Unlock Your Global Business Potential: The UK Point of Care opportunity

1. Unlock Your Global Business Potential: The UK Point of Care opportunity

2. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL The UK Point of Care 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 Point of Care 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 and 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 UK IVD market has over 200 companies employing 4000 FTE 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 The UK Government has introduced a wide range of fiscal measures and funding mechanisms to stimulate innovation and growth of industry in the UK • Point of Care Testing in the UK – A Growth Opportunity • An increasing proportion of diagnostic tests in the UK are now based on Point of Care Platforms. • Clinical Commissioning Groups will be seeking to improve prevention and diagnosis while improving the efficiency of the system and reducing the costs of unnecessary testing and referrals while accelerating the decision making processes. • As such, market share for Point of Care tests is expected to increase exponentially as the primary care physicians take on the responsibility and budget for commissioning care for their own patients. In Vitro Diagnostics

11. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL • The UK, with a single health care provider is one of the few markets where you can evaluate the full impact of a Point of Care diagnostic on a healthcare system. Through increased use of Point of Care testing, the NHS is aiming to reduce healthcare costs and improve patient outcomes. • In addition, the Social Care, Private Healthcare and Consumer segments of the UK market present a significant opportunity for your business to access. • Drivers for demand of Point of Care in the UK Point of Care

12. 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: • Point of Care in the UK – a change in healthcare delivery has led to opportunities for companies providing PoC testing • 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

13. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL • The UK is integrating Point of Care testing into routine practice making it easier for companies to enter the market • Liverpool Heart and Chest Hospital have developed a new clinical decision support tool which significantly improves the pathway for patients with Chronic Heart Failure from initial diagnosis to appropriate treatment. Driven by Point of Care BNP testing in the GP surgery the new pathway enables faster rule in/rule out decisions while also guiding decisions on the most appropriate referral route • International Normalised Ratio (INR) testing is well established as an integral part of warfarin treatment in the UK. The monitoring system is extremely costly and poses substantial burdens on the patient and the system as it involves the patient providing a blood sample on a 6-weekly ( or even shorter if levels are fluctuating) time scale. This is then sent off to the laboratory and the result then fed back to the clinician who will make a decision on Warfarin dose and communicate this to the patient. The availability of Point of Care Testing of INR levels has meant that the result is immediately available within minutes of the test being taken and decisions on dosage can be made immediately, avoiding adverse incidents and improving patient compliance.

14. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL The UK Point of Care opportunity: 3. A rich and diverse ecosystem

15. Understand disease biology Text comes here Deliver engineering and informatics solutions The UK can help your business.. Product and application development Text comes here Develop sensing and diagnostic technologies UNLOCK YOUR GLOBAL BUSINESS POTENTIAL • The UK has the visionary science, centres of academic and clinical excellence, key opinion leaders, experienced partners, and the tools to help your Point of Care business develop new technologies. The UK strengths in science and engineering providing a strong basis for the development of Point Of Care diagnostics which are based on a wide range of technologies from biomarkers development to new sensor technology and microfluidics • A Vibrant Research base • The Medical Research Council funds disease-focused consortia of academic and industry partners • NHS Reference laboratories provide expertise, access to samples and specialist services across a wide range of disease areas. • The 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. • HealthTech & Medicines Knowledge Transfer Network helps connect organisations to catalyse innovation through events and workshops in stratified medicine. • Cancer Research UK and Cancer Research Technology also provide core oncology research funding, and offer translational funding and expert capabilities, and support patient engagement.

16. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL • The UK has a rich history in genomics from the discovery of DNA to the Human Genome Project: • The Wellcome Trust Sanger Institute is one of the world’s leading genome centres and has been involved in the Human Genome Project, 1000 Genomes Project and the International Cancer Genome Consortium Institute. • The Institute for Cancer Research (ICR) is establishing a Tumour Profiling Unit to exploit the potential of molecular pathological analysis. • Building on this genomic heritage, in December 2012 the UK announced plans to pump-prime the sequencing of whole genomes of up to 100,000 NHS patients, starting with cancer and rare diseases. • Example: The UK is embracing the power of genomics to further research and development in Point of Care testing “We believe that the UK is well placed to lead the global adoption of genomic technologies within mainstream clinical practice and to support public health. The foundations lie in our world-class research, our existing use of genetics and the increasing partnerships between the NHS, academia and industry, making it possible, with the right motivation, to embrace innovation at every level.” Human Genomics Strategy Group report, January 2012

17. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL • Examples of the UK Centres of Excellence who house state-of-the-art innovative facilities for research in Point of Care testing • University of Cambridge Diagnostics Development Unit – the goal of the unit is to develop innovative tests that are rapid, simple, cost-effective and more sensitive than currently available rapid tests • Imperial College Molecular Diagnostic Unit – specialises in providing fast, accurate diagnostic tests for the management of infectious and genetic diseases • Oxford University (MADOX) – Oxford Centre for Monitoring and Diagnosis in Primary Care (MaDOx) is a research programme funded by the National Institute for Health Research (NIHR) based in the Department of Primary Care Health Sciences at the University of Oxford (PHC) • Inverness Diagnostics Cluster – The region is building a strong competency in preventative and personalised healthcare. The presence of Lifescan Scotland in Inverness has stimulated a cluster of expertise in clinical diagnostics leading to the creation of a Diabetes Research Institute • Cranfield University - has invested significantly in new, state-of-the-art facilities to house the health and applied science activities, and this has become a major centre for the healthcare activities within the university

18. 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

19. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL • Research in the UK both on biomarkers in diseases where there is an unmet need and also new platforms and technology to support the development of new Point of Care testing is driving new opportunities in this key area. • The Department of Health in the UK has announced that £4 million 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 promoting 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. • In March 2009 The Technology Strategy Board created a new Innovation Platform for the Detection and Identification of Infectious Agents and has now invested nearly £50 million to support the development of new point of care technologies to enable rapid detection of diseases such as HCAI, STI, Sepsis and TB as well as endemic animal diseases. . • The Technology Strategy Board has worked closely with the Department of Health and Department for Environment, Food and Rural Affairs (DEFRA) and other organisations in both the public and private sector to prioritise the disease areas, and determine the product capabilities and specifications likely to have the greatest impact. • In addition to the collaborative R&D programme the DIIA platform is also supporting projects examining the potential impact of Rapid POC Diagnostics on patient outcomes and systems efficiencies, • 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 UK offers a national infrastructure to support innovation and appraise new Point of Care testing

20. 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.

21. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL • A summary of the rich and diverse R&D ecosystem which 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, development, commercialisation, adoption and diffusion of new Point of Care tests 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 • 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 Point of Care opportunity: 4. Success stories

23. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL • DNA Electronics was spun out of Imperial College in 2001 • The company was founded on Professor Chris Toumazou’s invention of detecting protons released during DNA synthesis as a method for DNA sequencing using a standard silicon-chip based transistor. Based on this technology DNA Electronics is creating a suite of electronic microchip-based solutions to enable faster, simpler and more effective DNA analysis. The platform allows rapid sample-to-answer analysis that can be analysed by plugging into any consumer electronic device.

24. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL • Randox Laboratories develops Point of Care Testing for a range of disease applications • As the UK’s largest privately owned Diagnostics Company Randox, based in Northern Ireland, has been at the forefront of Point of Care Testing since it developed its unique Biochip Array Technology (BAT), an innovative assay technology for multi-analyte screening of biological samples in a rapid, accurate and easy to use formats. • The technology has enabled Randox to develop multi-analyte Point of Care Testing for a wide range of disease applications from cardiac disease to cancer. The company has been very active in the Technology Strategy Board Detection and Identification of Infectious Agents platform winning grants for projects to develop rapid POC Tests for HCAI, Sepsis and TB against stiff competition. • The company will continue to develop new technologies and platforms to deliver rapid POC tests that are specific and sensitive in an increasing number.

25. UNLOCK YOUR GLOBAL BUSINESS POTENTIAL • Founded in 2008 by Jonathan O’Halloran with Elaine & Julian Warburton, QuantuMDx started from somewhat humble beginnings over ten years’ ago in Jonathan’s garage where he re-arranged chemicals, reagents and biological processes and sensed them using computer transistors which provided sufficient proof of principle for his novel nucleic acid sequencing technology. Elaine, using her healthcare background and extensive commercial experience harnessed Jonathan’s technology to develop it into commercially viable and simple to use devices to meet many of today’s health challenges. • QuantuMDx Group leverages Technology Strategy Board funding to expand globally • QuantuMDx is now leveraging its global network and expertise across many fields and has developed a suite of diagnostic and sequencing bio-chips capable of being assembled into a wealth of low cost but highly accurate handheld devices for the next generation of doctors, health professionals, scientists, vets, military and police. The Group has now expanded to include subsidiaries in the USA & Asia as well as acquiring a commercial molecular laboratory, which it has subsequently ISO accredited. The company has recently won two Technology Strategy Board grants – one to develop a comprehensive PoC test for Multidrug-Resistant Tuberculosis (MDR-TB) and the other to develop a rapid tumour profiler. In addition QuantuMDx won the UKTI’s Exporting for Growth award in 2013.