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OPPORTUNITIES IN LIFE SCIENCES Scottish Enterprise Stratified and Personalised Medicine: An Overview Supporting a globally competitive Scotland

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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Page 1: Stratified and Personalised Medicine

OPPORTUNITIES IN LIFE SCIENCES

Scottish Enterprise

Stratified and Personalised Medicine: An Overview

Supporting a globally competitive Scotland

Page 2: Stratified and Personalised Medicine

OPPORTUNITIES 1

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.

3) The use of biomarkers to optimise dosage of drug, for prognosis and monitoring outcome of treatments.

Successfully deployed stratified medicine approaches serve to increase margins for pharmaceutical companies, markedly reducing cost and speeding drug development. This is particularly 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 & 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

Scottish Enterprise

The pace of change will be accelerated yet further by the imminent arrival of affordable

genome based personalised medicine.

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OPPORTUNITIES 2

BACKGROUNDStratified 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 on disease status and response to therapy.

The pace of change will be accelerated yet further by the imminent arrival of affordable genome based personalised 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.

Personalised medicine is very much in process and will lead to the sequencing of

individual genomes becoming a routine.

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OPPORTUNITIES 3

Market and Key Drivers

The leading market for both CDx and biomarkers has been cancer.

The market value of targeted cancer therapies, where there is a companion diagnostic element, is now $40 billion and is growing at CAGR of 15%. Landmark companion diagnostic (CDx) products such as the Her2 test for breast cancer patient stratification are now in extensive use in both Europe and US and generating significant revenues ($100 million).

The market for cancer biomarkers in general (i.e. Non CDx), employed in cancer clinical trials and discovery, was ten times greater at $1 billion in 2010. This in turn was part of the $20 billion market for all biomarkers used in drug development (BCC Research 2010).

Biomarkers for drug development and clinical trials for other indications are coming on line, and Rx-Dx combinations are evidently negotiating the complexities of regulatory approval for both diagnostics and therapeutics.

In short, stratified medicine is here to stay. Key drivers include needs for:

• Pharmaceutical companies to reduce the cost and increase the speed of the drug development process;

• Cost savings for healthcare providers;

• Improved clinical outcomes for patients.

Thus the ability of countries, life science industry sectors, companies and healthcare systems to quickly anticipate adapt and successfully exploit the opportunities created by advances in stratified medicine is of immediate commercial importance. Success in adapting to the changes brought by stratified medicine is strategically important. It will provide a foundation and bridgehead to take advantage of what may be much greater long-term opportunities created as personalised medicine becomes a technical and commercial reality.

Industry Needs

• Validated biomarkers: New technical breakthroughs have produced a huge pipeline of prospective biomarkers all of which require better and faster methods of validation, a major opportunity for Scottish CRO base and translational research base.

• Data handling (IT & Bioinformatics): The two major needs and opportunities are for seamless and secure medical records and data recording systems to efficiently deal with the sheer volume of data. This is an opportunity for Scottish IT companies to specialise in medical related data handling. Related to this are opportunities to statistically analyze data and put the data in a context relating biomarker changes to underlying biology.

• Adaptation to changes in the regulatory processes: Stratified and personalised medicine is going to produce major changes in regulatory authorities requiring more complex data submission packages which incorporate biomarker data within a regulatory submission for a new drug. There is an opportunity for Scottish companies, particularly specialist CRO’s and consultancies, to gain market share by anticipating and adapting to these changes quickly.

• Development of new business models & processes: New therapeutics have traditionally been priced by value – where a perceived monetary value is assigned to the impact of the treatment. In contrast diagnostics have been priced according to production cost with a margin added. This has created an as yet unresolved business challenge between the in vitro diagnostics providers and pharma partners. Similarly optimised processes to effectively incorporate novel biomarker and diagnostics development into the drug development process are required.

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OPPORTUNITIES 4

Solving these issues are both opportunities for Scottish companies, particularly in vitro diagnostic & CRO companies, to develop novel business pricing solutions re-engineered workflow processes and strategic partnerships.

• Adaptations within Healthcare Provider Systems: Change in clinical evaluation bodies (equivalent to NICE in UK), to evaluate cost effectiveness of new personalised medicines are needed. Adapting NHS and other healthcare systems to deliver stratified and personalised medicine, in particular handling of genomic data and long term education of clinicians and patients is required and will create new opportunities for prepared companies.

Scottish Strengths

• A strong presence of major international research tools companies: Major research tools companies are implanted in Scotland (Life Technologies, Gen-Probe, Millipore now Merck, Agilent and a number of SMEs). This cluster is capable of developing and manufacturing kits and services which provide stratified medicine tools for a global Pharma and biotechnology market.

• An internationally competitive cluster of pharma CRO’s with presence of majors such as Charles River, Aptuit & Quintiles: As with the research tools companies this cluster 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).

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If you require this publication in an alternative format and/or language please contact the Scottish Enterprise Helpline on 0845 607 8787 to discuss your needs.

Scottish Enterprise Atrium Court 50 Waterloo Street Glasgow G2 6HQ

Helpline: 0845 607 8787

www.scottish-enterprise.com

February 2012