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Ireland is reaching a ‘Pentium chip’ moment as the future of medicine becomes all about precision. The nation is in the right place at the right time.
If you read the news today then you would have learned that MSD, known as Merck in the States, is to create 330 new jobs at its manufacturing plants in Cork and Carlow as part of a €280m investment.
What is also riveting about the announcement is that the Irish sites are responsible for more than 50pc of MSD’s top 20 products. These new responsibilities put Ireland at the cutting edge of developments in the areas of biologics.
‘We see a day where every individual suffering from disease will have molecular drivers of that disease clarified, and have new treatment doors opened up for them that [are] as unique as they are. In that regard, we are on the cusp of a Pentium-type era in life sciences’
– COLIN MAC HALE
The pharma industry in Ireland has come a long way since the 1990s when the industry was largely involved in processing, a rather unglamorous but essential part of the supply chain.
Since then, the myriad of operations of biotech giants – from MSD to GlaxoSmithKline, Eli Lilly, Johnson & Johnson, Regeneron, Allergan and others – are higher up the value chain and have more in common with the Google campus than the old smokestack past.
Ireland is the seventh-largest exporter of medicinal products in the world
The latest numbers available from IDA Ireland indicate that there are now more than 120 biopharmaceutical operations in the country, out of which 40 are approved by the FDA to produce goods for the pivotal US market.
There are 29,000 people directly employed in the biopharma FDI sector alone, and nine out of the top 10 biopharma giants in the world are manufacturing in Ireland.
‘In the last 10 years, there has been a significant ramp-up in large molecule, biologics and manufacturing throughout Ireland’
– TOMMY FANNING
In 2015, the biopharma sector recorded €39bn worth of exports, and it contributes more than €1bn in corporation tax to the Irish exchequer annually.
According to IDA Ireland’s head of biopharmaceuticals and food division, Tommy Fanning, Ireland is the seventh-largest exporter of medicinal and pharmaceutical products in the world.
“In the last 10 years, there has been a significant ramp-up in large molecule, biologics and manufacturing throughout Ireland, adding to our substantial traditional manufacturing base in small molecule active pharmaceutical ingredient (API) and oral solid dose (OSD).
“Over €10bn in new investment has been committed in the last decade for new biotech manufacturing facilities in both drug substance (Alexion, Pfizer, Regeneron, Lilly, J&J, BMS and BioMarin) and drug product (Sanofi-Genzyme, Jazz Pharmaceuticals, Amgen and MSD).
“Our existing clients have continued to invest and have been joined by an exciting new group of high-growth companies.”
Fanning said that an exemplary compliance record, strong Government support for R&D and zero-defect biopharma manufacturing excellence have driven this wave of investment in new biotech facilities.
“Irish plants are regularly seen as global manufacturing sites, with FDA approvals in addition to European manufacturing licenses.
“The Irish Government is committed to continuing to invest in our education, research and broader ecosystem to ensure that Ireland remains the competitive location of choice for new biotech manufacturing operations.
“We have established the National Institute for Bioprocessing Research and Training (NIBRT), which, with its pilot-scale biotech manufacturing equipment, serves as a ‘flight simulator’ for biotech manufacturing. NIBRT is now working with world-leading companies, providing detailed and significant training as well as growing its investment in process research.”
According to Fanning, the original background in process engineering, the history in food processing and the quality of the education system gives Ireland a strong advantage when high-level skills are a priority.
“A key target is to grow out the sub-supply base, both in terms of manufacture and services. Ireland has attracted a number of the global CRO (clinical research organisations) companies, including Quintiles, PPD, Parexel and Icon, using Ireland as a base to support their international activities,” Fanning said.
Clinical trials environment is key
When it comes to discovery and clinical trials, the Irish Pharmaceutical Healthcare Association (IPHA) interfaces with both the pharma industry and health services in Ireland to increase clinical trials and boost discovery.
IPHA CEO Oliver McCarthy believes that Ireland’s ability to facilitate discovery and clinical research is an asset, but we need to move faster in terms of adoption of proven drugs by our health services.
‘We think Ireland can do well as a promoter, developer and adopter of innovation across the value chain’
– OLIVER MCCARTHY
“We represent the research-based pharma industry that is producing and researching and offering new medicines based on research. We work with over 47 companies here in Ireland, including 39 that are involved in making prescription drugs.
“In the value chain of biopharma, we would be involved in advocating for policies and improvements in the areas of discovery and adoption, [to] improve access to medicines in Ireland through clinical trials and research.”
McCarthy said that a welcome development has been the establishment of the Health Research Board’s Clinical Research Coordination Ireland (CRCI) network of clinical research hubs.
McCarthy said this is essential to the successful conduct of world-class, patient-focused research.
“We have seen the intensity of clinical trials increase in the last few years and the CRCI is definitely helping in this regard.
“It is a crucial part of the ecosystem and how we position Ireland as an innovation island. When companies look at Ireland, they often see the return on investment, the corporation tax and, of course, the people.
“But I think companies in this space also like to know that this is an environment where the innovation they are interested in capturing – from a discovery and translational research aspect – is being adopted too, and that there is an openness in the value chain for adoption of these companies’ medicines in our health services.”
McCarthy said companies that invest increasingly look at this kind of environment and assess the whole innovation ecosystem. “There is room to improve. We are not satisfied that it is as good as it should be and we are calling on State authorities to improve the efficiency of processes to get faster results.”
He said Ireland currently ranks 16th out of 26 countries in terms of the number of medicines approved for use in health services. “That’s not the best and we want to improve.
“We have a fantastic base here. We think Ireland can do well as a promoter, developer and adopter of innovation across the value chain. That’s our ambition to encourage policymakers to speed up adoption.”
Capturing the next wave
Matt Moran, director of BioPharmachem Ireland (the Ibec body that represents the industry) said that nevertheless, the industry’s shift in Ireland from being a process-based part of the supply chain to being at the pinnacle of product development is no mean feat.
“For a long time, the industry went through a patent-cliff period where things slowed down. But Ireland has caught the new wave of capital investment in new molecule and biotech. In a single decade, anything up to €10bn in capital investment has been announced. New and existing companies are investing – companies like BMS, Lilly and Mallinckrodt – and are driving a significant expansion of the sector.
‘It’s a good time in the industry. Its agility and responsiveness, reputation for high standards and compliance makes it a magnet for further investment’
– MATT MORAN
“It used to be just process and product, but you are also seeing shared services roles, and most are tacking on R&D to what was traditionally a manufacturing hub.”
Just like the digital sectors, Moran warns that finding people is difficult. “Talent is a challenge. Competitiveness is a challenge. The main problem is getting enough people to work in an expanding sector. It is an opportunity as well as a challenge, and we need more people coming out of college with STEM degrees.
“The work that needs to be done in promoting the industry is enormous and we are working with the Institute of Technology, for example, to create apprenticeship model for people with non-traditional skills to be trained to work in the sector.”
Moran said the infrastructural supports that have grown in recent years have been substantial, from the creation of NIBRT to the SSPC (Solid State Pharmaceutical Cluster), one of the Science Foundation Ireland Centres for Science, Engineering and Technology.
“You are seeing infrastructure growing up around the industry, resulting in a more integrated life sciences cluster. The key has been a supportive and responsive government that gets it.
“Overall, the industry has never been stronger. It’s a good time in the industry. Its agility and responsiveness, reputation for high standards and compliance makes it a magnet for further investment.
“What we are seeing is a shift from small molecule manufacturing to large molecule manufacturing, and BMS, Alexion, Regeneron and Pfizer are all hiring people.”
I put it to Moran that, as traditional pharma companies downsize, can’t the skills be shifted to the newer operations? “That’s the beauty of the sector. There is a lot of mobility in the sector if you have chemical engineering skills and qualifications, and that’s where NIBRT also comes in very useful in terms of training and upskilling.”
But, ultimately, Moran warns, the difficulty is encouraging parents and new generations of schoolkids to foster a love of science and consider rewarding careers in an industry that keeps giving. “It’s a constant challenge. That’s why we hope our BioPharma Ambition event at Dublin Castle in February will help raise the profile of the industry.
“The industry has a job of outreach to do. When you bring people to these facilities, they get it and their eyes light up. Also, the rise of entrepreneurs like Nora Khaldi of Nuritas, and Mark Barrett and Brian Glennon of APC, will help shine a light on the cluster,” said Moran.
A Pentium moment for pharma
As well as the rise of life sciences entrepreneurs, the opportunity for greater cross-pollination between the pharma and the technology industries is ripe for exploration, explained Colin Mac Hale, industry director (EMEA) for health and life sciences at Intel.
“Technology has redefined what is possible for life as we know it. The $2.7bn, 10-year international research effort to map all of the genes of our species that [was] completed in 2003, referred to as the ‘Human Genome Project’, will be viewed by historians as one of the most important medical research projects ever.
‘It’s an understatement to say that the life sciences industry is in the middle of the most dramatic transformation it has ever seen’
– COLIN MAC HALE
“10 years after that historic milestone, the industry became capable of building high-volume genome sequencing instruments that could sequence 18,000 human genomes per year, breaking the ‘$1,000 genome in one day’ barrier. This opened the door to population studies and clinical usage models that had not been possible before. Soon, we will be at the cusp of the $100 genome, where doctors will be able to unravel the DNA of a patient’s entire genome in an hour, opening the door to routine personalised diagnosis and treatment plans. This will transform our understanding of disease detection and prevention.
“Technology is underpinning all of this. It’s an understatement to say that the life sciences industry is in the middle of the most dramatic transformation it has ever seen. This is one of the most striking examples of Moore’s Law in action. Moore’s Law democratises computing. It’s a pretty powerful law of economics. It says that by advancing semiconductor manufacturing capability at a regular cadence, we can bring down the cost of any business model that relies on computing.
“Genomics data is the biggest of big data, and high-volume genome sequencing generates an enormous amount of it. That data needs to be analysed as fast as it is produced. Intel has teamed up with leaders in the life sciences industry to bring to market fast, scalable and affordable analytics solutions that have freed genomic data to be widely accessible for research around the world.”
Mac Hale cited the collaboration between Qiagen Bioinformatics and Intel to create a platform that could enable the full analysis of human genomes for as little as $22 each.
Qiagen’s Clinical Insight (QCI) platform was used by Rigshospitalet, one of Denmark’s largest and most specialised hospitals, to implement a precision medicine capability for more than 700 advanced cancer patients. Using actionable insights delivered by the QCI platform, doctors found clinically actionable onco-driver mutations and therapies in 40pc of those patients. More than half of those patients were able to enrol in clinical trials to receive drug therapies targeted at their genetic profile.
Mac Hale said that just like the moment when the Pentium processor made the PC mainstream, advances in precision medicine, genome sequencing and biologics are changing the game in areas such as oncology, paediatrics, pharmacogenomics and reproductive health.
And Ireland is in the right place at the right time.
“Our goal is to make healthcare a lot more precise for every individual that healthcare delivery organisations care for. We see a day where every individual suffering from disease will have molecular drivers of that disease clarified, and have new treatment doors opened up for them that [are] as unique as they are. In that regard, we are on the cusp of a Pentium-type era in life sciences.”
