Life Sciences - Q1 2020

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BERNARD MALLEE, IPHA Call for closer collaboration » p2

JOHN O’BRIEN, IRISH MEDTECH ASSOCIATION “Serious gap in the Irish innovation ecosystem” » p4

JOHN MILNE, NIBRT Biopharmaceutical industry is a complex arena for taining staff » p6

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Synthesised Nanoflowers The EDX image shows a cobalt phosphate microstructure; the nanoflakes grew outward in different directions, synthesised via a simple hydrothermal method. It forms a flower-like microstructure, which helps to enhance energy storage performance which can be employed in next-generation artificial cardiac pacemakers as a rechargeable energy source that will last for more than 15 years. © HAN SHAO

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Industry and policy leaders can share a stage for medicines’ innovation The biopharmaceutical industry is among Ireland’s most significant investors, accounting for 62% of Ireland’s goods exports. We have a large biopharmaceutical manufacturing presence, relative to other big sectors and to other similar-sized countries. Our scientists are contributing to global efforts to find treatments and cures for serious diseases - including for the COVID-19 pandemic.

Industry and the state None of Ireland’s prog ress in medicines innovation can be taken for granted. Product life cycles, industry consolidation patterns, the draw of emerging markets, skills readiness and slow speeds of adoption of new medicines in the health services are creating headwinds that could decelerate the pace at which the industry scales into the future in Ireland.

The response is to plan, together.

Closer col laboration bet ween industry and the State on the operating environment for medicine innovation and investments is the way forward. This happens in other countries in Europe, and it should happen here, too.

When we examine the response to COV ID -19, it is clea r t hat partnership between industry and policy leaders works. It is helping to fast-track collaborative research for a treatment or vaccine, assure patients that the supply chain is robust enough to cope with system shock s a nd rem i nd ever yone how important is continuous manufacturing in securing the global medicines pipeline.

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Cell and gene therapy In identifying new opportunities for Ireland, we must heed global industry trends. One of the most important of these is the sharp growth in cell and gene therapies (CGTs). Cell therapies can treat potentially fatal blood cancers by reinfusing patients with their own engineered immune cells to tackle the illness. In the longer run, companies will likely target more challenging solid tumours.

When we examine the response to COVID-19, it is clear that partnership between industry and policy leaders works.

At the same time, scientists are making progress on gene therapy by replacing faulty DNA to cure genetic diseases. Extraordinary clinical results in recent years have led to an explosion in the number of

new companies developing CGTs. Major investments will be needed to create CGT manufacturing capacity and capability at sites in Ireland. We will need to meet training and skills needs linked to manufacturing this new wave of medical therapies.

If we move quickly, Ireland can build on our reputation as a global leader in biologics manufacturing to become a leading European destination for CGT production.

‘BioPharma Ireland’ The industr y, through events like the recent BioPharma Policy Forum and BioPharma Ambition 2020, is working closely with policymakers on a shared vision for biopharmaceutical innovation. The upside for Ireland is clear - gains clinically, economically and socially by making the most of medicines innovation and investments.

The industry has called for a strateg y for the development, production and provision of 21st century medicines. It should be clear about Ireland’s potential in emerging areas like CGTs, Industry 4.0, immunotherapies and genomics.

BERNARD MALLEE Director of Communications and Advocacy, Irish Pharmaceutical Healthcare Association

It should ensure that we have the best operating environment for medicines’ innovation, including the availability of the right skills and talent, tax policies that catalyse research and development and draw new investments, a robust intellectual property regime, and a reformed approval and funding mechanism that makes us as fast a s o t h e r western European c ou nt r ie s in adopting new medicines in t he hea lt h services.

The beneficiaries will be people, communities and science.

That is what we call ‘innovating for life’; our industry’s rallying call to everyone with a stake in healthcare innovation to work in common purpose.

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Collaboration Ireland must continue to pursue excellence in m a nu fac t u r i n g a nd research, adapt public policy to the promise of science, and ensure standards of care are raised through the av a i labi l it y of new medicines to pat ient s and their doctors. All of this will require intense collaboration.

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Leaning into social distancing Ireland’s life sciences scene is booming, but the COVID-19 outbreak presents difficulties that test the industry’s ability for smart working.

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he pharmaceutical industry in Ireland has seen several large-scale acquisitions over the last decade, resulting i n con siderable cha nges a nd restructuring. Roles have evolved, i nd iv idu a l s ’ re s p on s i bi l it ie s have changed and demands on time, skills and capabilities have continued to grow. Companies need highly skilled, knowledgeable professiona l s to develop a nd manufacture new therapies along with an education system that recognises and delivers graduates with the skills that are required.

While t he sector continues to research and innovate there is an ongoing concern for the pharmaceutical industry around market access and reimbursement for new innovative medicines and the length of time it can take for new treatments to reach Irish patients.

Of course, the greatest risk facing not just the pharma industry, but the entire world right now is COVID-19. Our members and their colleagues in the industry are working closely to support the HSE healthcare professionals

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and patients throughout this challenging time.

As a result, a need has arisen for smart, flexible and remote working a r r a n g e m e nt s , e n c o u r a g i n g diverse thinking, participating in professional bodies and remaining connected while being physically d i s t a nt . S m a r t work i n g h a s to increase; now is the time to embrace it and empower our staff.

What is ‘smart working’?

Smart working is distinct from simply working remotely or working from home. It includes working from a flexible location, greater autonomy around work schedules and when hours are worked. It has been recognised that employees who feel more in control of the variables in their working world are much more likely to have a greater commitment to their role, which in turn benefits their company.

By giving employees tools needed to choose when, where and how they do their jobs, it contributes to a more even work-life balance, improves staff satisfaction, which in turn, aides retention. Over the coming weeks, communications

will be transformed, relying much less on face-to-face meetings and instead creating novel ways to connect and develop connections with colleagues both in Ireland and around the world.

The key to success will be in creating a virtual environment t hat bot h facilitates and encourages two-way conversation.

A n env iron ment t hat has an emphasis on creating space for people to have their voices heard and valued will be critical.

What challenges will we need to navigate?

We will need to enable, engage and reward people in innovative ways.

We’re in the middle of a rapidly changing situation, with social interaction curtailed. There’s a requirement for organisations to empower their staff efficiently, keeping them engaged, inspired and continually learning.

Reach out, lean in Wh i le so c ia l d i s t a nc i ng a nd isolation are, in effect, an attempt to halt the spread of this virus, there are things everyone can do to

FIONA DUNPHY Commercial Manager, The Pharmaceutical Managers’ Institute

reduce the downsides. While live, face-to-face connection is best, it’s often not an option at the moment.

So simply call people – a phone call is better than a text or email, and a video chat is better than a phone call. Use the time to learn a new skill, deepen your knowledge and build up your connections.

There are plenty of opportunities in professional communities to stay connected and continue to learn, connect and grow; don’t be afraid to reach out! We are better together and will get through this difficult time together even while physically apart.

More info The Pharmaceutical Managers’ Institute supports our members through the pillars of Learn, Connect and Grow, which contributes to having highly skilled and highly networked people across the wider industry.

The PMI represents over 80 companies involved in different areas across the life sciences industry: commercial organisations, supply chain companies, market access and a broad range of companies that supply services to the sector. www.thepmi.com

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Supply chain solutions and how they can help ADAM O’SULLIVAN Head of Pharmaceutical and Healthcare, Kuehne + Nagel Ireland

The life science industry’s rapid development requires future planning from companies involved in logistics and storage to ensure Ireland can stay ahead of the competition.

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he s en s it ive n at u re of pharmaceutical and healthcare products within the life science industry can create complex logistical challenges.

The importance of meeting supply chain needs Global life science companies located in Ireland need to carefully consider their supply chain solutions to ensure seam less access to international markets.

The supply chain can span across several stages, multiple locations, have many individuals involved, and extend across weeks of time.

Life science companies’ increased reliance on a global network of suppliers, coupled with evolving pat ient dema nds, add to t he complexity.

Therefore, it is crucial to first understand the end-to-end supply chain needs, from supplier to patient, and then design a solution to meet those needs.

Understanding supply chain needs It is important for any logistic c omp a n ie s op erat i n g i n l i fe sciences to ease the burden of this responsibility from their clients by focusing on meeting the rigorous compliance standards across all four modes of transport (air, sea, road, and contract logistics).

How companies can keep up In 2018, an investment in global solut ion development was undertaken to support this notion.

This investment resulted in 230 Goods Distribution Practices global operations that provide consistent pharmaceutical and healthcare grade services to reach over 95-97% of the globe and keep up with the sophisticated supply chain demands of the industry.

Par tnering w it h a log istics company that benefits from this global solution may help supply chain companies keep up with complex regulations.

The digital landscape of supply chain design has always played an important role in ensuring companies remain competitive.

Investing in information sharing software - connecting all supply chain stakeholders from suppliers

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to partners - to enable data sharing, can unlock value in the supply chain as a source of differentiation.

Ways in which companies can plan for the future Operations that follow Global Goods Dist r ibut ion P rac t ices offer securit y, reliabilit y and expertise through features such as temperature validation, dedicated storage facilities, high security, and real-time tracking information.

It is crucial to partner with a supply chain prov ider who understands the industry and offers value to life science companies navigating their way through everchanging environments.

Kuehne + Nagel Kuehne + Nagel is one of the world’s leading logistics companies, who funded the GxP solution in 2018 to expand their offering for their clients.

Their KN PharmaChain service includes features such as dedicated ‘Care Teams’ across the globe who actively monitor the status of shipments 24/7, and a mobile app called myKN which allows customers full control from booking to delivery.

Next Government must invest in innovation and ensure patient access to Medtech JOHN O’BRIEN Chair, Irish Medtech Association and CEO, S3 Connected Health

Ireland is one of the top locations for medtech FDI investment in Europe and is, per capita, the greatest employer of medtech professionals in Europe.

The impacts of the changing EU regulations Acting Irish Medtech Association Director, Nessa Fennelly, warns that changes in EU regulations could jeopardise this. “A high bar is set for manufacturers to demon s t rate s a fet y, ef f ic ac y and clinical benefit for medtech products to get to market. This is strengthened under the EU Medical Devices Regulation. However, over the past two and a half years, while industry has been preparing for the biggest regulatory change in over two decades, policymakers have failed to ensure that the regulatory system is ready for tens of thousands of life transforming technologies to transition under the 26 May deadline.”

Fennelly adds: “ The EU has historically been a location of choice for the launch of innovative m e d ic a l t e c h n o l o g ie s , w it h Ireland being chosen by many FDI multinationals as a gateway to the EU’s €115 billion market. Now, a lack of predictability under the EU regulations and increasingly favourable regulatory regimes in other markets, such as the United States, is undermining this position.

NESSA FENNELLY Acting Director, Irish Medtech Association “The Irish Medtech Association is calling on the next government to work with the EU to conduct a ‘readiness check’ to identify and prioritise the main implementation c h a l l e n g e s . A d d i t i o n a l l y, policymakers must work with the EU to maintain access to life transforming medical devices certified in the UK and avoid regulatory divergence after Brexit.”

A high bar is set for manufacturers to demonstrate safety, efficacy and clinical benefit for medtech products to get to market.

The Government’s impact on the future of manufacturing “Manufacturing is a vital part of the Irish economy, with major clusters in Galway, Limerick, C o r k , Wa t e r fo r d , S l i g o a n d Dublin. But, as we plan for the future, there is a serious gap in the Irish innovation ecosystem, which the government must address.

We are calling on the government

to i nve s t a mbit iou sly i n a n advanced, discrete manufacturing centre by adding €30 million to the IDA-led centre, with a wel l- coord i nated gover na nce structure that includes industry, to help compa n ies t a ke new technologies from proof of concept to c om merc i a l i s at ion,” s ay s Joh n O ’ B r ie n , C h a i r o f t h e Irish Medtech Association and S3 Connected Health CEO. “For Irish manufacturers to compete, they need to embrace new technologies such as AI, data analytics and 3D printing. They must also provide access for professionals to these technologies to ensure that they are equipped to embrace industry 4.0. To help Irish people prepare for the jobs of the future, the government must foster lifelong learning by continuing to support the Irish Medtech Skillnet and ensuring the sustainability of the new manufacturing apprenticeships.”

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Kuehne + Nagel Ireland have gone one step further, offering a way to mitigate the risks of temperature deviation through a pragmatic riskassessment tool that analyses all routes to market. The company’s recent acquisition of Quick International has extended value to customers in the areas of clinical trials and cell gene therapy by ensuring product quality to the last-mile delivery.

Sponsored by

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The continual growth of Ireland’s biopharma and chemical sectors

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n its 25 years of existence, B ioPh a r m aC hem I rel a nd has seen its membersh ip g row and d iversif y; from b ei n g pre dom i n a nt ly ac t ive pha r maceut ica l i ng red ient ma nu fac t u rers to now bei ng inclusive of biotech and biotech manufacturing, dr ug product formulation and specialist services, as well as chemical manufacturing.

This growth and diversification across Ireland are t he result of i nter nat iona l i nvest ment, cross fertilisation of skills and manufacturing excellence. But these are just a few contributing factors.

The industry has been growing steadily, with one billion euros being invested in the industry, every year, over the last decade.

However, we cannot rest on our laurels or be complacent – the world continues to change, and we need to keep pace with this change.

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COVID-19 is causing businesses to adapt This is especially true during the current pandemic, whereby business continuity is paramount. Businesses have shown extraordinary mobilisation in the way they have responded to the COVID-19 outbreak with many organisations having to shift to remote working. However, we must keep essential supply chains, manufacturing and people serving critical business alive, for it is only through this that we can ensure the sustainability of our public health, society and economy.

Biopharma and Industry 4.0 Ireland has seen major investments in biopharma with 10 of the top 10 biopharma companies having international operations in Ireland.

There are many reasons Ireland has been so successful in attracting foreign investment and operations

MATT MORAN Director, BioPharmaChem Ireland

from global corporations, one of which is the cutting-edge research and innovation.

Biopharma 4.0 (echoing Industry 4.0) heralds the onset of digitisation a nd emergence of d isr upt ive technologies. Companies need to understand and implement concepts and technologies around AI, continuous manufacturing, data analytics and 3D printing. By embracing these developments, we can continue to protect our competitiveness and to try to ensure that the prevailing business environment is supportive.

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Addressing the biomanufacturing skills needs in Ireland JOHN MILNE Training Director, National Institute for Bioprocessing Research & Training

A successful biopharmaceutical industry relies heavily on a skilled workforce, and a good training programme is key to developing future talent.

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reland has had tremendous s uc c e s s i n re c ent ye a r s, i n bu i ld i ng a h ig h lysuccessful biopharmaceutical industry, due largely to its ability to provide complex operations with vital technical talent.

A s t he biopha r maceut ic a l industry matures, particularly in the area of emerging advanced therapies, Ireland is increasingly being looked at for potential investment opportunities.

En su r i ng t he i ndust r y ca n continue to hire such talent will be a key determining factor in securing these investments for the country in the future.

The need for training programmes D e s pite a p erc eive d l ac k of talent available to fulfil certain job types within the industry, such as commissioning and validation, several solutions are already in place to address this need.

W h i l e c o m p a n i e s c a n l o o k to the market to fulfil some of their immediate hiring needs, training programmes that encourage the development of future talent, and that can upskill and cross-skill individuals from other closely aligned industries, are becoming more important and relevant.

Methods for training in the biopharmaceutical industry A s the biopharmaceutical industry is a highly regulated env iron ment, t ra in ing to perform ‘work’ requires a different paradigm and mentality than simply training to ensure compliance.

Training individuals to work in this complex arena typically involves trainees developing their skills using competency based learning solutions. Here, trainees fully participate and engage in practical sessions that will encourage and facilitate active learning.

Training programmes that encourage the development of future talent, and that can upskill and cross-skill individuals from other closely aligned industries, are becoming more important and relevant.

One of the ways this can be achieved is through presenting t r o u b l e s h o o t i n g s c e n a r i o s where t r a i ne e s c a n develop critical learning skills, in real life scenarios that are necessary for success in the industry.

Aristotle’s maxim, from nearly two thousand years ago, “for the things we have to learn before we can do them, we learn by doing them,” still rings true for the biopharmaceutical industry.

Collaboration is the key to success Ireland continues to display great potential to further develop its pre sence i n what i s a t r u ly exciting and changing global biopharmaceutical industry.

Central to this is workforce readiness and key talent d e v e l o p m e n t p r o g r a m m e s .

Further collaboration to address t he s k i l l s a g e n d a , b e t we e n government agencies, industry and academia, will undoubtedly equate with future success.

Customising training programmes The Nat iona l In st it ute for Biopro c e s s i n g Re s e a rch a nd Training (NIBRT) provides a wide training por tfolio to suppor t both the academic sector, where h i g her e duc at ion i n s t it ute s are tasked with educating and supplying the workforce of the f ut u re, a nd i ndu s t r y, where

customised training content is designed to meet specific learning outcomes of trainees.

Courses range from introductory elea r n i ng content hosted on N I B R T ’s r e c e n t l y l a u n c h e d online academy (NOA) that can provide ‘just in time’ learning, to specific short courses focusing on important aspects of the industry and offering opportunities for skills development.

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At Life Science Recruitment, we pride ourselves on the technical & academic expertise of our team who over a decade have built long-lasting relationships within the Life Science industry.

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Life sciences in Ireland is going from strength to strength Ireland is a global life sciences hub and the gateway to the European single market for many pharmaceutical companies. Never has this title and premise been so important than in the face of COVID-19.

Tackling COVID-19 In both keeping our hospitals and pharmacies functioning, and playing their part in the global supply chain, pharmaceutical companies are also working at pace to find a vaccine to rid the world of this highly contagious virus that has caused countless deaths, put our most precious in society in danger and changed the way in which we live.

What we do know is that even if a vaccine is proved safe and effective it may not be on the market for another year.

Ireland is well positioned in bringing a vaccine to fruition.

Big pharmaceuticals here have a proven track record in vaccine production.

Air cargo is vital to the life sciences industry, and with the constriction of passenger flights at this time we will need, as a nation, to think creatively in order to ensure this sector continues to be able to function and to get vital items both on and off Ireland.

Keeping life sciences in Ireland The sector, across medical devices, pharmaceuticals and biopharmaceuticals directly employs over 50,000 people in Ireland. Six of the top seven diagnostics companies operate here. This has built up a worldwide recognition that Ireland is the global centre for life sciences.

However, we do have challenges.

Recent soundbites from the US

indicate that leaders may want the production of pharmaceuticals and medical devices to be brought back to their shores.

Ireland is a major exporter of pharmaceutical and medical goods to the US, exporting €48.2bn

Recent soundbites from the US indicate that leaders may want the production of pharmaceuticals and medical devices to be brought back to their shores.

SIMON MCKEEVER Chief Executive, Irish Exporters Association

worth of pharmaceuticals last year, which accounts for 31% of Ireland’s total exports, most of which went to the US. However, overall, it accounts for a small share of the US’ total life sciences market.

Ireland’s talented workforce is a major draw for the industry I am confident that life sciences companies, that rely and believe in Ireland’s highly talented and skilled workforce, will not give up their European base easily.

Ireland’s workforce is a huge draw and strong attribute to set up operations here.

Third level education in life sciences is rising to meet the dem a nd s of t he s e c tor w it h

considerable expansions in many universities and institutes across the country. Ireland prides itself on its place as a global life sciences hub and will continue to attract companies in this space to set up and grow their operations within the European Union.

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Precision medicine will lead to improved outcomes for patients

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hrough significant i mprovement s i n t he treatment and prevention of diseases, we are now living longer. The average life expectancy in Ireland is currently 84 years for women and 80.4 years for men. Historically, most treatment options fall into a onesize-fit-all approach but, increasingly, evidence from research is demonstrating that by taking a more ‘personalised’ approach to the treatment and prevention of diseases, we will improve patient outcomes as well as reduce costs.

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Through advanced research, we can now begin to consider individual variability in genes, environment and lifestyle factors, along with the unique pathways of diseases or treatment response of individual patients. Increasingly, doctors are focused on developing personalised treatment programmes that are tailored to patients based on their individual needs.

Can cross sector collaboration carry us to the cure for cancer?

In Ireland, for example, more than

40,000 people are diagnosed with cancer each year, but outcomes for patients are improving. Recently, S c ie nc e F o u nd at ion I re l a nd supported the establishment of the Precision Oncology Ireland Consortium led by researchers in UCD. The consortium involves five Irish universities, six Irish cancer research charities and 10 companies all collaborating to take on the challenge of tailoring cancer treatments to individual patients based on their unique cancer. It is this type of collaboration that will keep Ireland at the forefront

PROFESSOR MARK FERGUSON Director General, Science Foundation Ireland and Chief Scientific Adviser to the Government of Ireland of discovery and ensure better outcomes for patients.

The a i m of t h i s r e s e a r c h consortium is to bring experimental a nd computat iona l adva nces t o g e t h e r t o d e ve l o p b e t t e r diagnostics (based on personal molecular markers), personalised cancer therapies and to accelerate c a n c e r d r u g d i s c o ve r y a n d development. The programme will also provide key infrastructural supports to researchers, co-ordinating access to tumour biobanks, and allowing access to state-of-the-art technologies.

Ireland has unique and worldleading expertise in precision oncology. This transformative collaborative research programme will harness that expertise to enable real progress in personalised medicine for cancer patients, allowing us to take a leadership position in this important area of healthcare.

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