Ireland Adventures: Letters from the Emerald Isle

An enterprising editor explores one of pharma’s most enterprising islands.

By Michele Vaccarello Wagner, Senior Digital Editor

Day One: Touchdown Shannon

Customs and border patrol officers love to make small talk. I’m pretty confident it’s part of their job. Where you headed? Got any big plans for the week? Minutes after I landed in the Shannon airport I found myself giving my week’s itinerary to Jocelyn, a polite border patrol officer, who seemed confused by my ratty passport. But, perhaps even more confused to hear my explanation that I had accidentally thrown it in the washer with my jeans a few years back.

“A trip sponsored with Enterprise Ireland, you say? Well, welcome to Ireland. We need all the enterprise we can get!” she said as she stamped my entry. It was her comment that set the tone for my week in one of the most beautiful and culture-rich countries in the EU, but also one of the many countries feeling the pains of the recent economic downturn.

But amidst a downtrodden economy, the Republic of Ireland, with its population of no more than 4.3 million, still represents a small but advanced market for pharmaceuticals and biotechnology. 

Ireland is one of the pharmaceutical industry’s leading manufacturing bases and has attracted huge levels of investment from the industry despite having little tradition of domestic manufacturing. Most Big Pharma companies have production facilities all over the country, but many companies such as Pfizer and Schering-Plough have reduced or stopped their Irish operations in recent years, which has greatly affected the economy.

When I told some of my new Irish pub friends what industry I worked in, their first question was, “Oh my . . . are you here to fire people?” The Irish pharmaceutical industry employed around 24,500 people in 2006, according to the Irish Pharmaceutical Healthcare Association (IPHA). Of these around 17,000 were employed directly by manufacturers. It is estimated that some 2,019 pharmaceutical manufacturing jobs have been lost in the past year in Ireland due to plant closings and outsourcing.  

However, many new investments have been made in Ireland, particularly in the biotech field. Companies such as Pfizer, Wyeth and Amgen  have invested millions in establishing new biotech plants in Ireland in recent years, helping create permanent jobs and further stimulate the economy.

Day Two: Celtic Compliance

After renting a car, figuring out how to drive on the left-side of the road and aging twenty years (yes, it is as hard as you think it would be), I paid a visit to two compliance

Michele Vaccarello, Senior Digital Editor, Cork, Ireland
That smile hides absolute fear.

software companies in industrial Cork: EHA Soft and Qumas. EHA Soft, established in 1992, is one of the largest consulting software companies in Ireland for environmental health and safety management. Their mai (measure, analyze, improve) software offers a modular, paperless suite for EH&S risk assessment, helping companies certify their facilities across national standards.

Managing Director Dan Gallagher sees a trend in the pharma and biotech industry that companies are not doing everything they can to manage environmental health and safety, but not without effort. “It’s always a challenge. Strictly again with the global crisis, people are losing resources, they’re not getting budgets released to them. In our surveys, most companies feel they are not doing enough risk assessment for environmental health and safety. 100% of respondents will tell you that the key factors for their companies are data protection, security, and traceability but they don’t have the resources to effectively manage these risks,” Gallagher says. To watch my full interview with EHA Soft, click here.

Enterprise compliance management software company Qumas, also headquarted in Cork, delivers a closed-loop compliance mode featuring ProcessCompliance and DocCompliance that standardizes and integrates common elements of compliance tasks on a single platform. CEO Kevin O’Leary is seeing more and more pharmaceutical companies looking for fewer systems and platforms in their development and delivery. “Companies are now looking at software and saying . . . this helps us to reach full compliance, but does this help us to get our drugs to market faster? It’s a business advantage and absolutely necessary to approach processes from a larger picture. It’s no longer accelerated delivery vs. a compliant system, it’s more integrated,” he believes.

Qumas recently rolled out MyQumas, a web-based compliance framework that provides a single point of access from which users can monitor their areas of responsibility and perform specific tasks across Compliance initiatives. MyQumas enables users to access functionality on Qumas platforms through a user-friendly interface that provides all compliance content and tasks in one view, promoting a competitive compliance advantage and allowing companies a more efficient management tool.

 

Day Three: Capturing the Irish Spirit

Michele Vaccarello Wagner, Senior Digital Editor in Nenagh, Tipperary Ireland
Nenagh, Tipperary

Next it was on to Nenagh, a county town of North Tipperary, which is famous for the Nenagh Castle and ruined Franciscan Abbey. (The plethora of hand-carved life-sized monks stationed throughout my hotel made much more sense to me once I learned the town history.)

I paid a visit to PharmaFlow, a contract manufacturing and packing company specializing in the processing of small to mid-sized batches, especially where multiple product presentations are required. PharmaFlow provides a range of flexible filling and packaging options for companies outside the EU who are looking to establish a supply chain platform for delivery of their products into Europe or companies applying Lean manufacturing principles and looking to outsource their short production runs.

PharmaFlow sees flexible product lines as being absolutely essential to any contract manufacturing organization, but a certain mindset is vital for continued growth and development. “Having flexible product lines is absolutely essential,” Joint Managing Director Jim Kernan says. “Flexibility is key, not just flexibility of products, but a flexibility of thinking . . . how can we do better and streamline our processes?”

When I asked Kernan why companies should be looking to Ireland for their contract manufacturing needs, aside from the fact that the country is English-speaking, has strong tax incentives, and is close to the European mainland, he told me, “It’s the Irish work ethic . . . if it can be solved, we’ll do it. That’s the essence of the Irish spirit and that’s worked for us so far.” To watch my full interview with PharmaFlow, click here.


Day Four: High-containment and Crystal

Next I traveled to Waterford, in search of crystal and Eirgen Pharma. The road from Tipperary to Waterford is a long one . . . and taken without my friendly British GPS helper who decided to error out 15 minutes into the drive. This left me on Irish “R” (rural) roads about which I was forewarned. Picture a two-lane winding road with only enough room for one car with beautiful country scenery but not another living soul in site, and that pretty much sums up my drive.

With luck, I did arrive at EirGen’s GMP facility, which specializes in the development, registration and manufacture of high potency solid dose products for global markets. EirGen offers a range of pharmaceutical development services for new active substances, generics and upgrades of existing formulations.

I had the chance to sit down with Managing Director Patsy Carney and Technical Director Tom Brennan over coffee and donuts to discuss the technology and initiatives behind their facility. Brennan, a Six Sigma black belt, explains that they have tried to innovate from the development phase to Design of Experiments in order to identify correct process parameters and determine the optimal formulations.
 
EirGen was also recently invited to sit on the FDA Risk MaPP committee with Big Pharma companies such as Pfizer and members of ISPE in order to establish a complete guidance for handling high-potency drugs. They’ve also met with FDA in Rockville to discuss their design and operational approaches to handling high-potency materials.

“We started out to build a facility specifically for high-containment so it’s a dedicated facility, and that’s certainly been of interest to FDA. It doesn’t do us any harm to be sort of engaged with the regulatory authorities in advance for when we’re going to have them for inspection,” Carney said.  To watch my full interview with Patsy Carney, click here.

After I left EirGen, I stopped at the Waterford Crystal factory, whose visitor center was still hopping, but manufacturing lines completely closed. I picked up a few Christmas ornaments and had them engraved by Waterford’s Master Engraver, who told me, “We’ve been really busy, thank God. It’s good to be busy.” The town lost some 800 jobs in the past few years from the manufacturing plant closing, but spirits still remain high, and tourists continue to visit in order to obtain a small piece of Irish history.

Day Five: College Roadtrip: The Dublin Bio/Pharma Tour

A rainy Dublin awaited me, but was all part of the experience. I was off to the Institute of Molecular Medicine at Trinity College to visit Cellix, Ltd., a company that has developed a microfluidics drug screening tool currently being used by companies such as AstraZeneca, Pfizer and Sanofi-Aventis to study drug effects on cell activity is the areas of cardiovascular, oncology, respiratory and bacteriology.

The company was developed in 2004 as a spinoff from research work at Trinity College.
By operating under continuous blood flow conditions, the Cellix platform simulates the human environment providing researchers with data before advancing to costly animal trials with the hopes of eliminating false leads and increasing the success rate of clinical trials. To watch my full interview with Cellix CEO Vivienne Williams, click here.

Located in the Biotechnology building of Trinity College is Merrion Pharmaceuticals, a specialty pharmaceutical company established in 2003 and engaged in the development of oral dosage forms that have poor absorption and are generally given by injection. Merrion's drug delivery technologies, Merrion’s GIPET (Gastrointestinal Permeation Enhancement Technology) and GIRES (Gastrointestinal Retention System), aim to increase bioavailability and provide enhanced drug efficacy. Merrion's formulation capabilities allow the in-house development of solid dose tablet and capsule formulations, as well as manufacturing facilities for Phase I/II clinical trials. To watch my full interview with CEO, John Lynch, click here.

Insert lovely toasted special lunch and shopping for things I may someday afford on Grafton Street.

My final stop was Dublin City College’s Invent Centre to visit Sigmoid Pharma. The company has developed a proprietary oral pharmaceutical formulation technology known as LEDDS (liquid/emulsion drug delivery system) adapted to enhance the safety, efficacy and convenience of orally administered pharmaceuticals. For difficult-to-formulate molecules, particularly water-insoluble drugs, LEDDS offers a solution that enables the controlled release of drugs, including biopharmaceuticals that are optimally formulated in liquid or emulsion form for oral delivery.

Dr. Ivan Coulter, managing director, explains the trends he has been seeing recently in the industry. “As drugs are becoming more specific, they are becoming more complex. And with this complexity comes a number of problems. You have solubility problems and permeability problems and about 40% of all drugs both in the clinic and in development have significant solubility and permeability problems . . . we work to address these problems and stability problems as one collective solution,” Coulter said. To watch my full interview with Coulter, click here.

Day Six: Homeward Bound

Michele Vaccarello Wagner, Senior Digital Editor, Clifden Ireland

 Sadly, I was headed home.

My mind enlightened by the innovative pharma and biotech work I had seen, my bags filled with Irish treasure and my common sense fighting the temptation of having just one more airport Guinness.

Ireland, thanks for the memories!

For more coverage of Ireland's pharmaceutical and biotech industry, visit our Ireland landing page.

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