Unlock Your Global Business Potential: Addressing the Dementia Challenge

Unlock Your Global Business Potential:Addressing the Dementia Challenge

UNLOCK YOUR GLOBAL BUSINESS POTENTIAL

Unlock Your Global Business Potential:Addressing the Dementia Challenge

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Government commitment to the life science and healthcare sector

David CameronPrime Minister

The Strategy for UK Life Sciences and Innovation Health and Wealth are the UK government’s response to a global sector under pressure

“In December 2011 I made a firm commitment to re-establish the UK's global leadership in the life science sector, announcing the Government's ten-year Strategy for UK Life Sciences.”

“By more closely integrating the UK's unique strengths, I believe that we can improve healthcare for patients, attract new investment to the UK, and create new jobs and business opportunities in an increasingly competitive and international industry.”

The Strategy makes the most of the UK’s core strengths: Basic science in universities Translational and clinical research excellence Industry and supply chain The National Health Service (NHS)

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The UK offers a globally competitive opportunity for your business

A National Health Service with more than 60 million patients

World-class science, universities, facilities, and principal investigators

The UK is committed to building an integrated health economy and offers a powerful combination of:


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Established industrial R&D, manufacturing and supply chain

Translational research infrastructure and clinical networks supported by KOLs

Quality, efficient R&D and product validation

A firm commitment to partner with industry

Unrivalled, clinically-coded health data and bioresources

Globally renowned research charities

A supportive business environment and incentives for R&D and business growth

A platform for global growth – with excellent connectivity to the rest of the world

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The UK government has introduced fiscal measures to stimulate innovation and growth for companies

A business environment that supports and rewards innovation

Low corporation

tax rate currently

standing at 23 per cent

decreasing further to 20 per cent by April 2015.

Patent box: 10% corporation tax on

qualifying profits

23%Corporati

on tax will drop further to

20%


£180m

£300m

Biomedical Catalyst a

£180m programme of public funding

for growth

To stimulate R&D partnerships

between universities

businesses & charities

R&D tax credits for SMEs worth

approximately 25p on every

£1 (7p for large companies)

Patentbox

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There is a new UKTI team – the Life Science Investment Organisation (LSIO) which combines private-sector expertise with Government teams.

Charged with:

The UKTI Life Science Investment Organisation

Matching UK strengths with global business needs

Translating benefits outlined in the Strategy for UK Life Science and Innovation, Health and Wealth into opportunities for business

Catalysing and empowering the UK Life Science community to work with international business


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Dementia is a major cause of disability and dependency among older people worldwide and impacts every country.

There is a significant unmet clinical need in dementia care and currently no dementia disease modifying therapies available on the market.

The UK offers a uniquely powerful combination of academia, industry, NHS and research charities from discovery, development to delivery of your product/ service to benefit dementia patients in the UK and abroad.

Global market opportunity for Dementia products and services


A drug that delays both disease onset

and progression by 1 year, would result in about 9 million fewer

cases of Alzheimer’s

Disease in 2050.

On a global scale there are an estimated

35 million people living

with dementia

The total estimated

worldwide cost of dementia

care is currently $600 billion, 1% of the world’s

GDP

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A new case of Alzheimer’s disease is occurring every 7

seconds

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The UK Dementia Opportunity: Prime Minister’s Challenge on Dementia

Prime Minister David Cameron launched The Prime Minister’s Challenge on Dementia in 2012.This commits the UK to:

Boost dementia research by doubling current funding levels on dementia research and mobilising the UK’s world-class specialist facilities and strengths in neuroscience

Drive improvements in the way people with dementia are diagnosed, treated and cared for

Make communities more dementia-friendly..

Offering clear priority areas and opportunities for your business to access, enabling you to test your product/ service and then launch into a global arena.


Currently, there are 800,000 people living

with dementia in the UK, a

number that will grow to 1million in less than 10

years¹

¹ ²Alzheimer’s Society

Dementia currently costs

the UK economy $37 billion per year, more than cancer and heart

disease combined²

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Boost dementia researchDoubling current funding levels on dementia researchInvesting in the research infrastructure: the NIHR Translational Research Collaboration.

Drive improvements in the way people with dementia are diagnosed, treated and cared forAim that two-thirds of people with dementia have a diagnosis, with appropriate post diagnosis supportFunding available in 2013-14 for the NHS and local authorities to work with providers to create care environments.

Make communities more dementia friendlyEstablishing 20 local dementia action alliances Delivering a nationwide campaign to raise awareness of dementia and to encourage people to visit their doctor if they are worried about dementia.

The UK Dementia Opportunity: Prime Minister’s Challenge on Dementia

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Prime Minister’s Challenge on

Dementia focussed on

three areas to deliver

improvements for patients

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Offering a range of opportunities, from providing the next disease modifying product to a medical technology that relieves symptoms or can enable independent living, through to new

care services that offer innovative approaches to dementia treatment and care in the community.

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The Prime Minister’s challenge on dementia has focussed its priority areas to ensure there are opportunities for the best innovations to progress through the pipeline to ensure patients are treated, cared for and are citizens of a dementia friendly community this is supported by a rich dementia discovery, development and delivery ecosystem.

How the Prime Minister’s Challenge on Dementia connects with the UK’s discovery, development and delivery ecosystem

DEVELOPMENT DELIVERYDISCOVERY

DEMENTIA RESEARCH

DIAGNOSIS, TREATMENT AND CARE

DEMENTIA FRIENDLY COMMUNITIES Prio

riti

es a

gain

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PM C

halle

nge

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Dem

enti

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The UK offers a fully integrated dementia discovery, development and delivery ecosystem


DEVELOPMENT DELIVERYDISCOVERY

The UK dementia ecosystems is underpinned by data to drive your

discovery through to delivery of care

Research funders and charities build capabilities and directly support academic research and partnership with industry

World class UK researchers are developing new tools and scientific approaches to probe disease mechanisms

A national research infrastructure and specialist clinical research networks support translation and access to patients for diagnosis and treatment

Robust regulatory and health technology assessments ensure portability of your products across the worldNHS access points facilitate uptake and diffusion of your products and services directly to patients

Data resources to enable research

Data to drive clinical translation

Anonymised data to deliver and monitor real-world

outcomes

DATA

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Collaborate with UK researchers who are experts in:

Foundational Neurobiology - healthy/normal pathological biology to generate and test disease hypothesesCognitive neuroscience to understand the manifestation of disease, impact on cognition, and to support early diagnosis and patient stratificationGenetic research to better understand genetic linkages, risk factors and novel disease targets for drug discovery and diagnosticsImaging, world class capabilities to use cutting edge neuroimaging platforms to identify biomarkers of disease progress to enable better diagnosisSocial care research to understand how systems and service redesign can improve dementia care and outcomes.

This research excellence enables your business to work with these world class researchers to generate and test disease and technology hypothesis, and to inform the development of products and services for dementia.

World class UK researchers are developing new tools and scientific approaches to probe disease mechanisms


Discovery Development Delivery Data

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Expert researchers are supported by expert research funders:Medical Research Council (MRC)

– Directly funds research programmes and capabilities such as the UK Brain Banks Network and UK Stem Cell Bank and a major initiative to undertake advance neuroimaging of a portion of UK Biobank participants.

Wellcome Trust– Focuses on major research challenges, to understand the brain and ageing – Funds innovative research programmes in neuroscience – Supports a joint initiative in Neurodegenerative diseases with the MRC

Alzheimer’s Research UK – Serves as an advocate for patients and directly funds research programmes – Runs a UK wide dementia research network including over 700 scientists. connected to one

of 15 centres of dementia research excellence. Alzheimer’s Society

– Funds and runs a research network with volunteers who directly with leading scientists looking into the cause, cure, care and prevention of dementia, setting the research agenda, award grants and assess outcomes.

Research funders and charities build capabilities and directly support academic research and partnership with industry



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The UK is committed to making clinical translation more efficient by:

Investing in health research infrastructure £500 million annually to support experimental medicine research and clinical trials in the NHS in England

Introducing the Health Research Authority to streamline approvals for clinical research

Encouraging patient participation in research studies

Introducing performance metrics for patient recruitment and study start-up

Unlocking data and bioresources Simplifying access for industry (NOCRI.

Early translation into clinical development underpinned by a dedicated national infrastructure



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The NIHR Translational Research Collaboration in Dementia brings together the considerable world-leading expertise and resources within the NIHR Dementia Biomedical Research Units and Centres which include dementia-themed research, to reduce the costs of commercial and non-commercial research and to answer questions about early diagnosis, patient stratification and novel therapeutics.

Enabling translation into the clinic: Translational Research Collaboration in Dementia



NIHR Cambridge Dementia

BiomedicalResearch Unit

NIHR Newcastle Dementia BiomedicalResearch Unit

NIHR Maudsley Dementia

Biomedical Research Unit

NIHR Queen Square Dementia Biomedical Research Unit

NIHR Imperial Biomedical

Research Centre

NIHR Oxford Biomedical ResearchCentre

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Dementia clinical research networks across the UK support the development, set-up and delivery of clinical studies in the NHS, working collaboratively with industry, NHS organisations and each other to ensure clinical trials are delivered at pace. Map of dementia clinical research networks across the UK:.

Delivering at pace and at scale: Dementia clinical research networks UNLOCK YOUR GLOBAL BUSINESS POTENTIAL


Scottish Dementia Clinical

Research Network

Northern Ireland Clinical Research Network

Dementias & Neurodegenerativ

e Disease Research Network

(DeNDRoN)

Wales Dementias and Neurodegenerative Disease Research Network

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The NHS has pledged in its Constitution to ‘do all it can to ensure that patients, from every part of England, are made aware of research that is of particular relevance to them.’Around 4 percent of UK patients with diagnosed dementias are currently involved in clinical research, but the NHS wants to increase this to 10 percent within the next 4 years.

The Dementias & Neurodegenerative Disease Research Network (DeNDRoN) has developed various facilities that will help to increase the proportion of people with dementia having the opportunity to participate in research through:Enabling Research In Care Homes (ENRICH): a toolkit for care home research providing simple, practical advice for researchers, care home staff and others

Recruitment and Feasibility Tool (RAFT): aims to develop a national system for people to register their interest in dementia research and be matched with potentially suitable research studies

Integrating NeTworks and Embedding Research into Clinical Practice (INTERACT): aims to improve the consistency of support to dementia research across England and integrate research into patient’s care and treatment; ensuring more patients are routinely offered the opportunity to participate in research. .

Dementia clinical networks supported by a national commitment to improve patient participation in dementia research



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Industry can leverage the UK’s expertise to meet regulatory standards and develop an evidence base.Medicine and Healthcare Products Regulatory Agency (MHRA) Innovation Office helps organisations who are developing innovative medicines, medical devices or novel manufacturing processes navigate the regulatory processes in order to be able to progress their products or technologies.The UK Government commits to open up the NHS to collaborate with your business on research and adoption and to ensure that products and services are critically appraised to the highest standard via the National Institute for Health and Care Excellence (NICE).

Robust regulatory and health technology assessments ensure portability of your products and services across the world



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Industry can leverage the commitments outlined in Innovation, Health and Wealth to facilitate market access, uptake and diffusion in the UK and around the globe.Combining research and adoption of innovative products and services, the 15 new Academic Health Science Networks (AHSNs) will facilitate access into the NHS and align education, clinical research, informatics, innovation, training and healthcare delivery. AHSNs present a unique opportunity to pull together the adoption and spread of innovation with clinical research and trials, informatics, education, and healthcare delivery. Working at a network to network levelUltimately your business can gain access to the largest national healthcare system in the world - the National Health Service (NHS) with 60 million patients.

NHS access points facilitate uptake and diffusion of your products and services directly to patients



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Delivering dementia solutions at scale will require a concerted effort integrating health and social care. From alignment of the policy and regulatory environment to mechanisms that enable the introduction, adoption and diffusion of innovative products and services, the UK is well placed to support better dementia treatment and care.On the policy side, under the Prime Minister’s Challenge on Dementia there is progress to:Scope opportunities for public-private partnerships, such as in target validation and experimental medicineSet a national ambition to improve dementia diagnosis rates and post diagnosis support so that two-thirds of people with dementia should have a diagnosis, with appropriate post diagnosis supportSet a new Enhanced Service for GPs which will reward practices for having a pro-active, case finding approach to the assessment of patients showing the early signs of dementiaOffer a dementia risk-assessment to all over-75s admitted to hospital, and referred for further investigation e.g. to a specialised memory service. NHS Trusts will appoint a senior clinical lead for dementia to ensure that staff are trained in dementia care and that hospitals are dementia-friendly.Work with Public Health England to develop a national approach to prevent dementia, and to reduce the stigma of dementiaMake cities, towns and villages more dementia-friendly, establishing local dementia action alliances to improve the lives of people with dementia and their carers. Supported by a nationwide campaign to raise awareness of dementia.

The Prime Minister’s Challenge on Dementia is providing further access to drive healthcare innovation and delivery to patients



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The UK, enabled by the NHS allows your business with access to unrivalled, clinically-coded health data and biorepositories, including linked datasets to understand care pathways. and anonymised electronic patient records, offering a unique opportunity to understand care pathways.

Unlocking data to drive innovation to further research in Dementia

More than 60 million people are served by a National Health System

Example data resources:– UK Biobank is a unique resource of data and

samples linked to medical histories and health records from 500,000 adult participants

– Clinical Practice Research Datalink (CPRD) enables observational studies, clinical trial feasibility and protocol optimisation, and post-market surveillance

– NIHR BioResource enables recall to clinical studies by genotype and phenotype and helps stratify and select patients for trials



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The UK is collecting a range of data samples that will exploit data from the lab, clinical-based studies and NHS records.The Medical Research Council UK Brain Banks Network, provides high quality brain tissue to scientists and clinicians to carry out cutting edge neurosciences research, and will support major initiatives on research into neurological disorders.The Medical Research Council UK Stem Cell Bank is responsible for storing, characterising and supplying ethically-approved, quality-controlled stem cell lines for medical research and treatment. Located at the National Institute for Biological Standards and Control (NIBSC), it is a repository for stem cells derived from adult, fetal and embryonic tissues and is open to scientists in the UK and overseas.Both the UK Brain Banks Network and UK Stem Cell Bank can supply tissue samples to academic and industry researchers. In addition, the MRC funds collaborative research with over 80 companies, ranging from large pharmaceutical companies to biosciences and healthcare companies.Major investment in brain scanning: £9.6million is being provided by the Medical Research Council for a pilot study involving 8,000 volunteers as the first phase of a brain imaging programme that will ultimately scan the brains of 100,000.The Medical Research Council and Department of Health have jointly been awarded £20 million to enable all 500,000 Biobank participants to be genotyped, with a particular focus on the identifying the genetic signature associated with risk of developing of dementia.

Unlocking data to drive innovation to further research in Dementia



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Dementia specific funds and grants available from basic research through to new approaches to the delivery of care

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A National Prime Minister led commitment to deliver major improvements in dementia care and research– Boost dementia research by increasing funding and mobilising the UK’s world-class specialist facilities and strengths in

neuroscience; – Drive improvements in the way people with dementia are diagnosed, treated and cared for; – Make communities more dementia-friendly, providing access for medtech companies to engage in the delivery of care A rich and diverse healthcare ecosystem that facilitates discovery, development and delivery of

products and technologies to dementia patients– Leading research funders and charities fund and support research whilst world-class researchers are leading thinking

on dementia disease biology and intervention.– Globally renowned clinical trial infrastructure, with dementia specific clinical networks enabling complex studies to be

undertaken at pace and scale.– A single healthcare system that treats 60 million patients, generating vast volumes of structured real world data.– Unrivalled access to patient data tissue samples and to enable discovery and development. – An integrated cradle to grave healthcare system that provides companies access to any stage of the healthcare

pathways A supportive business environment coupled with a commitment to increase funding in dementia

research– Business incentives such as year on year reductions in corporation tax, R&D tax credits and the Patent Box,

culminating in an improved business environment in the UK.– Annual funding on dementia research to increase to £66 million by 2015. A track record of successful collaboration with industry to improve dementia R&D, diagnosis,

treatment and care– Eli Lilly continues to invest in UK Neuroscience , specifically in a new early-stage research facility in Surrey, ensuring

access to the UK’s academic base with collaborative opportunities in neuroscience – IXICO and Cambridge Cognition awarded Biomedical Catalyst funding in 2012 to combine brain imaging with computer-

based tests to improve dementia diagnosis.– The 3millionlives programme led by the Department of Health and a range of industry members is working to ensure at

least three million people with long term conditions and/or social care needs can benefit from the use of telehealth and telecare services to aid independent living.

A Summary of the UK Dementia Offer


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Our practical help and advice is free and confidential UKTI’s professional trade and industry advisers operate in the UK alongside a global network of experts based in all British diplomatic offices overseas.UKTI can:Provide tailored information on the UK offer and capabilities that match your business needsSupport your business journey to invest in and grow in the UK

UKTI’s Life Science Investment Organisation (LSIO)The LSIO is here to help your business navigate the opportunity to partner with and invest in the UK and to connect you to the wider UK life science community

How UK Trade & Investment (UKTI) can help your business


For further details on the LSIO and the UK life sciences offer for industry, visit: www.ukti.gov.uk/lifesciences

Appendix Market Success Stories from across the UK

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Over the last decade Eli Lilly has invested more than £100 million in its Surrey research centre, home to much of the company’s neuroscience research and a new early-stage facility with 130 scientists working across disciplines such as clinical pharmacology, PK/PD, statistics and data sciences.

This global company has invested in the UK due to the UK’s academic strengths and collaborative opportunities in neuroscience. In 2010, Eli Lilly established the Centre for Cognitive Neuroscience which brings together a consortium of Eli Lilly scientists with world leading academics from six British universities, and aims to improve the probability of clinical success for molecules targeting the symptoms of cognitive decline in schizophrenia, Alzheimer’s and Parkinson’s disease.

Eli Lilly invests in UK Neuroscience


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A collaborative project led by IXICO is developing a novel, cost-effective digital healthcare system to enable earlier diagnosis in dementia. The system will be deployed in a memory clinic or a local brain health centre and will combine computerised cognitive testing and quantitative brain imaging, aiming to provide doctors with a quality of information currently available only in highly specialist centres. The project was awarded funding from the government funded Biomedical Catalyst in 2012.

“In medical imaging, and in the clinical aspects of medical imaging, the UK is especially strong. We have on our doorstep world experts we can engage as consultants, and bright scientists and research groups developing new technologies. The NHS structures are rapidly evolving to make it a superb platform for assessing new technology, and combined with health economic expertise, the UK can help us demonstrate the value of our technology in a way that can help translate to larger global markets.”

Derek Hill, Founder and CEO, IXICO

IXICO and Cambridge Cognition combine brain imaging with computer-based tests to improve dementia diagnosis


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…Successfully concludes an Alzheimer’s disease biomarker validation study.Preliminary data generated by the NIHR BRC for Mental Health and Proteome Sciences suggest that proteins in blood may act as biomarkers that could help to identify dementia in the pre-clinical phase.The capability to distinguish between the levels and progression of Alzheimer’s disease will enable drug developers to substantially improve patient care and people with mild cognitive impairment are likely to benefit the most from such disease-modifying drugs.Professor Simon Lovestone, Director of the NIHR Biomedical Research Centre for Mental Health commented: “This is the largest study of plasma biomarkers to date that we are aware of, and builds on our earlier findings to identify diagnostic and prognostic signals in plasma. As new treatments for Alzheimer's disease are being developed, there is an increasing need for accurate and accessible markers of disease severity and progression. If our results are positive, we will move quickly to support the development of clinical tests based on these biomarker panels.” Christopher Pearce, CEO of Proteome Sciences, said: “This study is a major step towards a series of simple blood tests that would facilitate the early diagnosis and management of Alzheimer’s.

NIHR BRC in collaboration with Proteome Sciences and Merck Millipore…


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GE Healthcare in early 2013 submitted a Marketing Authorisation Application to the European Medicines Agency for [18F]flutemetamol use in the visual detection of beta amyloid in the brains of adult patients who are being evaluated for Alzheimer’s Disease. [18F]Flutemetamol, which is currently under regulatory review, is one component of a GE Healthcare’s portfolio of investigational diagnostic solutions the company is developing in the Alzheimer’s field.

“PET imaging with [18F]flutemetamol has the potential to be part of a larger diagnostic workup that may help doctors rule out Alzheimer’s disease by reliably showing the absence of beta amyloid deposits in patients who are being evaluated for AD,” said Jonathan Allis, PhD, General Manager, PET, GE Healthcare Medical Diagnostics. “Our commitment to advance clinical knowledge and provide technologies to aid the fight in this epidemic may assist physicians in the acceleration of diagnosis and improvement of personalized treatment decisions in all stages of the disease.” This solution aligns with the UK’s Dementia Challenge, a programme to tackle dementia by improving diagnosis rates.

GE Healthcare progresses its diagnostic solution in Europe to better understand Alzheimer’s Disease


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….which demonstrate improved cognition in Alzheimer’s modelBritish based company Proteome Sciences; lead compounds for case in kinase 1 delate (CK1d) have demonstrated improved cognitive function. These results provide important in-vivo proof of principle and demonstrate the efficacy of the compounds. “Our goal was to deliver in-vivo proof of principle for CK1d in Alzheimer’s disease. We are delighted that this has been successfully achieved in 2012. These results are most timely as major pharmaceutical companies and academia have increasingly been switching attention to the importance of tau tangles in combination with amyloid aggregation in Alzheimer’s. In light of UK Government's recent commitment to fully fund NHS access to novel treatments for AD we believe that these is significant potential for CK1d inhibitors to positively affect the lives of sufferers and their carers. We will continue to push our CK1d programme forwarf and will actively engage with the pharmaceutical industry to bring our compounds to clinical trials as soon as possible.”

Christopher Pearce, CEO, Proteome Sciences

Proteome Sciences follow tau hypothesis to show early stage research of CK1d inhibitors…


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Researchers at the University of Bristol will investigate whether a compound originally evaluated by AstraZeneca for the treatment of prostate cancer could delay, or even reverse, the progression of Alzheimer’s disease by improving blood flow through the brain.

The Bristol-based collaborative study will test the AstraZeneca compound (zibotentan) to assess whether they are capable of blocking the effects of Abeta on brain blood flow.

“We were delighted to have the chance to collaborate with AstraZeneca on such an exciting project. We now have a great opportunity to test a fundamentally new approach to Alzheimer’s treatment that if successful could be rapidly translated into the clinic.” Professor Seth Love, University of Bristol

Astra Zeneca shares compound with UK based researchers to look into cerebral blood flow in Alzheimer's


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Created a data management platform to improve the understanding of mental health genetics and treatment

The centre, hosted by Cardiff University, has established the Wales Mental Health Network and is recruiting 6,000 volunteers over the next two years and will capture more than 300 clinical attributes for each person

IDBS’ platform will integrate clinical, biobanking and genetic data, providing a data management and analytics system for this and future studies

National Centre for Mental Health in Wales partners with IDBS to improve understanding in mental health genetics


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A consortium of 10 UK government and charity research funders led by the Medical Research Council has awarded £19 million to four E-health Research Centres based in London, Manchester, Dundee and Swansea.

The aim is to develop more effective treatments, improve drug safety, identify risks to public health and gain insight into the cause and development of diseases by linking anonymised patient records and health research data.

In addition the centres will train the next generation of researchers to have the skills to analyse and link large and complex data. The Centres will work together as a network, collaborating with pharma and IT industries to ensure the UK remains at the forefront of global medical research.

Medical Research Council leads on awarding funds to E-health Research Centres


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AHSC – Academic Health Science Centre AHSN – Academic Health Science Network ARUK – Alzheimer’s Research UK BRC – Biomedical Research Centre BRU – Biomedical Research Unit CPRD – Clinical Practice Research Datalink DeNDRoN – Dementias & Neurodegenerative Diseases Research

Network HES – Hospital Episode Statistics LSIO – Life Science Investment Organisation MRC – Medical Research Council MHRA – Medicines and Healthcare products Regulatory Agency NHS – National Health Service NICE – National Institute for Health and Care Excellence NIHR – National Institute for Health Research NOCRI – NIHR Office for Clinical Research Infrastructure UKTI – UK Trade and Investment

Medical Research Council leads on awarding funds to E-health Research Centres


Unlock Your Global Business Potential: Addressing the Dementia Challenge

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