Stratified and Personalised Medicine

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A complete report of Stratified Medicine as the new approach to deliver healthcare and fully Personalised Medicines. Market and key drivers, industry needs and the Scottish strengths, are all presented in this report.

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<ul><li> 1. OPPORTUNITIES IN LIFE SCIENCESScottish Enterprise Stratified and Personalised Medicine: An OverviewSupporting a globally competitive Scotland</li></ul> <p> 2. OPPORTUNITIES1 Scottish Enterprise SUMMARY Stratified medicine encompasses the following approaches: 1)The use of a range of genomic and other biomarkers to improve the drug development process by significantly reducing cost and risk. 2)The use of companion diagnostics (CDx) to identify patient populations into those most likely to respond favourably, and without adverse effects, to a particular therapeutic (Rx) treatment option. The pace of change will be 3)The use of biomarkers to optimise dosage of drug, foraccelerated yet further by the prognosis and monitoring outcome of treatments.imminent arrival of affordable Successfully deployed stratified medicine approaches serve to increase margins for pharmaceutical companies, markedlygenome based personalised reducing cost and speeding drug development. This is particularly medicine. important at a time when major pharmaceutical companies are coming under intense pressure as patents on key products expire and these products are substituted by generics. To date the application of stratified medicine approaches has been primarily associated with drug based therapeutics and molecular or protein based biomarkers. However the process is generic and is likely to develop and encompass a wider range of both therapeutic modalities (cellular, surgical &amp; behavioural) and analytical techniques (physiological measurements and functional imaging). Stratified medicine can also generate significant savings for healthcare providers and most importantly deliver better clinical outcomes to the patient. Full reports on the markets covered here can be downloaded from the Scottish Enterprise website www.scottish-enterprise.com/lifesciences 3. OPPORTUNITIES 2 BACKGROUND Stratified medicine is a new approach to delivering healthcare, and can be seen as a step on the road to delivering fully personalised medicines. It encompasses biomarkers derived from all omics technologies (genomics, proteomics and metabolomics) and increasingly other analytical technologies such as imaging. To date such biomarkers have been principally used as a tool to accelerate drug discovery and development and develop a small group of Rx-CDx products to stratify patient populations based onPersonalised medicine is very much in disease status and response to therapy.process and will lead to the sequencing of The pace of change will be accelerated yet further by the imminent arrival of affordable genome based personalisedindividual genomes becoming a routine. medicine. The commercial availability of a $1,000 genome was announced by a major research tools company in early 2012. An affordable $100 genome by 2018 is a realistic proposition. Thus the transition from the current era of stratified medicine to one of personalised medicine is very much in process and will lead to the sequencing of individual genomes becoming a routine and accepted part of clinical practice. Stratified medicine has already significantly changed the pharma, diagnostics, biotechnology and impacted IT industries by generating a much greater evidence base for informed decision making. Personalised medicine is likely to similarly change clinical practice. This will present not only major challenges for the life science sectors and NHS in Scotland but also tremendous commercial and societal opportunities. 4. OPPORTUNITIES 3 Market and Key Drivers Industry Needs The leading market for both CDx and biomarkers has been cancer. Validated biomarkers: New technical breakthroughs The market value of targeted cancer therapies, where there is a have produced a huge pipeline of prospective biomarkers companion diagnostic element, is now $40 billion and is growing atall of which require better and faster methods of CAGR of 15%. Landmark companion diagnostic (CDx) products suchvalidation, a major opportunity for Scottish CRO base and as the Her2 test for breast cancer patient stratification are now intranslational research base. extensive use in both Europe and US and generating significant Data handling (IT &amp; Bioinformatics): The two major revenues ($100 million).needs and opportunities are for seamless and secure The market for cancer biomarkers in general (i.e. Non CDx), employedmedical records and data recording systems to efficiently in cancer clinical trials and discovery, was ten times greater at $1deal with the sheer volume of data. This is an opportunity billion in 2010. This in turn was part of the $20 billion market for allfor Scottish IT companies to specialise in medical biomarkers used in drug development (BCC Research 2010).related data handling. Related to this are opportunities to statistically analyze data and put the data in a context Biomarkers for drug development and clinical trials for other relating biomarker changes to underlying biology. indications are coming on line, and Rx-Dx combinations are evidently negotiating the complexities of regulatory approval for Adaptation to changes in the regulatory processes: both diagnostics and therapeutics.Stratified and personalised medicine is going to produce major changes in regulatory authorities requiring more In short, stratified medicine is here to stay. Key drivers includecomplex data submission packages which incorporate needs for:biomarker data within a regulatory submission for a new Pharmaceutical companies to reduce the cost and drug. There is an opportunity for Scottish companies, increase the speed of the drug development process; particularly specialist CROs and consultancies, to gain market share by anticipating and adapting to these Cost savings for healthcare providers;changes quickly. Improved clinical outcomes for patients. Development of new business models &amp; processes: Thus the ability of countries, life science industry sectors, New therapeutics have traditionally been priced by value companies and healthcare systems to quickly anticipate adapt where a perceived monetary value is assigned to the and successfully exploit the opportunities created by advancesimpact of the treatment. In contrast diagnostics have been in stratified medicine is of immediate commercial importance. priced according to production cost with a margin added. Success in adapting to the changes brought by stratified medicine This has created an as yet unresolved business challenge is strategically important. It will provide a foundation andbetween the in vitro diagnostics providers and pharma bridgehead to take advantage of what may be much greater long-partners. Similarly optimised processes to effectively term opportunities created as personalised medicine becomes a incorporate novel biomarker and diagnostics development technical and commercial reality. into the drug development process are required. 5. OPPORTUNITIES4 Solving these issues are both opportunities for ScottishScottish Strengths companies, particularly in vitro diagnostic &amp; CRO companies, to develop novel business pricing solutions A strong presence of major international research re-engineered workflow processes and strategictools companies: Major research tools companies are partnerships. implanted in Scotland (Life Technologies, Gen-Probe, Millipore now Merck, Agilent and a number of SMEs). This Adaptations within Healthcare Provider Systems:cluster is capable of developing and manufacturing kitsChange in clinical evaluation bodies (equivalent to NICE and services which provide stratified medicine tools for ain UK), to evaluate cost effectiveness of new personalised global Pharma and biotechnology market.medicines are needed. Adapting NHS and other healthcaresystems to deliver stratified and personalised medicine, An internationally competitive cluster of pharma CROsin particular handling of genomic data and long term with presence of majors such as Charles River, Aptuit &amp;education of clinicians and patients is required and willQuintiles: As with the research tools companies this clustercreate new opportunities for prepared companies. is competitive and capable of adapting its processes and services to exploit the growth of stratified medicine. A vibrant group in vitro diagnostic (IVD) and imaging companies: Scottish IVD and imaging companies have the technical capability of developing and providing companion diagnostics co-marketed with new pharmaceuticals. To date most marketed CDx products have been molecular biomarker based tests using DNA/RNA or proteins. However in future other diagnostic modalities such as imaging based CDx tests will be deployed. An internationally competitive clinical translational research base: Scotland clinical translational researchers are working on most of the disease areas that stratified medicine is predicted to impact upon in the coming decade. The major Wyeth TMRC investment created infrastructure, and more importantly a cohort of clinical researchers (now within Health Science Scotland), with extensive experience of industry lead stratified medicine development. Other initiatives which will support stratified medicine include biobanks notably Generation Scotland, significant initiatives in bioinformatics through Scottish Bioinformatics Forum (SBF) and coordinated mechanism of patient recruitment through Scottish Health Informatics Partnership (SHIP). 6. If you require this publication in an alternative formatand/or language please contact the Scottish EnterpriseHelpline on 0845 607 8787 to discuss your needs.Scottish EnterpriseAtrium Court50 Waterloo StreetGlasgowG2 6HQHelpline: 0845 607 8787www.scottish-enterprise.comFebruary 2012 </p>

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