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  • 1. PROFITING FROM SCIENCEWWW.MATRIX-NI.ORG MATRIX REPORT : VOL 2 10.2008 LIFE & HEALTH SCIENCES HORIZON PANEL REPORT PROSPERITY AND HEALTH DELIVERED BY SCIENCEPREPARED FOR MATRIX BY
  • 2. PROFITING FROM SCIENCE WWW.MATRIX-NI.ORGMATRIX LIFE & HEALTHPANEL MEMBERS SCIENCES HORIZON PANEL MEMBERSAlan Blair Bernie Hannigan (Co Chair)Albert Sherrard Albert Sherrard (Co Chair)Bryan Keating Alan Stitt (QUB)Clare Passmore Bert Rima (QUB)Colin Elliott John Lamont (Randox)Damien McDonnell (Chair) Michael Neely (HSC R&D Office)Ed Vernon David Brownlee (HSC Innovations)Frank Bryan Neville McClenaghan (UU & Diabetica Ltd)Gerry McCormac Peter Donnelly (BioBusiness NI)Bernie Hannigan Stephen Barr (Almac)Jim McLaughlin Tony Bjourson (UU) Werner Dubitzky (UU)
  • 3. PAGE 03PROSPERITY AND HEALTHDELIVERED BY SCIENCENORTHERN IRELAND’S LIFE & HEALTH The whole sector employs around 4,000 Over the past 18 months our intensive workSCIENCES COMMUNITY IS READY people, many in genuinely sustainable, with colleagues from academia, industry andTO MEET THE SECTOR’S GLOBAL high-value jobs. Around 30 companies in the healthcare has led to many insights and aCHALLENGES. region have a clear focus on research and real understanding of how best to move this development (R&D) - some very intensively sector forward. For us, this was a pleasureThe Life & Health Sciences Horizon Panel so - and in 2005 they spent some £33 and a privilege.was formed in 2007 to recommend actions million on the area, directly employing 600that will accelerate the development of R&D staff in the process. It is no secret that We would like to thank all of those whoour vibrant life and health sciences sector, in recent years major opportunities have participated in the compilation of this reportboosting economic benefits for the region, resulted from rising investment in R&D. and to acknowledge the work of Phil Towersand improving the quality of health and and Diana Iacob of PricewaterhouseCooperswellbeing products and services available. Given our region’s small size in the who assisted at all stages in the work of the context of this vast global industry, we Life & Health Sciences Horizon Panel.With the trend towards individuals taking accept that we cannot excel at everything.increased responsibility for their own health However, this report puts forward strategicand vitality increasing amid the spectre of recommendations that identify the key R&Dnew or re-emerging infectious diseases and capabilities and future market opportunitiesthe need for new treatments, this sector can to exploit for maximum economic return forbe hugely important. the decades ahead.Our work highlights the strength and depth By implementing these recommendations weof the sector and advances made to date. can ensure not just our continued successComprising around 60 companies with a but look forward to the time when Northerncombined turnover of some £400 million, Ireland will feature in the world rankings ofthe industry is growing. These businesses significant participants in the huge globalcreate wealth through products as diverse healthcare and pharmaceuticals market. Thisas medical devices and diagnostics, would provide great economic benefits andpharmaceuticals, bio-pharmaceuticals and position us to meet the challenges that our Bernie Hannigan & Albert Sherrardmedical disposals, as well as biotechnology- healthcare systems are facing. Joint Chairs - Life & Health Sciencesbased services and clinical trials. Horizon Panel
  • 4. PROFITING FROM SCIENCE WWW.MATRIX-NI.ORGLIFE & HEALTH SCIENCESHORIZON PANEL REPORT
  • 5. PAGE 05EXECUTIVE SUMMARYTHE ECONOMIC IMPORTANCEOF THE HEALTH TECHNOLOGIES& LIFE SCIENCES SECTORImportance to the Northern Ireland (that includes NIBEC and the Centre emergence of new diseases due toeconomy: high value-add, export oriented for Advanced Cardiovascular Research), increased global travel and climatesector Biomedical Sciences Research Institute, Centre changes; growing antibiotic resistance in for Cancer Research and Cell Biology, the some existing diseases.Over the past five years, Northern Ireland Northern Ireland Clinical Cancer Centre and the • Focus on prevention and pay-forindustry, academia and government have made McClay Research Centre for Pharmaceutical performance. In a bid to control spirallingsignificant commitment to the development of Sciences. costs, a growing number of governments,life sciences capabilities. According to Invest in both developed and developing countries,NI data, in excess of $160 million has been In addition to its intrinsic clinical practice are trying to shift the focus from thebudgeted for infrastructure enhancement, expertise, the clinical sector is placing an treatment of disease to its prevention. Atcollaborative research, new product increasing focus on clinical research and the same time, industry will be expected todevelopment and staff development initiatives. development (also known as translational prove to healthcare payers that its productsThis illustrates the local stakeholders’ medicine) and commercialisation of innovation really work and provide value for money.determination to maximise the opportunities arising from its activities. Its strengths lie in the • Increasing role of Informationderiving from a long history of technological seven Recognised Research Groups and the Technology (IT). This is anticipated toinnovation, backed by a highly educated, young Northern Ireland Clinical Research Network become a key enabler to more effectiveworkforce and an internationally recognised that includes HSC Innovations. storage and retrieval of patient records,research base. improved tracking of medical research and A growing global market therapy outcomes, and better remote care.The business sector counts approximately 60 At global level, the sector is set to benefit from • Pharma industry crisis. Thecompanies, offering a very diverse range of rising demand for effective medicines as the pharmaceutical industry is undergoing aproducts, services and capabilities. Data from population ages, new medical needs emerge period of change as it seeks to increase theInvest NI and DETI suggests that the industry, and the disease burden of the developing world pace of innovation in face of its collapsingas a whole, has a combined turnover of around increasingly resembles that of the developed blockbuster model and financial pressure£310m and employs approximately 4,000 world. By 2020, the global pharmaceuticals from healthcare funders. Biotechnology andpeople. This tends to be a high value-add market is projected to be worth some $1.3 gene therapy are anticipated to yield moresector and export-oriented, with around 80% trillion. A number of key trends are anticipated new products than the traditional molecularof sales generated from external markets. to shape-up the future of this industry: chemistry-based R&D activity. • Globalised market place. CollaborativeThe academic sector offers a strong science • Changes in disease patterns put product development across boundariesbase, both in life sciences and related sectors, more pressure on healthcare costs. and companies is anticipated to becomethrough its two world class Universities and Increase in chronic diseases as a result more pervasive. India and China are fastthe six regional Colleges of Further & Higher of ageing population, rise of obesity and becoming preferred centres of productEducation. Examples are the Nanotechnology previously terminal diseases becoming development and manufacturing activity.and Advanced Materials Research Institute chronic through therapy development;
  • 6. PROFITING FROM SCIENCE WWW.MATRIX-NI.ORGWHAT ISPERSONALISED MEDICINE?At its most basic, Personalised Medicine refers - to develop new treatments and to identify theto the use of information about a person’s sub-groups of patients for whom they will workgenetic makeup to tailor strategies for the best. It can also help determine which groupsdetection, treatment, or prevention of disease.* of patients are more prone to developing some diseases and, ideally, help with the selection ofPeople vary from one another in many ways - lifestyle changes and/or treatments that canwhat they eat, the types and amount of stress delay onset of a disease or reduce its impact.they experience, exposure to environmental Personalised medicine is expected to transformfactors, and their DNA. Many of these healthcare over the next several decades. Newvariations play a role in health and disease. The diagnostic and prognostic tools will increasecombination of these variations across several ability to predict the likely outcomes of druggenes can affect each individual’s risk of therapy, while the expanded use of biomarkers -developing a disease or reacting to something biological molecules that indicate a particularin the environment, and can be one of the disease state - could result in more focusedreasons why a drug works for one patient and and targeted drug development. Personalisednot another. medicine also offers the possibility of improved health outcomes and has the potential to makePersonalised medicine aims to use these healthcare more cost-effective.variations - both in the patient and in themolecular underpinnings of the disease itselfTHE PARADIGM OF PERSONALISED MEDICINE RISK PREVENTION TARGETED ASSESSMENT MONITORING DIAGNOSIS THERAPY RESPONSE MONITORING EARLY DETECTION TESTINGSource: Personalised Medicine Coalition
  • 7. PAGE 07BENEFITS OFPERSONALISED MEDICINEA PERSONALISED APPROACH TO MEDICINE OFFERSSIGNIFICANT BENEFITS FOR EACH OF THE MAJORSTAKEHOLDER GROUPS - PATIENTS, GOVERNMENTS, AS WELLAS INDUSTRY. THESE ARE SUMMARISED BELOW.GOVERNMENT/HEALTHCARE SYSTEMS PATIENTS INDUSTRYDetect disease at an earlier stage, when it is Effective and specific therapies Improve the selection of targets for drugeasier and more economic to treat effectively discovery Less risk of adverse effectsRational therapeutic decisions based on Reduce the time, cost and failure rate ofpathomechanism of disease rather than on Less time lost compared to trial-and-error clinical trialstrial-and-error approach approach to treatment Monopoly in a specified segment of theIncorporate diagnostic guidance to treatment Lower cost of treatment (in the longer term) market - early entry and longer dominance of market niche; no competition from genericsReduced adverse drug reactions and Facilitates preventive medicinecomplications of treatment Increased drug effectiveness will command Improvement of quality of life higher pricesShift the emphasis in medicine from reactionto prevention Increased revenues from combination of diagnostics packaged with therapeuticReduce the overall cost of healthcare productsIncreased professional satisfaction Increase patient compliance with therapy prescribed Revive drugs that failed clinical trials or were withdrawn from the market Expanding demand for enabling products and technologies, such as ICT, Agri-food, nanotechnology.
  • 8. PROFITING FROM SCIENCE WWW.MATRIX-NI.ORG KEY DRIVERS AND CHALLENGES TO DEVELOPMENT OF PERSONALISED MEDICINE PROGRESS OF SCIENTIFIC CAPABILITY ADOPTION IN HEALTHCARE SYSTEMS ADOPTION BY INDUSTRY Scientific progress - whole genome Shift to prevention and early intervention in a The ‘blockbuster’ model of one drug fits allKEY DRIVERS sequencing, rapid gene characterisation, bid to manage spiralling costs. is under pressure; improved effectiveness molecular diagnostics. levels are required for better defined patient Current drugs are not effective for all patients. populations. Declining cost of sequencing the human genome. Bid to reduce costs associated with Adverse The need for enhanced pace of innovation, as Drug Reactions (ADRs). current R&D methods are yielding fewer new Advances in information technology and products. management of health information. The 2004 General Practitioner contract links remuneration with clinical outcomes. Financial pressure is mounting, as governments press for lower prices. Mapping of the genome is still in its infancy. Payment/Reimbursement policies are not Perceived fragmentation of drug markets.KEY CHALLENGES tailored to such a system. Personalised Current availability of bio-banks may restrict medicine is more expensive and more clinical Intellectual property ownership difficult to the pace of research. data is needed on associated health outcomes secure, particularly if derived from collaborative and costs benefits. projects. There are non-genomic factors involved in the development of personalised medicine, which Education and resources implications Scale of adoption is uncertain - a niche rather require additional scientific research. - including changes to medical curricula, GP than all-encompassing adoption may be practices, and other healthcare providers. envisaged, at least in the shorter term. Policy framework - ethical and privacy concerns regarding gathering, using and storing genetic information need addressed.
  • 9. PAGE 09COMMERCIAL PROSPECTS FORPERSONALISED MEDICINEThe market for personalised medicine is • Molecular diagnostics as a stand-alone ineffective and disruptive for patients. Strongmultifaceted, with overlaps between components market; demand is also anticipated from other fields,and disciplines, and interdependencies with • Remarket of existing drugs (generic and such as central nervous system disorders,associated sectors - e.g. pharmaceutical, patented); cardiovascular disease and inflammatory disease.advanced materials, information technology • Development of new biologic drugs; andetc. The diagram below captures the main • Development of new therapies, such as Assuming a scenario where Personalisedconstituents of this complex sector. cell therapy, gene therapy, monoclonal Medicine will grow to account for a quarter of antibodies etc. total pharmaceutical market value, this indicatesPersonalised Medicine has the potential a market potential in excess of $200bn.to transform healthcare over the next Companies may specialise in certain diseaseseveral decades. areas or provide technologies that cut across However, the evolution of the market a number of disease groups. Cancer is the is expected to follow a gradual trend. AThe commercial opportunity for companies area generating the greatest interest for personalised approach to medicine has far-involved in Personalised Medicine can be pharmacogenomic therapies, as it is a very reaching implications, and a re-examination ofviewed as coming from a number of key areas: complex and heterogeneous disease which current approaches to a wide range of industry requires better classification, and because the practices and policies will be required to allow therapies currently available are, by and large, its promises to be fully realised.Markets & Technologies Underlying DisciplinesMolecular Diagnostics Personalised Therapies Disease Areas GenomicsDNA Sequencing Pharmaceuticals Cancer PharmacogeneticsGene expression profiling Recombinant human proteins Diabetes PharmacogenomicsSNP Genotyping Therapeutic monoclonal antibodies Obesity PharmacoproteomicsBiochips and microarrays Gene and cell therapy etc. Cardiovascular PharmacometabonomicsBiomarkers Central nervous system etc.Molecular imaging etc. Systems biology Bioinformatics NanotechnologyTHE PARADIGM OF PERSONALISED MEDICINE RISK PREVENTION TARGETED ASSESSMENT MONITORING DIAGNOSIS THERAPY RESPONSE MONITORING EARLY DETECTION TESTING
  • 10. PROFITING FROM SCIENCE WWW.MATRIX-NI.ORGNORTHERN IRELANDCURRENT CAPABILITY INPERSONALISED MEDICINEA NUMBER OF KEY BUILDING BLOCKS IN THE DEVELOPMENT OFPERSONALISED MEDICINE ALREADY EXIST IN NORTHERN IRELAND,ACROSS THE ACADEMIC, PRIVATE BUSINESS AND CLINICAL (ABC)SECTORS. OVER THE PAST FEW YEARS, NORTHERN IRELANDINDUSTRY, ACADEMIA AND GOVERNMENT HAVE MADE SIGNIFICANTCOMMITMENT TO THE DEVELOPMENT OF LIFE SCIENCES CAPABILITIES.The Northern Ireland business sector has a The health service is placing an increasing Successful development of Personalisednumber of leading players, providing highly focus on clinical research and development, Medicine in Northern Ireland is dependent oninnovative products and services. The sector and commercialisation of innovation arising the sector’s ability to draw on and develophas witnessed a period of growth since 2000, from the clinical sector. It has enormous local capability in complementary sectorswith a number of new companies having been potential to underpin the development of and technologies, particularly ICT (e.g.set-up to exploit the opportunities offered Personalised Medicine in Northern Ireland, bioinformatics) and Advanced Materials (e.g.by this exciting sector; they consist of both for example through its seven recognised nanostructures). In turn, developments in lifeuniversity spin-outs and pure industry ventures. Research Groups, the Northern Ireland Clinical sciences can be a source of innovation and Research Support Centre and the Northern development for the Agri-food sector (e.g.The academic sector offers a strong science Ireland Cancer Research Centre. functional foods, personalised diets etc)base, both in life sciences and related sectorsthrough its two world class Universities and the The diagram opposite suggests that in areassix Colleges of Further and Higher Education. such as clinical trials and biotechnologyExamples are the Nanotechnology and the commercial sector is more advanced inAdvanced Materials Research Institute (that successfully exploiting the local scientificincludes NIBEC and the Centre for Advanced capability. However, a focused effort isCardiovascular Research) and Biomedical required to more fully realise the potentialSciences Research Institute at the University offered by the scientific strengths in areasof Ulster and the Centre for Cancer Research such as systems biology and diagnostics.and Cell Biology, the Northern Ireland Clinical This could be achieved through collaborativeCancer Centre and the McClay Research programmes for knowledge and skill transfer,Centre for Pharmaceutical Sciences at technology licenses, or creation of wellQueen’s University Belfast. supported spin-off companies.Source: Technology Capabilities Study for Northern Ireland, MATRIX, 2007
  • 11. PAGE 11FIGURE 11: LIFESCIENCES CAPABILITY IN NORTHERN IRELAND Identify how to improve capability Support and Encourage Clinical Potential impact on NI economy trials Biotechnology Small Strong Medical disposals Medium Agribiology Exploitation Capability Biotechnology Major services Pharmaceuticals Medical devices diagnostics Timescale to realise impact Systems Current (<2 years) biology Weak 2-5 years 5-10 years 10 years Consider strategically how to support Build exploitation pathway Weak Scientific Capability Strong
  • 12. PROFITING FROM SCIENCE WWW.MATRIX-NI.ORGREALISING THEPERSONALISED MEDICINE OPPORTUNITYFOR NORTHERN IRELANDAs the market intelligence indicates, in the and raising its position in the internationallonger term this sector has the potential to arena. The sector would also be able totransform the way medicine is delivered. Many communicate with a single voice and engagenations have identified the opportunities offered in a coherent manner with the local supportby this high risk - high reward sector, and mechanisms and stakeholders, for exampleinvestment in research and commercialisation to promote skills development and raise thein this space has intensified in recent years. profile of the local cluster.The Life and Health Sciences Horizon Panelhas identified an opportunity for NorthernIreland to carve out a share of this growingmarket, by becoming a centre for IntegratedResearch & Development in PersonalisedMedicine. This would fuel the developmentof Personalised Medicine in Northern Ireland, Northern Ireland to become a centre for Integrated Research & Developmentand place the local cluster on the international in Personalised Medicine to:map in this highly dynamic sector. The Deliver services to the PM industry;competitive advantage would be conferred by Commercialise innovations & form spin-outsthe integrated nature of the services provided, Achieve global recognition for excellence in a number of strandsharnessing academic scientific expertise, Act as Northern Ireland ‘shopwindow’ to the international communityclinical data and practice and a focus oncommercialisable outputs.The Panel believes that the sector could bestimulated locally by creating the environment Local Appliedfor the initiation of commercially-targeted ABC Players ResearchR&D projects, focussing funding and supporttowards applied research not elsewhere fundedand the gap between initial Proof of Conceptand Phase II Clinical trials. Being open to thefull spectrum of the Personalised Medicine Leading Developmenttechnologies and practices, is expected to Pharma & Biotechstimulate interest from across the sector and Companiesallow the most economically valuable proposalsto emerge.It is believed that, given the recent Medical Applied Researchdevelopments in local infrastructure, a ‘virtual’ Charities & Developmentsupport mechanism would be sufficient,providing leadership, funding and expertsupport rather than new physical infrastructure.A highly focused approach to the development Enabled by Northern Ireland Scientific & Clinical Capabilityof this exciting sector would help drive closercooperation and capability transfer acrossthe ABC boundaries, thus enhancing theexploitation capability within the local sector
  • 13. PAGE 13KEY STAKEHOLDERINPUTS & OUTPUTSTHE IMPLICATIONS IN TERMS OF COMMITMENT, RESOURCES ANDBENEFITS FOR EACH OF THE LOCAL STAKEHOLDER GROUPS INREALISING THE PERSONALISED MEDICINE MARKET OPPORTUNITYCAN BE SUMMARISED AS FOLLOWS:GOVERNMENT ACADEMIC STAKEHOLDERS BUSINESS SECTOR CLINICAL SECTORInputs Inputs Inputs Inputs• Creating an innovation- and • Academic research staff • Business expertise • A commitment towards business-friendly environment • Enhanced PhD pool • Research expertise & facilities adoption within the local• Help raise the profile of the • Research facilities • Financial investment clinical practice local capability • IT capability • Clinical research expertise• Attract lead scientists from • International research partners • Clinical data abroad and international • Research facilities research partnersOutputs Outputs Outputs Outputs• Development of existing • IP creation, which can be • Extended new product • IP creation, which can be businesses, by accessing commercialised through pipeline commercialised through expertise from the local and spin-out companies or • Reduced R&D costs spin-out companies or international scientific licensing deals • IP creation, which can be licensing deals community • Spin-out companies commercialised through • Improved patient care,• Spin-out companies, • Skills development & export spin-out companies or through rational therapeutic generating associated tax • Enhanced international profile licensing deals decisions rather than trial- revenues and employment • Attract and retain talent and-error approach• FDI traction • Industry cross-fertilisation • Cost savings in the long-term,• Emergence and recycling of (e.g. ICT, Advanced Materials, through increasing emphasis local entrepreneurs Agri-food) on prevention and early• International reputation, which intervention in turn generates new business.
  • 14. PROFITING FROM SCIENCE WWW.MATRIX-NI.ORGWHAT IS HOME-BASED CARE?THE CORE PROPOSAL FROM THE HORIZON PANELCONCERNS THE LINK BETWEEN PATIENTS IN THEIR HOMESAND THE HEALTH SYSTEM. THIS LINK CAN BE CONSIDEREDTO INCLUDE THE FOLLOWING THREE MARKET COMPONENTS.1 Telehealth 2 Telecare 3 Secure web messaging and e-visitsTelehealth monitoring is the remote exchange Telecare is the continuous, automatic and This technology usually acts as an enablerof physiological data between a patient at remote monitoring of real time lifestyle changes for the previous two areas of remote care.home and medical staff at hospital to assist in and emergencies over time, in order to manage Consumer familiarity with the Internet anddiagnosis, progress monitoring and prevention the risks associated with independent living. e-mail allows for more efficient communicationof various conditions. Specific product Telecare is usually designed to create home with medical staff and for novel healthcareexamples include home-based blood pressure environments which meet the needs of older solutions. A specific example of an e-visit couldmonitors that relay information to the patients or disabled people. Specific product examples be an email exchange between a doctor andGP surgery. Their immediate applications tend include fall or bed sensors. patient. The market also includes technologiesto lie in the management of chronic disease and services based exclusively within the health(e.g. diabetes, cardiovascular etc). The system (telemedicine) or within the patients’preventative and personal health management physical home infrastructure (assistive devices).aspects are expected to become more These do not form part of the Panel’s corepervasive in the longer term. proposals, but instead are recommended for consideration in the longer term.
  • 15. PAGE 15KEY MARKET DRIVERS ANDCHALLENGES TO DEVELOPMENTKEY MARKET DRIVERS KEY CHALLENGES TO DEVELOPMENT• Current healthcare systems are unsustainable, in great part due to • Slow adoption by healthcare systems, due to factors such as an ageing, more chronically-ill population resistance to adoption of information technology and new work• There have been numerous pilot studies that have demonstrated practices, and difficulties in changing reimbursement systems within social and financial benefits associated with the home care concept the GP community; significant policy issues therefore remain to be• Advancement of technologies and IT infrastructures has led to addressed higher IT spend within healthcare budgets, in a bid to achieve • Integration into existing structures is made more difficult by the need efficiencies and improve service delivery for a joined-up approach across health, housing and social care• Rising expectations of consumers with regards to own health status • Maintaining individual privacy - there are concerns regarding and involvement in their healthcare decisions surveillance and possible loss of privacy and autonomy, and legal• Adoption of Electronic Health Records (EHR) will act as an enabler issues relating to data confidentiality and protection. for remote care • Lack of coherent approach - both within health systems (so far based on regional, small scale pilots) and industry (interoperability issues among devices and telecommunications providers) • Level of technology development - there is a need for further development for example to provide more consumer-friendly devices • Country variations in policies and structures make exporting more difficult
  • 16. PROFITING FROM SCIENCE WWW.MATRIX-NI.ORGCOMMERCIAL PROSPECTS FOR THEHOME-BASED CARE MARKETTHE CORE PROPOSAL FROM THE HORIZON PANEL CONCERNSTHE LINK BETWEEN PATIENTS IN THEIR HOMES AND THEHEALTH SYSTEM.The US is, and will remain, easily the largest In comparison, the entire European marketnational market for telehealth, reaching $4.51 is expected to only reach about $1.00 billionbillion in 2010 according to Datamonitor by 2010, despite having a projected 502forecasts. It will also show faster growth than million people.Canada at 64% CAGR, compared with 32%for the latter. This very high growth and large The European market may be smaller thanmarket share are the result of two that in the North America, but it will still showmain features of the US market: very rapid growth, with an expected CAGR of• Very high overall US healthcare spending, 60% over the period. The UK is the largest given the private care and insurance- single market at $23 million and will grow by based system; 66% CAGR to $286 million in 2010. The ten• High and rapidly growing rates of chronic new EU nations (NEU 10) will be the fastest diseases such as diabetes. growing market, with a CAGR of 69%, but will still only reach a value of $60 million in 2010.
  • 17. PAGE 17 TELEHEALTH MARKET IN NORTH AMERICA BY COUNTRY (2005-2010)* 6,000 100% Canada United States 5,000 Growth Percentage Growth 4,000 60%Million US $ 3,000 2,000 30% 1,000 0 0% 2005 2006 2007 2008 2009 2010 TELEHEALTH MARKET IN EUROPE BY COUNTRY (2005-2010)** 1,200 80% Switzerland 70% NEU 10 1,000 Spain 60% Percentage Growth 800 Rome 50%Million US $ Italy 600 40% Benelux 30% 400 Nordics 20% France 200 10% Germany 0 0% United Kingdom 2005 2006 2007 2008 2009 2010 Growth * Source: From report ** Source: Datamonitor, Extending the delivery of healthcare beyond the hospital setting, June 2006
  • 18. PROFITING FROM SCIENCE WWW.MATRIX-NI.ORGREALISING THE HOME-BASED CAREOPPORTUNITY FOR NORTHERN IRELANDThe Life and Health Sciences Horizon Panel The overall aim of the model proposed forrecommends that Northern Ireland becomes the Northern Ireland is to join up local capabilityfirst UK region committed to the early adoption across all four of these domains in anof a telehealth system within the Health and integrated manner and in a real clinical setting.Social Care practice. This means establishinga strong local capability across the telehealth The Panel concluded that to maximise thecontinuum, and deploying this locally to achieve market opportunity in this area, telehealthwhole connectivity between the health sector technology should be implemented within ourand the home within 15-20 years. own health system.The Home-based care market encompasses • This would allow the DHSSPS to benefita wide range of products and services. The from savings achieved from the deliveryunderpinning technologies and systems of health services in this manner, whilstnecessary to deliver those services can be improving patient care; andsub-divided into four key domains along the • At the same time, it would create antelehealth continuum, as summarised in the attractive Whole System Integration Testdiagram below. Bed for local and international technology providers, who could use Northern Ireland as a gateway to UK and European home care export markets.NORTHERN IRELAND POSITION ALONG THE HOMECARE CONTINUUM: WHOLE SYSTEM CONNECTIVITY Medical Devices Home Telecomms Data Analysis Response System Assistive devices Broadband Software solutions Family/carer Sensors ICT Integration Data management NHS - GP, PCT, ACT, Alert systems Physical structure Social Services Vital signs monitoring devices Third party service provider
  • 19. PAGE 19The Panel considered the Northern Ireland Data Analysis Government supportcapability’s strengths and gaps against the four • The development of a Home-based care • The announcement made in Januarykey areas judged to constitute the home based market will require a capability in managing 2008, regarding the development of ancare continuum, and the level of support and and analysing large volumes of data. The European Centre for Connected Healthcommitment provided by the local government. Panel judged this was not an area were supported by three Northern Ireland a significant capability existed locally at government departments, is a powerfulMedical Devices present but from preliminary discussions springboard for future development of• The panel noted that a local capability with the Horizon ICT Panel it was an area the concept. The project has significant existed within Northern Ireland within the that could be further explored for future buy-in from the private sector locally and medical device sector. However, it was investment. internationally. also noted that these companies lacked a scale within the market. All of the Response System companies had to seek an export market • The specific circumstances of each patient as there was currently little potential for group and the economic case for each growth domestically. initiative will determine the response• It was acknowledged that a strategy could system employed. The options to consider be developed to build upon the existing would include: capability by seeking additional foreign - Response to be delivered within the direct investment into the province and by DHSSPS; if so, what are the interface developing partnership agreements. points, e.g. GPs, Social services, others;Home-based Telecommunications - Response to be provided by a family• The development of a Home-based member; care market will require a high speed - Response to be delivered by a 3rd telecommunications infrastructure. The party provider; if so, what panel members judged that Northern type of activities specifically and Ireland was already well served in this associated governance; or area compared to other regions in the - Combination of service delivery; UK given the existing 100% broadband • The Panel considered that the most coverage. However, the ability to generate important success factor was not the a economic capability by developing creation of infrastructure. Instead, it companies to compete within the was ensuring that the existing response technology infrastructure sector was not resources (e.g. GP surgeries, District judged to be strong given the dominance nurses etc) were motivated and of the existing technology competitors. incentivised to adopt this way of working.
  • 20. PROFITING FROM SCIENCE WWW.MATRIX-NI.ORGKEY STAKEHOLDERINPUTS & OUTPUTSTHE TABLE BELOW SUMMARISES THE COMMITMENT NECESSARY FROMGOVERNMENT, ACADEMIA, BUSINESS AND THE CLINICAL FIELD TOSUCCESSFULLY DELIVER HOME-BASED CARE WITHIN THE NORTHERNIRELAND ECONOMY. THE TABLE ALSO HIGHLIGHTS THE POTENTIAL RETURNFOR EACH RESPECTIVE GROUP.GOVERNMENT ACADEMIC SECTOR BUSINESS SECTOR CLINICAL SECTORInputs Inputs Inputs Inputs• A commitment to a • Social studies • An investment in new • A commitment to changing ‘connected health’ agenda • ICT capability technologies working practices and establishment of NI as a • Curricula for new disciplines • A long-term contractual • Adjusting reward structures test-bed for associated in eHealth commitment to the technology public sector• A commitment to a joined up approach to the market opportunity• Embrace an attitude of changeOutputs Outputs Outputs Outputs• Stimulate indigenous • Graduates to fulfil a new • An opportunity to participate • A new model of healthcare companies model of health delivery in a locally significant market management• Create a knowledge base • Growing reputation in the • Potential to export proven • Improved health and quality of from which export potential Connected Health field technology and know-how to life for relevant patient groups can be exploited US and European markets through enhanced• Attract FDI companies, independent living interested in using NI as a • Improved work practices for gateway to UK and European health professionals markets • Realisation of cost savings• Demonstration of the which can be redistributed government’s commitment to towards other priority areas, smarter working practices to thus increasing productivity improve patient care levels
  • 21. PAGE 21FRAMEWORKCONDITIONSThe health technologies and life sciences Personalised medicine specific factors:sector has the potential to become a major • Participation from the clinical sectorcontributor to Northern Ireland’s knowledge- would be critical to help demonstratebased economy. There are however a number of the economics and clinical benefits ofprerequisites to successfully realising the market pharmacogenetics in clinical practice;opportunities identified by the Horizon Panel. • Application in existing vs. new drugs would imply forming public-private partnerships toGeneral enabling factors: enable enhancements of existing generic• Most importantly, accomplishing the drugs; and healthcare opportunities identified by • Addressing the ethical framework - the Life & Health Sciences Panel is safeguards need to be put in place to dependent on the sector’s ability to prevent the misuse of genetic information. exploit and develop local capability in a number of allied areas. This is an era of Home-based care specific factors: convergence of technologies, and Life & • Scalable approach to roll-out - it is Health Sciences sits right at the interplay recommended that DHSSPS retains the of technologies from related sectors control over the patient groups and the - Advanced Materials, ICT, Advanced parts of the healthcare system impacted at Engineering etc; each stage;• The competitive position of Northern • Defining technology standards and Ireland is dependent on the ability to protocols - common technology standards provide an integrated service and product and protocols need developed to provide portfolio. This means a joined-up approach interoperability of devices; among the private sector companies, • Stakeholder engagement - existing but also the use of academic and clinical response resources (e.g. GP surgeries, capability as a catalyst to innovation and District nurses etc) need motivated and science. Collaboration with international incentivised to adopt this way of working; partners, including RoI and GB, would also and help address some of the gaps that may • Adjusting funding policy - aim to use and exist adjust the existing reward and operational in the local capability; structures (e.g. GP contracts) as much• The availability of an adequate skills base as possible, rather than creating a new, is of paramount importance. The right parallel system. quality and volume of skills is necessary to fuel the growth of the sector. The education system has been engaging a lot more with the industry in the last few years, but even more can be done to align the curriculum to the changing needs of the industry; and• Supportive policy environment - this would involve the creation of an innovation- and business- friendly environment, which would support indigenous existing and new companies, as well as overseas companies considering operating in Northern Ireland.
  • 22. PROFITING FROM SCIENCE WWW.MATRIX-NI.ORGSUMMARY OFPROPOSALSTWO DISTINCT MARKET OPPORTUNITIES HAVE BEEN IDENTIFIED BY THE HEALTH AND LIFE SCIENCESHORIZON PANEL: PERSONALISED MEDICINE AND HOME-BASED CARE. WHILST THEY HAVE A NUMBEROF COMMON FEATURES, IN THAT BOTH ADDRESS ISSUES FACING THE GLOBAL HEALTH AND ECONOMYIN THE LONG-TERM, AND THEY ULTIMATELY COMPLEMENT EACH OTHER WITHIN THE INTEGRATEDHEALTHCARE CONCEPT, THE TWO MODELS OFFER DIFFERENT PROPOSITIONS IN TERMS OF TYPE OFCAPABILITY IMPACTED LOCALLY, ECONOMIC IMPACT, TIMESCALE AND RISK FACTORS. THE TWO MARKETPROPOSALS ARE SUMMARISED BELOW.PERSONALISED MEDICINE HOME-BASED CAREMarket rationale Market rationale• Large, emerging market across all segments, driven by need for • Developing market, driven by the need for more efficient healthcare more effective treatments & shift to preventative medicine, and the provision and increasing consumer demand for enhanced quality of innovation & patent crisis in the pharmaceuticals sector life• Obstacles: costs, data availability, ethical concerns, reimbursement • Market currently dominated by pilots. Proven benefits, but also show policy that ‘one size doesn’t fit all’• Number of players & government investment increasing globally • Main technology platforms exist, albeit requiring further development• High risk, high reward market • Obstacles to adoption: Device & IT Interoperability, Variation in• NI has some of the building blocks in place, but lacking critical mass regional policy, Healthcare system resistance to technology & change, Reimbursement policy • Northern Ireland capability lagging behindNorthern Ireland Opportunity Northern Ireland Opportunity• Focus on clear commercialisable applications in the Personalised • Focus on telehealth and telecare segments (excludes telemedicine Medicine space and house aids)• Open/Bottom-up approach - based on competitive projects • Adoption within mainstream healthcare system to become Northern• Create a virtual mechanism, using existing physical infrastructure & Ireland’s competitive differentiator tech transfer structures • Top-down approach, with decision on policy and strategic approach• Support collaborative networks, resource development, profile to roll-out resting exclusively with DHSSPS. raising • Phased roll-out• Use funding to incentivise collaboration, technology transfer and attract international players
  • 23. PAGE 23PERSONALISED MEDICINE HOME-BASED CAREAdvantages Advantages• Potential for immediate engagement of existing companies and • High FDI traction prospects impact on their commercially-targeted R&D activity • Technology platforms available internationally, albeit requiring• Draws on and stimulates R&D in related and complementary fields improvement• Additional funding leveraged through public sources (UK, RoI and • Lower risk and more immediate economic impact on both patient European sources) and major international players care and local economy (3 years +)• Attract PhD and other highly skilled professionals. Retain indigenous • Significant interest in full adoption from DHSSPS locally, which talent would be a key competitive advantage compared to other pilot-• Longer term - creation of new companies based schemes.Draw-backs Draw-backs• Long-term economic impact (10 years +) • Limited indigenous scientific capability locally• High risk portfolio • Global market prospects dependent of adoption rates in each countryKey success factors Key success factors• Building critical mass and profile through sustained investment • Adjust reimbursement strategy to incentivise adoption• Combining academic and clinical capability will confer a strong • Embedding behavioural changes - among healthcare professionals competitive advantage and patients• Commitment from all stakeholders
  • 24. PROFITING FROM SCIENCE WWW.MATRIX-NI.ORGCONTENTS1 425 INTRODUCTION 69 FRAMEWORK CONDITIONS26 Economic importance of the sector 71 General Enabling Factors29 The Horizon Panel objectives 73 Personalised Medicine30 Approach to delivery 74 Home-based Care232 PERSONALISED MEDICINE - THE OPPORTUNITY FOR NORTHERN IRELAND33 What is Personalised Medicine?34 Applications of Personalised Medicine36 Benefits of Personalised Medicine37 Key market drivers and challenges to development41 The Market for Personalised Medicine is Multifaceted42 Commercial Prospects48 Northern Ireland Capability52 The Opportunity for Northern Ireland355 HOME-BASED CARE MARKET - THE OPPORTUNITY FOR NORTHERN IRELAND56 Defining the market57 Key market drivers and challenges to development59 Driving Policies and Iniatives in the Sector60 Commercial prospects62 The Opportunity for Northern Ireland64 Realising the Home-Based Care Opportunity for Northern Ireland66 Northern Ireland Capability67 Economic Benefits68 Key Stakeholder Inputs & Outputs
  • 25. PAGE 25INTRODUCTION1
  • 26. PROFITING FROM SCIENCE WWW.MATRIX-NI.ORGTHE ECONOMIC IMPORTANCE OFTHE HEALTH TECHNOLOGIES & LIFESCIENCES SECTORNORTHERN IRELANDCONTEXTAs technologies converge, ‘life sciences’ • The need for stronger links with academia Over the past five years Northern Irelandrepresents an all-encompassing title capturing and clinicians in order to bolster technology industry, academia and government have madea wide range of industry sub-sectors such transfer and innovation significant commitment to the development ofas pharmaceuticals, biotechnology, medical • Shortage of ‘veteran’ entrepreneurs in life sciences capabilities. In excess of $160devices and diagnostics, drug delivery, clinical Northern Ireland, with the experience and million has been budgeted for infrastructuretrials etc. The sector in Northern Ireland time to mentor life science businesses enhancement, collaborative research, newcomprises organisations across the Academic, • Need to remain at the forefront of R&D, product development and staff developmentBusiness and Clinical (ABC) sectors. in light of increasing competition from low initiatives. cost manufacturing regionsThe business sector counts approximately 60 In the same timeframe, Northern Irelandcompanies, offering a very diverse range of The academic sector offers a strong science life science companies have committed toproducts, services and capabilities. Data from base, both in life sciences and related sectors strategic investment expenditure in the orderInvest NI and DETI suggests that the industry through its two world class Universities and of $340 million including approved governmentas a whole has a combined turnover of around the six regional Colleges of Further & Higher assistance of $70 million. In a country with a£310 million and employs approximately 4,000 Education. Examples are the Nanotechnology population of just 1.7 million people, employingpeople. This tends to be a high value-add and Advanced Materials Research Institute (that around 4,000 in life sciences, this level ofsector and export-oriented, with around 80% includes NIBEC and the Centre for Advanced investment (almost $125,000 per employee) isof sales generated from external markets. Cardiovascular Research), Biomedical Sciences impressive. Research Institute, Centre for Cancer ResearchThe top five companies by size account for and Cell Biology, the Northern Ireland Clinical This illustrates the local stakeholders’some two thirds of the sector’s turnover Cancer Centre and the McClay Research Centre determination to maximise the opportunitiesand 3,838 of its employees. The majority for Pharmaceutical Sciences. deriving from a long history of technologicalof companies in the sector are small, with innovation, backed by a highly educated, youngturnovers of under £500,000. In addition to its intrinsic clinical practise workforce and an internationally recognised expertise, the clinical sector is placing an research base.The issues facing local industry include: increasing focus on clinical research and• Difficulty of gaining access to early stage development and commercialisation of funding, due to the higher risk and longer innovation arising from the clinical sector. Its lead times to commercialisation that apply strengths lie in the seven recognised Research to this sector Groups, the Northern Ireland Clinical Research• Skill shortages in certain areas Support Centre and multiple joint programmes• Long and costly product development, with equivalent organisations in Ireland and the due to compliance with a strict regulatory UK as well as the local academic and business regime sectors.
  • 27. PAGE 27GLOBALCONTEXTA growing market Growing antibiotic resistance However, the human genome has proved moreAt global level, the sector is set to benefit from in existing diseases. complex and less amenable to mechanisticrising demand for effective medicines as the The overuse of antibiotics, and the limited analysis than many scientists anticipated,population ages, new medical needs emerge number of new ones in the pipeline, has when the draft map was completed in 2001.and the disease burden of the developing world left little defence against several previously Hence the fact that Pharma is still strugglingincreasingly resembles that of the developed contained pathogens. Examples include to apply the insights it has gleaned from theworld. By 2020, the global pharmaceuticals hospital infections and tuberculosis. molecular sciences - genomics, proteomics,market is projected to be worth some $1.3 metabonomics and the like - to improvetrillion. The market is anticipated to be shaped Industry innovation crisis its performance. The industry requiresup by a number of key trends: Currently, it appears that the global a fresh approach to its R&D processes, pharmaceutical industry is not in a strong and identification of target molecules andChanges in disease patterns put position to capitalise on the market compounds.pressure on healthcare costs opportunities, unless it can change the way inIncrease in chronic diseases. The global which it operates. Its core problem is the slowing Globalising marketplacepopulation is projected to rise from 6.5 billion pace of innovation in providing effective new Globalisation will bring fundamental changes,in 2005 to 7.6 billion in 2020. It is also aging therapies for the world’s unmet medical needs. particularly in the area of product development.rapidly; by 2020, about 719.4m people - 9.4% With an inexpensive supply of highly trainedof the world’s inhabitants - will be 65 or more, The industry’s best hope of earning higher researchers and improving intellectualcompared with 477.4 million (7.3%) two years returns lies in the development of packages of property norms, China and India look likely toago. Older people typically consume more products and services targeted at patients with become a focus of product development andhealthcare products and services than younger specific disease subtypes and that, if it was to manufacturing activity in life sciences.people, as they tend to develop multiple make such “targeted treatments”, it would havechronic diseases. Obesity, especially in the US, to start by focusing on diseases rather than Changing relationshipsis another driver of higher costs, as it tends compounds. Co-operation will be a critical element ofto lead to chronic diseases such as diabetes, success in life sciences. Biotech and bigcoronary heart disease and osteoarthritis. Biotechnology research is anticipated to pharma will work together to bring new deliver more new products than the traditional products to market. Teams will co-operateMore new diseases. molecular R&D activities. Gene therapy is globally on processes such as productGreater population density, increased travel likely to move from treatment of conditions to development or test analysis. Increasing levelsand climate changes have increased the cures by modifying patient DNA. Previously of patient choice and knowledge will place aappearance of new pathogens. These are untreatable conditions could therefore find premium on successful relationships betweenoften viral, initially difficult to treat, and highly a treatment, as is, for example, the case of physicians and those in their care.dangerous. Examples include ebola, SARS and cancer and other genetic conditions.potentially avian flu.
  • 28. PROFITING FROM SCIENCE WWW.MATRIX-NI.ORGIncreasing Role of Information Pay-for-performanceTechnology (IT) The provision of healthcare is not all thatMore pervasive use of IT will lead to more is changing; so is the way in which it iseffective storage and retrieval of patient measured. Several countries have set uprecords, improved tracking of medical agencies specifically to compare the safety andoutcomes and better remote care. Automation efficacy of different forms of intervention andof simpler processes is also anticipated to promote the use of evidence-based medicine.free up physicians’ time to focus on higher- The US Agency for Healthcare Research andvalue activities such as diagnosis and patient Quality is one such body, as is the UK Centrecommunication. for Health Technology Evaluation - a division of the National Institute for Clinical HealthBlurring Healthcare Boundaries and Effectiveness (NICE). The industry willChanges in the way healthcare is delivered have to prove to healthcare payers, who arewill arguably play an a critical role in shaping increasingly interested in establishing bestthe industry’s future. The primary-care sector medical practice, that its products really workis expanding and becoming more regimented, and provide value for money.as general practitioners perform more minorsurgical procedures and healthcare payers Focus on preventionincreasingly mandate the treatment protocols A growing number of governments in boththey must follow, including the drugs they can developed and developing countries are tryingprescribe. Conversely, the secondary-care to shift the focus from the treatment of diseasesector is contracting, as clinical advances to its prevention. For example, at least 18render previously terminal diseases chronic; countries have already introduced nationwidehealthcare providers like Clinovia in the UK, bans on smoking in enclosed public places, asand Gentiva in the US, deliver secondary care have a number of US states. Similarly, someat home; and hospitals focus on the specialist countries are waging war against rising levelscare that cannot be supplied anywhere else. of obesity. The role of genetics in identifyingThe self-medication sector is also growing, as those at risk and in early interventions is alsomore and more products that would once have expected to play a major role in preventativebeen available only on prescription are sold in medicine.OTC formats.
  • 29. PAGE 29THE HORIZONPANEL OBJECTIVESThe Life and Health Sciences Horizon Panel The Life and Health Sciences Horizon Panel was tasked to deliver on theis one of the five technology horizon scanning following objectives:panels established under the auspices of theNorthern Ireland Science Industry Panel -MATRIX. The other four Horizon panels i Identify the sustainable market opportunities that could berepresent the following sectors: ICT, Advanced exploited distinctively by the NI science and industry base;Materials, Agri-food and Advanced Engineering(Transport). ii Identify the research and technology strengths of the NorthernMATRIX is an expert advisory panel Ireland science and industry base relevant to the identifiedreporting to DETI and the DETI Minister onmatters pertinent to the exploitation and market opportunities;commercialisation of science, technology andR&D. It is led by high-technology and R&D iii Determine the opportunities for external collaboration thatintensive industry and advises Northern IrelandGovernment on the development of improved would supplement critical gaps in NI research and technologyinterfaces between Northern Ireland business capability in ensuring early delivery of potential outputs;and the research, science and technologybase, with a view to ensuring the region’s iv Engage with key stakeholders and partners critical to thescience and R&D strengths are exploitedfor maximum economic and commercial success of relevant market opportunities (public, private andadvantage. academic) in Northern Ireland to assist in the prioritisation of the key technology enabled business opportunities for the sector; v Identify internal and external networks (including those networks wider than the life and health sciences sector) essential to deliver technology and business growth and establish processes to build and sustain these networks; and vi Identify investment opportunities in the sector.
  • 30. PROFITING FROM SCIENCE WWW.MATRIX-NI.ORGAPPROACH TO DELIVERYWe adopted a step driven approach to 1 Project Mobilisationachieving the project deliverables, underpinned An initial meeting was held with the Matrixby monthly Panel working meetings. The secretariat to agree the approach to delivering12-strong Panel brought together leading and managing the project. This was thenrepresentatives from across the local captured in the Project Initiation Document.industry - academics (6), clinical sectorR&D representatives (2), and private sector 2 Project Scopingcompanies (2 large businesses and 2 SMEs). Given the broad and complex nature of theThe Panel was co-chaired by leaders from health technologies and life sciences sector,business and academia. it was important to select the most appropriate Project mobilisation MONTHLY MEETINGS WITH THE HORIZON LIFE & HEALTH SCIENCES PANEL Project scoping Define key areas of focus Market Opportunities Assessment Market Opportunities Assessment Personalised Medicine Home-based Care Consolidation of options Roadmap to Development 5. Report production
  • 31. PAGE 31approach to identifying the relevant market The profile of the local sector capability wasopportunities for Northern Ireland. It was also analysed, drawing information from DETI’sultimately agreed that the most effective means parallel study on Northern Ireland Technologyto achieving this was through a brainstorming capability, and the BioBusiness and Invest NIsession, which would harness the collective Sector review conducted in 2006.knowledge of the Panel members and themarket acumen of the PwC core team and In light of the research findings, a number ofexpert advisors. The event was held in May suggestions were made on potential areas2007 and elicited views on ‘Sustainable Market of focus for the Northern Ireland cluster, andOpportunities for Northern Ireland plc’ from models for implementation.a wide number of standpoints: World diseaseprevalence, Key industry trends, Emerging and 4 Consolidation Of Optionscross-cutting technologies, Policy & regulation, The options on the best approach forand Northern Ireland competitive position. Northern Ireland approaching this market and establishing a competitive position wereOver 100 innovative ideas were generated, deliberated with the Panel members. A numberwhich were then analysed and found to cluster of options to the implementation models werearound 11 principal market-related themes. The discussed, together with the implications forPanel filtered these further and selected the top the local stakeholders.priorities through a voting process. The resultswere discussed at the Panel meeting in June, The emerging thoughts were shared and testedwhen the top two key areas of focus for Northern with a limited number of key sector leaders inIreland were agreed as: Personalised Medicine the local economy. These discussions helpedand Home-based Care. gauge their views on how the proposed models could be effectively deployed, and initiated3 In-depth Market Analysis early buy-in and engagement across theIn-depth market research was carried out industry community.within the two selected themes, to explorespecific technology application opportunities 5 Reportingwithin each. The research used analysis of The final report explores the recommendationsextensive market intelligence and interviews of the Life and Health Sciences Horizon Panelwith international and local industry experts, in the areas of Personalised Medicine andto establish: Key areas of market growth, Home-based Care and summarises the marketEmerging technology applications, Key players, rationale for these recommendations.and Potential collaboration partners.
  • 32. PROFITING FROM SCIENCE WWW.MATRIX-NI.ORGPERSONALISED MEDICINE -THE OPPORTUNITY FORNORTHERN IRELAND2
  • 33. PAGE 33WHAT IS PERSONALISEDMEDICINE?At its most basic, Personalised Medicine refers of patients are more prone to developing some specific genetic risk for certain diseases.to the use of information about a person’s diseases and, ideally, help with the selection of A key factor that will drive the integration ofgenetic makeup to tailor strategies for the lifestyle changes and/or treatments that can diagnostics and therapeutics is the availabilitydetection, treatment, or prevention of disease.* delay onset of a disease or reduce its impact. of improved and more precise diagnostic methods, which are easy to perform and arePeople vary from one another in many ways - Personalised Medicine is expected to transform not prohibitively expensive.what they eat, the types and amount of stress healthcare over the next several decades. Newthey experience, exposure to environmental diagnostic and prognostic tools will increase Although scientific advances such asfactors, and their DNA. Many of these the ability to predict the likely outcomes of drug the mapping of the human genome andvariations play a role in health and disease. The therapy, while the expanded use of biomarkers computation technology are underpinningcombination of these variations across several - biological molecules that indicate a particular fast scientific developments, adoption in thegenes can affect each individual’s risk of disease state - could result in more focused mainstream clinical system lags behind. Ifdeveloping a disease or reacting to something and targeted drug development. Personalised Personalised Medicine is to realise its potential,in the environment, and can be one of the Medicine also offers the possibility of improved it will require an extensive system of support.reasons why a drug works for one patient and health outcomes and has the potential to make This system will include new regulatorynot another. healthcare more cost-effective. approaches, revamped medical education curricula, integrated health informationPersonalised Medicine aims to use these The illustration arrow reflects the current and systems, legislation to protect againstvariations - both in the patient and in the anticipated flow of healthcare services, and genetic discrimination, insurance coveragemolecular underpinnings of the disease itself changing points of intervention, as medicine for sophisticated molecular diagnostic tests,- to develop new treatments and to identify the becomes more personalised. Early detection and a reimbursement system that encouragessub-groups of patients for whom they will work testing will play an increasing role, with proactive care.best. It can also help determine which groups expanded screening programmes for detectingTHE PARADIGM OF PERSONALISED MEDICINE** RISK PREVENTION TARGETED ASSESSMENT MONITORING DIAGNOSIS THERAPY RESPONSE MONITORING EARLY DETECTION TESTING* (Source: Personalised Medicine Coalition)** (Source: Personalised Medicine Coalition)
  • 34. PROFITING FROM SCIENCE WWW.MATRIX-NI.ORGAPPLICATIONS OFPERSONALISED MEDICINEA PERSONALISED APPROACH TO MEDICINE PROMISES A NUMBEROF BENEFITS IN ADDRESSING THE KEY CHALLENGES FACINGHEALTHCARE SYSTEMS WORLDWIDE:Currently, physicians often have to use trial Governments and medical communities are screening programmes and diagnostic testsand error methods to find the most effective increasingly stressing preventive medicine as at personal and General Practitioner levelmedication for each patient. As more is learnt the most cost-effective approach to improving would enable people to be more in charge ofabout which molecular variations best predict the quality of life. Developments in molecular their own health and health practitioners tohow a patient will react to a treatment, and diagnostics and genetic testing will drive this recommend life style, nutritional and medicaldevelop accurate and cost-effective tests, market. The design and validation of preventive action at an early stage.doctors will have more information to guidetheir decision about which medications arelikely to work best. Testing is already beingused to find the one in four women likely torespond to a particular breast cancer drug. Inaddition, testing could help predict the best BETTER DIAGNOSESdosing schedule or combination of drugs for a AND EARLIERparticular patient. INTERVENTIONMolecular analysis could determine preciselywhich variant of a disease a person has, orwhether they are susceptible to drug toxicities,to help guide treatment choices. For preventivemedicine, such analysis could improve the abilityto identify which individuals are predisposed INCREASED MORE BENEFIT ADOPTION OFto develop a particular condition - and guide EFFECTIVE FOR HEALTHCARE PREVENTATIVEdecisions about interventions that might THERAPIES SYSTEMS CAREprevent it, delay its onset or reduce its impact.Toxicity associated with inappropriate use ofapproved drugs is a real problem and a cost tohealthcare systems, that Personalised Medicinecan provide a partial solution to. In the USAalone, adverse drug reactions (ADRs) are IMPROVEDresponsible for approximately 100,000 drug- SAFETYrelated deaths and 2.2 million hospitalisations OF DRUGSper year, representing a cost of roughly$100 billion.
  • 35. PAGE 35PERSONALISED MEDICINE ALSO HAS THE POTENTIAL TO HELPTHE PHARMACEUTICAL INDUSTRY TO IMPROVE ITS PERFORMANCEAROUND BOTH NEW PRODUCT R&D AND EXISTING DRUGS.Genotyping may be used for rescuing ‘dead and toxicity in some patients. By defining the Repositioning of a drug throughdrugs’ that have failed clinical trials because genotypic characteristics, patients who are pharmacogenomics can extend the patentof lack of efficacy and toxicity problems. non-responders and those liable to adverse life of a drug. A drug with redefined newNew indications can be explored in defined reactions, can be excluded. indications for a particular group of patientspopulations groups where the drug use is safe would start a new patent life.and effective.Redefining the patient population for marketeddrugs would enhance effectiveness and safety.Upper figures for efficacy of medical treatmentof most diseases are less than 100%. Examplepercentage of patients that show lack of MORE EFFICIENT DRUGresponse to current therapy in key disease DEVELOPMENTareas: Epilepsy - 70%, Hypertension - 65%, PROCESSDepression - 60%, Diabetes mellitus - 55%,Rheumatoid arthritis - 50%, Alzheimer’sdisease - 30%. Improvement in treatment isan opportunity for development of PersonalisedMedicines.A better understanding of genetic variations EXPAND RESCUING BENEFIT MARKET OFcould help scientists identify new disease ‘DEAD DRUGS’ FOR EXISTINGsubgroups and their associated molecular INDUSTRY DRUGSpathways, and design drugs that target them.Molecular analysis could also help selectpatients for inclusion in, or exclusion from,late stage clinical trials - helping gain approvalfor drugs that might otherwise be abandonedbecause they appear to be ineffective in thelarger patient population. EXTEND IMPROVED PATIENT LIFE BY EFFICACY OF IDENTIFYING NEWPharmacogenomics may be applied to expand TREATMENTS APPLICATIONSmarkets for approved drugs with generallyrestricted use because of limited efficacy
  • 36. PROFITING FROM SCIENCE WWW.MATRIX-NI.ORGBENEFITS OFPERSONALISED MEDICINEA PERSONALISED APPROACH TO MEDICINE THEREFORE OFFERS THEPROSPECT FOR SIGNIFICANT BENEFITS FOR EACH OF THE MAJORSTAKEHOLDER GROUPS - PATIENTS, GOVERNMENTS, AND INDUSTRY.THESE ARE SUMMARISED BELOW.GOVERNMENT/HEALTHCARE SYSTEMS PATIENTS INDUSTRYDetect disease at an earlier stage, when it is Effective and specific therapies Improve the selection of targets for drugeasier and more economic to treat effectively discovery Less risk of adverse effectsRational therapeutic decisions based on Reduce the time, cost and failure rate ofpathomechanism of disease rather than on Less time lost compared to trial and error clinical trialstrial-and-error approach approach to treatment Monopoly in a specified segment of theIncorporate diagnostic guidance to treatment Lower cost of treatment (in the longer term) market - early entry and longer dominance of market niche; no competition from genericsReduced adverse drug reactions and Facilitates preventive medicinecomplications of treatment Increased drug effectiveness will command Improvement of quality of life higher pricesShift the emphasis in medicine from reaction toprevention Increased revenues from combination of diagnostics packaged with therapeuticReduce the overall cost of healthcare productsIncreased professional satisfaction Increase patient compliance with therapy prescribed Revive drugs that failed clinical trials or were withdrawn from the market Expanding demand for enabling products and technologies, such as ICT, Agri-food, nanotechnology.
  • 37. PAGE 37KEY MARKET DRIVERS ANDCHALLENGES TO DEVELOPMENT -PROGRESS OF SCIENTIFIC CAPABILITYKEY KEYDRIVERS CHALLENGESScientific progress Advances in technology and Mapping of the genome is still inPractical pharmacogenomics has only become management of health information its infancypossible in recent years due to whole genome Costs of genomics sequencing and Recent research has shown that there issequencing and rapid gene characterisation. bioinformatics analyses are decreasing, whilst substantial undescribed variation in theBy testing for gene variation, gene expression, their capabilities are expanding substantially. human genome which has implications forproteins and metabolites it is now possible personalised genome sequence as reliableto find new uses for existing drugs, enhance The development and use of semantic ‘reference’ human genomes will be required.efficacy of new drugs with the aid of molecular technologies which will enable scientists In addition, other research has shown thatdiagnostics and expand the area of prevention to move seamlessly from one database to there are large scale disparities in the DNAwith predictive medicine. another and connect genomic, proteomic and of healthy people revealing a largely ignored metabonomic data with clinical data along source of genome variation.Declining cost of sequencing the with increased capability of predictive analyticshuman genome which will identify trends and patterns and Availability of bio-banksCurrently it costs nearly $1 million to sequence predict future outcomes. Ideally researchers should have an extensivethe 3.2 billion base pairs of DNA found in tissue repository from which they can pullhumans. Therefore, large scale sequencing More and more government initiatives to move material to determine genetic markersis carried out mostly at special sequencing patient records onto electronic format - responsible for specific disease states. Somecentres and is restricted to major expensive for example the UK aims to have its health countries, but not all, have established bio-projects. The US NIH’s National Human information system operational by 2012, US banks and this shortage of research materialGenome Research Institute (NHGRI) is by 2014. could prove to be a limiting factor in thesupporting research into breakthrough development of personalised medicines.technologies that will enable a human-sizedgenome to be sequenced for $1,000 by 2015. Non-genomic factors in the developmentThe process can then be used in routine of personalised medicinemedical tests and allow physicians to tailor Although Personalised Medicine is considereddiagnosis, prevention, and treatment to a to be mostly based on pharmacogenomics,patient’s individual genetic makeup. a number of other factors that vary among individuals need to be taken into consideration, such as: circadian rhythms, cytomics, intestinal microflora and role of drug delivery in Personalised Medicine.
  • 38. PROFITING FROM SCIENCE WWW.MATRIX-NI.ORGKEY MARKET DRIVERS ANDCHALLENGES TO DEVELOPMENT -ADOPTION IN HEALTHCARE SYSTEMSKEYDRIVERSShift to prevention and early intervention Bid to reduce cost associatedin a bid to manage spiralling costs with Adverse Drug ReactionsWith an ageing population, current healthcare In the US Adverse Drug Reactions (ADRs) aresystems cannot be sustained long term, and responsible for some 100,000 drug-relatedalternative models are required. The bias deaths and 2.2 million hospitalisations pertowards treatment will become increasing year, representing a cost to the economyunsustainable and there will be a growing of over $100 billion. Deaths in England andemphasis on promoting wellness rather Wales from prescription errors and ADRs havethan managing illness. As a consequence, increased 500% over ten years, resulting inPersonalised Medicine and the information it 1,100 deaths in 2002.provides could underlie a healthcare strategyfocused on prevention and early intervention Pharmacogenetics offers the opportunityrather than reaction. to reduce some of the burden of ADRs by identifying patients at high risk, leadingCurrent drugs are not effective for either to reduced dose or use of alternativeall patients treatments.It is considered that blockbuster drugs maybe efficacious in only 40-60% of the general The 2004 General Practitioner contractpopulation. Essentially traditional drugs cannot links remuneration with clinical outcomes indifferentiate among different types of patients the areas of cardiovascular disease, stroke,(Source PwC Personalised Medicine). In the asthma, diabetes and epilepsy. These areUnited States, it is currently estimated that difficult challenges for the practitioner and50% of individuals fail to respond to drug would likely welcome the future promise oftherapies as initially prescribed. pharmacogenetics to deliver better-targeted medicines and therapies.
  • 39. PAGE 39KEYCHALLENGESPayment/Reimbursement policy Regulatory frameworkPersonalised Medicine tends to be more Pharmaceutical industry governance andexpensive than other treatments - already regulations are currently built around themany primary care trusts in the UK have blockbuster business model and strategy - forrefused to fund treatment with Herceptin (for the last 40 years. Clear guidelines will needbreast cancer) citing cost issues. to be in place to foster innovation and to build confidence in the process by which productsAt the same time, national healthcare services are developed and regulated. In addition, ifand private insurers generally do not have a much higher number of drugs are to bepolicies to cover pre-emptive care. More clinical approved than previously then this could pushdata is required on the health outcomes and the regulatory bodies’ ability to cope, in theircost benefits for predictive screening and current structures.associated treatments, to justify coverage.Ultimately, a lack of clarity over who willpay for these drugs and tests may limit thedevelopment of personalised therapies.Education and resourcesExtensive education and resources will berequired to implement Personalised Medicinein everyday care facilities. This is pertinent forall the components along the healthcare chain- from medical schools’ curricula, to practiceswithin GPs and other healthcare providers.Ethical frameworkEthical and privacy concerns regardinggathering, storing and using geneticinformation. The implications of being identifiedas predisposed towards a certain conditionor non-responsive to available treatmentsmay impact upon insurance coverage, workopportunities etc.
  • 40. PROFITING FROM SCIENCE WWW.MATRIX-NI.ORGKEY MARKET DRIVERS ANDCHALLENGES TO DEVELOPMENT -ADOPTION BY INDUSTRYKEY KEYDRIVERS CHALLENGES1. The blockbuster model* of ‘one drug 3. Financial pressure is mounting Scale of adoptionfits all’ is under pressure Pharmaceutical companies come under Some large pharmaceutical companies remainIt is increasingly recognised by the increasing pressure from governments to sceptical about adoption of Personalisedpharmaceutical industry that better defining reduce prices. Medicine on an all-encompassing scale forthe target patient population would enhance a number of reasons: scientific barriers, feareffectiveness and safety of drugs. Molecular Pharmacogenomics could reduce the most that addressing individual niches implies adiagnostics and Pharmacogenomics are cost intensive part of new drug development, multiplication of R&D costs, and uncertaintybeginning to provide the tools that allow better clinical trials. Stratifying clinical trial over the reimbursement prospects.patient profile and control and monitoring of participants, to include those most likely todrug reaction. benefit from the drug, will enable more specific Industry can be expected to continue to favour results with a smaller number of patients and, drug candidates that avoid the effect of genetic2. The need for enhanced pace of most importantly, may reduce or eliminate variation. However, where that is not possibleinnovation adverse events. Estimates state that this (for example in cases of limited efficacy levelsThe impact of patents ending and the approach could reduce clinical development and high ADRs), the development of drugs withaccelerated entry into market of ‘me too’ time from 8-12 years to 3-5 years. an associated diagnostic test is expected todrugs causes a further dent in a blockbuster become routine in the next ten to twenty years.drug/company’s profitability. There has beenlittle apparent innovation in the last number Perceived fragmentation of drug marketsof years and this dearth of new products is Segmentation of a common disease intodebilitating for pharmaceutical companies who subcategories on pharmacogenomic basismust continually seed their product pipeline might create a small population for a certaindue to the significant cost and time to market drug (known as the ‘orphan drug syndrome’).of a blockbuster drug. The economic impact of a reduction in market size is believed to be overcome byPharmacogenomics based drugs would the monopoly that can be established withinprovide and enhance the pipeline. Although the each niche and the higher product price that ismarkets may be smaller, there will be more of consequently chargeable.them. Pharmacogenomics could also be usedto reintroduce terminated late stage products Intellectual property ownershipback into clinical trials to try to identify the A number of issues arise as bio-techgenotypic reason for the product’s failure. companies, life science companies, clinical centres and pharmaceutical companies work closely together: Who owns the intellectual property rights? How should these be shared?*A block buster drug is currently defined as one worth more than $1 billion annual sales, and taking 8-12 years to reach market.
  • 41. PAGE 41THE MARKET FOR PERSONALISEDMEDICINE IS MULTIFACETEDTHE MARKET FOR PERSONALISED MEDICINE IS MULTIFACETED,WITH OVERLAPS BETWEEN COMPONENTS AND DISCIPLINES,AND INTERDEPENDENCIES WITH ASSOCIATED SECTORS - E.G.PHARMACEUTICAL, ADVANCED MATERIALS, INFORMATIONTECHNOLOGY ETC. THE DIAGRAM BELOW CAPTURES THE MAINCONSTITUENTS OF THIS COMPLEX SECTOR.Markets & Technologies Underlying DisciplinesMolecular Diagnostics Personalised Therapies Disease Areas GenomicsDNA Sequencing Pharmaceuticals Cancer PharmacogeneticsGene expression profiling Nutraceuticals Diabetes PharmacogenomicsSNP Genotyping Recombinant human proteins Obesity PharmacoproteomicsBiochips and microarrays Therapeutic monoclonal antibodies Cardiovascular PharmacometabonomicsBiomarkers Gene and cell therapy Central nervous systemMolecular imaging Personalised cancer vaccines Osteoarthritis etc. Systems biologyNanodiagnostics etc. Antisense therapy etc. Bioinformatics NanotechnologyTHE PARADIGM OF PERSONALISED MEDICINE RISK PREVENTION TARGETED ASSESSMENT MONITORING DIAGNOSIS THERAPY RESPONSE MONITORING EARLY DETECTION TESTING
  • 42. PROFITING FROM SCIENCE WWW.MATRIX-NI.ORGCOMMERCIAL PROSPECTSThe market value forecasts for Personalised Cancer is the area generating theMedicine vary across industry sources. They greatest interest for pharmacogenomicall project significant growth in the longer term, therapies, because it is a very complex andalbeit the timescale for realisation may differ heterogeneous disease which requires betterfrom one source to another. Exact market size classification, and because the therapiesforecasts are difficult to pinpoint for two main currently available are by and large ineffectivereasons: and disruptive for patients. Strong demand• The pace of market growth is dependent is also anticipated from the fields of central on scientific advancements, and the nervous system disorders, cardiovascular swiftness of industry and government disease and inflammatory disease. developing a policy framework that would ease its adoption in mainstream practice; The commercial opportunity from Personalised and Medicine can be viewed as coming from four• Defining the market growth added by key areas: personalised medicine technologies • Molecular diagnostics as a stand-alone is difficult to dissociate from the overall market; pharmaceutical and other associated • Remarket of existing drugs (generic disciplines which it interconnects with. and patented); • Development of new biologic drugs; andFor example, Jain Biotech anticipates the • Development of new therapies, suchmarket value to rise from $11.5 billion in as cell therapy, gene therapy, monoclonal2006 to $40.5 billion by 2015. At the same antibodies etc.time, the Technology Strategy Board quotesan estimated market value of $500 billion for All segments offer vast and growing prospects,regenerative medicine alone. albeit they are progressing at different paces. For example, whilst the molecular diagnosticsPharmacogenetics is unlikely to revolutionise or market is more advanced, the development ofpersonalise medical practice in the immediate individualised drugs and therapies is still in itsfuture. Rather it will be a gradual process; as infancy, thus making it more difficult to forecastresearch identifies sub-groups of common the associated market value.diseases based on different genetic orenvironmental causes, and as the technology There is considerable overlap among theof applying information derived from complex components, since all involve common fieldsmultifactorial systems in the clinical context, it and techniques, and are inter-related. Forshould become possible to introduce genetic example, molecular diagnostics will increasinglytesting to predict people’s response to at become integrated in drug formulationleast some drugs. Appropriate trials and cost development, as a pharmacogenomic testanalyses will first have to be performed on a would be required to predict therapy responsecase-by-case basis. based on a patient’s genomic profile. Market size data available for individual fieldsAssuming a scenario where Personalised and technologies is summarised in the tablesMedicine will grow to account for a quarter overleaf.of total pharmaceutical market value, thisindicates a market potential in excess of $200bn. (By 2020 the pharmaceutical market isestimated to be worth between $800 billion to$1.3 trillion).
  • 43. PAGE 43EXAMPLES OF SUCCESSFUL PERSONALISED MEDICINE DRUGS,TREATMENTS, AND DIAGNOSTICSTHERAPY BIOMARKER/TEST INDICATIONHerceptin® (trastuzumab) HER-2/neu For the treatment of patients with metastatic breast cancer whose tumors overexpress Receptor the HER2 protein and who have received one or more chemotherapy regimens for their metastatic disease.Anti-retroviral drugs TruGene®-HIV 1 Guides selection of therapy based on genetic variations that make the HIV virus Genotyping Kit resistant to some anti-retroviral drugs.Cancer treatment regimens Oncotype DXTM Quantifies the expression of 21 genes linked to the likelihood of breast cancer 21-gene assay recurrence in women, and the magnitude of benefit from certain types of chemotherapy and hormonal therapy.Camptosar® (irinotecan) UGT1A1 Colon cancer: “Variations in the UGT1A1 gene can influence a patient’s ability to break down irinotecan, which can lead to increased blood levels of the drug and a higher risk of side effects.”Drugs metabolised by cytochrome Amplichip® FDA classification 21 CFR 862.3360: “This device is used as an aid in determiningP450 CYP2D6/ treatment choice and individualising treatment dose for therapeutics that are CYP2C19 metabolised primarily by the specific enzyme about which the system provides genotypic information.”Gleevec® (imatinib mesylate) c-KIT Gleevec is also indicated for the treatment of patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors.Immunosuppressive drugs AlloMap® Monitors patient’s immune response to heart transplant to guide immunosuppressive gene profile therapy.Pharmaceutical and surgical BRCA 1,2 Guides surveillance/preventive treatment based on susceptibility risk for breast andprevention options and surveillance ovarian cancer.Pharmaceutical and lifestyle Familion® Guides prevention and drug selection for patients with inherited cardiacprevention options 5-gene profile channelopathies such as Long QT Syndrome (LQTS), which can lead to cardiac rhythm abnormalities.Pharmaceutical and surgical p16/CDKN2A Guides surveillance/preventive treatment based on susceptibility risk for melanoma.treatment options and surveillanceTamoxifen Oestrogen receptor “The oestrogen and progesterone receptor values [in breast cancer patients] may help to predict whether adjuvant tamoxifen citrate therapy is likely to be beneficial.”*This list is not intended to be comprehensive, but reflects commonly used products as of September 2006. Chart is based on research and industry sources.BCR-ABL = breakpoint cluster region – Abelson; BRCA 1,2 = breast cancer susceptibility gene 1 or 2; c-KIT = tyrosine kinase receptor; CYP = cytochrome P450 enzyme; HER2 = human epidermal growthfactor receptor 2; TPMT = thiopurine S-methyltransferase; UGT1A1 = UDP-glucuronosyltransferase 1A1
  • 44. PROFITING FROM SCIENCE WWW.MATRIX-NI.ORGANTICIPATED SECTOR DEVELOPMENTPresymptomatic TreatmentIntegrated Healthcare Personalised 2010+ 2020+Automated Systems MedicineRational TherapiesBioinformatics Evolving 2005-2010 2010-2020Genetic Screening MedicinePharmacoproteomicsPharmacogenomicsPharmacogenetics Current 2005 2005Molecular Diagnostics MedicineEmpirical Treatments © Jain Pharma Horizon Panel Biotech estimatesThis diagram indicates the anticipated evolution overcrowded and there is need for these • Health insurance industryof the sector on two different timescales: services in the pharmaceutical sector. • Venture capital companiesone provided by an industry report, and one • Medical devices, e.g. Imagingadjusted by the Panel, who have a more Development of Personalised Medicine will • Miniaturisation technology (inc in testingcautious view of the rate of commercial growth also drive new business opportunities in related kits), sensorswithin this sector. branches and industries, e.g.: • Point-of-care diagnostics • ICT - Providers of information storageSome technologies such as molecular and data analysis technologies; Genetic Collaboration between global pharmaceuticaldiagnostics and SNP genotyping already information databases players and smaller biotechnology companieshave a fast rate of growth (in excess of 20% • Consultants with background in medicine and academic researchers has increased inper year). and biotechnology recent years, and it is expected to intensify in • Clinical laboratories the future.Companies providing toxicogenomic and • Intelligent materials, such aspharmacogenetic services also enjoy good nanotechnologyprospects, because the field is not as • Healthcare counsellors
  • 45. PAGE 45COMMERCIAL PROSPECTS -TECHNOLOGY MARKETSGROWTH OF MARKETS RELEVANT TO PERSONALISED MEDICINE - SUMMARY BASEDON DATA COLLATED FROM A NUMBER OF INDUSTRY REPORTS.TECHNOLOGY MARKETS 2006 (BILLION $) 2010 (BILLION $) 2015 (BILLION $) SOURCEMolecular Diagnostics 7.3 12.0 22.5/92.1 (2016) Jain PharmaBiotech 2007, Kalorama, 2007Pharmacogenomics 1.9 2.5 3.8 Jain PharmaBiotech 2007SNP Genotyping 1.3 2.0 3.5 Jain PharmaBiotech 2007Pharmacogenetics 0.9 1.8 2.3 Jain PharmaBiotech 2007Pharmacoproteomics 0.6 1.5 3.8 Jain PharmaBiotech 2007Point-of-Care Diagnostic Testing 9 11.0 15.0 Jain PharmaBiotech 2007Genetic Screening 0.9 2.1 4.4 Jain PharmaBiotech 2007Biomarkers 5.0 (2007) Waldman & Terzic 2007Biochips/Microarrays 0.6 4.0 Piribo, 2007Monoclonal Antibodies 16.0 Arrowhead, 2007RNAi 0.4 (2005) 0.9 Jain PharmaBiotech 2007Nanohealthcare products 50.0 (2011) 107.0 (2016) Freedonia 2007Nanomedicines 41.0 (2011) 84.0 (2016) Freedonia 2007Biomaterials 22.2 (2007) 30.9 (2012) Business Communications Company 2007Systems Biology (products & 0.8 (2008) Drug & Market Development Publishing 2004services)Bioinformatics 3.0 RNCOS 2006Epigenomics 0.3 4.1 (2012) Business Communications Company 2007Metabolomics 2.0 (2012) Jain PharmaBiotech 2007Functional Foods 72.0 Nutrition Business Journal, 2005Regenerative medicine $500bn (2020+) Technology Strategy Board 2007The figures are not totalled because of considerable overlap between markets, e.g. some technologies such as biochips are part of the overall diagnostic market.
  • 46. PROFITING FROM SCIENCE WWW.MATRIX-NI.ORGCOMMERCIAL PROSPECTS -GEOGRAPHICAL MARKETSMARKETS FOR PERSONALISED MEDICINE FORSELECTED THERAPEUTIC AREAS Cancer is the area generating theTHERAPEUTIC AREAS 2006 ($ BN) 2010 ($ BN) 2015 ($ BN) greatest interest for pharmacogenomic therapies, because it is a very complex andCancer 3.9 10.5 16.2 heterogeneous disease which requires better classification, and because the therapiesNervous system 2.5 5.1 7.1 currently available are, by and large, ineffective and disruptive for patients.Cardiovascular system 1.2 2.2 3.5Genetic disorders 0.6 1.3 3.3Pain 0.4 0.7 1.2Inflammatory disorders 1.3 2.5 3.5Miscellaneous diseases 1.6 2.7 5.7Total 11.5 25 40.5Source: Jain PharmaBiotech, Personalised Medicine: Scientific and Commercial Aspects, July 2007
  • 47. PAGE 47FORECAST GEOGRAPHICAL MARKETS FORPERSONALISED MEDICINE This is still an immature market; there are onlyREGIONAL MARKETS 2006 ($ BN) 2010 ($ BN) 2015 ($ BN) a few personalised medicines and therapies in the marketplace at present. Some of these areUSA 7.0 13.2 19.5 combinations of therapeutics and diagnostics. Their number, however, is anticipated toEurope 2.7 6.1 10.2 increase during the next decade.Japan 1.1 1.5 2.0 In addition to the development of new drugs, the market will also see some of the existingRest of the world 0.7 4.2 8.8 drugs becoming used in a personalised manner.Total 11.5 25 40.5Source: Jain PharmaBiotech, Personalised Medicine: Scientific and Commercial Aspects, July 2007
  • 48. PROFITING FROM SCIENCE WWW.MATRIX-NI.ORGNORTHERN IRELAND CAPABILITY -LIFE SCIENCES SECTORThe primary focus of the Life and Health into the development of the Personalised The clinical sector capability could play aSciences Horizon Panel was to consider Medicine sector; these are: Pharmaceuticals, major role in supporting the development ofthe global market opportunities within this Diagnostics and Clinical research organisations. Personalised Medicine locally. The clinicalsector. A parallel study commissioned by The boundaries between fields are expected strengths stem from a number of key areas:the broader Matrix panel examined the to blur in the future, as more companies begin • Clinical research: through the sevenexisting Northern Ireland capability within to incorporate a genomics-based approach to Recognised Research Groups (Cancer,technology intensive sectors (Life sciences, product development. Child Health and Welfare, Vision, Diabetes,Advanced Manufacturing; Advanced Materials; Endocrinology and Nutrition, NeuroscienceSustainable Production and Consumption, Northern Ireland lacks the presence of large and Mental health, Infectious Diseases;including energy technologies, and Information multinational companies that would help drive Trauma and Rehabilitation), the Northernand Communications Technology). BioBusiness demand locally and enhance the profile of the Ireland Clinical Research Network, TheNorthern Ireland has also conducted cluster. Experimental Cancer Medicine Centre, anda capability review of the local Health the Clinical Research Support Centre.technologies cluster in 2006. The academic sector in Northern Ireland • Clinical data - The Northern IrelandThis section provides a snapshot of the local offers a strong scientific base. There are over Longitudinal study, the Nucleic Acidcapability profile across the ABC sectors, 33 relevant research clusters and groups Extraction Centre (extraction and storagewith full details available in the two preceding across QUB and UU, carrying out high of DNA and RNA to support clinicalcapability studies. standard research in areas such as molecular genetics research) biology, cell biology, genomics, proteomics, • Clinical practice: clinical trials expertise,Life Sciences Capability metabolomics, bioimaging, bioinformatics, clinical chemistry and pathology, etc.A number of key building blocks in the systems biology, human nutrition etc.development of Personalised Medicine This diagram summarises the scientificalready exist in Northern Ireland, across the Understandably, the largest part of the capability in the Health technologies sector inprivate, academic and clinical (A B C) sectors, research carried out within the two universities Northern Ireland and the level of commercialalbeit they have developed by and large tends to be fundamental in nature. Most of the exploitation; the dotted circle highlights thoseindependently from each other and are lacking commercial research undertaken tends to be components that are of particular relevance forcritical mass compared to other regions. exported to leading companies in the UK and the development of Personalised Medicine. further afield. Whilst collaborative programmes The diagram suggests that in areas such asIn the business sector, the emerging with local companies are expanding (e.g. clinical trials and biotechnology the commercialbiotechnology sector is represented by a Almac, Warner Chilcott, Diabetica), there is sector is more advanced in successfullynumber of leading edge companies that scope for enhancing further the links with the exploiting the local scientific capability, However,operate entirely or in part in this space. local private sector. a focused effort is required to more fully realiseFour of them are longer established (Almac the potential offered by the scientific strengths inDiagnostics - Cancer Diagnostics and An emerging research area in the FE sector areas such as systems biology and diagnostics.contract genomic services; Fusion Antibodies is functional foods, which focuses on the This could be achieved through collaborative- antibody-based therapeutics for cancer and convergence of pharmaceutical, health and programmes for knowledge and skill transfer,recombinant proteins contract services, Randox agri-sciences and aims to develop a holistic technology licenses, or creation of welllaboratories – protein biochip multinanalyte system, integrating genomics and customised supported spin-off companies.diagnostics; Warner Chilcott – feminine care diets through to packaging and environmentalproducts) and two are smaller, more recent management. Where the local capability is weaker or gapsspin-off companies (Diabetica - Diagnosis and exist, Northern Ireland needs to be proactivetreatment of obesity and diabetes, and Gendel There is a call for the education sector overall to in sourcing the necessary skills or resources,Ltd - Cancer treatment device). respond more closely to the skill needs within the be it through acquisition (e.g. target leading industry, for example in terms of a mix of pure scientists) or collaborative programmes withThe private sector also consists of a number and applied science specialisms, recognition of external research and commercial partners.of companies from related fields of life converging technologies and fields, and volumesciences that can both benefit from and feed and quality of graduates and PhDs.
  • 49. PAGE 49Whilst collaboration programmes between the Hospital), Advanced Biological Imaging Centre exploitation capability of the two sectors.local ABC sectors have intensified in recent (North-South Collaboration). DETI’s Technology Capability Study profilesyears, most of the local players recognise the these complementary sectors in more detailopportunity for further partnerships for mutual Complementary capability and indicates that there is scope for furtherbenefit. Examples of significant joint initiatives Adoption of Personalised Medicine in Northern strengthening the level of cross-sectoralinclude: Nanotec Northern Ireland (QUB and Ireland should also draw on local capability collaboration in Northern Ireland, forUU), Northern Ireland Clinical Research Facility in complementary sectors and technologies, mutual benefits.(QUB, UU and Royal Group of Hospitals Trust particularly ICT (e.g. bioinformatics) and– due to commence in 2010), ABC Research Advanced Materials (e.g. nanostructures). TheInnovation Facility (UU and Altnagelvin diagrams overleaf summarise the scientific andLIFE SCIENCES CAPABILITY IN NORTHERN IRELAND Identify how to improve capability Support and Encourage Clinical Potential impact on NI economy trials Biotechnology Small Strong Medical disposals Medium Agribiology Exploitation Capability Biotechnology Major services Pharmaceuticals Medical devices diagnostics Timescale to realise impact Systems Current (<2 years) biology Weak 2-5 years 5-10 years 10 years Consider strategically how to support Build exploitation pathway Weak Scientific Capability StrongTechnology Capabilities Study for Northern Ireland, MATRIX, 2007
  • 50. PROFITING FROM SCIENCE WWW.MATRIX-NI.ORGNORTHERN IRELAND CAPABILITY -COMPLEMENTARY SECTORSICT CAPABILITY IN NORTHERN IRELAND Identify how to improve capability Support and Encourage Telecommunications Potential impact on NI economy Application Software Small Strong IT Services Medium Exploitation Capability Major Product Hardware Software and Systems Timescale to realise impact Digital Content Computational Current (<2 years) Science/ Bioinformatics Weak 2-5 years 5-10 years IC Design Knowledge 10 years Engineering Consider strategically how to support Build exploitation pathway Weak Scientific Capability StrongSource: DETI Technology Capability Study, Nov 2007
  • 51. PAGE 51ADVANCED MATERIALS CAPABILITY IN NORTHERN IRELAND Identify how to improve capability Support and Encourage Nanostructured materials Multifunctional materials Potential impact on NI economy Composites Coatings/metals/ Small Strong polymers Electronic Medium Magnetic materials Exploitation Capability materials Biomaterials Major Ceramics Computational Science Timescale to realise impact Current (<2 years) Catalysts 2-5 years Weak 5-10 years Superconducting 10 years Consider strategically how to support Build exploitation pathway Weak Scientific Capability Strong
  • 52. PROFITING FROM SCIENCE WWW.MATRIX-NI.ORGTHE OPPORTUNITYFOR NORTHERN IRELANDAs the market intelligence indicates, in thelonger term this sector has the potential to Northern Ireland to become a centre for Integrated Research & Developmenttransform the way medicine is delivered. Many in Personalised Medicine to:nations have identified the opportunities offered Deliver services to the PM industry;by this high risk - high reward sector, and Commercialise innovations & form spin-outsinvestment in research and commercialisation Achieve global recognition for excellence in a number of strandsin this space has intensified in recent years. Act as Northern Ireland ‘shopwindow’ to the international communityThe Life and Health Sciences Horizon Panelhas identified an opportunity for NorthernIreland to carve out a share of this growingmarket, by becoming a centre for Integrated Local AppliedResearch & Development in Personalised ABC Players ResearchMedicine. This would help fuel the developmentof Personalised Medicine in Northern Ireland,and place the local cluster on the internationalmap in this highly dynamic sector. Thecompetitive advantage would be conferred by Leading Developmentthe integrated nature of the services provided, Pharma & Biotechharnessing academic scientific expertise, Companiesclinical data and practice and a focus oncommerciable outputs.This will allow the local cluster to develop in a Medical Applied Researchnumber of ways: Charities & Development• Development of existing businesses, by accessing expertise and knowledge from the local and international scientific community;• Attracting high quality research and FDI Enabled by Northern Ireland Scientific & Clinical Capability to Northern Ireland; and• Generating new company spin-outs from the existing science base.
  • 53. PAGE 53REALISING THE PERSONALISED MEDICINEOPPORTUNITY FOR NORTHERN IRELANDThe Panel believes that the sector could be Being open to the full spectrum of the communicate with a single voice and engagestimulated locally by creating the environment Personalised Medicine technologies and in a coherent manner with the local supportfor the initiation of commercially-targeted practices, would stimulate interest from across mechanisms and stakeholders, to promoteR&D projects, focussing funding and support the sector and allow the best economically skills development and raise the profile of thetowards applied research not elsewhere funded valuable proposals to emerge. local cluster.and the gap between initial Proof of Conceptand Phase II Clinical trials. A highly focused approach to the development of this exciting sector would help drive closerIt is believed that, given the recent cooperation and capability transfer acrossdevelopments in local infrastructure, a ‘virtual’ the ABC boundaries, thus enhancing thesupport mechanism would be sufficient, exploitation capability within the local sectorproviding leadership, funding and expert and raising its position in the internationalsupport rather than new physical infrastructure. arena. The sector would also be able toPOTENTIAL HOLISTIC APPROACH TO REALISING THE PERSONALISED MEDICINEOPPORTUNITY IN NORTHERN IRELAND Project development and support Facilitate Raise profile collaboration and of NI capability partnerships Facilitate skills development
  • 54. PROFITING FROM SCIENCE WWW.MATRIX-NI.ORGKEY STAKEHOLDERINPUTS & OUTPUTSTHE IMPLICATIONS IN TERMS OF COMMITMENT, RESOURCES AND BENEFITS FOR EACH OFTHE LOCAL STAKEHOLDER GROUPS CAN BE SUMMARISED AS FOLLOWS:NI ECONOMY ACADEMIC STAKEHOLDERS BUSINESS SECTOR CLINICAL SECTORInputs Inputs Inputs Inputs• Creating an innovation- and • Academic research staff • Business expertise • A commitment towards business-friendly environment • Enhanced PhD pool • Research expertise & facilities adoption within the local• Help raise the profile of the • Research facilities • Financial investment clinical practice local capability • IT capability • Clinical research expertise• Attract lead scientists from • International research partners • Clinical data abroad and international • Research facilities research partnersOutputs Outputs Outputs Outputs• Development of existing • IP creation, which can be • Extended new product • IP creation, which can be businesses, by accessing commercialised through pipeline commercialised through expertise from the local and spin-out companies or • Reduced R&D costs spin-out companies or international scientific licensing deals • IP creation, which can be licensing deals community • Spin-out companies commercialised through • Improved patient care,• Spin-out companies, • Skills development & export spin-out companies or through rational therapeutic generating associated tax • Enhanced international profile licensing deals decisions rather than trial- revenues and employment • Attract and retain talent and-error approach• FDI traction • Industry cross-fertilisation • Cost savings in the long term,• Emergence and recycling of (e.g. ICT, Advanced Materials, through increasing emphasis local entrepreneurs Agri-food) on prevention and early• International reputation, which intervention in turn generates new business
  • 55. PAGE 55HOME-BASED CARE MARKET -THE OPPORTUNITY FORNORTHERN IRELAND3
  • 56. PROFITING FROM SCIENCE WWW.MATRIX-NI.ORGDEFINING THE MARKETThe terminology and definitions for this market Telecare is usually designed to create home This includes the delivery of medical care,vary across industry sources. The expressions environments which meet the needs of older diagnosis, consultation and treatment, as well‘eHealth’, ‘telemedicine’, ‘telecare’, or disabled people. Specific product examples as health education using interactive audio,‘telehealth’, and ‘assistive technology’ tend to include fall or bed sensors. visual and data communications.be used interchangeably. Secure web messaging and e-visits Assistive devices/AidsA brief description of the key market segments This technology usually acts as an enabler Assistive technology products are designed tomaking up this broad sector is given below. for the previous two areas of remote care. compensate for motor, sensory and cognitive Consumer familiarity with the Internet and difficulties frequently experienced by disabledThe first three market segments concern the e-mail allows for more efficient communication people or older adults. Assistive technologylink between patients in their home and the with medical staff and for novel healthcare encompasses a broad range of devices, fromhealth system, and these fall within the scope solutions. A specific example of an e-visit could “low tech” products such as eyeglasses,of the Horizon Panel’s core proposals. be an email exchange between a doctor and large-print books or a walking stick, to patient. technologically sophisticated products such asTelehealth voice synthesisers, smart seats, and stair-Telehealth monitoring is the remote exchange The market also includes technologies and climbing wheelchairs.of physiological data between a patient at services based exclusively within the healthhome and medical staff at hospital to assist in system (telemedicine) or within the patients’ Intelligent housesdiagnosis, progress monitoring and prevention physical home infrastructure (assistive devices). Intelligent houses provide a number of physicalof various conditions. Specific product These do not form part of the Panel’s core and electronic features which facilitate day-examples include home-based blood pressure proposal, but instead are recommended for to-day activities in the house for older peoplemonitors that relay information to the patients consideration in the longer term. They are or those suffering form certain disabilities. AnGP surgery. Their immediate applications tend defined as follows: example of such a device in a smart home mayto lie in the management of chronic disease be a water tap that can be turned on and off(e.g. diabetes, cardiovascular etc). The Telemedicine using a button panel or a remote control devicepreventative and personal health management Telemedicine refers essentially to doctor-to- rather than the conventional tap.aspects are expected to become more doctor communications, and typically involvespervasive in the longer term. consultations with specialists at a distance (e.g. general hospital or General practitioner toTelecare Specialist doctors, Ambulance staff to AcuteTelecare is the continuous, automatic and Care hospital).remote monitoring of real time lifestyle changesand emergencies over time, in order to managethe risks associated with independent living.
  • 57. PAGE 57KEY DRIVERS AND CHALLENGESIN THE DEVELOPMENT OF THE GLOBALHOME-BASED CARE MARKETKEYDRIVERSIn coming to their conclusion, the Panel Advancement of Technologies andmembers considered the key drivers and IT infrastructureschallenges influencing the development of There is a consensus that healthcare IT canthe global Home-based care market. transform the care delivery systems. IT will form a higher proportion of healthcare budgetsCurrent healthcare systems are as the sector tries to achieve the efficienciesunsustainable seen in other industries;Healthcare systems in the developed worldare under pressure due to an ageing, more Rising expectations of consumerschronically ill population that requires more The developed world population is more educatedand more medical attention. The traditional and mobile. They demand more informationcare delivery model is based on an acute regarding their health status and involvement incare model (disease is only treated when it their healthcare decisions and telehealth can, instrikes) and is bound to healthcare facilities principle, allow them to have both.(patients have to go to hospitals or clinics to betreated). A shift in approach will be required to Adoption of Electronic Health Recordsimprove people’s overall quality of life through (EHR)preventive programmes, whilst at the same The adoption of EHR for more general medicaltime significantly reducing medical costs. record-keeping will act as a further driver of remote health in terms of the requirement toThere are social and financial benefits manage the large the volume and differentassociated with the home care concept types of data (text, sound, picture) that will beComprehensive telecare is anticipated to reduce produced.the scope of institutional approaches becauseit is less costly while also delivering greaterbenefits to people living in their own home.
  • 58. PROFITING FROM SCIENCE WWW.MATRIX-NI.ORGKEYCHALLENGESSlow adoption by healthcare systems Lack of coherent approachAlthough the role that telecare could play in Many telecare pilots and initiatives have beenreducing costs and enhancing independent run independently and on a small scale. Theliving is recognised at strategic level across consequent lack of co-ordination has led toEuropean and other national governments, some technical incompatibility and duplicationadoption in mainstream care is still limited. of effort. At the same time, in the privateThere are a wide range of explanations given sector there is a lack of standardisation andfor this including a resistance to the adoption inter-compatibility between markets andof Information Technology and difficulties in manufacturers.changing reimbursement systems within theGP community. Technology development While currently available telehealth solutionsPolicy issues remain to be addressed are new and exciting, they are alsoA viable model for implementation of telecare undeveloped. As an emerging technology,is yet to be fully defined. Prioritising certain telehealth has not reached its potentialpatients for ‘additional’ services can only be technological capabilities nor has it successfullyachieved against established procedures. This targeted the different aspects of healthcare.is made more complex in circumstances werethe intervention is preventative.Integration into existing healthcare systemTelecare should be an integrated health,housing and social care service, and thisraises a number of administrative and fundingquestions. Integration across public serviceshas so far been slow.Maintaining individual privacyTelecare raises ethical questions aboutsurveillance and possible loss of privacyand autonomy, and legal issues relating toconfidentiality and data protection.
  • 59. PAGE 59DRIVING POLICES ANDINITIATIVES IN THE SECTORWhilst the USA leads in the adoption of funding towards addressing the issues in Northern Ireland. The outcome of thistelehealth technology, given the insurance- around deployment of technology in study was published early in 2008 anddriven structure of the health sector, the healthcare and user-centred delivery; is proceeding with stated support frombenefits of telehealth are becoming of • The ‘Whole System Long Term Conditions DHSSPS, DETI and DEL as well as theincreasing interest to European countries and Demonstrator Programme’ was private sector locally and internationally.the rest of the world. announced in November 2006. This is the Any assessment by the Matrix panel of largest ever pilot of telecare and telehealth the prospects offered by the Home-basedA high number of key driving policies and in the UK, covering three sites: Kent, Care market should consider concurrentlyinitiatives within this sector within the UK, Newham and Cornwall. Funding is worth the outcome of this study.Europe and the wider world have been identified £12 million and will cover a population ofand reviewed as part of this research. Three one million between 2007-2009. The first Examples of projects that have tested andparticular initiatives of direct relevance to the evaluation results from this programme will demonstrated the viability of home-based caremodel proposed by the Panel should be noted: be available early in 2008; are provided below.• In the UK, the Assisted Living Innovation • Locally, the DHSSPS recently supported Platform (ALIP) was launched in a feasibility study on the establishment of November 2007 and promises significant a European Centre for Connected HealthFUNDER PROJECT DESCRIPTION OUTCOMESNorthants Council ‘Safe at Home’ Deployment of a variety of Net saving of £6,458 per Focused on individuals with some assistive devices; 15% of service treatment per person over 21 degree of cognitive impairment or users also received selected months dementia wireless monitoring sensors linked with a telecare response centreWest Lothian Council ‘Opening Doors for Older People’ Participating households were Net average saving of £14,719 Running from 1999: By 2006 supported with a ‘community assisting 2,150 elderly persons package’ which included telecare Saving of £1.9 million annually on (+65) living at home, some with technology, a 24/7 Council run acute care hospital bed days dementia alarm response facility and 10 hours/week of at home health Project’s current target is to keep care services 10,000 people at home; it only needs to keep 40 people out of institution care per year to break evenCroydon Council and South Launched in February 2004 Range of stand-alone assistive The average telecare packageLondon and Maudsley NHS Trust specifically for people with devices and telecare sensors costs over £1,100 per service dementia; now expanded to other linked with a 24-hour response user but achieved savings of over patient groups team operated by a community £7,000 per service user. When alarm service care package costs are subtracted from nursing or residential care fees that would otherwise apply, this is equivalent to annual savings of £12,000/user.
  • 60. PROFITING FROM SCIENCE WWW.MATRIX-NI.ORG COMMERCIAL PROSPECTS OVERALL TELEHEALTH MARKET IN EUROPE AND NORTH AMERICA BY HOME AND CLINICAL SETTINGS (2005-2010)* 7,000 90% Clinical Homecare 6,000 Growth 5,000 Percentage GrowthMillion US $ 4,000 3,000 2,000 1,000 0 0% 2005 2006 2007 2008 2009 2010 The overall market for telehealth in Europe scale of the homecare market will help to 2010, despite having a projected population and North America is anticipated to show rapid power growth at a 91% CAGR. Homecare of 502 million people. growth, rising from of $591 million in 2005 to telehealth in Europe and North America is $5.96 billion in 2010. forecast to reach $5.39 billion by 2010. The European market may be smaller than that in the North America, but it will still show Clinical environments currently form the largest The US is, and will remain, easily the largest very rapid growth, with an expected CAGR of market. This is a more mature market, but national market for telehealth, reaching $4.51 60% over the period. The UK is the largest is still forecast have an 8% CAGR to 2010. billion in 2010. It will also show faster growth single market at $23 million and will grow by This will be driven by both new applications in than Canada at 64% CAGR, compared with 66% CAGR to $286 million in 2010. The ten the traditional remote treatment market and 32% for the latter. This very high growth and new EU nations (NEU 10) will be the fastest the extension to new environments such as large market share are the result of two main growing market, with a CAGR of 69%, but will hospital ICUs. features of the US market: still only reach a value of $60 million in 2010. • Very high overall US healthcare spending, The homecare market is anticipated to show given the private care and insurance-based the highest growth, as installations in the home system; move from trials to full-blown implementations. • High and rapidly growing rates of chronic With 20 million sufferers with Congestive diseases such as diabetes. Heart Failure (CHF), 34 million with Chronic Obstructive Pulmonary Disease (COPD) and In comparison, the entire European market is 46 million with Diabetes, the sheer potential expected to only reach about $1.00 billion by * Source: Datamonitor, Extending the delivery of healthcare beyond the hospital setting, June 2006
  • 61. PAGE 61 TELEHEALTH MARKET IN NORTH AMERICA BY COUNTRY (2005-2010) 6,000 100% Canada United States 5,000 Growth Percentage Growth 4,000 60%Million US $ 3,000 2,000 30% 1,000 0 0% 2005 2006 2007 2008 2009 2010 TELEHEALTH MARKET IN EUROPE BY COUNTRY (2005-2010) 1,200 80% Switzerland 70% NEU 10 1,000 Spain 60% Percentage Growth 800 Rome 50%Million US $ Italy 600 40% Benelux 30% 400 Nordics 20% France 200 10% Germany 0 0% United Kingdom 2005 2006 2007 2008 2009 2010 Growth Source: Datamonitor, Extending the delivery of healthcare beyond the hospital setting, June 2006
  • 62. PROFITING FROM SCIENCE WWW.MATRIX-NI.ORGTHE OPPORTUNITY FORNORTHERN IRELANDThe Life and Health Sciences Horizon Panelrecommends that Northern Ireland becomes Northern Ireland to become the first UK regionthe first UK region committed to the early adopting a real Integratedadoption of a telehealth system within the Home-based Care DeliveryHealth and Social Care practice. This meansestablishing a strong local capability across the Potential Customers/ Potential Activitiestelehealth continuum, and deploy this locally to Beneficiariesachieve whole connectivity between the healthsector and the home within 15-20 years. Northern Ireland Population Support adoption ofThe Panel considers that such a policy will Integrated Care Modelaccrue the following benefits to the NorthernIreland economy:• Economic benefits - the establishment of Northern Ireland as a test bed for new technology is anticipated to attract Foreign Healthcare Sponsor Applied Direct Investment, stimulate indigenous systems Research companies in the sector and create a knowledge base from which export potential can be exploited;• Positioning Northern Ireland as a good Local Advise on Best Practice place to live, hence retaining and attracting Companies people to the local economy;• Improved health and quality of life for relevant patient groups through enhanced independent living; and Large Companies Tender Product• Realisation of cost-savings in the Health, ICT etc deployment local healthcare system, which can be redistributed towards other priority areas within the healthcare system, thus increasing productivity levels. Attract FDI and stimulate indigenous companies Attract Government, Industry and NGO fundingThe illustration provides a high level depictionof the proposed concept.Such an approach would support and helpaccelerate the adoption of home-based carewithin the Northern Ireland. At the same time,it would provide a consistent and coherentmessage to the private sector, encouragingthem to invest within the Province.
  • 63. PAGE 63The Home-based Care market encompasses The Panel concluded that to maximise thea wide range of products and services. The market opportunity in this area, telehealthunderpinning technologies and systems technology should be implemented within ournecessary to deliver those services can be own Health system.sub-divided into four key domains along the • This would allow the DHSSPS to benefittelehealth continuum, as summarised in the from savings achieved from the deliverydiagram above. of health services in this manner, whilst improving patient care; andThe overall aim of the model proposed for • At the same time, it would create anNorthern Ireland is to join-up local capability attractive Whole System Integration Testacross all four of these domains in an Bed for local and international technologyintegrated manner and in a real clinical setting. providers, who could use Northern Ireland as a gateway to UK and European home care export markets.NORTHERN IRELAND POSITION ALONG THE HOMECARE CONTINUUM: WHOLE SYSTEM CONNECTIVITY Medical Devices Home-telecomms Data Analysis Response System Assistive devices Broadband Software solutions Family/carer Sensors ICT Integration Data management Third party service provider Alert systems Physical structure NHS - GP, PCT, ACT, Vital signs monitoring devices Social Services
  • 64. PROFITING FROM SCIENCE WWW.MATRIX-NI.ORGREALISING THE HOME-BASED CAREOPPORTUNITY FOR NORTHERN IRELANDThe Panel considered the market opportunityagainst the four key areas judged to be partof the home-based care continuum. Each ofthe four areas were examined in turn and theopportunities for exploitation considered. Eacharea is considered in more detail opposite.DEMAND VS NORTHERN IRELAND POTENTIAL ALONG THE HOMECARE CONTINUUM Medical Devices Home-telecomms Data Analysis Response System Assistive devices Broadband Software solutions Family/carer Sensors ICT Integration Data management Third party service provider Alert systems Physical structure NHS - GP, PCT, ACT, Vital signs monitoring devices Social ServicesSupport indigenous companies Provide ‘simple’ broadband IT/data management/ Structural organisation connection system or leverage bioinformatics includingBuild partnership(s) with global existing connections nutritional data Take barriers awayleaders Broadband speed to match e.g. NHS Direct capability Effective and efficientFDI opportunities Europe and Japan Link second generation solutions Structure in place that rewards Ensure device fits around the to shortcomings identified in integrated healthcare system family and not vice versa large scale programs engagement
  • 65. PAGE 65Medical Devices Response SystemThe Panel noted that a local capability existed The specific circumstances of each patientwithin Northern Ireland within the medical group and the economic case for each initiativedevice sector. However it was also noted will determine the response system employed.that these companies lacked a scale within The options to consider would include:the market. All of the companies had to seek • Response to be delivered within thean export market as there was currently little DHSSPS; if so, what are the interfacepotential for growth domestically. points - e.g. GPs, Social services, others; • Response to be provided by a familyIt was acknowledged that a strategy could be member;developed to build upon the existing capability • Response to be delivered by a 3rd partyby seeking additional foreign direct investment provider; if so, what type of activitiesinto the province and by developing partnership specifically and associated governance; oragreements. • Combination of service delivery;Home-based telecommunications The Panel considered that the most importantThe development of a home-based care market success factor was not the creation ofwill require a high speed telecommunications infrastructure. Instead, it was ensuring thatinfrastructure. The panel members judged that the existing response resources (e.g. GPNorthern Ireland was already well served in surgeries, District nurses etc) were motivatedthis area compared to other regions in the UK and incentivised to adopt this way of working.given the existing 100% broadband coverage.However, the ability to generate a economic Government supportcapability by developing companies to compete The announcement made in January 2008,within the technology infrastructure sector was regarding the development of an Europeannot judged to be strong given the dominance of Centre for Connected Health supportedthe existing technology competitors. by three Northern Ireland government departments, is a powerful springboard forData Analysis future development of the concept. The projectThe development of a Home-based care has significant buy-in from the private sectormarket will require a capability in managing and locally and internationally.analysing large volumes of data. The Paneljudged this was not an area were a significantcapability existed locally at present but frompreliminary discussions with the Horizon ICTPanel it was an area that could be furtherexplored for future investment.
  • 66. PROFITING FROM SCIENCE WWW.MATRIX-NI.ORGNORTHERN IRELAND CAPABILITYA few examples of the Northern Ireland Tomcat Systems of public and private sector partners. Theexisting capability in this sector are provided Provide tailored computerised information project is led by Fermanagh-based McElwainebelow. systems for managing all the clinical and SMART Technologies. Valentia Technologies administrative records of today’s hospital (Ireland based) will deploy its CareMonXTMPrivate sector companies departments. Home Appliance system in conjunction with McElwaine’s newly-opened monitoring andHealth Tek A number of other companies operate services centre in Lisnaskea to provide elderlyWork in partnership with hospitals and other in complementary areas, such as: IT, clients with a range of integrated healthcareclinical units to provide clear, high quality, real telecommunications (BT), precision and social services via a simple-to-use touchtime data on a variety of patient behaviours. engineering, contact centres, medical devices screen appliance that will be installed inProvide devices that automatically update a etc. clients’ homes. The monitoring and responsedatabase at a control centre as the patient service will utilise a Bosch telecommunicationsuses them. Academic & Clinical Developed platform and homecare monitoring devices. Technologies A University of Ulster team is also involved inQuality Health Care at Home developing new telehealth components.Use technology to remotely monitor patients Diabetes - Di@logwith Congestive Heart Failure, COPD, Created by the UU Infor-MED team of PhD Nestling Technologies projectDiabetes and CHD. Quality Healthcare monitor students and consultants and Dr Roy Harper, A collaborative project between the Universitydata transmitted to them from the patients Ulster Hospital. The device allows doctors to of Ulster and the Dundalk Institute ofhome. monitor and track diabetes patients from home Technology. Aims to provide environments using intelligent spoken dialogue technologies that promote and sustain independence andBootRooms.com which can relay patient data directly to the well-being for older people through the fusionExperts in robotic home automation which clinic through telephone conversations. The of innovative accommodation, technology andincludes adjusting the security, cooling, heating product has recently entered home patient integrated community care-based approaches.and lighting of a home automatically. trials. The project will run over a five year period and will consist of an integrated care demonstrationST&D Ltd Neurological conditions model of 12 homes, in Dundalk.Develop and manufacture non-invasive vital Dr David Craig, QUB and Dr Victor Patterson,signs monitoring systems. UU - involved in a major EU-funded Knockeden project international project which aims to develop and Based on a partnership between CraigavonJames Leckey Design prototype a portable, easily configurable, device & Banbridge Community HSS Trust , FoldDesign and manufacture positioning equipment that is available to those people with memory Housing Association and Tunstall Group.for children with cerebral palsy, muscular lapses and other symptoms of early mild Telecare devices such as epilepsy sensorsdystropy, spina bifida and other special needs. dementia and associated disorders. were used to monitor patients remotely.Bluescope Medical Technologies Cardio conditions Going Home, Staying HomeDevelop products for the cardio-pulmonary Dr Frank Casey, UU A small scale programme supported by Foylemonitoring and care of patients including Health & Social Services Trust, the Northerna non-invasive device for the long term Similar to other regions of the UK, a number Ireland Housing Executive and Fold Housingcontinuous recording and monitoring of breath of telecare pilots and technology development Association. The project run between 2002-and heart sounds. programmes have taken place in Northern 2004 and involved three parts: telecare (tested Ireland as well in recent years. Examples a number of assistive devices in an elderlyDiabetica include: household), telehealth (reablement of twoInnovative research in diabetes and obesity patients discharged early from hospital) andtherapeutics. Lisnaskea Information & Technology linking a GP practice to 10 users. Enterprise (LITE) Centre (Source: www.tis.bl.uk) A cross-border initiative involving a number
  • 67. PAGE 67ECONOMIC BENEFITSCommercial benefits Furthermore the Panel considered theThe economic return from this sector must evidence presented within a report preparedbe viewed not only from the perspective by Professor Barlow, Imperial College London,of the savings that can be achieved within entitled ‘A systematic review of the benefits ofthe local healthcare budget, but also from home telecare for frail elderly people and thosethe perspective that, by generating a local with long-term conditions.’ J Telemed Telecare.capability to service our internal market, an 2007;13(4):172-9.export opportunity will have been created. This paper examined the results from 8,666This is anticipated to happen as a result of studies and concluded ‘the most effectiveattracting FDI companies to use Northern telecare interventions appear to be automatedIreland as a UK/European hub for their vital signs monitoring (for reducing healthoperations, and by enabling indigenous service use) and telephone follow-up by nursescompanies to expand their reach after (for improving clinical indicators and reducingsuccessfully trialling their products within health service use).’a Northern Ireland ‘test bed’. The Panel also engaged with a number ofBenefits to the local healthcare system leading experts in the Home-based CareThe Panel concluded that to maximise the market to validate the findings of the researchmarket opportunity in this area Home-based undertaken.Care technology should be implemented withinour own Health system. This would allow the The Panel acknowledged that savingsDHSSPS to benefit from savings achieved that may be achieved as a result of thefrom the delivery of health services in this implementation of this technology were likelymanner. to be redistributed elsewhere within the Health service, which is under considerable budgetThe panel considered the evidence published constraint.by a number of pilot studies within theUK. In particular, a study in West Lothianentitled ‘Experience Independent Living’ wasconsidered. The key highlights from that studywere as follows;• Hospital stays down to 30 days (cf. 112 Scottish ave.) for those assessed ready to leave;• 3000+ hospital bed nights saved p.a. (net £0.3M saving p.a.);• Private care home occupancy 18mths average (was 36mths); and• 10% of users at home as alternative to ‘institutional care’ meeting demands for independence & choice (net saving £1.69M per annum)
  • 68. PROFITING FROM SCIENCE WWW.MATRIX-NI.ORGKEY STAKEHOLDERINPUTS & OUTPUTSTHE TABLE BELOW SUMMARISES THE COMMITMENT NECESSARY FROM GOVERNMENT,ACADEMIA, BUSINESS AND THE CLINICAL FIELD TO SUCCESSFULLY DELIVER HOME-BASED CARE WITHIN THE NORTHERN IRELAND ECONOMY. THE TABLE ALSO HIGHLIGHTSTHE POTENTIAL RETURN FOR EACH RESPECTIVE GROUP.GOVERNMENT ACADEMIC STAKEHOLDERS BUSINESS SECTOR CLINICAL SECTORInputs Inputs Inputs Inputs• A commitment to a • Social studies • An investment in new • A commitment to changing ‘connected health’ agenda • ICT capability technologies working practices• A commitment to a joined • Curricula for new disciplines • A long-term contractual • Adjusting reward structures up approach to the market in eHealth commitment to the public opportunity sector• Embrace an attitude of changeOutputs Outputs Outputs Outputs• Stimulate indigenous • Graduates to fulfil a new • An opportunity to participate • A new model of healthcare companies model of health delivery in locally significant market management• Create a knowledge base • Growing reputation in the field with the potential to export • Improved independent living from which export potential of Home-based Care know-how and quality of life for patients can be exploited • Improved work practices for• Attract FDI companies, health professionals interested in using NI as a • Better management of test bed for their technology healthcare costs and gateway to UK and European markets• A demonstration of the Government’s commitment to smarter working practices to improve patient care
  • 69. PAGE 69FRAMEWORK CONDITIONS4
  • 70. PROFITING FROM SCIENCE WWW.MATRIX-NI.ORGFRAMEWORK CONDITIONSWhilst the emphasis of the Panel’s work Personalised Medicine frameworkhas been on identifying significant market conditions:opportunities that could be exploited by • Adoption in clinical practice;Northern Ireland health technologies sector, the • Application in existing vs. new drugs;local industry consultations have highlighted the • Adjusting the education system;importance of a number of enabling factors in • Ethical framework;realising the market opportunities identified. • Intellectual property protection; and • Joined-up approach and commitmentThe general conditions for success can begrouped in three key categories, which were Home-based Care framework conditions:also brought to the fore during the Capability • Scalable approach to roll-out;Study carried out by BioBusiness Northern • Defining technology standards andIreland and Invest NI in 2006: protocols;• Adequate skill base, both in terms of • Stakeholder engagement; and quality and volume; • Adjusting funding policy• Effective networking to foster collaboration; and Each of these framework conditions is• Supportive policy environment. discussed in the following pages.There are also a number of conditionspertaining specifically to the realisation ofthe two opportunities identified: PersonalisedMedicine and Home-based Care.
  • 71. PAGE 71FRAMEWORK CONDITIONSGENERALAdequate skill base awareness skills; and likely to be a long-term process, which needsAvailability of the appropriate skill sets at • Support recruitment campaigns on behalf consistent commitment across the sector. Theall levels is crucial in this highly specialised of local companies (e.g. ‘returners’ actions suggested below would help create theindustry. This is a pre-requisite for the future programmes). forum for regular information sharing and assistdevelopment of indigenous companies as with projects implementation:well as in retaining and attracting international The companies themselves also have a role • Centralised and easily accessibleplayers. to play in actively influencing the education point of information on sector players, agenda and transferring skills to the academic including complementary industries (e.g.Closer communications and integration staff, students and graduates. IT, engineering, packaging). Providebetween the education sector and industry is controlled access to target contacts &required to identify and address the key skills Actions by industry: international associations;gaps. A number of specific suggestions for • Increase hosting of internships and modern • Central signposting to available supportboth the education and sector and industry apprenticeships; mechanism (see Scottish Enterpriseplayers have bee put forward in this respect: • Upskill existing employees with short model); and sharp training - company, or industry • Special interest groups for experienceActions by education sector/government: specific, management skills; sharing (business experience and• Develop and maintain a register of key • Attract back returners; opportunities for collaboration); skills needs and gaps (both in volume • Improve staff retention at Province level; • University-run seminars on current and quality terms) across the various sub- • Conversion of non-specific graduates; research projects and opportunities for sectors, to help respond to the changing • Work with other sectors on common collaboration; needs of the industry; problems; • Monthly e-newsletters to members &• Instil interest in science in general, and the • Work with further and higher education to target investors; health technologies industry in particular at raise awareness of career opportunities at • Guidance on IPR issues. the early stages of education; all education levels;• Raise awareness and promote career • Highly targeted recruitment overseas and Northern Ireland, similar to regions like opportunities to students, parents, careers approach Northern Ireland natives working Scotland and Republic of Ireland, should advisors; abroad. capitalise on the small geographical size and• Place science at the heart of education establish stronger interfaces between the curriculum from primary education through Effective networking to foster academic, business and clinical sectors to to further and higher education levels; collaboration accelerate innovation and manage the costs• Increase the number and quality of PhD The emphasis is on putting in place of clinical trials. The role of already established throughout Universities; mechanisms to help local players to identify mechanisms, such as the Recognised• Balance graduates’ technical skills with collaboration opportunities themselves and to Research Groups and clinical trials cluster, entrepreneurship/business/commercial aid the success of individual projects. This is should be leveraged.
  • 72. PROFITING FROM SCIENCE WWW.MATRIX-NI.ORGInterfaces with other Horizon Panels would knowledge transfer from University • Emphasis on the value added by thehelp draw out the opportunities for collaboration research, enabling access to skilled intellectual strength of the Province, ratheron a cross-sectoral basis. Examples of related workforce, greater support from the clinical than solely on volume of job creationsectors include: capability) • An environment that enables and protects• ICT; • Focus on FDI targets with an interest in intellectual property rights• Advanced Materials/Engineering; and locating or sourcing high value added R&D • Need for taking a long-term view to return• Agri-food. activities (e.g. niche value-add processes, on investment, and supporting risk taken fundamental research for next generation by entrepreneurs;The realm of collaboration should extend products) • Help raise the profile of the local capabilitybeyond Northern Ireland, particularly to - Lobbying to Northern Ireland and UKRepublic of Ireland and the rest of UK. This will An innovative package of financial incentives governments;strengthen capability and enhance the offer to and funding programmes will be required - Maintaining links with other nationalpotential international targets. to support young SME’s to develop (see and international relevant organisations SBIR programme in the USA as a means to - Helping organise trade visits andSupportive Policy Environment sustaining costly R&D activity) and attract industry exhibitions.A successful cluster is characterised by both international players to locate or source indynamic start-up activity and existence of Northern Ireland (see for example packageslarger, more mature companies which generate offered by Republic of Ireland).demand in the local sector and act as ‘successstories’, hence helping raise the profile of This would also involve the creation of anNorthern Ireland. This implies a balanced, innovation- and business- friendly environment,three-prong approach for Northern Ireland: which would support indigenous existing• Facilitate seed companies spin out of and new companies, as well as overseas Universities (for example by allowing companies considering operating in Northern commercially oriented researchers to take Ireland, including: sabbaticals to concentrate on product • Cohesive policy across government development) and back these up, along departments and agencies; with the young SME’s already formed, with • Timely decision making; the appropriate mechanisms to increase • Reduced bureaucracy and improved their chance of survival – e.g. specialist coordination surrounding business mentors/business angels, VC contacts, processes (e.g. planning applications, business management skills. grant applications etc);• Support growth of established companies • Balance between FDI vs. and support of (for example by faster technology/ indigenous companies.
  • 73. PAGE 73FRAMEWORK CONDITIONSPERSONALISEDMEDICINEAs Personalised Medicine becomes more to enable the use of pharmacogenetic testing Intellectual property protectionpervasive, with far-reaching implications, to improve drug prescribing in routine clinical A strong intellectual property systemre-examination of current approaches to a practice. is necessary to stimulate investment inwide range of industry practices and policies innovation. It is essential that governmentwill be required. Northern Ireland has the Education system patent systems offer protection for innovationsopportunity to be a leader or early adopter Education in genetics at undergraduate, relating to Personalised Medicine as well asin some of these areas. postgraduate and continuing medical education high quality patent examination that allows levels has trailed behind the enormous patents of appropriate scope and quality.Adoption in clinical practice scientific and technical advances in this field. InTo enable pharmacogenetics to enter the future doctors, nurses and pharmacists will Joined-up approach and commitmentthe mainstream clinical practice, it will be require a much stronger basic training in the to developing the sectornecessary to demonstrate clinical benefits on a fundamentals of human genetics. Given the array of issues still to be addressed,case-by-case basis, through well constructed it is important that the broad spectrumand statistically significant clinical trials. Ethical framework of stakeholders - pharmaceutical andFurther information needs to be obtained on Studies of pharmacogenetic variability will biotechnology companies, researchers, medicalthe economics of using pharmacogenetics in require the analysis of large repositories educators, information technology suppliers,clinical practice; clinical trials therefore need of clinical data during and after a clinical healthcare providers, policymakers and payersthe input of health economists to address trial. Industrial and academic researchers - participate in shaping the evolution of thisissues of clinical cost effectiveness and the undertaking such studies will require an ethical new opportunity. Only through such jointbest use of public money. framework that provides guidance on how to efforts, will Personalised Medicine be able to collect and store information and samples with fulfil its promise as rapidly as possible. (Source:Application in existing vs. new drugs proper consent, while protecting the rights and Royal Society, 2005)For new drugs, the clinical trials will be confidentiality of the individual. Governmentsconducted by industry. However, information is will also need to put enough safeguardsalso needed about the use of pharmacogenetic in place to prevent the misuse of geneticscreening of existing medicines, including information, and consequent risks to patients.off-patent generic medicines, which constitutethe bulk of those used in the National Further engagement with the public is requiredHealth Service (NHS). Under the current both for educational purposes (disseminatearrangements, the pharmaceutical industry information on the progress and benefits ofhas no obvious motive to investigate the Personalised Medicine), and for assessingpharmacogenetics of most of these products ethical concerns and barriers.on its own. Therefore an opportunity existsfor public-private partnership to be developed
  • 74. PROFITING FROM SCIENCE WWW.MATRIX-NI.ORGFRAMEWORK CONDITIONSHOME-BASEDCARETop-down & scalable approach to roll-out Common Technology standards and Adjusted funding policyThe Panel suggests a ‘top-down’ approach to protocols The reimbursement strategy for each productroll-out, which would provide DHSSPS with the A key issue in the adoption of Home-based and service would need to be assessed. Thecontrol over the patient groups and the parts Care in other regions has been the lack of feasibility of charging patients, where theof the healthcare system impacted at each interoperability between devices and the economic argument for implementation is notstage, and over selection of those technology associated perceived risk that service buyers as strong should also be considered.propositions that demonstrate the highest may become effectively tied to one supplierlevels of patient benefit and economic impact. as a result of adopting an infrastructure not The Panel believes adoption of Home-based compliant with competitive products. Care would be facilitated by using andThe adoption of Home-based Care would adjusting the existing reward and operationaltherefore occur incrementally both in terms of So that the deployment process is not structures (e.g. GP contracts) as much asthe type of patient groups targeted (disease/ constrained by or dependent on this factor, it is possible, rather than creating a parallel system.condition type, risk of intervention etc), and strongly recommended that any implementation This would risk increasing resistance to changethe type of technology deployed (complexity, model adopted in Northern Ireland is based on by the health professionals and funders.risk etc). common technology standards and protocols. It is preferable that such standards are developedIt is possible to initiate adoption relatively through an ‘open-source’ approach.quickly, by deploying minimal infrastructure. Forexample, it would be expected that the initial Initial discussions with the Connected Healthphases would make use of off-the-shelf ICT feasibility team has indicated that the Continuahardware, such as wireless routers of existing Health Alliance, an organisation comprised ofbroadband connections. some of the leading global companies in the Home-based Care field, is seeking to agreeThe Panel believes it is important that the common protocols for all members of theproject adopts a Province-wide approach from alliance.the outset, to prove the viability of the ‘wholesystem connectivity’ concept. Stakeholder engagement The Panel considered that the most importantThe roll out plan would benefit from the lessons success factor was not the creation anddrawn from pilots conducted in other UK and deployment of infrastructure. Instead, it wasEuropean regions, as and when these are ensuring that the existing response resourcescompleted. (e.g. GP surgeries, District nurses etc) were motivated and incentivised to adopt this way of working.
  • 75. MATRIXNORTHERN IRELANDSCIENCE INDUSTRY PANELINNOVATION POLICY UNITDEPARTMENT OF ENTERPRISE,TRADE AND INVESTMENTNETHERLEIGHMASSEY AVENUEBELFAST BT4 2JPPROFITING FROM SCIENCEWWW.MATRIX-NI.ORG