Unlock Your Global Business Potential: Supporting Life Sciences in the UK

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1 Unlock Your Global Business Potential: Supporting Life Sciences in the UK Dr Mark Treherne, Chief Executive, Life Science Investment Organisation Health Research Authority 31 st March, 2014 THE UK HAS THE MOST OPEN AND BUSINESS-ORIENTATED ECONOMY OF EUROPE, WITH THE MOST FLEXIBLE LABOUR MARKETS, AND THE LEAST RESTRICTIVE SYSTEMS 1

2 UK Government s Commitment to the Life Science Sector 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 Life Science Strategy is the UK s response to a global sector under pressure

3 The UK Ecosystem: Connect, Research, Develop, Validate, and Export The UK s increasingly integrated biomedical ecosystem is underpinned by: A supportive business environment An open and flexible regulatory framework Simplified industry access points Global connectivity and export potential

4 A Business Environment that Supports and Rewards Innovation The UK government has introduced fiscal measures to stimulate innovation and growth for companies: Patent box: 10% corporation tax on qualifying profits R&D tax credits: Up to 27p back per 1 spent 300 million UK Research Partnership Investment Fund 180 million Biomedical Catalyst Regional funding and incentives

5 Private Funding in the UK

6 Providing Access to Drive Healthcare Innovation: Active Partnership Between Academia, Industry, and the NHS Industry can leverage the UK as an innovation partner to develop an evidence base, supporting market access, uptake and diffusion in the UK and around the world In Northern Ireland: Connected Health and Prosperity Action Plan ensures cross-sectorial support for R&D and technology adoption In Scotland: Academic Health Sciences Collaboration facilitates partnerships between universities and health boards In England: In Wales: Academic Health Science Collaboration maximises links between health boards, trusts, universities and industry Academic Health Science Centres open up routes to market Biomedical Research Centres and Units link universities and NHS trusts Academic Health Science Networks will work with industry and drive adoption across the NHS in England

7 Unlocking Data to Drive Innovation In the UK, your business will have access to unrivalled, clinically-coded health data and biorepositories, including linked datasets to understand care pathways More than 60 million people are served by a National Health System Example data resources: UK Biobank is 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 postmarket surveillance NIHR BioResource enables recall to clinical studies by genotype and phenotype and helps stratify and select patients for trials

8 Growing Global Market for Stratified Medicine By 2020, the pharmaceutical industry will invest as much as 20% of its R&D budget in genetics and genomics 1 In oncology: Companion diagnostic tests like Her2 generate significant annual revenues 2 Market value of targeted cancer therapeutics over $40bn and growing Market for biomarkers for drug discovery and clinical trials is more than $1bn 2 The UK has prepared for and understands this shift, and is rapidly adapting to support industry success in stratified medicine 1=PriceWaterhouseCooper; 2=BCC Research

9 As part of a long term strategy, the UK is investing to develop stratified medicine capabilities and support industry success

10 UK Opportunity in Stratified Medicine: Consumer of research tools, platform technologies, and informatics solutions Example: The UK plans to undertake whole genome sequencing of up to 100,000 NHS patients over the next 3-5 years Partnership with industry combining research and clinical delivery Example: Cancer Research UK Stratified Medicine Programme Test-bed for products and services With 60+ million patients across the National Health Service, the UK offers a sizeable domestic opportunity UK can help your business demonstrate clinical and commercial proof of concept and support export opportunities

11 UK Stratified Medicine: Rich and Diverse Ecosystem First-class research and expertise Understand disease biology, develop or implement stratification tools, find expertise in genomics to advanced diagnostics Research and innovation funders and charities World-leading data and translational infrastructure NHS serving more than 60 million patients Industry access points and dedicated networks for R&D and clinical delivery Established value and supply chain Thriving industry base with deep expertise Expert suppliers, service providers, and collaborators

12 Creating 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 MHRA and the EMA Earlier Access and, potentially, Adaptive Licensing An expert stakeholder group meets quarterly to discuss regulatory innovation MHRA recently established an Innovation Office to promote early dialogue between the MHRA and companies developing innovative products including: advanced therapies, stratified medicines, nanotechnology, advanced manufacturing, and novel drug/device combinations

13 Year-on year improvement (reduction) in times to review all applications Time to complete review, all application types, England

14 Steady increase in uptake of Proportionate Review since introduction 700 Trends of Applications and Review Types Full Review 200 Proportionate Review Apr-2010 Apr-2011 Apr-2012 Apr-2013

15 Mean time to complete Full Review is stable at less than 35 days. PR is stable at less than 12 days

16 Long-term downward trend in the use of Provisional Opinions Increase in the use of Favourable with Additional Conditions

17 Less than 6% of applications receive an Unfavourable final opinion Final Decisions (UK) % 21.7% 11.9% 5.5% 6.7% Favourable Favourable with AC FIFO FIFO with AC FIUO Unfavourable 0.3%

18 Creating 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 Significant improvements in times to review all application types

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