THE
PHARMACEUTICAL INDUSTRY Working for well-being
Working in pharma Career opportunities Future trends
WHY
MEDICINES MATTER in association with
CONTENTS
Foreword
Working in production
04
Minister for Enterprise, Trade and Employment, MicheĂĄl Martin TD
20
In the hub of the industry
Working in biotechnology 22 Overview
06
A growing area
A profile of the industry and its prospects
Investment Medicines
Science Foundation Ireland’s priorities and a new biopharma centre
10
Where jobs fit into the development cycle
Human resources
24
Commercialisation
26
An innovative SME and the Enterprise Ireland view
12
Directors share their views
Services Education
14
Technology, legal and manufacturing supports
16
Technology
Third-level courses
Working in innovation
30
Track-and-trace systems
R&D employees
Working in marketing
28
18
Getting products to customers
Editors: Sorcha Corcoran, Linda Daly Editorial and design: Whitespace Publishing Agency Ltd Email: info@whitespace.ie
Sales: Trish Murphy, Sally Faherty Tel: 01 6251400 Printed by: Independent Newspapers www.whitespace.ie
THE PHARMACEUTICAL INDUSTRY
03
FOREWORD
A national treasure Minister for Enterprise, Trade and Employment, Micheรกl Martin TD, on the contribution the pharmaceutical sector makes to the Irish economy and the importance of continued investment in R&D
04 THE PHARMACEUTICAL INDUSTRY
FOREWORD
THE pharmaceutical sector has been targeted by the government as a key driver of industrial development in Ireland in recent decades and the industry has made a very significant contribution to the economy of the country. The high-value and knowledge-intensive nature of the industry is reflected in the level of exports, which now accounts for approximately 40pc of total manufacturing exports from Ireland and has been the largest contributor of corporation tax. It is an exciting time to be in the phar-
maceutical sector in Ireland as it continues to grow steadily. Ireland has attracted 13 of the top 15 pharmaceutical companies, and it is significant that almost all the companies located here have been involved in continuing re-investment. These include: Pfizer; Abbott; Johnson & Johnson; Wyeth; Schering Plough; BristolMeyers Squibb; Merck Sharp & Dohme; Glaxo Smith-Kline; and Takeda. This is an industry that has its footprint all over the country and we are conscious that not only do we have to bed
down and consolidate, but we also have to change our activities and move up the muchquoted value chain. The backward integration from manufacturing into the various stages of research and development (R&D) and ultimately the core product discovery research is the key to establishing long-term sustainable businesses in Ireland. Amgen’s recent investment in Cork, creating 1,100 jobs, is exactly the kind of investment the Government and IDA Ireland seek to attract and it is in line with our strategy to win high-quality, high-skilled projects from world-class leaders in the area. The intense global competition for investments has been well publicised, though Ireland is now competing for and winning world-class R&D investments. Our young, highly skilled and educated workforce is a key component in attracting investment, and our universities and institutes of technology are providing a key regional spread of graduates and postgraduates, providing an accessible pool of world-class employees for multinational investors. We are now seeing the results of a concerted effort in Government policy to build a foundation of science and technology in our academic institutions and in particular to encourage strong business and academic collaboration. This is enabling the build-up of the R&D capability of Irishbased businesses, which is fundamental to Ireland’s future competitiveness. The availability of highly skilled and educated graduates is critical if Ireland is to consolidate its position as a leading knowledge-based society. The Government is committed to cultivating an attitude that values scientific curiosity and endeavour and that encourages young people to consider scientific careers.
OVERVIEW
A healthy pharma future For employees and students, the pharmaceutical sector represents a highly attractive career option as the industry here moves into a new phase of its evolution, writes Brian O’Grady
IN less than 30 years, Ireland’s pharmaceutical industry has become the country’s biggest exporter and one of its major employers. For the economy the pharmaceutical sector has become integral to the nation’s prosperity, generating ¤3bn in tax payments and making Ireland one of the top four locations for the industry worldwide. When the Minister for Enterprise, Trade and Employment, Micheál Martin TD, announced one of the country’s biggest foreign direct investments to date this January, by biotechnology company Amgen, he was keen to point out the significance it held for Ireland’s future. “Investments of this scale speak volumes about Ireland’s ability to compete and win the most advanced biotechnology company in the world,” he said, noting that the ¤0.82bn investment in Cork would employ 1,100 there by 2010. Two years earlier, Wyeth Medica Ireland had announced the biggest foreign direct investment in the history of the State — a ¤1.5bn investment in a 90-acre site in Grangecastle, Co Dublin — bringing the overall value of industry investment here to more than ¤40bn. Clearly, Ireland’s pharmaceutical industry is on a roll that has been steadily building momentum, having attracted 14 of the world’s top 15 pharmaceutical companies to set up operations here. Year-on-year job growth in the sector has been increasing by 1,200 annually for the past five years, with 24,000 now employed directly in the industry and many more employed by its suppliers. “The fact that nine of the top 10 companies here have Irish CEOs is a very strong selling point,” says Barry O’Leary, IDA Ireland’s divisional manager for the sector, the offices of which have been pivotal in attracting the industry here. Ireland’s pharma industry has gone from strength to strength, with its expanding profile and capabilities here steadily attracting more companies and investment.
06 THE PHARMACEUTICAL INDUSTRY
“Our track record in execution here is a big attraction and our track record in compliance is also important,” says O’Leary. “The difference with pharma is that it’s an expensive industry to build. You wouldn’t be far off ¤1m per employee in terms of investment.”
RAMPING UP In 2004, Ireland’s pharmaceutical sector generated 44pc of the country’s exports, making us the biggest net exporter of medicines worldwide. In a decade of improving exports across all sectors, such successes might seem to be almost the norm. But the achievement 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 pharmaceuticals exported by Germany, a country that has spawned some of the industry’s biggest pharmaceutical companies and medicines. For a country that began from a standing start in the Sixties, Ireland’s growth in pharmaceuticals has been impressive by any standards, with 12 of the world’s best-selling medicines being produced here. With a further ¤1bn of investment announced already this year, Ireland is showing itself to be much more than just a short-term expedient for multinationals seeking out tax breaks. A skilled labourforce, a favourable Government attitude, tax incentives, market access, climate and a constantly improving infrastructure have all been contributors in making Ireland one of the world’s most attractive investment locations for the industry, now only rivalled by Singapore, Puerto Rico and Switzerland, according to IDA Ireland. Competitive advantage for the future, however, may rely less on financial incentives than it will on Ireland’s reputation as a centre for innovation in developing new medicines. This means, in managerial jargon,
OVERVIEW
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
‘Ireland’s pharmaceutical industry is on a roll that has been steadily building momentum’
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 being manufacturing led to knowledge led. As a researchdriven industry, pharmaceutical companies reinvest 15-20pc of their sales in research and development (R&D). Medicines typically cost upwards of ¤800m to develop and that R&D investment, which in 2003 amounted to ¤21bn in Europe alone, makes this a truly knowledge-based industry. 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 innovation in medicine, an area it dominated in the 19th Century through the work of then pioneering medical innovators such as Robert Graves, William Stokes, Dominic Corrigan, Abrahem Colles and EJ Conway. Kelleher defines innovation as “the conversion of knowledge and ideas into a benefit which may be for commercial use or the public good”, something that is now reaching fruition here through public and private investment. By providing the R&D medicines for bigger companies, Ireland’s rapidly growing biotech sector is now
providing just such an opportunity, he argues, along with many exciting career and entrepreneurial opportunities. “Ideas are now key. New technologies level the playing field, giving new, smaller companies similar capabilities to larger ones. We’re getting a respectable level of innovation here. The challenge now is developing the right culture so it can prosper,” he says. Such innovation and R&D activities will become the key drivers in bringing Ireland’s pharmaceutical industry to its next level of competitiveness in what is truly a global industry. “Manufacturing sites need to have the technical capability to compete when new drugs are coming down the pipeline and corporations look to decide on where to locate these facilities around the globe,” says O’Leary. “So you must have more capabilities onsite; it’s not enough just to have lower tax rates, because other jurisdictions have lower ones. The technical capability and the people become a far more critical piece of the whole thing.” The result has been a series of investments linking industry with academic research, with ¤36m invested last year by various companies. Bristol Myers Squibb, one of the first arrivals here in 1964, spent ¤9.6m on research facilities at Dublin City University. Wyeth also invested
THE PHARMACEUTICAL INDUSTRY 07
OVERVIEW
in University College Dublin’s Conway Institute as part of its ¤1.8bn biotech investment here. Similarly, Pfizer, Glaxo SmithKline, Johnson & Johnson, Genzyme and others have all made recent multimillion euro investments in creating R&D capability in this country, while the most recent announcement of Amgen’s ¤1bn investment in Cork is mirrored by a new pharmacy faculty in University College Cork. “These investments represent more than just links between industry and academia,” says Conn Clissmann, president of the Irish Pharmaceutical Healthcare Association. “These have the capability to turn themselves into major hubs of research that not just benefit the economy here, but also bring major benefits for patients by providing new and better treatments. If you consider that more than a quarter of the world’s medicines have been developed in the UK, our neighbour, there is every reason we should aim for some of this market.”
GLOBAL MARKETS MEAN GLOBAL COMPETITION Ireland’s success has of course been based on its ability to export to countries that could soon be competing for the same work. Pharmaceutical investments are prized by development agencies worldwide because of the depth of their investment, highly skilled employment base and resulting longer-term tenure. But in such a globally competitive market, security can only be maintained through competitiveness. “Ireland Inc needs to nurture the sector as its future could be a lot less certain, should the country take it for granted,” says director of IBEC’s PharmaChemical Ireland, Matt Moran. The rising costs of doing business here, ongoing government support for the sector, tax and infrastructural issues are all pressing concerns. In response to such competition, companies here have focused on developing capabilities that generate and deliver higher value — by consistently moving up the value chain. Increasing the numbers and value of services by improving workforce skills, research capabilities and infrastructure have become ever more important when competing with countries with vastly lower labour costs and zero corporate tax rates such as Singapore and Switzerland. Singapore, for example, offers 0pc tax compared with Ireland’s rate of 12.5pc and Puerto Rico’s 3pc, 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 developing new molecules for medical use to clinical trials and discovering how to produce safe and viable products. “In a multinational environment, every site is trying to convince senior management that it should be the site for investment,” says John Condon, EMEA director of public affairs 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 a much better position to justify being able to produce it. It’s all about internal competition.”
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For Ireland’s pharmaceutical sector, the competitive challenges from overseas have meant evolving from bulk manufacturing of active agents to adding complementary activities, finishing completed products and researching and developing new products and production methods. IDA Ireland’s strategy focus has been to encourage companies to start earlier and finish later by adding activities from the pre-clinical stages to the launch. The emphasis is on introducing Irish-generated research as early as possible in the development cycle. Such valueadding activities have only been possible through the expanding skillset of Irish workers and closer tie-ins with academia. The future of the industry lies in combining this immense manufacturing capability and expertise with the innovation that will drive product development. Much of the success in adding new capabilities has been due 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 industry here 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 learn has been impressive at all levels of recruitment, something with 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 industry in Ireland.”
THE EDUCATION IMPERATIVE Among the most critical factors in sustaining Ireland’s competitive 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 evident with the increase in the number of students taking science subjects, but efforts are pointless without the necessary government investment in education,” says Glynn. There are good reasons to consider careers in Ireland’s pharmaceutical sector. In addition to a wide diversity of career opportunities, new figures from the Central Statistics Office show that workers in the sector earned almost 30pc more than the national average. As the industry here moves towards being knowledge led in all its activities, the prospects for employees and the economy are considerable and growing. This still depends, however, on maintaining Ireland’s extraordinary pharmaceutical manufacturing base. Cultivating a business climate where innovation can flourish involves many factors, foremost of which must be acknowledging the extraordinary asset that the country has already created. Brian O’Grady is communications manager at the Irish Pharmaceutical Healthcare Association.
OVERVIEW
‘Among the most critical factors in sustaining Ireland’s competitive advantage is ensuring a constant stream of science graduates at second, third and postgraduate level’
MEDICINES
One industry,
many careers WHILE the benefits and rewards pharmaceuticals provide are huge, so too is the effort and investment that goes into developing and making a new medicine that can save lives or drastically improve people’s quality of life. By the time a new medicine reaches patients, it will typically have been in development for up to 12 years (see box), from the initial stages of identifying and isolating molecules to three phases of testing and an ongoing phase of ‘pharmacovigilance’ that ensures its safety and ever-improving performance. In Ireland, more than 24,000 people are employed in the pharmaceutical industry in roles from manufacturing to marketing and from research to patient education. In the journey to developing and delivering a medicine, a whole range of skills and professions are involved, including chemists, researchers, doctors, engineers, marketers and machine operators. Every step of the process has to be managed carefully and adhere to strict regulations, generating many jobs in compliance, regulatory affairs and quality assurance throughout.
The growth in the pharmaceutical sector here has seen companies expand their operations and activities to provide a growing number of career paths
THE LIFE CYCLE OF MEDICINES FROM CONCEPT TO PRODUCT: STEPS IN GENESIS OF A DRUG 10,000 molecules screened
▼
JOBS IN IRELAND
100 molecules tested
In Ireland, the industry is going from strength to strength as pharmaceutical companies continue to expand their operations here and add new activities such as research, finance and supply chain management. Ireland’s success in attracting biotechnology companies adds another exciting dimension to the careers on offer. Biotechnology uses biological systems or cells to make or modify products that can be used as medicines and will generate many more medicines in the future, many of which will be personalised for individual use. The following broad categories outline some of the jobs and career opportunities currently available in the industry.
▼
▼
10 candidate molecules
1 drug
RESEARCH AND DISCOVERY This is the starting point for a new medicine. Because many diseases still cannot be cured or because existing treatment may cause unwanted side effects, new medicines that work in different ways are constantly in demand. Chemists, biologists, pharmacologists, IT specialists and a variety of other science disciplines work in teams to try to identify chemical compounds that might eventually become medicines.
DEVELOPMENT Once a chemical compound has been found that could possibly work to treat the target disease, a variety of tests must be carried out to ensure that the compound can be made on
10 THE PHARMACEUTICAL INDUSTRY
Test phase
Research phase 0
Development phase 5 years
10 years R&D
Administrative phase 10 years
2 TO 3 YEARS
▼ Patent filing
Source: LEEM - Key Facts 2003
Commercialisation phase 15 years
20 years
▼ Patent expiry
MEDICINES
a viable scale, formulated into a medicine and given to patients without causing harm. This work takes several years and involves a variety of different people, mainly scientists and engineers. Jobs here include: analytical chemist; development chemist; process chemist; pharmacist; biologist; validation scientist; microbiologists; product development scientist; researcher; doctor; process development scientist.
CLINICAL TRIALS To ensure the medicine works safely and effectively, it’s first tested on animals before moving on to phase one trials on humans. At this stage doctors and scientists first determine the correct dose to give to human volunteers and then carry out controlled trials in patients suffering from the disease. Jobs here include: clinical research specialist/associate; clinical monitor; clinical trials specialist; compliance specialist; laboratory technician; documentation and compliance scientist; regulatory affairs officer/manager; quality assurance specialist; validation specialist; quality and compliance specialist; medical scientist; formulation scientist; doctor; nurse.
MANUFACTURING Manufacturing the medicine involves making the chemical compound and then mixing it with other substances to make a tablet, cream or aerosol. Safety and quality assurance 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 operator; science technician; pharmaceutical technician; chemistry laboratory technician; biology laboratory technician; quality control lab technician; medical laboratory technician; environmental officer/technician; health and safety advisor; production and operations specialist.
ENGINEERING Engineers do everything from designing and commissioning new machinery (and the buildings to house it) to maintaining 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 operator; validation engineer.
REGULATORY AFFAIRS/MARKETING AUTHORISATION Scientists in regulatory affairs draw together information on tests that have been carried out on the drug substance and use this to apply for permission to carry out clinical trials and market the medicine. Jobs here include: regulatory affairs specialist/ manager; quality and regulatory affairs engineer; research scientist; process development chemist; formulation scientist; pharmacist.
SALES AND MARKETING/HEALTH PROMOTION Researching and developing new medicines would not be sustainable if doctors were not aware of new medicines and what they can do for patients, both by providing new solutions and improving existing ones. Educating physicians and patients on new developments and treatments therefore plays a vital role. Medical sales representatives visit hospitals and GPs’ surgeries to inform doctors about the benefits of the new medicines their companies produce. Jobs here include: marketing manager; medical sales representatives/specialists; hospital sales representative/specialist; communications specialists.
HUMAN RESOURCES Human resources (HR) supports the people behind the scientific work, helping to make the most of their talent and training. In HR, you will find yourself recruiting for many different roles and developing the skills of a huge range of people. Jobs here include: HR manager; HR general; recruitment consultant; trainer. To find out more about these and other jobs, visit: www.pharmachemireland.ie, www.fas.ie/pharmachem_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. The risks are very considerable, as between 40 and 50pc of potential medicine that enters the third and final phase of clinical trials still fails to make it to market. Clinical trials that ensure the safety and efficacy of medicines take years and involve thousands of patients and procedures to ensure the product is suitable for its intended purpose. Developing any new medicine is, therefore, a difficult and very expensive operation, with the estimated costs typically exceeding €800m before a medicine reaches its market. On average, only one of every 10,000 promising substances will successfully pass testing in the research and development (R&D) phase to be eventually approved as a marketable product. In total it takes an average of 10 to 12 years to turn a promising new compound into a marketable medicine that is proven to be safe and effective enough for patients. Once on the market, the average medicine then has only eight to 10 years of copyright protection left before its patents lapse and generic drug manufacturers can sell similar products based on its research, without having to pay for R&D. Historically only three out of 10 marketed medicines generate revenues to match or exceed the costs of R&D. Researching new medicines therefore requires massive expenditure with no guarantee of return.
‘In the journey to developing and delivering a medicine, a whole range of skills and professions are involved’
THE PHARMACEUTICAL INDUSTRY 11
HUMAN RESOURCES
The
headhunters Caroline Allen asks a selection of human resource directors what they look for when it comes to taking on new people SCHERING PLOUGH
LEO PHARMA
A passion for pharmaceuticals, a ‘can do’ attitude and an ability to thrive in a changing environment are just some of the qualities recruiters look for, according to Elaine Boyd, director of human resources (HR) at Schering Plough. The company, which manufactures active pharmaceutical ingredients, hires across the board from business people to chemists and scientists. It recruits BSc and Phd chemists to support its technical services and chemical development and also has a large quality group consisting of analysts, document specialists and technical writers. “When recruiting in manufacturing, you’re looking for people with engineering or chemistry qualifications. For the engineering function, chemical, electrical and mechanical engineers are employed. We also have the enabling functions of finance, HR and IT departments where prior knowledge of the sector, while desirable, is not required,” explains Boyd.
According to Pat McCarthy, HR director at LEO Pharma, Dublin, a career in the pharmaceutical industry will provide tremendous satisfaction. “Apart from the technical challenge, you’re dealing with products that save and improve the quality of people’s lives. Salaries for graduates generally start from ¤30,000 and benefits packages usually incorporate health insurance and pensions.
“There are lots of opportunities to become multiskilled and work on cross-functional projects,” she says. Schering Plough is currently looking for plant managers, production managers and systems engineers. Its employees often get the opportunity to move up the ranks.
“Certain areas are experiencing a skills shortages, with a demand for chemistry and engineering graduates and analytical staff,” he says. “To some extent the scarcity is being covered by the pool of talent from the EU accession states, especially Poland. “The ongoing expansion of the sector and the arrival of new firms such as Centocor, Amgen and Genzyme provide plenty of opportunities for candidates. The biotech area is undergoing rapid expansion at the moment. There is a lot of scope for career progression, with analysts, for example, often moving on to become laboratory supervisors or managers. Good people skills, dedication and ambition are the qualities essential to get ahead in the industry.”
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MERCK SHARP & DOHME (MSD) IRELAND (HUMAN HEALTH) The pharmaceutical industry offers employees a very stimulating and challenging 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 organisation with the entrepreneurial drive of a truly Irish company. We work in an achievement-driven environment where how you reach your goals is just as important as actually reaching them. We are always looking for employees with exceptional capabilities who can demonstrate creativity and innovation and we invest heavily in their development throughout their careers.” She adds:
“We currently employ people in Ireland with expertise 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 at Pfizer Ireland Pharmaceuticals, says that apart from demonstrating the required skills and ability to do the job properly, candidates should be able to show they want the job, are highly motivated and have a willingness to learn. They should be able to give examples at an interview of having worked both as part of a team and on their own initiative.
“When several people with the same qualifications come in for interview, we look at whether they really want the job, have done their research on the company and are willing to get on with people,” she explains. “As well as opportunities in science and engineering, there are openings in finance, administration, HR, IT and procurement. Candidates tell us they are attracted to work for Pfizer because of its reputation, credibility, strong benefits package, working hours, sports and leisure facilities and the diversity of its workforce.”
HUMAN RESOURCES
Softly, softly Candidates for pharmaceutical positions often forget to sell their non-technical skills to employers as well as their technical abilities ONE of the most common mistakes candidates for pharmaceutical jobs make is focusing too much on the technical requirements and not placing enough emphasis on softer skills, according to Helen McGardle, managing director of Science Recruitment Ireland (SRI). “For example, as part of their job in a pharmaceutical company, 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 staff is whether they are motivated to do it and do it well — will they add energy to the area of work? Can they multi-task?” says McGardle.
“We appreciate that the recruitment process can be fraught with difficulties for many candidates and we strive to give them an experience that is both of immediate benefit and long-term value.” SRI offers a range of training courses geared towards those looking for work in the pharmaceutical sector as well as existing employees. Through its personal development programme, SRI enables candidates to develop and map their career paths through what they can learn about themselves, even if this means a change in direction for them. It has recently enhanced its personal development programme to help employers better understand the influencing factors that often result in people leaving
organisations. “Most of the time, it boils down to a lack of communication,” says McGardle. In her view, there is not enough training going on in the sector i soft skill areas, such as communications skills. “Soft skills are the leverage to technical skills. There is a lot of technical training, for example, in CTMP [clinical trials in marketed products] and HPLC [high-performance liquid chromatography]. This is definitely worthwhile and has to be done, but it’s also important to look at the whole person and his or her motivation.”
EDUCATION
Meeting
market demands JOURNALISTS, TDs and industry analysts have been telling students the same thing for the past three or four years — that there has never been a better time for science graduates in Ireland. Now one of the world’s largest exporters of pharmaceuticals, Ireland is home to 13 of the top 15 companies. More than 17,000 people are employed by these companies, with many more working in associated firms and industries. Multinationals continue to recruit graduates; the Higher Education Authority is investing ¤1.5bn in scientific research; and the points requirements for many science programmes are the lowest they have been in years. To coincide with the growing pharmaceutical sector, many colleges and universities have adapted their programmes to suit the industry’s needs. Galway-Mayo Institute of Technology began offering a new chemical and pharmaceutical science degree this year. National University of Ireland Maynooth (NUIM) offers chemistry with pharmaceutical science; University of Limerick offers pharmaceutical and industrial chemistry; and Dublin City University (DCU) offers a chemical and pharmaceutical sciences degree. “The courses we offer here equip our students with the knowledge they’d need to work in any pharmaceutical company,” says Kieran Nolan, a lecturer in the School of Chemical Sciences at DCU. “We teach formulation and regulation, which are essential in the industry. Pharmaceuticals operates 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 interdisciplinary approach to educating students in a way that is directly relevant to the industrial sector. The theoretical and practical aspects of chemical, biochemical and microbiological analysis are taught side by side. The university enjoys close links with the industry and the course includes a work placement. “One of the reasons we changed our programme is that we have to supply the market with graduates. We tailor-made our chemical programme for the pharmaceutical industry,” says Nolan. DCU also offers a degree in biotechnology, which is a science degree with an engineering component to educate students in the manufacture of useful products from living organisms and biological systems. The university’s ability to provide hands-on experience has gone down well with the industry. “From DCU’s perspective, we will be supplying and producing a lot of graduates over the next few years. Some of our students have gone on to do PhDs and some have gone straight into industry. Most end up in the
14 THE PHARMACEUTICAL INDUSTRY
With more and more job opportunities in pharmaceuticals, Irish third-level institutions are tailoring their courses to match. Linda Daly reports
EDUCATION
pharmaceutical industry if they leave straight after the undergraduate 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 production of drugs,” he says. “There’s an adage we have — what in the world isn’t chemistry?” Chemistry is the central science for a wide range of industrial applications. Not only do chemists develop new drugs and pharmaceuticals, they also design cleaner and more efficient reaction processes to produce them. They monitor the environment and ensure its protection and they help provide new materials, devices and medicines. The institutes of technology in Athlone, Sligo and Tallaght offer pharmaceutical science, while Limerick Institute of Technology (IT) combines this with forensic analysis. Ireland’s first pharmaceutical technology training centre was opened at Tallaght IT in 2002. Since opening, the facility has provided the skills and training necessary for graduates to immediately enter the pharmaceutical and biotechnology industries. While the courses are targeted at careers in the pharmaceutical industry, they are broad-based and graduates are employable in many other areas of industrial and scientific work. James Brennan, head of the department of applied sciences at IT Sligo, says opting for a pharma-
‘The pharmaceutical industry is recession-proof; people are always sick so you always need the production of drugs’ 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. You can choose at the end of it where you want to go and even then if you don’t like the direction you’ve taken, you can change again,” he says. A year before the centre was opened in Tallaght, IT Sligo opened a pharmaceutical science centre, which is offered to local companies such as Abbott for process development work and staff training. Its establishment highlighted the institute’s ability to provide top-level degrees. IT Sligo now has the biggest school of science in the institute of technology sector, with more than 850 students. It offers 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, which is designed to educate and train professional scientists for the pharmachemical industry. It is a multi-disciplinary programme, meaning science subjects are taught as well as applied modules such as quality assurance validation
and management. “The programme is very well regarded by the industry and there are many job opportunities. Unfortunately, the difficulty 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 degree and most of those who have taken the course so far haven’t done. Pharmacology, microbiology and computing are just some of the modules and students also undertake a five-month paid placement in the healthcare or pharmachemical 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 pharmaceutical industry is flourishing here. The top pharmaceutical firms are among the richest in the world and even in bad economic times people can expect steady employment. Many employees also talk of job satisfaction and the feeling that they are making a difference.
WORKING IN INNOVATION
On the FRONT LINE RESEARCH and development (R&D) offers the opportunity to work at the cutting edge of the pharmaceutical sector. There are many diseases for which there are still no cures and the role of the pharmaceutical industry is to try to develop new medicines by understanding them, according to Dr John Farrell, medical director of Pfizer, which has more than 100 medications on the Irish market. “Cancer is a huge area and has multiple forms. By better understanding each form, we learn about its spread and the damage caused. The industry is developing better methods of killing these cancer cells with fewer side effects,” he says. “Over the next 10 to 15 years, it is expected that a lot of cancer medication will become available.” Pfizer has made strides towards doing just that by developing medication to treat macular degeneration, which causes blindness in elderly people and is often linked to smoking. Research in the universities and industry probes common diseases and develops medicines to target them. Farrell’s role is to test medication at an early stage to ensure it works and is safe. “Once you know the benefits and risks, you can advance a drug and 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 supposed to do so that we can go to the Irish Medicines Board and the European Agency to get a licence.” The industry emphasis on safety generates 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 five years,” he remarks. “I always had an interest in research. In the pharmaceutical industry, you have to stay on top of research from a scientific viewpoint. You’re at the cutting edge of genetic and molecular work.”
MARGARET COONEY, HEAD OF MEDICAL AFFAIRS AND CLINICAL OPERATIONS, SANOFI-AVENTIS Cooney implements and manages clinical trials at SanofiAventis. 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 population on 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 University College 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, monitoring and subsequently managing phase two and three picotal clinical studies. She then spent four years in the pharmaceutical
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A job in research and development for the pharmaceutical industry involves understanding diseases in order to develop medicines to counter them. Caroline Allen reports
Margaret Cooney, head of medical affairs and clinical operations, Sanofi-Aventis
industry, working in clinical development and operational implementation of clinical studies. Cooney currently manages clinical operations studies, both product-related and epidemiological. She is also involved in phase four studies in which, as part of a global or European trial, medication post-approval is studied. “On a daily basis, I oversee all of those areas as well as 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 in R&D. “Typically, when people graduate, they firstly go into a clinical trial administration role. There they learn the ground rules and track the studies, co-ordinating from an administrative level but learning about the regulations and studying designs at the same time,” says Cooney. Another option for people coming out of college, she adds, is to join a contract research organisation. The next position to move into is monitoring, says Cooney. “A clinical research associate goes out to hospitals,
looks at patient charts, studies protocols and reports all the information to a project manager,” she says. “As candidates become more senior, they can take on project management roles, to a point where they will eventually be project managing small studies of their own, while still reporting to someone in a senior position.”
NOELEEN FARRELLY, SENIOR CLINICAL RESEARCH ASSOCIATE, MERCK SHARP & DOHME Farrelly monitors clinical trials to ensure they are done in accordance 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 or GP,” she says. “I have to ensure the investigator is qualified to conduct the studies and has the resources to ensure they are run properly. Ultimately, my job is to ensure that the rights and well-being of the subjects are protected.” Farrelly’s work is mainly in phase three of clinical trials with drugs that have already undergone rigorous testing. Getting out and about is part of the role. “I go to the sites
WORKING IN INNOVATION
and make sure the data and source documents are accurate and up to date,” she says. “I also regularly visit hospitals.” Training is also part of her remit. “I train the site staff on how to conduct the study, which involves giving presentations. I also teach them how to perform lab assessments, deal with drugs onsite and 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 was just myself and the medical director. There will be seven of us within the next month. There has been a great improvement in the number of jobs available in this country in this area.”
ROBERT WILLIAMS, DIRECTOR OF ANALYTICAL R&D, BIOVAIL As well as being involved in the early stage development of new drugs, Williams works on the dosing regime of existing medicines. “We take a drug on the market that may be dosed twice or three times a day and develop a once-a-day table,” he says. “The benefit is improved compliance.” US research has revealed that 50pc 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
‘Once you know the benefits and risks, you can advance a drug and know what type of patients will benefit from it’ extent how they will behave in the body before proceeding with any clinical studies.” According to Williams, working in early stage development is challenging and exciting. “The environment is constantly changing. I support the junior analysts from day to day. I also work with the manufacturing side to transfer the product once it is developed.” Troubleshooting technical issues that crop up also takes up some of 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 how the 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 the formulation,” he says. “Once the methods have been developed, they are thoroughly validated to ensure they are fit for use. Then we support the management of the drug for clinical trials and quality control release.” Williams graduated from Trinity College Dublin in 1991 with a chemistry degree and in 1995 he received a PhD in organic chemistry from the university. He acknowledges that working in R&D isn’t for everyone. “A lot of people enjoy the challenge but others prefer routine and having their day laid out for them. If you want the cut and thrust of a rapidly changing environment and have the technical ability to cope with that, it’s a great career.”
WORKING IN MARKETING
Ger Brennan, senior product manager, wyeth pharmaceutical
Playing the market Increased competition between pharmaceutical companies has made the marketing of products all important. Caroline Allen reports THE pharmaceutical sector in Ireland has expanded significantly over the past decade. With the majority of the international companies in the sector now based in this country, competition is fierce to make one product shine more than the rest. All of the major companies have marketing divisions and all will be seeking to hire the best. Those who work in marketing must deal with anyone who needs to know anything about the product and so must have a thorough knowledge of the business they are in and the products they represent. In addition, marketing managers make recommendations to senior management on critical decisions, so they must always be at the top of their game. There has never been a more interesting time to work in marketing in the Irish pharmaceutical industry. With
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Ireland now a leader in pharmaceuticals and with more and more discoveries made every day, working in the marketing division of the top companies can be challenging but very rewarding.
GER BRENNAN, SENIOR PRODUCT MANAGER, WYETH PHARMACEUTICAL Having a marketing role in the pharmaceutical sector means being the brand champion of the product, according to Brennan. “The top-line area is in the preparation and agreement of business and operation strategic product plans. Once we develop the plan and get agreement on it, we have to implement it, working with the sales team,” he says. Brennan’s background is in nursing. Working in the industry for the past seven years, he started off as a general practictioner sales representative and moved on to calling into hospitals as a consultant, before being promoted to product specialist and moving into marketing. “The normal role of a product manager is to do with commercial awareness and responsibility for all aspects of the business. You have to achieve targets and 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 and working closely with the medical profession, Brennan
says. While it is mainly office-based, it also requires meetings with key opinion leaders such as consultants. “Once the product is licensed, we are involved in setting up a link between the medical trials department in the US and the consultants here,” says Brennan “A campaign is put together and we have representatives on the road who go to visit the consultants.” Extensive research is carried out as well as campaign testing. There is, says Brennan, an emphasis on achieving a partnership with the medical profession. “We also work with patient associations to try to raise awareness 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 is involved, both to Wyeth company meetings and to medical symposiums in Europe and the US. The candidates who get ahead are those who are dynamic and creative, says Brennan. “You have to be able to think on your feet and you can’t be afraid to make decisions.” The ability to work as part of a team is vital. “You work with medics, people in regulatory affairs, 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,
Martin Morrissey, sales and marketing director, Roche Products Ireland
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 be approved by medics, marketing, sales and legal people. You can’t make any claims unless it is fully researched, marketable data.”
MARTIN MORRISSEY, SALES AND MARKETING DIRECTOR, ROCHE PRODUCTS IRELAND Morrissey says the strategic marketing of medicines involves looking into the future. Getting products used by the right patients is important and market research is mainly conducted through doctors, GPs, nurses and pharmacists. “I’m involved in the strategic planning of the company,” says Morrissey. “This involves working on future trends in terms of treatment and usage as well as medical developments.” Morrissey worked his way up from sales. “I started with Roche more than 16 years ago in a selling capacity. I was involved with very specialist areas such as cystic fibrosis, oncology, transplantation and HIV,” he recalls. “Selling is a common route into marketing. It gives you a good insight into the challenges doctors face and how we can address their needs.” However, many candidates are now studying marketing after doing a degree, Morrissey says. “There are a wide variety of avenues into the area. Someone from sales could come in at product management level. We have had someone working as a clinical research associate who became interested in marketing and got a product management role in their company before joining us in marketing 18 months ago.” Believing that you can make a real difference in patient care is key, according to Morrissey. “You have to believe in your own product and that ultimately what you are doing can make a difference.”
WORKING IN PRODUCTION
On the PRODUCTION line Although it helps, a science degree is by no means vital for someone wishing to pursue a career in pharmaceuticals. Grainne Rothery reports
Brian Killen, production manager, Merck Sharp & Dohme
EMPLOYMENT in Ireland’s pharmachem industry has increased by more than 50pc in the past 10 years. According to industry body PharmaChemical Ireland, the sector now employs more than 24,000 people, of whom more than half are third-level graduates. Companies in the Irish pharmaceutical sector tend to put a strong emphasis on career development and on encouraging staff to move between functions and sometimes even between international sites. As a result, the industry tends to have quite high retention rates, particularly among graduates. At the moment, salaries are generally higher in this industry than in regular manufacturing. According to Pharmacareers Ireland, starting salaries for graduates are usually around the ¤25,000 to ¤30,000 mark. This rises to between ¤40,000 and ¤50,000 with four or more years’ experience and reaches ¤60,000 to ¤80,000 at team leader/middle management level. While pharmaceutical companies tend to favour science graduates, there are opportunities for people without third-level qualifications. Production operators, for example, usually need to be educated to Leaving Cert standard and, after receiving training, are primarily involved in 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
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Michael Cleere, process engineer, Pfizer
‘While pharmaceutical companies tend to favour science graduates, there are opportunities for people without thirdlevel qualifications’
Fiona Carroll, supervisor, GE Healthcare
consists of chemistry and micro-lab analysts, who monitor products at all stages and in all batches to ensure they have not become contaminated. Analysts can move up to senior lab analyst and group leader level within the QC department. There may also be opportunities to move into the validation department, which is responsible for testing and certifying equipment. While QC checks the product, the quality assurance department is responsible for ensuring the facility operates according to the standards issued by regulatory authorities. Among other things, this involves communicating standards and writing and updating operating procedures and batch records. Another key department in pharmaceutical companies is engineering, which is responsible for providing support to production as well as maintaining, modifying and repairing plant.
BRIAN KILLEN, PRODUCTION MANAGER, MERCK SHARP & DOHME team leader and then to supervisor level, there may also be opportunities to move into other areas, such as finance or human resources. However, production operators moving into more technical roles will usually already have a qualification related to the new function. The quality control (QC) department generally
Responsible for four factories in Tipperary, Killen has a staff of approximately 60 operators as well as 12 supervisors, team leaders and engineers. The job involves managing the execution of all processes in factories dedicated to wet processing, dry finishing, solvent recovery and pilot plant. Specific duties include: daily, weekly and long-term planning of the
WORKING IN PRODUCTION
facility; ensuring that production schedules are met and that the right quality and yield are achieved for each process step; resolving technical issues; and making sure the facility operates to the highest possible safety, environmental and quality standards. Killen joined the company nine years ago after completing his masters in chemical engineering at Queens University Belfast. After a one-year stint in a chemical engineering technical support role, he spent three years at a sister plant in France working as a production shift engineer. When he moved back, he worked initially as a team leader in the pilot plant and then as a technical manager, before taking up his current role two years ago. “For me, the most interesting aspects of this job are the longterm production planning, the manpower planning and the human resource (HR) issues associated with that, such as dealing with the unions about how we’re going to have to move people and restructure work practices,” he says. Now at senior section manager level, Killen believes his next step will involve either taking a director position on site or relocating 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
FIONA CARROLL, SUPERVISOR, GE HEALTHCARE
Working in the production department at Pfizer’s Little Island facility, Cleere’s main objective is to ensure the plant is set up in a safe and environmentally compliant way. “I ensure that systems and equipment can be used effectively by the operators and I take their comments and feedback on board,” he explains, pointing out that it’s vital to listen to the concerns of end users in order to understand the issues and identify problems. Cleere says one of the most interesting things about the role is seeing a critical stage in the commercialisation of a product, from introduction through to large-scale manufacture. After graduating from University College Dublin with a degree in chemical engineering in 1995, Cleere worked for Merck Sharpe & Dohme before moving to Pfizer in 2000. All his roles to date have focused on production and production support, apart from a short spell in safety at Merck Sharp & Dohme. He will shortly move to more of a project management role, as he is responsible for the commissioning and qualification of a large new on-site plant.
Carroll has been in her position in the production department at GE Healthcare since January. The job involves putting together the production schedules and ensuring that they are adhered to. It also involves solving problems and participating in projects for production process improvement. After graduating in 1997 with a masters in microbiology, Carroll worked in a QC role in Schering Plough for three years. She then moved to GE Healthcare, where she was involved in quality assurance for four and a half years before taking up her present position. So far, she has particularly enjoyed the feeling of being close to the action. “Production is the centre of things in the pharmaceutical industry,” she explains. “The office is in the production area so you’re in the hub of it.” In the long term, Carroll sees herself returning to quality. “I first want to learn more about an operations department,” she says. “I think for anyone who works in quality, it’s a good idea to work in production. Sometimes when you’re working in a support department, you don’t see all that’s involved in producing a batch.”
WORKING IN BIOTECHNOLOGY
Buying into
biotechnology ALWAYS full of promise, but initially slow to develop, the biotechnology sector is now believed to be finally starting to deliver on its strong potential, both in Ireland and on a global scale. Involving the use of living cells and cell components to manufacture a wide range of products, including food, fuel and pharmaceuticals, it’s a highly sustainable technology. According to the Irish BioIndustry Association, the representative body for the biotech sector, this will enable economic growth and increase the competitiveness of many industries in Ireland. Nearly 60 Irish-based biotechnology companies, employing an estimated 4,000 people, are involved in biopharmaceutical discovery and manufacture and in diagnostic, agri-food, pharmaceutical services and bio-environment activities. The sector is also supported by many specialist service providers in the legal, patents, clinical trial, contract manufacturing and waste handling and disposal areas. Biotechnology is increasingly viewed as a priority area by Irish agencies. Enterprise Ireland, for example, has its own biotech strategy and prioritises start-ups in this area. IDA Ireland is actively trying to attract biotechnology companies into this country. And, when Science Foundation Ireland was established in 2003, it identified biotechnology as a key area for investment and research. The high-profile employers in the biotech sector in Ireland include Wyeth BioPharma, Schering Plough, Genzyme, Trinity Biotech, Biotrin and Megazyme. While biotechnology, microbiology, chemistry and biochemistry graduates are always in demand, having a science degree is not an absolute requirement for working in the sector. In addition to the scientific roles, positions are available in production, quality engineering and production support areas. Salaries are generally quite competitive in the sector. In its Salary Survey Ireland 2006, recruitment and human resources consultancy Hudson found that: lab technicians working in biotech earn between ¤25,000 and ¤35,000; analytical chemists with one to four years’ experience are in the same range and those with between four and seven years’ experience can earn up to ¤45,000; biochemists can command up to ¤40,000; and validation managers are paid between ¤45,000 and ¤60,000.
The use of living cells and cell components to manufacture products is a strong growth area. Grainne Rothery reports
JULIANNE HOGAN, DEVELOPMENT SCIENTIST, WYETH BIOPHARMA Hogan works in development operations, where she is primarily focused on process development. “We are manufacturing a vaccine for meningitis and I’m involved in the development of that manufacturing process,” she explains. “A lot
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‘Biotechnology is increasingly viewed as a priority area by Irish agencies’
WORKING IN BIOTECHNOLOGY
of my job involves going to meetings and co-ordinating projects. I also do a lot of pilot scale work here for the manufacture of the vaccine.” While the products she’s working on have already been developed and manufactured in the US, the technology transfer process requires Julianne Hogan, initial small-scale manufacdevelopment scientist, ture in the lab in Dublin to Wyeth BioPharma ensure all the process information is accurate before moving to large-scale production. Hogan completed her industrial biochemistry degree at University of Limerick in 1999 before working for a small biotech research company in Cork, where she remained for more than three years. While she gained a lot of experience in the cell biology area during this time, the job was very research-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 in the manufacturing process. That was a quality lab so it was very focused on good manufacturing practices and very regulated.” She says that while this was somewhat overwhelming, 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 new experience and work in a new environment. “I’ve kind of stepped away from the cell biology side of things now,” she says. “It’s more about chemistry process engineering, which is great because I now have a greater depth of knowledge. I’ve seen the whole thing evolve from early stage research and looking for targets up to how we make it and then how we make it really, really well.” In the future, she hopes to move into a project management position, having picked up a range of relevant skills since starting in development operations. “Moving from virology into this role, I’ve noticed that you become a people person and you really have to get with the programme when it comes to co-ordinating, communicating and project management,” she says.
PAUL CONDON, MATERIALS DIRECTOR, GENZYME Condon experiences various aspects of the biotech industry. He is responsible for purchasing all the materials Genzyme uses as well as customer service and international distribution. Genzyme supplies 40 countries worldwide and Condon and the group of 28 people he works with are responsible for getting the materials to them. Genzyme, which opened in Ireland in 2002, employs 300 at its Waterford site and is currently recruiting. Condon joined the company when it was first set up, after working for 15 years
in the pharmaceutical industry. He has a degree in management from the Irish Management Institute as well as a masters and he is currently studying for a master’s degree in supply chain management. In the past 20 years, Condon has seen many changes in the sector. “It has become increasingly regulated and Ireland has become a centre for pharmaceutical companies, which is great. The biotech industry is an extension of that, 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 lifethreatening and debilitating diseases and you’re doing something that’s impacting in a very real way.” Condon says ongoing training is vital. “We have a strong training and development culture as a company and a lot of focus on continuing education. We work closely with Waterford Institute of Technology, which was a very big plus in terms of Genzyme coming to this area.” He emphasises that science graduates aren’t the only people who work in the industry. “In some of the functions there is a focus on science graduates, but not all the disciplines within the company require a science background. If you take biotechnology, a lot of it is to do with drug development and formulation, but then when you get to the commercialisation of the product, you’re into another realm to do with serving and supplying patients.”
Celebrating 25 years of manufacturing in Kinsale Eli Lilly and Company is a leading innovation-driven corporation committed to developing a growing port-folio of best-in-class and first-in-class pharmaceutical products that help people live longer, healthier and more active lives.
INVESTMENT
Biotech and ICT the ones to watch After much consideration, the two areas earmarked for particular attention in terms of research are information and communications technology and biotechnology
Dr Maurice Treacy, director of bioscience and bio-engineering at Science Foundation Ireland
‘Nine of the big 10 pharma companies, all of the major medical devices companies and most of the global diagnostics companies are active in Ireland’
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SINCE it was founded in 2000, Science Foundation Ireland (SFI) has invested ¤200m in biotechnology and biosciences research in academic institutions. Biotechnology, along with information and communications technology (ICT), are the areas that were prioritised 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 to the formation and existence of SFI: “In 1999, a technology foresight exercise was commissioned by the government, which examined the potential areas for future investment in research that could significantly and positively impact the Irish economy. This took more than a year to complete and involved numerous lectures from invited experts as well as workshops and public events. That process identified two areas — ICT and biotechnology — which, in the context of Ireland’s strengths, should be the areas of future focus for research investments.” The criteria that led to a focus on these sectors included the fact they represented short, medium and long-term return on investments with the potential for 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 sciences sectors, the timeframe for the output of commercial products is very different and represents a continuous range of products coming from both sectors. ICT software is the quickest to market, hardware represents a mid-term return and biotech a mid to longterm return. In biosciences in Ireland, the medical devices and diagnostics sector constitutes the mid-term timeframe to economic return, while the therapeutic products sector represents long-term and high-value return.” Although the potential return on investment for biotechnology is very high given the knowledgeintensive nature of the research, there is a proportional increase in risk. “Return on investment will be larger than your typical manufacturing activity, but only on the successful projects,” Treacy remarks. “The fall-off or attrition rates in drug development
are high, which makes this research high cost, high risk and high return. We cannot afford to be risk averse or we wouldn’t achieve anything, however we must insist on quality. The Government is imaginative in this adopted innovation-driven strategy.” Treacy says that while the return is important, it should also be remembered that these investments immediately benefit people. He emphasises that, apart from direct return on investment in the form of commercialisation of research, the teaching and training of students is good for the economy and society in general. Having said that, economically viable applications of the research are needed. While SFI funds academic researchers, there is an onus placed on them to contemplate the possible market potential of their work. “When we receive applications from academic researchers, we examine the quality and competitive and innovative nature of the proposed research programmes using international peer assessment,” explains Treacy. “We also ask the question as to the strategic importance of the proposed research to Ireland — how does it map on to embedded industries and, if it does not, how can that be grown?” Luckily, Ireland is well served by life sciences and healthcare companies. “We are fortunate to have a rich, embedded base of relevant industries. Nine of the big 10 pharma companies, all of the major medical devices companies and most of the global diagnostics companies are active here. This strong position needs to be leveraged so they broaden their activities to include research,” says Treacy. “Exposing them to quality researchers is a key mechanism to ensure that academic-industry collaborative research activity begins and grows, as they are attracted to high-value research and researchers and the promise of quality, exploitable intellectual property emerging from that. We ask researchers to think about how they might work with these companies and to plan out a road map accordingly. In this way we are systematically linking up researchers with the most relevant industry partners,” says Treacy.
INVESTMENT
The Wyeth way Wyeth’s Newbridge facility is one of the company’s two strategic pipeline sites for soliddose pharmaceutical products worldwide WITH the announcement earlier this year that ¤350m is to be invested in Wyeth’s manufacturing facility in Newbridge, Co Kildare, the pharmaceutical industry in Ireland has received yet another vote of confidence. Wyeth is one of the largest pharmaceutical companies in the world and this investment will be used to expand production capabilities at the facility for the company’s emerging pipeline of products. The next five years will be exciting times for the Newbridge plant, which is one of Wyeth’s two global strategic pipeline sites for solid-dose pharmaceutical products. The investment has been eagerly welcomed by politicians and Wyeth staff in Newbridge. “We would see it as something that really validates the sort of work we do,” says Daryl Kennedy, associate director of technology at the Newbridge site. “That sort of investment doesn’t come easily. Every day you have to earn the right to be a strategic site.
The emerging pipeline is positive and we will continue to engage in attracting the transfer of new products into the site.” The technology department at Wyeth Newbridge is a relatively small but vital part of the company. In the technology group, 67 people are employed in roles from senior managers to technology specialists. They have a diverse range of backgrounds, from PhD chemists and pharmacists to industrial engineers and statisticians. “At Wyeth Newbridge it’s all about crossfunctional team work. Everybody must work together and not operate in isolated units. Technology is a key function that operates within this framework,” says Kennedy. “We are focused on achieving four common goals in quality, safety, customer service and cost effectiveness. The technology department has a pivotal role, whether there are new or existing products coming through the pipeline. We work on optimising the
Biopharma ambitions A new biopharma process training facility in Cork hopes to act as a magnet for major biopharmaceutical investments. Brian Skelly reports THE keen aspirations the Government has for the biopharma sector were underlined recently when it announced it is to invest ¤3.5m in a new biopharma process training facility in Carrigaline, Co Cork. Locating the facility in Cork is a reflection of the high concentration of pharmaceutical and biopharma companies in the southern region, with 23 plants in the Cork area and 40 in Munster as a whole. However, as if to
prove the south has no monopoly on biopharma investments, the Government announced that another major biopharma project, the ¤72m National Institute for Bioprocessing, Research and Training (NIBRT), would be based at University College Dublin’s (UCD) Industry Park. The facility is being established by four leading colleges: UCD, Trinity College Dublin, Dublin City University and Institute of
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 blow for employees at the company, but it does not spell bad times. As a strategic pipeline site, Newbridge continues to be very much at the heart of Wyeth’s future. The company has a worldwide workforce of 52,000.
Like many pharmaceutical companies in Ireland, Wyeth continues to promote lifelong learning within the firm, with staff doing diplomas at Institute of Technology Tallaght and partaking in an extensive in-house training programme. “Everybody needs to be up to speed with the latest state of the art technologies or initiatives,” says Kennedy.
Technology Sligo. The majority of the funding will be provided by IDA Ireland over the next seven years. The facility, with world-class research and training programmes, will be a cornerstone in the agency’s efforts to attract the next wave of industrial development. One of just a small number of such industry-focused facilities in the world, it will be a centre of excellence in bioprocessing and biomanufacturing technology training and research and will support the rapidly growing biopharmaceutical industry in Ireland. A key element will be the substantial investment in the scale-up capability within which the training and research can take place. This capability will make the training and research carried out highly relevant to the needs of the biopharmaceutical industry in Ireland and throughout the world. Through the involvement of the acad-
emic partners, the new facility will provide a substantial output of people across the spectrum of bioprocessing skills. It will also build up a substantial research team to undertake collaborative research between academia and industry. The Minister for Enterprise, Trade and Employment, Micheál Martin TD, said the new facility would give Ireland a competitive advantage and act as a magnet for major biopharmaceuticals investments from both overseas and indigenous companies. “The establishment of NIBRT sends out a clear signal to the biopharmaceutical industry worldwide that the Irish Government is committed to a strategy of development for the industry and to creating a highly competitive environment in terms of skills, training and research capabilities,” he said. “Biopharmaceuticals and bioprocessing have been identified as key growth areas for the future.”
THE PHARMACEUTICAL INDUSTRY 25
COMMERCIALISATION
Making it in biotech THE ability to convert innovative technologies into commercial products with a broad range of applications has propelled Luxcel Biosciences into a strong position. The Cork-based biotechnology company is already working with some of the leading players in the pharmaceutical and food safety sectors and, over the next five years, has the potential to capture a significant share of a combined market worth US$2bn. Luxcel won the innovator category at this year’s Small Firms Association National Small Business Awards, announced on 3 March. Having started life as a spin-out from University College Cork (UCC), it was incorporated in February 2002 by Dr Richard Fernandes, who has a background in biochemistry and previously worked as a researcher at UCC, and Dr Dmitri Papkovsky, who is in charge of the biophysics and bio-analysis lab in UCC’s biochemistry department. The company now employs 10 people and has its research and development (R&D) base in the new BioInnovation Centre in Cork. Luxcel has already developed several technology platforms, including respirometric screening technology (RST), phosphorescent label technology and the oxygen sensor system, each of which has the potential to generate several product types and be adapted for related biotechnology markets. The technologies have been in development for the past 12 years or so and originated in various major research institutes around Europe, with the majority of the research carried out in UCC. The company has developed its own intellectual property and has also been granted exclusive licences from other institutions. For start-up biotechnology companies, the road to revenue is typically a fairly lengthy process because of the amount of R&D involved. 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 that field. We were formed in 2002 and launched the first product in less than a year. Since then, we’ve managed to sell to the majority 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 to the marketplace so rapidly comes down to the quality of the technology 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 the end user in the science. Now we’re getting the support of the big pharmaceutical companies and are getting ready to go into the growth phase of the product.” Luxcel’s flagship technology is RST, which measures oxygen uptake in biological samples and has important applications in drug development as well as in food and water safety. For example, RST enables pharmaceutical companies to identify potential toxicity problems in early-stage drug development. “Luxcel has developed a very fast test that enables it to look at new
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Luxcel Biosciences, which was named Innovator of the Year at the SFA’s National Business Awards in March, is in a position to capture a significant share of a very valuable market
DR RICHARD FERNANDES, CO-FOUNDER, LUXCEL BIOSCIENCES
‘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 indication that they may become toxic,” says Fernandes. “Pharmaceutical companies will still have to do further tests, but what they’re looking for are quick, flag-waving tests.” The technology has also been adapted for food safety and the company is about to launch a product in this area. “We can identify if bacteria are present by the rate at which oxygen is being consumed,” says Fernandes. “The strength of this technology is that it dramatically increases the speed
of the test. While current sterility tests can take anywhere from two to three days, Luxcel’s takes hours.” According to Fernandes, approximately 600 million food safety tests are carried out each year and each test can cost up to US$2 or US$2.50. As regards drug discovery, he points out that Pfizer alone spends more than US$7bn each year on R&D. “We’re looking at targeting a combined market of US$2bn and are working with the leaders in these markets.”
COMMERCIALISATION
Eli Lilly — 25 years on Eli Lilly will celebrate 25 years’ successful operation at Dunderrow, Co Cork with an open day for staff, their families and members of the public ELI Lilly is a pharmaceutical company with a history of medical innovation, most notably in the treatment of oncolytics, diabetes and depression. The company was founded in 1876 by Colonel Eli Lilly, is headquartered in Indianapolis in the US and now employs approximately 44,000 people worldwide. Celebrating 25 years in operation this year, Eli Lilly’s Irish manufacturing facility is a bulk active pharmaceutical ingredient
facility at Dunderrow, Co Cork, 5km from Kinsale. The first products were produced in 1981 and more than 450 people are employed 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 for employees, their families, members of the community and contract staff. Over the years the Cork facility has built a strong reputation within the Eli Lilly organ-
isation for its ability to safely manufacture and supply a range of new medicines to patients worldwide. “I think one of the most significant success factors for us has been the people who work
here,” says Donal Johnson, business leader, public affairs. “We have terrific people, many of whom grew up in the locality and have worked with the company for the past 25 years. In that time they have developed deep technical expertise in manufacturing medicines that is recognised throughout the organisation.” Johnson also cites the educational system in Ireland as being a significant factor. “We have always been successful in attracting top graduates from the country’s educational institutions and many of these people, having spent time in Kinsale, have gone on to senior leadership positions in other Eli Lilly locations,” he says. “We have had great support from our local Dunderrow community. Our open day on 6 May is an opportunity for us to say thank you and also to show our facilities to people who are newly settled in the locality.” He also acknowledges the support of key Government agencies and local authorities.
SERVICES
Eliminating inefficiency As a rapidly growing industry, pharmaceuticals needs all the help it can get to make sure it operates in an effective and cost-efficient way AS the pharmaceutical industry in Ireland continues to evolve, there is a growing need for greater efficiency. The sector is highly regulated and manufacturers face reduced patent lifecycles, increased competition and high costs. Because of this, they need to reduce the cost of supply as well as optimise efficiency and regulatory compliance. That’s where Orbis Information Systems comes in. The leading systems integrator provides enterprise-enabled manufacturing solutions. The company’s laboratory automation software solutions and services allow companies to have accurate information storage, data traceability and increased productivity. “Our skills are very specialised in this area. The combination we have in Orbis of laboratory and life sciences is quite unique,” says Michael Gannon, managing director, Orbis.
Providing the only true commercial off-the-shelf LIMS for the pharmaceutical sector in Ireland today
Orbis’ dedicated lab automation team has much experience in the automation of 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 industry knowledge and integration skills,” says Gannon. “There’s an increasing 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 and put in these solutions from the start, so they can avoid having too many overheads. We provide planning and justification for those solutions.” Orbis benefits hugely from its partnership with Thermo Electron, the world’s leading supplier of laboratory information management systems (LIMS). Thermo Electron has relationships with several of the world’s major pharmaceutical 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, which was launched recently. The only LIMS from a major vendor, the product is designed specifically for pharmaceutical quality control and R&D. In addition, Thermo Electron has launched Lifecycle Asset Management Services. This is designed to optimise the lifecycle cost and performance of laboratory assets across the enterprise, from acquisition to disposition. Orbis’ leading LIMS, SampleManager, has advanced since it was launched in the late Eighties and the company now offers SampleManager 9. “It is an exciting time. We see new solutions coming on stream, which involve shorter implementation timescales, and that allows us to provide higher levels of service to the customer that are geared to meet their strategic objectives,” says Gannon.
‘There’s an increasing demand for more efficiency in the lab to bring down the cost of production’
SERVICES
MAPPING THE LEGAL MAZE Pharmaceuticals is a highly regulated industry and solid legal advice is crucial
GOOD legal representation is important in 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 at Irish law firm BCM Hanby Wallace. In addition, pharmaceutical companies usually want to sell in several countries and enlisting the services of a top-notch legal firm will help clear the path to success. “Even if you’re a small Irish company, the US market is potentially the most impor-
tant,” says Alex Nesbitt, consultant for BCM Hanby Wallace and co-author of The Irish Commercial Precedents Service. “The complex regulatory and legal framework marks the life sciences sector apart from others. Because you have to go through so many different stages of development and the patent has a limited life, you need to work out your legal strategy carefully.” Intellectual property plays an important part in the pharmaceutical industry, notes Sainsbury. “If you’re going to put in place a strategic
ON THE RIGHT TRACK SkidTek is exactly the kind of high-value manufacturing and service company that the Government has been so keen on of late SKIDTEK, a division of the BCD Group, is a high-value manufacturing, design and service company that represents where the Government wants Irish industry to go. Based in Charleville, Co Cork, this stainless
steel engineering firm manufactures skids for the pharmaceutical, brewing and food industries. Skids are self-contained units located in a dedicated section of the pharmaceutical
agreement with a partner and be involved with that company over several years, the relationship has to stand the test of time. Almost certainly the agreement will require tweaking and amendment as the relationship develops. In the pharmaceutical sector it is particularly important to consult with lawyers at all stages of the process.” Both Nesbitt and Sainsbury have worked with Elan Corporation over the years and they had a high degree of interaction with various parts of the company, including research and development, clinical development and finance. Both men were involved in the Elan recovery plan, which realised almost US$2bn worth of assets for the company. Although they left Elan at the end of 2003, they continue to act for them on certain matters. BCM Hanby Wallace has also acted for 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 selling products, you are forced to look at your deals in a different light. Clients need that long-term perspective. One day, the company that is developing a technology is going to have to market it and in practice that means a big-ticket collaboration. The agreement it makes today might make that deal easy or, if not properly constructed, it might make it a lot more difficult.” One of the largest law firms in Ireland, BCM Hanby Wallace is recognised as a leader in all areas of legal practice. The company is well known for its dealings in employment law and commercial property, having been involved in the Dundrum Town Centre and other high-profile deals. The company deals locally, nationally and internationally and has links with various law firms throughout Europe, the US and Australasia. Sainsbury says working in the pharmaceutical industry is particularly enjoyable. “I enjoy acting for companies in the life sciences sector and feel that we can add real value.”
building, attached to the manufacturing area by interconnecting pipe-work. They are designed to clean all processing equipment between production cycles. In business for the past 10 years, SkidTek models and manufactures clean-in-place (CIP) and two-rinse-system skids. The company has a workforce of 70, while the BCD Group employs 200. In an increasingly busy and competitive market, it is vital that pharmaceutical industries optimise their time and SkidTek’s products and services allow them to do just that. The company’s process engineers provide ready-to-operate modular process systems. SkidTek’s CIP modules pump de-ionised water, bases, acids and hot or cold rinse water around the process pipe work in the plant at different stages in the cleaning cycle. The rinse modules, meanwhile, supply
de-ionised and rinse water to the CIP skids for final flushing of the pipe work. In addition to providing modular process systems for the pharmaceutical and biopharmaceutical industry, SkidTek does a lot of work in the biotech industry, for example in buffer preparation. According to Colin Kelly, commercial director at SkidTek, the modular concept has really taken off. “It is particularly useful to pharmaceutical companies because it saves a lot of time on construction,” he says. “We’re building the system while they’re putting the building together. We have put in all of the utilities and facilities at our new facility in Charleville, which is approximately 25,000 sq ft in size, and we can effectively make the entire system here. That cuts the construction time considerably. We also do all of the testing here, which cuts down the testing time onsite.”
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TECHNOLOGY
Trace evidence A new track-and-trace system for drugs, successfully trialled in Ireland, will mean more safety and accountability for patients. John Kennedy reports THE successful trial of the world’s first 100pc track-and-trace technology system has just been completed by the National Centre for Hereditary Coagulation Disorders (NCHCD) in Ireland and the global supply chain standards organisation GS1. The technology enables the full tracking of a drug from the manufacturer to the patient. “This ground-breaking track-and-trace pilot will help ensure safer delivery of haemophilia care in Ireland and across 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 Drug Administration, the World Federation of Haemophilia and other stakeholders,” he adds. The fully integrated electronic barcoding technology system enables 100pc tracking and tracing of drugs administered to haemophilia patients at St James’s Hospital in Dublin. It is believed the project heralds a new era for drug administration programmes in the healthcare and pharmaceutical sectors worldwide. The successful trial of a fully traceable and secure haemophilia drug administration programme in Ireland from manufacturer to patient can now be adapted to resolve a whole range of patient safety and supply chain issues across the immediate healthcare sector and beyond. The track-and-trace system uses GS1’s latest electronic bar coding technology to trace temperature-sensitive clotting factor concentrates (CFCs), the products used to treat haemophiliacs. The integrated electronic product code technology assigns a unique number to every item that rolls off a manufacturing line, allowing every company in the supply chain to track products. Following a two-year trial period, the solution has been successfully implemented and is ready to be rolled out nationally. The use of unique serial numbering and barcoding on each
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‘It is believed the project heralds a new era for drug administration programmes in the healthcare and pharmaceutical sectors worldwide’ vial box to enable automatic electronic data collection and processing will result in safer patient treatment and full traceability and accountability for every drug and patient involved in this critical treatment process. The pilot project linked up to the existing track-and-trace solution implemented in August 2005. This was the brainchild of Dr Barry White, director of the NCHCD, whose vision was to establish a comprehensive and fully traceable drug administration programme from manufacturer through to patient.
His concerns were in response to the publication of the Lindsay Report in 2002, which reported the infection of hundreds of haemophiliacs with HIV and hepatitis C as a result of receiving contaminated blood products. White says: “The contamination of blood products was one of the most catastrophic medical complications of the past century and some of the infections were due to defects in the supply chain. There were considerable difficulties in identifying who had received the infected CFCs and in recalling all the contaminated products.”
Medicines Make A Difference — Your Work Can Make a Difference
Working in the pharmaceutical industry is different from other industries. What you produce here helps people 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 life expectancy 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.
Ireland’s pharmaceutical industry — developing and delivering medicines