Industrial Strategy

Life Sciences Sector Deal 2 Industrial Strategy Life Sciences Sector Deal 2 Foreword

Last year the Life Sciences develops to encourage and spread Sector Deal set out the first these new technologies. Advanced phase of implementing the Life therapies are making precision Sciences Industrial Strategy medicines, targeted to the individual patient, a reality here in the UK. through joint commitments between the government This second Life Sciences Sector Rt Hon Greg Clark MP and the sector to invest in the Deal deepens our partnership with industry, universities and charities and United Kingdom’s life sciences Secretary of State for Business, demonstrates how the NHS is pivotal as Energy and Industrial Strategy landscape. a delivery partner. It contains significant The agreements made in the first action to address the Industrial Strategy deal capitalised on the enormous Grand Challenges and our mission to opportunities for growth that the life transform the prevention, diagnosis sciences sector presents for the UK. and treatment of chronic diseases by We are seeing a continual flow of new 2030: it will support the creation of a investments across the health tech cohort of healthy participants that will and pharmaceutical sectors since the enable research into the hidden signs deal was published, with this year’s of disease and ways of diagnosing Rt Hon Matt Hancock MP second deal seeing more life sciences diseases early when interventions Secretary of State for companies investing in the UK and and treatments can be the most Health and Social Care creating high-quality, well-paid jobs. effective. The cohort will involve the public, the research community and Life sciences is a sector that operates industry with the results benefiting at the cutting-edge of technological the whole health service – an example developments. Government of the collective endeavours driving investments in these emerging our modern Industrial Strategy. areas are being matched by greater contributions from the sector, and We are taking action in the work this is building on existing strengths underway from the first Sector Deal, Professor Sir John Bell spanning research and healthcare to and the new commitments set out in GBE, FRS create and grow new industries in the this deal, to achieve the vision of the Regius Professor of Medicine, UK. It is right that NHS patients stand UK as a top-tier hub for life sciences The University of Oxford to benefit from these home-grown globally. The benefits will be felt by innovations. Data-driven technologies UK citizens through economic growth, have the potential to transform the good jobs and a strong and sustainable way the health system works and health service for future generations. support faster and cheaper clinical research. We must ensure the system

2 3 Industrial Strategy Life Sciences Sector Deal 2 Executive summary of NHS data, while maintaining Sector Deal, these programmes are public trust in how data is used building an ecosystem that will help The life sciences industry is one of the most important pillars of and maximising the benefits of life sciences to thrive in the UK: innovation for NHS patients. Our ``A major new commitment, the UK economy, contributing over £70bn a year and 240,000 five new centres of excellence in jobs across the country1. In 2017, a wide coalition of industry and backed by up to £79m of digital pathology and radiology funding, to develop a first-of- charity partners, led by Professor Sir John Bell, published a bold will provide more precise diagnosis, 2 its-kind, world-leading cohort Life Sciences Industrial Strategy that set a clear direction for the applying AI tools to digital images to of healthy participants that will sector’s future growth. detect abnormalities more quickly attract significant global investment and accurately than humans. They The strategy was underpinned by the globally-successful entities; and the need from industry and charities. The will also help to reduce costs. very significant competitive advantages to drive up research and development project will enable research into the UK already possesses – an funding to remain globally competitive. ``We are delivering on our aim to make the hidden signs of disease and the UK a global hub for advanced the development of tools to detect outstanding research base in world- The government’s response to this therapies and building an impressive and diagnose diseases earlier. This class universities; significant capabilities call from industry came with the first end-to-end national infrastructure will lead to a type of ‘predictive in clinical and translational medicine in Life Sciences Sector Deal3, a key part through a £146m commitment prevention’ which is crucial to ensure the NHS; longitudinal datasets within a of the modern Industrial Strategy. to medicines manufacturing. This the NHS has a sustainable future. national healthcare system; the largest The deal included close to £500m includes: doubling capacity at the biotech cluster outside the United of government support for major ``A world-first commitment to Cell and Gene Therapy Catapult States; a highly-productive and skilled new research programmes and over sequence one million whole Manufacturing Centre; three new workforce; and strong capabilities £1bn of new industry investment. genomes in the UK within the advanced therapies treatment centres; in emerging fields, such as digital It brought together partners from next five years including 500,000 and two new innovation centres for health and artificial intelligence (AI). across the pharmaceutical and health through the NHS in addition to the vaccines and medicines manufacturing. Taking these strengths as the basis for tech sectors, charities, government 500,000 in the UK Biobank project. future growth, the strategy set out how agencies and the NHS to deliver its ``The government, industry, the NHS Our broader aspiration is to reach to maintain and build on them under vision at pace. Strong progress is and its partners are delivering on five million genomic analyses in the fierce international competition, and to being made on implementation: their clear commitment to work same timeframe, truly making the UK together to improve the innovation the home of genomic healthcare. capitalise on emerging opportunities. ``An investment of £85m in our and access environment in the It set a roadmap for the UK to create already world-leading genomics ``An additional £50m investment in UK, with strong progress made on whole new industries over the next assets at UK Biobank has attracted our digital pathology programme as implementing the Accelerated two decades in the fields of early significant support for what will be a first step towards making this a truly Access Review4, supported by disease detection and genomics; the largest whole genome sequencing national asset to support early and £86m in government funding. digital technologies and data analytics; project ever undertaken. A £30m improved diagnosis across the UK and and in advanced therapeutics. vanguard study, the first phase of One year on, we are now going deliver more efficient NHS services. further still through this second Life The strategy also set out the areas work, is already underway, sequencing ``£37.5m funding and a plan for where key developments could fix the first 50,000 participants. Sciences Sector Deal with significant a network of regional Digital additional measures and innovative issues which have slowed down growth; ``In digital technologies and data Innovation Hubs, providing expert programmes to secure a global lead such as NHS uptake of innovative analytics, we are laying down the clinical research data services, data in the areas of greatest opportunity technologies; the difficulty in scaling building blocks to realise the full analysis and sharing capabilities. for the UK. Together with the first UK biotech companies to create large, potential of the scale and diversity This is part of a wider programme

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delivering on the government’s tech ``Measures to support the supply vision to reform the architecture of capital for innovative firms, of technology in the NHS and helping them to grow, through the make it work better for patients, government’s Patient Capital Review5. Life Sciences clinicians and researchers. Industry partners have responded ``A wide-ranging new policy package to this significant commitment Sector Deal to support uptake and adoption of with further investment: innovation in the NHS and ensure ``UCB, a global pharmaceutical the UK continues to be a world company, is investing in one Key commitments leader in health tech. Through of their two major global R&D its long-term plan and the recent hubs in the UK. This will involve a branded medicines pricing deal, the purpose-built, state-of-the-art facility NHS will set out how it will be a crucial to enable cutting-edge R&D, early national partner, acting as both a manufacturing and commercial real-world testbed and a beneficiary operations, with planned investment of many of the innovations flowing of £150-200m in the facility and from the life sciences industry. around £1bn total investment Wider policy measures are reinforcing over five years. The transition this approach, including: to the new facility will support ``A suite of measures to make our around 650 high-value jobs across clinical research environment R&D, enabling further collaborations faster, more efficient, streamlined with UK universities, biotechs and and innovative, including the medical research charities. use of digital platforms. ``Over £200m of new investment ``A commitment to innovative from a wide range of companies, regulation that ensures the including GW Pharmaceuticals, UK framework keeps pace with Roche, Celgene, IQVIA Ltd. emerging technology developments, and Oxford Biomedica. such as artificial intelligence, and The strength of the partnership between supports their entry into the NHS. the government, the NHS and the life ``A new package of skills sciences sector is making the UK a commitments between the global standard-bearer for discovery government and industry partners research and advanced manufacturing. to help deliver the priority skills the We are committed to continuing the sector needs now and to make the hard work of implementation over most of future opportunities. the coming years because the prize ``Ongoing work to deliver on our – a globally-leading UK life sciences commitment to increase public environment – will deliver huge benefits and private R&D spend, reaching to the people of this country through a 2.4 per cent of GDP by 2027. stronger economy and a stronger NHS.

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Ideas Strengthening the UK environment for clinical research Life Sciences Sector Deal 1: significant action has been taken over the last year to strengthen the environment for clinical trials. Sector collaborations To be the world’s most innovative economy. between companies and academia are developing innovative clinical trials. Establishing the Health Advanced Research Programme Life Sciences Sector Deal 1: the government committed to initial collaborations in Sector Deal 2 genomics and digital diagnostics, with leading health charities exploring concepts and structures to shape the future of the Health Advanced Research Programme. Sector action Government action The government’s comprehensive We will further improve the speed Sector Deal 2 plan to improve our clinical research and efficiency of clinical trials by: environment has unlocked new Sector action Government action ``Establishing five centres for late- commitments from companies: phase commercial research. ``Wellcome Trust, the Bill & ``The government is announcing ``Celgene provides support for ``Exploring opportunities to Melinda Gates Foundation and a major new commitment to the studies and is making a new recognise and incentivise NHS Cancer Research UK have come ‘Accelerating detection of disease’ investment in excess of £7m, with Trusts and GP practices acting as together with the government to challenge, backed by up to £79m an overall £38m investment. participant identification centres. define the concept of a Health from the Industrial Strategy ``With National Institute for Health Advanced Research Programme. Challenge Fund6. The challenge will ``Continuing to improve Research (NIHR) facilitation build a world-first cohort of healthy research set-up timelines. ``Wellcome Trust has committed support, IQVIA Ltd. will invest participants to support research, to progressing very high-risk/ £24m over five years into a ``Addressing challenges in NHS early diagnosis, prevention and high-reward pioneering science fourth UK Prime Site for clinical workforce resourcing to deliver treatment across the major diseases. through a major £250m trials across the North of England. commercial research. commitment to their Leap Fund. ``Committing an additional £50m ``IQVIA Ltd. and Genomics England We will consolidate our world- investment in our digital pathology ``Prof Sir John Bell will bring together are investing £20m over five years leading position in delivering programme to help make this a leading health charities including to develop services that will enable novel and innovative trials by: truly national asset and deliver Cancer Research UK, British more efficient drug research. ``Promoting the UK’s expertise Heart Foundation and Alzheimer’s more efficient NHS services. ``T h eBrain Tumour Charity in designing and delivering Research UK on the government’s Committing to sequence at least `` will invest £2.8m in the Tessa innovative trials. ‘Accelerating detection of disease’ one million whole genomes within Jowell BRAIN-MATRIX, a trial challenge, which we also expect five years, including 500,000 ``Enabling industry, including aimed at increasing opportunities to attract significant further whole genomes through the NHS. SMEs, and the wider research for brain tumour patients to try investment from the sector. community to access advice to ``Genomics England will undertake non-standard treatments. support innovative trial design. development work on a new service to enable genomic volunteers ``Delivering a skills programme to pay for a personalised report to embed expert understanding on their unique genetic make- of how innovative studies can up. With permission, the genetic be run across the NHS. data will be made available to researchers and scientists.

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Raising the intensity of R&D in the UK Business Environment Life Sciences Sector Deal 1: last year’s deal highlighted the commitment to increase investment in R&D to 2.4 per cent of GDP by 2027 and various company investments. To be the best place to start and grow a business. Making the UK a global hub for advanced therapies manufacturing Sector Deal 2 Life Sciences Sector Deal 1: the below measures build on £146m support for medicines manufacturing from the Industrial Strategy Challenge Sector action Government action Fund (ISCF), leveraging significant matched industry funding. We are seeing further commitments We will build on action to increase from companies demonstrating the UK’s R&D spend to reach confidence in the UK’s science base: 2.4 per cent of GDP by 2027 by: Sector Deal 2 ``UCB will invest up to £150- ``Working across UKRI and Sector action Government action 200m in a state-of-the-art global industry to develop a roadmap R&D hub – a commitment which to achieve 2.4 per cent. ``Investors have recognised the Capitalising on the opportunities strength in UK advanced therapy presented by advanced therapies: totals around £1bn over five years ``Announcing additional support at and will support 650 jobs. biotech companies with Orchard ``A significant portion of the £146m Budget 2018, including £1.6bn to Therapeutics Plc, Autolus Ltd. ``R o c h e will invest a further £30m ISCF support for medicines strengthen the UK’s leadership and Freeline Therapeutics in the UK including 100 new manufacturing announced in in science and innovation. Ltd. raising significant finance highly-skilled jobs by 2020. the first sector deal has been ``Setting the ambition to triple in the second half of 2018. targeted at advanced therapies. ``Celgene are investing over £22m in a industry contract and ``Bellicum Pharma Ltd., a cell ``NHS Blood and Transplant are five-year drug discovery collaboration collaborative R&D spend in therapy company, has committed to expanding their infrastructure with Cancer Research UK. the NHS to over £900m. its first European investment in the to facilitate adoption of cell ``F u r t h e roncology R&D investments UK with £2m and 20 jobs initially. include: £14m from Cancer and gene therapies. ``UK companies are scaling up cell Research UK into a London hub for and gene therapy manufacturing cancer biotherapeutics research and including Oxford BioMedica Plc treatment; £2.4m investment by (£19m) and Roslin Cell Therapies Bristol-Myers Squibb into a project Ltd. (£4m) planning to invest. with the Francis Crick Institute and Cancer Research UK into AI ``Autolus Ltd. is planning to analysis of lung cancer images. invest a further £50m to expand its UK presence, including a ``A nElectron Bio-Imaging Centre was new global headquarters. opened by Diamond Light Source backed by a £15.6m grant from Wellcome Trust and UKRI, with £9m from ThermoFisher Scientific. ``E i s a i announced an extension to its UK investment in dementia research, a new five-year collaboration with UCL.

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Supporting growth of life sciences manufacturing Improving UK environment for businesses to scale up Life Sciences Sector Deal 1: in addition to advanced therapies manufacturing, Life Sciences Sector Deal 1: last year’s deal outlined the government’s response to last year’s Sector Deal committed support to drive growth in high-value the Financing Growth in Innovative Firms5 consultation, addressing scale-up issues medicines manufacturing, including for two new innovation centres for with an action plan to release over £20bn of patient capital investment over 10 Vaccines and Medicines Manufacturing. years. We are now going further still through announcements made at Budget 2018.

Sector Deal 2 Sector Deal 2

Sector action Government action Sector action Government action Industry are making new investments The government is going further to ``Many of the UK’s largest defined- ``The government is going further to in life sciences manufacturing build on progress seen in life sciences contribution pension providers increase opportunities for pension facilities and technologies: manufacturing since the sector deal: will work with the British funds to invest in the sector by ``GW Pharmaceuticals has invested ``£8m ISCF funding was Business Bank to explore pooled addressing regulatory barriers and over £20m expanding its announced as an initial step investment in patient capital. announcing plans to help them invest manufacturing facilities in Kent. to facilitate the application of ``The UK BioIndustry Association in growing UK businesses through the British Business Bank (BBB). ``Eli Lilly and Company has digitally-enabled technologies is conducting analysis of life committed £5m to research for medicines manufacturing. sciences investment to inform a into more efficient medicines ``Up to £121m was announced for campaign to promote investment manufacture, in collaboration with the Made Smarter Programme and growth opportunities. Imperial College London and UCL. through ISCF wave 3 to support the transformation of manufacturing, including in life sciences.

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NHS innovation and collaboration Innovative regulation Life Sciences Sector Deal 1: the government committed to implementing Life Sciences Sector Deal 1: last year’s deal included a suite of the Accelerated Access Review, including £86m funding to support actions to support the UK environment for life sciences businesses. innovators and the NHS. The sector is delivering collaborative An effective regulatory environment that works for innovative, programmes in the NHS to transform services and improve care. emerging new technologies is key to this.

Sector Deal 2 Sector Deal 2

Sector action Government action Sector action Government action Collaborations are demonstrating We are now going further The sector will work with the The Medicines and Healthcare improvements to patient services: and committing to: Medicines and Healthcare Products Products Regulatory Agency ``T h ewound care industry is ``Build a stronger innovation Regulatory Agency through its (MHRA) has set out how it will be working with Academic Health ecosystem through a much- industry liaison groups to provide input the most forward-thinking regulator, Science Networks to improve enhanced and strengthened and expertise as the agency develops essential for a strong business patient outcomes and help local Accelerated Access its approaches to ensure that the environment for life sciences, by: areas maximise budgets. Between Collaborative (AAC). regulatory framework delivers a ``Supporting advanced therapies strong business environment. them Smith and Nephew and ``Improving patient access to manufacturing by developing Convatec are investing over £20m more innovations – the AAC will a framework for point-of- in UK R&D and academia. be given greater flexibility over the care manufacture. ``Barts Health NHS Trust, Queen number of products it can support, ``Leading the way on precision Mary University of London as long as they deliver good value. medicine by developing a clear and other partners are working ``Improve the innovation UK regulatory pathway for with the Department of Health infrastructure that underpins the genomic medicines and tests. and Social Care to develop a AAC’s work through stronger ``P r o m o t i n g patient major new life sciences hub in testing infrastructure. access and safety. Whitechapel. Total investment is expected to reach £500m. ``Tackle the challenge of spreading the best innovations across the system through a new health tech funding requirement.

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Infrastructure Places

A major upgrade to the UK’s infrastructure. To have prosperous communities throughout the United Kingdom. Life Sciences Sector Deal 1: the government committed to support the Life Sciences Sector Deal 1: the government committed to implement development of measures to improve the UK’s health data infrastructure, a regional approach to the Sector Deal, working closely with devolved working with NHS England, NHS Digital and Health Data Research UK. administrations and cluster organisations representing the sector.

Sector Deal 2 Sector Deal 2

Sector action Government action Sector action Government action Industry is helping to pioneer the We are making the UK the home of The sector is proactively identifying We are taking action to help use of digitally-enabled research data-driven life sciences research growing areas of opportunity for areas with clear life sciences and digital technologies: and innovation, improving outcomes life sciences in the UK regions strengths to grow: ``The ORION-4 trial is a partnership for patients and the NHS by: and devolved administrations: ``The government is renewing our between the University of Oxford’s ``Ensuring secure and appropriate ``Bruntwood in partnership with offer of Life Sciences Opportunity Clinical Trial Service Unit, its use of patient data. Legal & General Capital are Zone status to help areas raise their Epidemiological Studies Unit and ``Creating the right framework investing £360m of capital, profile at an international level. The Medicines Company on a new for commercial agreements property and intellectual assets to ``The Department of International cholesterol-lowering investigational involving data. create the UK’s largest portfolio Trade, with the Office for Life drug given just once or twice a of science and technology assets Sciences and leading cluster year using digitally-enabled tools ``Improving the UK’s health data in the Northern Powerhouse infrastructure, including through organisations will work together to lower costs, and identify sites and Midlands Engine initially. to make the life sciences and participants more easily. investments to improve NHS Digital’s core services; and to ``New projects and partnerships landscape easier for investors to ``A group of innovators will be invited develop the Local Health and Care are being developed across the navigate and support growth. to validate their algorithms on Record Exemplars and the Digital devolved administrations and English ``Budget 2018 announced £20m synthetic datasets created as Innovation Hubs programmes. regions, generating significant to further develop the plan part of MHRA’s Regulator Pioneer investment throughout the UK. for the critical central section Fund project. This pilot ultimately ``Supporting and expanding digitally- enabled clinical research. of East-West rail between aims to prove the concept and Oxford and Cambridge. act as a regulatory sandbox to ``Creating a regulatory framework help with product validation. fit for the future and able to keep pace with technological developments, such as AI. The MHRA has secured £740,000 from the Regulator’s Pioneer Fund to work with NHS Digital on developing a pilot in order to test and validate algorithms and other AI used in medical devices.

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People

To generate good jobs and greater earning power for all. Life Sciences Sector Deal 1: the government and sector committed to work together to monitor the impact of the apprenticeship levy and to support standards brought forward by the sector.

Sector Deal 2

Sector action Government action The sector is developing new We are working to increase uptake joint programmes targeted of life sciences apprenticeships: at key skills needs: ``The government is taking action on ``Encouraging young people to the apprenticeship levy to facilitate study STEM subjects, e.g. The greater flexibility and improve Association of the British uptake, particularly for SMEs. Pharmaceutical Industry (ABPI) ``We are also committing to is supporting the British Science explore the potential for a pilot Ideas Association’s work to inspire young programme with UK Research and people about STEM through a Innovation (UKRI), the Department competition around the Industrial for Education and the Education Establishing the Health Advanced Research Programme (HARP) Strategy Grand Challenges. and Skills Funding Agency to The Life Sciences Industrial Strategy & Melinda Gates Foundation and ``The Science Industry Partnership better enable SMEs in the set out a bold vision for a pioneering Cancer Research UK have come (SIP), with key partners, including sector to take on apprentices. Health Advanced Research Programme together with the government to ABPI and the BioIndustry The government is taking a range (HARP) that would put the UK at determine how to make a success Association will lead and of further measures to develop the the forefront of addressing the of the enormous opportunity HARP deliver a Life Sciences 2030 skills the sector needs, including: unprecedented challenges facing presents. This work identified four core Skills Strategy, funded by healthcare systems globally. It categories of science and research £100,000 from SIP, with further ``Increasing uptake of science, proposed that industry, charities opportunities that, taken together, funding from trade association technology, engineering and and the NHS take on far-sighted, create a powerful portfolio that will partners and the government. maths (STEM), through a new life sciences projects, underpinned help the UK lead the way in tackling external working group, led by by novel technology and higher-risk major global healthcare challenges. ``SIP is delivering on commitments the Department for Education. to roll out regional approaches science. In the first Life Sciences Sector Backed by £210m of Industrial on skills, including apprenticeships ``New UKRI programmes that are Deal, the government committed Strategy Challenge Funding (ISCF) uptake by building on the success of helping to deliver on opportunities to working with partners to explore from UK Research and Innovation SIP Cambridge with a commitment that emerge through joint how this vision could be achieved. (UKRI), the first set of HARP projects to establish SIP Liverpool. working between life sciences In the last year, leading charities, are now becoming a reality. and other disciplines. including Wellcome Trust, the Bill

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Category One: Investing and potential new investment to the to adults suffering from certain rare scans and tissue samples more in long-term assets to UK: several companies and charitable conditions or specific cancers. quickly and accurately than humans. sustain health research organisations are forming a partnership In addition, Genomics England will In the first Life Sciences Sector Deal, In the first Life Sciences Sector Deal, we to work with the government on the undertake detailed development work the government committed to work committed to a ground-breaking project project, demonstrating that the UK on a new service to enable genomic with companies to shape a programme to build on our world-leading genomics remains a leading destination for volunteers to pay for a personalised of NHS and industry collaboration, assets and ensure that the UK remains investment in cutting-edge genomic report on their unique genetic make- backed by Industrial Strategy Challenge globally competitive in this area. The UK research. The government is continuing up. As part of this and with the Funding, that will ultimately develop already has the largest, highest-quality to work with Genomics England permission of these volunteers, the and demonstrate new solutions at whole genome database in the world and other partners to progress genetic data will be made available scale. Since then, the government through the 100,000 Genomes Project, the cancer genome sequencing to researchers and scientists working has completed a competition to which reached its target in December, announced in last year’s deal. on tackling some of our country’s establish a network of five centres but the first Sector Deal recognised The government is now going further greatest health challenges. Genomics of excellence in digital pathology that we cannot afford to stand still and faster in its commitment to England will work with NHS England and radiology with AI, supported by in the face of global competition. drive advancements in personalised, and public and patient groups to lead £50m from the Industrial Strategy While we are still at the early stages targeted healthcare for the benefit of the development of the service. Challenge Fund, to demonstrate of using genomics to treat rare and patients. In October 2018, the Health This joint commitment from the how this can work in practice in the hard-to-treat conditions, the strategic and Social Care Secretary announced government and our industry and NHS. Major players including Philips, direction is that over the next 10 years an ambition to become the global charity partners to building unique, Roche Diagnostics, Canon, Siemens the volume of genomic data combined leader in genomic care through: long-term genomics assets will help Healthineers, GE Healthcare and with insights derived from clinical ``Launching the most ambitious attract further investment from Leica are key partners with the NHS data and experiential data – including genomics programme in the world the biopharmaceutical industry and academia in this ground-breaking from wearables and Internet of Things to sequence at least one million seeking to use large-scale genomic programme, which has leveraged over devices – means genomics has the whole genomes within five years, data to validate targets and produce £33m in investments from industry potential to become a key pillar of including 500,000 whole genomes more successful medicines. It will and other sources and will put the UK preventative healthcare, enabling much through the NHS in addition to the also enable the development of new at the forefront of leadership in digital more precise advice and treatments. 500,000 in the UK Biobank project. and emerging UK-based technology pathology and radiology using AI. In the space of the last year, the Our broader aspiration is to reach companies, for example in DNA The centres will work with innovative government has allocated £85m five million genomic analyses in the sequencing and annotation. SMEs to identify, develop and learn of ISCF funding to kick start the same timeframe, truly making the UK new processes, practices, knowledge the home to genomic healthcare. Category Two: Development and skills, and to develop new whole genome sequencing of all programmes applying cutting- 500,000 UK Biobank participants. ``Making the NHS the first national products and services for the benefit edge technology and science of the NHS and patients that also This will be the largest whole genome healthcare system in the world to to current problems offer whole genome sequencing have global commercial applications. sequencing project ever undertaken The Life Sciences Industrial Strategy as part of routine care for NHS Centres will work closely within their and should be completed in two years. highlighted the important role artificial patients. During 2019, the new regional NHS partnerships, as well as A £30m vanguard study, representing intelligence can play in healthcare – National Genomic Medicine Service national infrastructure, to develop and the first phase of work, is already helping to reduce costs and provide will begin to offer whole genome implement interoperability standards underway with the sequencing of the more precise, earlier diagnosis – for sequencing to seriously ill children and to commit to the adoption of first 50,000 participants having begun example, transforming NHS services likely to have a rare genetic disorder national standards as these in August 2018. And this project has such as radiology and pathology by and children with cancer, in addition are defined. already generated significant interest detecting abnormalities in digitised

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Coupled with other significant the Prime Minister has announced a challenge under the Industrial Professor Sir John Bell will bring government investments in genomics, mission to use data, AI and innovation Strategy Challenge Fund Wave 3, together UKRI, Cancer Research the image analysis from the centres to transform the prevention, early that is expected to leverage significant UK, the British Heart Foundation, will revolutionise understanding of diagnosis and treatment of chronic industry and charity matched funding Alzheimer’s Research UK and other the development of complex diseases, diseases such as cancer, diabetes, from the life sciences sector. This leading health charities, the NHS and enabling the development of new tools heart disease and dementia by 2030, will help deliver the Early Diagnosis industry to build a first-of-its-kind, for early diagnosis and new treatments whilst the Health and Social Care Mission, announced by the Prime world-leading cohort of one million targeted at specific diseases. The Secretary has set out his vision for Minister in May 2018 – a key part of healthy participants initially, aiming programme is an early deliverable an NHS which spends much more the Industrial Strategy’s AI and Data to grow to five million. The project under the Prime Minister’s of its resources on keeping people Grand Challenge – as well as delivering will support research, early diagnosis, Early Diagnosis and AI mission, well and healthy for longer. on a major recommendation in the prevention and treatment across demonstrating the opportunity for The scale of opportunity is enormous: Life Sciences Industrial Strategy. the major diseases, including cancer, digitising care and using data with success would mean saving many AI to enable scientific research and more lives, reducing NHS costs, Case study: Leading the way in the early diagnosis of cancer develop AI-based diagnostic tools. attracting investment to the UK from In this second Life Sciences Sector global pharmaceutical and health Deal, the government is now going tech companies, and helping new Oncimmune is a leading UK cancer By utilising a simple blood test run further and announcing additional UK industries, for example, in data diagnostic technology that has on inexpensive standard laboratory investment of up to £50m in our analytics and diagnostics, to grow. It pioneered the development of a equipment, the technology digital pathology programme as would also empower all UK citizens blood test that has the potential to is frictionless, resulting in an a first step towards making this a to understand their individual risk of transform the detection and diagnosis unprecedented rate of recruitment truly national asset to support early developing diseases as never before, of cancer through the measurement compared to similar screening and improved diagnosis across the and take steps to remain healthy for of autoantibodies. The technology studies. The test was able to identify UK, and deliver more efficient NHS longer. In the UK, we are spending is being used as part of the Early a small population for follow-up services. This will accelerate the £97bn a year on treating diseases, Cancer detection test – Lung cancer when compared to other screening speed at which the NHS and patients and only £8bn on preventing them7. Scotland (ECLS) study, which is programmes, significantly reducing are able to realise the benefits from Cancer Research UK estimates believed to be the largest randomised the risks of false positives associated our investment and enable these that by 2033, if the number of late- trial for the early detection of with large-scale screening trials. benefits to be shared by everyone. stage diagnoses were reduced by 50 lung cancer using a blood-based Interim results have demonstrated per cent just across bowel, ovary, biomarker ever conducted. that Oncimmune’s technology has Category Three: Visionary prostate and lung cancer, each year The ECLS study is specifically the potential to save lives and avert programmes looking 20 years over 55,000 more people would be targeted at a population with a lower costs to the NHS by detecting many ahead to revolutionise healthcare diagnosed at an early stage rather risk of developing lung cancer, 0.5% more early-stage cancers (75% early- The Life Sciences Industrial Strategy than a late stage. This could result compared to 2% or even 3.5% in stage versus 20% today). By using a highlighted an opportunity for the UK in over 22,000 fewer deaths within other screening studies, successfully blood test, the screening approach to lead the way globally in changing five years of diagnosis, per year8. recruiting over 12,000 participants. is more acceptable to participants the healthcare paradigm so that we In this second Life Sciences Sector and has fewer implications are proactive in identifying, preventing Deal, the government is announcing for NHS imaging capacity. and treating disease early, rather a major new commitment of up than reactive in seeking to manage to £79m R&D funding9 in the late-stage illness or merely prolong Accelerating Detection of Disease life. Since the Sector Deal last year,

22 23 Industrial Strategy Life Sciences Sector Deal 2 dementia and heart disease. This will This is particularly true of high-risk, Strengthening the UK environment for clinical research be a ground-breaking national health high-ambition programmes that fall programme that will develop new outside the remit of conventional diagnostic tests through applying life sciences funding because of The UK’s expertise in clinical research is world-leading. leading-edge AI and other cutting-edge the high level of risk involved. We continue to punch above our research through a standard technologies. It will attract additional Wellcome Trust has decided to weight in many areas and rank costing methodology, a model site global investment from the sector. play a significant role in filling this second globally for commercial Phase agreement in the NHS standard Category Four: Very high-risk/ gap through a major new £250m I studies10. In 2017/18, the National contract and beginning to implement high-reward pioneering science commitment to their far-reaching Institute for Health Research (NIHR) a single contract review to increase to create new technologies Leap Fund programme. This new, Clinical Research Network achieved transparency and reduce variation. and breakthroughs not-for-profit fund will place big bets on record levels of recruitment with over ``Removing the 70 day benchmark ambitious research programmes with 725,000 people taking part in clinical The Life Sciences Industrial Strategy for clinical trials in favour of the potential to fundamentally change research studies, of which over 50,000 the publication of accurate was clear that delivery of the Health science or transform health over a participants were recruited to studies Advanced Research Programme’s performance data using a five-to-ten year horizon. The fund sponsored by the life sciences industry, standard national framework13. (HARP) ambitions would require will support researchers, engineers, including 24 global-first patients. 99 a coalition of partners and that innovators and technologists from per cent of NHS Trusts were actively ``Increasing the uptake of the Clinical charities would play a leading role. around the world to pursue bold engaged in clinical research11. Practice Research Datalink in GP ideas at scale and speed, drawing practices in England by almost 30 Responding to Life Sciences Industrial per cent since the end of 2017. inspiration from the technology Strategy recommendations, the first and venture capital industries. Sector Deal committed to further ``The Health Research Authority improvements in our clinical research (HRA) and the Medicines and environment. Since then we have: Healthcare Products Regulatory Agency (MHRA) piloting Made significant progress in improvements to the approvals delivery of NHS England and process - by offering a combined the NIHR’s commitments to 12 approach, researchers are receiving Actions to support and apply 12 better quality and more efficient research in the NHS by: approvals in parallel rather than ``Awarding more than £950m in sequence – which we are now NIHR investment in research rolling out more widely14. infrastructure in the NHS to The life sciences sector is also translate findings from basic science delivering on commitments made in to patient and healthcare benefit. the first Sector Deal demonstrating ``Making it significantly easier to that the UK is already a great place set up a study by implementing to do innovative clinical trials. a new national model to manage ``Using anonymised electronic health excess treatment costs in records to improve efficient trial non-commercial research. designs for mood disorders, the ``Simplifying processes for NHS University of Oxford and Janssen

24 25 Industrial Strategy Life Sciences Sector Deal 2

Pharmaceutica NV concluded that ``Establishing five purpose- ``Addressing challenges in NHS to identify opportunities for the NIHR-supported Clinical Record designed centres dedicated to workforce resourcing required collaboration. The NIHR CRN will also Interactive Search (CRIS) database late-phase commercial research in to deliver commercial contract establish which NHS providers are can support effective identification 2019/20. Identified through NIHR research. Working closely with able to deliver innovative trial designs of trial candidates. Wider application Clinical Research Network (CRN) industry and NHS Trusts, the NIHR to support faster site selection. of this approach is being considered. competition, the centres will offer CRN will investigate the workforce ``Enabling industry, including SMEs, ``The Medicines Company has begun rapid set-up of late-phase commercial resource challenges in commercial and the wider research community the two projects announced in the research, standardised contracting contract research, and develop to access advice to support first Sector Deal – the first with the and delivery approaches where recommendations to government innovative trial design. The MHRA’s University of Oxford to perform a appropriate, and dedicated facilities for innovative approaches to early engagement offer includes its large multinational cardiovascular and staff. They will increase the tackle them by summer 2019. Innovation Office where exploratory disease clinical trial (see case study, NHS’s capacity to deliver research, We also believe the UK can discussions can take place and a p.49). The second, with The Greater enabling significant growth and consolidate its world-leading position scientific advice service where experts Manchester Health and Social opportunities for patients to benefit in delivering novel and innovative can produce written guidance on a Care Partnership, to improve from early access to innovation. trials, making delivery of these specific question relating to a product the understanding, management ``Identifying opportunities to studies ‘business as usual’ across the or study. This can be particularly and economics of cardiovascular recognise and incentivise NHS system. The Life Sciences Industrial helpful where trial aspects challenge disease has begun large-scale big Trusts and GP practices acting Strategy proposed a strategic goal to the current regulatory framework. data analysis to model the risk of as participant identification grow the proportion of clinical trials The MHRA will engage with industry heart disease using a medication centres. The NIHR CRN will explore with novel methodology over the to understand how it can further to reduce certain risk factors. mechanisms to ensure patients next five years. Following on from develop this offer by the end of 2019. are offered the opportunity to excellent work by the Clinical Research ``Wellcome Trust and the Bill & ``Taking a range of measures Melinda Gates Foundation are participate in research of relevance Working Group, a partnership between to maximise the value of the progressing with their aim of to them, whether or not it is being industry and government, to identify UK’s unique data assets in delivering more efficient and fit-for- delivered by their regular healthcare innovation in trial design, we pledge clinical research, set out in full purpose clinical trials for non-product provider, making recommendations to turn this vision into a reality by: in the Infrastructure chapter. registration trials. They are taking to the Department of Health and Identifying and promoting the `` ``Delivering a skills programme a global lead through an inclusive Social Care by spring 2019. UK’s world-leading expertise in to embed expert understanding process in developing an alternative ``Continuing to improve research designing and delivering innovative of how innovative studies can international equivalent to the set-up timelines by achieving HRA trials, including opportunities for be run across the NHS. The good clinical practice guidelines, approval within timelines specified industry collaboration. We will work NIHR Clinical Research Network delivering on a recommendation in the EU Clinical Trials Regulation; with NIHR early translational research will deliver e-learning courses, in the Life Sciences Industrial increasing the transparency of infrastructure (NIHR Biomedical designed to increase awareness Strategy. The African Academy performance data through common Research Centres, Clinical Research and understanding of innovative of Sciences has recently become use of the HRA/NIHR research Facilities, and Experimental Cancer trial designs, supplemented with a partner of this joint initiative. study minimum dataset across Medicine Centres) to make available targeted learning for specific groups. However, we can do more to improve NHS organisations, and providing details of their expertise in delivering ``The government will explore with our clinical research environment industry with access to this data in innovative trials, making it easier NHS England how they can publish for both pharmaceutical and health a searchable format to inform site for industry and other researchers an action plan on ways to optimise tech companies. We will continue to selection and intelligence-driven improve speed and efficiency by: performance improvement.

26 27 Industrial Strategy Life Sciences Sector Deal 2

the use of real-world evidence. research, and to develop more robust Raising the intensity of R&D in the UK Our comprehensive plan this year has evidence to support treatment value helped to secure new commitments and greater access to personalised from the sector who recognise the medicines for NHS patients. The UK has a world-leading science base, with four of the top 10 UK as a leading place to invest and ``In May 2018, the Prime Minister globally-ranked universities and with UK-based scientists winning to undertake innovative trials: announced £40m over the next five more than 80 Nobel Prizes in chemistry, physics, and medicine - ``Celgene provides support for studies years as part of the Tessa Jowell most recently winning chemistry prizes in both 2017 and 2018. initiated by the researcher in areas Brain Cancer Mission, doubling The Life Sciences Industrial Strategy contributor at 18% of the UK total, including haematology, oncology and funding for brain tumour research. emphasised the importance of building spending over £4bn in R&D16 and making immunology. They are making a new This will be invested through the NIHR on this and continuing to increase R&D excellent progress against significant investment in excess of £7m and to support a wide range of research spend. In the Industrial Strategy White commitments in the first Sector Deal: a total investment of £38m. It will and the Mission’s running costs. The Paper15 and the first Life Sciences Sector Brain Tumour Charity has now ``MSD announced last year that it result in 12,500 UK patients receiving Deal the government committed last would locate its new Discovery the best standard of care and novel announced £2.8m for the Tessa year to work with industry to increase Jowell BRAIN-MATRIX trial, aimed Centre in London. Since then, Dr Fiona treatments, free of charge to the NHS. combined public and private expenditure Marshall was appointed as VP Head of at radically increasing opportunities on R&D to 2.4 per cent of GDP by ``With NIHR facilitation support, for brain tumour patients to try non- Discovery Research at MSD UK and the IQVIA Ltd. (formerly IMS Health & 2027, increasing to three per cent over plan is for 19 scientists to be in place by standard treatments. The NIHR will the longer term. In the last year UK Quintiles) is committed to opening support the recruitment of patients, the end of the year, increasing to 150 a fourth UK Prime Site to focus on Research and Innovation (UKRI) has new roles once the Centre is complete. and start-up and delivery of the been formally established to work in the delivery of life-changing clinical trial via the UK-wide Experimental The team of scientists will be studying research across the North of England. partnership with academia, research cell homeostasis in the context of ageing Cancer Medicine Centres (ECMCs) organisations, industry, charities, and the In addition, IQVIA Ltd. will invest and the Clinical Research Network. that can lead to disease. The aim will up to £24m over five years with government to create the best possible be to identify mechanisms that can be NHS England has also commenced a research and innovation environment. the ambition of employing over 50 national neurosciences transformation targeted for new drug development additional highly-skilled staff to drive project, a strand of which will Building on this, Budget 2018 announced for a range of diseases such as additional trials across the UK. The focus on improving the pathway of significant additional support for cutting- Motor Neurone disease, Parkinson’s Northern Prime Site will include NHS care for neuro-oncology patients, edge science and technologies, including disease and Alzheimer’s disease. research-ready hospitals across building on existing work offering £1.6bn to strengthen the UK’s global ``In September 2018, Novo Nordisk the Greater Manchester, Leeds neuro-oncology patients access to leadership in science and innovation. opened its £115m Oxford research and Sheffield region, embracing dedicated outpatient clinics and BEIS is working across industry and with centre, employing up to 100 scientists a data-enabled approach to the pre-operative consultations with UKRI to develop a roadmap that sets out aiming to discover innovative design and delivery of hundreds multidisciplinary teams. Health the steps needed to reach the 2.4 per treatments for Type 2 diabetes of additional clinical trials and real- Education England is committed to cent ambition. A new ambition to triple and cardiometabolic diseases. world evidence studies to the benefit ensuring the UK has leading neuro- industry contract and collaborative of thousands of NHS patients. oncologists to provide outstanding R&D spend in the NHS to over £900m As part of this second Sector Deal, we care and deliver ground-breaking will provide a significant contribution are seeing further new commitments ``IQVIA Ltd. and Genomics England from industry, reinforcing confidence have announced a new partnership, research, so it is exploring further to the overall 2.4 per cent ambition. education and training opportunities in the UK’s R&D strengths and investing £20m over five years to Latest figures for 2017 show that excellent science base: develop services to allow authorised such as credentialing in this area. the total spend on UK R&D by UK researchers to run studies enabling businesses was £23.7bn. Of this, life The world-class research environment faster and more efficient drug sciences continues to be the largest has led global pharmaceutical

28 29 Industrial Strategy Life Sciences Sector Deal 2 company UCB to invest in one of their oncology R&D investments including: two major global R&D hubs in the UK17. £14m from Cancer Research UK to This will involve a purpose-built state-of- turn London into a world-leading hub the-art facility to enable cutting-edge R&D, for cancer biotherapeutics research and early manufacturing and commercial treatment; and a £2.4m investment by operations, with planned investment Bristol-Myers Squibb to collaborate of £150-200m in the facility and in a one-year project, Rubicon, around £1bn total investment over with the Francis Crick Institute five years. The transition to the and Cancer Research UK to assess new facility will support around the feasibility of using AI to analyse 650 high-value jobs across R&D, images of lung cancer study samples. enabling further collaborations with In September 2018, the Electron Bio- UK universities, biotechs and medical Imaging Centre (eBIC) in Harwell was research charities, and build on UCB’s opened by Diamond Light Source highly successful endeavours in following the award of a £15.6m researching and developing medicines in grant from the Wellcome Trust and the UK to transform the lives of people UKRI, with £9m from ThermoFisher living with severe diseases globally. Scientific. Wellcome Trust subsequently Roche will invest an additional £30m invested an additional £9m to significantly in the UK including approximately expand the facility. The facility is the first 100 new highly-skilled jobs by 2020, high-end cryo-electron microscopy (cryo- Business Environment including £20m over three years into EM) facility worldwide to be embedded a precision cancer research partnership in a synchrotron and will firmly place the with The Christie NHS Foundation Trust UK as a global leader in providing large- Making the UK a global hub for advanced therapies manufacturing. in Manchester. They will use cutting- scale industrial access to cryo-EM for The first Life Sciences Sector Deal transformative benefits of these edge Foundation Medicine genomic drug discovery and structural biology. set out the government’s ambition to medicines being felt by NHS patients. technology alongside big data to In May 2018, Eisai announced make the UK a global hub for advanced The UK’s capability in this field means accelerate the next generation of digital an extension to its investment in therapies manufacturing, responding clinical trials for rare cancers, making the we are securing highly-skilled jobs and dementia research within the UK, to Life Sciences Industrial Strategy 18 UK a leading global hub for rare cancer accessing a global market estimated a new five-year collaboration with analysis that highlighted the emerging to be worth between £9-14bn per trials and potentially benefiting nearly UCL, recognising the high standard opportunities for the UK economy 5,000 patients annually. Roche will also year by 2025. The UK is home to of UK science and its universities. from new technologies such as cell the highest number of cell and gene invest £10m into its Welwyn Garden and gene therapies. This ambition City site in 2019/20, whilst creating In September 2018, KalVista therapy commercial developers (64) has been supported by a further in Europe, as well as the most cell approximately 100 new highly-skilled jobs. Pharmaceuticals opened the anchor £70.6m of government funding for facility at the Porton Down Science and gene therapy clinical trials19. A Emphasising the strength of the UK the Cell and Gene Therapy Catapult cell and gene therapy cluster has Park, enabled by £5m funding from two (CGTC) to build on our impressive cancer research ecosystem Celgene earlier Biomedical Catalyst grants. The formed in Stevenage, supported by are investing over £22m in a five- existing national infrastructure and the Stevenage Bioscience Catalyst and facility will house its UK drug discovery allow the UK to offer end-to-end year drug-discovery collaboration and development group and will focus the Cell and Gene Therapy Catapult with Cancer Research UK to discover, capability in cell and gene therapies, Manufacturing Centre: the Campus on development of new medicines for from research to manufacturing, develop and commercialise new anti- diseases with significant unmet need. hosts 14 companies in this industry cancer treatments. This is one of many to clinical use and export, with the

30 31 Industrial Strategy Life Sciences Sector Deal 2 employing more than 350 people, received £2.5m to support their Barnsley will include clean rooms in a Series B financing round. that between them have raised over £8m investment in expanding to increase NHSBT’s capacity for ``The UK’s ecosystem encouraged £680m from commercial investors20. their Keele site to enable production the manufacture of advanced cell Bellicum, a clinical-stage cell therapy A significant portion of the £146m of commercial GMP quality viral therapies, creating 12 highly-skilled company, to locate its first European Industrial Strategy Challenge Funding vectors for advanced therapies, new jobs. Further expansion of the investment in the UK, initially awarded for medicines manufacturing adding 25 new jobs onsite. Filton facility is proposed and will committing £2m and 20 jobs. in the first Sector Deal has been directly  - £3m of support enabled Oxford double NHSBT’s capacity for plasmid, ``UK companies are scaling up cell targeted at advanced therapies: Biomedica to invest £19m in a viral vector and protein manufacture, creating 10 new specialist jobs. and gene therapy manufacturing ``£12m to double capacity at the new manufacturing site which will capabilities: in addition to Oxford Cell and Gene Therapy Catapult enable them to target 25 per cent These strong signals of UK commitment BioMedica’s £19m investment in Manufacturing Centre. The to 30 per cent of the global lentiviral are generating significant industry activity: a new manufacturing site, we are vector bioprocessing market and CGTC opened its Manufacturing ``Investors have recognised the able to announce that both Autolus Centre in April 2018 to help cell create 100 new highly-skilled jobs. strength in UK-grown advanced and Roslin Cell Therapies Ltd. and gene therapy developers build ``£21m has been awarded to create therapy biotechs: Orchard are investing in new manufacturing manufacturing capability, backed by three Advanced Therapy Treatment Therapeutics raised $150m sites. RoslinCT, a cell and gene £60m of government investment. Centres (ATTCs). The ATTCs were (£117m) from investors in Series therapy contract development In September, the MHRA granted set up in March 2018 to develop easily- C fundraising in August 2018 and manufacturing organisation the Centre a Good Manufacturing run solutions for the adoption of cell and $225m (£175m) in its initial is planning to invest a projected Practice (GMP) licence, cementing and gene therapies that can be rolled public offering (IPO) in November £4m in the first phase of a new its role as one of the world’s leading out across the NHS. The centres 2018, to help it develop clinical manufacturing facility in Edinburgh. facilities for the development have attracted £5.7m in co-funding programmes to treat rare inherited This is expected to bring up to 50 and production of cell and gene from industry and involve over 20 diseases. Autolus raised over new jobs and will provide commercial- therapies. Companies are recognising different companies, in addition £120m through IPO in June stage manufacturing services to the facility’s value and reaping to NHS organisations, universities 2018, while Freeline Therapeutics advanced therapy developers. the benefits. In 2018 two further and national blood services. raised over £88m of new capital collaborators, Freeline Therapeutics ``Over £12m of the ISCF funding and Adaptimmune, signed an allocated for medicines Case study agreement with the Catapult and manufacturing collaborative discussions are already taking place R&D projects has gone to UK-based company Autolus, spun- London and as the first partner of for use of new capacity which is advanced therapy projects, out from University College London the Cell and Gene Therapy Catapult under construction at the facility. de-risking investment in in 2014, is developing potentially Manufacturing Centre in Stevenage, ``£5.5m of capital support innovation and attracting over life-changing T-cell cancer therapies. Autolus is planning further announced in the first Sector £6m of industry co-funding. Initially supported by UK venture investments of approximately Deal has enabled leading UK In addition to investments supported capital from Syncona, Woodford £50m in the UK. Over the next viral vector manufacturers by Innovate UK, NHS Blood and Arix, and grants awarded by three years they intend to bring a to expand their capacity: and Transplant (NHSBT) are Innovate UK, Autolus recently new global launch manufacturing - Cobra Biologics, an international expanding their human and capital raised over £120m in a successful facility on-stream and expand contract development and infrastructure to facilitate the NASDAQ IPO. Autolus now their global headquarters and manufacturing organisation in adoption of advanced cell and gene employs more than 180 people. research laboratories, generating biologics and pharmaceuticals, therapies. A new £16m centre at Building on its existing presence in 100 high-value UK jobs.

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Supporting the growth of life sciences manufacturing Improving the UK environment for businesses to scale up

The government has also supported a variety of projects that will The first Sector Deal outlined the government’s response to the drive up productivity in high-value medicines manufacturing Financing Growth in Innovative Firms consultation, addressing more generally, in particular two pioneering new UK centres: issues raised in the Life Sciences Industrial Strategy about ``The Medicines Manufacturing Government is continuing to go further supporting scale-up with an action plan to drive over £20bn of Innovation Centre, Strathclyde. to build on this strong progress: patient capital investment over 10 years. The MMIC will help the UK lead ``£8m was announced in September Since the first Sector Deal was £250m Dementia Discovery Fund, globally in the development of 2018 as an initial step to facilitate published, private investment in UK life a specialist, 15-year venture capital process technologies for small the application of digitally-enabled sciences has continued to grow: UK fund that invests in novel science to molecule pharmaceutical and methods or technologies to improve biotech companies raised more than create new medicines for dementia. fine chemical manufacturing. The medicines manufacturing. £1.5bn in the first eight months of The government also set out a £56m centre is supported by 2018, surpassing the 2017’s £1.2bn series of new actions that will help £13m from the ISCF, as well as ``Up to £121m for the Made Smarter total22. Venture capital is particularly 21 address the Life Sciences Industrial funding from Scottish Enterprise Programme through ISCF wave 3 . strong with £900m raised. Strategy’s recommendation to increase (£15m), AstraZeneca (£7m) and Announced at Budget 2018, this A full update on the package of opportunities for pension funds to invest GSK (£7m). It is expected to lead challenge will build on this to support measures set out in the first Sector Deal in the sector by addressing regulatory to £80m in R&D investment the transformation of manufacturing, was published alongside Budget 201823. barriers. For example, the government by 2028, creating 80 direct jobs including in life sciences, through A particular highlight for life sciences will consult in 2019 on the function by 2023 with more indirectly. digitally-enabled technologies. was the launch of the British Business of the pension charge cap to ensure ``The Vaccines Manufacturing Industry are also making new investments Bank’s new £2.5bn investment that it does not unduly restrict the use Innovation Centre, Oxford. The in life sciences manufacturing: programme, British Patient Capital, of performance fees within default centre will help create new, cost- ``GW Pharmaceuticals, a pioneering and its investment of £9m in the pension schemes. It also announced effective ways of developing and UK-based biopharmaceutical company manufacturing vaccines, building our developing and delivering rigorously- ONI – Next generation super-resolution microscopy resilience in the face of pandemic tested and regulatory-approved threats. Led by the Jenner Institute cannabis-derived medicines for at the University of Oxford, Imperial seriously ill patients, has spent over In 2016, ONI was founded as a 100 high-value jobs in Oxfordshire and College London and the London £20m expanding its manufacturing university spin-out with the aim of will be used to create further local jobs in School of Hygiene & Tropical Medicine, facilities in Kent in the past year making high-end life science research the coming years. Such an international the new centre has been awarded and more than £100m in R&D, more accessible to every researcher investment is a vote of confidence £66m from the Industrial Strategy creating 111 highly-skilled roles, on the planet by miniaturising Nobel in the UK’s science companies to Challenge Fund. Additional funding with an additional 98 planned. prize-winning microscopy technology. grow and scale in the UK. In the of £10m will come from commercial ONI has recently completed a future, ONI’s technology could have and other partners, including ``Eli Lilly and Company has significant series A funding round significant diagnostic applications Janssen Vaccines & Prevention committed £5m to fund research in with international investors and leading particularly in the cancer space, as B.V. and MSD, and will be supported collaboration with Imperial College life sciences patient capital investor, it can identify pathology on cells far by bioprocessing expertise and London and UCL into the more Oxford Sciences Innovation (OSI). This more accurately than current state-of- training from GE Healthcare. efficient manufacture of medicines. investment has created an additional the-art techniques used in the clinic.

34 35 Industrial Strategy Life Sciences Sector Deal 2

NHS innovation and collaboration How do the Life Sciences Sector Deals benefit SMEs?

SMEs comprise 82 per cent of life innovative SMEs to develop The Life Sciences Industrial Strategy set out a vision for a system that sciences businesses, over 56,000 products for the NHS and support has NHS-industry collaboration at its heart, setting a challenge to create jobs (24 per cent of employment) and to develop real world evidence and an innovation ecosystem that will deliver improved patient outcomes, £7.2bn in turnover24. UK life sciences access to innovative trial design. service efficiency and economic growth, driving the innovation required spin-out companies outnumber the next ``Supporting the infrastructure to address the challenges that the health system faces. largest sector (IT & digital) by almost needed for growth including: two to one25. This year we highlight: In the first Sector Deal, we set out our Across the system we have also Industrial Strategy Challenge Fund initial steps to achieve this by committing seen improvements to the access ``HM Treasury’s Patient Capital support for Centres of Excellence to deliver on the recommendations from environment. The average time Review – in response, HM Treasury in digital pathology and radiology; the Accelerated Access Review and tackle from marketing authorisation to first launched an action plan to drive over Advanced Therapy Treatment long-standing barriers to innovation NICE output is now six months, and £20bn of patient capital investment Centres; and, extending the Cell in the NHS: a fragmented landscape to final NICE guidance is now 10.2 to finance growth in innovative, high- and Gene Therapy Catapult and where innovators find it hard to access months — 3.4 months quicker and growth potential firms over 10 years. Manufacturing centre. These support and the NHS has limited visibility 5.7 months quicker than five years ``As part of this action plan, programmes will support innovative of innovations in the pipeline; limited ago27. And, the Innovation Scorecard doubling the annual allowance for SMEs to identify, and develop new and variable NHS-industry collaboration shows that 77 per cent of the investments through the Enterprise products, processes and services that leading to misalignment of product medicines it measures were prescribed Investment and Venture Capital can be rolled out across the NHS. development and procurement with NHS more than the previous year28. Trust Schemes – after which UK SMEs delivering jobs and growth priorities, or new technologies failing to Industry and government have BioIndustry Association’s (BIA) in the UK include Puridify, now provide sufficient evidence for uptake; successfully reached heads of 26 venture capital data for 2018 shows part of GE healthcare who opened and difficulty getting new technologies agreement for a new voluntary a large increase in fundraising for the their new factory in Stevenage in into NHS use and spreading what works. branded medicines pricing scheme. sector in the second half of the year. November 2018 and Purolite, with One year on, we have made clear and The new scheme will ensure patients ``Strengthening collaboration a new factory in South Wales in concrete progress with partners: for benefit from access to the best between the NHS and innovators October 2018 supporting advanced example, the NHS is the first health available treatment, through faster through schemes to support global bioprocessing demand. system in Europe to agree access to adoption of clinically and cost-effective CAR-T treatments, achieved through medicines, and demonstrates the the fastest product approvals in government’s ongoing commitment to plans to help pension funds invest The sector is also taking action the NHS’s 70-year history and NHS sustainability, health innovation in growing UK businesses. Chaired on this issue: to complement the supporting our goal to be a world- and the UK pharmaceutical sector. by the British Business Bank, government’s work to give pension leading hub for advanced therapies. many of the UK’s largest defined- funds the confidence to invest in assets The proposals are expected to This success — with a disruptive technology contribution pension providers, supporting innovative firms, the BIA include measures to improve uptake that required a new pathway and route including Aviva, HSBC, L&G, NEST, is conducting a detailed analysis of life of transformative new medicines, to market — provides a clear signal that The People’s Pension, and Tesco sciences investment by large institutional as well as commitments from NHS the NHS is eager to embrace innovative Pension Fund, have committed to investors and private wealth managers England to provide more proactive treatments and can respond with flexibility undertake a feasibility study to explore to inform a strategic communications uptake support and implementation and agility to adapt its processes, giving options and develop a blueprint for a campaign to promote the investment planning for innovative, cost-effective patients access to the most effective new pooled investment in patient capital. and growth opportunities of early medicines that provide a significant treatments faster than ever before. and growth-stage companies. health gain. This includes committing

36 37 Industrial Strategy Life Sciences Sector Deal 2 to achieving uptake levels in the upper ``£7m under the NHS Test Bed quartile of comparator countries for the programme (Wave Two) is helping Progress on industry Sector Deal commitments five highest health gain disease classes; seven projects to support real- more and faster NICE appraisals for new world testing of innovations, and One year on from signing, an additional theatre and medicines; increased support for small prove their suitability for scaling. the Orthopaedics Managed recovery beds will enable 1500 businesses, through exemptions from ``A new scheme for SMEs has been Service partnership between additional procedures in 2019. the cost control mechanism; targeted established, with £1.5m to design Johnson & Johnson Managed Johnson and Johnson Medical case management of commercial and undertake real-world evidence Services and Guy’s and St discussions with NHS England; and greater Devices Companies (JJMDC) development and a further £4.5m Thomas’ NHS Foundation has now entered the evaluation commercial flexibility for companies that available over the next two years. Trust is delivering results: offer the best value new medicines. phase of its three-year orthopaedic We are improving access to new ``Demand-led supply chain partnership with Barts Health In addition to these significant technologies in the NHS: management is improving NHS Trust, and is on track to: achievements, we have taken the operating theatre efficiency and following additional steps to tackle ``Three medicines have been appraised ``Realise a target increase in freeing up clinicians’ time to be theatre efficiencies of 12%. the barriers to innovation: and recommended through NICE’s fast- able to focus on patient care track appraisal process – delivering rather than operational tasks. ``Bring together multidisciplinary To simplify and improve the recommendations on average four fragmented landscape, we have: teams to agree standardised months faster than standard appraisals. ``Improved assets management is enhanced recovery ``Established the Accelerated reducing procedure cancellations pathways for patients. ``The new commercial function at and improving productivity. Access Collaborative (AAC) under NHS England is increasing the NHS’s the leadership of Lord Darzi to improve ``Deliver the target of an additional capability to engage earlier, and more ``The expansion of current theatre 1500 bed days to the Trust. patient access to innovation. In October, flexibly, with the life sciences sector. capacity is on track meaning we announced the first 11 products that we will support, potentially improving ``We have strengthened Academic the lives of 500,000 patients. In early Health Science Networks (AHSNs) 2019 the AAC will select more products with a clear mandate to work with to accelerate through the system. industry and local NHS partners to: understand local health and care ``Coordinated horizon scanning needs; support system navigation; through ‘HealthTech Connect’, provide access to testing; and support developed by NICE and NHS England to the adoption and spread of products help innovators hold early discussions in the NHS. This has underpinned about market access, and give the NHS a AHSN engagement with 1,173 better sense of emerging technologies. companies this financial year leading We are strengthening collaboration to 86 long term strategic partnerships and co-development between for companies with the NHS. the NHS and innovators: ``NHS England’s Innovation ``£24m from the Digital Health Technology Payment is supporting Technology Catalyst awarded to products to overcome procurement 26 SMEs is supporting growth in the and financial challenges, with further digital health sector and developing products to be agreed in 2018/19. digital solutions the NHS needs.

38 39 Industrial Strategy Life Sciences Sector Deal 2

Building a stronger innovation ecosystem demonstrating significant value for considering different types of the health system. This would apply innovation, including digital products. to health tech products, other than To support this, NICE will begin We have made strong progress, but partners across the system pharmaceuticals, which have been presenting guidance and standards agree that there is more to do to meet the ambition of being a assessed as cost saving by NICE. In as a series of pathways, mirroring world leader in developing and rapidly adopting proven and addition, by 2020, we will significantly the patient experience and the affordable innovations at scale. increase the number of evaluations of sequence of care clinicians recognise. these health tech products conducted To achieve this, we are embarking support through the system. It will by NICE, giving greater scope for on a new programme of work with a be given greater flexibility over the much-enhanced and strengthened number of products it can support, Accelerated Access Collaborative with as long as they deliver good value. Wound care solutions a mandate to oversee the innovation ``Improving the innovation landscape for all types of technology: infrastructure that underpins The wound care industry, working effectively. Between them, Smith ``Putting the Accelerated Access the AAC’s work through stronger with AHSNs, are pulling together a and Nephew and Convatec are Collaborative (AAC) at the heart testing infrastructure — we will consortium across the health and investing over £20m in UK R&D of health innovation — making it enable iteration and co-development care sector to explore how the use and academia. Smith and Nephew the umbrella organisation across between the NHS and industry by of digital clinical decision support has already invested some of this the innovation landscape, and the ensuring that we have sufficient tools (like the tool named in the money into a pilot with Northumbria front door to support for innovators facilities to support product first Life Sciences Sector Deal) can Healthcare NHS Foundation Trust and the health system. It will set the development and pathway testing in reduce variation and improve patient to validate this technology and strategy and priorities for a more real-world settings across multiple outcomes and help local areas wound care solution in the NHS. effective innovation ecosystem: locations. This will improve adoption maximise the impact of their budget overseeing and coordinating health of innovations by giving the NHS and utilise their workforce more funding and support for innovation, greater confidence in the evidence and maximising the opportunity base for new technologies and provided by the NHS long-term enabling innovators to be sure their funding settlement. The AHSNs products align with NHS need. Developing a major new life sciences hub in London will be a key element of the AAC ``The government will make funding and will deliver a consistent, high- available to enable NICE to Working with Barts Health NHS Including some space for clinical quality offer to innovators and the undertake more support for medical Trust, Queen Mary University of use by Barts, we plan to develop health system across the country. devices, diagnostics and digital London and other partners, the in the region of one million square ``Improving patient access to more products. We will tackle the challenge Department of Health and Social feet of space, creating exciting innovations — the AAC will continue of spreading the best innovations Care intends to develop a major new opportunities for businesses to play an important role in identifying across the system through a new life sciences hub in Whitechapel on and property investors. We transformative innovations, including health tech funding requirement land vacated by Barts. We see a real anticipate total investment in digital and diagnostic products, for for the very best products opportunity to support, strengthen the property to exceed £500m. and capitalise on the life sciences expertise and potential in the area.

40 41 Industrial Strategy Life Sciences Sector Deal 2

Innovative regulation The MHRA will collaborate with This will give industry greater support relevant partners to develop a clear to gather the evidence they need to UK regulatory pathway for genomic underpin licensing applications, in An effective regulator, working within well-functioning regulatory medicines and genomic tests by addition to early engagement with frameworks, is an essential part of a strong business environment March 2021, helping to accelerate MHRA, NICE and the health system. for the life sciences sector. developments in precision medicine so Patients will continue to benefit from that treatments can be directly targeted earlier access to medicines, often for The Life Sciences Industrial Strategy In order to provide this clarity, the to patients based on their genetic conditions with unmet clinical need. highlighted the Medicines and MHRA will develop a framework profile. These pathways would apply Healthcare Products Regulatory for point-of-care manufacture, Patient safety is paramount to all to, for example, a medicine targeted of MHRA’s work, and data and new Agency’s (MHRA) global reputation between April 2019 and March 2021, in at a gene-based marker, or aimed for innovation and leadership in this collaboration with research councils and technologies present opportunities to at specific gene defects in a disease further develop world-leading expertise: field.The MHRA’s vision is to be the the Cell and Gene Therapy Catapult, like cystic fibrosis, with a companion most forward-thinking regulator building on learnings from scientific diagnostic. This work aims to produce ``The MHRA will look to assess for both innovative approaches to advice and clinical trial applications. a roadmap to help industry, academia the feasibility of using artificial regulation and the regulation of intelligence (AI) to identify Leading the way on and healthcare bodies understand innovative new types of products. safety signals in large datasets precision medicine which types of clinical trials are most They have set out how they will support appropriate for their products. of health records, enabling real- priority areas in the strategy: advanced Advancements in genomic technologies time identification of issues arising therapies manufacturing, precision present opportunities for the UK to Promoting patient access with medicines. In addition to clear medicine, and furthering our leading develop forward-thinking regulation and patient safety patient benefit, industry will better position on patient safety, ensuring that will operate dynamically for the The MHRA will continue to pioneer understand how their products that the MHRA remains at the global future. World-leading UK science fast-tracked and safe patient access to work in a real clinical setting. forefront in these areas and meets was pivotal in the development of ground-breaking treatments, benefiting ``The MHRA are exploring whether the needs of industry in the UK. genomic technologies and precision both patients through early access to a MHRA Yellow Card Biobank medicine applications. The UK was the medicines and the sector, as they are Supporting advanced source of the technology on which can be developed to capture therapies manufacturing able to better gather evidence for the genetic information from patients Illumina, the world leaders in DNA medicines licensing process. It will build As the UK seeks to become a global hub sequencing technology, was founded experiencing adverse drug reactions on the success of the Early Access (ADRs). This would create a resource for advanced therapies manufacturing, and now Oxford Nanopore is making to Medicines Scheme, a world- our regulatory framework must keep a significant impact with its new to help the MHRA identify where class scheme helping innovative genetics influence who is most at risk pace with developments in the field and long-read technology. Maintaining medicines reach patients quickly provide clarity to industry. Advanced regulatory leadership and expertise in from ADRs so that industry and the and safely, ahead of licensing, with NHS can reduce these incidents. therapies require different methods of this field is a crucial step in ensuring over 1,500 patients benefitting so far. manufacturing and delivery to patients. that the industries developing products This, coupled with advancements in based on this science continue to invest The MHRA will work with industry and technologies such as 3D printing, may in the UK and that UK patients stand to other partners to define a supportive mean that increasingly medicines and benefit early from new developments. framework for the collection of devices will be manufactured in situ real-world data during the scheme. close to the patient, and an effective framework to ensure the safety of these products will be essential.

42 43 Industrial Strategy Life Sciences Sector Deal 2

Ensuring secure and appropriate included in the first Sector Deal is live use of patient data in beta, enabling external customers The first Sector Deal emphasised to remotely and appropriately access that improving the UK’s health data data for analysis, with more datasets infrastructure must be done in a to be added in 2019. NHS Digital are way that keeps data secure; gives working with partners to streamline patients a choice about how data is legal and ethical approvals so that used; is transparent about its use they hold more data in trust, meaning and gives confidence that its use was easier, secure access for researchers. appropriate, secure and legal. The Creating the right framework government committed to implement to realise benefits for patients the National Data Guardian’s (NDG) and the NHS where data recommendations and has since: underpins innovation ``Led a cross-system programme Our shared goal, working with partners to embed the NDG’s Data Security across the healthcare system and Standards through a re-designed working hand-in-hand with NHS England Data Security and Protection Toolkit, and NHS Improvement, is to improve relaunched in April 2018. This is part outcomes for patients, make the NHS Infrastructure of a wider programme, including: more efficient and cost-effective, £60m of critical IT infrastructure and make the UK home to the latest investment in 2017/18; a new Cyber data-driven scientific advances in Improved use of high-quality, cost-effective healthcare data Security Operations Centre; and healthcare. Our starting point is that the presents an opportunity to make the UK the home of data-driven an additional £150m to support government wants NHS partnerships to life sciences research, innovation and development – and in so cybersecurity in the health and care flourish within the strictest parameters sector over the next three years. doing, improve outcomes for patients and the NHS. of transparency and accountability. We ``Launched the national data opt- recognise that each partnership will be The Life Sciences Industrial Strategy of all sizes to set up and grow here on out service in May 2018, a major different, and that there is no ‘one-size- set out how to capitalise on this the strength of UK health data, and to milestone in our commitment to fits-all’ solution. Some datasets may unique global opportunity. make navigating the complex system of build public trust, alongside taking increasingly be made openly available to access, testing and monitoring of data- We are laying down the building steps to improve accessibility and enable innovators to develop solutions driven healthcare as simple as possible. blocks to realise the full potential of transparency for patients on data use. to some of our greatest healthcare the scale and diversity of NHS data, A lot has happened since the first and technology challenges, but we also NHS Digital are also delivering on their while also maintaining public trust Life Sciences Sector Deal, with rapid anticipate that NHS organisations will commitments: a new draft framework30, in how data is used and maximising progress on all its commitments. The enter increasing numbers of commercial published alongside the Health and the benefits of innovation for NHS government is now going further arrangements, where it is right that Social Care Secretary’s tech vision, patients. We will realise the Health and to create the right framework for NHS patients benefit directly from the sets out core standards on technology Social Care Secretary’s tech vision29 commercial data agreements, address innovations enabled using NHS data. and data for all NHS IT systems and for a modern technical architecture, regulatory challenges and support digital services to ensure a more joined- We recognise that NHS organisations underpinned by robust, common digitally-enabled pharmaceutical up, safer, more efficient system. need expert guidance in reaching these standards, that improves services and and health tech clinical research. types of commercial agreements. The remote data access environment drives innovation. We want companies The Office for Life Sciences has

44 45 Industrial Strategy Life Sciences Sector Deal 2 already begun detailed policy work arrangements, nor include conditions with patients, the public and partners. are hosted through NHS Digital, for to consider the different commercial limiting any benefits from being applied Supporting the development of example the Health Episodes Statistics models that could be appropriate and at a national level, nor undermine the measures to improve the UK’s (HES), a comprehensive, coded dataset what kind of national guidance and wider NHS digital architecture, including on all hospital admissions. Other major health data infrastructure hands-on commercial support NHS open standards and interoperability. data assets include: primary care records; organisations will need. We know As previously highlighted, the UK’s ``Principle 4: Any commercial registries such as the Cancer Registry health data assets provide an exceptional that these are complex issues which arrangements agreed by NHS managed by Public Health England; opportunity to lead in both pharmaceutical generate different views and we want organisations should be transparent, and unique, specialised datasets such and health tech discovery and clinical to hear from patients, the public and clearly communicated, and not as Genomics England’s. In addition, the development, and also to greatly partners on whether these five guiding undermine public trust and UK has significant assets in consented enhance the functionality of the NHS. principles are the right basis for the more confidence either in the NHS or populations from its large cohorts, detailed national policy framework: wider government data policies. These assets have been significantly particularly UK Biobank, and disease- Principle 1: Any commercial use of expanded and enhanced thanks to specific charities, which often manage `` ``Principle 5: Any commercial increasing digitisation of the system significant registries of patients. NHS data must have an explicit aim arrangements agreed by NHS and increased interoperability, based to improve the health and care of organisations should fully adhere The government is investing to on technology improvements. patients in the UK, including through to all national level legal, privacy further enhance the UK’s health data the discovery of new treatments, and security obligations, including The government is continuing to capabilities through complementary, diagnostics, and other scientific in respect of the National Data drive this, with a £475m digitisation well-aligned programmes that will improve breakthroughs. Where possible, the Guardian’s Data Security Standards. package, announced by the Health and connectivity and interoperability across terms of any arrangements should Social Care Secretary, to accelerate the datasets, in line with the Life Sciences In parallel, we are developing the include quantifiable and explicit roll-out of innovative technology aimed at Industrial Strategy. This includes: concept of a national centre of benefits for UK patients which will be improving care for patients and to support expertise which would oversee the ``Health Data Research UK (HDR realised as part of the arrangement. staff to embrace technology-driven health policy framework, provide specialist UK) has announced a Strategic and care. This builds on the Global ``Principle 2: NHS data is an commercial and legal advice to NHS Partnership Agreement with NHS Digital Exemplar programme – backed important asset and, in entering into organisations entering commercial Digital to ensure joined-up alignment by a further £200m of government commercial arrangements, NHS agreements, develop standard contracts of data ecosystem initiatives, such funding in September 2018 – where organisations should ensure they and ensure that the advantages of scale as NHS Digital’s Data Processing NHS providers who have reached agree mutually-beneficial and fair in a single-payer health system deliver Services, Digital Innovation Hubs and globally-recognised levels of digital terms. In particular, the boards of benefits for UK patients. The centre the National Clinical Trials Platform. maturity share their learning on delivering NHS organisations should consider would be expected to work closely with ``HDR UK is also working with NHS exceptional care, efficiently, through the themselves ultimately responsible the Centre for Data Ethics and align Digital to establish a UK Health use of world-class digital technology for ensuring that any arrangements with the National Data Strategy. Data Research Alliance to encourage entered into by their organisation and information with other trusts. The Department of Health and Social widespread access to health data in a are mutually beneficial and fair. The unique feature of UK health data Care intends to publish more detail trustworthy, ethical and secure way. resource is its longitudinal nature, covering ``Principle 3: Any commercial on the emerging policy framework, As the Alliance forms, members individuals across the system from birth arrangements agreed by NHS including any required alignment with will work together to support and to death in both primary and secondary organisations should not undermine, the initial code of conduct for data- promote a common set of behaviours care. Along with its sheer scale, this inhibit or impact the ability of the NHS, driven health and care technology31, around responsible data sharing provides the UK with one of the most at national level, to maximise the value and the structure and responsibilities of for research and innovation. powerful health datasets in the world. or use of NHS data. NHS organisations the national centre in the first quarter should not enter into exclusive of 2019 following detailed discussions A large number of national data assets

46 47 Industrial Strategy Life Sciences Sector Deal 2

``A £43m investment to enhance running a sprint innovation competition In addition, over the next year, the conventional, labour-intensive methods. NHS Digital’s core data services, to identify exemplars which could government will explore the potential Along with digitally-enabled recruitment, including more automated processing, test the technical solutions required of patient registries with stakeholders this would dramatically reduce the less movement and replication of for Hubs. A period of detailed design like the NHS, PHE and the Association cost and speed of recruitment to and data, and the utilisation of modern and dialogue with stakeholders on of Medical Research Charities (AMRC), running of large-scale clinical studies, solutions on the cloud. This will the Hubs will then be followed by a who have already published a report on particularly for late-stage clinical trials, increase security, reduce the cost full specification and UK-wide call for this subject32, to understand whether the most costly component of the drug and increase the efficiency of NHS applicants in May 2019. Three to five there is untapped potential which discovery process. By 2020, the NHS Digital services, while continuing to regional and interoperable Digital could be better utilised by the sector. app will also be a channel to provide fully respect citizens’ data rights. Innovation Hubs will be selected to NHS Digital and NHS England, working participants with information about the ``Funding to further develop Clinical further integrate health data assets with research partners including the outcome of the research they were part Practice Data Link (CPRD) to both regionally but also in collaboration NIHR, will deliver new services via of. By 2021, it will allow people to upload enable secondary care data flows with NHS Digital across the country. the NHS App from autumn 2019 data from their wearables and lifestyle from hospitals to support specific Alongside improving patient care, to enable patients to become more apps, swiftly, safely and securely, and real-world clinical and patient- a major focus of this work is on directly engaged in clinical research consent for it to be linked with their consented studies in combination supporting and expanding digitally- relevant to them, by registering their health records, in order to help improve with CPRD primary care data, which enabled clinical research so that willingness to participate and indicating NHS patient care through research. will achieve even greater efficiencies both clinical and real-world data their preferences for types of research. in delivering real-world clinical trials studies can be greatly facilitated, Crucially, subject to consent, it should across the health care spectrum. uniquely positioning the UK to take be possible to obtain relevant data ``Five Local Health and Care Record advantage of this digital revolution. from the digital records of patients Exemplars, selected by NHS England Under the Strategic Partnership enrolled in research, reducing costs and supported by £37.5m national Agreement announced between NHS and improving efficiency, compared to funding alongside local investment, Digital and HDR UK, Professor Martin to further integrate patient records Landray will lead work on the creation The ORION-4 Trial on a new cholesterol-lowering drug between primary, secondary and of data services to support a 21st social care. The addition of a second century clinical trials platform. It will The ORION-4 trial, a partnership 50 hospitals. This provided them cohort of health and care systems focus on the creation and linkage of between the University of Oxford’s with faster, earlier assurance on will provide 63 per cent coverage national data systems to support rapid, Clinical Trial Service Unit, its the feasibility of the trial, identified of the English population. efficient trials that meet the needs of Epidemiological Studies Unit and a more diverse range of sites than ``The creation of Digital Innovation regulators and NHS patients, while The Medicines Company, aims to usually possible for large-scale trials, Hubs announced in the first Life protecting individuals’ data rights. This recruit 15,000 participants, including and enabled a wider, representative Sciences Sector Deal. Backed by includes a system for assessing the 12,000 in the UK, for a trial of a new cross-section of the UK population £37.5m of UKRI Industrial Strategy feasibility of recruiting well-defined cholesterol-lowering investigational at risk of cardiovascular disease to Challenge Funding, Health Data patient populations into trials, with a drug given just once or twice a year. participate. Thoughtful design and Research UK has now been appointed vision to demonstrate an efficient In an NHS Digital pilot, following effective use of digital tools mean to deliver the programme, aligned and industry-friendly, England-wide advice from data governance experts, the trial is due to be completed on with its wider activity to create a clinical trials service for feasibility the team accessed national health time, at high quality, for a fraction UK-wide infrastructure and common and eligibility by autumn 2019 to data for England to identify one of the cost of similar recent trials. framework for the use of data for complement the NIHR Clinical Research million eligible participants across research and innovation. HDR UK is Network Study Support Service.

48 49 Industrial Strategy Life Sciences Sector Deal 2 Creating a regulatory framework fit for the future Places The UK regulatory regime needs to be fit-for-purpose and keep pace with rapid technological developments so that patients, Over half the UK life sciences workforce is outside the south east clinicians and care professionals can access the best possible cluster34. Last year the first Life Sciences Sector Deal committed to treatments quickly and safely, and innovators are supported to develop more regional approaches in future phases of work. develop health and care solutions in safe spaces. We are now setting out new and accelerators that demonstrate a Clarifying existing frameworks and The MHRA recognises the need to commitments in this regional high level of commitment to attract how they work for digital technology keep pace with the opportunities component of the deal, as well as companies and support growth. will be essential if we are to create offered by data-driven technologies, casting a spotlight on the full breadth The sector is already spotting potential the right conditions for innovation. specifically algorithms and AI. For of UK activity, demonstrating the opportunity zones and Bruntwood, sheer scale of opportunity. The first iteration of the code of example, developing the necessary the owner of Alderley Park, in conduct for data-driven health structures to deal with learning The government is investing in place- partnership with Legal & General and care technology provides algorithms that continuously change based approaches and has launched the Capital, have announced a deal that clarification on what is expected from based on a continual flow of data. Strength in Places fund, a new approach sees the two partners invest £360m our technology partners, in terms To harness these opportunities, the to research and innovation funding. The of capital, property and intellectual of commercial arrangements and MHRA has successfully bid into the Local Industrial Strategy programme is assets to create the UK’s largest standards, to ensure that technology Industrial Strategy’s ‘Regulator’s well underway with the West Midlands, portfolio of science and technology firms are able to quickly and efficiently Pioneer Fund’ for £740,000 to Greater Manchester and Thames assets. Initially expanding within the deliver the best possible outcomes work with NHS Digital on a proof- Valley publishing progress reports Northern Powerhouse and Midlands for patients and the system. We are of-concept pilot to develop synthetic highlighting their life sciences strengths. Engine regions, Bruntwood SciTech working with a number of technology datasets that mimic real-world data With so much economic potential, partnership seeks to make the most firms, pharmaceutical companies, to validate algorithms, including AI we are taking action to help market of untapped potential in the UK’s national funders and medical charities algorithms used in medical devices. regional strengths. In response to science and technology sector. With a who have agreed to incorporate the The pilot will invite a small group of industry feedback, we are renewing plan to create over 20,000 high-value principles from the code of conduct innovators to validate their algorithms the government’s offer of Life jobs over the next 10 years, the deal 33 in their work . We will continue to against the synthetic datasets. If Sciences Opportunity Zone status, represents the largest investment engage with stakeholders to ensure successful, the synthetic datasets so that areas of existing or emerging made in science and technology that the code continues to be fit-for- will be made available to innovators strength can apply for the designation property assets in Europe this year. purpose and supports innovation. and act as a regulatory sandbox to to help raise their profile at international Within each region, self-assembled, We expect to publish an updated help with product validation. This will level. The existing Opportunity Zone place-based organisations act as version of the code in due course. help make the UK an excellent place is the Charnwood Campus which, multi-faceted convening bodies to for AI and diagnostic companies since its designation in 2016, has bring together the breadth, value, to develop and test their products, become a focal point for life sciences and expertise across the health and and help develop an effective in the Midlands. Applications will be life sciences supply chain to drive route to market for innovations. considered from existing or new UK economic growth. Over the next life science locations, such as science year the government, led by the or manufacturing parks, incubators Department of International Trade

50 51 Industrial Strategy Life Sciences Sector Deal 2

The distribution of the UK’s vibrant life sciences industry35

Scotland North East Employment: 15,770 Employment: 7,430 Turnover (£m): £3,193 Turnover (£m): £1,152

Yorkshire & The Humber Employment: 18,020 Turnover (£m): £2,735

East Midlands Northern Ireland Employment: 14,900 Employment: 6,230 Turnover (£m): £2,648 Turnover (£m): £842

East of England Employment: 39,410 Turnover (£m): £16,229 and the Office for Life Sciences, will reputation for being the best place in Northern West continue to work with our Life Sciences the world to do discovery science. In Employment: 25,500 Champion, Professor Sir John Bell, the first Life Sciences Sector Deal we Turnover (£m): £6,072 in collaboration with the leading highlighted government investments in UK cluster organisations (including local infrastructure in the Cambridge- Health Science Scotland, Northern Milton Keynes-Oxford corridor to West Midlands Health Science Alliance (NHSA), ensure the area’s continued growth. Employment: 16,400 MedCity, Midlands Innovation, the GW4 In the 2018 Budget, the government Turnover (£m): £5,429 Alliance, Life Science Hub Wales and has gone further, announcing £20m Life Sciences Northern Ireland) and to further develop the plan for the national centres of excellence, to make critical central section of East-West Wales the landscape easier for investors rail between Oxford and Cambridge. Employment: 11,510 to navigate and support growth. Other thriving UK clusters are growing, Turnover (£m): £2,054 London based on strong government and sector The most well-known cluster in the Employment: 24,060 partnerships, and are showcased here. UK, referred to as the golden triangle South West Turnover (£m): 9,608 of Oxford, Cambridge and London, Employment: 10,070 is extremely strong and rightly has a Turnover (£m): £1,640 South East Employment: 56,480 Turnover (£m): £18,731

52 53 Industrial Strategy Life Sciences Sector Deal 2

Thames Valley cancer treatment centre – ‘The in the heart of Manchester’s 2017/18 to expand initiatives in The Thames Valley is at the heart Rutherford Cancer Centre, Thames health innovation district. The genomic medicine, diagnostics, of the golden triangle and is home Valley’ on the park which includes new Genomic Health Innovation clinical trials, healthcare informatics to the highest concentration high-energy proton beam therapy. Campus aims to attract a cluster and medical technologies of companies to Manchester to underpinning the strategy for of disruptive technology and The Northern Powerhouse AI companies in the UK36: drive pioneering research and development of the new £300m The Northern Powerhouse is home development. The investment Birmingham Life Sciences Park. ``In the Thames Valley, industry, to 21 per cent of the total UK life will create 250 new jobs whilst During 2018, Boehringer Ingelheim academia and medical research science sector workforce, and has `` supporting more than 1000 jobs has partnered with the Leicester institutions, under the umbrella of grown by more than nine per cent indirectly in the Manchester corridor. Diabetes Centre and the Leicester the Thames Valley Life Sciences to over 50,000 employees since T h eLeeds Medtech Hub has Real World Evidence unit to design Partnership, chaired by Bayer, are 2012. Latest figures for 2017 show `` secured £70m towards its £250m and deliver high-quality, real-world collaborating on data analytics and the value of this sector in the North investment target and its Nexus studies. This is a prime example of artificial intelligence to develop to be over £13.6bn37. With £1.6bn of Centre is nearing completion. the Midlands’ cutting-edge, data a ‘global artificial intelligence planned investment in the pipeline Alongside this, £15m has been science-enabled ecosystem that is and imaging hub’ to develop over the next five years put forward secured to deliver connected delivering large, collaborative, NHS- next generation targeting, going by the Northern Health Science electronic patient records and partnering innovation platforms. across a range of therapy areas, Alliance in response to the first Life a further £9.5m to back Grow to identify undiagnosed and sub- Sciences Sector Deal, it is clear that ``Supported by strong Midlands Medtech and its 20 new partners optimally treated patients. this is a significant, growing cluster. partnerships, the new £300m who will support work to deliver early Defence and National ``At Thames Valley Science Park in Investments include: stage medical technology innovation. Reading, the University of Reading Rehabilitation Centre, also awarded is developing a strong cluster of ``Fujifilm Diosynth in Tees Valley ``A tSheffield Olympic Legacy £70m from government, the NIHR R&D focused health life sciences has invested £5.7m this year, Park, good progress has been Trauma Management MedTech companies. Opened in March 2018, building on a £6.7m investment made on plans for an Orthopaedic Cooperative and Medical Device the park will be amongst the biggest made in 2017 in high throughput and Rehabilitation Research and Testing & Evaluation Centre are dedicated science parks in the region process development of monoclonal Innovation Centre and a Centre driving development of technologies and one of the largest in the South antibodies, which will support its of Child Health and Technology. such as robotic exoskeletons and East. Funded by a £35m investment growing portfolio of projects to scar-reducing wound care products. develop and manufacture life- The Midlands Engine from the University of Reading and In 2017/18 the Institute of changing medicines for its clients. The Midlands is the manufacturing `` the European Regional Development Translational Medicine leveraged heart of the UK, one of the largest Fund, the investment has enabled ``Liverpool and Northumbria are now over £44m in new research and clinical trials clusters in Europe the provision of office and laboratory home to two of Proton Partners clinical innovation funding across and host to impressive health data space for around 20 companies, International Rutherford Cancer industry, philanthropy and public platforms. The region integrates from start-ups to global research Centres with an initial investment bodies to accelerate precision industry (particularly SMEs) with local and development centres. This is the of £70m, with Rutherford medicine studies and clinical trials. first step in the establishment of a Diagnostics recently announcing government, universities and the NHS significant new Science Park which, a £15m diagnostic centre in the to deliver new technologies, tests and The Great West once complete, will have the potential Liverpool Knowledge Quarter. treatments in a stable but ethnically- The Great West region has a fast- diverse population of 11 million. to provide up to 5,000 new jobs. ``QIAGEN are working with Health growing life science industry Birmingham Health Partners presence, realised by the sector’s ``Proton Partners International Innovation Manchester to develop `` has recently completed a £30m a world-leading genomics campus raised more than £100m during synergy with more mature regional

54 55 Industrial Strategy Life Sciences Sector Deal 2 technology and digital businesses Northern Ireland generation of its AI-enabled digital is one of six that make up the - through convergence with AI, high- Northern Ireland is enjoying a growing pathology platform. UK Dementia Research Institute performance computing and quantum international reputation in key areas Queen’s University Belfast’s (UK DRI) with a total £290m technologies, a flourishing SME such as diagnostics, precision medicine new £10m Precision Medicine investment. It will build upon ground- ecosystem and world-leading academic and advanced manufacturing: Centre of Excellence, supported breaking scientific research strengths expertise in biodesign, genomics in dementia genetics; immunology; ``R a n d o xLaboratories is leading by £5.8m from government, and epidemiology, and quantum will aim to improve treatment for computational analytics; and science. This is exemplified by: a £50m investment in three neuroimaging to identify disease new R&D centres of excellence cancer patients and develop an ``NovoNordisk acquired University of internationally-accredited clinical mechanisms and therapies. in clinical diagnostics in Northern This will identify new targets for Bristol spin-out Ziylo Ltd in August Ireland. Randox is partnering with laboratory focusing on diagnostics, 2018 in a staged acquisition with bringing together genomics, digital drug development, develop new Queen’s University Belfast and approaches for delivering effective a potential deal value that could Ulster University, and committing pathology and big data analytics. exceed £640m ($800m) and clinical trials and attract industry £27m to the project, supported Wales partnerships to develop new has entered into a collaboration by a further £23m in government Wales has a whole-system approach therapeutics and diagnostics. with Carbometrics, based at fast- support from Invest Northern to health and social care, underpinned growing incubator facilities, UnitDX. Ireland. Randox, who have Scotland by a national digital infrastructure. invested over £300m to date in ``Charles River acquired University It is a global leader in value-based Scotland’s life sciences community their proprietary Biochip Array of Bristol spin-out KWSBiotest, healthcare and tracking outcomes. is working closely with NHS Scotland Technology, aim to drive significant a leading Contract Research This is linked to economic development to develop an ecosystem which improvements in healthcare through Organisation specialising in through projects like the £200m supports growth and development earlier, more accurate diagnosis. immunology oncology discovery Wellbeing Village, which makes within the sector. The unique Scottish testing services, in January 2018. ``Almac Discovery, a research-driven Wales an ideal partner system for Health Research and Innovation This milestone-based £18m ($24m) drug discovery company, is making rapid adoption and evaluation of Ecosystem is a portal which will investment cements a strong service a £15m investment in a Centre for new medicines, technologies and facilitate collaborations between provider presence in the region. Precision Therapeutics to develop services. Key projects include: Scottish businesses and the NHS. new therapeutic approaches for Major collaborations include: ``External investment of around ``Through a partnership that brings diseases of unmet medical need, £90m has been made into world- together EU, Welsh government and ``The new Industrial Centre for AI in collaboration with Queen’s leading quantum technologies academic investment of £24m, Research in Digital Diagnostics University Belfast and supported research at the University of Bristol. the ACCELERATE Programme, led (iCAIRD) was announced in by £5.4m of government funding. The University will establish a by the Life Sciences Hub Wales will November 2018. With its hub in new £43m Quantum Technology ``Northern Ireland is a centre of focus on accelerating the exploitation the Glasgow Clinical Innovation Innovation Centre to accelerate expertise in digital pathology: of innovation and technology Zone, this collaboration from NHS life sciences industrial impact Philips computational digital opportunities that meet needs across Scotland, academia and industry is in three areas: (i) improving the pathology capability is in Belfast and the health and social care system. expected to incubate more than 40 speed of genomic data processing will be heavily involved in delivering companies, generating over 500 ``The UK Dementia Research and drug discovery; (ii) quantum two of the new Industrial Strategy highly-skilled, sustainable jobs over Institute at Cardiff is a £20m enhanced sensing and imaging Challenge Fund centres of excellence the next 10 years of the project. research centre aimed at finding for diagnostic devices and for digital pathology with AI. Invest effective treatments for dementia, cell biology; and (iii) quantum NI has recently awarded Philips a with more than 70 global scientists communication for data security, grant of £1.3m towards a £3.6m and plans to grow to 100. The centre for example medical records. investment to develop the next

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Highly-skilled workers are at the heart of the Life Sciences Industrial Strategy and the first Sector Deal set out initial measures to further develop the home-grown skills the sector needs, whilst also ensuring it can access talent from around the world. The government and the sector are now going further in their commitments. Increasing uptake of life sciences apprenticeships The Life Sciences Industrial Strategy bioinformatics, and regulatory affairs. noted that apprenticeships will play an The government is now taking further increasing role in addressing industry’s action on the levy in response to need for highly-skilled employees. 38 ongoing discussions with industry, A survey by the ABPI found a 31 helping to address an issue raised in the per cent increase in apprenticeships Life Sciences Industrial Strategy and since 2015, up by 169 per cent since the Science Industry Partnership’s (SIP) 2013 — this increase being primarily Apprenticeships survey39. Action includes higher-level apprenticeships — showing measures announced at Budget 2018: how they are increasingly seen as a viable option to more traditional ``Larger employers highlighted they academic routes. In the first Sector would value the ability to transfer Deal, government committed to work more levy to SMEs in their supply with the Institute for Apprenticeships chain to support the development of ``Industry partners, Canon Medical Centre for Sensors and Imaging a broader life sciences ecosystem. and Philips, and innovative SMEs, Systems (CENSIS), developed a (IfA) to prioritise the development of standards for life sciences. Budget 2018 announced that such as Bering, Cytosystems bio-imaging platform which can this would increase from 10 per Ltd, Deep Cognito Ltd, Glencoe perform accurate, live, intracellular Since then, through the IfA’s ‘Faster cent to 25 per cent from April Software, Intersystems, Kheiron analysis in 3D. This project addressed and Better’ programme, industry 2019. Up to £90m will be made Medical Technologies and Nvidia, a need within various cell markets trailblazer groups developing standards available in 2019/20 to fund have together invested over £5m. but is particularly key for stem cell have received specialist support from the costs of apprenticeships Collaborating with research-active research, impacting on areas such as a dedicated relationship manager supported by transfers. clinicians, they will combine to solve tissue engineering and cell therapy. to guide employers through each healthcare challenges and create step of the process. The IfA’s Health ``SMEs will be further supported an effective route to market. and Science route panel (formed of by a £240m commitment in industry leaders) has worked with Budget 2018 to help reduce the ``The University of Strathclyde worked 20 life sciences trailblazer groups to amount that smaller employers with Biogelx Limited and supported have to contribute to training by the Innovation Centre – Scottish deliver standards in priority areas for the Life Sciences Industrial new apprentices from 10 per Strategy, for example clinical trials, cent to 5 per cent in 2019.

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However, the government recognises enable SMEs in the life sciences Accelerating convergence across life that there are specific issues affecting sector to take on apprentices. sciences and other disciplines the life sciences sector, particularly SIP is delivering on its commitment in SMEs, that could mean barriers remain the first Sector Deal to roll out regional to their uptake of apprenticeships. approaches to meeting industry skills The Life Sciences Industrial Strategy highlighted enormous We are therefore announcing our needs, particularly on apprenticeships opportunities for innovation at the interface between life sciences intention to work with UKRI, DfE and uptake: following the successful the Education and Skills Funding and other disciplines, recommending funding to facilitate cross- set-up of SIP Cambridge, it is looking to disciplinary and cross-sectoral working and the exchange of ideas. Agency to explore the potential extend this approach to SIP Liverpool. for a pilot programme to better New UKRI programmes are ``Centres for Doctoral Training in helping to deliver this: Applications and Implications of Increasing uptake of science, technology, ``Clinical academic research Artificial Intelligence:A UKRI-wide engineering and maths (STEM) partnerships: A new pilot scheme call was opened earlier this year will be launched to enable research- for universitites to apply and will qualified, but not research-active, support up to 950 new students The Life Sciences Industrial Strategy recommended taking steps to NHS consultants to participate in over five years, some of which will be aligned with life sciences. further strengthen UK STEM education. collaborative high-quality research partnerships, facilitating engagement The government has established a new, for young people, inspiring them and better connecting basic Department for Education-led STEM about STEM through learning how biomedical science to clinical research. External Working Group to feed views society, technologies and jobs will The scheme will be launched in late and expertise from industry into change as a result of addressing the 2018, supported by £10m from cross-government work, operating Industrial Strategy Grand Challenges. the Medical Research Council. as a working group to test current ``The ABPI will convene key partners and future thinking on STEM. The in healthcare and industry to Building a 2030 Skills Strategy group comprises major stakeholders identify opportunities to improve across STEM industry representation support focused on research and bodies, academic institutions and innovation for medics throughout The Life Sciences Industrial Strategy recommended the employers, and includes membership their training and career, for example from the life sciences sector, ensuring development of a skills action plan based on a gap analysis developing the ABPI’s careers of key skills for sciences. their views are well represented. resource into a new joint portal Industry is also developing innovative that will support medical students, The Science Industry Partnership will build a clear evidence base of new solutions to encourage young amongst others, with their career. (SIP), with key partners including the status of life science skills and the Association of the British future scenarios to 2030, focusing people to take up and pursue ``The ABPI will also work with Health STEM subjects and careers: Pharmaceutical Industry and the on medicines manufacturing for Education England to align industry’s UK BioIndustry Association, will established medicines and advanced ``The Association of the British support for work on medical careers lead and deliver a Life Sciences therapies (supported by the Medicines Pharmaceutical Industry (ABPI) with the Topol Review, which will 2030 Skills Strategy, funded by Manufacturing Industry Partnership), will support the British Science make recommendations next year £100,000 from SIP, with further as well as other emerging technologies, Association’s work to deliver a new on how to prepare the healthcare funding from trade association such as AI, and to identify what is government-funded competition workforce to deliver the digital future. partners and the government. It needed in addition to current provision.

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The Board meets quarterly to review Since many of the projects are currently progress on sector deal commitments in early stages of implementation, and to consider wider implementation we expect to monitor this data over of the Life Sciences Industrial Strategy’s a period of years to be able to see vision, for example, advising on the a long-term impact. As well as the proposals for new commitments overall success metrics, delivery made in this second Sector Deal. partners will also evaluate individual projects and their impacts on the Metrics industry, using the specific metrics To monitor the overall impact of the developed on a project-by-project first Life Sciences Sector Deal, we have basis. New metrics to measure the worked with our delivery partners impact of new commitments in this through the Life Sciences Industrial second Life Sciences Sector Deal Strategy Implementation Board to will also be developed with the Life develop metrics for each of the projects Sciences Implementation Board. included in the first deal, in addition Some of the high-level life sciences to a set of overall success metrics metrics collected will be reported based on the expected long-term to evaluate the Industrial Strategy impacts of each individual project: Sector Deal programme as a whole. ``Increased investment in the UK life science industry and an increase in UK GDP ``Growth of UK Life Implementation Science companies ``Improved patient access and uptake 40 Governance of cost-effective innovations The Life Sciences Council has been representing the full breadth of ``Increased investment in clinical established as the most senior the sector; the Chief Executive of research and increased share of strategic partnership forum between NHS England; the government’s clinical research participation the government and the sector to Life Sciences Champion; and senior To be able to monitor and evaluate provide oversight of the future of UK representatives of relevant government long-term impact we have used a life sciences, including delivery of the funding organisations and policy leads. combination of existing annual targets, vision of the Life Sciences Industrial The Council is supported in its forecasting and current trends in the Strategy and the Life Sciences Sector strategy and oversight role by the data to create the baselines which will Deals. Chaired by the Secretaries Life Sciences Industrial Strategy help us evaluate our performance. of State for Business, Energy and Implementation Board, chaired jointly Industrial Strategy and for Health by the government and industry. and Social Care, along with the Chair It includes senior representatives of the British Pharmaceutical Group from the government, the NHS, for industry, the Council consists of industry and charities. global industry and charity CEOs

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14 HRA and MHRA - The combined Review 2018 – www.ct.catapult.org.uk/ References ways of working pilot (2018) - https:// annualreviews www.hra.nhs.uk/planning-and- 21 Subject to business case approval improving-research/policies-standards- 1 Office for Life Sciences – Strength service.gov.uk/government/uploads/ legislation/clinical-trials-investigational- 22 UK BioIndustry Association – and Opportunity 2017: the landscape of system/uploads/attachment_data/ medicinal-products-ctimps/combined- Biotech Financing Update (2018) - the medical technology and biopharma- file/753688/Prevention_is_better_ ways-working-pilot/ https://www.bioindustry.org/resource- ceutical sectors in the UK (2018) - than_cure_5-11.pdf listing/biotech-financing-update-june 15 Department for Business, Energy ---august-2018.html www.gov.uk/government/publications/ 8 Calculated by the Cancer Intelligence and Industrial Strategy – Industrial bioscience-and-health-technology- Team, Cancer Research UK. Based on Strategy: building a Britain fit for the 23 HM Treasury – Financing growth in database-annual-report-2017 current distribution of stage at diagnosis future (2017) - https://www.gov.uk/ innovative firms: one year on (2018) 2 Professor Sir John Bell – Life for cancers with a recorded stage of government/publications/industrial- - https://www.gov.uk/government/ Sciences Industrial Strategy: a report disease in England (obtained from PHE), strategy-building-a-britain-fit-for-the publications/financing-growth-in- to the government from the life cancer incidence projections for 2033 -future innovative-firms-one-year-on sciences sector (2017) - https://www. and estimates for 5 year cancer survival 16 Office for National Statistics - 24 Office for Life Sciences –Strength gov.uk/government/publications/ by stage. Contact cancerintelligence@ Business enterprise research and and Opportunity 2017: the landscape life-sciences-industrial-strategy cancer.org.uk for more information. development UK: 2017 https://www.ons. of the medical technology and 3 Office for Life Sciences – Industrial 9 Subject to business case approval gov.uk/economy/governmentpublic biopharmaceutical sectors in the UK sectorandtaxes/researchanddevelopment (2018) - www.gov.uk/government/ Strategy: Life Sciences Sector 10 Association of the British Deal (2017) - https://www.gov. expenditure/bulletins/businessenterprise publications/bioscience-and-health- Pharmaceutical Industry – Number of researchanddevelopment/2017 technology-database-annual-report-2017 uk/government/publications/ Phase 1 trials - global (2016) - https:// life-sciences-sector-deal www.abpi.org.uk/facts-and-figures/ 17 This is subject to finalising a 25 Spinouts UK - Spinouts UK annual 4 Department of Health and Social science-and-innovation/number- suitable site and contractual negotiations report 2017 - http://www.spinoutsuk.co.uk/ news/2017/12 Care and Department for Business, of-phase-1-trials-global/ 18 Medicine Manufacturing Industry Energy and Industrial Strategy – Making 11 National Institute for Health partnership – Advanced Therapies 26 UK BioIndustry Association – Biotech a reality of the Accelerated Access Research - Key statistics 2017-18 (2018) Manufacturing Action Plan: Retaining Financing Update (2018) - https://www. Review: improving patient access to - https://www.nihr.ac.uk/about-us/how- and attracting advanced therapies bioindustry.org/resource-listing/biotech- breakthrough treatments (2017) - we-are-managed/managing-centres manufacture in the UK (2016) - https:// financing-update-june---august-2018.html https://www.gov.uk/government/ /crn/key-statistics.htm www.abpi.org.uk/media/1458/advanced 27 Office for Life Sciences –Life Science publications/accelerated-access -therapies-manufacturing-taskforce Competitive Indicators (2018) - https:// -review-response 12 NHS England – 12 actions to support -report.pdf and apply research in the NHS (2017) assets.publishing.service.gov.uk/ 5 HM Treasury - Financing growth in https://www.england.nhs.uk/ 19 Cell and Gene Therapy Catapult - government/uploads/system/uploads/ innovative firms: consultation publication/12-actions-to-support- Annual Review (2018) - http://fr.zone- attachment_data/file/706963/life- response (2017) – https://www.gov.uk/ and-apply-research-in-the-nhs/ secure.net/5521/860265/#page=4 sciences-competitiveness-indicators- government/consultations/financing- 2018.pdf growth-in-innovative-firms 13 National Institute for Health 20 Sources: The number of companies Research - Performance in initiating drawn from the SBC and catapult 6 Subject to business case approval and delivering clinical research (2018) - websites. The financial figures drawn 7 Department of Health and Social https://www.nihr.ac.uk/research-and from publicly available investment Care - Prevention is better than cure: -impact/nhs-research-performance/ information collated by SBC. Job numbers our vision to help you live well for performance-in-initiating-and-delivering from: Building the world’s most complete longer - https://assets.publishing. -research/ advanced therapies ecosystem: Annual

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28 NHS Digital - NICE Technology biopharmaceutical sectors in the UK Appraisals in the NHS in England (2018) - www.gov.uk/government/ (Innovation Scorecard) (2018) - https:// publications/bioscience-and-health- digital.nhs.uk/data-and-information/ technology-database-annual-report- publications/statistical/nice-technology- 2017 appraisals-in-the-nhs-in-england-innovation- 35 Office for Life Sciences –Strength scorecard/to-march-2018 and Opportunity 2017: the landscape 29 Department of Health and Social of the medical technology and Care – The future of healthcare: our biopharmaceutical sectors in the UK vision for digital, data and technology (2018) - www.gov.uk/government/ in health and care (2018) - https://www. publications/bioscience-and-health- gov.uk/government/publications/the- technology-database-annual-report- future-of-healthcare-our-vision-for-digital- 2017 data-and-technology-in-health-and-care 36 TechNation and TechCity - 30 NHS Digital - BETA: NHS digital, data Growth of the UK’s digital tech and technology standards framework sector (2015) - https://technation. (2018) - https://digital.nhs.uk/about-nhs- techcityuk.com/growth-tech/ digital/our-work/nhs-digital-data-and- 37 Office for Life Sciences –Strength technology-standards/framework and Opportunity 2017: the landscape 31 Department of Health and Social of the medical technology and Care – Initial code of conduct for data- biopharmaceutical sectors in the UK driven health and care technology - (2018) - www.gov.uk/government/ https://www.gov.uk/government/ publications/bioscience-and-health- publications/code-of-conduct-for-data- technology-database-annual-report-2017 driven-health-and-care-technology/ini- 38 Association of the British tial-code-of-conduct-for-data-driven- Pharmaceutical Association - https:// health-and-care-technology www.abpi.org.uk/media-centre/ 32 Association of Medical Research news/2018/june/apprenticeships-hit- Charities – Saving lives with patient data 4-year-high-in-pharmaceutical-industry/ registries (2018) - https://www.amrc.org.uk/ (2018) Handlers/Download.ashx?IDMF=e535 39 Science Industry Partnership – be59-a25c-4bfa-9ead-52a24648d08f SIP Apprenticeship Survey 2018 33 This includes: IQVIA, Kheiron Medical, (2018) - https://www.scienceindustry Great Ormond Street Drive Unit, Babylon partnership.com/skills-issues/ Health and Genomics England sip-apprenticeship-survey-2018/ 34 Office for Life Sciences –Strength 40 NHS data refers to England only and Opportunity 2017: the landscape of the medical technology and

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