Life Sciences - Q1 - Mar 2019 by Mediaplanet UK&IE

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HEALTH INNOVATION HUB IRELAND Ireland is ideally placed to be a world leader in the provision of total connected health solutions. » ONLINE

MATT MORAN Biopharma requires qualification, aptitude and experience. » p4

CONOR HANLEY Ireland is home to nine of the world’s top ten medtech companies. » p4

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CREDIT: DR ANTHONY MAHER

Former SFI Research Image of the year Most of the medicines people consume are made up of compacted powders - the individual particles are in fact tiny crystals of the active compound, known as polymorphs. ‘Starship Enterprise’, is an Optical Micrograph image that shows a Form II piracetam crystal (rough, dissolving) undergoing a polymorphic transformation to a more stable Form III crystal (smooth, defined faces) in methanol at 25°C.

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Ireland must make bio-innovation count by investing in tomorrow’s cures Ireland is a place where innovation thrives and foreign direct investment finds a home. Thirty years ago, just 5,200 worked in an industry characterised by basic manufacturing. Now, the originator pharmaceutical companies directly employ 30,000 people, working on complex biologics manufacturing and the discovery of tomorrow’s cures.

e are part of a globally networked system of innovation. All the top 10 global pharmaceutical companies operate in Ireland the likes of GSK, Pfizer, AbbVie, Novartis, MSD and many more. They are part of Ireland’s enterprise ecosystem, with a huge impact in societal, economic and human health terms. Over the past 10 years, the originator pharmaceutical industry has invested close to €10 billion in manufacturing and research sites around the country. That represents close to the biggest wave of investment in new biotechnology facilities anywhere in the world. Between 2003 and 2018, the number of biotechnology manufacturing sites jumped from two to twenty. These numbers are impressive - but they are no cause for complacency. Ireland must continue to pursue excellence in manufacturing and research, and adapt public policy to the promise of innovation in new medicines.

If we do that, our industry will remain a reliable source of highquality, well-paid jobs well into the future. Investing smartly to meet the needs of our ageing population As Ireland’s population ages and medical conditions grow more complex, healthcare will come under increasing pressure to deliver the same, or better, services. The task will be to invest smartly. How we plan for the adoption of bio-technology innovation into the health services must be coordinated centrally by the State. For that reason, we have called for the appointment of a Chief Innovation Officer at the Department of Health. Ireland must be quicker at ensuring access to new medicines Through innovation, we can develop therapies that, in the long run, will save the system money by reducing hospital stays. In the

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Over the past 10 years, the originator pharmaceutical industry has invested close to €10 billion in manufacturing and research sites around the country. That represents close to the biggest wave of investment in new biotechnology facilities anywhere in the world. short term, these new medicines – if they are made available efficiently to patients – will change people’s lives for the better. But, as things stand, Ireland is an outlier in Western Europe when it comes to the speed of availability of innovative medicines for patients. Our ‘Manifesto for Better Health’ makes the case for a better environment for reimbursement and innovation. Ireland should be in the top seven countries in the EU-28 for speed of access to new medicines. Instead, it is among the slowest. This is an urgent challenge.

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

Vaccines save 2.5 million children a year Scientific advancements mean that we know more about illness than ever before. This knowledge is being translated into new ways of treating common conditions. Medical progress has led to a dramatic decline in death rates for diseases such as cancer, HIV, polio and measles. Hepatitis C has virtually been cured by innovative medicines. Today, if diagnosed early, leukaemia can be driven into remission with a once-daily treatment. Vaccines have rid the world of smallpox, driven polio to the brink of eradication, and virtually eliminated measles, diphtheria and rubella in many parts of the world. Vaccines save the lives of over 2.5 million children every year. This is the dividend of innovation. Transforming patient care Promising medicines in development have the potential to transform care, helping patients

live longer and with a better quality of life. In some cases, medicines could prevent further illness, reduce the need for other treatments or even offer a cure. To capture the value of innovation, we need better outcomes data. The structuring and use of data are among the most promising projects for the future of medical progress. Irish hospitals and healthcare professionals hold a huge volume of historical data. This data, properly mined and applied, could lead to the development of a predictive and preventative approach to medicine. An exciting global wave of medical innovation is breaking around the world. Ireland should be ready to catch it. With the right policy moves matched to industry pioneers, we can have a leadership role in powering patient care through innovation.

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Image: Irish Medtech Association Vice Chair and S3 Connected Health CEO John O’Brien; Irish Medtech Association Director Sinead Keogh and; Irish Medtech Association Chair and FIRE1 CEO Conor Hanley

Ireland targets connected health market worth €15.5bn by 2024

This year, the Irish Medtech Association is putting a spotlight on our innovative start-up community, which continues to attract international attention, and strategic growth markets like connected health, which is expected to be worth an estimated €15.5 billion in sales by 2024.

reland is home to nine of the world’s top 10 medtech companies and a strategic base for the European market, worth €110 billion. The group now wants to make Ireland an international leader in innovative, patient-centred medtech products and and is a strategic to tackle changing health needs. Healthcare spending in the Organisation for Economic Cooperation and Development (OECD) grew an estimated 2.5% in 2017. That year saw an increased demand for services with ageing populations and the rise of chronic diseases. Hospitals account for 40% of health spending. Connected health is a way to support better care pathways and empowered patients as well as tackle rising costs. Leading a healthcare revolution As we look to the future, we need to help small companies make it big, with medtech start-ups fuelling innovation and the burgeoning connected health scene in Ireland ready to start a healthcare revolution. Ireland is uniquely placed to become a global leader in this exciting space. Not only are we home to top medtech companies, 10 of the world’s top 10 biopharma and ICT companies also have a base here. Helping small companies make it big My top priority for this year is to drive policies and conditions to ensure entrepreneurship can thrive with as many as four out of five medtech businesses here being either start-ups or SMEs, with these businesses acting as the lifeblood of medtech innovation. Globally, the top 30 medtech companies dominate the medtech market, accounting for 64% of the market with €226 billion in sales. To make Ireland one of the top 10 start-up communities in the world, we’re urging the government to focus on three key areas: create a supportive tax environment, promote better funding avenues, and help develop research talent. Priorities for growth Ireland is one of the best places in the world to do business, with a strong and stable business environment along with a rich pool of talent underpinned by dynamic programmes, like Skillsnet. Now, we must do more to nurture entrepreneurship. We must work with the government to make our capital gains tax more competitive to help entrepreneurs take risks to succeed. We must Looking forward to support relief programmes to encourage investment, as well as connected health in ensure access to venture capital medtech in 2019: and seed funding for early stage FIRE1 CEO, Conor Hanley, start-ups. and S3 Connected Health With the right business CEO, John O’Brien, environment, not only will the have been appointed as medtech industry drive growth, but Chair and Vice Chair, it will also develop new ways to save respectively, of the Irish and transform lives.

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DR IAN JONES CEO, Innopharma

How Innopharma Education has helped up-skill Ireland’s pharma industry Government funding and support has been instrumental in helping people and industry get the right skills. Since 2010, Innopharma Education are incredibly proud to have helped thousands of people gain pharma qualifications through initiatives like Springboard+. Over 70% of these people are now employed in all regions of Ireland’s pharma industry. Without this commitment from the government, our industry talent gap would be even larger. In addition to the Springboard+ initiative, approaches like the recently announced Human Capital

Initiative will help even further in addressing this skills gap, provide Ireland with a competitive advantage in attracting pharma investment. Innopharma Education look forward to working with industry, government and our academic partners Technical University Dublin (Tallaght) and Griffith College, to map out the next phase of professional learning and skills development that will keep Ireland’s pharmaceutical industry competitive and prepared for what’s next.

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Addressing the manufacturing challenges of Brexit SIMON MCKEEVER CEO, Irish Exporters Association

The European Union has some of the strictest health and safety manufacturing rules and requirements on human and veterinary medicinal products. The UK’s scheduled departure from the European Union will have significant consequences on the regulatory approval, supply chain and manufacturing process for companies producing both active substances and final goods in the UK.

nce the UK leaves the European Union – on 29 March or following a potential transition period – the United Kingdom and goods manufactured within the UK will be classified as a third-country and third-country manufactured product. Therefore, any medicinal and other pharmaceutical product manufactured by a marketing authorisation holder in the UK will have to comply with all the EU’s strict rules on imported pharmaceutical goods. Under EU legislation, authorised manufacturers are obliged to use only active substances that have been manufactured in accordance with the detailed guidelines on good manufacturing practices for starting materials. Written approval needed for UK medicinal exports to EU In addition, active substances for medicinal products for human use can only be imported into the Union if, among other things, the active substances are accompanied by a written confirmation from a relevant competent authority in the exporting third country, which confirms that the standards of good manufacturing practice and control of the plant are equivalent to those in the Union. If the final manufacturing site of a product is located in the United Kingdom following Brexit, European Union legislation stipulates strict rules on the importation of medicinal products from third countries. Under EU legislation, importers of medicinal and other pharmaceutical goods must be in possession of manufacturing licences granted by national competent authorities under Article 40(3) of Directive 2001/83/ EC and Article 44(3) of Directive 2001/82/EC. Such licences may be granted to third-country manufacturers under a number of conditions such as EU-licensed representatives and inspected goods-manufacturing processes. Medicinal manufacturing processes to need adapting for EU compliance According to EU-Brexit notices, for centrally authorised medicinal products, marketing authorisation holders must therefore need to specify an authorised importer established in the Union and submit the corresponding variation. Moreover, they may also be required to adapt processes and to consider changes to the terms of the marketing authorisation in order to ensure its continued validity. Furthermore, when importing medicinal and other pharmaceutical goods from a third-country into the EU, marketing authorisation holders are required to specify an EUbased site of batch control in order to facilitate full qualitative and quantitative tests, among others, on each production batch of at least all active substances as required by the national competent authority. For further information on how to prepare and mitigate the impacts of Brexit on your business, consult the HPRA, European Commission or European Medicines Agency. Read more at healthnews.ie

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Becoming ever-more personalised in treatment development PROFESSOR MARK FERGUSON Director General, Science Foundation Ireland and Chief Scientific Adviser, Government of Ireland

Health research impacts almost everyone, whether it be through treating a life-altering disease, informing nutrition for the optimal diet, or dealing with the challenging problems of an ageing population.

dvances in science and technology mean that we are rapidly moving away from a “one size for all” healthcare to a “personalised” approach, tailored to individual health and lifestyle needs. In Ireland, we are at the forefront of many of the research developments in this sector both in our academic institutions and in industry. Here are a few examples: FutureNeuro, the SFI Research Centre for Chronic and Rare Neurological Diseases, is based at the Royal College of Surgeons in Ireland. Led by Professor David Henshall, the team seeks a better understanding of brain diseases like epilepsy, which allows them to develop treatments that are not only effective, but which are also personalised. They are tailored to the patient, taking into account both individual genetic differences as well as those elicited through studying individual brain waves and responses to different treatments. At CÚRAM, the SFI Research Centre for Medical Devices based at NUI Galway, research teams led by Professor Abhay Pandit explore and develop innovative personalised medical technologies. With a particular focus on respiratory, neural, cardiovascular, musculoskeletal, renal and soft tissue disorders, the overarching aim of CÚRAM is to provide affordable, transformative solutions for chronic diseases. Likewise the cell-based research

in regenerative medicine, led by Professor Fergal O’Brien of the SFI Amber Research Centre, addresses individual patient needs following trauma or arthritis. Professor Walter Kolch’s research group at the Conway Institute UCD are pioneering approaches to tailor personalised effective pharmaceutical treatments to individual cancer patients. A major area of growth is the development of wearable sensors to continuously monitor various parameters e.g. blood pressure, heart rate, sweat, distance walked etc. and analysis of the large amounts of data these devices generate to provide tailored advice to the individual on e.g. sports training, maintaining a healthy lifestyle, detecting early disease onset etc. Much of this occurs in the SFI Research Centre for Big Data Analytics - Insight - and several innovations have resulted in startup companies, most recently Outdoor Sports who, in March 2019, announced a partnership with major US league soccer team, Colorado Rapids, to bring their technology to individual athlete testing and tracking. In all of the above examples, there is extensive, and mutually beneficial, research collaboration and cooperation with companies both large and small e.g. J&J, Boston Scientific, Stryker, Astra Zeneca, Arch Therapeutics. In a new, all-inclusive, approach to funding competitive research,

which will improve Irish society and the economy, including the health of people living in Ireland, SFI have launched Challenge Based Funding. To compete for the SFI Future Innovator Prize, multidisciplinary teams must identify economical and societal challenges and develop potential new solutions. Many of the competing teams have identified personalised health related challenges e.g. creation of personalised orthopaedic implants, treatment of rare diseases like epidermolysis bullosa (EB) through gene-editing, reducing the burden of chronic pain, and improving breast cancer diagnosis. Given the rapid pace of scientific discovery and its application, and the ever-growing opportunities arising from the convergence of genetic analysis, sensors, ICT, big data analytics and artificial intelligence, the potential to develop better diagnostic tools and therapeutic interventions that are more effective because they are focused on the individual, has never been greater. It is important that researchers in Ireland from both academia and industry remain at the forefront of these exciting developments - so that all of us can benefit by leading healthier, longer and fulfilling lives.

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AMBER is the SFI Centre for Advanced Materials and BioEnginnering hosted at Trinity College Dublin

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NUI Galway CÚRAM supports industry from basic scientific research, through translational preclinical and clinical development, into regulatory and commercialisation readiness. Our vision is to develop affordable, innovative and transformative devicebased solutions to treat global chronic diseases. Our research in innovative ‘smart’ medical devices and implants will benefit patients with chronic ailments such as cardiovascular, musculoskeletal, neural, soft tissue, renal and urology, and respiratory diseases.

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