Unlock Your Global Business Potential: The UK Laboratory Medicine opportunity

1. Unlock Your Global Business Potential: The UK Laboratory Medicine opportunity

2. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL The UK Laboratory Medicine opportunity: 1. Introduction to UKTI’s Life Science Investment Organisation

3. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL • New UKTI team – the Life Science Investment Organisation (LSIO) • Combines private-sector expertise with Government teams • Charged with • The UK Prospectus: A new approach to promoting UK health science excellence • Translatingbenefits of the UK’s Life Science Strategy and capabilities for business x10 x20 • Creating focused messaging matching UK strengths with global business needs x30 x20 x30 x10 • Catalysingand empowering the UK Life Science community to work with international business

4. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL • The UK Prospectus: A new approach to promoting UK health science excellence

5. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL Government commitment to the Life Sciences and Healthcare “In December 2011 I made a firm commitment to re-establish the UK's global leadership in the life science sector, announcing the Government's ten-year Strategy for UK Life Sciences.” “By more closely integrating the UK's unique strengths, I believe that we can improve healthcare for patients, attract new investment to the UK, and create new jobs and business opportunities in an increasingly competitive and international industry.” David Cameron Prime Minister • The Strategy makes the most of the UK’s core strengths: • Basic science in universities • Translational and clinical research excellence • Industry and supply chain • The National Health Service (NHS) Life Science Strategy and Innovation Health and Wealth are the UK government’s response to a global sector under pressure

6. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL • The UK government has introduced fiscal measures to stimulate innovation and growth for companies • A business environment that supports and rewards innovation Patent box £300m 23%Corporation tax will drop further to 20% Patent box: 10% corporation tax on qualifying profits R&D tax credits for SMEs worth approximately 25p on every £1 (7p for large companies) To stimulate R&D partnerships between universities businesses & charities £180m Low corporation tax rate currently standing at 23 per cent decreasing further to 20 per cent by April 2015. Biomedical Catalyst a £180m programme of public funding for growth

7. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL The UK Laboratory Medicine opportunity: 2. The market opportunity for your business

8. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL The UK In Vitro Diagnostic (IVD) market, worth $1.09bn in 2011 is one of the fastest-growing IVD markets n Europe, with growth forecast to average 7.1% from 2011 to 2018 - outpacing both France and Germany. • In Vitro Diagnostics - the UK opportunity UK IVD market valued at £1.09bn in 2011 2 Million Pathology tests are carried out every day in the NHS • In England in one year the following are carried out, processed and/ or examined: • over 500 million biochemistry tests • 130 million haematology tests • over 50 million microbiology requests • over 13 million histopathology slides • 4 million cytology slides. 2 Million Pathology tests are carried out every day in the NHS In Vitro Diagnostics The UK IVD market has over 200 companies 70% of clinical decisions in the NHS are based on diagnostics tests

9. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL • Treating almost 1 million patients every day, the NHS is the largest unified healthcare system in the world • In 2011-12, the UK spent approximately £128bn on the NHS, of which 4% was spent on pathology services. • In Vitro Diagnostics - the UK opportunity Point of care testing comprises of the performance of a test in the immediate vicinity to a patient to provide a rapid result outside the conventional laboratory environment In Vitro Diagnostics Laboratory medicine comprises services which provide knowledge and diagnostic information for the care of individual patients through the scientific analysis of specimens of blood, fluids, tissue and other samples.

10. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL • Demand across virtually all disciplines of pathology has risen within the UK. • 95% of pathology testing services (laboratory medicine) are still provided in house by the NHS. Despite this, the independent market in pathology, is a rapidly expanding opportunity for industry to engage directly with the NHS to service the increasing demand. • The Report of the Review of NHS Pathology Services in England by Lord Carter of Cole in 2008 recognised Pathology as a large and important clinical service which touches the lives of many: • Employing 25,000 staff • Costing the NHS in the order of £2.5 billion a year • Representing nearly 4 per cent of total NHS expenditure • Laboratory Medicine in the UK – A Growth Opportunity for industry In Vitro Diagnostics

11. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL The emergence of new organisations and programmes within the NHS to meet the changing healthcare delivery model provide a range of opportunities for your business to tap into: • Laboratory Medicine in the UK – a change in healthcare delivery has led to opportunities for companies providing pathology services • Delivery of healthcare within the NHS is shifting towards: • Earlier prevention • Increasing personalisation (i.e. via the ‘genomic revolution’) • Care delivery closer to the patient’s home • Increasingly integrated healthcare delivery between care providers Public Health England (PHE) will lead on the development of a 21st Century health and well being service. The UK National Screening Committee and NHS Screening programmes have become part of PHE in the restructuring of the NHS through the 2012 Health and Social Care Act. Public Health England The NHS Screening Programme looks at a wide range of disease areas at different stages in the life of the population. Some tests are population wide but triggered by reaching ceratin age points while others can be focused on at risk populations. Many of these service rely significantly on pathology services opening new opportunities for developing improved technology or data management systems. NHS Health Check NHS Health Check I focuses on prevention and early intervention and is a national risk assessment and prevention programme that systematically targets the top seven causes of preventable deaths: high blood pressure, smoking, high cholesterol, obesity, poor diet, physical inactivity and alcohol consumption. NHS Screening Programme The NHS Genetic Testing Network was established to: ensure the same level of genetic services across the UK ensure that the services are of high quality, check that new genetic tests put forward for acceptance into the UKGTN listing are effective to influence the way the NHS manages genetic services. NHS Genetic Testing Network

12. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL • The Report of the Review of NHS Pathology Services in England outlined the need for NHS laboratory medicine to: • Embrace a process of modernization • Adapt to the genomic revolution, along with the new tests it will bring • Develop to meet people’s changing expectations: high quality, safe and efficient health care services, delivered closer to home • Redesign and streamline services around people and the main users’ requirements for pathology-based investigations • Create a strong local clinical leadership and a business orientated management infrastructure • Recognise its services as a core clinical service in relation to its impacton the patient’s journey and therefore must be planned, commissioned anddelivered as part of an integrated health care system • Embrace managed networks as a new delivery model. For the NHS to work with industry in the creation of a small number of well-equipped facilities to provide the vast majority of pathology services in England. • Laboratory Medicine in the UK – movement towards managed networks with industry collaboration The move from small in-house laboratories to managed networks Path Links is a single managed Clinical Pathology Network operating across Lincolnshire. Path Links has demonstrated substantial gains that came from consolidation and integration of laboratory testing (including histopathology and microbiology) across multiple hospitals .Moving towards a managed service across hospital department to consolidate costs and maximising the benefits for patients. Serving a population of approximately 1 million, Path Links processes 4.5 million specimens, performs 20 million tests and generates 5 million test reports every year.

13. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL • Laboratory Medicine in the UK – opportunities for digital pathology and genetic testing • Digital Pathology – Innovative technologies are opening the way for improving efficiencies and outcomes • The emergence of new Digital Pathology systems could enable a completely new approach to histopathology, coupling efficiency savings with more accurate diagnosis. Companies such as Roche Diagnostics, GE and Philips are working directly with the NHS to understand the potential impact of this new technology on both system efficiencies and patient outcomes. • Genetic Testing – New tests being delivered to personalise healthcare • The NHS genetic Testing Network provides a strong base for the introduction and validation of new genetic tests into the healthcare provision in the UK. • Companies such as DNA Electronics a spin put of Imperial College and Oxford Nanopore spun out from Oxford University have led the move to enable rapid genome analysis which will support a much wider use of genetic testing and enable the use of new tests to support stratified medicine developments.

14. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL The UK Laboratory Medicine opportunity: 3. A rich and diverse ecosystem

15. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL • Some of the UK Centres of Excellence who house state-of-the-art innovative facilities for research in laboratory medicine • Oxford Laboratory Medicine – brings together the expertise, services and Bio Resources in laboratory medicine from across the Oxford University Hospitals NHS Trust and the University of Oxford partnership in support of clinical service, medical research and training and education. • University of Glasgow – The Advanced Medical Diagnostics research group at the University of Glasgow has a strong track record in many aspects of bioengineering, especially those associated with advanced biomedical diagnostics, biosensors, cell engineering, Lab-on-a-Chip and Bionanotechnology– specialises in providing fast, accurate diagnostic tests for the management of infectious and genetic diseases • Manchester Cancer Research Centre has harnessed the expertise, ambition and resources of partner organisations which already have formidable reputations in the fields of cancer treatment and clinical research. Among the partners are The Christie NHS Foundation Trust, Cancer Research UK and the world renowned Paterson Institute for Cancer Research. The Centre provides a range of Specialist diagnostics and treatments together with laboratory, translational and clinical research • University of Bristol – The Diagnostic Laboratories are part of Langford Veterinary Services (LVS), which is a totally owned subsidiary of the University of Bristol. LVS provides an extensive high quality range of laboratory tests.

16. The UK actively encourages research partnerships between academia, industry, and the NHS: • Building a Collaborative Research Ecosystem: Active Partnership • Scotland, the Scottish Academic Health Sciences Collaboration facilitates partnerships between Scottish universities and health boards. This offers industry a coordinated system to contract and cost research studies across Scotland. • In Northern Ireland, Northern Ireland’s Connected Health and Prosperity Action Plan ensures cross sectorial support for health & social care R&D, innovation and widespread deployment of healthcare technologies. • In England, five Academic Health Science Networks open up routes to market, supporting the development of new therapies and techniques • In Wales, the National Institute for Social Care and Health Research Academic Health Science Collaboration maximises links between health boards , trusts, universities and industry to facilitate high quality research and improve healthcare.

17. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL • The UK, enabled by the NHS allows your business with access to unrivalled, clinically-coded health data and biorepositories, including linked datasets to understand care pathways. and anonymised electronic patient records, offering a unique opportunity to understand care pathways. • Data to drive innovation and to further research More than 60 million people are served by a National Health System • Example data resources: • UK Biobankis a unique resource of data and samples linked to medical histories and health records from 500,000 adult participants • Clinical Practice Research Datalink (CPRD) enables observational studies, clinical trial feasibility and protocol optimisation, and post-market surveillance • NIHR BioResourceenables recall to clinical studies by genotype and phenotype and helps stratify and select patients for trials

18. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL • The Department of Health in the UK has announced that £4 million pounds will be invested to improve the way diseases are diagnosed within the NHS. This money will fund research that looks at the way a number of different diseases are diagnosed, so patients can access the best available treatments more quickly. The National Institute for Health Research (NIHR) will share the funding across four NHS organisations in London, Leeds, Newcastle and Oxford, which will become national centres of expertise called NIHR Diagnostic Evidence Co-operatives. These centres will promote research into medical tests used to diagnose conditions like cancer, liver and respiratory diseases, so patients across the NHS can benefit from advances in technology. • The National Institute for Health and Care Excellence (NICE) Diagnostics Assessment Programme makes recommendations to the NHS on the efficacy and cost effectiveness of new diagnostic technologies. The programme is driven through Industry submitting their technologies for technology appraisal direct to NICE • The UK offers a national infrastructure to support innovation and appraise new technologies in laboratory medicine

19. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL • The UK continues to create an open and flexible regulatory framework • Government commitments: • Opening up the NHS to collaborate with your business on research and adoption • Ensuring that products and services are critically appraised to the highest standard • Transparent expert advice to support decisions on access to personal health information • A streamlined health research approvals process • Globally-respected regulators: The UK is home to the Medicines and Healthcare Products Regulatory Agency (MHRA) and the European Medicines Agency (EMA) • An expert stakeholder group meets quarterly to discuss regulatory innovation • The MHRA recently established an Innovation Office to promote early dialogue between the MHRA and companies developing innovative products. The MHRA has also produced some general guidance feeding into the IVD Medical Devices Directive, 98/79/EC.

20. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL • Pathology in the NHS is being commissioned through CCGs • The NHS Pathology services are commissioned both by Clinical Commissioning Groups (CCGs) and Specialist Commissioning Groups (SCGs) to provide a range of tests in a cost effective manner. Understanding the changing service model and demands of these groups will lead to a higher level of success when bringing your service to the market. • In order to fulfil these contracts the existing pathology labs will procure a wide range of equipment, consumables and service arrangements. • OJEU is the main source for lab installation tenders • Laboratory installations will be put out to tender either by individual hospitals, Hospital Buying Groups or Larger Buying Organisations such as the Government Procurement Service. Tenders may include equipment but in the majority of cases will also include consumables, reagents and maintenance within the same tender. European Law requires all tenders to be made public via the Official Journal of the European Union (OJEU). • Consumables may also be available via the NHS supply chain catalogue and this route is often an easier one for smaller volume tests and lab consumables. NHS Supply Chain will put out their own tenders via the OJEU process. • Procurement mechanisms to facilitate launch into the market

21. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL • A summary of the supportive UK ecosystem your business can access • The UK has a long history in developing new technologies in the diagnostics area and has a unique ecosystem to support collaborative research, commercialisation and adoption and diffusion of new ideas in the diagnostic space. A number of associations, networks, evaluation panels and funding streams are available • British In Vitro Diagnostics Association (BIVDA) – represents over 90% of the UK IVD industry, it aims to identify key issues affecting the industry and provide a national platform for discussion creating a more favourable climate for operations and investment • Knowledge Transfer networks in Medical Devices, Biosensors and nanotechnology – The HealthTech and Medicines Knowledge Transfer Network (Health KTNs) are dedicated to accelerating innovation and technology exploitation in the health industries sector. This includes the Medical Biotechnology, Medical Technology, Diagnostics and Pharmaceutical industries • Academic Health Science Networks (AHSNs) – have the potential to transform health and healthcare by putting innovation at the heart of the NHS. This will improve patient outcomes as well as contributing to economic growth • National Institute for Health and Care Excellence the Medical Technologies Evaluation Programme (NICE MTEP) –selects and evaluates new or innovative medical technologies (including devices and diagnostics) • National Institute for Health and Care Excellence the Diagnostics Assessment Programme (DAP) – makes recommendations to the NHS on the efficacy and cost effectiveness of new diagnostic technologies. • Technology Strategy Board Innovation Platforms in Infectious Diseases and Stratified medicine – seeks to build on the UK's strength within the global healthcare industries and put it at the centre of the next generation of medicine • Technology Strategy Board – has announced the formation of a new Catapult to drive the development of effective Stratified Medicine solutions. A TSB spokesman said that the catapult would “act as a rallying point to enable linkages between biopharma, diagnostics and healthcare systems,” and said that the catapult would help businesses tap into stratified medicine. • Medicines and Healthcare Regulatory Agency (MHRA) – is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.

22. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL The UK Laboratory Medicine opportunity 4. Success stories and pilots

23. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL • Digital Pathology pilot heralding new approach to histopathology within the NHS • Roche Diagnostics has established two clinical test sites at Birmingham Heartlands Hospital and the Princess Alexandra Hospital, Harlow, working directly with NHS Pathology services, they can evaluate the impact of introducing digital histopathology on both efficiency and outcomes. Roche Diagnostics believes that working together with the NHS on distinct projects, will provide outcome data for the UK and help sites to visualise the advantages of digital pathology for select applications. This information would be beneficial for the uptake of this new and innovative technology.

24. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL • National database of tumour genetic information and demonstrate a hub-and-spoke model for clinical tumour profiling • Cancer Research UK, AstraZeneca, Pfizer, and other partners build a national database of tumour genetic information and demonstrate a hub-and-spoke model for clinical tumour profiling • The Cancer Research UK (CRUK) Stratified Medicine Programme is a partnership between government, charity and commercial organisations to help the NHS adopt new targeted therapies, as well as making the UK a better place for research into more personalised cancer treatment. • Core funding for the programme is provided by CRUK, AstraZeneca and Pfizer with investment from the Technology Strategy Board and co-ordinated with other organisations including the NHS. • The first phase has two main objectives: 1) to improve molecular profiling and 2) to capture clinical and genetic research data, forming cohort datasets of mutations, treatments and outcomes. • Phase I is now complete, and the eight clinical hubs have consented analysis of 7,229, patients across six major solid tumour types and a range of biomarkers. Phase II started in Q1 2013 with a focus on integrating Phase I learning into broader practice in the NHS.