key products. MSD have an older biotech facility in Brinny, Co. Cork, the first in Ireland. Back in 2011 they reinvested in that facility to make it ready for new Merck products coming through the pipeline. That facility is going to be responsible for the launch

of a new really exciting drug for cancer called MK3475 – a very exciting drug that appears to be highly efficacious in treating various types of cancer. Merck also have a facility announced in 2009 in Carlow, a greenfield facility, which will share responsibility for manufacture of MK3475 and other products.

Last year, Pfizer announced an investment of $130m, $30m of which is going into their small molecule manufacturing in Cork, with the other $100m invested in an expansion of their biotech facility in Grange Castle. They have recently held an opening of their $30m “new product development facility” in

The Irish PharmaChem industry is currently going through a period of innovation and positive change.

16

Investment & Development

Cork, and in some ways that's the more exciting investment because they are going to bring in the ability to produce a wide variety of highly potent small molecule products.

IDA Encourages Collaborative Clusters IDA want to help companies move from having sites that just make one product in large volume to being flexible and also being able to produce a wide variety of next generation drugs.

More generally, the IDA strategy is built around encouraging collaborative clusters to grow.

The first example of this is the medical device industry itself, which continues to be an area of strength for Ireland. We are seeing increased “convergence” between medical devices and bio-pharmaceuticals, for example: • • • •

Recent investments by Mylan: respiratory drug-device combination; J&J Ethicon Biosurgery: biomaterial and bio-pharmaceutical for wound health; Sanofi-Genzyme: long acting insulin blockbuster Lantus; Nypro: investment in development and manufacturing of drug-delivery devices in Bray and Waterford.

CLeantech Initiatives A second example of a collaborative cluster is when pharma companies invest in “cleantech” initiatives as part of their corporate social responsibility and also improve the competitiveness and sustainability of their manufacturing plants.

A unique initiative in recent months saw the collaboration of J&J, GSK and Novartis to form the Lower Harbour Energy Group to build a case for the recent investment in three wind turbines associated with these companies in Cork’s Lower Harbour. Companies are also collaborating across sectors to explore how to conserve energy in manufacturing facilities.

Many companies are also investing heavily in operational excellence initiatives in their Irish manufacturing sites. A big part of these operational excellence initiatives is practitioner to practitioner knowledge sharing and this works extremely well in Ireland, where companies in the same or different sectors share insights and approaches.

Organisations such as the Irish Centre for Business Excellence (ICBE) and

IBEC work with Enterprise Ireland and IDA to facilitate this best practice-sharing between companies. The medical device sector has made enormous progress in this space, with three companies (J&J Depuy, Abbott and Covidien) joining Lake Region in being awarded the international Shingo Gold award in 2014.

Strong Regulatory Track Record Ireland’s regulatory track record remains extremely strong and the Irish medicines Board, recently rebranded as the Health Product The bio-pharmaceutical sector has grown from 400 employees in one site in 2004, to approximately 5,000 people at 18 sites in 2014. regulatory Authority (HPRA) has an internation$8 billion, the vast majority of which has al reputation in regulatory compliance. occurred in the last 10 years. $2 billion in HPRA have recently initiated Regulatory capital expenditure has been committed Science Ireland to explore opportunities by companies in the last two years alone. for investment in research to increase understanding of processes and products Upskilling Staff and thereby support Ireland’s reputation It is also worth pointing out that NIBRT for regulatory excellence in manufacturhas been working closely with companies ing. such as MSD, Lilly, Biomarin, Amgen

In recent times, there have and Regeneron, who are currently also been significant investments by the upskilling existing staff, training new hires Government to support job creation in or preparing to hire as facilities come onthe bio-pharmaceutical sector, in particustream. For example: lar the €57m investment in the National • Industry funded “real world” training institute for Bioprocess Research and has been provided to over 1,500 Training (NIBRT), which is a state-ofpeople (existing staff and recent the-art facility focused on supporting the hires) in the NIBRT facility in 2013; growing bio-pharmaceutical sector.

• In addition, the Higher Education

And growth there has been. The Authority’s Springboard funding bio-pharmaceutical subsector has grown training programs (in NIBRT) have from 400 employees in one site in 2004, allowed over 500 unemployed to approximately 5,000 people at 18 sites graduates to increase “employability” in 2014. Many of the newly announced by preparing them for the specific sites are still under construction, so needs of the bio-pharma industry. employment is set to grow further.

Based on this type of industry

In the meantime, there are very support and the very innovative work significant construction jobs associated being done by companies themselves, with these investments. The cumulative this leaves me very optimistic about the capital investments in these facilities is industry in Ireland over future years.

17

Traceability

Tracing the Future of Medicines The regulatory landscape for traceability of medicines continues to evolve globally, including the advent of the Falsified Medicines Directive, writes Siobhán Duggan, Healthcare Sector Director, GS1 Ireland.

H

ealthcare systems around the globe are facing challenges that affect the entire supply chain. The 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 globally. Indeed, 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. Preventing medical errors, enabling traceability & recall and combating counterfeiting are key concerns facing the sector, and GS1 Standards are helping to solve these issues.

Key Benefits The ley benefits of adopting GS1 Standards in healthcare can be summarised as follows: • • • • • • • • • • •

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.

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.

Ensuring Regulatory Compliance Product serialisation, compliance with EU, FDA and other international drug pedigree requirements and establishing anti-counterfeiting solutions are key priorities for the pharmaceutical industry.

The deadline for compliance with the European Falsified Medicines Directive (FMD) is 2017 for those countries that don’t have a pre-existing authentication system. All manufacturers will be expected to print a 2D datamatrix with serialisation data on medicine packs and these packs then need to be verified at the point of dispense. This requires significant changes for pharmaceutical manufacturers and will require IT development changes in hospitals and community pharmacies.

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

Both pharmaceutical and medical device manufacturers are leveraging GS1 Standards and the support of GS1 experts to prepare for these new requirements and ensure regulatory compliance.

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Get involved! Go to: www.GS1ie.org/Healthcare Background GS1 is an international, neutral, notfor-profit organisation with operations in more than 110 countries around the world, including Ireland. The GS1 System of Standards is the most widely-used system of supply chain standards, serving more than two million organisations (both public and private sector) worldwide.

In addition to the traditional sectors of Grocery, Food Service and DIY, membership in Ireland also includes the Health Service Executive (HSE), with over 40 hospitals and many suppliers of healthcare products. GS1 is recognised by organisations such as the International Organisation for Standardisation (ISO), and the European Committee for Standardisation (CEN).

For more information please contact: Siobhain Duggan Healthcare Sector Director siobhain.duggan@gs1ie.org www.gs1ie.org Tel: 01 208 0660

GS1 STANDARDS IN HEALTHCARE FOR PATIENT SAFETY GS1 makes it possible to follow pharmaceuticals and medical devices from the manufacturer to the patient, improving efficiency and patient safety.

GS1 Standards are for identifying, capturing and sharing information about products, locations, assets and more.

The GS1 System is the most widely-used system of supply chain standards. More than 2 million organisations worldwide use GS1 Standards to revolutionise the way they do business and to find collaborative solutions to industry challenges such as compliance with existing and emerging regulatory requirements.

To learn more about how GS1 Standards can make patient safety, traceability and supply chain efficiency possible for your organisation please visit www.GS1ie.org/Healthcare or email healthcare@gs1ie.org.

T: +353 1 2080660 E: info@gs1ie.org W: www.gs1ie.org THE GLOBAL LANGUAGE OF BUSINESS

Clinical Trials

European Regulation on Clinical Trials: Have We Reached the Finish Line?

The new Regulation No 536/2014 of the European Parliament and the Council of April 16 on Clinical Trials on medicinal products for human use is intended to set the global gold standard for clinical trials, writes Fionnuala Gibbons, Clinical Industry Liaison Officer, Molecular Medicine Ireland/ Irish Clinical Research Infrastructure Network.

I

n April 2014, the Clinical Trials Regulation (EU) No 536/2014 on the authorisation of clinical trials was adopted by the Council of the European Union (hereafter EU)¹, following its approval by the European Parliament in December 2013. The new Clinical Trials Regulation No 536/2014 replaces two existing Directives, 2001/20/EC and 2005/28/EC, which establish rules for good clinical practice and requirements for authorisation of the manufacturing or importation of medicinal products for human use, respectively.

It is well recognised that the Clinical Trials Directive 2001/20/EC has brought about significant improvements in the conduct of Clinical Trials. Major improvements have been seen in safety reporting, ethical review and most importantly, in the reliability of clinical trial data.

Decreasing Numbers of Trials However, the divergence in its implementation within Member States, the administrative burden, high cost, and lack of harmonisation of the applicable rules imposed by its scope and procedures, including the duplication of effort required for multi-state trials, led to criticism from patients, clinical investigators and pharmaceutical companies. It is well recognised that all of these restrictions have contributed to a significant decline in the number of trials conducted in the EU. It is estimated that during the period 2007-2011, the number of applications for clinical trials decreased by 25%².

The aim of the ‘Voluntary Harmonisation Procedure’ in April 2009³ was to harmonise the procedures for assessing multinational clinical trials by 20

the National Competent Authorities in the EU: however, the restrictions remained.

This resulted in a public consultation by the European Commission 2009/10 which led to the publication of a summary of responses from stakeholders in March 2010⁴.

A ‘concept paper’ was published in February 2011 for public consultation on a proposed revision of the Directive 2001/20/EC⁵. Following consultation, the Commission published its proposal for a new Regulation in place of Directive 2001/20/EC⁶. In order for a smooth transposition of the rules of Directive 2001/20/EC to the rules of the proposed Clinical Trials Regulation (EU) No 536/2014, both sets of rules will apply in parallel for a period of time. This will facilitate the transition of the Regulation,

Clinical Trials

which is expected to apply from 2016.

Complete Overhaul The new Clinical Trials Regulation (EU) No 536/2014 represents a complete overhaul of the existing regulation of clinical trials for medicinal products in the EU. As a regulation, it will be directly binding in all EU Member States without the need for any national implementing legislation. This should result in the harmonisation of the regulatory framework for clinical trials, thus restoring the reputation of competitiveness in clinical research within the EU.

The scope of the proposed Clinical Trials Regulation (EU) No 536/2014 is limited to clinical research on medicinal products, but has a wide scope which only excludes clinical studies that do not involve an ‘intervention’ (e.g. surveys or ‘data mining’). The proposed Regulation defines a sub-category of clinical trials falling within its scope, namely ‘low-intervention clinical trials’, where the investigational medicinal products are used in accordance with the terms of their marketing authorisation or where the additional diagnostic or monitoring procedures do not impose more than minimal additional risk or burden to the safety of the subjects compared to normal clinical practice.

Clinical Trials Regulation (EU) No 536/2014 introduces a new authorisation procedure for clinical trials. The key change includes submission of a single application dossier via a centralised web-based portal (EU web-portal)¹, in which the sponsor wishes to conduct a clinical trial. The web-portal will be managed by the European Medicines Agency (EMA) in cooperation with the European Commission and the EU Member States.

The Sponsor will propose a member state to act as the ‘Reporting Member State’ (RMS), which will facilitate the approval process for the clinical trial.

The application will undergo joint scientific assessment by the RMS, and will be subject to strict deadlines for review. This should result in a straightforward harmonised authorisation procedure, allowing for a fast and thorough assessment of the application by all Member States (MS) concerned and will result in one single assessment outcome.

Assessment of an Application The assessment of an application has two parts, Part 1 and Part II: Part I assessment is completed by the

RMS in a timeline of 45 days. They are required to give a preliminary report in six days, whether or not the MS accepts being the RMS and if the trial falls into the new regulation, and 10 days for validation. The assessment over a period of 26 days will focus on details such as the expected therapeutic and public health benefits, risks for the patients and compliance with the various requirements, ! taking into account considerations from the concerned MS. This will be followed by a 12-day coordinated review involving the concerned member states, before the final seven-day consolidation phase completed by the RMS.

Part II of the procedure is performed by each concerned MS where the Sponsor wishes to conduct the trial and is completed in parallel with Part I. Each Member State will assess the intrinsic

21

aspects of each MS (legislation, ethics, health culture) and more technical details of the trial, such as informed consent, payments to subjects, recruitment procedures, data protection, site feasibility, suitability of the investigator and site staff working on the trial, and compensation insurance for any damage suffered by a subject resulting from participation in a clinical trial.

If further information is required from the Sponsor, the RMS can extend the Part I and Part II assessment by a maximum of 31 days. The Sponsor has 12 days to respond with the required information. If the information required is not provided by the Sponsor, the application will lapse in all MS’s.

The Part II assessment report, along with the conclusion of the MS state, will be made available to the

Clinical Trials

Sponsor and other MS’s via the web-portal.

The RMS shall ensure the persons validating and assessing the application do not have conflicts of interest, are independent of the Sponsor, of the clinical trial site and the investigators involved and have no financial or personal interest in the trial. The assessment of the clinical trial application must be done by a team of people who collectively have the necessary qualifications and experience to do the assessment, and this must include at least one layperson.

Transparency Of Research There is concerted effort to make research transparent and open to the public. The new Clinical Trials Regulation (EU) No 536/2014 aims to increase the transparency of data generated from authorised clinical trials conducted within the EU.

Results will be made publicly accessible in the EU database, unless confidentiality is justified on the grounds of protection of personal data or commercially confidential information. Detailed summaries of the study results, including a summary in plain language, are to be submitted within one year of termination of the clinical trial. Final clinical study reports that are submitted to support a marketing authorisation are to be uploaded onto the EU database within 30 days of authorisation, rejection, or withdrawal of the marketing application. Sponsors are subject to penalties if they fail to adhere to these transparency obligations¹.

If a trial is being performed outside the EU, the fundamental rules for the protection of subjects must be applied. The rules clearly outline that trials referred to in a clinical trial application must comply with regulatory requirements which are equivalent to those in the EU, including rules on transparency.

The Clinical Trials Regulation (EU) No 536/2014 aims to streamline and simplify the rules on safety reporting for clinical trials. It stipulates the provision that suspected unexpected serious adverse reactions (hereafter ‘SUSARs’) can be reported by the sponsor directly to the online EU pharmacovigilance database, EudraVigilance, instead of being

submitted to each EU MS¹.

It is the responsibility of the Sponsors to notify each EU MS within 15 days of certain events during the conduct of a clinical trial. Notifications include the start and end of the trial, end of recruitment and any suspension or early termination of trial.

Data Protection Responsibilities The Sponsors of clinical trials must comply with the provisions of the Data Protection Directive⁷. They will be permitted to seek the consent of the trial subject to use his or her data for purposes which are outside the scope of the trial protocol but it must be used exclusively for scientific purpose. Consent for use of personal data for scientific purposes may be sought at the same time as consent for participation in the clinical trial.

Consent may be withdrawn by the trial subject at any time.

The Clinical Trials Regulation (EU) No 536/2014 provides that insurance cover-

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ing the investigator, the institution, or product liability insurance will be sufficient for low-intervention clinical trials.

Fionnuala Gibbons, Clinical Industry Liaison Officer, Molecular Medicine Ireland/Irish Clinical Research Infrastructure Network.

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Clinical Trials

As a result, Sponsors of low-intervention clinical trials will not be obliged to provide a specific insurance or indemnity compensation.

Ethics committees will be involved in the assessment of clinical trials applications.

However, as is the current situation, their responsibilities and detailed composition will be determined independently by each EU country. In this way, the different traditions in the various MS’s are respected.

The Regulation permits the co-sponsorship of clinical trials. Each cosponsor will assume full regulatory responsibility for the entire clinical trial unless the co-sponsors agree otherwise.

The new Regulation clearly outlines that the principal investigator will be responsible for ensuring the compliance of a clinical trial at a clinical trial site.

This proposal will have significant implications, with a higher level of responsibility being delegated to the principal investigators that have normally been the remit of the Sponsor alone.

The Sponsor, if not established in the EU, is now obliged to have a ‘legal representative’ responsible for compliance.

A Key Milestone This new Regulation offers a major opportunity regarding clinical trials and is a key milestone towards the development of a model that meets real public health needs. Without knowledge of which trials were conducted in the past, research cannot move forward. We now have a real chance of reducing the risks of ineffective treatments being developed and approved without complete evidence being available.

This Regulation is not a panacea, and no doubt will come under as much criticism as the Clinical Trial Directive. However, it is expected to be a major improvement over the previous

"This Regulation will aim to streamline and harmonise the approval process conducted across MS’s, and with true transparency of clinical trial results, we can make a real difference to the research environment. " CT Directive and will aim to streamline and harmonise the approval process conducted across MS’s, and with true transparency of clinical trial results, we can make a real difference to the research environment. This will result in the EU being more attractive for clinical trial research, reversing the decrease in the number of investigations of new innovative medicines conducted in the EU and bringing patient-oriented research back to Europe, while maintaining the high standards of patient safety.

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References 1.

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7.

http://ec.europa.eu/health/ human-use/clinical-trials/ index_en.htm European Commission, Fostering EU’s attractiveness in clinical research: Commission proposes to revamp rules on trials with medicines, 2012, visit: http://europa.eu Guidance document for a Voluntary Harmonisation Procedure (VHP) Doc.: CTFG// VHP/2010/Rev1 http://ec.europa.eu/health/ files/clinicaltrials/concept_ paper_02-2011.pdf http://ec.europa.eu/health/ files/clinicaltrials/concept_ paper_02-2011.pdf http://ec.europa.eu/health/ files/clinicaltrials/2012_07/ proposal/2012_07_proposal_ en.pdf http://www.dataprotection.ie/ docs/EU-Directive-95-46-EC/89. htm

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• F056:0/65C)!>1:2@1) ,235,IJ1*,,$5J8"#J23,*30$#*",<#5% and a wealth of application knowledge to our!"#$%&'()*)(+",-&+() clients. • "875:)12/=632)75;)@765:257532) 014#&*"%(1&2("*+5*-1"3-*(0,&"-,$(%.%"*+%8( $/011)(23456378)!089:6051)':;<) Ownership of research or formulae that may come into ---<J1*,,$5J8"#J23,*30$#*",<#5% !"#$%&'()*)(+",-&+() • !6:2)19/=2>)?)1>1:2@))/230@@25;7:605)) !"#$%&'(%)**+,$*-"%."/0,$1#23%4,$2$5% ( $/011)(23456378)!089:6051)':;<) % • !6:2)19/=2>)?)1>1:2@))/230@@25;7:605)) !"#$%&'(%)**+,$*-"%."/0,$1#23%4,$2$5% !"#$%&'()*)(+",-&+() our possession is protected on behalf of the customer • !9AA8>B)651:7887:605)?)30@@61160565C) )**+,$*-"(%6233278$(%90:3#"%&;% $/011)(23456378)!089:6051)':;<) • !9AA8>B)651:7887:605)?)30@@61160565C) With a vast knowledge of the refrigeration industry and the ( )**+,$*-"(%6233278$(%90:3#"%&;% • !6:2)19/=2>)?)1>1:2@))/230@@25;7:605)) )*<%90:3#"%=%.1532"/% !"#$%&'(%)**+,$*-"%."/0,$1#23%4,$2$5% • "/0D23:)@757C2@25:) )*<%90:3#"%=%.1532"/% on whose behalf we work.

• "/0D23:)@757C2@25:) 653%>?@A@B%CD%;CA%'EEE% • !9AA8>B)651:7887:605)?)30@@61160565C) )**+,$*-"(%6233278$(%90:3#"%&;% • #52/C>)!7=65C)"73E7C21) Pharmaceutical sector in particular, we are the first choice for 653%>?@A@B%CD%;CA%'EEE% • #52/C>)!7=65C)"73E7C21) F2G%>?@A@B%CD%;D@'H@&% )*<%90:3#"%=%.1532"/% • "/0D23:)@757C2@25:) • F056:0/65C)!>1:2@1) Products are sourced and supplied against the specified F2G%>?@A@B%CD%;D@'H@&% our large client base when• itF056:0/65C)!>1:2@1) comes• to servicing, maintaining, ,235,IJ1*,,$5J8"#J23,*30$#*",<#5% 653%>?@A@B%CD%;CA%'EEE% #52/C>)!7=65C)"73E7C21) • "875:)12/=632)75;)@765:257532) ,235,IJ1*,,$5J8"#J23,*30$#*",<#5% • "875:)12/=632)75;)@765:257532) ---<J1*,,$5J8"#J23,*30$#*",<#5% F2G%>?@A@B%CD%;D@'H@&% monograph without substitution except with the prior • equipment F056:0/65C)!>1:2@1) and replacing all types refrigeration from large ---<J1*,,$5J8"#J23,*30$#*",<#5% % ,235,IJ1*,,$5J8"#J23,*30$#*",<#5% • "875:)12/=632)75;)@765:257532) %

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capacity chillers to medical storage cabinets and temperature control systems.

Cross Technical Solutions Ltd. !"#$%&'()*)(+",-&+() Unit 26, Cookstown Industrial Estate !"#$%&'()*)(+",-&+() Cookstown, Tallaght, Dublin 24 • !6:2)19/=2>)?)1>1:2@))/230@@25;7:605)) Co.•Dublin - Ireland • !6:2)19/=2>)?)1>1:2@))/230@@25;7:605)) !9AA8>B)651:7887:605)?)30@@61160565C) Tel •(+353) 01 405 6777 • !9AA8>B)651:7887:605)?)30@@61160565C) "/0D23:)@757C2@25:) Fax (+353) 01 4136932 #52/C>)!7=65C)"73E7C21) • • "/0D23:)@757C2@25:) sales@crosstechnicalsolutions.ie F056:0/65C)!>1:2@1) • • #52/C>)!7=65C)"73E7C21) www.crosstechnicalsolutions.ie • "875:)12/=632)75;)@765:257532)

• F056:0/65C)!>1:2@1) • "875:)12/=632)75;)@765:257532)

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

CHEMICALS LIMITED

agreement and approval of the customer.

---<J1*,,$5J8"#J23,*30$#*",<#5% Associated Chemicals% is BS EN ISO 9001:2008 Certified and has received IBEC Accreditation to Responsible Care.

$/011)(23456378)!089:6051)':;<) !"#$%&'(%)**+,$*-"%."/0,$1#23%4,$2$5% $/011)(23456378)!089:6051)':;<) 16D Euro Business Park, Little Island, )**+,$*-"(%6233278$(%90:3#"%&;% !"#$%&'(%)**+,$*-"%."/0,$1#23%4,$2$5% )*<%90:3#"%=%.1532"/% Telephone: +353-21-4351014 )**+,$*-"(%6233278$(%90:3#"%&;% 653%>?@A@B%CD%;CA%'EEE% )*<%90:3#"%=%.1532"/% Fax: +353-21-4351015 F2G%>?@A@B%CD%;D@'H@&% 653%>?@A@B%CD%;CA%'EEE% E-mail: info@acl.ie ,235,IJ1*,,$5J8"#J23,*30$#*",<#5% F2G%>?@A@B%CD%;D@'H@&% ---<J1*,,$5J8"#J23,*30$#*",<#5% ,235,IJ1*,,$5J8"#J23,*30$#*",<#5% %

---<J1*,,$5J8"#J23,*30$#*",<#5% %

Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson.

We have over 2,500 employees across Ireland, located in the following sites...

Johnson & Johnson (Ireland) Ltd. Airton Road, Tallaght, Dublin 24.

Ph: 00 353 1 466 5200 www.jnj.com

Janssen Pharmaceutical Little Island, Cork, Co. Cork Ph: 00 353 21 497 8500 www.janssen.ie

DePuy Synthes Loughbeg, Ringaskiddy, Co. Cork.

Ph: 00 353 21 491 4000 www.depuy.com

Vistakon National Technology Park, Castletroy, Limerick.

Ph: 00 353 61 232 000

Cork

Supply Chain

Can you Ensure the Integrity of Your Supply Chain?

I

Ann McGee, MD of McGee Pharma International, examines the Falsified Medicines Directive and the MA Holder’s responsibilities in ensuring the integrity of the pharmaceutical supply chain.

n July 2011, the EU strengthened the protection of patients and consumers by adopting the Falsified Medicines Directive (FMD). The directive identified three categories of falsified medicines: (1) those that contain ingredients of low quality or in the wrong doses; (2) those that are deliberately and fraudulently mislabelled with respect to their identity or source; (3) those that have fake packaging, the wrong ingredients, or low levels of the active ingredients.

Implementation of the FMD commenced in January 2013 and the implementing measures can be grouped into four main pillars: (1) Safety features of medicines; (2) Active Pharmaceutical Ingredients (API) and excipients; (3) supply chain and Good Distribution Practice (GDP); and (4) internet sales.

FMD has resulted in a trend towards more stringent enforcement of GDP and supply chain control by regulators worldwide to ensure that product security and quality is maintained throughout the storage and distribution stages of the pharmaceutical supply chain.

Increasingly Complex Supply Chain The escalating risk of falsified and poor quality medicines, APIs and excipients is partly due to the increasing complexity of the supply chain. Companies are progressively outsourcing some elements of their business activities. Furthermore, financial performance drivers have resulted in relocation of manufacturing activities to lower cost jurisdictions, often outside the EU, with different regulatory structures and, sometimes, standards that are not aligned with those of the EU. Multiple outsourced activities and locations add further com-

plexity to management of the supply chain.

One of the updates proposed by the draft version of EudraLex, Volume 4, Annex 16, relates to the role of the QP with respect to oversight of the supply chain. Section 3.5.5 of the draft Annex 16 states:

“The entire supply chain of the medicinal product, starting from the manufacturing sites of the starting materials and components, and including all parties involved in any The falsified Medicines Directive has resulted in more stringent supply manufacturing and chain control. importation activities of the medicinal product, is documented and available for the QP [Qualified Person]. …..each party, including subcontractors of critical steps such as e.g. the sterilisation of components and equipment for aseptic processing, are included.”

This would imply a responsibility for QPs to satisfy themselves that a robust supply chain is in place and that critical pharmaceutical materials can be easily tracked and traced throughout their supply chain.

The proposed requirement to map the supply chain will need to take account of API, critical excipients, intermediate and finished product manufacture, storage and distribution. The roles and

“Does your QP have access to a detailed supply chain map per medicinal product? If not, have you considered how you will meet this requirement?”

26

Supply Chain

“How robust is your vendor performance management program: are your metrics telling you what you should know?” activities of each party in the supply chain should be documented. Often this information is not located in one place and the effort required to access and collate this information can be underestimated.

Do You Have A Supply Chain Map? Does your QP have access to a detailed supply chain map per medicinal product?

If not, have you considered how you will meet this requirement?

Ultimately, the MA Holder is responsible for the quality of its pharmaceutical materials in the supply chain.

Therefore, responsibility for the quality, safety and integrity of materials lies with the MA Holder. Losing control of even a portion of the supply chain can impact the quality of and the overall medicinal product and can result in potentially harmful falsified medicines entering the supply chain. If this occurs, it can cause significant impact to public health and damage to a company’s reputation.

To safeguard against this, it is necessary for MA Holders to have knowledge of the transportation routes and the ability to control the routes that are used on a day-to-day basis. In some cases, this can present a significant problem: for instance, some distributors may be hesitant to provide specific details of the transportation route as it may provide commercially sensitive information, such as the location of other customers.

However, if confidentiality of the information is assured through contracts and technical agreements, this can enable tighter control and oversight of the supply chain.

In addition to the shipping origin and destination of the material concerned, the MA Holder must define the route(s) by which the material may be transported.

Temperature, Humidity & Physical Impact in Transit Furthermore, although it is not discussed in this article when defining routes, the MA Holder should take account of the conditions of temperature, relative humidity and physical impact to which the product may be exposed along that route, ideally in the form of a risk assessment. The MA Holder must demonstrate that the material was transported within In order for the MA Holder to ensure the safety and integrity of the supply chain, it must be mapped in detail and the its label claim for temperature transportation activities and controls for all critical materials and relative humidity (where should be risk assessed. relevant); this requirement supply chain maps and associated risk is applicable to all medicinal assessments should be managed under products, including medical samples and the Quality System and should be readily investigational medicinal products (IMP). accessible by the QPs, so they can satisfy themselves that appropriate controls Vendor Performance are in place.

Management Program

An integrated way of thinking Under EU Good Manufacturing Practice and acting will help to ensure that the (GMP) “any activity covered by the GMP guide that is outsourced should be appro- industry structures and manages the supply chain with a holistic approach to priately defined, agreed and controlled”. material quality, safety and integrity. How It is necessary to ensure that there are well do you know your supply chain? robust contracts between manufacturers, wholesalers, distributors and brokers, involving the MA Holder as required, that ensure the product is traceable throughReferences out the supply chain, and that the product • The Health Products quality and integrity is maintained at all Regulatory Agency, Guide times. An appropriate vendor performto Control and Monitoring of ance management program should be Storage and Transportation in place, supported by appropriate metTemperature Conditions for rics to confirm that their performance Medicinal Products and Active meets the needs and expectations of Substances (IA-G0011-1, 05 the Contract Giver and the terms of the October 2011); Technical Agreement.

• EudraLex, Annex 15 (draft)

How robust is your vendor persection 5.4; formance management program - are • Guidelines of 7 November 2013 your metrics telling you what you should on Good Distribution Practice know? of Medicinal Products for

Due to the complexity of the Human Use (2013/C 343/01); supply chain, its management as part • Pharmaceutical Security of the Quality System and specifically in Institute (PSI) PSI-Inc.org; relation to Quality Risk Management is • DIRECTIVE 2011/62/EU OF THE highly important. Change, deviation and EUROPEAN PARLIAMENT CAPA management are critical quality AND OF THE COUNCIL of 8 system elements that must be used to June 2011 amending Directive manage the supply chain once it has 2001/83/EC on the Community been mapped (end-to-end) and defined. code relating to medicinal

To conclude, in order for the MA products for human use, as Holder to ensure the safety and integrity regards the prevention of the of the supply chain, it must be mapped entry into the legal supply chain in detail and the transportation activiof falsified medicinal products, ties and controls for all critical materials Official Journal of the European should be risk assessed.

Union.

Knowledge in the form of the

28

Advanced control and optimisation for the life sciences industry?

Absolutely.

You’re under more pressure than ever before to run your operation profitably – to achieve greater results with fewer resources. System 800xA’s ‘xA’ stands for Extended Automation and utilises the Industrial IT architecture which was built for integration in a fully redundant, reliable environment. System 800xA extends the reach of traditional automation systems - beyond control of the process - to increase energy efficiency, asset utilisation, energy savings and operator effectiveness. www.abb.ie/800xA

ABB Ltd. Tel. +353-1-4057300 Fax. +353-1-4057327 E-mail: marketing@ie.abb.com

DINhalfpage.indd 1

4/25/2013 10:28:08 AM

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

HORIZON 2020

Bright Future on the Horizon Horizon 2020, the EU programme for research and innovation, brings a wealth of opportunities for Ireland’s PharmaChem industry.

R

unning from 2014 to 2020 and with an €80 billion budget, the European Union’s programme for research and innovation, Horizon 2020, is part of the drive to create new growth and jobs in Europe.

It will build on the progress made under the Seventh EU Framework Programme for R&D (FP7), which ended in December 2013.

This is an opportunity that cannot be ignored by the PharmaChem industry in Ireland and there are many supports available to win some of this funding, as our peers do across Europe.

Horizon 2020 is the financial instrument implementing the Innovation Union, a Europe 2020 flagship initiative aimed at securing Europe's global competitiveness.

Ambitious Targets This funding is highly competitive.

Indeed, winning it is seen as a measure of excellence. Ireland has set itself an ambitious target of winning €1.25 billion of this funding, more than double what it achieved under FP7. In order to achieve the target, Ireland has put in place a dedicated team across 11 state agencies, which is led by Enterprise Ireland. This team provides support in all areas of Horizon 2020, including ICT, Health, Manufacturing, Environment, Energy, Security and the Social Sciences.

Participants are being encouraged to look for opportunities throughout the programme. A traditional ICT company that might previously have looked to the ICT part of the programme is encouraged to explore opportunities in logistics, security, health systems and a much broader

range of topics, for example. It is recognised that Ireland needs to broaden its participation base and reach out to cohorts of industry that have not traditionally participated.

Horizon 2020 has seen a renewed focus on the participation of industry from all sectors, with the introduction of a number of industry specific opportunities. Among these, the new SME Instrument aims to fund highpotential innovation and close to market

opportunities through a phased support system.

Additionally, throughout the Horizon 2020 programme, a large number of opportunities have an industrial focus to them, most notably in the Leadership in Enabling and Industrial Technologies area, with its focus on new and breakthrough technologies, this part of the programme will contribute to boosting competitiveness, creating jobs and supporting growth.

Julie Sinnamon, CEO, Enterprise Ireland, is pictured with European Research, Innovation and Science Commissioner Máire Geoghegan-Quinn, discussing how Irish companies can access finance for ‘high-risk’ research and innovation activities at Enterprise Ireland’s offices during a visit to Dublin by the Commissioner in June 2014.

30

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HORIZON 2020

Increased Funding Rate To make the programme more attractive to industry, the funding rate has been increased so that a research project is funded at 100% plus 25% overhead and a closer to market project is funded at 70% plus 25% overhead. European programmes have traditionally been accused of complexity and this new funding model is one part of the overall simplifications to encourage wider participation, in particular that of industry.

This is something that has been widely welcomed across Europe. Other simplifications include a standard set of rules across the programme and lighter financial reporting obligations.

Because so much of Horizon 2020 is aimed at collaborative projects, there are exciting opportunities to work with leading academia, both within Ireland and across Europe, and also to participate in research collaboration through staff exchanges between academia and industry, large and small.

Despite the natural competition within an industry sector, there exist opportunities to collaborate, for example in areas such as standardisation and regulation and in the area of pre-competitive research.

Innovative Medicines Initiative In relation to the pharmaceutical area, a significant opportunity for participation is within the Innovative Medicines Initiative, built on the European Technology Platform on Innovative Medicines that was supported under the European Commission's Sixth Framework Programme for Research (FP6).

This technology platform was essentially a gathering of stakeholders, led by the pharmaceutical industry. However, in a drive to increase the competitiveness of the European Pharmaceutical industry, with support from the European Commission, the Innovative Medicines Initiative was launched in 2008, and has to date, been successful in launching 13 calls for research proposal and committed to spending the entire €2 billion budget.

Under Horizon 2020, IMI will continue as IMI2 and will run from 2014 to the end of 2024 and it will have a total budget of up to €3.276 billion. Of this, up to €1.638 billion will come from the EU’s Horizon 2020 programme, to match the contribution of the industrial partners, EFPIA and other large companies that decide to join IMI2 as associated partners at project or programme level.

Enterprise Ireland is leading Ireland’s participation in Horizon 2020. Dr. Imelda Lambkin, Director of Horizon 2020, Enterprise Ireland (left) launching the almost €80 billion fund for research and innovation in December 2013, with Maire Geoghegan-Quinn, EU Commissioner for Research, Innovation and Science, and the then Minister for Research & Innovation, Sean Sherlock TD.

While, traditionally, IMI has seen small numbers successfully competing for funding, Ireland has consistently been successful at participating in the programme, with industrial, academic and patient organisation success across a broad number of projects.

These range from multiple Irish participation (Trinity College Dublin, Hibernia College) in educational protects such as Pharmatrain (www.pharmatrain.eu), where the goal is to build and implement a new modular Master level programme for advanced studies in Pharmaceutical Medicine and Drug Development Sciences, to more research focused projects such as SAFE-T (Argutus Medical, now EKF Diagnostics), where the focus is on

developing improved tools for prediction, detection, and monitoring of druginduced injuries to the kidney, the liver, and the vascular system, using markers in patients’ blood and/or urine.

New applicants to any of the EU programmes detailed above are strongly encouraged to contact the Irish Horizon 2020 team of European Advisors to explore potential opportunities across public procurement, advanced manufacturing and process improvement, to name but a few. The team can guide you easily through the system, from project concept to success!

For more details, visit www.horizon2020.ie.

Launching the Horizon 2020 app developed by Invest Northern Ireland; then Minister Sean Sherlock TD; Maire Geoghegan-Quinn, EU Commissioner for Research, Innovation and Science; and Bernadette McGahon, Invest Northern Ireland.

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Chromatography

Making Mass Detection Affordable Waters’ ACQUITY® QDa™ Detector is the culmination of their committed experience in mass spectrometry, resulting in an instrument with purposeful innovation that addresses size, ease of use, and affordability concerns that their customers have been asking them to attend to.

D

esigned as a synergistic element of your chromatographic separations system, the ACQUITY QDa is mass detection built around the needs of your analytical scientists for their chromatographic analysis. Robust, reliable, and requiring no sample-specific adjustments, it seamlessly integrates with your current LC, UPLC®, UPC2®, and purification systems.

Minimise the risk of unexpected co-elutions, and you will be able to confirm trace components with certainty, because of the analytical confidence of mass detection. You’ll enhance the analytical value and productivity of each analysis, and you won’t need to run all the additional assays or time-consuming alternative techniques or even wait for results from specialist labs that cost your laboratory productivity.

Mass detection is widely recognised as a reliable method to derive more meaningful information from your samples, but is not necessarily used by all analytical scientists.

Mass detection is an orthogonal, complementary technique to optical detection, allowing you to discriminate between analytes of similar absorbance properties. It enables you to confirm compound identity and purity. And, as it’s also compatible with optical detection, you could benefit from both in the same sample analysis.

The ACQUITY QDa is mass detection built around the needs of your analytical scientists for their chromatographic analysis.

Analytical Confidence However, traditionally, mass detection is seen as a costly technique, consuming bench space and needing sample-specific, careful adjustment. Often requiring training of an expert user to manage its complexity, mass detection is generally not suitable for integration into most LC analyses. So, mass detection tends to be inaccessible to many laboratories.

Now you can have access to the analytical confidence from the selectivity that mass detection brings to your analysis, within your own analytical or purification system.

With the ACQUITY QDa Detector, you now have information-rich mass spectral data to complement data from your current Waters® optical detectors, including the ACQUITY UPLC PDA, TUV, ELS, and FLR detectors, as well as the ACQUITY UPC2 PDA Detector.

This mass spectral information integrates seamlessly into the same workflow, routinely giving you more complete separation characterisation.

The benefits include: Plug and Play Performance It’s as intuitive as an optical detector with the robustness to handle all of your analyses. Working in harmony with your chromatography, it’s pre-optimised to work with your samples, without the sample-specific or user adjustments typical of traditional mass spectrometers.

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Accessibility It is the industry’s most accessible, affordable, and usable mass detector.

For the first time, any analytical scientist can consistently generate the highest quality mass spectral data routinely – no special training or expertise required.

Confidence The most information you can get out of your separation for complete characterisation. In synergy with optical detection, you can significantly reduce the chance that a sample component will go undetected.

Increased Efficiency Purposeful innovation that gives you the only mass detector that integrates with, and even fits on top of, your instrument stack. Using less bench space and less energy than a traditional mass spectrometer, it fits easily within your existing laboratory set-up as part of your regular workflow. Cleaning and routine maintenance are minimal, thereby maximising your uptime.

“The intuitive design of the ACQUITY QDa Detector gives you the additional data you need without the cost and complexity of traditional mass spectrometry,” concluded a Waters spokesperson, “and it’s compatible with all of our ACQUITY UPLC, ACQUITY UPC2, Alliance® HPLC, and purification LC and SFC systems."

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.

Contract Manufacturing

The Brains of B. Braun OEM When it comes to contract manufacturing, B. Braun OEM, the B2B division of B. Braun, offers tailormade solutions for the healthcare industry.

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Braun supplies healthcare markets worldwide and employs approximately 50,000 people. The company is currently represented in more than 50 countries and its portfolio comprises more than 120,000 pharmaceutical and medical articles.

Based on the synergy of this concentrated expertise, the B. Braun OEM Division offers tailor-made solutions for the healthcare industry. With a broad range of standard products and contract manufacturing services for medical devices and pharmaceutical products, the division is the ideal partner to develop customer-specific solutions.

The product and service portfolio comprises contract manufacturing of parenterals, medical devices for the application of parenteral drugs, product development and combination, regulatory support and technical documentation, as well as competent local sales managers and international project managers.

Standard Products B. Braun OEM offers standard products or customised versions. Even the standard range contains hundreds of product versions, with which countless applications can be implemented.

Standard products are infusion and injection solutions, medical devices for drug admixture, automated infusion pumps, products for venipuncture and injection and products for infection prevention.

Customised Products and Services OEM specialises in developing customerspecific solutions for the industry. Most of their products can be individually adapt-

ed to customers’ requirements.

The customised products and services are reflected in contract manufacturing, product development and private labelling, as well as product combination.

Contract Manufacturing “If you are searching for a reliable partner for contract B. Braun OEM offers contract manufacturing for infusion, irrigation and volume replacement solutions, as well as standard injectables, anaesthetics and manufacturing dermatological products. of your drugs, B. Braun OEM Product Combination is the pick of the bunch,” notes Gary B. Braun OEM offers a flexible tailorGlennon, Business Unit Manager, OEM made solution to market your products in Ireland. “Based on our profound experia ready-to-use package. Thanks to their ence, we manufacture and fill pharwide range of products and services, B. maceuticals according to your needs.

Braun OEM is the ideal partner to proAt B. Braun OEM, we offer contract vide customers with standard products manufacturing for infusion, irrigation and or products with modified characteristics volume replacement solutions, as well as assembled in customised kits. standard injectables, anaesthetics and

“Partnering with B. Braun can dermatological products like creams, gels speed results in the market and help and pomades. Depending on the product you to increase your profit,” Glennon requirements, we can fill in containers of concludes. “Challenge us and we will different sizes, shapes and materials.” provide you with your tailor-made solu If customers cannot find a suitation. Medical device and pharmaceutical ble product in their 120,000-strong range, companies need the security of supply B. Braun OEM are happy to provide indifrom a global, leading fully regulated and vidual solutions, from product variation to validated supplier: B. Braun is that partcomplete new developments. ner.”

B. Braun has been designing, engineering and manufacturing mediFor more information, cal devices for 170 years. It’s this depth contact: of experience and expertise that helps B. Braun Medical Ireland Ltd. them to produce customised products OEM Division Europe with the same unmatched quality as 3 Naas Road Industrial Park standard products. Customers all over Naas Road, Dublin 12, Ireland the world take advantage of their ability Tel: (01) 7091834 to build and assemble medical devices Fax: (01) 7091889 with efficiency and accuracy. “If you need private labelling for standard or custom E-Mail: gary.glennon@bbraun.com devices or pharmaceutical products, B. Web: www.bbraunoem.com, Braun OEM is the place to turn,” Glennon www.kitpacking-bbraun.com boasts.

36

Calibration

Legislation

the importance of Calibration

A person over the age of 15 but under 18 may be in the allowing people under 18 years on the premises shall not bar of a licensed premises unaccompanied until 9pm in itself constitute discrimination.

(10pm in Summertime), but only after 9pm (10pm in highlight any deficiencies in the process tory and has a better accuracy than the alibration is critically important Summertime) in the event of a private function where a (4) Provided notices are publicly displayed, and the policy instrument being tested: the ratio of this to any company that is serious where possible wastage or sub-standard substantial meal is product served. it sells. It is is implemented in good a policy product is being outputted. willfaith, vary licensees dependingcan on adopt criticality. about the of not serving alcohol to people below a specified age

To discuss your plant’s calibracrucial that companies avoid There is a �300 fine for a first offence on the publican which exceeds 18 years.

Accordingly, pubs can set House tions and systems, contact PJBonner at Quality Documentation the mistake of thinking that calibration up to �300 forrequirement the parent.to Licensees use due R&D, Rules regarding not serving under 21’s, 23’soretc. This shall Nocan manufacturing, quality or engisales@pjbonner.com isand simply a regulatory be service@pjbonner.com. satisfied; is much more valuable to the neering department can without diligenceit as a defence. notfunction constitute discrimination on age grounds. the correct documentation - calibration process than just that. Having a docuAbout PJ Bonner mented and traceable calibration for crucial to any standards of District Production of Evidence ofeach Age records by 18are - 20 Jurisdiction Court in Cases PJ Bonner has been providing all sized measurement instrument ensures that being maintained.

A good calibration Year Olds of Prohibited Conduct on Licensed management system should be installed companies throughout Ireland with a the readings being obtained and relied Publicans cannot allow 18-20 year olds to be in the bar of Premises quality and reliable Instrumentation & upon are within acceptable tolerances to where all Instrument & Loop records are a licensed premises an appropriate age document the Calibration transfer ofservice equality and Weighing for more maintained, along withThis everyessentially calibration involves keep the process to awithout high standard for (passport, EU identity card, driving licence, Garda age card). discrimination cases from the Equality Authority to or maintenance tasks associated with than 35 years. PJ Bonner employ the dediproduct quality or ensure safety aspects Publicans are liable to a �1,500 fine for a first offence while District Court.

Penalties, convicted ofcomplete such offences, catedifqualified staff, with certithe instrument for evidence and analyof the system are adhered to. faces a fine notgive exceeding �300. compensation,fied orders to take a test specific course to of and traceable equipment, sis of its performance include and its criticality the person Theinvolved results of a calibration provide within the process. A further in the company an understanding of the action,aspect and temporary closureon-site orders.calibrations for a variety of parameters including but not limited to performance of the instruments being15 of the Amendments of Section thecalibration Equal documenting process is Temperature, Pressure, Humidity, Flow, to understand the traceability theoverview test calibrated effect- on the process. Discretion This is ofan only, for full provisions please Status and Acttheir 2000 Publican’s Level, Electrical, pH, Conductivity and instrument being used and that it has Analysing any deviations or comparconsult the Intoxicating Liquor Acts, available on www.

3(a) Licensees can allow people under 18 years of age Weighing. been certified in an accredited laboraing with previous calibration results can oireachtas.ie or from Government Publications Office to be on the premises at their discretion, subject to time on 01 647 6834 limitations outlined above (i.e. not after 9.00 p.m.). Not

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13/12/2011 14

LVA Directory & Diary 2013

51

Materials Handling

Toyota Extends Traigo 80 Range The Toyota Traigo 80 counterbalanced range is being extended up to 5.0 tons, bringing a host of benefits to users, from longer operating time to higher productivity.

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oyota Material Handling Europe (TMHE) is releasing new models of 4.0, 4.5 and 5.0 tons at the end of this year to complete the Traigo range of 80-volt electric counterbalanced trucks and boost heavy duty operations.

The complete range of Toyota Traigo 80 forklift trucks (now including models from 2.0t to 5.0t) covers a variety of applications: from stacking in narrow aisles with the more compact models, through to heavy load handling in tough working conditions with the latest high tonnage models. The new models are more productive, safer and more energy efficient than ever.

Maximum Benefits The benefits of working with the Toyota Traigo 80 have been maximised: the range offers longer operating time and longer service intervals, as well as various energy management solutions.

The new 4.0 to 5.0 tons forklifts also bring higher productivity, thanks to improved driving speeds of up to 18 km/h, stronger acceleration and quicker lifting, resulting in 15% more pallet movements compared to its predecessor.

The new range includes a 5.0 ton model rated at 600mm load centre, offering increased residual capacities and ideal for lifting longer loads or working with heavy attachments.

The Toyota Traigo 80 delivers major improvements in areas such as travel speed, acceleration, lifting speed and truck compactness.

Reliable & Durable Built with the world’s unique Toyota System of Active Stability (SAS), a highly durable chassis and ergonomic operator compartment, the trucks are extremely reliable in heavy-duty operations and excel in overall visibility. Furthermore, they perform on an energy consumption level, which has been improved up to 22% compared to the previous models.

“Toyota never ceases to find new solutions to suit all customers’ needs,” explains David Backx, Product Management, Counterbalanced Trucks at Toyota Material Handling Europe.

“Manufactured on the same values as the 2.0 to 3.5 tons range previously introduced and well appreciated by cus-

tomers, the three newest heavy-duty models of the Toyota Traigo 80 family add to a highly versatile range of material handling equipment. All trucks fulfil the needs of the occasional or frequent user and are essential in fleet operations and intensive applications.”

For more information, contact: Toyota Material Handling Ireland Killeen Road Dublin 12 Email: jpacelli@toyota.ie Tel: (01) 4190321 Web: www.toyota-forklifts.ie

The complete range of Toyota Traigo 80 forklift trucks now includes models from 2.0t to 5.0t.

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www.toyota-forklifts.ie or Toyota Material Handling Ireland at Toyota Ireland, Killeen Road, Dublin 12. Tel: 01 4190200.

TEMPERATURE CONTROL

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, 8701_CRS_ADVERT_ART.pdf 10/06/2013 Freezers 8701_CRS_ADVERT_ART.pdf to Incubators. Also, new to 10/06/2013 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 15:20:35 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.

Energy Management

Veolia: A Partner for Sustainable Growth

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ecreasing the energy and water demand of production facilities, reducing CO2 emissions, ensuring that production processes and outputs meet the strictest environmental, quality and regulatory standards; these are just some of the challenges faced by pharmaceutical and chemical manufacturers every day.

Veolia’s core expertise is rooted in its understanding of the water-energy-waste nexus and finding ways to reduce the environmental and economic impact of this vital interdependency: Dalkia Ltd., Veolia’s energy activity, became Veolia in July 2014.

Firstly, Veolia delivers efficient energy management solutions for all utilities and buildings, from supply of energy, through distribution of steam

and hot water, to plant and equipment maintenance, calibration and reduction of consumption at point of use. The design and deployment of new energy centres to incorporate biomass or combined heat and power plants is securely managed under a guaranteed performance framework.

Water is a strategic asset and this reality has prompted Veolia to develop metrics to help large water users to grasp the obvious and hidden cost of water so they can make sustainable business decisions, while ensuring long-term profitability.

The ‘True Cost of Water’ tool combines traditional Capex and Opex calculations with analysis of water risks and their financial implications, to ensure that optimal investment and operational

decisions are taken over the lifetime of a plant.

Veolia helps clients to transform their waste streams into valuable resources. Incineration may have traditionally been the only option for the disposal of waste solvents, with zero energy recovery possible. Now these waste streams are being blended and converted into sustainable alternative fuels, which can supply other local industrial processes and reduce the reliance on fossil fuels.

Veolia partners with some of the world’s leading pharmaceutical companies to adopt this full life cycle approach to their activities and support their journey towards sustainable growth.

For more information, log on to www.veolia.ie

Resourcing Pharmaceuticals Industries Pharmaceutical industries now need to rise to a combination of major environmental, regulatory, social, economic and operational challenges. As a result, they have begun to look beyond simple service solutions in search of a truly creative partner able to innovate.

This is the kind of ongoing challenge at which Veolia excels.

Some of our solutions include:

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Environmental solutions: energy, water and waste Utilities services incl. compliance, risk-based and lean approach Multi-technical asset management services

Innovation House, DCU Innovation Campus, Old Finglas Road, Glasnevin, Dublin 11 Tel: +353 (0)1 870 1200

www.veolia.ie

41

New Product Development

Pfizer Evolves To Meet Market Demand Pfizer have constructed a New Products Technology Laboratory, allowing innovation in low volume, small molecule API manufacture.

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une 2013 saw Pfizer Pharmaceuticals approve a $30m investment in a New Products Technology Laboratory (NPTL) at its Ringaskiddy site. The NPTL facility provides Pfizer API, with fit-for-purpose capability for manufacture of its small molecule portfolio.

The NPTL manufacturing facility meets the shift in demand from large volume blockbuster drugs to small volume potent precision medicines through major innovations with containment and an innovative combination of new flexible manufacturing technologies. The facility has the capability to manufacture low volume products requiring high containment, for commercial market approvals, to cGMP standards.

NPTL addresses the shortage of this type of capacity, while providing the most ideal ergonomic environment and processing capability for small products at an early stage in the development lifecycle. The new facility provides capacity for future expansion at minimal cost.

The NPTL was developed to allow Pfizer’s pharmaceutical manufacturing capabilities to meet the changing market demands, providing capability for both 0-5 kg and 5-25 kg scale manufacturing capacity within two separate equipment trains.

Innovation by Design Facilities include:•

•

A Small Scale Production Suite to accommodate 0-5 kg product volumes, including head tanks, reactors, condensers, filters, contained filters and dryers, liquid drum booths for dosing accurate quantities and flow skid capacity; An Intermediate Scale Production Suite to accommodate 5-25 kg

•

•

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product volumes, including head tanks, reactors, centrifuge, contained filter dryer, receiver vessels and High Shear wet milling; Dispensary Area with contained glove box isolator technology common to both suites; A Hydrogenation Suite with gas turbine and dispersion Agitator for optimised mixing; Process services and utilities common to both suites for up to 20 services; Two Flow skid technology plates for process skids up based on ISO transport container sizes.

Best Practice Best practice has moved forward in terms of flexible manufacturing with containment capability, where process knowledge is at the fingertips of everyone involved in the process development and manufacture lifecycle. For example: •

•

Dramatic reductions in changeover timelines that cost the business significantly can be achieved with ease, following the implementation of technologies developed for the NPTL. Pfizer’s capabilities are best in class and advanced chemistry can move from the laboratory to scale up quickly and efficiently. Manufacturing technologies in areas such as mixing studies for hydrogenation, high

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•

•

containment handling of relatively toxic materials and flexible processing are now greatly enhanced and simplified.

Pfizer, Cork, now have a best in class facility that allows them to scale up processes with remote real time visibility of performance.

Improved process visibility and technologist interaction provide more precise and accurate control of the processes.

Next Generation Page 1 Manufacturing Pfizer’s NPTL represents the next generation in terms of flexible, high containment manufacturing facilities. The technologies and the work practices enabled in the NPTL provide new opportunities to the rest of Pfizer’s business and the pharmaceutical manufacturing community as a whole.

Pfizer Pharmaceuticals employs 3,200 people in Ireland. Pfizer API is based in Ringaskiddy, Co. Cork, employs 420 people and has a strategic role as the default launch site for new products.

WORKING ON ANSWERS FOR THOSE WHO HAVE LIVED A LIFETIME. Seniors should have treatments that not only help them live longer, but also live well. That’s why Pfizer is working to provide them with better nutrition through vitamin supplements, and to help fill their golden years with vitality through specialized medicines for health needs later in life such as high cholesterol, arthritis and chronic pain.

AND FOR THOSE WITH A LIFETIME TO LIVE. Keeping those at the earliest stage of life healthy is one of our highest priorities.

Pfizer is a leader in paediatric products ranging from children’s vitamins to medicines for serious diseases. In many countries around the world, we work to deliver better nutrition to moms during pregnancy and breastfeeding to help give our little ones the best chance for a healthy life. See how we’re putting our commitments to work at pfizer.com/health

Working together for a healthier world™ Copyright ©2013 Pfizer Inc. All rights reserved.

PHI/2013/002/1 April 2013

Research & Development

SSPC Points the Way for Collaborative Research The Synthesis and Solid State Pharmaceutical Centre, hosted at the University of Limerick, has already achieved unprecedented success in terms of international collaboration between industry and academia.

With a broadened remit, the future points to more breakthroughs from molecule to medicine.

T

he name may have changed but the remit at the SSPC remains focused on cutting edge research, pharmaceutical innovation and advanced manufacturing. The Synthesis and Solid State Pharmaceutical Centre, formerly known as the Solid State Pharmaceutical Cluster (2007-2013), is a unique collaboration between some of the biggest names in the global pharmaceutical business, Irelandâ&#x20AC;&#x2122;s foremost academic institutions and a host of international academic collaborators.

In essence, the SSPC is designed to link scientists and engineers in partnerships across academia and industry to address crucial research questions and is jointly funded by SFI and industry. The SSPC carries out research, ranging from molecule to medicine, with the objective of gaining a better understanding of mechanisms, controlling processes and predicting outcomes for the efficient and environmentally sustainable production of safe

medicines. The aim of the SSPC is to deliver relevant solutions that address the manufacturing needs of pharmaceutical companies and through this, to build a strong pharmaceutical community and a pharmaâ&#x20AC;?friendly environment in Ireland.

The initial phase, the Solid State Pharmaceutical Cluster, focused exclusively upon the crystallisation stage of the active pharmaceutical ingredient (API) in the manufacturing process.

Within the pharmaceutical industry, this stage is a significantly challenging aspect of manufacturing, as there is a significant lack of fundamental understanding of the science and engineering challenges at this stage of the process. Significant breakthroughs here led to the establishment of the Synthesis and Solid State Pharmaceutical Centre, which has seen the focus expand from crystallisation

upstream into wet chemistry, including synthetic organic chemistry and biocatalysis, and downstream into advanced formulation of the API into a drug product.

Pictured are SSPC General Manager, Jon Oâ&#x20AC;&#x2122;Halloran, and SSPC Scientific Director, Prof. Kieran Hodnett.

44

Research & Development

This expansion is a logical progression of SSPC’s remit, due primarily to the unprecedented success of the Cluster.

“The Cluster was successful for a number of reasons. It was the first time that a large group of diverse researchers, from chemists to engineers to pharmacists, collaborated towards a common goal. The model of engagement, where resources were shared equitably across all partners, was unique and led to real engagement of all partners”, explains SSPC General Manager, Jon O’Halloran. “We also demonstrated the value that academia could bring to industry early on, through short, single company projects. This led to trust across the Cluster to the point where all industrial and academic partners were comfortable collaborating with each other in the precompetitive space. This level of collaboration is unprecedented globally and happened much faster than we had projected. With the Cluster, we got real three-way collaboration: between companies, with companies and academics, and between academics.”

The expansion of the remit for the Centre has seen a corresponding increase in the number of industry partners involved, which is now up to 22, as well as 34 post-doctoral researchers (up from six) and 60 PhDs, triple the original 20. The SSPC continues to welcome new industry and academic partners from Ireland and globally and is currently in the process of partnering with two new multinational pharmaceutical companies.

The Three Strands of SSPC The SSPC research programme is organised into three interconnecting strands, which actively reflect the three distinct steps in the manufacture of modern medicines.

Strand 1: New Frontiers in Pharmaceutical Synthesis This focuses on better and more environmentally sustainable ways to make active pharmaceutical ingredients; Strand 2: Crystal Growth and Design Investigating optimal ways to produce active pharmaceutical ingredients; Strand 3: Drug Product Formulation and Manufacture Developing the dosage forms of the future.

The SSPC research programme focuses on next generation drug manufacture and spans the entire pharmaceutical production chain, from synthesis of the molecule to the isolation of the material and the formulation of the medicine.

Projects For The Future SSPC General Manager, Jon O’Halloran highlights some of the projects currently underway.

Strand 1

Development of Novel Biocatalysts “There is a push, globally, for a greener pharmaceutical industry. If, for example, we could develop biocatalysts from naturally occurring materials, these could replace more environmentally hazardous materials, as well as having the potential to telescope chemical reactions, thereby reducing the number of synthetic synthesis steps,” O’Halloran explains.

Strand 2

Multicomponent Pharmaceutical Compounds “One of the most exciting projects currently, involves research into delivering the next generation of medicines via multicomponent pharmaceutical compounds and, for example, co-crystals. Lots of drugs that don’t make it to clinical trials fail because of poor solubility,” O’Halloran explains. “We can possibly pave the way for the introduction of new active ingredients that wouldn’t have processed through clinical trials heretofore. Currently, it is estimated that for every 10,000 molecules that are screened, only one makes it to market. If you can overcome the solubility issue, you can significantly improve that ratio.”

Strand 3

Novel Mechanisms for Drug Delivery “While some amorphous APIs show significant therapeutic effect, their stability can remain a challenge,” O’Halloran notes. “SSPC researchers are looking to understand and enhance this stability through novel drug product design such as hot melt extrusion or spray drying. Success here could lead to significant savings for the pharmaceutical industry and greater availability of medicines.”

45

Research & Development

O’Halloran predicts a bright future for SSPC and its impact on the Irish pharma industry. “The presence of such a large number of multinational manufacturing pharmaceutical companies in Ireland has led, in the last five years in particular, to the emergence of some really exciting SMEs to support that sector, companies like EirGen Pharma, who work in low dosage high potency drugs, Glantreo in silica support systems and Innopharma Labs in advanced analytics. This is where we see job retention and growth through SSPC. Multinationals are retaining their existing numbers and growing in the BioPharma space, while the SME business space is where we can grow Irish jobs in Irish companies.”

He cites APC Ltd, established in 2011 by SSPC Principal Investigator Professor Brian Glennon and SSPC Post-Doctoral Researcher Dr Mark Barrett, as a shining example of an SME that grew out of Cluster. Finalists in the Irish Times Innovation Awards in 2014, APC deliver chemical engineering solutions and technologies to enable streamlined development, optimisation and supply of new and existing chemical and biological entities.

Platform and Targeted Projects The SSPC research programme is divided into nine platform projects, which aim towards the progression of scientific state-of-the-art; nine targeted projects, which are driven by scientific challenges of specific industrial needs; and two linker projects, which connect the three strands. These two projects concentrate effort at the strand interfaces where the most important developments need to take place.

One of the benefits of SSPC’s research is that it will have real impact on the industry, according to O’Halloran. “30% of our budget is retained for traditional or platform research,” he explains, “but the funding model for SFI Centres dictates that a minimum of 50% of the budget must be spent on targeted projects, which will deliver a real value to industry in a three-year time horizon.”

He distinguishes it thus: “Platform research concentrates on fundamental research, via PhD students, where they challenge the scientific state-of-the-art in their subject areas.

Target projects address the industrial

SSPC General Manager, Jon O’Halloran.

state-of-the-art, and in general, this is carried out by post doctoral researchers, who deliver real impact for companies.”

A Global Reach Academically One of the biggest successes of SSPC has been its global reach, with unprecedented levels of international academic collaboration, including strong relationships with Purdue University in Indiana, the University of Toronto, the University of South Florida, the University of Leeds and the University of Manchester, amongst others.

“Academics have seen how the SSPC model works and are very keen to become involved,” O’Halloran states “We have managed to build that relationship internationally from an academic perspective.”

Indeed, the SSPC has managed to attract some fantastic researchers globally. One of the top 20 research chemists in the world, Professor Michael Zaworotko, has moved from the University of South Florida to the University of Limerick, the home of SSPC, which is a huge vote of confidence in the future success of the SSPC.

46

Expansion into BioPharma One of SSPC’s latest developments sees their remit extending into the BioPharma area, via a collaboration with NIBRT, the National Institute for Bioprocessing, Research and Training. “We’re using the SSPC model of collaboration with seven BioPharma companies, and researchers in NIBRT, DCU and TCD,” explains Jon O’Halloran.

Extractable and leachable (E&L) compounds, arising from the interaction of culture media with disposable components within bioprocessing, represent a major concern for companies and regulators. The SSPC project aims to develop advanced technologies to maximize biotherapeutic production, reduce adverse effects of E&L’s and increase bioengineering capability during cell bioprocess in polymeric disposable systems.

Research & Development

“We’ve developed a very good model for collaboration,” O’Halloran states, “Our doors are always open to new researchers and new companies to develop the value proposition to the pharma sector globally.”

Real Benefits to Industry From an industry viewpoint, O’Halloran feels that much of the focus of the Cluster was to demonstrate to multinational pharma companies the value their Irish operation could deliver to the global business.

This time around, however, it’s slightly different, he explains: “Now, we’re not just dealing with the Irish entity, but we are having direct meetings with the corporate R&D divisions in both the US and mainland Europe.”

This is very exciting for the future of the Irish PharmaChem sector.

“Absolutely,” he agrees. “It’s about demonstrating the value proposition that the Irish sites have for their corporate colleagues. We want to ensure that Irish sites are not simply seen as manufacturing entities in the future, Ireland is now a solution-based economy.

Our companies can import problems from their sister sites abroad, solve them in Ireland through knowledge gained in the SSPC and present that solution to the global HQ, demonstrating the value Irish sites bring to these global pharmaceutical companies, through their academic links here in Ireland.”

The SSPC research programme focuses on next generation drug manufacture and spans the entire pharmaceutical production chain, from synthesis of the molecule to the isolation of the material and the formulation of the medicine.

Indeed, it has become a shining example of what can be achieved when industry and academia truly collaborate. The future for SSPC, it seems, is extremely bright indeed.

The SSPC continues to welcome new industry and academic partners from Ireland and globally.

The SSPC is a unique collaboration between some of the biggest names in the global pharmaceutical business, Ireland’s foremost academic institutions and a host of international academic collaborators.

47

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Recruitment

How To Attract Talent to your Company When it comes to the pharma sector, Ireland’s tight talent pool is attracted to companies with strong employer branding, writes Steve Greenwood of Berkley Recruitment.

M

ergers, acquisitions, investment and expansion activities within the pharmaceutical sector have seen 2014 herald the revitalisation of Ireland’s pharmaceutical sector.

Much of this activity has resulted in significant, positive change in the Irish pharmaceutical landscape. Many organisations have made significant capital investments and expanded their manufacturing presence. Conversely, others have continued the trend towards the establishment of smaller external supply operations to contain the cost of goods sold by outsourcing manufacturing of the lower-margin products in their portfolios.

Already this year, we have seen significant M&A activity, between Abbvie/ Shire, Mylan/Abbott, BMS/AstraZeneca

and others battling to maintain competitiveness while stimulating innovation: this has led to job creation in some cases and cuts in others. Any negative impacts of these strategies to Ireland, however, have been offset by significant investment by companies such as Regeneron, Ethicon, Alexion, Jazz Pharma, Mylan, Biomarin, Novartis and others: this has created a wealth of career opportunities for those seeking progression and development in the sector.

Recruitment Market/Trends Overall, 2014 has manifested itself as a year of opportunity, following the period of uncertainty after the industry fell victim to the recent and well publicised patent

49

cliff.

Ireland now has a situation where there are skills shortages rather than job shortages: the above mentioned sites are investing heavily in headcount, increasing competition for key skills in Quality, Manufacturing, Regulatory Affairs, Engineering and Supply Chain.

We are also seeing a change in how the above skills are being applied by organisations. This year has seen a continuation in the shift from traditional, site-based pharmaceutical manufacturing model towards the ‘virtual hub’ model. While companies like Shire have operated solely in this way for many years, many companies have redefined

Recruitment

their supply chains to incorporate this ,&#$ type of operation to ensure cost competitiveness. This has created a need +&#$ for more candidates with strong ‘soft’ )"#$ skills in addition to technical proficiency. )&#$ In managing outsourced operations, ("#$ cultural awareness, the ability to influ('#$ ence rather than direct, and the flexibility (&#$ !%#$ ./01$ !"#$ !"#$ to travel as part of one’s job description !!#$ 21314$ have become as important as academic !&#$ !&#$ !&#$ excellence in securing roles with the '(#$ 56471$ major players in today’s pharmaceutical '&#$ *%#$ *"#$ landscape. *'#$

The key successes in this virtual *&#$ manufacturing space in the year to date include Alexion, who have established &#$ an external supply hub in Dublin, backed -*$'&*'$ -'$'&*'$ -*$'&*!$ -'$'&*!$ -*$'&*($ by the establishment of a manufacturing facility in the midlands; Jazz Pharma are How is your company performing in comparison with recent years? currently operating in the same space and locations. Continued investment, reported that their organisation was oper- similar to the global average, in which both in virtual operations and site-level ating 9% are expecting a pay cut of some sort !)$at the same level, with just 12% expansions, by many other organisations stating performance was worse, highduring 2014. !&$ has created a buoyant environment and lighting the continued improvement being Considering the significant is a testament to Ireland’s value as a ,&#$made ')$ by Irish businesses following the developments in the pharmaceutical /life global investment hub for the companies economic recession. sciences sector in Ireland, it’s unsurpristhroughout the pharmaceutical sphere. +&#$ '&$ This is in direct correlation with ing that very few respondents from this =>6?/>$ )"#$

As per the status quo estab*)$ from IBEC, which revealed in its reports area are expecting a pay cut. @41>/AB$ lished in the last number of years, the *&$ quarterly forecast that investment )&#$recent emphasis in the Irish pharmaceutical ("#$ in the economy is set to rise by 21.5%, Job Creation )$ sector continues to be on secondary up on the initial 15.5% increase previ- ('#$It is encouraging to note that 67% of manufacturing rather than primary, with (&#$ously !%#$those surveyed in Ireland./01$ &$ !"#$ predicted for!"#$ the year. reported a rise more and more organisations outsourc The vast majority Irish in headcount their organisation *8'$#$ !8(#$ of !!#$ (8)#$ )8%#$ *&#$9$ in:;<$*8)$#$ :;<$+#$9$within ing the manufacture of APIs, preferring !&#$respondents !&#$ are expecting a pay rise the past!&#$ year, the highest21314$ of all global to retain manufacturing capacity for more over the next 12 months, with 93% prescores surveyed in our index. '(#$ 56471$This is value-added products. a in keeping with reports suggesting the '&#$dicting some form of salary increase, *%#$

The API sector remains volatile, !)$ increase on results from our last *"#$country’s job market is continuing to slight with a number of organisations currently (90%). However, of those predictimprove,*'#$ following its emergence from !&$ *&#$survey suffering hiring freezes or headcount ing a pay rise, the majority (54%), are the recession. While 33% of our respondreductions. It is certainly the case, how')$ anticipating a rise of under 4%, highlightents saw job cuts in their organisation, ever, that the secondary manufacturing &#$ing that business decision makers are the overall sentiment has been that '&$ sector remains buoyant, as exemplified still -*$'&*'$ being somewhat cautious with their-'$'&*!$ Ireland-*$'&*($ is very much bucking the global -'$'&*'$ -*$'&*!$ by the significant investments made budgets. trend in terms of job creation, following =>6?/>$ *)$ by the aforementioned groups. These

These figures are relatively years of uncertainty in the job market. *&$ investments are undoubtedly positive @41>/AB$ for the economy, and for candidates )$ it has increased the level of choice !)$ &$ for job-seekers.

So, what does this mean for !&$ C177$<D/A$ **8)&#$E6?$ )*#$9$E6?$ C177$<D/A$ **8)&#$E6?7$ )*#9$E6?7$ workers? *&#$E6?$F;<7$ F;<7$ F;<7$ *&#$E6?7$ F41/<1B$ F41/<1B$ ')$

Berkley’s Market Sentiment F41/<1B$ survey for H1 2014 shows an '&$ encouraging increase in positivity in =>6?/>$ *)$ the outlook of workers towards the @41>/AB$ work environment, both in terms of *&$ performance and opportunity.

Company Performance 58% of Irish respondents said that their company is performing better than it was 12 months ago, up 16% on H2 2013 results. A further 30%

)$ &$ *8'$#$

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50

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Recruitment

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The jobs market: cuts versus creation.

Are People on the Move?

Among those surveyed, the general positivity in the Irish jobs market has perhaps led to more confidence from employees in terms of making a career move. 20% of all respondents were considering new career opportunities. Of these individuals, 44% intend to move in the next six months, with a further 20% intending to do so within a year.

Winning the Competition For Talent How pharmaceutical groups adjust to a candidate-driven employment market will be interesting to see over the short-tomedium term. How employers position themselves in the market is critical to ensure that the best possible candidates can be attracted, so that these investments can pay off.

With so many organisations competing for talent, the employer value proposition has emerged as a factor far outweighing salary for many candidatesâ&#x20AC;&#x2122; decision-making processes. Candidates are now finding themselves in a position

of choice in many cases.

Choices are being driven by how well employer values match their own, and how performance and commitment are rewarded in terms of responsibility and career progression. It is paramount for employers to place emphasis on selling their culture and vision in building their reputation in the employment market, to ensure that they rise above their competitors. Forward thinking organisations are thus investing heavily in employer branding to remain competitive, given the increasing tightness in the talent acquisition sphere.

So what is important to candidates in choosing an employer for their next career move? The sentiment seen

by Berkley is very much that fulfilment, rather than salary or benefits, tops candidatesâ&#x20AC;&#x2122; wish-list. Following a number of years of limited opportunity and growth, candidates are now seeking to join growing organisations that place value on helping candidates develop themselves, gain exposure to different functional areas, promote a healthy work-life bal-

+&$ )&$ (&$ !&$

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51

ance and foster an effective working environment which ultimately benefits the patient.

The days of hiring solely via job advertisements are truly dead and gone. It is now up to companies to adopt innovative, attractive strategies to ensure maximum awareness of their presence in the market, their culture and values, their commitment to patient care and how potential staff can develop their careers by working with them.

It is paramount for employers to place emphasis on selling their culture and vision in building their reputation in the employment market, to ensure that they rise above their competitors.

About The Author Berkley Group works with international and multinational organisations on employer branding, attraction strategies and talent management projects through its Talent Management group. For more information, please contact Steve Greenwood at sgreenwood@berkley-group.com.

C H EM IC AL S U PPL I ER S

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63 53 30/05/2012 16:57

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CABINETS ProSys Containment and Sampling Technology Sartorius Mechatronics Weber Packaging Solutions Ltd

CAD Callaghan Engineering

CALIBRATION Endress & Hauser (Ireland) Ltd Labplan Ocon Chemicals Ltd P.J. Bonner & Company Sartorius Mechatronics Veolia Water Chromatography Ireland

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

CHEMICAL CONSULTANTS Callaghan Engineering

CHROMATOGRAPHY Fisher Scientific Ireland Ltd Labplan Ocon Chemicals Ltd Particular Sciences Ltd

SciChem - Cork SciChem - Dublin Water Chromatography Ireland

CLEANROOMS Callaghan Engineering Millmount Healthcare Ocon Chemicals Ltd Veolia

COOLING SYSTEMS CPI Technology Ltd Cross Technical Solutions Veolia

DATA ACQUISITION

CLeaning SERVICES / EQUIPMENT

ABB Ltd Endress & Hauser (Ireland) Ltd Labplan P.J. Bonner & Company Weber Packaging Solutions Ltd

WrenTech Ltd

DESIGN

COLD CHAIN PACKAGING

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

Catalent Pharma Solutions CRS Pharma Solutions Millmount Healthcare

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

COMPUTER SYSTEMS Premier Validation Weber Packaging Solutions Ltd

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

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 CPI Technology Ltd

CONDITION MONITORING

DRUMS / CONTAINERS

Flexachem Manufacturing Ltd P.J. Bonner & Company Veolia

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

CONSTRUCTION MANAGEMENT Callaghan Engineering Portakabin Allspace

CONract Pharma Services Alkermes Pharma Ireland Limited

CONVEYORS Weber Packaging Solutions Ltd WrenTech Ltd

EDUCATION & TRAINING

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

55

EFFLUENT MONITORING / TREATMENT TREATMENT Carbon Group Endress & Hauser (Ireland) Ltd Flexachem Manufacturing Ltd Lancaster Laboratories P.J. Bonner & Company Veolia

ELECTRICAL Callaghan Engineering P.J. Bonner & Company Veolia

ELECTRONIC COMPONENTS Pilz Ireland

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

ENGINEERING SERVICES Berkley Group Callaghan Engineering Cross Technical Solutions Henley Forklift Group Limited Pilz Ireland P.J. Bonner & Company Veolia

eNVIRONMENTAL CONSULTING ABB Ltd Callaghan Engineering Pilz Ireland Veolia

ENVIRONMENTAL SERVICES/ EQUIPMENT ABB Ltd Indaver Ireland Pilz Ireland P.J. Bonner & Company Quitmann O'Neill

EVAPORATORS Cross Technical Solutions Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd Graham Hart (Process Technology) Ltd Labplan

g e n eral S U PPL IER S

Irish PharmaChem 2015

g en eral S U PPL I ER S

Irish PharmaChem 2015

EXHIBITION DESIGN & DISPLAY Clip Ltd Ireland

SciChem - Dublin WrenTech Ltd

FUME CUPBOARDS

Technology

HOMOGENISERS

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

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

FURNACES

HOSES

EXPLOSION PROTECTION / PANELS

SciChem - Cork SciChem - Dublin

CPI Technology Ltd

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

GAS DETECTION

EXPLOSION PROOFING Henley Forklift Group Limited Pilz Ireland Sartorius Mechatronics

FACILITY DESIGN

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

Callaghan Engineering

GAUGES

FACILITIES MANAGEMENT

Fisher Scientific Ireland Ltd Ocon Chemicals Ltd P.J. Bonner & Company

Hochtief Facility Managemen Portakabin Allspace

FILLING EQUIPMENT Quitmann O'Neill WrenTech Ltd

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

FLUID HANDLING CPI Technology Ltd Idex Pump Technologies (Ireland) Ltd Labplan SciChem - Cork

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

GRINDING CPI Technology Ltd

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

HEALTH & SAFETY / FIRST AID Ocon Chemicals Ltd Pilz Ireland

HEAT EXCHANGERS

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

56

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

INSPECTION EQUIPMENT Lister Machine Tools Ltd P.J. Bonner & Company Sartorius Mechatronics Weber Packaging Solutions Ltd

INSTRUMENTATION ABB Ltd Callaghan Engineering Endress & Hauser (Ireland) Ltd Labplan Ocon Chemicals Ltd P.J. Bonner & Company SciChem - Cork SciChem - Dublin Tyco Valves & Controls Ireland Ltd Veolia

IT Callaghan Engineering Weber Packaging Solutions Ltd

INVESTMENT Goodbody Stockbrokers

INVESTMENT promotion agency ida Ireland

lab equipment / supplies Carbon Group Labplan Ocon Chemicals Ltd P.J. Bonner & Company Solv-Echem Ireland Ltd SciChem - Cork SciChem - Dublin WrenTech Ltd

legal / financial / insurance

Callaghan Engineering CPI Technology Ltd Cross Technical Solutions Henley Forklift Group Limited Pilz Ireland Tyco Valves & Controls Ireland Ltd Veolia Weber Packaging Solutions Ltd

mechanical & process engineering Callaghan Engineering CPI Technology Ltd Tyco Valves & Controls Ireland Ltd Veolia Weber Packaging Solutions Ltd

Goodbody Stockbrokers

medical device manufacture

logistics

B. Braun Medical

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

membrane filtration systems

lifts & hoists Henley Forklift Group Limited WrenTech Ltd

machine tools Lister Machine Tools Ltd Soltec (Ireland) Ltd

maintenance CPI Technology Ltd Hochtief Facility Management Sartorius Mechatronics UK Ltd Veolia Water Chromatography Ireland Weber Packaging Solutions Ltd

manUfacture Portakabin Allspace Sartorius Mechatronics

materials handling / forklifts / pallet trucks Henley Forklift Group Limited Toyota Material Handling Ireland Ltd Weber Packaging Solutions Ltd WrenTech Ltd

mechanical engineering services Berkley Group

MICROFILTRATION:

Fisher Scientific Ireland Ltd Merck Millipore

NANOFILTRATION:

Merck Millipore Ocon Chemicals Ltd Fisher Scientific Ireland Ltd

Ultrafiltration: Merck Millipore Ocon Chemicals Ltd

reverse osmosis: Merck Millipore Ocon Chemicals Ltd

meters CPI Technology Ltd Fisher Scientific Ireland Ltd Ocon Chemicals Ltd Veolia

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

milling CPI Technology Ltd WrenTech Ltd SciChem - Cork SciChem - Dublin

57

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

noise / odour control Associated Chemicals Ltd Flexachem Manufacturing Ltd

oem manufacturing Anecto B. Braun Medical Idex Pump Technologies (Ireland) Ltd Tyco Valves & Controls Ireland Ltd

packaging / design Anecto Catalent Pharma Solutions Charles Tennant & Co Ltd Complas Packaging Ltd Industrial Packaging Ltd Quitmann O'Neill SteriPack Weber Packaging Solutions Ltd

packaging / machinery Interpac Millmount Healthcare NPP Group Ltd Quitmann O'Neill Smurfit Kappa Ireland Weber Packaging Solutions Ltd WrenTech Ltd

pallets Quitmann O'Neill

pharmaceuTical fabrication 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

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g en eral S U PPL I ER S

Irish PharmaChem 2015 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 P.J. Bonner & Company

process control

REACTORS

ABB Ltd Callaghan Engineering Endress & Hauser (Ireland) Ltd Pilz Ireland P.J. Bonner & Company Sartorius Mechatronics Tyco Valves & Controls Ireland Ltd

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

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

recruitment Berkley Group Brightwater ICDS Recruitment Consultants Lancaster Laboratories Thornshaw Scientific Recruitment

refrigeration / freezing

pollution control

process & mechanical engineering contractors

Callaghan Engineering Veolia

Pilz Ireland Tyco Valves & Controls Ireland Ltd

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

powDer handling

project management

renewable energy

Carbon Group CPI Technology Ltd Idex Pump Technologies (Ireland) Ltd ProSys Containment and Sampling Technology Quitmann O'Neill Tyco Valves & Controls Ireland Ltd WrenTech Ltd

ABB Ltd Callaghan Engineering Pilz Ireland

ABB Ltd Callaghan Engineering Sustainable Energy Authority of Ireland Veolia

pressure measurements / switches / vessels

pumps

BS&B Safety Systems Ltd Flexachem Manufacturing Ltd

pressure relief

protective clothing / apparatus Fisher Scientific Ireland Ltd Ocon Chemicals Ltd

CPI Technology Ltd Fisher Scientific Ireland Ltd Idex Pump Technologies (Ireland) Ltd Water Chromatography Ireland

Quality & compliance

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

ABB Ltd McGee Pharma International Weber Packaging Solutions Ltd

pressure vessels

r&d

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

Euraxess Ireland Fisher Scientific Ireland Ltd Lancaster Laboratories SciChem - Cork SciChem - Dublin Synthesis and Solid State Pharmaceutical Centre TopChem Pharmaceuticals Ltd Tyco Valves & Controls Ireland Ltd

print packaging Contego Packaging Group SteriPack Weber Packaging Solutions Ltd

58

RESPIRATORY PHARMACEUTICALS Teva Pharmaceuticals Ireland

robotics Labplan

sanitary tubing CPI Technology Ltd Flexachem Manufacturing Ltd

scada / dcs / mis ABB Ltd Callaghan Engineering P.J. Bonner & Company

scrubbers Flexachem Manufacturing Ltd Graham Hart (Process Technology) Ltd

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

sieving

tanks

validation

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

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

software

temperature control

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

Sartorius Mechatronics

Endress & Hauser (Ireland) Ltd Flexachem Manufacturing Ltd Labplan Ocon Chemicals Ltd P.J. Bonner & Company Tyco Valves & Controls Ireland Ltd

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

stainless steel / fitting / products

Portakabin Allspace

warehouse management

testing services

C&G Logistics Group Celtic Forwarding Ltd Chemsource Industrial Division Chemsource Logistics Complas Packaging Ltd Portakabin Allspace 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 Henley Forklift Group Limited KWE (Ireland) Ltd National Chemical Company Quitmann O'Neill Weber Packaging Solutions Ltd

storage of hazardous materials C&G Logistics Group

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

tableting equipment Flexachem Manufacturing Ltd WrenTech Ltd

vision systems Weber Packaging Solutions Ltd

Anecto CPI Technology Ltd Henley Forklift Group Limited Lancaster Laboratories P.J. Bonner & Company SteriPack

CRS Pharma Solutions SciChem - Cork SciChem - Dublin

Callaghan Engineering Pilz Ireland Veolia

temporary lab & office accomodation

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

storage / bunding

ventilation

tube sets / disposables Fisher Scientific Ireland Ltd Langanbach Services Ltd Ocon Chemicals Ltd

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

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

59

washing equipment Fisher Scientific Ireland Ltd SciChem - Cork SciChem - Dublin WrenTech Ltd

waste management / balers / recycling Ocon Chemicals Ltd Quitmann O'Neill Veolia

water treatment

Carbon Group Chemco Ireland Ltd Fisher Scientific Ireland Ltd Flexachem Manufacturing Ltd Ocon Chemicals Ltd Tyco Valves & Controls Ireland Ltd Veolia

weighing P.J. Bonner & Company Sartorius Mechatronics SciChem - Cork SciChem - Dublin Weber Packaging Solutions Ltd

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Charles Tennant & co Ltd

COMPANY LISTINGS

Address: 71 Cookstown Ind Estate,

Belgard Road, Tallaght,

Dublin 24.

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hazchem training ltd Address:

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HENLEY FORKLIFT GROUP LIMITED Address:

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Henley Industrial Park, Killeen Road, Dublin 10.

(01) 620 9200 (01) 626 5406 fwilson@henley.ie phammett@henley.ie www.henley.ie Forklift and warehousing equipment, sales, service, hire, parts, driver training, thorough examinations.

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IDA Business Park, Clogherane, Dungarvan, Co. Waterford.

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47 Merrion Square, Dublin 2.

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Dr. Yvonne McKeown

30/05/2012 16:57

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McGee Pharma International Address:

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

Jane Lyons

merck millipore Address: Tullagreen,

Carrigtwohill,

Co. Cork.

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measom freer Address:

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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.

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NATIONAL CHEMICAL COMPANY Address:

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Tel: Email:

Web: Business:

Contact:

Unit 509, Mitchelstown Road, 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

O

o'flynn medical ltd Address:

Tel: Fax: Email: Web: Business:

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:

Tel: Fax: Email:

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

P

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: Email: Web: Business:

Contact:

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

(021) 434 6535 (021) 480 4994 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

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.

Contact: National Hire Manager:

Mike Sheedy

PPD, Inc. Address:

Tel: Fax: Email: Web: Business:

Contact:

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

Web: Business:

Contact:

premiervalidation.com www.premiervalidation.com Validation and regulatory compliance specialist.

Director of Operations: Graham O’Keefe

Prime Pac Ltd Address:

Tel: Fax: Email: Web: Business:

Contact:

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

ProSys Containment And Sampling Technology Address:

Tel: Fax: Email: Web:

UIDA Business Park, Carrigtohill, Co. Cork.

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

Q

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 O’Neill Packaging Ltd Address:

Tel: Fax: Email: Web: Business:

Contact:

St. Brendan’s Road, Portuma, Co. Galway.

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

General Manager: David O’Neill

S

SARTORIUS MECHATRONICS UK LTD Address:

Tel: Fax: Email: Web: Business:

Contact:

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

SCICHEM - CORK Address:

Tel: Fax: Email: Web: Business: Contact:

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 – DUBLIN Address:

Tel: Fax: Email: Web: Business: Contact:

Greenhills Industrial Estate, Walkinstown, Dublin 12.

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

Branch Manager: Seamus Amond

SMURFIT KAPPA IRELAND Address:

Tel: Fax: Email: Web:

Business:

Ballymount Road, Walkinstown, Dublin 12.

(01) 409 0000 (01) 456 4506 info@smurfitkappa.ie www.smurfitkappa.ie www.skpackaging.ie Packaging.

Premier Validation

SOLTEC (IRELAND) LTD

Address:

Tel: Fax: Email:

Address:

Tel: Email:

Tyone, Nenagh, Co. Tipperary.

(01) 443 4016 (0906) 460 301 graham.okeeffe@

67

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

(044) 933 5133 info@soltec.ie

c o mpan y lis t i n g s

Irish PharmaChem 2015

C o mpa n y lis t i n g s

Irish PharmaChem 2015 Web: Business:

Contact:

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 - Strategy and Communications: Dr. Ruth Freeman

STERIPACK Address:

Tel: Fax: Email:

Web: Business:

Contact:

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

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

Glasnevin, Dublin 9.

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

TOPCHEM PHARMACEITICALS LTD

Synthesis and solid state pharmaceutical centre Address:

Tel: Web: Business: Contact:

University of Limerick, Limerick, Ireland.

(061) 234 898 www.sspc.ie Research Centre.

Communications Officer: Yvonne Diggins

Address:

Tel: Fax: Email: Web: Business:

Contact:

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.

Managing Director: Donal Convey

T

TEDAC LTD Address:

Tel: Fax: Email: Web: Business:

.Contact:

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

Toyota Material Handling Ireland Ltd Address:

Tel: Fax: Business:

Contact:

Killeen Road, Dublin 12.

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

Terry O’ Reilly

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teva pharmaceuticals ireland Address:

Tel: Web: Business:

Contact:

Unit 301, IDA Industrial Park, Waterford.

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

Managing Director: Andy Crowley

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Thornshaw Scientific Recruitment Address:

Tel: Email: Web: Business: Contact:

6 Old Dublin Road, Stillorgan, Co. Dublin. +353 1 278 4671 info@thornshaw.com www.thornshaw.com Scientific Recruitment Tina Dunne

68

Univar B.V. Address:

Tel: Fax: Email: Business:

Contact:

536 Grants Crescent, Greenogue Business Park, Rathcoole, Co. Dublin.

(01) 401 9800 (01) 401 9142 pharma.sales@univar.com Ingredients: pharma industry including API’s, excipients, process chems, solvents & intermediates.

Niall Behan niall.behan@univar.com

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waters chromatography ireland

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69

Weber Packaging Solutions Ltd Address:

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Web: Contact:

Kilcannon Industrial Estate, Old Dublin Road, Enniscorthy, Co. Wexford.

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B. Braun OEM - The B2B division of B. Braun

Tailor-made solutions 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. Based on your individual product and manufacturing requirements, we fill pharmaceuticals according to your needs.

At B. Braun OEM we offer contract manufacturing for infusion, irrigation and volume replacement solutions as well as standard injectables, anesthetics and dermatological products like creams, gels and pomades. Depending on the product requirements, we can fill in containers of different sizes, shapes and materials.

Standard products

Infusion and injection solutions Medical devices for drug admixture Automated infusion pumps Products for venipuncture and injection Products for infection prevention

Customized products and services

Contract manufacturing Product development and private labeling Product combination

Contact us and benefit from our complete system solution from a single source.

B. Braun Medical Ltd. | OEM Division | 3 Naas Road Industrial Park | Dublin 12 | Ireland | gary.glennon@bbraun.com Phone +353 (0)1 7091 834 | Mobile +353 86 8339836 | www.bbraunoem.com

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