The Irish BioIndustry Association (IBIA), established in 1998, currently represents 44 companies. It is the leading representative body for the biotechnology industry in Ireland.  Membership includes manufacturers, distributors, and those who support the industry either through services or provision of advice, finance, and capital. Biotechnology company members primarily occupy distinctive niches in the healthcare related areas. Indigenous companies include Elan, Biotrin, Tridelta, and Megazyme. There is also an exciting level of campus company activity with increasing numbers of spin-offs from Irish University organizations. 

The primary goal of IBIA is to enhance the environment in Ireland for the development of a successful biotechnology sector. IBIA's role is to promote, support, and encourage further development of the multinational and indigenous biotech sector in Ireland. IBIA achieves this by building and maintaining excellent relations with government, state agencies, other representative organizations, and patient groups.   

IBIA works closely with the research community to build a thriving biotech sector in the country. It is a full-time member of the US and European trade associations, BIO and EuropeBIO, respectively.  

The association actively participates in a range of activities, including intellectual property and patents, regulatory affairs, and the promotion of research and development (R&D) collaborations within the sector. IBIA is very conscious of the role of R&D in supporting bio-industries, and the association works closely with research institutions within universities and Enterprise Ireland's Biotechnology Directorate. 

The membership has outlined key objectives and aims for the association, which are reviewed on an ongoing basis and adapt to evolving challenges and opportunities. Overall objectives include:  					

Ensuring a regulatory regime which allows biotechnology companies to grow and prosper

Communicating effectively to all stakeholders the benefits of biotechnology to society 

Actively promoting research and development in biotechnology and related sciences and partnerships between industry and universities and institutes of technology

Actively promoting an educational infrastructure which will support the biotechnology sector

Actively participating in the work of the biotechnology industry with other members of the European Union

Promoting a business environment that will enhance development of the biotech sector on the entire island of Ireland.

While advancing the objectives of members, IBIA reviews and revises its activities to ensure they are consistent with these objectives. A cross-section of some key activities within the past year includes:  

. IBIA and Enterprise Ireland have teamed up to bring industry and academia together to develop specific R&D projects that will help address the short-term needs of  the industry. The initiative is based on the Tekes model that has been used successfully in Finland. IBIA members were surveyed, and two areas of particular interest to companies emerged: in-line testing capability for bioprocessing and diagnostic miniaturization. Feasibility studies have been conducted in both areas by groups consisting of both industry and academic leaders. If approved by the board of Enterprise Ireland, €2 million could be made available to fund the research. 

Conducting network events for industry and academic research entities

. IBIA organized events in collaboration with Science Foundation Ireland (SFI). These platforms allowed SFI researchers to present their research areas to the industry and enabled the industry to showcase their companies and the R&D they are currently conducting. 

Promoting the Irish biotech industry at international forums

. For the first time, the IBIA joined with the Industrial Development Agency, Enterprise Ireland, and Science Foundation Ireland and commissioned a trade booth, which was unveiled at the BIO 2005 conference in Philadelphia. The stand was developed to serve as an information center about Ireland to promote its advantages to biotechnology companies, researchers, and entrepreneurs who wish to locate in Ireland.   

. The IBIA joined forces with The Chalfont Project, an international consulting group, to provide members with a free periodical advisory seminar on how to address strategic, organizational, and personnel issues from start-up through various stages of company growth. The seminars covered numerous areas such as strategy articulation, product management, management for scientists and behavioral changes. 

. IBIA participated in BioMed Ireland, the first North-South network for the health technology and biotechnology industries. This joint initiative with the Irish Medical Devices Association (IMDA), the Irish BioIndustry Association, BioBusinessNI, and Inter

Ireland, capitalizes on recent rapid growth in these sectors by developing cross-border business networks. These networks create an all-island critical mass for innovation, growth, and overall global competitiveness and provide a forum to: 									

Consolidate and maximize mutual learning, knowledge transfer, and networking activities

Identify and roll out models of best practice

Provide strategic benchmarking, both internally and externally for the island

Provide the first all-island economic impact study for the sector

Provide an all-island focal point for the sector and facilitate the global promotion of health technology and biotechnology companies based in Ireland

The Irish BioIndustry Association (IBIA) is the leading representative body for the biotechnology industry in Ireland. IBIA's role is to promote, support, and encourage further development of the multinational and indigenous biotech sector in Ireland.  

To achieve these aims, the association engages in a range of activities to protect intellectual property and patents, encourage a positive regulatory environment, and promote research and development collaborations. In these activities, IBIA works closely with research institutions and organizations such as Enterprise Ireland's Biotechnology Directorate, Industrial Development Agency, and Science Foundation Ireland, 

Articles

Through a series of collaborative activities with other industry groups, the Irish BioIndustry Association supports the continued development of the biotech sector in Ireland.

Setting The Stage For Success: The Irish Bioindustry Association

During the last 10 years, Ireland has transformed itself. Once Europe's economic backwater, the country is now one of the strongest European economies. In the late 1980s, Irish per capita income was less than two-thirds that of the United Kingdom. But in the first half of the 1990s, the Irish economy experienced a growth rate of 5% per year, and during the second half, its yearly growth was nearly 10%. Today the per capita income in Ireland is more than 10% greater than that of the UK. Moreover, nine of the world's top 10 pharmaceutical companies have manufacturing operations in Ireland. The Irish government continues to work to make Ireland attractive both to investors and to intellectual talent, and to establish the country as a center for investment, innovation, and inspiration. 

 Aerial view of Wyeth Biopharma campus in Ireland			

Through foreign direct investment since the 1960s, Ireland has grown a globally significant life sciences industry. Today Ireland has over 170 companies employing 35,000 people in the pharmaceutical, biopharmaceutical, medical device, and diagnostic sectors. Add to this mix a large-scale government investment in research and an increase in entrepreneurial and venture capital activity, and one can easily see why Ireland is developing as a world-class cluster in life sciences, and particularly in biotechnology. 

The global consulting firm AT Kearney published its Offshore Location Attractiveness Index in 2004. The index measured the viability of countries around the world as offshore destinations, based on financial structure; people and skills; and business environment. Ireland ranked fourth in the world for people and skills, and third for business environment. The regional picture is even brighter, as Ireland was ranked as the leading location in Europe in both of these categories. 

The results of this index will be no surprise to many multinationals. Multi-facility companies such as Abbott Laboratories; Gilead Sciences, Centocor, Allergan, Boston Scientific Corporation; Essilor; Johnson & Johnson; and Wyeth Biopharma chose Ireland as the location from which to service their worldwide markets, with 25 separate Irish manufacturing facilities among these 7 companies alone. 

In September 2005, an Industrial Development Agency (IDA) Ireland proposal to establish the National Institute for Bioprocessing, Research and Training at a cost of €72 million was approved. This facility will provide critical research and training facilities for bioprocessing technologies, and will help demonstrate that Ireland is determined to be a leader in this industry. The facility will also provide assurance for overseas companies looking to invest in Ireland that the country will continue to have the skill base to support key biopharmaceutical research and product development.  

Investing in Biotechnology Research and Infrastructure

Major research investment in biotech has taken place in recent years. Funding from the Higher Education Authority (HEA), Science Foundation Ireland (SFI), Health Research Board, and Enterprise Ireland means that a research ecosystem is being established with a strong base in the third level sector (universities and technology institutes). Several HEA and SFI projects are particularly noteworthy. 

 Nearly €300 million has been allocated to bioscience through the HEA's Program for Research in Third Level Institutions (PRTLI). Sixteen projects comprising national centers, institutes, networks, and research programs have been established. These include the Biosciences Research Institute, an interdisciplinary research center based at University College Cork; the Conway Institute of BioMolecular and Bio-medical Research at University College Dublin; and the National Centre for Biomedical Engineering Science at the National University of Ireland in Galway (NUI Galway). 

 SFI has created a number of world-class research Centers of Science, Engineering, and Technology (CSETs). CSETs support research partnerships that link scientists and engineers with their industrial counterparts. One such CSET is the Alimentary Pharmabiotic Center (APC), which is receiving €16.5 million over five years to research drug treatments and pharmaceutical products. The APC's commercial partners include global giant Procter & Gamble, as well as Alimentary Health Limited, a company established to commercialize the output from the University College Cork. SFI has also made a €15 million CSET award to NUI Galway to establish the Regenerative Medicine Institute. Regenerative medicine is an emerging discipline that involves developing gene and cell therapy to promote tissue repair and regeneration. As a result of regenerative medicine's use of minimally invasive techniques, it promises to partially replace current conventional medicine. 

Enterprise Ireland's biotechnology strategy aims to maximize the creation and growth of commercially focused biotechnology companies in Ireland. On campus, Enterprise Ireland, the state agency responsible for the development of indigenous Irish industry, is active in funding applied research, which has a commercial output through its Commercialization Fund. Over 100 life sciences technologies are currently in the pipeline, with a number of these forming the basis for spinoff companies while others are being licensed to existing firms.  

Enterprise Ireland commercialization specialists work with university technology transfer offices to help identify, protect, and exploit the technologies being developed. Campus-based incubation space for life sciences start-up companies has doubled in the last two years. Moreover, many facilities funded by Enterprise Ireland are fully occupied by client companies. Enterprise Ireland has provided almost €4 million to establish six facilities that are available to a range of clients, including university spinoffs, company spinoffs, entrepreneurs from overseas, and foreign companies wishing to relocate in Ireland. The incubators are a combination of laboratory and business space, with access to financial, legal, and marketing advice.  

Enterprise Ireland, in conjunction with the Irish BioIndustry Association, is bringing industry and academia together to develop specific research and development projects that will help address the needs of industry in the short term. The initiative concentrates on two areas of particular interest to companies: in-line testing capability for bioprocessing, and miniaturization of diagnostics.  

Enterprise Ireland has also been instrumental in promoting private sector seed and venture capital development in Ireland.  

Networks have been very important for the life sciences sector, both within Ireland and abroad. BioConnect Ireland, BioLink USA-Ireland, and TechLink UK-Ireland are three organizations established in recent years that cooperate to keep individuals in Ireland, the US, and the UK in touch and informed about developments and opportunities within the sector.  

Many of the best and brightest graduates left Ireland in the 1980s and 1990s when the level of scientific funding was low and jobs in science were hard to find. The situation has turned around since the late 1990s, when major funding became available for science and R&D for the first time, in the shape of PRTLI, set up in 1998, and SFI, established in 2000. Enterprise Ireland also significantly increased support for applied research and life sciences companies with high potential for growth. The positive upshot of these developments is that some of Ireland's top minds, who had nearly given up on the possibility of returning home, started to view things very differently. Given the transformation of the research climate, a return home became attractive. 

Tim O'Brien, professor of medicine at NUI Galway, reports, "I'm a Corkman, and I returned to Ireland to take up a post with SFI. I had studied medicine in University College Cork, and for four years after I graduated I worked in Cork University Hospital. In 1988 I went to the US. There I worked for 13 years, mostly at the Mayo Clinic, where I had a post as a clinical investigator. I worked in the area of diabetes to enhance the care of those patients. About four years ago I started to look with glee at what was happening in Ireland. NUI Galway was setting up a number of clinical research posts, and the Program for Research in Third Level Institutions and Science Foundation Ireland had been established to fund individual researchers." 

He continues, "I was appointed as professor of medicine at NUI Galway in 2001. The Ireland of 2001 was very different than the Ireland of 1988. There has been massive capital put into the hospital in Galway, there was a strategic research plan in place, and the individual environment for researchers had improved." 

O'Brien goes on to note that when he returned to Ireland in 2001, there was a cluster of medical device companies in Galway that was the biggest in Europe. Moreover, there was an industrial partner, Medtronic, that he felt he could call at any time. 

For CSET funding, O'Brien and his colleagues felt they were well-positioned, because they had a regular medical institute partner, as well as university and industry partners.  

"That was the key to our success," he points out. "We also managed to attract another Corkman, Frank Barry, who had worked with stem cell technology for 14 years in the US, to return home." 

For potential biotech start-up companies in Ireland, much of the infrastructure is already in place. This infrastructure includes both facilities and talented scientists. The start-up company in Ireland is, therefore, launching its business within an existing and well-developed system.  

One such business is Opsona Therapeutics Limited. Founded in March 2004, it is a campus company based at Trinity College, Dublin. Opsona Therapeutics is a drug development organization that focuses on the regulation of the human immune system and is identifying and developing new drugs and vaccines to treat and prevent autoimmune and inflammatory diseases.  

Opsona's academic founders are among Ireland's leading immunologists, and are considered world leaders in their areas of expertise. One of them is Luke O'Neill, a professor and department head in biochemistry at Trinity College. He is also an SFI Fellow, whose research group focuses on the signaling processes involved in innate immunity.  

According to O'Neill, "There are hundreds of researchers in the universities that were not there a few years ago. We need to capture that knowledge and put it into companies. There is an enormous amount of intellectual property coming out of Ireland's universities. I would continue to urge investors to contribute to venture capital funds. Funding start-ups is not easy, but it can be based on very good science." 

John Pethica graduated from the University of Cambridge in the UK with a Ph.D. in physics. He was a staff scientist at Brown, Boveri & Co, Ltd, in Switzerland from 1980 to 1982 and held Fellowships at Cambridge from 1983 to 1987. He subsequently became professor of materials science at the University of Oxford.   

Pethica moved to Ireland in 2001 and became a Science Foundation Ireland Principal Investigator at Trinity College, Dublin in December 2001. The recipient of numerous awards, he conducts research into nanomechanics and the manipulation and control of matter at the atomic and molecular scale, with application to novel devices and biological structures. His nano-science research has possible applications in biotechnology, medicine, and pharmaceuticals as well as in information technology.  

Explaining how and why he chose to relocate in Ireland he says, "People have asked me why I left Oxford [University]. Well, Ireland was a live opportunity, and there was a sense that things were happening there. Ireland was not an option 10 years ago. Twenty-five years ago Ireland was a little backwater, but now it has a new Nanocenter at Trinity College, Dublin, involving TCD, University College Dublin, and University College Cork. Ireland is now drawing people, and a critical mass of people is important, because of the need to have people to bounce ideas off. We also need benefactors to make Ireland the land of scholars." 

Wyeth is the largest pharmaceutical firm in Ireland. The company has been manufacturing in Ireland since 1974, and it now has operations at four locations: Limerick, Kildare, Sligo, and Dublin. With 3,000 employees, Wyeth is also the largest employer in pharmaceuticals in Ireland. 

Reg Shaw is managing director at the Wyeth BioPharma Campus in Dublin.   

He recalls, "Against stiff competition, early in 2000 we decided to locate a plant at Grange Castle (west Dublin). It is a $1.8-billion investment. This is a biopharmaceutical plant, making product. We will make our rheumatoid arthritis product in Dublin, and a vaccine for children under the age of five. Then we have a new innovative antibiotic that can be used to treat very serious hospital infections." 

Shaw continues, "The quality of the people funded under SFI was very important to us. Of our workforce, 6% are non-national workers, and 15 countries are represented at Wyeth Ireland. Another 6% are returning nationals who have experience mainly in the biopharm business."  

He concludes, "The government's commitment to R&D was a critical consideration for us when we decided to locate at Grange Castle. The talent pool available was even more critical, since 60% of our workforce are graduates."  

Ireland's dynamic life sciences industry attracts investors, both foreign and domestic, and lures its brightest minds back home.

Investing, Innovating, Inspiring

As companies evolve, they often must select new locations where they can centralize or expand their operations. This can be a daunting challenge that demands consideration of numerous factors.  

, in collaboration with Enterprise Ireland, has produced this special supplement that highlights the biotech environment in Ireland. This issue expands on our recent series of articles that explores countries around the world and US regions where the biotech industry thrives and opportunities abound.  

During the last 10 years, Ireland has developed into one of the strongest European economies, with per capita income 10% higher than in the UK. The country has more than 170 companies employing 35,000 people in the pharmaceutical, biopharmaceutical, medical device, and diagnostic sectors. And nine of the world's top 10 pharmaceutical companies have manufacturing operations in Ireland. 

Government research funding and private venture capital investment have largely fueled this growth. The Higher Education Authority alone has invested approximately US $350 million in bioscience projects that include national centers, institutes, networks, and research programs. On top of that, venture capital increased 25.7% during the first half of 2005, over the same period in 2004. This is especially impressive when considering the 11.5% decrease in the total amount invested across Europe. 

Many are taking note. In 2004, AT Kearney's Offshore Location Attractiveness Index ranked Ireland fourth in the world for people and skills, and third for business environment. The same year, Ireland led the Harvard Business Online Global Creative-Class Index. This compares countries by the size of their "creative classes" — their scientific, intellectual, cultural, and entrepreneurial talent. 

In September 2005, the Industrial Development Agency Ireland received approval to establish a National Institute for Bioprocessing, Research, and Training, with an investment of more than US $80 million.  

Ireland now has a viable biotech infrastructure and a dynamic intellectual environment. Best of all, skilled personnel – both new graduates and experienced professionals – are once again calling Ireland home.  

We hope the features that follow will fill you in on the reasons behind the growing excitement in Ireland's business and biotech communities, and also suggest opportunities you may not yet have considered. 

 is committed to providing you with the latest information you need to advance your business, and we welcome your comments and suggestions.  

As companies evolve, they often must select new locations where they can centralize or expand their operations. This can be a daunting challenge that demands consideration of numerous factors.

From The Publisher Why Ireland?

Elan Corporation, PLC, is a neuroscience-based biotechnology company focused on discovering, developing, manufacturing, and marketing advanced therapies for neurology, autoimmune diseases, and severe pain. Head-quartered in Dublin, Ireland, the company operates on a global basis and has locations in Athlone, Ireland, Bermuda, Japan, and the United States. Elan shares trade on the New York, London, and Dublin Stock Exchanges.  

Elan is unique in an Irish context because it possesses the range of expertise required to develop, test, validate, manufacture, market, and broker international contracts in Ireland. In 2002, more than $18.4 billion was wiped off Elan's value following a consent decree issued by the US Food and Drug Administration (FDA) and an investigation into the company's accounting practices. By February 2004, Elan had completed a recovery and restructuring plan that resulted in divestiture proceeds of more than $2 billion. The settlement of the US Securities and Exchange Commission's investigation, announced in February 2005, removed this uncertainty about Elan's future and allowed the company to focus more on bringing its innovative science to patients. 

Elan's future now looks bright, and the restructuring of the company provided both a stimulus and an opportunity for the emergence of more than half a dozen new companies headed by former Elan personnel.  

Some of the largest private equity transactions in Ireland over the past couple of years have involved companies with some form of connection to Elan. Most recently, Azur Pharma Limited raised €40 million to fund a strategy based on in-licensing rights to products that have either received FDA approval, or that are in late-stage clinical development. Azur Pharma's founding team includes chairman and chief executive officer Seamus Mulligan who, as executive vice-president of business and corporate development at Elan, led the $2 billion asset-disposal program that enabled the company to restructure its balance sheet and stave off bankruptcy.  

Another company with ties to Elan is AGI Therapeutics Limited. It is led by John Devane, who was formerly executive vice-president of research and development at Elan. He raised €9.5 million in first-round funding in 2004 to develop a pipeline of therapies targeting functional gastrointestinal disorders such as irritable bowel syndrome and dyspepsia.  

A third example is Merrion Pharmaceuticals, Inc. This Irish-American firm has operations in Dublin and in Wilmington, North Carolina. It was founded to continue the progress of drug delivery technologies originally developed by Elan. 

In addition, a slew of service-oriented firms have also emerged, including PharmaPlaz, an ambitious firm offering process development, clinical development, and manufacturing services. PK Pharma Innovations Limited is a specialist provider of pharmacokinetic analytical services. And InfoSight Corporation is offering specialist statistical services to companies in the pharmaceutical industry, food industry, and medical device sector, and to research groups conducting clinical trials.  

These post-Elan ventures fall into two distinct categories. Azur, AGI Therapeutics, and Merrion and are engaged in the high-risk activity of drug development, which has potentially high rewards. The others are more service-oriented and, consequently, are able to tap into an immediate revenue stream. 

BioClin Research Laboratories was established by CEO Mary Burke, who previously was responsible for clinical pharmacology at Elan, and by chief scientific officer Brian McKenna, who had managed Elan's bioanalytical laboratory. BioClin secured a lease on Elan's 6000-ft

 , purpose-built bioanalytical facility. The laboratory is the largest of its kind in Ireland. It enables BioClin to offer services to a growing number of small drug discovery and drug delivery companies that have limited development capabilities, and to virtual organizations that do not operate their own wet laboratories.  

			Regarding the BioClin venture, Burke and McKenna jointly commented, "We felt there was a niche for a high-class, regulatory-compliant research organization, and the restructuring gave us the final push to do it."			

Initially, BioClin started out providing bioanalytical support during preclinical and Phase I clinical development, including both methodological development and analysis of pharmacokinetic data. "We have broadened that out to an integrated package as well," Burke says. The company, which was profitable in its first year, now has a broad range of facilities for mass spectrometry, chromatography, and immunochemistry. "We've invested back about €600,000 in upgrading our equipment," says Burke. BioClin can offer trouble-shooting, and it is currently adding assay development services. Burke explains, "We're expanding into becoming a broader contract development organization." That may involve an acquisition, she says, to enable the company to enter the drug formulation area as well. 

Ena Prosser, a former Elan executive, is now in the process of helping to create a dedicated biotech venture capital fund. Colin Sainsbury, previously vice-president and general counsel at Elan, has set up a legal practice dedicated to life sciences at BCM Hanby Wallace, one of Ireland's largest and best-known law firms. Sainsbury notes, "Working in Elan for 10 years enabled me to gain huge experience in the legal and commercial aspects of the life sciences sector. It was also a great learning ground for building and developing international long-term relationships, which are an imperative in the life sciences sector." 

Elan's Drug Technologies division is performing very strongly, and its recently announced third-quarter revenue doubled for 2005 over 2004. The facility at Athlone has seen $178 million of investment in the past three years, including new sterile fill–finish line and nanocrystal technology. Current employment levels are at approximately 540 onsite, including a large team of scientists. 

Elan's proprietary NanoCrystal technology is especially exciting. Elan is working with many pharmaceutical companies to help them to manage their products' life cycles and also to reformulate products to deliver significant benefits to patients with greatly increased bioavailability. As an example, Elan worked with Par Pharmaceutical Companies, Inc, to reformulate its Megace product, which helps AIDS patients gain weight. Previously patients had to ingest 20 mL of a thick liquid, with food. Thanks to Elan's NanoCrystal delivery system, Megace can now be taken on an empty stomach and is 16 times less viscous than it was originally. In addition, patients need take only 5 mL instead of 20 mL.  

To date, four pharmaceutical products have been commercialized that incorporate NanoCrystal technology. Several additional NanoCrystal-related product launches are anticipated over the next two years. Elan is in negotiations with a number of additional companies, and Elan scientists are investigating the NanoCrystal application across a large range of drugs. 

Elan's Prialt (ziconotide intrathecal infusion) is the first innovation in the treatment of severe chronic pain in 25 years. It was approved in the US in December 2004 and launched in the US in the first quarter of 2005. The drug was inspired by the hunting ability of the tiny but deadly South Sea snail, 

 The snail, though only inches long, uses its venom to paralyze its prey for hours, so it can feed at leisure. It was found that one of the peptides in the snail's venom blocks N-type calcium channels and prevents pain signals from reaching the brain. Elan has synthesized this peptide to produce Prialt, which as a non-opioid does not depress the respiratory system or result in withdrawal effects. Reaction from physicians and patients using Prialt has been very positive. 

Following the voluntary suspension of the multiple sclerosis medication Tysabri in February 2005 by Elan Pharmaceuticals and Biogen Idec, the companies have completed a detailed safety evaluation and review. This investigation yielded no new confirmed cases of progressive multifocal leukoencephalopathy. Among patients taking Tysabri, three cases had previously been identified, of which, sadly, two were fatal. The companies have filed a supplemental biologic license application with the FDA and with European authorities, and a decision on Tysabri's return to market will be made during 2006. Elan remains very confident about the value of Tysabri, especially to patients with multiple sclerosis, which has a high unmet medical need. 

Elan is building on its breakthrough research and extensive experience in Alzheimer's disease and is also studying other neurodegenerative disorders, such as Parkinson's disease. Two of Elan's compounds from the Alzheimer's disease immunotherapy program, in collaboration with Wyeth, are currently progressing through clinical trials. Dosing of patients with ACC-001 in a Phase I clinical trial began in the third quarter of 2005. Phase II trials of the humanized monoclonal antibody AAB-001, designed and engineered to remove the neurotoxic beta-amyloid peptide that accumulates in the brains of patients with Alzheimer's disease, began in the first half of 2005. 

As it emerges from a challenging period, Elan Corporation remains committed to filling significant unmet medical needs by bringing scientific innovations in science to market. Its proprietary NanoCrystal technology offers substantial patient benefit, and its research in the areas of inflammatory and neuropathic pain, autoimmune diseases, and neurology hold promise to relieve patient suffering.  

Paradoxically, the company's challenges also have spawned broader growth in the Irish biopharmaceuticals industry. Former Elan executives have launched new companies such as Azur Pharm Limited, AGI Therapeutics Limited, Merrion Pharmaceuticals, Inc., PharmaPlaz, PK Pharma Innovations Limited, InfoSight Corporation, BioClin Research Laboratories, and a venture fund and a life sciences law practice. Focused on a range of services ranging from new therapeutic areas to drug delivery and analytical support services, these companies are contributing to the strengthening of the biopharmaceuticals sector in Ireland.  

With a bright new future following restructuring, Dublin-based Elan sees former executives establish exciting new businesses in Ireland, while it continues its own strong R&D program.

The Elan Effect

The EU Framework Program has operated for the last twenty years, dedicating large sums of funding over five-year periods, all the time aiming to achieve scientific excellence, improved competitiveness, and innovation through promoting increased cooperation between researchers and industry across Europe. 

Ireland's international reputation has benefited significantly over the years from participation in the EU Frame-work Programs.  The Framework Programs have offered valuable opportunities for Irish small and medium enterprises (SMEs), multi-national corporations (MNCs), colleges, and academic researchers to participate in high-quality research collaborations with their European counterparts. Biotrin, EiRx, and Alltech are among the Irish companies that have participed successfully in the EU Framework programs. 

Irish diagnostics company, Biotrin International Ltd., together with the leading Parvovirus B19 researchers in Europe, secured Framework Program funding to carry out pioneering research into B19 infection and diagnosis.   Parvovirus B19 is a human pathogen transmitted by respiratory droplets and blood products. Infection can lead to chronic disease and death in certain high-risk groups such as organ transplant recipients, HIV-infected individuals, pregnant women, and haemophiliacs.  Dr Cormac Kilty, CEO of Biotrin Holdings commented "This project strengthened Biotrin's role at the forefront of research into B19 infection and diagnosis." 

EiRx Therapeutics Ltd. was part of a consortium, which was awarded a Framework grant to study the p53 family of proteins. The consortium was made up of some of Europe's most noted scientists in the apoptosis field from the University of Roma in Italy, the Karolinska Institute in Sweden and the Institute of Science in Israel. To this group, EiRx brought its Genomics and Bioinformatics capabilities, as well as its knowledge of the commercial environment. Being part of the Framework project allowed EiRx the opportunities to network with specialists in the field and to commercialize project findings. 

Alltech Ireland Ltd., received Framework funding for a project to solve longstanding nutritional, welfare, and environmental problems associated with ruminant livestock production and dairying. Specifically, the participants, Rowett Research Institute, University of Leon, University of Hohenheim, University of Reading, CRINA S.A., (Akzo Nobel) and Alltech Ireland Ltd., collected new plant materials not presently used in agriculture but cultivable in the EU and then test them for their potential as feed additives for ruminants in order to inhibit methane formation, inefficient protein retention, lactic acidosis, and bloat.  

Framework Program 7 (FP7) will begin in 2007.  The objective of the Health Theme in FP7 will center on increasing competitiveness of European health-related industries and businesses, while addressing global health issues.   Research will span many disease areas, including cancer, cardiovascular disease, diabetes, brain disorders and infectious diseases. Methods for health promotion and disease prevention, as well as sustainable and efficient healthcare systems will also be addressed in FP7.   

 will complement the work in the health theme whereby systems can be funded and created for use in bioinformatics research, eHealth, and eClinical trials. Funding the application of nano material and technology for use in health will also be possible through the 

. This will include nano-based targeted drug delivery and Nanodiagnostics.  The FP7 

Food, Agriculture and Biotechnology Theme

 provides funding for enabling technologies-genomics, proteomics and system biology approaches to micro-organisms, plants and animals, as well as activities involving health related issues of food and diet.  

The European Technology Platform on Innovative Medicine will also be implemented in FP7. This aims to remove bottlenecks hampering the efficiency of the development of new medicines.  This is essential to revitalize the biopharmaceutical R&D environment for Europe to become more competitive.    This initiative proposes clear practical paths to accelerate the development of safe and more effective medicine. 

For companies looking to progress new drug products or devices to market without exhausting venture capital funding, the EU Framework program can provide considerable benefits. There are opportunities for part or full funding for Phase I and Phase II trials. Companies or researchers who coordinate a consortium are best placed to benefit from the consortium. 

Active, continued, and increased participation in the Framework Program will be one of the key building blocks in the ongoing development of Ireland's biotechnology and biomedical community. Enterprise Ireland provides up-to-date information, advice, workshops, seminars and training courses on the EU Framework Programs.  

The EU Framework Program has operated for the last twenty years, dedicating large sums of funding over five-year periods, all the time aiming to achieve scientific excellence, improved competitiveness, and innovation through promoting increased cooperation between researchers and industry across Europe.

European Research Collaborations

The biotech industry in Ireland has grown substantially during the past decade, and yet more growth is on the horizon.  This is due in part to the groundwork laid during the past 10 years by various organizations and agencies in Ireland, and to the considerable increase in investments in Irish biotech research and development (R&D).  Irish biotechnology in the near future stands to benefit from financial support available from Science Foundation Ireland, Enterprise Ireland, the Higher Education Authority, the Health Research Board, the European Union and others.  Indeed, the combined potential funding from these organizations totals more than €1 billion.  With these resources at its fingertips, Ireland is poised to create an extraordinary high-tech research and industrial base in the biotechnology sector. 

In February 2002, Enterprise Ireland (EI) — the Irish development agency focused on accelerating the development of world-class Irish companies that are market focused and innovation driven — published its Building Biotech Businesses strategy.  The strategy is now fully operational and is contributing significantly to the development of Ireland's entrepreneurial-led biotechnology industry.  The strategy has a number of key elements, including applied research funding, commercialization and technology transfer, international networks, bioincubation, venture capital, and fast-track company growth. 

EI's commitment to funding and commercializing high-quality applied research has led to the establishment of a range of supports brought together under its Commercialization Fund.  The fund consists of 3 elements:  proof of concept, technology development, and business development.  Funding is provided on a competitive basis to researchers in all institutes and colleges, for projects leading to technologies of commercial interest to existing companies in Ireland or having the potential to be the basis for new Irish business. 

Commercialization and Technology Transfer

Enterprise Ireland's Biotechnology Directorate (EI Bio) focuses on technology transfer and campus-based activities.  It forms a crucial link in the commercialization chain by connecting those who conduct the research, and the entrepreneurs, industrialists, and companies who apply the fruits of that research.   

So that EI Bio is best placed to commercialize the results of Irish biotech research, it has located staff as close as possible to where the research happens.  A number of biotech commercialization specialists and biotech project officers are embedded at selected campus technology transfer offices.  EI Bio commercialization specialists are assigned to Dublin City University, Trinity College, Dublin, University College Cork, University College Dublin, National University of Ireland in Galway, University of Limerick, and Royal College of Surgeons in Ireland.  EI Bio also continues to forge strong new relationships with other campuses involved in biotechnology. 

In 2004 EI Bio added the TechMate module to its web portal at 

.  TechMate showcases the latest life sciences and food technologies that have been developed in Irish universities and research institutes and are now available for licensing, collaboration, and business development. Companies can also submit requests for the technology or expertise they require.  In addition, TechMate showcases technologies from the National Institutes of Health in the US and has links to sources of European technologies.  EI Bio also runs Next Wave technology showcase events to highlight the applications and commercial potential of emerging technologies. For more information about this exciting tool, visit 

Paul Roben, Ph.D., is director of Enterprise Ireland's Biotechnology Directorate.  In October 2005, to take this leadership position, Roben returned from San Diego. Earlier in his career, he had worked with the Scripps Research Institute specializing in antibody phage display.  Roben has a broad background in the development of commercial opportunities from research activities and has successfully negotiated licensing deals and collaborations with academic and commercial entities.  He led the molecular biology department at NovaDx International, Inc, and at Corvas International, Inc, he led the molecular biology section of the vascular targeting group.  In addition, in 1999 he founded Target Protein Technologies, Inc.     

Roben recently noted, "The environment for starting and growing innovative biotechnology companies in Ireland is excellent.  Enterprise Ireland is focused on market and industry demands, and we are working proactively with the Irish biotech sector, Irish universities, and research institutes to bring emerging high-quality technologies to market."  

In association with the Irish BioIndustry Association, EI Bio is working on a project to stimulate bioindustry-relevant research at Irish universities.  This program brings leading scientists and business managers from industry together with leading university researchers. The businesses involved include: Elan Corporation PLC, Wyeth, Biotrin International Ltd, Deerac Fluidics, Luxcel Biosciences, BioClin Research Laboratories, Omega Research, and Life Scientific.  Meanwhile, academicians from 6 universities bring expertise in sensors, microfluidics, microelectronics, biodiagnostics, and process engineering.  The project aims to solve generic biological problems faced by the Irish bioindustry.  Phase 1 of the project involves investigating quantitative point-of-care test systems and in-line and at-line bioprocess monitoring. 

In addition, Enterprise Ireland is tapping into the Irish Diaspora as a means of attracting entrepreneurs, as well as scientists who have developed international experience.  EI was instrumental in establishing networks in the US (Biolink USA-Ireland) and in the UK (TechLink UK-Ireland), and it also supports the network for biotech professionals within Ireland (BioConnect Ireland). 

BioLink USA-Ireland now has more than 700 members.  Chapters have been established in 10 locations throughout the US.  The newest chapter was formed in April 2005 in Chicago.  BioLink members contribute to the growth of the biotechnology sector in Ireland as mentors, company founders, scientific advisors, and board members. 

Many Irish professionals living in the UK and working in biotech, nanotech, or pharma have joined TechLink UK-Ireland.  They are interested in the advancement of these sectors in Ireland, and in developing their own careers through networking. 

BioConnect Ireland hosts networking meetings attended by academics, industry, venture capital, government, and service providers.  These events provide an opportunity to network, discuss issues relevant to the sector, and learn from expert speakers. 

One of the Building Biotech Businesses strategy's early objectives, central to creating the proper support infrastructure for a fledgling biotechnology industry, was to ensure an adequate supply of wet lab incubators to support the development of early-stage companies.  On-campus bioincubation space has now doubled.  Enterprise Ireland has provided financial support for the conversion of 6 existing buildings into bioincubators that provide laboratory and office space for 20 start-up companies.  The facilities are located at Dublin City University, National University of Ireland in Galway, St. James's Hospital, Trinity College, Dublin, University College Cork, and University College Dublin.  The facilities are available to a range of clients, including university spinoffs, company spinoffs, entrepreneurs from overseas, expatriate entrepreneurs, and foreign companies that wish to relocate to Ireland.  The bioincubators provide professional research and commercialization services; access to financial, legal, and marketing advice; and help for start-up companies seeking to establish themselves. 

Feargal O'Morain is director of science, innovation, and corporate support services, for Enterprise Ireland.  Speaking of the bioincubation program, he recently observed, "Specialized bioincubators will provide the appropriate business and scientific support needed for new companies to survive and grow.  Increased funding for research in life sciences will result in increased commercial capitalization of basic and applied research in Ireland in the next decade.  The bioincubators  will provide a launch pad for innovative new ideas and products, which are the future for our knowledge-based economy.  This is a central objective of Enterprise Ireland's biotechnology strategy, Building Biotech Businesses." 

The first tenant for the Trinity College, Dublin bioincubator was IdentiGEN Ltd, a company that has developed the world's first DNA-based traceability system for meat (TraceBack™).  This development grew from research initially carried out at the Institute of Genetics at Trinity College, Dublin.  Using IdentiGEN's system to assure consumers of the source of their meat, Irish supermarket chain Superquinn saw an 11% increase in beef sales.  The Irish and UK Food Control Agencies have also selected IdentiGEN's DNA-testing technology for high-profile studies.  IdentiGEN's tests were shown to be the only ones sufficiently sensitive to consistently detect low amounts of target-DNA in certain processed food samples.  For more information about the bioincubation aspect of EI's Building Biotech Businesses strategy, visit 

Since 2001, EI has invested 19% of its €133 million seed and venture capital funds in life sciences.  EI has also been successful in stimulating the emergence of the private sector seed and venture capital environment.   

EI has worked successfully with numerous Irish companies as part of its Building Biotech Businesses program.  The company profiles in the following section illustrate this success. 

, based in Cork, specializes in the development of human therapeutic products derived from probiotic bacteria. The probiotic strains are being developed to treat irritable bowel syndrome, inflammatory bowel disease, and Crohn's disease/ulcerative colitis. 

To assist the start-up of Alimentary Health, EI Bio licensed technology into the company. Following this, Enterprise Ireland invested start-up funds by way of grant and equity. The company has been invited to participate in overseas missions to the US and more recently, has been approved for an innovation partnership grant. 

  Dr. Barry Kiely, CEO, Alimentary Health Ltd, Simla Villa, Passage West, County Cork, Ireland, +353.021.477.4715, 

BioClin Research Laboratories is Ireland's leading good laboratory practice certified, US Food and Drug Administration (FDA) audited, independent contract research laboratory. 

High-volume sample analysis (small molecules, proteins, peptides, and biomarkets)

Pharmacokinetic analysis and integrated study management

BioClin's scientific expertise and extensive experience is internationally recognized. Its state-of-the-art equipment includes mass spectrometry, chromatography, immunochemistry, capillary electrophoresis, and the Watson™ LIMS system. BioClin provides flexible and personalized services to all clients. 

EI has supported the company through feasibility and mentor programs, and has invested funds by way of grant and equity. In addition BioClin is working with EI's UK office under the business acceleration program to generate new market leads. It has also participated in EI-sponsored missions and trade fairs in the UK, Europe, and North America. 

	 Amanda Byrne, Business Development, BioClin Research Laboratories, Monksland Industrial Estate, Athlone, County Westmeath, Ireland, +353.0. 90.648.0400, 

Biotrin International Ltd is a diagnostics company that specializes in providing a range of novel and proprietary tests for the clinician and the research scientist. The company has two distinct business units: Infectious diseases, which provides tests for the detection of new and emerging viruses; and biomarkers, which includes a range of novel, proprietary biomarkers to assess organ and tissue damage. 

Biotrin International owns subsidiaries in France and Germany and is an FDA- registered site, with compliance to the International Standards Organization 13485 standard, the Canadian Medical Devices Conformity Assessment System, and the EU 98/79/EC in vitro diagnostic medical devices directive. 

Enterprise Ireland has been assisting the development of Biotrin since the early 1990s. Funding and grant equity have been provided for feasibility studies, capital equipment purchase, and participation in overseas trade missions organized by EI in Europe, Asia, North America, and Australia.  Product development, business consultancy, and market research projects have also been supported. 

 Dr. Cormac Kilty, CEO, Biotrin Holdings PLC, 93 The Rise, Mount Merrion, County Dublin, Ireland, +353.0.1.283.1166, 

Ireland's Forward-Thinking Business Support Strategy Encourages Research Funding and Fast-Track Company Growth

Building Biotech Businesses

The latest available figures for venture capital activity in Ireland show that for the first half of 2005 there was an increase of 25.7% in comparison with the same period in 2004, despite a decrease of 11.5% in the total amount invested across Europe. 

, recently released by Dow Jones VentureOne and Ernst & Young, reveals that Ireland has continued to buck the European trend of declining venture capital investment. According to Garry O'Rourke, Senior Manager, Ernst & Young Corporate Services Department, "Ireland continues to perform well against a backdrop of overall decline across Europe. Also, in terms of overall investment into businesses in Ireland, venture capital is only one source, with many companies also receiving corporate and private equity investment. " 

Enterprise Ireland, through its "Seed and Venture Capital" program, has been instrumental in stimulating the development of seed funds to address gaps in the financing of business start-ups. A number of new life-sciences venture capital funds have been established and a number of existing firms have ramped up their activity in that sector. The funds active in life sciences investment are Seroba Bioventures, Growcorp, Kernel Capital Partners, 4th Level Ventures, Delta Partners, and ACT Venture Capital. There is also another large fund being mooted for 2006. Listed below is a sampling of the types of companies that are attracting investment. More information also is available at the Irish Venture Capital Association's website at 

AGI Therapeutics Limited, based in Dublin and Athlone, is a specialty pharmaceutical company engaged in the development of innovative therapeutic products to treat a variety of gastrointestinal diseases and disorders including irritable bowel syndrome, non-ulcer dyspepsia, functional diarrhea, gastroparesis, acid disorders, and inflammatory bowel disorders. 

 Seroba BioVentures and a syndicate of Irish and US investors. 

Alimentary Health Limited, based in Cork, is a biotechnology company focused on the discovery, development, and commercialization of therapeutics derived from human probiotics for gastrointestinal disorders including irritable bowel syndrome and 

 Seroba BioVentures and Enterprise Ireland 

Celtic Catalysts' focus is on the niche area of chiral chemistry. The company works with chemical catalysts and processes of significant commercial potential to the fine chemical, agrochemical, and pharmaceutical industries to produce products of enhanced therapeutic activity while at the same time allowing innovator companies to extend product life cycles and stave off generic competition. 

 4th Level Ventures and Enterprise Ireland. 

Deerac Fluidics is a bioinstrumentation company providing low-volume dispensing solutions for the life sciences industry. The company's first product, a bench-top liquid dispensing device, has been launched in Europe and the United States. 

 Seroba BioVentures, 4th Level Ventures, Enterprise Ireland, and a syndicate of Irish investors. 

Eclipse Clinical Technologies is a clinical informatics company headquartered in Dublin with offices in the US and continental Europe. Eclipse provides multilingual clinical data collection, management, and statistical analysis services to the pharmaceutical, biotechnology, and medical device sectors.  

 Seroba BioVentures, Enterprise Ireland and a syndicate of Irish investors. 

Fluorocap is commercializing a new and more-efficient biochip for use by the biotech and life sciences industries. A basic prototype has been developed that provides a 20-fold improvement on current biochip technology. A review of potential customers for the completed product has indicated strong interest in commercial exploitation of the next prototype. 

www.growcorp.net/site/portfolioa_flour.html

This company has a strong portfolio of innovative gas sensor technologies to solve unmet needs across a wide range of valuable applications, including packaging permeability testing, food quality, oxygen sensitive package integrity, as well as medical and environmental analysis.  

Genable has developed an innovative technology for the suppression and replacement of genes. It is potentially applicable to a broad range of dominant-negative genetic diseases, all of which are incurable today. Its lead program has recently completed a proof-of-principle study in retinitis pigmentosa, an eye disease that causes blindness.  

 Raised €1.1 million ($1.3 million) in an investment round led by Delta Partners. 

Merrion is a specialty pharmaceutical company based on proprietary technologies for oral drug delivery acquired from the Elan Corporation in 2003. Merrion has multiple market-ready, advanced oral drug delivery technologies with several significant products already proven in human clinical trials.  

NEUtekBio commercializes novel diagnostic and prognostic assays aimed at increasing the efficacy of critical drug treatments involving interferons and other cytokines. The company leverages its research programs through its collaboration agreement with the Centre National de la Recherche Scientifique in Paris.  

 More than €4 million ($4.7 million) over the last two years. 

 Growcorp led a €1.8 million ($2.1 million) round; Enterprise Equity has also invested. 

Venture capital activity in Ireland grew 25.7% in the first half of 2005 compared with the same period in 2004. New life-sciences venture capital funds have been established and existing firms have ramped up their activity in the sector.

Irish Venture Capital: Sowing the Seeds

Given the importance of the pharmaceutical, healthcare, agriculture, and food industries to Ireland, it is critical that we have a strong biotech sector in place to keep pace with global developments. 

The Irish government has placed research and development (R&D) at the heart of our economic development strategy. Irish bioscience today is benefiting from combined funding of more than €1 billion ($1.17 billion) from Science Foundation Ireland, Enterprise Ireland, the Higher Education Authority, the Health Research Board, the European Union, and others. This level of investment is aimed at improving our research and development base, which is critical to strong growth.   

In recent years, Ireland has attracted major biotech players including Wyeth, Genzyme Corporation, and Centocor, Inc. In September of this year, I announced government approval for an IDA (Industrial Development Agency) Ireland proposal to establish the National Institute for Bioprocessing, Research and Training at a cost of €72 million ($84 million). This facility will provide critical research and training facilities for bioprocessing technologies, which will demonstrate that Ireland is determined to be a leading center in this industry. It will also provide assurance for overseas companies looking to invest in Ireland that we will continue to have the skill base to support key biopharmaceutical research and product development.  

In 2002, Enterprise Ireland (the Irish state development agency focused on accelerating the development of world-class Irish companies) launched "Building Biotech Businesses," a strategy to grow and develop Ireland's entrepreneurial-led biotechnology and life sciences industries. The strategy focuses on interventions designed to nurture early-stage companies by funding applied research with commercial potential; by providing incubation, mentoring, and commercialization expertise; and by developing the venture capital environment. The strategy is now beginning to pay dividends as companies doing world-class research are emerging, and as technologies are being licensed to existing companies. For the first half of 2005, venture capital activity in Ireland increased by 25.7% in comparison with the same period last year, and 70% of the deals completed were in the life sciences area. 

I welcome the opportunity, in this special 

supplement, to highlight the advances that the Irish biotechnology sector is making.  

Micheál Martin,  T.D., is Minister of Ireland’s Department of Enterprise, Trade, and Employment, 23 Kildare Street, Dublin 2, Ireland, +353.1.631.2121, fax +353.1.631.2827, 

The Irish Minister for Enterprise, Trade, and Employment supports and encourages biotech research and development.

The Heart of Ireland's Economic Development Strategy

The creation, dissemination, and exploitation of knowledge are the keys to unlocking the potential of Ireland's economy. Expertiseireland.com  is a comprehensive research portal that provides a fast and effective gateway to the island's knowledge base. The portal offers a mechanism for identifying current research locations and support institutions for commercial and social capitalization. It presents in one searchable database up-to-date information on: 

3,900+ industry experts:  research interests, projects, publications, conference history, patents, and consultancy background

Funding: viable funding sources on a local, national, and European level. 

Technology transfer: innovative ideas produced in the third level sector available for capitalization  	

For added convenience, the portal also provides email alerts, which are triggered by changes to targeted expert profiles or funding opportunities, and current news that highlights issues relevant to R&D, education, finance, and capital investments.  

				Expertiseireland.com is directly populated from knowledge management systems originating at Ireland's academic institutions. The portal is designed primarily to help identify industry expertise and to serve as the contact point between those who create new ideas and those who implement them.  

 facilitates industry-academic collaborations and business-to-business alliances that utilize the world-class expertise and intellectual capital found on the island. 

				Expertiseireland.com  is owned by the Irish Universities Association (Dublin, Ireland), formerly known as the Conference of Heads of Irish Universities. It is funded by InterTradeIreland. You may learn more about the association by visiting 

The creation, dissemination, and exploitation of knowledge are the keys to unlocking the potential of Ireland's economy.

BioPharm International-12-15-2005