< PreviousINTERNATIONAL MARKETS20Pharma Business International www.pbiforum.net© Shutterstock / anyaivanovaWhere innovation andinvestment collide Ireland is a key market for pharmaceutical innovation and exports, here Pharma BusinessInternational sat down with Sheila O’Loughlin, Senior Market Advisor at Enterprise Ireland, to talkexports, investors, developments and, of course, Brexit. 20-23_Layout 1 05/12/2017 13:05 Page 1Pharma Business International 21www.pbiforum.netINTERNATIONAL MARKETSPharma Business International: Towhat extent will Brexit affect the Irishpharmaceutical market and domesticcompanies looking to export toEurope?Sheila O’Loughlin: Enterprise Irelandis working closely with the indigenouspharma sector – for whom the UK is andwill remain a critical market, to navigatethe uncertainties of Brexit, particularlyaround regulatory concerns, a key issueacross Europe. The UK continues to be Ireland’s maintrading partner and Ireland’s third largestinvestor. In light of Brexit, we are evenmore determined to uphold these strongtrading relations and help Irishcompanies continue to deepen theircollaboration with the UK. In terms of investment, with its strongreputation in the sector, there is certainlythe potential for Ireland to consolidate itsposition as a gateway to Europe formany overseas companies.PBI: Obviously, fostering tiesbetween the UK and Ireland will becritical going forward, but to whatextent will this relationship play for theindustry in the future?SO:Ensuring collaboration betweentwo countries so closely entwined ismore important than ever. The UK willremain a key export market for ourindigenous pharma clients and many UKpharma companies are looking at theadvantages of an Irish base as an EUhub, seen recently with pharma servicescompany Wasdell’s announcement of aplanned Irish facility.Science Foundation Ireland will fund240 PhD researchers in an Irish-UKinitiative, jointly funded by leading UKuniversities and SFI research centres,with students dividing their time betweenboth locations.Ireland will continue to deepen itsalready close collaborations with the UKpartners such as the Research Councils,the Royal Society and Wellcome and withindividual research and educationorganisations.23 Á20-23_Layout 1 05/12/2017 13:05 Page 2INTERNATIONAL MARKETS22Pharma Business Internationalwww.pbiforum.net© Shutterstock / Per Bengtsson20-23_Layout 1 05/12/2017 13:05 Page 3Pharma Business International 23www.pbiforum.netINTERNATIONAL MARKETSPBI: What can the Irish market offeroverseas investors?SO:Ireland is one of the world’s topbiopharmaceutical manufacturing locations andhas seen more than €10 billion of investment inthe last 10 years. It’s a hugely importantindustry for Ireland and one of our fastestgrowing sectors. The presence of the top tenglobal biopharma companies is testament tothe country’s commitment to buildinginvestment. These companies are investing,not just in manufacturing but also inprocess and product development,embedding companies deeper in the Irishecosystem.Ireland benefits from an increasinglyintegrated cluster, including highlyrenowned researchers, innovative start-ups and established indigenouscompanies supported by EI; leadingglobal multinationals supported by theIDA.As the only English-speaking countryin the EU and with advantages of talent,a well-developed ecosystem, thepresence of multinationals and leading-edge research centres, Ireland is wellpositioned to continue to attract globalpharma FDI.PBI: How big an effect does Ireland haveon the world stage?SO:Having experienced exponential growthand a stream of significant investments inrecent years, Ireland is today regarded as amajor player on the global pharma stage. Fromits early days as a largely API manufacturingcentre in the 1960s, it has developed in recentyears to expertise in finished products, R&Dand shared services. The Irish biopharma industry generatesrevenue of €66 billion per annum and is thelargest net exporter of pharmaceuticals inEurope, accounting for over 50% of exportsfrom the country. 75 pharmaceuticalcompanies operate in Ireland with 40 FDAapproved pharma & biopharma plants. On the research side, Ireland has seen asteady rise through the global scientificrankings to a position of 10th in 2016 foroverall quality of scientific research. PBI: Start-ups have a key role to play innew developments and disruptivetechnologies, how is Enterprise Irelandhelping? SO: A critical part of Ireland’s pharmaceuticalsector is the vibrant cluster of highly innovative,home-grown companies. The indigenous sector has enjoyed growthrates averaging 14% per annum over the lastfour years. As a small open economy, Irishfirms must innovate to compete globally fromthe start. Enterprise Ireland’s remit is to workwith companies at every stage- from research,development, commercialisation through toscaling, both through financial supports andour extensive overseas network. In 2016, Enterprise Ireland supported 25 lifesciences new start-ups who we consider ourfuture stars, with both the innovation and theambition to and deliver scale in the future. Inrecent years, these have ranged from rangefrom analytics software and drug discoverytechnologies, to clinical trial platforms andsmall molecule therapeutics for cancer.PBI: As a major employer, what steps inthe pharma industry taking to ensure aconstant pipeline of talent?SO: Given the robust growth in the sectorglobally and the resulting competition for roles,it’s essential to ensure the right skills areavailable to meet demand.A 2016 report on Future Skills Needs of theBiopharma Industry in Ireland estimates 8,400potential job openings will arise in thebiopharma industry to 2020.The more vibrant the Irish pharma sectorbecomes, the stronger the draw for talent. Thegrowth within the sector should also encourageinterest in STEM subjects within the Irishschool system. Ireland has one of the youngest and mosthighly educated populations in Europe and thegovernment has invested to provide the righttraining and upskilling for employees. TheNational Institute for Bioprocessing Researchand Training, for example, is a global centre ofexcellence for training and research inbioprocessing, its purpose built to closelyreplicate a modern bioprocessing plant withstate of the art equipment and used bycompanies who have invested in biotechmanufacturing in Ireland in recent years, suchas Lilly, BioMarin, Merck. 20-23_Layout 1 05/12/2017 13:05 Page 4REGULATORS AND APPROVAL24Pharma Business International www.pbiforum.netThe pharmaceutical sector is oneof the most tightly regulated of all –unsurprising when product safety hasto be absolutely intense to ensureproducts reach consumers at thehighest quality and avoid potentialflashpoints. Happily, manufacturersand distributors are meeting theserequirements; ensuring products areproduced in a clean and secureenvironment.Pharmaceutical companies areexpected to comply with the variouscriteria introduced by organisationssuch as the FDA and the EU. Oneway in which they can do this is bymaking use of high quality inspectionand detection systems. Chief amongthe requirements from many bodiesis that the clinical trials stages of adrug’s development are adhered toas stringently as possible.Clinical trials often make or break anew product, with much of the futuresuccess of huge investments beingdetermined on how the productinteracts with humans. While there isalways vast amounts of tests thatshould – and will – have beenundertaken on the product, there isalways the disastrous possibility thatthere will be an adverse reactionwhen it is introduced to volunteers inthe clinical trials.Clinical trials only come into playonce the preclinical and testingprocedures have been completed,and in most cases can only beundertaken after receiving approvalby an authorised body such as theFDA. Figures suggest that it can takeup to ten years on average, and costan incredible $2.6 billion for a drug tomake it through all the stages ofclinical trials. And less than 12% ofnew medicines even make it pastFDA screening, and into phase 1 ofclinical trials. And it is a multi-phaseprocess, of course. In most cases itwill first be tested on a small numberof volunteers, with the results ofsuch being monitored before it isthen tested on hundreds – andeventually thousands of volunteers.Compliance with theserequirements is a difficult hurdle, butone all companies are faced with andEnsuring new products meet with the approval of governingbodies can be a long and frustrating process, but ensuresgreater success in the long run26 ÁRegulated and approved24-27_Layout 1 05/12/2017 13:06 Page 1Pharma Business International 25www.pbiforum.netREGULATORS AND APPROVAL© Shutterstock / gopixa24-27_Layout 1 05/12/2017 13:06 Page 2REGULATORS AND APPROVAL26Pharma Business International www.pbiforum.netmust adhere to. It’s not just trials wherecompliance needs be observed, however,and there is increasing focus on highstandards within the laboratory now aswell. For many companies this takes theform of the GLP or Good LaboratoryPractice.In most cases GLP refers to a qualitysystem of controls and management forlaboratories, which helps to make surethat there is a certain reliability andintegrity to any results. This involves anumber of requirements, as any goodnon-clinical research must be consistent,reliable and above all reproducible. GLP was born in 1972 in New Zealandand Denmark, but only spread to the USin 1978 following a BioTest Labs scandal.The Organisation for Economic Co-operation and Development (OECD)helped to spread the principles of GLP tomany other countries, and now it iscommon around the world. Obviously GLP does not refer to thebasic safety necessities of lab health andsafety, such as gloves, glasses and PPE.These are basic requirements that shouldcome as standard in every way. GLP is split into many differentcategories, all of which carry equalimportance in the eyes of the OECD. Theresponsibilities of individual personneland their roles are clearly defined, as isthe need for these members of a team ifany are not present. The guidelines are mostly broken downinto the different stages of research,including test facility organisation andpersonnel – which looks into theresponsibilities of the Study Director,Principal Investigator and StudyPersonnel. These aim to ensure thatstudies are carried out in a way thataligns with conduct requirementsexpected of the positions. There are also© Shutterstock / Gorodenkoff24-27_Layout 1 05/12/2017 13:06 Page 3Pharma Business International 27www.pbiforum.netREGULATORS AND APPROVALguidelines to indicate and set upexpectations for the recording,documenting and archiving process. Following after that is QualityAssurance programmes, including theresponsibilities of QA Personnel withinthe lab. Facilities in general, whichinvolves not just test system facilities butalso facilities for handling tests andarchiving. Waste disposal is alsocovered, particularly with the hazardousand dangerous nature of many by-products created in the lab. When it comes to study plans andreports, the GLP lays out requiredcontent for the study plan in terms ofaims and goals, details of the sponsorand any additional test facilities involvedin the tests, and much more. The goalhere is to ensure that any and alltransparency is observed when it comesto looking over or publishing the resultsof any tests. Scandals in past years haveshown that labs sponsored by individualcompanies may find results that benefitthose companies to the detriment ofscientific protocol. GLP can help reducethis, or at least put safeguards into placethat allow investigators to look back overthe process and identify if this might bethe case.GLP has always been referenced assomething of a guideline, but for manycountries certain aspects – or the entirety– of it have been put into law. TheEuropean Union adopted two basicDirectives and a Decision relating to theapplication of the GLP principles in 1987,while some changes were made to this in2004, much of it still does apply. Theseinclude compulsory audits andinspections to ensure that lab facilitiesconform to GLP rules and regulations –so it is very much an issue ofcompliance.24-27_Layout 1 05/12/2017 13:06 Page 4INTELLECTUAL PROPERTY28Pharma Business International www.pbiforum.netAny pharmaceutical company is only asgreat as its intellectual property – butshakeups across the world are making theact of keeping an IP difficult.The intellectualproperty market 28-31_Layout 1 05/12/2017 13:07 Page 1Pharma Business International 29www.pbiforum.netINTELLECTUAL PROPERTYIntellectual property (or IP) is integralto the pharmaceutical industry’s long-term survival. It is where the biginvestment is, and is the cause of manymergers and acquisitions within theindustry. However, there have beennumerous challenges to this and to IPwithin the industry – and manyGovernments are siding againstpharma.In the US, for instance, there havebeen several patent challenges inrecent years, with many of these goingthrough the US Patent and TrademarkOffice’s inter parties review process(IPR). Numerous pharma companieshave expressed concerns that theprocess disadvantages holders ofpatents, specifically because IPRreviews remain separate from thefederal court. Allergan courtedcontroversy when they attempted towriggle past the IPR review and werecaught doing so – prompting wide-spread criticism and controversy, aswell as a move by the US Congress toclose what they called a “brazenloophole”. Allergan came out with defence oftheir actions, of course, but it’sundeniable that this – along withnumerous price-raising strategies ofpharma giants – has turnedGovernments against the sector,creating an obvious “us versus them”divide. This is dangerous in the long-term and not worth any immediategains companies may receive, and yetit has become a staple part of theindustry. © Shutterstock / becky’s31 Á28-31_Layout 1 05/12/2017 13:07 Page 2Next >