The Pharmaceutical Industry: Working for Well-Being

in association with

WHY

MATTER

Working inpharma

Career opportunities

Future trends

MEDICINES

PHARMACEUTICAL THE

INDUSTRYW o r k i n g f o r w e l l - b e i n g

CONTENTS

THE PHARMACEUTICAL INDUSTRY 03

Foreword 04

Minister for Enterprise, Trade andEmployment, Micheál Martin TD

Overview 06

A profile of the industry and itsprospects

Medicines 10

Where jobs fit into the development cycle

Human resources 12

Directors share their views

Education 14

Third-level courses

Working in innovation 16

R&D employees

Working in marketing 18

Getting products to customers

Working in production 20

In the hub of the industry

Working in biotechnology 22

A growing area

Investment 24

Science Foundation Ireland’s prioritiesand a new biopharma centre

Commercialisation 26

An innovative SME and the Enterprise Ireland view

Services 28

Technology, legal and manufacturingsupports

Technology 30

Track-and-trace systems

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04 THE PHARMACEUTICAL INDUSTRY

FOREWORD

Minister for Enterprise, Trade andEmployment, Micheál MartinTD, on the contribution thepharmaceutical sector makes tothe Irish economy and theimportance of continuedinvestment in R&D

A national treasure

FOREWORD

THE pharmaceutical sector has been targeted by the government as a key driver of industrial development in Irelandin recent decades and the industry hasmade a very significant contribution to theeconomy of the country. The high-valueand knowledge-intensive nature of theindustry is reflected in the level of exports,which now accounts for approximately40pc of total manufacturing exports fromIreland and has been the largest contrib-utor of corporation tax.

It is an exciting time to be in the phar-

maceutical sector in Ireland as it conti-nues to grow steadily. Ireland has attr-acted 13 of the top 15 pharmaceutical companies, and it is significant that almostall the companies located here have beeninvolved in continuing re-investment.These include: Pfizer; Abbott; Johnson &Johnson; Wyeth; Schering Plough; Bristol-Meyers Squibb; Merck Sharp & Dohme;Glaxo Smith-Kline; and Takeda.

This is an industry that has its foot-print all over the country and we are conscious that not only do we have to bed

down and consolidate, but wealso have to change our activ-ities and move up the much-quoted value chain. Thebackward integration frommanufacturing into the various stages of research anddevelopment (R&D) and ulti-mately the core product discovery research is the keyto establishing long-term sustainable businesses in Ireland.

Amgen’s recent investmentin Cork, creating 1,100 jobs, isexactly the kind of investmentthe Government and IDA Ireland seek to attract and itis in line with our strategy towin high-quality, high-skilledprojects from world-class leaders in the area. Theintense global competitionfor investments has been wellpublicised, though Ireland isnow competing for and winning world-class R&Dinvestments. Our young, highly skilled and educatedworkforce is a key componentin attracting investment, andour universities and institutesof technology are providing akey regional spread of gradu-ates and postgraduates, providing an accessible pool ofworld-class employees formultinational investors.

We are now seeing theresults of a concerted effort inGovernment policy to build afoundation of science andtechnology in our academicinstitutions and in particularto encourage strong businessand academic collaboration.This is enabling the build-upof the R&D capability of Irish-based businesses, which isfundamental to Ireland’sfuture competitiveness.

The availability of highlyskilled and educated gradu-ates is critical if Ireland is toconsolidate its position as aleading knowledge-based society. The Government iscommitted to cultivating anattitude that values scientificcuriosity and endeavour andthat encourages young peopleto consider scientific careers.


OVERVIEW

For employees and students, the pharmaceuticalsector represents a highly attractive career option asthe industry here moves into a new phase of itsevolution, writes Brian O’Grady

A healthy pharma future

IN less than 30 years, Ireland’s pharmaceutical indus-try has become the country’s biggest exporter and oneof its major employers. For the economy the phar-maceutical sector has become integral to the nation’sprosperity, generating ¤3bn in tax payments andmaking Ireland one of the top four locations for theindustry worldwide.

When the Minister for Enterprise, Trade andEmployment, Micheál Martin TD, announced one ofthe country’s biggest foreign direct investments todate this January, by biotechnology company Amgen,he was keen to point out the significance it held forIreland’s future. “Investments of this scale speakvolumes about Ireland’s ability to compete and winthe most advanced biotechnology company in theworld,” he said, noting that the ¤0.82bn investmentin Cork would employ 1,100 there by 2010.

Two years earlier, Wyeth Medica Ireland hadannounced the biggest foreign direct investment inthe history of the State — a ¤1.5bn investment in a90-acre site in Grangecastle, Co Dublin — bringingthe overall value of industry investment here tomore than ¤40bn.

Clearly, Ireland’s pharmaceutical industry is on aroll that has been steadily building momentum, having attracted 14 of the world’s top 15 pharma-ceutical companies to set up operations here. Year-on-year job growth in the sector has beenincreasing by 1,200 annually for the past five years,with 24,000 now employed directly in the industryand many more employed by its suppliers.

“The fact that nine of the top 10 companies herehave Irish CEOs is a very strong selling point,” saysBarry O’Leary, IDA Ireland’s divisional manager forthe sector, the offices of which have been pivotal in attracting the industry here. Ireland’s pharma industry has gone from strength to strength, with itsexpanding profile and capabilities here steadilyattracting more companies and investment.

“Our track record in execution here is a big attrac-tion and our track record in compliance is alsoimportant,” says O’Leary. “The difference with phar-ma is that it’s an expensive industry to build. Youwouldn’t be far off ¤1m per employee in terms ofinvestment.”

RAMPING UPIn 2004, Ireland’s pharmaceutical sector generated44pc of the country’s exports, making us the biggestnet exporter of medicines worldwide. In a decade ofimproving exports across all sectors, such successesmight seem to be almost the norm. But the achieve-ment of Ireland’s pharmaceutical sector has been considerable, with medicines now accounting for¤1 of every ¤5 of Irish exports. In 2003, for instance,Ireland exported 10 times the value of pharmaceuti-cals exported by Germany, a country that has spawnedsome of the industry’s biggest pharmaceutical companies and medicines. For a country that beganfrom a standing start in the Sixties, Ireland’s growthin pharmaceuticals has been impressive by any stan-dards, with 12 of the world’s best-selling medicinesbeing produced here.

With a further ¤1bn of investment announcedalready this year, Ireland is showing itself to bemuch more than just a short-term expedient formultinationals seeking out tax breaks. A skilledlabourforce, a favourable Government attitude, taxincentives, market access, climate and a constantlyimproving infrastructure have all been contributorsin making Ireland one of the world’s most attractiveinvestment locations for the industry, now onlyrivalled by Singapore, Puerto Rico and Switzerland,according to IDA Ireland.

Competitive advantage for the future, however, mayrely less on financial incentives than it will on Ireland’sreputation as a centre for innovation in developingnew medicines. This means, in managerial jargon,


OVERVIEW

moving up the value chain (the steps from concept to manufacturing in developing a product) from manufacturing-led to knowledge-led activities.

THE MOVE UP THE VALUE CHAIN Since the first investments in the Sixties and Seventies,Ireland’s pharma industry has steadily moved from beingmanufacturing led to knowledge led. As a research-driven industry, pharmaceutical companies reinvest 15-20pc of their sales in research and development (R&D).Medicines typically cost upwards of ¤800m to develop andthat R&D investment, which in 2003 amounted to ¤21bnin Europe alone, makes this a truly knowledge-basedindustry. Five of the top 10 spenders in European R&D

are pharmaceutical companies.Professor Dermot Kelleher of Trinity College Dublin, a

member of the Health Research Board, argues that Ireland is now regaining its historical tradition of inno-vation in medicine, an area it dominated in the 19th Century through the work of then pioneering medicalinnovators such as Robert Graves, William Stokes,Dominic Corrigan, Abrahem Colles and EJ Conway.

Kelleher defines innovation as “the conversion ofknowledge and ideas into a benefit which may be for commercial use or the public good”, something that is nowreaching fruition here through public and private invest-ment. By providing the R&D medicines for bigger companies, Ireland’s rapidly growing biotech sector is now

providing just such an opportunity, he argues, alongwith many exciting career and entrepreneurial oppor-tunities. “Ideas are now key. New technologies level theplaying field, giving new, smaller companies similarcapabilities to larger ones. We’re getting a respectable levelof innovation here. The challenge now is developing theright culture so it can prosper,” he says.

Such innovation and R&D activities will become the keydrivers in bringing Ireland’s pharmaceutical industry toits next level of competitiveness in what is truly a global industry. “Manufacturing sites need to have thetechnical capability to compete when new drugs arecoming down the pipeline and corporations look todecide on where to locate these facilities around theglobe,” says O’Leary. “So you must have more capabilitiesonsite; it’s not enough just to have lower tax rates,because other jurisdictions have lower ones. The technicalcapability and the people become a far more criticalpiece of the whole thing.”

The result has been a series of investments linkingindustry with academic research, with ¤36m invested lastyear by various companies. Bristol Myers Squibb, one ofthe first arrivals here in 1964, spent ¤9.6m on researchfacilities at Dublin City University. Wyeth also invested

‘Ireland’s pharmaceutical industry is on a roll that has been steadily building momentum’

From left: Conn Clissmann, president, Irish Pharmaceutical Healthcare Association (IPHA); Micheál Martin TD, Minister for Enterprise, Trade and Employment; Anne Nolan, CEO, IPHA;and Professor Dermot Kelleher, Trinity College Dublin

OVERVIEW


in University College Dublin’s Conway Institute as part ofits ¤1.8bn biotech investment here. Similarly, Pfizer, GlaxoSmithKline, Johnson & Johnson, Genzyme and others haveall made recent multimillion euro investments in creating R&D capability in this country, while the mostrecent announcement of Amgen’s ¤1bn investment in Corkis mirrored by a new pharmacy faculty in University College Cork.

“These investments represent more than just linksbetween industry and academia,” says Conn Clissmann,president of the Irish Pharmaceutical Healthcare Asso-ciation. “These have the capability to turn themselves intomajor hubs of research that not just benefit the economyhere, but also bring major benefits for patients by pro-viding new and better treatments. If you consider thatmore than a quarter of the world’s medicines have beendeveloped in the UK, our neighbour, there is every reasonwe should aim for some of this market.”

GLOBAL MARKETS MEAN GLOBAL COMPETITIONIreland’s success has of course been based on its abilityto export to countries that could soon be competing forthe same work. Pharmaceutical investments are prized bydevelopment agencies worldwide because of the depth oftheir investment, highly skilled employment base andresulting longer-term tenure. But in such a globally competitive market, security can only be maintainedthrough competitiveness.

“Ireland Inc needs to nurture the sector as its futurecould be a lot less certain, should the country take it forgranted,” says director of IBEC’s PharmaChemical Ireland,Matt Moran. The rising costs of doing business here,ongoing government support for the sector, tax and infra-structural issues are all pressing concerns.

In response to such competition, companies here havefocused on developing capabilities that generate anddeliver higher value — by consistently moving up the valuechain. Increasing the numbers and value of services byimproving workforce skills, research capabilities andinfrastructure have become ever more important whencompeting with countries with vastly lower labour costsand zero corporate tax rates such as Singapore andSwitzerland. Singapore, for example, offers 0pc tax compared with Ireland’s rate of 12.5pc and Puerto Rico’s3pc, while boasting far lower labour costs. Switzerland,as a non-EU member, can waive tax rates on specific industry activities, enabling it to become an R&D powerhouse for the industry.

Research in pharmaceuticals extends from developingnew molecules for medical use to clinical trials and discovering how to produce safe and viable products. “Ina multinational environment, every site is trying to convince senior management that it should be the site forinvestment,” says John Condon, EMEA director of publicaffairs at Merck Sharp & Dohme’s manufacturing division.“By including research in your manufacturing activities,you’re familiar with the process at a much earlier stage,so if the drug gets market approval later then you’re in amuch better position to justify being able to produce it.It’s all about internal competition.”

For Ireland’s pharmaceutical sector, the competitive chal-lenges from overseas have meant evolving from bulkmanufacturing of active agents to adding complemen-tary activities, finishing completed products and researching and developing new products and productionmethods. IDA Ireland’s strategy focus has been to encou-rage companies to start earlier and finish later by addingactivities from the pre-clinical stages to the launch. Theemphasis is on introducing Irish-generated research asearly as possible in the development cycle. Such value-adding activities have only been possible through theexpanding skillset of Irish workers and closer tie-ins withacademia. The future of the industry lies in combining thisimmense manufacturing capability and expertise with theinnovation that will drive product development.

Much of the success in adding new capabilities has beendue to the calibre of the industry’s people and their ability to upskill and deliver new areas of expertise.

“The calibre of the people working in the industryhere has certainly made a major difference to our competitive advantage and has been a very significant factor in attracting investment here,” says Dr Mark Glynn, public affairs and education officer at PharmaChemical Ireland. “Our workforce’s ability and willingness to learnhas been impressive at all levels of recruitment, somethingwith which I think everyone in the industry would agree.In addition to the standard and supply of our graduates,postgraduates and others, the human factor has been a

major source of competitive advantage for the industryin Ireland.”

THE EDUCATION IMPERATIVEAmong the most critical factors in sustaining Ireland’s com-petitive advantage is ensuring a constant stream of science graduates at second, third and postgraduate levels. “Industry has invested heavily in recent years promoting science and the results are startlingly evidentwith the increase in the number of students taking sciencesubjects, but efforts are pointless without the necessarygovernment investment in education,” says Glynn.

There are good reasons to consider careers in Ireland’spharmaceutical sector. In addition to a wide diversity ofcareer opportunities, new figures from the Central Statistics Office show that workers in the sector earnedalmost 30pc more than the national average.

As the industry here moves towards being knowledgeled in all its activities, the prospects for employees and theeconomy are considerable and growing. This still depends,however, on maintaining Ireland’s extraordinary phar-maceutical manufacturing base. Cultivating a business climate where innovation can flourish involves many factors, foremost of which must be acknowledging theextraordinary asset that the country has already created.

Brian O’Grady is communications manager at the IrishPharmaceutical Healthcare Association.

OVERVIEW

‘Among the mostcritical factors insustaining Ireland’scompetitive advan-tage is ensuring aconstant stream ofscience graduates atsecond, third andpostgraduate level’


WHILE the benefits and rewards pharmaceuticals provide arehuge, so too is the effort and investment that goes into devel-oping and making a new medicine that can save lives or dras-tically improve people’s quality of life. By the time a newmedicine reaches patients, it will typically have been in devel-opment for up to 12 years (see box), from the initial stages of iden-tifying and isolating molecules to three phases of testing and anongoing phase of ‘pharmacovigilance’ that ensures its safety andever-improving performance.

In Ireland, more than 24,000 people are employed in the phar-maceutical industry in roles from manufacturing to marketingand from research to patient education. In the journey to devel-oping and delivering a medicine, a whole range of skills and professions are involved, including chemists, researchers, doctors, engineers, marketers and machine operators. Every stepof the process has to be managed carefully and adhere to strictregulations, generating many jobs in compliance, regulatoryaffairs and quality assurance throughout.

JOBS IN IRELANDIn Ireland, the industry is going from strength to strength aspharmaceutical companies continue to expand their operationshere and add new activities such as research, finance and supply chain management.

Ireland’s success in attracting biotechnology companies addsanother exciting dimension to the careers on offer. Biotech-nology uses biological systems or cells to make or modify prod-ucts that can be used as medicines and will generate manymore medicines in the future, many of which will be person-alised for individual use.

The following broad categories outline some of the jobs andcareer opportunities currently available in the industry.

RESEARCH AND DISCOVERYThis is the starting point for a new medicine. Because manydiseases still cannot be cured or because existing treatmentmay cause unwanted side effects, new medicines that work indifferent ways are constantly in demand. Chemists, biologists,pharmacologists, IT specialists and a variety of other sciencedisciplines work in teams to try to identify chemical compounds that might eventually become medicines.

DEVELOPMENTOnce a chemical compound has been found that could possibly work to treat the target disease, a variety of tests mustbe carried out to ensure that the compound can be made on

MEDICINES

The growth in the pharmaceutical sector herehas seen companies expand their operationsand activities to provide a growing number ofcareer paths

One industry,

many careers

THE LIFE CYCLE OF MEDICINESFROM CONCEPT TO PRODUCT:STEPS IN GENESIS OF A DRUG

10,000 molecules screened

100 molecules tested

10candidatemolecules

1 drug

Researchphase

10 years R&D

0 5 years 10 years 15 years 20 years

Testphase

Developmentphase

Administrativephase

2 TO 3 YEARS

Commercialisationphase

Patent expiryPatent filing

▼

▼

▼

▼

▼Source: LEEM - Key Facts 2003


MEDICINES

a viable scale, formulated into a medicine and given topatients without causing harm. This work takes severalyears and involves a variety of different people, mainly scientists and engineers.

Jobs here include: analytical chemist; developmentchemist; process chemist; pharmacist; biologist; valida-tion scientist; microbiologists; product development scientist; researcher; doctor; process development scientist.

CLINICAL TRIALSTo ensure the medicine works safely and effectively, it’s firsttested on animals before moving on to phase one trials onhumans. At this stage doctors and scientists first determinethe correct dose to give to human volunteers and then carryout controlled trials in patients suffering from the disease.

Jobs here include: clinical research specialist/associate;clinical monitor; clinical trials specialist; compliancespecialist; laboratory technician; documentation andcompliance scientist; regulatory affairs officer/manager;quality assurance specialist; validation specialist; quality and compliance specialist; medical scientist; formulation scientist; doctor; nurse.

MANUFACTURINGManufacturing the medicine involves making the chem-ical compound and then mixing it with other substancesto make a tablet, cream or aerosol. Safety and quality assur-ance is paramount, demanding constant vigilance and careful controls at every step. Scientists, engineers, IT specialists and many others are involved at both stages.

Jobs here include: process development chemist; quality control analyst/supervisor; environmental oper-ator; science technician; pharmaceutical technician;chemistry laboratory technician; biology laboratory tech-nician; quality control lab technician; medical labora-tory technician; environmental officer/technician; healthand safety advisor; production and operations specialist.

ENGINEERINGEngineers do everything from designing and commis-sioning new machinery (and the buildings to house it) tomaintaining and managing production.

Jobs here include: process and project engineer; quality assurance systems co-ordinator; chemical engineer;production engineer; mechanical engineer; physics laboratory technician; validation officer; production oper-ator; validation engineer.

REGULATORY AFFAIRS/MARKETING AUTHORISATIONScientists in regulatory affairs draw together informationon tests that have been carried out on the drug substanceand use this to apply for permission to carry out clinicaltrials and market the medicine.

Jobs here include: regulatory affairs specialist/manager; quality and regulatory affairs engineer; researchscientist; process development chemist; formulation scientist; pharmacist.

SALES AND MARKETING/HEALTH PROMOTIONResearching and developing new medicines would not besustainable if doctors were not aware of new medicinesand what they can do for patients, both by providing newsolutions and improving existing ones. Educating physi-cians and patients on new developments and treatmentstherefore plays a vital role. Medical sales representativesvisit hospitals and GPs’ surgeries to inform doctors aboutthe benefits of the new medicines their companies produce.

Jobs here include: marketing manager; medical salesrepresentatives/specialists; hospital sales representa-tive/specialist; communications specialists.

HUMAN RESOURCES Human resources (HR) supports the people behind the scientific work, helping to make the most of their talentand training. In HR, you will find yourself recruiting formany different roles and developing the skills of a hugerange of people.

Jobs here include: HR manager; HR general; recruitmentconsultant; trainer.

To find out more about these and other jobs, visit:www.pharmachemireland.ie, www.fas.ie/pharma-chem_industry_careers, www.mrii.ie and www.pmii.ie.

DEVELOPING NEW MEDICINES

Discovering, developing, testing and gaining regulatory approval for new medicines is a highly complex, long and expensive process. Therisks are very considerable, as between 40 and50pc of potential medicine that enters the thirdand final phase of clinical trials still fails to makeit to market. Clinical trials that ensure the safetyand efficacy of medicines take years and involvethousands of patients and procedures to ensurethe product is suitable for its intended purpose.

Developing any new medicine is, therefore, adifficult and very expensive operation, with theestimated costs typically exceeding €800mbefore a medicine reaches its market. On average, only one of every 10,000 promisingsubstances will successfully pass testing in theresearch and development (R&D) phase to beeventually approved as a marketable product.

In total it takes an average of 10 to 12 years toturn a promising new compound into a marketable medicine that is proven to be safeand effective enough for patients. Once on themarket, the average medicine then has only eightto 10 years of copyright protection left before itspatents lapse and generic drug manufacturerscan sell similar products based on its research,without having to pay for R&D. Historically onlythree out of 10 marketed medicines generate revenues to match or exceed the costs of R&D.Researching new medicines therefore requiresmassive expenditure with no guarantee of return.

‘In the journey to developing and delivering amedicine, a whole range of skills and professionsare involved’


HUMAN RESOURCES

Caroline Allen asks a selection of human resource directors whatthey look for when it comes to taking on new people

TheheadhuntersSCHERING PLOUGH

A passion for pharmaceuticals, a ‘cando’ attitude and an ability to thrive in achanging environment are just some ofthe qualities recruiters look for, accor-ding to Elaine Boyd, director of humanresources (HR) at Schering Plough.

The company, which manufacturesactive pharmaceutical ingredients, hiresacross the board from business peopleto chemists and scientists. It recruits BScand Phd chemists to support its tech-nical services and chemical develop-ment and also has a large quality groupconsisting of analysts, document spe-cialists and technical writers.

“When recruiting in manufacturing,you’re looking for people with engi-neering or chemistry qualifications. Forthe engineering function, chemical,electrical and mechanical engineers areemployed. We also have the enablingfunctions of finance, HR and IT depart-ments where prior knowledge of thesector, while desirable, is not required,”explains Boyd.

“There are lots ofopportunities tobecome multi-skilled and work oncross-functionalprojects,” she says. Schering Plough is currentlylooking for plant managers, produc-tion managers and systems engineers.Its employees often get the opport-unity to move up the ranks.

LEO PHARMA

According to Pat McCarthy, HR directorat LEO Pharma, Dublin, a career in thepharmaceutical industry will providetremendous satisfaction. “Apart from thetechnical challenge, you’re dealing withproducts that save and improve thequality of people’s lives. Salaries forgraduates generally start from ¤30,000and benefits packages usually incorpo-rate health insurance and pensions.

“Certain areas areexperiencing a skillsshortages, with ademand for chemistry and engineering graduates and analytical staff,” he says. “To some extent the scarcity isbeing covered by the pool of talent fromthe EU accession states, especiallyPoland.

“The ongoing expansion of the sectorand the arrival of new firms such as Centocor, Amgen and Genzyme provide plenty of opportunities for candidates. The biotech area is under-going rapid expansion at the moment.There is a lot of scope for career progression, with analysts, for example,often moving on to become laboratorysupervisors or managers. Good peopleskills, dedication and ambition are thequalities essential to get ahead in theindustry.”

MERCK SHARP & DOHME(MSD) IRELAND (HUMANHEALTH)

The pharmaceutical industry offersemployees a very stimulating and chal-lenging environment in which to work,says Emer O’Byrne, HR director at MSD.

“At MSD Ireland (Human Health),employees experience the unique benefits of working in a global organi-sation with the entrepreneurial drive ofa truly Irish company. We work in anachievement-driven environment wherehow you reach your goals is just asimportant as actually reaching them.We are always looking for employeeswith exceptional capabilities who candemonstrate creativity and innovationand we invest heavily in their develop-ment throughout their careers.”

She adds:

“We currentlyemploy people in Ireland with exper-tise in medicine,clinical research, regulatory affairs,sales, marketing, public affairs, market research, administration,human resources and IT.”

PFIZER IRELAND PHARMACEUTICALS

Roisin O’Grady, recruitment leader atPfizer Ireland Pharmaceuticals, says thatapart from demonstrating the requiredskills and ability to do the job properly,candidates should be able to show theywant the job, are highly motivated andhave a willingness to learn. They shouldbe able to give examples at an interviewof having worked both as part of a teamand on their own initiative.

“When several people with the samequalifications comein for interview, welook at whether theyreally want the job,have done theirresearch on the company and arewilling to get on withpeople,” she explains.

“As well as opportunities in scienceand engineering, there are openings infinance, administration, HR, IT andprocurement. Candidates tell us they areattracted to work for Pfizer because ofits reputation, credibility, strong bene-fits package, working hours, sports andleisure facilities and the diversity of itsworkforce.”

HUMAN RESOURCES

Candidates for pharmaceutical positions often forget to sell theirnon-technical skills to employers as well as their technical abilities

Softly, softlyONE of the most common mistakes candidates for phar-maceutical jobs make is focusing too much on the tech-nical requirements and not placing enough emphasis onsofter skills, according to Helen McGardle, managingdirector of Science Recruitment Ireland (SRI).

“For example, as part of their job in a pharmaceuticalcompany, employees could be expected to run an analysis. They may be able to run it efficiently and to certain specifications. While that is important, the real criteria employers will look for when taking on new staffis whether they are motivated to do it and do it well — willthey add energy to the area of work? Can they multi-task?”says McGardle.

“We appreciate that the recruitment process can befraught with difficulties for many candidates and westrive to give them an experience that is both of immed-iate benefit and long-term value.”

SRI offers a range of training courses geared towardsthose looking for work in the pharmaceutical sector as wellas existing employees. Through its personal developmentprogramme, SRI enables candidates to develop and maptheir career paths through what they can learn about them-selves, even if this means a change in direction for them.It has recently enhanced its personal development programme to help employers better understand theinfluencing factors that often result in people leaving

organisations. “Most of the time, it boils down to a lack ofcommunication,” says McGardle.

In her view, there is not enough training going on in thesector i soft skill areas, such as communications skills. “Softskills are the leverage to technical skills. There is a lot oftechnical training, for example, in CTMP [clinical trials in marketed products] and HPLC [high-performanceliquid chromatography]. This is definitely worthwhileand has to be done, but it’s also important to look at thewhole person and his or her motivation.”


JOURNALISTS, TDs and industry analysts have been tellingstudents the same thing for the past three or four years — thatthere has never been a better time for science graduates inIreland.

Now one of the world’s largest exporters of pharmaceuticals,Ireland is home to 13 of the top 15 companies. More than 17,000people are employed by these companies, with many moreworking in associated firms and industries. Multinationals continue to recruit graduates; the Higher Education Auth-ority is investing ¤1.5bn in scientific research; and the pointsrequirements for many science programmes are the lowest theyhave been in years.

To coincide with the growing pharmaceutical sector, manycolleges and universities have adapted their programmes tosuit the industry’s needs. Galway-Mayo Institute of Tech-nology began offering a new chemical and pharmaceutical science degree this year. National University of IrelandMaynooth (NUIM) offers chemistry with pharmaceutical science; University of Limerick offers pharmaceutical andindustrial chemistry; and Dublin City University (DCU) offersa chemical and pharmaceutical sciences degree.

“The courses we offer here equip our students with theknowledge they’d need to work in any pharmaceutical company,” says Kieran Nolan, a lecturer in the School ofChemical Sciences at DCU. “We teach formulation and regu-lation, which are essential in the industry. Pharmaceuticalsoperates under a regulated environment, which is quite a culture shock for someone with a science background to see.”

The analytical science degree at DCU takes an interdiscipli-nary approach to educating students in a way that is directlyrelevant to the industrial sector. The theoretical and practicalaspects of chemical, biochemical and microbiological analysisare taught side by side. The university enjoys close links withthe industry and the course includes a work placement.

“One of the reasons we changed our programme is that we haveto supply the market with graduates. We tailor-made our chem-ical programme for the pharmaceutical industry,” says Nolan.

DCU also offers a degree in biotechnology, which is a sciencedegree with an engineering component to educate studentsin the manufacture of useful products from living organismsand biological systems.

The university’s ability to provide hands-on experience hasgone down well with the industry. “From DCU’s perspective,we will be supplying and producing a lot of graduates over thenext few years. Some of our students have gone on to do PhDsand some have gone straight into industry. Most end up in the

EDUCATION

With more and more job opportunities inpharmaceuticals, Irish third-level institutions aretailoring their courses to match. Linda Daly reports

Meeting

market demands

EDUCATION

pharmaceutical industry if they leave straight after theundergraduate degree.”

Nolan believes that the pharmaceutical industry will continue to thrive and that its ability to compete even during adverse times should attract students.

“The pharmaceutical industry is recession-proof; people are always sick so you always need the productionof drugs,” he says. “There’s an adage we have — what inthe world isn’t chemistry?”

Chemistry is the central science for a wide range of indus-trial applications. Not only do chemists develop newdrugs and pharmaceuticals, they also design cleaner andmore efficient reaction processes to produce them. Theymonitor the environment and ensure its protection andthey help provide new materials, devices and medicines.

The institutes of technology in Athlone, Sligo and Tallaght offer pharmaceutical science, while LimerickInstitute of Technology (IT) combines this with forensicanalysis. Ireland’s first pharmaceutical technology training centre was opened at Tallaght IT in 2002. Sinceopening, the facility has provided the skills and trainingnecessary for graduates to immediately enter the phar-maceutical and biotechnology industries.

While the courses are targeted at careers in the phar-maceutical industry, they are broad-based and gradu-ates are employable in many other areas of industrial andscientific work. James Brennan, head of the departmentof applied sciences at IT Sligo, says opting for a pharma-

ceutical science degree will give students many options. “By doing the pharmaceutical programme you’re not

making the decision to be a chemist or microbiologist. Youcan choose at the end of it where you want to go and eventhen if you don’t like the direction you’ve taken, you canchange again,” he says.

A year before the centre was opened in Tallaght, IT Sligoopened a pharmaceutical science centre, which is offeredto local companies such as Abbott for process developmentwork and staff training. Its establishment highlighted theinstitute’s ability to provide top-level degrees.

IT Sligo now has the biggest school of science in the insti-tute of technology sector, with more than 850 students. Itoffers three courses: the pharmaceutical science (add-on)degree; the ab initio degree; and the honours degree.

The ab initio degree is a four-year, full-time course, whichis designed to educate and train professional scientists forthe pharmachemical industry. It is a multi-disciplinary pro-gramme, meaning science subjects are taught as well asapplied modules such as quality assurance validation

and management. “The programme is very well regarded by the industry

and there are many job opportunities. Unfortunately, thedifficulty is selling it to second-level students. We’re starting now to bring the message to transition-year students,” says Brennan.

Students don’t need to have studied chemistry at second level to do the pharmaceutical science degreeand most of those who have taken the course so farhaven’t done. Pharmacology, microbiology and comp-uting are just some of the modules and students also under-take a five-month paid placement in the healthcare or phar-machemical industry. There is also an option to go abroad.

In an era when jobs are no longer for life, students choosing a career path should bear in mind that the phar-maceutical industry is flourishing here. The top pharma-ceutical firms are among the richest in the world and evenin bad economic times people can expect steady employ-ment. Many employees also talk of job satisfaction and thefeeling that they are making a difference.

‘The pharmaceutical industry is recession-proof;people are always sick so you always need theproduction of drugs’

WORKING IN INNOVATION


RESEARCH and development (R&D) offers the opportunity towork at the cutting edge of the pharmaceutical sector. There aremany diseases for which there are still no cures and the role ofthe pharmaceutical industry is to try to develop new medicinesby understanding them, according to Dr John Farrell, medicaldirector of Pfizer, which has more than 100 medications on theIrish market.

“Cancer is a huge area and has multiple forms. By betterunderstanding each form, we learn about its spread and the damage caused. The industry is developing better methods ofkilling these cancer cells with fewer side effects,” he says. “Overthe next 10 to 15 years, it is expected that a lot of cancer medica-tion will become available.”

Pfizer has made strides towards doing just that by developingmedication to treat macular degeneration, which causes blind-ness in elderly people and is often linked to smoking.

Research in the universities and industry probes common dis-eases and develops medicines to target them. Farrell’s role is totest medication at an early stage to ensure it works and is safe.“Once you know the benefits and risks, you can advance a drugand know what type of patients will benefit from it,” he says.

He runs medical trials, getting involved in phases two and three.“These involve ensuring that the drug does what it is supposedto do so that we can go to the Irish Medicines Board and the Euro-pean Agency to get a licence.” The industry emphasis on safetygenerates a huge amount of work in areas such as clearly defining and labelling medication, he says.

Having trained in kidney medicine in this country and the US,Farrell relishes his role in innovation. “You are working on medicine that may not make it to the Irish market for three to fiveyears,” he remarks. “I always had an interest in research. In thepharmaceutical industry, you have to stay on top of research froma scientific viewpoint. You’re at the cutting edge of genetic andmolecular work.”

MARGARET COONEY, HEAD OF MEDICAL AFFAIRS ANDCLINICAL OPERATIONS, SANOFI-AVENTISCooney implements and manages clinical trials at Sanofi-Aventis. These consist of epidemiology trials, which look at disease prevention and a breakdown of the population of Ireland,and the company is also often part of global or European trials.

“I run local observational trials too, looking at the populationon a certain medical study and seeing the results of patients taking the medication in normal clinical practice,” she explains.

Cooney has a masters in research pharmacology from UniversityCollege Dublin. She started in the pharmaceutical industry in Ireland but then moved to the US, where she spent nine years.She first worked for a contract research organisation, monit-oring and subsequently managing phase two and three picotalclinical studies. She then spent four years in the pharmaceutical

A job in research and development for the pharmaceuticalindustry involves understanding diseases in order to developmedicines to counter them. Caroline Allen reports

On the FRONT LINE

industry, working in clinical development and opera-tional implementation of clinical studies.

Cooney currently manages clinical operations studies,both product-related and epidemiological. She is alsoinvolved in phase four studies in which, as part of a global or European trial, medication post-approval isstudied. “On a daily basis, I oversee all of those areas as wellas monitoring trials to make sure they are properly conducted and that patient safety is to the fore.

“More and more clinical trials are being conducted in Ireland,” says Cooney.

Many doctors and nurses are attracted to working inR&D. “Typically, when people graduate, they firstly go intoa clinical trial administration role. There they learn theground rules and track the studies, co-ordinating from anadministrative level but learning about the regulations andstudying designs at the same time,” says Cooney. Anotheroption for people coming out of college, she adds, is to joina contract research organisation.

The next position to move into is monitoring, saysCooney. “A clinical research associate goes out to hospitals,

looks at patient charts, studies protocols and reports all theinformation to a project manager,” she says. “As candidatesbecome more senior, they can take on project managementroles, to a point where they will eventually be project managing small studies of their own, while still reportingto someone in a senior position.”

NOELEEN FARRELLY, SENIOR CLINICAL RESEARCHASSOCIATE, MERCK SHARP & DOHMEFarrelly monitors clinical trials to ensure they are done inaccordance with protocols, good clinical practice and regulatory requirements.

“I act as the main contact with the site of the clinical trials, which are normally run by a consultant, doctor orGP,” she says. “I have to ensure the investigator is qualifiedto conduct the studies and has the resources to ensure theyare run properly. Ultimately, my job is to ensure that therights and well-being of the subjects are protected.”

Farrelly’s work is mainly in phase three of clinical trialswith drugs that have already undergone rigorous testing.Getting out and about is part of the role. “I go to the sites

Margaret Cooney, head of medical affairs and clinical operations, Sanofi-Aventis

WORKING IN INNOVATION

‘Once you know the benefits and risks, you can advance a drug and know what type ofpatients will benefit from it’

and make sure the data and source documents are accurate andup to date,” she says. “I also regularly visit hospitals.”

Training is also part of her remit. “I train the site staff on howto conduct the study, which involves giving presentations. I alsoteach them how to perform lab assessments, deal with drugs onsiteand store them in accordance with regulations.”

Farrelly says Ireland is now deemed to be a good place to conduct clinical research. “When I started in March, there wasjust myself and the medical director. There will be seven of us within the next month. There has been a great improvement inthe number of jobs available in this country in this area.”

ROBERT WILLIAMS, DIRECTOR OF ANALYTICAL R&D,BIOVAILAs well as being involved in the early stage development of newdrugs, Williams works on the dosing regime of existing medicines.

“We take a drug on the market that may be dosed twice or threetimes a day and develop a once-a-day table,” he says. “The benefit is improved compliance.” US research has revealed that50pc of patients do not comply with their prescriptions, he adds.

Biovail can evaluate the stability of the drug in the new formulation. “We develop quality tests to determine the performance of products,” Williams says. “We can infer to some

extent how they will behave in the body before proceeding with any clinical studies.”

According to Williams, working in early stage devel-opment is challenging and exciting. “The environment isconstantly changing. I support the junior analysts fromday to day. I also work with the manufacturing side to transfer the product once it is developed.” Trouble-shooting technical issues that crop up also takes up someof Williams’ time However, he sees his main role as supporting the analytical development of the product.

“The first step is to develop an understanding of howthe drug behaves from a stability or release perspective.Then we develop analytical methods to control the

quality of the product and support the development of theformulation,” he says. “Once the methods have beendeveloped, they are thoroughly validated to ensure theyare fit for use. Then we support the management of thedrug for clinical trials and quality control release.”

Williams graduated from Trinity College Dublin in1991 with a chemistry degree and in 1995 he received a PhDin organic chemistry from the university. He acknowledgesthat working in R&D isn’t for everyone. “A lot of peopleenjoy the challenge but others prefer routine and havingtheir day laid out for them. If you want the cut and thrustof a rapidly changing environment and have the tech-nical ability to cope with that, it’s a great career.”

THE pharmaceutical sector in Ireland has expanded significantly over the past decade. With the majority of theinternational companies in the sector now based in thiscountry, competition is fierce to make one product shinemore than the rest. All of the major companies havemarketing divisions and all will be seeking to hire the best.

Those who work in marketing must deal with anyonewho needs to know anything about the product and somust have a thorough knowledge of the business they arein and the products they represent. In addition, mark-eting managers make recommendations to senior management on critical decisions, so they must always beat the top of their game.

There has never been a more interesting time to workin marketing in the Irish pharmaceutical industry. With

Increased competition betweenpharmaceutical companies hasmade the marketing ofproducts all important.Caroline Allen reports

Ireland now a leader in pharmaceuticals and withmore and more discoveries made every day, working inthe marketing division of the top companies can be chal-lenging but very rewarding.

GER BRENNAN, SENIOR PRODUCT MANAGER,WYETH PHARMACEUTICAL Having a marketing role in the pharmaceutical sectormeans being the brand champion of the product,according to Brennan. “The top-line area is in thepreparation and agreement of business and operationstrategic product plans. Once we develop the plan andget agreement on it, we have to implement it, workingwith the sales team,” he says.

Brennan’s background is in nursing. Working in theindustry for the past seven years, he started off as a general practictioner sales representative and moved onto calling into hospitals as a consultant, before being promoted to product specialist and moving into marketing. “The normal role of a product manager isto do with commercial awareness and responsibility forall aspects of the business. You have to achieve targetsand if they’re not met, you have to examine the reasons.”

The role requires a lot of product knowledge, keeping up to date with newly published data andworking closely with the medical profession, Brennan

says. While it is mainly office-based, it also requires meet-ings with key opinion leaders such as consultants.

“Once the product is licensed, we are involved in setting up a link between the medical trials departmentin the US and the consultants here,” says Brennan “Acampaign is put together and we have representativeson the road who go to visit the consultants.”

Extensive research is carried out as well as campaign testing. There is, says Brennan, an emphasison achieving a partnership with the medical profession.“We also work with patient associations to try to raiseawareness of specific diseases,” he says.

Working with what Brennan describes as the next generation of pharmaceuticals, biologicals and a global product is exciting, he says. A lot of travel isinvolved, both to Wyeth company meetings and tomedical symposiums in Europe and the US.

The candidates who get ahead are those who aredynamic and creative, says Brennan. “You have to be ableto think on your feet and you can’t be afraid to makedecisions.” The ability to work as part of a team isvital. “You work with medics, people in regulatoryaffairs, the sales division, global public relations and marketing. It’s a cross-functional role.”

Other crucial qualities, he says, are business acumen,change orientation, customer focus, a drive for results,

Playing the marketGer Brennan, senior product manager, wyeth pharmaceutical


WORKING IN MARKETING

innovation, planning and organisation, leadership and the ability to solve problems.

There is a major responsibility to ensure adherence to strict regulatory procedures, Brennan says. “Any promotional material has to go through a very strict ‘job bag’ process and beapproved by medics, marketing, sales and legal people. You can’tmake any claims unless it is fully researched, marketable data.”

MARTIN MORRISSEY, SALES AND MARKETING DIRECTOR,ROCHE PRODUCTS IRELANDMorrissey says the strategic marketing of medicines involveslooking into the future. Getting products used by the rightpatients is important and market research is mainly conductedthrough doctors, GPs, nurses and pharmacists.

“I’m involved in the strategic planning of the company,” says Morrissey. “This involves working on future trends in termsof treatment and usage as well as medical developments.”

Morrissey worked his way up from sales. “I started with Rochemore than 16 years ago in a selling capacity. I was involved withvery specialist areas such as cystic fibrosis, oncology, transplan-tation and HIV,” he recalls. “Selling is a common route into marketing. It gives you a good insight into the challenges doctorsface and how we can address their needs.”

However, many candidates are now studying marketing afterdoing a degree, Morrissey says. “There are a wide variety ofavenues into the area. Someone from sales could come in atproduct management level. We have had someone working as aclinical research associate who became interested in marketingand got a product management role in their company before join-ing us in marketing 18 months ago.”

Believing that you can make a real difference in patient care iskey, according to Morrissey. “You have to believe in your own prod-uct and that ultimately what you are doing can make a difference.”

Martin Morrissey, sales and marketing director, Roche Products Ireland


EMPLOYMENT in Ireland’s pharmachem industry hasincreased by more than 50pc in the past 10 years. According to industry body PharmaChemical Ireland,the sector now employs more than 24,000 people, ofwhom more than half are third-level graduates.

Companies in the Irish pharmaceutical sector tend to puta strong emphasis on career development and on encour-aging staff to move between functions and sometimes evenbetween international sites. As a result, the industrytends to have quite high retention rates, particularlyamong graduates. At the moment, salaries are generallyhigher in this industry than in regular manufacturing.According to Pharmacareers Ireland, starting salaries forgraduates are usually around the ¤25,000 to ¤30,000mark. This rises to between ¤40,000 and ¤50,000 with fouror more years’ experience and reaches ¤60,000 to ¤80,000at team leader/middle management level.

While pharmaceutical companies tend to favour sciencegraduates, there are opportunities for people withoutthird-level qualifications. Production operators, for example, usually need to be educated to Leaving Cert stan-dard and, after receiving training, are primarily involvedin carrying out and monitoring processing operations.

According to recruitment consultancy Brightwater,operators earn between ¤18,000 and ¤25,000 per year.While they may progress within their own department, to

team leader and then to supervisor level, there may alsobe opportunities to move into other areas, such as financeor human resources. However, production operators moving into more technical roles will usually alreadyhave a qualification related to the new function.

The quality control (QC) department generally

consists of chemistry and micro-lab analysts, who monitor products at all stages and in all batches to ensurethey have not become contaminated. Analysts can moveup to senior lab analyst and group leader level within theQC department. There may also be opportunities to moveinto the validation department, which is responsible for testing and certifying equipment.

While QC checks the product, the quality assurancedepartment is responsible for ensuring the facility oper-ates according to the standards issued by regulatoryauthorities. Among other things, this involves communi-cating standards and writing and updating operatingprocedures and batch records. Another key department inpharmaceutical companies is engineering, which is respon-sible for providing support to production as well as main-taining, modifying and repairing plant.

BRIAN KILLEN, PRODUCTION MANAGER, MERCKSHARP & DOHMEResponsible for four factories in Tipperary, Killen has a staffof approximately 60 operators as well as 12 supervisors,team leaders and engineers.

The job involves managing the execution of all proce-sses in factories dedicated to wet processing, dry fini-shing, solvent recovery and pilot plant. Specific dutiesinclude: daily, weekly and long-term planning of the

WORKING IN PRODUCTION

Although it helps, a science degree is by no means vital for someone wishing topursue a career in pharmaceuticals. Grainne Rothery reports

On the PRODUCTION line

‘While pharmaceuticalcompanies tend tofavour science graduates, there areopportunities for people without third-level qualifications’

Brian Killen, production manager, Merck Sharp & Dohme Michael Cleere, process engineer, Pfizer Fiona Carroll, supervisor, GE Healthcare

WORKING IN PRODUCTION

facility; ensuring that production schedules are met and thatthe right quality and yield are achieved for each process step;resolving technical issues; and making sure the facility oper-ates to the highest possible safety, environmental and quality standards.

Killen joined the company nine years ago after completinghis masters in chemical engineering at Queens UniversityBelfast. After a one-year stint in a chemical engineering tech-nical support role, he spent three years at a sister plant inFrance working as a production shift engineer. When hemoved back, he worked initially as a team leader in the pilotplant and then as a technical manager, before taking up hiscurrent role two years ago.

“For me, the most interesting aspects of this job are the long-term production planning, the manpower planning and thehuman resource (HR) issues associated with that, such as dealing with the unions about how we’re going to have to movepeople and restructure work practices,” he says.

Now at senior section manager level, Killen believes his nextstep will involve either taking a director position on site or relo-cating to another site or to corporate Merck.

“If you have the potential and are willing to put yourself forward, the options do arise,” he says.

MICHAEL CLEERE, PROCESS ENGINEER, PFIZER Working in the production department at Pfizer’s Little Island facility, Cleere’s main objective is to ensurethe plant is set up in a safe and environmentally compliant way.

“I ensure that systems and equipment can be usedeffectively by the operators and I take their commentsand feedback on board,” he explains, pointing out thatit’s vital to listen to the concerns of end users in orderto understand the issues and identify problems.

Cleere says one of the most interesting things aboutthe role is seeing a critical stage in the commerciali-sation of a product, from introduction through tolarge-scale manufacture.

After graduating from University College Dublinwith a degree in chemical engineering in 1995, Cleereworked for Merck Sharpe & Dohme before moving to Pfizer in 2000. All his roles to date havefocused on production and production support, apartfrom a short spell in safety at Merck Sharp & Dohme.He will shortly move to more of a project managementrole, as he is responsible for the commissioning andqualification of a large new on-site plant.

FIONA CARROLL, SUPERVISOR, GE HEALTHCARECarroll has been in her position in the productiondepartment at GE Healthcare since January. The jobinvolves putting together the production schedulesand ensuring that they are adhered to. It also involvessolving problems and participating in projects for production process improvement.

After graduating in 1997 with a masters in micro-biology, Carroll worked in a QC role in ScheringPlough for three years. She then moved to GE Health-care, where she was involved in quality assurance forfour and a half years before taking up her present posi-tion. So far, she has particularly enjoyed the feeling ofbeing close to the action. “Production is the centre ofthings in the pharmaceutical industry,” she explains.“The office is in the production area so you’re in thehub of it.”

In the long term, Carroll sees herself returning to quality. “I first want to learn more about an operationsdepartment,” she says. “I think for anyone who worksin quality, it’s a good idea to work in production. Some-times when you’re working in a support department,you don’t see all that’s involved in producing a batch.”


ALWAYS full of promise, but initially slow to develop, the biotech-nology sector is now believed to be finally starting to deliver onits strong potential, both in Ireland and on a global scale. Involving the use of living cells and cell components to manu-facture a wide range of products, including food, fuel and phar-maceuticals, it’s a highly sustainable technology. According to theIrish BioIndustry Association, the representative body for thebiotech sector, this will enable economic growth and increase thecompetitiveness of many industries in Ireland.

Nearly 60 Irish-based biotechnology companies, empl-oying an estimated 4,000 people, are involved in biopharma-ceutical discovery and manufacture and in diagnostic, agri-food,pharmaceutical services and bio-environment activities. Thesector is also supported by many specialist service providers inthe legal, patents, clinical trial, contract manufacturing andwaste handling and disposal areas.

Biotechnology is increasingly viewed as a priority area byIrish agencies. Enterprise Ireland, for example, has its ownbiotech strategy and prioritises start-ups in this area. IDA Ireland is actively trying to attract biotechnology companies intothis country. And, when Science Foundation Ireland was estab-lished in 2003, it identified biotechnology as a key area forinvestment and research.

The high-profile employers in the biotech sector in Irelandinclude Wyeth BioPharma, Schering Plough, Genzyme, Trinity Biotech, Biotrin and Megazyme. While biotech-nology, microbiology, chemistry and biochemistry graduatesare always in demand, having a science degree is not an absoluterequirement for working in the sector. In addition to the scien-tific roles, positions are available in production, quality engineeringand production support areas.

Salaries are generally quite competitive in the sector. In its SalarySurvey Ireland 2006, recruitment and human resources consul-tancy Hudson found that: lab technicians working in biotech earnbetween ¤25,000 and ¤35,000; analytical chemists with one tofour years’ experience are in the same range and those withbetween four and seven years’ experience can earn up to ¤45,000;biochemists can command up to ¤40,000; and validation man-agers are paid between ¤45,000 and ¤60,000.

JULIANNE HOGAN, DEVELOPMENT SCIENTIST, WYETH BIOPHARMAHogan works in development operations, where she is primarily focused on process development. “We are manufacturing a vaccine for meningitis and I’m involved in thedevelopment of that manufacturing process,” she explains. “A lot

WORKING IN BIOTECHNOLOGY

The use of living cells and cell components tomanufacture products is a strong growth area.Grainne Rothery reports

Buying into

biotechnology

‘Biotechnology is increasingly viewed as a priority area by Irish agencies’

WORKING IN BIOTECHNOLOGY

of my job involves going tomeetings and co-ordinatingprojects. I also do a lot of pilotscale work here for the manufacture of the vaccine.”While the products she’sworking on have already beendeveloped and manufacturedin the US, the technologytransfer process requires initial small-scale manufac-ture in the lab in Dublin toensure all the process infor-mation is accurate before

moving to large-scale production.Hogan completed her industrial biochemistry degree at

University of Limerick in 1999 before working for a smallbiotech research company in Cork, where she remained formore than three years. While she gained a lot of experiencein the cell biology area during this time, the job was veryresearch-focused and didn’t involve manufacturing anything. “I thought I’d really like to see this on a large scale,”she explains. “So I moved to Wyeth and started in virology.We were setting up our onsite virus lab for virus detection inthe manufacturing process. That was a quality lab so it wasvery focused on good manufacturing practices and very regulated.” She says that while this was somewhat over-whelming, it also gave her a good grounding in the whole area

of compliance. Six months ago, when the virus lab was up and running,

she decided to move to her current role in order to gain newexperience and work in a new environment. “I’ve kind ofstepped away from the cell biology side of things now,” shesays. “It’s more about chemistry process engineering, whichis great because I now have a greater depth of knowledge. I’veseen the whole thing evolve from early stage research and looking for targets up to how we make it and then how wemake it really, really well.”

In the future, she hopes to move into a project management position, having picked up a range of relevantskills since starting in development operations. “Movingfrom virology into this role, I’ve noticed that you become apeople person and you really have to get with the programme when it comes to co-ordinating, communicatingand project management,” she says.

PAUL CONDON, MATERIALS DIRECTOR, GENZYMECondon experiences various aspects of the biotech indu-stry. He is responsible for purchasing all the materials Genzyme uses as well as customer service and interna-tional distribution. Genzyme supplies 40 countries worldwideand Condon and the group of 28 people he works with areresponsible for getting the materials to them.

Genzyme, which opened in Ireland in 2002, employs 300at its Waterford site and is currently recruiting. Condon joinedthe company when it was first set up, after working for 15 years

in the pharmaceutical industry. He has a degree in manage-ment from the Irish Management Institute as well as a masters and he is currently studying for a master’s degree insupply chain management.

In the past 20 years, Condon has seen many changes in thesector. “It has become increasingly regulated and Ireland has become a centre for pharmaceutical compa-nies, which is great. The biotech industry is an extension ofthat, meaning there are a lot of like-minded companies in Ireland operating in the same environment.”

He says that a career in the biotech industry is very satisfying. “It’s very rewarding. You have a strong sense of making a difference to people’s lives because these are life-threatening and debilitating diseases and you’re doing some-thing that’s impacting in a very real way.”

Condon says ongoing training is vital. “We have a strongtraining and development culture as a company and a lot offocus on continuing education. We work closely with Water-ford Institute of Technology, which was a very big plus in termsof Genzyme coming to this area.”

He emphasises that science graduates aren’t the only people who work in the industry. “In some of the functionsthere is a focus on science graduates, but not all the disciplineswithin the company require a science background. If you takebiotechnology, a lot of it is to do with drug development andformulation, but then when you get to the commercialisationof the product, you’re into another realm to do with servingand supplying patients.”

Eli Lilly and Company is a leading innovation-driven corporation committed to developing a growing port-folio ofbest-in-class and first-in-class pharmaceutical products that help people live longer, healthier and more active lives.

Celebrating 25 years ofmanufacturing in Kinsale

Julianne Hogan,development scientist, Wyeth BioPharma

INVESTMENT


After much consideration, the two areas earmarked forparticular attention in terms of research are information andcommunications technology and biotechnology

Biotech and ICT the ones to watch

SINCE it was founded in 2000, Science FoundationIreland (SFI) has invested ¤200m in biotechnologyand biosciences research in academic institutions.Biotechnology, along with information and commu-nications technology (ICT), are the areas that wereprioritised in the examination process that led directly to SFI’s establishment.

Dr Maurice Treacy, director of bioscience and bioengineering at SFI, explains the events that led tothe formation and existence of SFI: “In 1999, a tech-nology foresight exercise was commissioned by thegovernment, which examined the potential areasfor future investment in research that could signifi-cantly and positively impact the Irish economy. Thistook more than a year to complete and involvednumerous lectures from invited experts as well asworkshops and public events. That process identifiedtwo areas — ICT and biotechnology — which, in thecontext of Ireland’s strengths, should be the areas offuture focus for research investments.”

The criteria that led to a focus on these sectorsincluded the fact they represented short, medium andlong-term return on investments with the potentialfor high returns and that they could capitalise on nascent assets, an educated young workforce, low corporate tax and a stable and agile government.

“If you look at both the ICT and biotech/life sciencessectors, the timeframe for the output of commercialproducts is very different and represents a contin-uous range of products coming from both sectors. ICTsoftware is the quickest to market, hardware repre-sents a mid-term return and biotech a mid to long-term return. In biosciences in Ireland, the medicaldevices and diagnostics sector constitutes the mid-term timeframe to economic return, while thetherapeutic products sector represents long-termand high-value return.”

Although the potential return on investment forbiotechnology is very high given the knowledge-intensive nature of the research, there is a propor-tional increase in risk. “Return on investment will belarger than your typical manufacturing activity, butonly on the successful projects,” Treacy remarks.“The fall-off or attrition rates in drug development

are high, which makes this research high cost, highrisk and high return. We cannot afford to be riskaverse or we wouldn’t achieve anything, however wemust insist on quality. The Government is imagina-tive in this adopted innovation-driven strategy.”

Treacy says that while the return is important, itshould also be remembered that these investmentsimmediately benefit people. He emphasises that,apart from direct return on investment in the formof commercialisation of research, the teaching andtraining of students is good for the economy and society in general.

Having said that, economically viable applicationsof the research are needed. While SFI funds academicresearchers, there is an onus placed on them to contemplate the possible market potential of theirwork. “When we receive applications from acad-emic researchers, we examine the quality and competitive and innovative nature of the proposedresearch programmes using international peerassessment,” explains Treacy. “We also ask the ques-tion as to the strategic importance of the proposedresearch to Ireland — how does it map on to embed-ded industries and, if it does not, how can that be grown?”

Luckily, Ireland is well served by life sciences andhealthcare companies. “We are fortunate to have arich, embedded base of relevant industries. Nine ofthe big 10 pharma companies, all of the major medical devices companies and most of the globaldiagnostics companies are active here. This strongposition needs to be leveraged so they broaden theiractivities to include research,” says Treacy.

“Exposing them to quality researchers is a keymechanism to ensure that academic-industry collaborative research activity begins and grows, asthey are attracted to high-value research andresearchers and the promise of quality, exploitableintellectual property emerging from that. We askresearchers to think about how they might work withthese companies and to plan out a road map accord-ingly. In this way we are systematically linking upresearchers with the most relevant industry part-ners,” says Treacy.

‘Nine of the big 10 pharma companies, all of the major medicaldevices companies andmost of the global diagnostics companiesare active in Ireland’

Dr Maurice Treacy, director of bioscience and bio-engineering at Science Foundation Ireland

INVESTMENT


Wyeth’s Newbridge facility is one of thecompany’s two strategic pipeline sites for solid-dose pharmaceutical products worldwide

A new biopharma process training facility inCork hopes to act as a magnet for majorbiopharmaceutical investments. Brian Skellyreports

The Wyeth way

Biopharma ambitions

WITH the announcement earlier this yearthat ¤350m is to be invested in Wyeth’s manufacturing facility in Newbridge, Co Kildare, the pharmaceutical industry inIreland has received yet another vote ofconfidence. Wyeth is one of the largest phar-maceutical companies in the world and thisinvestment will be used to expand productioncapabilities at the facility for the company’semerging pipeline of products.

The next five years will be exciting timesfor the Newbridge plant, which is one ofWyeth’s two global strategic pipeline sites forsolid-dose pharmaceutical products.

The investment has been eagerly welcomed by politicians and Wyeth staff inNewbridge. “We would see it as somethingthat really validates the sort of work we do,”says Daryl Kennedy, associate director oftechnology at the Newbridge site. “That sortof investment doesn’t come easily. Every dayyou have to earn the right to be a strategic site.

The emerging pipeline is positive and we willcontinue to engage in attracting the transferof new products into the site.”

The technology department at Wyeth Newbridge is a relatively small but vital partof the company. In the technology group, 67people are employed in roles from seniormanagers to technology specialists. Theyhave a diverse range of backgrounds, fromPhD chemists and pharmacists to indust-rial engineers and statisticians.

“At Wyeth Newbridge it’s all about cross-functional team work. Everybody must worktogether and not operate in isolated units.Technology is a key function that operateswithin this framework,” says Kennedy.

“We are focused on achieving four commongoals in quality, safety, customer service andcost effectiveness. The technology departmenthas a pivotal role, whether there are new orexisting products coming through thepipeline. We work on optimising the

processes and delivering reduced cycle times.” The recent announcement that there is to

be a reduction in the number of jobs at Newbridge over the next two years was a blowfor employees at the company, but it does notspell bad times. As a strategic pipeline site,Newbridge continues to be very much atthe heart of Wyeth’s future. The company hasa worldwide workforce of 52,000.

Like many pharmaceutical companies inIreland, Wyeth continues to promote lifelonglearning within the firm, with staff doingdiplomas at Institute of Technology Tallaght and partaking in an extensive in-house training programme. “Everybodyneeds to be up to speed with the latest stateof the art technologies or initiatives,” says Kennedy.

THE keen aspirations the Government hasfor the biopharma sector were underlinedrecently when it announced it is to invest¤3.5m in a new biopharma process trainingfacility in Carrigaline, Co Cork.

Locating the facility in Cork is a reflectionof the high concentration of pharmaceuticaland biopharma companies in the southernregion, with 23 plants in the Cork area and40 in Munster as a whole. However, as if to

prove the south has no monopoly on bio-pharma investments, the Governmentannounced that another major biopharmaproject, the ¤72m National Institute for Bio-processing, Research and Training (NIBRT),would be based at University College Dublin’s(UCD) Industry Park.

The facility is being established by fourleading colleges: UCD, Trinity College Dublin,Dublin City University and Institute of

Technology Sligo.The majority of the funding will be

provided by IDA Ireland over the next sevenyears. The facility, with world-class researchand training programmes, will be a corner-stone in the agency’s efforts to attract the nextwave of industrial development.

One of just a small number of such industry-focused facilities in the world, itwill be a centre of excellence in bioproc-essing and biomanufacturing technology training and research and will support therapidly growing biopharmaceutical industryin Ireland.

A key element will be the substantial invest-ment in the scale-up capability within whichthe training and research can take place.This capability will make the training andresearch carried out highly relevant to theneeds of the biopharmaceutical industry inIreland and throughout the world.

Through the involvement of the acad-

emic partners, the new facility will provide a substantial output of people across the spec-trum of bioprocessing skills. It will also buildup a substantial research team to undertakecollaborative research between academiaand industry.

The Minister for Enterprise, Trade andEmployment, Micheál Martin TD, said thenew facility would give Ireland a competitiveadvantage and act as a magnet for major biopharmaceuticals investments from bothoverseas and indigenous companies.

“The establishment of NIBRT sends out aclear signal to the biopharmaceutical indu-stry worldwide that the Irish Government iscommitted to a strategy of development forthe industry and to creating a highly competitive environment in terms of skills,training and research capabilities,” he said.“Biopharmaceuticals and bioprocessing havebeen identified as key growth areas for thefuture.”


THE ability to convert innovative technologies into commercialproducts with a broad range of applications has propelled Luxcel Biosciences into a strong position. The Cork-based biotech-nology company is already working with some of the leading players in the pharmaceutical and food safety sectors and, overthe next five years, has the potential to capture a significant shareof a combined market worth US$2bn.

Luxcel won the innovator category at this year’s Small FirmsAssociation National Small Business Awards, announced on 3March. Having started life as a spin-out from University CollegeCork (UCC), it was incorporated in February 2002 by Dr RichardFernandes, who has a background in biochemistry and previouslyworked as a researcher at UCC, and Dr Dmitri Papkovsky, whois in charge of the biophysics and bio-analysis lab in UCC’s biochemistry department. The company now employs 10 peopleand has its research and development (R&D) base in the newBioInnovation Centre in Cork.

Luxcel has already developed several technology platforms,including respirometric screening technology (RST), phospho-rescent label technology and the oxygen sensor system, each ofwhich has the potential to generate several product types and beadapted for related biotechnology markets. The technologies havebeen in development for the past 12 years or so and originatedin various major research institutes around Europe, with themajority of the research carried out in UCC. The company hasdeveloped its own intellectual property and has also been granted exclusive licences from other institutions.

For start-up biotechnology companies, the road to revenue istypically a fairly lengthy process because of the amount of R&Dinvolved. However, Luxcel’s progress to date has been exceptional.“It can typically take up to five or six years from company start-up to the formation of a biotechnology product,” says Fernandes. “However, Luxcel has been quite innovative in thatfield. We were formed in 2002 and launched the first product inless than a year. Since then, we’ve managed to sell to the majo-rity of the top 10 pharmaceutical companies in the world. Revenue, meanwhile, increased by 120pc between 2004 and 2005.”

According to Fernandes, Luxcel’s ability to bring products tothe marketplace so rapidly comes down to the quality of the tech-nology and research and the way the products are being commercialised. “We actively engage with the end users,” he says.“We put a lot of resources into working with and educating theend user in the science. Now we’re getting the support of the bigpharmaceutical companies and are getting ready to go into thegrowth phase of the product.”

Luxcel’s flagship technology is RST, which measures oxygenuptake in biological samples and has important applications indrug development as well as in food and water safety. For example, RST enables pharmaceutical companies to identifypotential toxicity problems in early-stage drug development. “Luxcel has developed a very fast test that enables it to look at new

COMMERCIALISATION

Luxcel Biosciences, which was named Innovator of the Year atthe SFA’s National Business Awards in March, is in a position tocapture a significant share of a very valuable market

Making it in biotech

‘We’re looking at targeting a combined market of US$2bn and are working with the leaders in these markets’

drugs as quickly as possible to see if there’s an indicationthat they may become toxic,” says Fernandes. “Pharma-ceutical companies will still have to do further tests, butwhat they’re looking for are quick, flag-waving tests.”

The technology has also been adapted for food safety andthe company is about to launch a product in this area. “Wecan identify if bacteria are present by the rate at which oxygen is being consumed,” says Fernandes. “The strengthof this technology is that it dramatically increases the speed

of the test. While current sterility tests can take anywherefrom two to three days, Luxcel’s takes hours.”

According to Fernandes, approximately 600 millionfood safety tests are carried out each year and each test cancost up to US$2 or US$2.50. As regards drug disco-very, he points out that Pfizer alone spends more thanUS$7bn each year on R&D. “We’re looking at targeting acombined market of US$2bn and are working with the leaders in these markets.”

DR RICHARD FERNANDES, CO-FOUNDER, LUXCEL BIOSCIENCES

COMMERCIALISATION

Eli Lilly will celebrate 25 years’ successful operationat Dunderrow, Co Cork with an open day forstaff, their families and members of the public

Eli Lilly — 25 years on

ELI Lilly is a pharmaceutical company witha history of medical innovation, mostnotably in the treatment of oncolytics, diabetes and depression. The company wasfounded in 1876 by Colonel Eli Lilly, is head-quartered in Indianapolis in the US and nowemploys approximately 44,000 peopleworldwide.

Celebrating 25 years in operation thisyear, Eli Lilly’s Irish manufacturing facilityis a bulk active pharmaceutical ingredient

facility at Dunderrow, Co Cork, 5km fromKinsale. The first products were producedin 1981 and more than 450 people areemployed at the site today.

The milestone will be marked by a series of celebratory events at the site on Friday and Saturday, 5 and 6 May foremployees, their families, members of thecommunity and contract staff.

Over the years the Cork facility has built astrong reputation within the Eli Lilly organ-

isation for its ability to safely manufacture andsupply a range of new medicines to patientsworldwide.

“I think one of the most significant successfactors for us has been the people who work

here,” says Donal Johnson, business leader,public affairs. “We have terrific people, manyof whom grew up in the locality and haveworked with the company for the past 25years. In that time they have developed deeptechnical expertise in manufacturing medicines that is recognised throughout theorganisation.”

Johnson also cites the educational systemin Ireland as being a significant factor. “Wehave always been successful in attractingtop graduates from the country’s educat-ional institutions and many of these people,having spent time in Kinsale, have gone onto senior leadership positions in other Eli Lillylocations,” he says.

“We have had great support from our localDunderrow community. Our open day on 6May is an opportunity for us to say thank youand also to show our facilities to people whoare newly settled in the locality.” He alsoacknowledges the support of key Governmentagencies and local authorities.

SERVICES

AS the pharmaceutical industry in Ireland continues to evolve, there is a growing need forgreater efficiency. The sector is highly regulated and manufacturers face reduced patent life-cycles, increased competition and high costs. Because of this, they need to reduce the costof supply as well as optimise efficiency and regulatory compliance.

That’s where Orbis Information Systems comes in. The leading systems integrator providesenterprise-enabled manufacturing solutions. The company’s laboratory automation softwaresolutions and services allow companies to have accurate information storage, data traceabilityand increased productivity.

“Our skills are very specialised in this area. The combination we have in Orbis of labora-tory and life sciences is quite unique,” says Michael Gannon, managing director, Orbis.

As a rapidly growing industry, pharmaceuticalsneeds all the help it can get to make sure itoperates in an effective and cost-efficient way

Eliminating inefficiency

Orbis’ dedicated lab automation team has much experience in the automationof laboratories in all of the main environments, including manufacturing,research and development (R&D), private contract and government contract labs.

“It’s not just that we’re bringing best in class, but we’re bringing our own indu-stry knowledge and integration skills,” says Gannon. “There’s an increa-sing demand for more efficiency in the lab to bring down the cost of production.

“A lot of new pharmaceutical companies are in the position to set up here andput in these solutions from the start, so they can avoid having too many over-heads. We provide planning and justification for those solutions.”

Orbis benefits hugely from its partnership with Thermo Electron, the world’sleading supplier of laboratory information management systems (LIMS). Thermo Electron has relationships with several of the world’s major pharma-ceutical companies, including Amgen, which is currently setting up in Ireland.

“Through Thermo Electron we have access to the best products on the market,” notes Gannon. The latest product from Orbis is Darwin LIMS, whichwas launched recently. The only LIMS from a major vendor, the product isdesigned specifically for pharmaceutical quality control and R&D. In addition,Thermo Electron has launched Lifecycle Asset Management Services. This isdesigned to optimise the lifecycle cost and performance of laboratory assets acrossthe enterprise, from acquisition to disposition.

Orbis’ leading LIMS, SampleManager, has advanced since it was launched inthe late Eighties and the company now offers SampleManager 9.

“It is an exciting time. We see new solutions coming on stream, which involveshorter implementation timescales, and that allows us to provide higher levelsof service to the customer that are geared to meet their strategic objectives,” saysGannon.

‘There’s an increasing demandfor more efficiency in the lab to bring down the cost of production’

Providing the only true commercial off-the-shelf LIMSfor the pharmaceutical sector

in Ireland today

SERVICES

SkidTek is exactly the kind of high-valuemanufacturing and service company that theGovernment has been so keen on of late

ON THE RIGHT TRACK

SKIDTEK, a division of the BCD Group, is ahigh-value manufacturing, design and service company that represents where theGovernment wants Irish industry to go.Based in Charleville, Co Cork, this stainless

steel engineering firm manufactures skids forthe pharmaceutical, brewing and food industries.

Skids are self-contained units located in adedicated section of the pharmaceutical

building, attached to the manufacturing areaby interconnecting pipe-work. They aredesigned to clean all processing equipmentbetween production cycles.

In business for the past 10 years, SkidTekmodels and manufactures clean-in-place(CIP) and two-rinse-system skids. The company has a workforce of 70, while the BCDGroup employs 200.

In an increasingly busy and competitivemarket, it is vital that pharmaceutical indus-tries optimise their time and SkidTek’s prod-ucts and services allow them to do just that.The company’s process engineers provideready-to-operate modular process systems.

SkidTek’s CIP modules pump de-ionisedwater, bases, acids and hot or cold rinsewater around the process pipe work in theplant at different stages in the cleaning cycle.The rinse modules, meanwhile, supply

de-ionised and rinse water to the CIP skidsfor final flushing of the pipe work.

In addition to providing modular processsystems for the pharmaceutical and biopharmaceutical industry, SkidTek does alot of work in the biotech industry, for example in buffer preparation. According toColin Kelly, commercial director at SkidTek,the modular concept has really taken off.

“It is particularly useful to pharmaceuticalcompanies because it saves a lot of time onconstruction,” he says. “We’re building the system while they’re putting the buildingtogether. We have put in all of the utilities andfacilities at our new facility in Charleville,which is approximately 25,000 sq ft in size,and we can effectively make the entire systemhere. That cuts the construction time considerably. We also do all of the testing here,which cuts down the testing time onsite.”

Pharmaceuticals is a highly regulated industryand solid legal advice is crucial

MAPPING THE LEGAL MAZE

GOOD legal representation is importantin all industries, but in the pharmaceutical sector it is imperative. The industry is highly regulated and transaction-driven,both at an Irish and international level,according to Colin Sainsbury, partner atIrish law firm BCM Hanby Wallace.

In addition, pharmaceutical companiesusually want to sell in several countriesand enlisting the services of a top-notch legalfirm will help clear the path to success.

“Even if you’re a small Irish company, theUS market is potentially the most impor-

tant,” says Alex Nesbitt, consultant for BCMHanby Wallace and co-author of The Irish Commercial Precedents Service.

“The complex regulatory and legal frame-work marks the life sciences sector apartfrom others. Because you have to go throughso many different stages of development andthe patent has a limited life, you need towork out your legal strategy carefully.”

Intellectual property plays an importantpart in the pharmaceutical industry, notesSainsbury.

“If you’re going to put in place a strategic

agreement with a partner and be involvedwith that company over several years, the rela-tionship has to stand the test of time. Almostcertainly the agreement will require tweaking and amendment as the relationshipdevelops. In the pharmaceutical sector it isparticularly important to consult with lawyersat all stages of the process.”

Both Nesbitt and Sainsbury have workedwith Elan Corporation over the years and theyhad a high degree of interaction with variousparts of the company, including researchand development, clinical development andfinance. Both men were involved in the Elanrecovery plan, which realised almost US$2bnworth of assets for the company.

Although they left Elan at the end of 2003,they continue to act for them on certainmatters. BCM Hanby Wallace has also actedfor companies such as Alimentary Health,Mead Johnson, Procter & Gamble and Newport Pharmaceuticals.

“The Elan experience was instructive,”says Nesbitt. “When your entire focus

switches from licensing technology to sellingproducts, you are forced to look at your dealsin a different light. Clients need that long-termperspective. One day, the company that isdeveloping a technology is going to have tomarket it and in practice that means a big-ticket collaboration. The agreement itmakes today might make that deal easy or, ifnot properly constructed, it might make it alot more difficult.”

One of the largest law firms in Ireland, BCMHanby Wallace is recognised as a leader in allareas of legal practice. The company is wellknown for its dealings in employment law andcommercial property, having been involvedin the Dundrum Town Centre and otherhigh-profile deals. The company deals locally, nationally and internationally and haslinks with various law firms throughoutEurope, the US and Australasia.

Sainsbury says working in the pharma-ceutical industry is particularly enjoyable. “Ienjoy acting for companies in the life sciencessector and feel that we can add real value.”



THE successful trial of the world’s first 100pc track-and-tracetechnology system has just been completed by the National Centre for Hereditary Coagulation Disorders(NCHCD) in Ireland and the global supply chain standardsorganisation GS1. The technology enables the full trackingof a drug from the manufacturer to the patient.

“This ground-breaking track-and-trace pilot will helpensure safer delivery of haemophilia care in Ireland andacross the world in the future,” explains Jim Bracken, director of GS1 Ireland.

“The NCHCD project is being studied by an expert group,which includes the EU Commission, the Food and DrugAdministration, the World Federation of Haemophilia andother stakeholders,” he adds.

The fully integrated electronic barcoding technology system enables 100pc tracking and tracing of drugs admin-istered to haemophilia patients at St James’s Hospital inDublin.

It is believed the project heralds a new era for drugadministration programmes in the healthcare and phar-maceutical sectors worldwide.

The successful trial of a fully traceable and securehaemophilia drug administration programme in Ireland frommanufacturer to patient can now be adapted to resolve awhole range of patient safety and supply chain issues acrossthe immediate healthcare sector and beyond.

The track-and-trace system uses GS1’s latest electronic barcoding technology to trace temperature-sensitive clotting factor concentrates (CFCs), the products used to treathaemophiliacs. The integrated electronic product codetechnology assigns a unique number to every item that rollsoff a manufacturing line, allowing every company in the supply chain to track products.

Following a two-year trial period, the solution has beensuccessfully implemented and is ready to be rolled outnationally.

The use of unique serial numbering and barcoding on each

vial box to enable automatic electronic data collection andprocessing will result in safer patient treatment and full trace-ability and accountability for every drug and patient involvedin this critical treatment process.

The pilot project linked up to the existing track-and-trace solution implemented in August 2005. Thiswas the brainchild of Dr Barry White, director of theNCHCD, whose vision was to establish a comprehensive andfully traceable drug administration programme from manufacturer through to patient.

His concerns were in response to the publication of theLindsay Report in 2002, which reported the infection of hundreds of haemophiliacs with HIV and hepatitis C as aresult of receiving contaminated blood products.

White says: “The contamination of blood products was oneof the most catastrophic medical complications of the pastcentury and some of the infections were due to defects in thesupply chain. There were considerable difficulties in iden-tifying who had received the infected CFCs and in recallingall the contaminated products.”

TECHNOLOGY

A new track-and-trace systemfor drugs, successfully trialled inIreland, will mean more safetyand accountability for patients.John Kennedy reports

Trace evidence

‘It is believed the project heralds a new era fordrug administration programmes in the health-care and pharmaceutical sectors worldwide’

Medicines Make A Difference— Your Work Can Make a Difference

Ireland’s pharmaceutical industry — developing and delivering medicines

Working in the pharmaceutical industry is different from other industries. What you produce here helpspeople get on with their lives. It helps them fight and prevent illness and extend and improve the quality

of their lives. Research-based medicines make up 90pc of all medicines; they have helped increase lifeexpectancy by a third and have virtually eliminated killer diseases such as TB, polio and pneumonia.

Creating a medicine brings together a whole range of skills and job functions. From innovation and research through to manufacturing, marketing, compliance and education, Ireland’s pharmaceutical sector brings together researchers, doctors, machine

operatives, pharmacists, engineers, marketers and others to produce products with extraordinary power — the power to prolong and improve the quality of people’s lives.

Documents

The Pharmaceutical Industry: Working for Well-Being