Brexit Stage Left? Ireland Eyes Pharma Prize

Pharm Exec recently spoke with Tommy Fanning, head of biopharmaceuticals and food at IDA Ireland, about the measures his organization is taking to bolster foreign direct investment by corporations in Ireland’s life sciences industry. The UK’s Brexit vote last year to pull out of the European Union may be a potential boost for the Irish biopharma market. The European Medicines Agency (EMA) is vacating its London headquarters in search of a new home, resulting in IDA Ireland ramping up efforts to attract the drug regulator to Ireland. At the same time,  IDA Ireland, which acts as a

Tommy Fanning

non-commercial, semi-state body, is busy continuing to promote the country as a manufacturing base for international life sciences companies in search of a strong source of talent.  

IDA Ireland was founded in 1949 as the Industrial Development Authority. The organization partners with potential and existing investors to help them establish or expand their operations in Ireland. Its major goal is to encourage investment by foreign-owned companies. Fanning’s background and experience are heavily involved in business strategy, development, and marketing. He’s held multiple business roles across IDA’s Irish and overseas operations.

PE: Can you outline your personal journey in the life sciences space?

Fanning: I’ve always been in the foreign direct investment area, working for IDA Ireland for more than 30 years in multiple sectors-with financial services companies, software and digital media companies, as well as with engineering and biopharmaceutical companies. When I was based in Tokyo, I worked with Asian companies to urge them to invest in Ireland. The two largest Japanese pharmaceutical companies, Takeda Pharmaceutical Co. and Astellas Pharma, operate two plants each in Ireland today, both API (active pharmaceutical ingredients) and final finished product. 

I’ve been in my current position for about two years. My job involves running our biopharma department that promotes investment while working with the major pharmaceutical companies that have manufacturing facilities for small molecule pharmaceuticals and large molecule biologics. The companies manufacture both drug substance/API and also final finished product. Nine of the top 10 global drug companies have manufacturing activities in Ireland. There is quite a depth of knowledge and experience in the Irish pharmaceutical industry-an excellent skill base.  

PE: What are the key changes you’ve seen in the pharma space in the last 10 years? 

Fanning: We have a truly globalized economy in Ireland, so things that happen in the broader pharma market also happen here in Ireland. Up until the early 2000s, we were seeing a lot of pharmaceutical small molecule investment. But the last decade has really seen biologics take off. In the last 10 years in Ireland, we’ve seen an investment of more than $10 billion in biopharma facilities. Today, we have about 20 biologics manufacturing facilities dotted around the country. We are also seeing a lot of European supply chain operations. And more recently, we’ve attracted biopharma-specific services, including regulatory affairs, medical writing, pharmacovigilance, and pharmacoeconomics operations. 

Over the years, the biopharma industry has sold products using very large sales forces. But that’s starting to change as we see companies build more targeted teams around digital sales platforms, so they can obtain analytics data about a product to see how it is succeeding in the marketplace against the competition. 

PE: Is Brexit potentially a boost for the Irish pharma market? 

Fanning: It is potentially a boost in the context of foreign direct investment. As Ireland is English-speaking, we are very attractive, particularly for North American investment. Politically, it looks like there may be more of a protectionist environment in the future. As a result, North American companies will need to have a real footprint in Europe, and they can have that in Ireland. 

Moreover, as soon as Britain leaves the European Union, any European agency based in the UK will have to leave the country. And in that context, Ireland can support EMA. We believe that Ireland would be the best location for a seamless transition of that highly-respected agency. What’s most important for us as European citizens is that the agency continues to operate at a high level so that all countries in Europe continue to have access to the new life-saving medicines they

need for their citizens.

PE: Will Ireland make a serious bid to attract the EMA to the country? What are the benefits of the agency operating there? 

Fanning: Absolutely. Our regulator in Ireland, the Health Products Regulatory Authority (HPRA), works closely with EMA and the Medicines and Healthcare Products Regulatory Agency (MHRA), which is the British equivalent of HPRA. Our HPRA members already sit on a number of management working groups within EMA, and understand the needs and requirements of the agency. We have a very strong and professional regulatory environment in Ireland, due to the stringency of HPRA. So, there’s a regulatory culture and background already in place that would support EMA. And when EMA moves from London, some of the clinical and regulatory affairs staff of pharmaceutical companies may have to relocate as well.

There’s also a broader issue. EMA does not employ only scientifically-qualified staff. The agency also requires IT, business, and financial staff. In recent years, Ireland, notably Dublin, has become a multicultural and multilingual society. So there is access to a broad range of people and talent for EMA to choose from. Also in terms of travel, Dublin is easily accessible to the other major cities of Europe.  

PE: How might President Trump’s proposals to bring US pharma companies back to the US affect the set-up in Ireland? 

Fanning: There’s no doubt that the global drug discovery market would be quite different without the major US companies. Many of these same US companies have manufacturing and other operations in Ireland serving international markets. President Trump may be able to bring more of this manufacturing back on-shore, and support his own home market. But these same companies are still going to need an international base, such as in Ireland, to sell and distribute their drugs globally and get access to the international talent they need in order to service their global markets.

PE: What has Ireland been doing to advance investment in local pharma leadership talent? 

Fanning: IDA Ireland continuously updates the skill needs of various business sectors, including the biopharma sector. In August 2016, the Irish government published its most recent biopharma sector skills report, which detailed specific steps to take to support the biopharmaceutical companies with existing facilities in Ireland, as well as a pipeline of new investments. We are now implementing the recommendations of the report in conjunction with our universities and institutes of technology.  

Also, we have put in place job activation programs to make people job-ready. Many people with academic degrees have never seen the inside of a factory. These programs are short “boot camps” intended to make people job-ready and more productive and valuable to a company at an early stage. In this manner, companies can hire those job candidates who are best qualified.

PE: How is Ireland managing the development and registration of biosimilar drugs? 

Fanning: Our regulator, the HPRA, has responsibility for this, and will be taking its lead from EMA, which reviews and assesses applications from companies looking to market biological medicines for use in the EU, including biosimilars. The HPRA is ready to review biosimilar applications. While some have been approved, there has not been a large number of them yet.

PE: How are Irish drug companies poised with regards to developing and manufacturing more complex biologics? 

 Fanning: There have been a number of investments in this area in Ireland by major companies. One of the first large biologics plants was built in Ireland by Wyeth in 2005, which was acquired by Pfizer. Today, Pfizer has a workforce of more than 1,000 involved in the manufacture of biologics and vaccines. In 2016, Shire announced plans to expand its global biotechnology manufacturing capacity over the next four years by investing $400 million in Ireland. Shire is creating a new, state-of-the-art biologics manufacturing campus, which it expects will lead to the creation of approximately 400 permanent jobs in Ireland. A new investment at a more advanced stage of development is Bristol-Myers Squibb’s $900 million investment. The company is well advanced in recruiting its workforce.

These companies are establishing facilities in Ireland because they realize that the skills they need are here in Ireland. Our agency supports companies in process development, and some of the best global process engineers and technicians, who have experience needed to move drugs from clinical trials through to commercialization, can be found in Ireland. 

PE: What is Ireland doing to preserve the safety and integrity of the pharmaceutical supply chain? 

Fanning: To maintain the integrity of the pharmaceutical supply chain in Ireland, we need a highly regulated environment. We don’t want issues with the supply chain that might hold up product introductions. The HPRA and other elements of government are working to maintain the safety and integrity of the supply chain. Plants in Ireland are both EMA- and FDA-approved for drug substance and for API, and they supply other manufacturing plants globally for final fill finish of product. My agency, IDA Ireland, works on the constant transformation of these sites to make sure they are one step ahead in terms of technology and innovation. 

In addition, in 2011 the National Institute for Bioprocessing Research and Training opened its doors in Dublin. The Institute is a global center of excellence for training and research in bioprocessing. This biologics facility closely replicates a modern bioprocessing plant with state-of-the-art equipment. It’s a real boon to companies in terms of workforce training and trying out new technologies. The Institute trained more than 4,000 people last year, including some from companies not based in Ireland. That number continues to increase. 

PE: Can Ireland sustain more indigenous pharmaceutical growth alongside its efforts to provide a base for large multinational corporations? 

Fanning: Indigenous companies play an important role as manufacturing partners for the large multinationals in Ireland who may need additional capacity, particularly for small molecule drugs. This includes companies working in process development research, and others in the design and construction of new manufacturing facilities, which is an area Ireland now has a depth of expertise in. 

One piece missing in the puzzle is a biologics contract manufacturing organization. This is a real opportunity for a global contract development and manufacturing organization (CDMO), with such a cluster of their major clients in one location. GE Healthcare announced a proposed major investment in Ireland in 2016 in a new biopark concept, choosing  the city of Cork because there is a strong biopharma cluster there.

While there is some research and discovery work taking place in our universities, the transition to commercialization is difficult because of the costs involved. And we do not have a large venture capital community for life sciences in Ireland. Generally, if a small company develops what is considered a valuable product with potential, the company will likely be acquired. 

PE: Can you outline the major priorities and challenges for Ireland in the coming years to advance its position as a preferred location for biopharma research, manufacturing, and investment? 

Fanning: One of the key challenges globally involves finding the right talent for the job, and we have an excellent talent pool here. But we need to continue to develop that talent, and we must purpose it toward the life sciences sector, specifically biopharma. 

Also, Ireland wants to be at the forefront of what’s happening in the biopharma sector. The majority of biologics investment to date in Ireland has been in large stainless steel factories. The next generation of drugs will be manufactured using disposable technologies. We are seeing newer investments in this space. 

Another opportunity involves drug-device combinations-combination products. These are the “sweet spot” for Ireland because we have a large number of the world-leading medical device companies with operations here. They are collaborating with indigenous companies in terms of their next generation of intelligent products. Ireland continues to attract more of this business. 

In addition, regarding process development, commercialization, and the manufacture of products, we think there are opportunities to move into earlier clinical Phase III work, attracting companies involved in this area. We’d also like to attract companies involved in digital clinical trials, managing and running them in Ireland in collaboration with contract research organizations. 

Finally we believe Ireland is the ideal home for the EMA to allow it to seamlessly continue to do the excellent work it already undertakes in London on behalf of European citizens.  This is a priority for all of us. 

Joseph Constance is an independent writer and analyst based in New Jersey. He can be reached at jacpub@gmail.com