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Title: UKTI LSIO Stratified Medicine slides


1
Unlock Your Global Business Potential UK
Stratified Medicine
2
UNLOCK YOUR GLOBAL BUSINESS POTENTIAL
The UKTI Life Science Investment Organisation
In December 2011 I made a firm commitment to
re-establish the UK's global leadership in the
life science sector, announcing the Government's
ten-year Strategy for UK Life Sciences. By
more closely integrating the UK's unique
strengths, I believe that we can improve
healthcare for patients, attract new investment
to the UK, and create new jobs and business
opportunities in an increasingly competitive and
international industry.
David Cameron Prime Minister
Life Science Strategy and Innovation Health and
Wealth are the UK governments response to a
global sector under pressure
3
UNLOCK YOUR GLOBAL BUSINESS POTENTIAL
  • The UKTI Life Science Investment Organisation
  • New UKTI team the Life Science Investment
    Organisation (LSIO)
  • Combines private-sector expertise with Government
    teams
  • Charged with

Translating benefits of the UKs Life Science
Strategy and capabilities into a
business-friendly format
1
2
Creating focused messaging matching UK strengths
with global business needs
3
Catalysing and empowering the UK Life Science
community to work with international business
4
UNLOCK YOUR GLOBAL BUSINESS POTENTIAL
  • There is a Global Market opportunity for
    Stratified Medicine
  • By 2020, the pharmaceutical industry will invest
    as much as 20 of its RD budget in genetics and
    genomics1
  • In oncology
  • Companion diagnostic tests like Her2 generate
    significant annual revenues2
  • Market value of targeted cancer therapeutics over
    40bn and growing
  • Market for biomarkers for drug discovery and
    clinical trials is more than 1bn2

The UK has prepared for and understands this
shift, and is rapidly adapting to support
industry success in stratified medicine
5
UNLOCK YOUR GLOBAL BUSINESS POTENTIAL
  • The UK Opportunity Globally Competitive

The UK is committed to building an integrated
health economy and offers your business powerful
combination of

World-class science, universities,
facilities, and principal investigators Establish
ed industrial RD, manufacturing and supply
chain Translational research infrastructure and
clinical networks supported by KOLs

Globally renowned research charities A firm
commitment to partner with industry
A National Health Service with more than 60
million patients Unrivalled, clinically-coded
health data


Quality, efficient RD and
product validation A supportive business
environment and incentives for RD and business
growth A platform for global growth with
excellent connectivity to the rest of the world
1.
6.
2.
7.
3.
8.
4.
9.
10.
5.
6
UNLOCK YOUR GLOBAL BUSINESS POTENTIAL
  • The UK Opportunity Stratified Medicine

1
2
  • Partnership with industry combining research
    and clinical delivery
  • Example Cancer Research UK Stratified Medicine
    Programme
  • Consumer of research tools, platform
    technologies, and informatics solutions
  • Example The UK plans to undertake whole genome
    sequencing of up to 100,000 NHS patients over the
    next 3-5 years
  • Test-bed for products and services
  • With 60 million patients across the National
    Health Service, the UK offers a sizeable domestic
    opportunity
  • UK can help your business demonstrate clinical
    and commercial proof of concept and support
    export opportunities

3
7
UNLOCK YOUR GLOBAL BUSINESS POTENTIAL
  • The UK is committed to supporting the development
    and delivery of stratified medicine

UK Biobank begins recruiting participants aged
40-69.
The UK Life Sciences Strategy includes an
investment of 130 million to support the
discovery, development and commercialisation of
Stratified Medicine
MRC and Wellcome Trust will fund detailed imaging
assessments of up to 100,000 UK Biobank
participants.
First patients enrolled in the Cancer Research UK
Stratified Medicine Programme a partnership with
UK Government and industry to develop a tumour
profiling database and explore how multi-gene
panel tests could be used routinely within the NHS
2009
As part of a long term strategy, the UK is
investing to develop stratified medicine
capabilities and support industry success\
2009
2010
2011
2011
2012
2012
2012
2012
2013
The Technology Strategy Board begins funding
industry-led consortia to support
commercialisation of stratified medicine products
and services UK Biobank opens for research in the
interest of public health, offering access to a
unique dataset and samples from 500,000 adults
across the UK.
Launch of a national Stratified Medicine
Innovation Platform to accelerate the rate of
development and uptake of stratified medicine in
the UK for the benefit of patients, healthcare
providers and business.
MRC funds new disease focused stratified
medicine Programme, a partnership with UK
Government and industry in rhematoid arthiritis
and diabetesMRC-NIHR Phenome Centre funded, the
first national-level phenome centre in the world.
Announcement of a new vision for the UK to be a
global leader in genomic medicine with plans to
invest 100 million to pump-prime whole genome
sequencing of up to 100,000 patients, starting in
cancer and rare diseases.
8
UNLOCK YOUR GLOBAL BUSINESS POTENTIAL
  • A Business Environment that Supports and Rewards
    Innovation
  • The UK government has introduced fiscal measures
    to stimulate innovation and growth for companies

60 million from the Medical Research Council
over four years to fund non-oncology applications
of stratified medicine
Patent box 10 corporation tax on qualifying
profits
50 Million Cancer Research and European
Investment Fund
23Corporation tax
60 million funding from the Technology Strategy
Board to support industry-led projects in
stratified medicine, as part of the 200 million
Stratified Medicine Innovation Platform.
50 million joint initiative between Cancer
Research Technology (CRT) and the European
Investment Fund, the CRT Pioneer Fund, to bridge
the gap between cancer drug discovery and early
development (end of Phase I).
Low corporation tax rate currently standing at 23
per cent decreasing further to 20 per cent by
April 2015.
9
UNLOCK YOUR GLOBAL BUSINESS POTENTIAL
  • UK Stratified Medicine Rich and Diverse Ecosystem
  • First-class research and expertise
  • Understand disease biology, develop or implement
    stratification tools, find expertise in genomics
    to advanced diagnostics
  • Research and innovation funders and charities
  • World-leading data and translational
    infrastructure
  • NHS serving more than 60 million patients
  • Industry access points and dedicated networks for
    RD and clinical delivery
  • Established value and supply chain
  • Thriving industry base with deep expertise
  • Expert suppliers, service providers, and
    collaborators

The UK life sceince comprises over 4,500
companies
Companies employing over 167,000 people
and generating a turnover of over 50bn
10
UNLOCK YOUR GLOBAL BUSINESS POTENTIAL
  • UK Stratified Medicine Basic Research Expertise
  • The UK has the visionary science, centres of
    academic and clinical excellence, key opinion
    leaders, experienced partners, and the tools to
    help your business
  • The Medical Research Council funds
    disease-focused consortia of academic and
    industry partners to enable stratified medicine
  • The Wellcome Trust funds both basic biomedical
    research and translational projects.
  • HealthTech Medicines Knowledge Transfer Network
    helps connect organisations to catalyse
    innovation through events and workshops in
    stratified medicine.
  • Cancer Research UK and Cancer Research Technology
    also provide core oncology research funding, and
    offer translational funding and expert
    capabilities, and support patient engagement.

11
UNLOCK YOUR GLOBAL BUSINESS POTENTIAL
  • UK Stratified Medicine The power of genomics
  • The UK has a rich history in genomics from the
    discovery of DNA to the Human Genome Project.
  • The Wellcome Trust Sanger Institute is one of the
    worlds leading genome centres and has been
    involved in the Human Genome Project, 1000
    Genomes Project and the International Cancer
    Genome Consortium Institute.
  • The Institute for Cancer Research (ICR) is
    establishing a Tumour Profiling Unit to exploit
    the potential of molecular pathological analysis.
  • Building on this genomic heritage, in December
    2012 the UK announced plans to pump-prime the
    sequencing of whole genomes of up to 100,000 NHS
    patients, starting with cancer and rare diseases.

We believe that the UK is well placed to lead
the global adoption of genomic technologies
within mainstream clinical practice and to
support public health. The foundations lie in our
world-class research, our existing use of
genetics and the increasing partnerships between
the NHS, academia and industry, making it
possible, with the right motivation, to embrace
innovation at every level. Human Genomics
Strategy Group report, January 2012
12
UNLOCK YOUR GLOBAL BUSINESS POTENTIAL
  • UK Stratified Medicine Epigenetics and the
    Phenome
  • The UK offers a unique combination of
    capabilities at a scale that enables ambitious
    research to link genes, phenotypes and disease
  • The Babraham Institute in Cambridge is a leader
    in epigenetics, recognised for its pioneering
    investigations of the principles of epigenetic
    gene regulation in early development and in the
    fundamental regulation of the genome.
  • The MRC has committed 2 million to the EU Joint
    Programme Neurodegenerative Disease Research
    (JPND) aimed at identifying genetic, epigenetic
    and environmental risk and protective factors for
    age-related neurodegenerative diseases.
  • MRC-NIHR Phenome Centre, based at Imperial
    College London, will analyse hundreds of
    thousands of samples of body fluids to discover
    how our genes interact with the environment to
    create metabolic phenotypes that relate to
    population disease risks.

Many of these analytical technologies are now
mature and are immensely powerful for telling us
about someones physical condition and disease
state. Bringing them fully into the clinical
setting will help doctors make a more informed
diagnosis, choose the best treatment based on the
individual characteristics of the patient, and
monitor their progress more precisely. It is the
dawn of a new age of precision
medicine Professor Jeremy Nicholson, Head of
the Department of Surgery and Cancer, Imperial
College London, and Director of the MRC-NIHR
Phenome Centre
13
UNLOCK YOUR GLOBAL BUSINESS POTENTIAL
  • Stratified Medicine Oncology Ecosystem
  • Cancer Research UK is worlds largest cancer
    research charity
  • Drug development office, sponsors Phase I-II.
  • Clinical Development Partnership takes forward
    de-prioritised cancer agents.
  • Experimental Cancer Medicine Centres (research to
    PhII).
  • Stratified Medicine Programme in partnership with
    industry
  • National database of tumour genetic info,
    treatments and outcomes.
  • Supports patient stratification Roche and
    Bristol-Myers Squibb plan to run new trials of
    targeted cancer drugs.
  • NIHR Cancer Research Network
  • Strong track record of clinical trial delivery,
    gt600 open studies.
  • Increased patient participation in cancer studies
    by five-fold.

The UK has a single National Cancer Registry, a
powerful tool for research and clinical trials.
Oncology
For Every 100 patients diagnosed with cancer in
the UK. 21 enter clinical studies including 7 in
randomised controlled trials.
Key statistics
85,000 patients per year to cancer research
studies More than in the whole of the USA
14
UNLOCK YOUR GLOBAL BUSINESS POTENTIAL
  • Stratified Medicine Oncology Success Stories
  • Bristol-Myers Squibb (BMS) and Cancer Research UK
    expand drug indications
  • BMSs Yervoy (ipilimumab) recommended by NICE for
    advanced melanoma.
  • Cancer Research UK funding and delivering
    clinical trials to investigate possible expansion
    to treat small cell lung and prostate cancers.
  • Institute for Cancer Research (ICR)
  • Tumour Profiling Unit - molecular pathological
    analysis and drug MOA.
  • ICR scientists developed a genetic test to
    predict which men are most likely to benefit from
    treatment with abiraterone (Janssen) for prostate
    cancer.
  • Biomedical Catalyst funds development of the
    first sub-20 minute tumour profiler.
  • A collaborative project led by QuantumDx was
    awarded 1.4 million.
  • Device will enable rapid and accurate diagnosis
    and staging of cancer and treatment selection
    within minutes.

15
UNLOCK YOUR GLOBAL BUSINESS POTENTIAL
  • Unlocking Data to Drive Innovation
  • In the UK, your business will have access to
    unrivalled, clinically-coded health data and
    bio- repositories, including linked datasets to
    understand care pathways

More than 60 million people are served by a
National Health System
  • Example data resources
  • UK Biobank is a unique resource of data and
    samples linked to medical histories and health
    records from 500,000 adult participants
  • Clinical Practice Research Datalink (CPRD)
    enables observational studies, clinical trial
    feasibility and protocol optimisation, and
    post-market surveillance
  • NIHR BioResource enables recall to clinical
    studies by genotype and phenotype and helps
    stratify and select patients for trials

We have had a very productive relationship with
the Cambridge Bioresource (CBR) over the last two
to three years where collaboration has resulted
in provision of genetic resource, conduct of
clinical and translational trials, and
publication of both clinical and
immuno-inflammatory mechanistic study results
related to pharmacogenetic interactions. The
initial interactions between us (industry) and
CBR have been very successful and this is a
collaboration we are keen to maintain and
develop. Simon McHugh, Director of Scientific
Operations at GlaxoSmithKline
16
UNLOCK YOUR GLOBAL BUSINESS POTENTIAL
  • Providing Access to Drive Healthcare
    InnovationActive Partnership Between Academia,
    Industry, and the NHS
  • Industry can leverage the UK as an innovation
    partner to develop an evidence base, supporting
    market access, uptake and diffusion in the UK and
    around the world
  • IN NORTHERN IRELAND
  • Connected Health and Prosperity Action Plan
    ensures cross-sectorial support for RD and
    technology adoption
  • Invest Northern Ireland, the regions business
    development agency, provides a single access
    point for industry investment interest.
  • IN SCOTLAND
  • Academic Health Sciences Collaboration
    facilitates partnerships between universities and
    health boards
  • Scottish Enterprise is a single industry access
    point for investing in Scotland
  • IN WALES
  • Academic Health Science Collaboration maximises
    links between health boards, trusts, universities
    and industry
  • The Welsh Government gives you easy access to key
    decision-makers and private sector specialists,
    to help fast-track your investment.
  • IN ENGLAND
  • Academic Health Science Centres open up routes to
    market
  • Biomedical Research Centres and Units link
    universities and NHS trusts
  • Academic Health Science Networks will work with
    industry and drive adoption across the NHS in
    England

17
UNLOCK YOUR GLOBAL BUSINESS POTENTIAL
  • Creating an Open and Flexible Regulatory Framework
  • Government commitments
  • Opening up the NHS to collaborate with your
    business on research and adoption
  • Ensuring that products and services are
    critically appraised to the highest standard
  • Transparent expert advice to support decisions on
    access to personal health information
  • A streamlined health research approvals process
  • Globally-respected regulators The UK is home to
    the MHRA and the EMA
  • Earlier Access and Adaptive Licensing are under
    consideration
  • An expert stakeholder group meets quarterly to
    discuss regulatory innovation
  • MHRA recently established an Innovation Office to
    promote early dialogue between the MHRA and
    companies developing innovative products
    including advanced therapies, stratified
    medicines, nanotechnology, advanced
    manufacturing, and novel drug/device combinations

18
UNLOCK YOUR GLOBAL BUSINESS POTENTIAL
  • A Summary of the UK Stratified Medicine Offer
  • A rich and diverse healthcare ecosystem that
    facilitates stratified medicine
  • Expert UK researchers that can assist your
    business in drug discovery, the development of
    novel sensing technologies, biomarker discovery
    and validation, imaging or informatics, or with
    product and application development through
    centres of academic, clinical excellence and key
    opinion leaders.
  • Globally renowned clinical trial infrastructure
    and capabilities to undertake complex studies,
    new and adaptive trial designs, and to better
    stratify patients accessed through simplified
    industry entry points.
  • A single healthcare system that treats 60mn
    patients generating vast volumes of structured
    data to drive therapeutic discovery, development
    and delivery.
  • A supportive business environment coupled with
    significant and diverse funding support at all
    stages of development in stratified medicine
  • Central government lead business incentives such
    as year on year reductions in corporation tax,
    RD tax credits and the Patent Box.
  • Funding for advances in stratified medicine
    200m from the TSB, 60m from the MRC and 50m
    from CRT.
  • A track record of successful collaboration with
    industry and commercialization and uptake of
    stratified medicine
  • The successful development of the stratified
    therapy Abiraterone (Zytiga) through successful
    collaboration between the Institute of Cancer
    Research and specialist healthcare company BTG.
  • Bristol-Myers Squibbs Yervoy (ipilimumab) was
    recommended by NICE as an option for treating
    advanced (unresectable or metastatic) melanoma
    that has progressed in people who have received
    prior therapy.

19
UK Stratified Medicine Success
Stories
20
UNLOCK YOUR GLOBAL BUSINESS POTENTIAL
  • The Salford Lung Study GlaxoSmithKline Tests the
    Effectiveness of Pre-License Medicine Using Real
    World Data in Manchester
  • A collaboration between GlaxoSmithKline, North
    West e-Health (NWeH), The University of
    Manchester, Salford Royal NHS Foundation Trust,
    NHS Salfords local general practitioners, and
    local community pharmacists.
  • Testing the safety and effectiveness of a new
    treatment for asthma and COPD.
  • Draws on Salfords e-Health records
    infrastructure, a clinical information system
    that provides a single, integrated electronic
    patient record across primary and secondary care.
  • Is recognised as a world first for the use of
    such data.

This study is a first in the world, testing a
pre-license medicine in a real world setting and
is a tribute to the partnerships weve created
together, our collaborators and the health care
professionals and people of Salford. Dr David
Leather, Medical Director of GSKs respiratory
Centre of Excellence
21
UNLOCK YOUR GLOBAL BUSINESS POTENTIAL
  • Conducting a comprehensive and robust clinical
    and economic evaluation of KALYDECO (ivacaftor)
  • The first medicine to treat the underlying cause
    of cystic fibrosis
  • The NIHR has been supporting Vertex
    Pharmaceuticals Incorporated (Vertex) to
    undertake a comprehensive and robust clinical and
    economic evaluation of KALYDECO (ivacaftor), the
    first medicine to treat the underlying cause of
    cystic fibrosis, for people with a specific
    genetic mutation.
  • The NIHR Royal Brompton Respiratory Biomedical
    Research Unit (BRU) was involved in the UK adult
    and paediatric clinical trials of KALYDECO which
    were carried out in the BRU funded Clinical
    Research Facility with additional support from
    the NIHR Medicines for Children Research Network.
  • Simon Lem, Country Manager, UK, Ireland and
    Scandinavia for Vertex said We are pleased to
    have worked with the NIHRs clinical researchers
    and to have received the decision that the NHS
    will fund KALYDECO this is great news for
    patients
  • Dr Jane Davies, honorary consultant in paediatric
    respiratory medicine at the NIHR Royal Brompton
    Respiratory Biomedical Research Unit said
    Kalydeco changes the way cystic fibrosis can be
    treated because for the first time, clinicians
    are now able to target the underlying cause of
    the disease, instead of just the symptoms and
    complications.

22
UNLOCK YOUR GLOBAL BUSINESS POTENTIAL
  • NIHR BRC in collaboration with Proteome Sciences
    and Merck Millipore
  • Successfully concludes an alzheimers 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 Alzheimers 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
    Alzheimers.

23
UNLOCK YOUR GLOBAL BUSINESS POTENTIAL
  • National Institute of Health Research funds the
    development of a new diagnostic for early lung
    cancer diagnosis with industry partners
  • In 2010, almost 35,000 people died from lung
    cancer in the UK approximately 96 people every
    day.
  • The advanced lung disease biobank at the NIHR
    Royal Brompton Biomedical Research Unit is
    tacking this in partnership with Clearbridge
    BioMedics and ScreenCell by developing an
    advanced screening method detecting lung cancer
    before symptoms arise.
  • The development and use of a diagnostic blood
    test offers a faster, safer and more
    cost-effective method of diagnosing lung cancer.
  • Clinical research studies performed by Dr Eric
    Lim and his team of NIHR clinicians have shown
    that the screening process can diagnose 40-60
    of sufferers at early stages of the disease.
  • Dr Eric Lim commented Developing an
    alternative, sustainable and less invasive method
    for the early detection of lung cancer is a huge
    responsibility, which has the potential for
    making an equally huge impact on patients
    recovery rates and, ultimately, extending the
    time lung cancer patient have with their
    families. The use of the fantastic resources of
    the biobank at the NIHR Royal Brompton Biomedical
    Research Unit has been crucial to this research.

24
UNLOCK YOUR GLOBAL BUSINESS POTENTIAL
  • Development and validation of a method for
    Diffusion Tensor Magnetic Resonance Imaging
    (DT-MRI) in the human heart
  • Hypertrophic Cardiomyopathy (HCM) is a genetic
    heart disease one of the known conditions to
    cause sudden death syndrome in even the fittest
    of athletes.
  • Current tests to detect indications of HCM
    include electrocardiography and echocardiography.
    Whilst these techniques display decreased cardiac
    function and a thickening of the myocardium, they
    may not reveal the condition before it has
    significant impact on the patient.
  • Researchers at the NIHR Royal Brompton
    Cardiovascular Biomedical Research Unit (BRU) are
    leading in the development and validation of a
    method for Diffusion Tensor Magnetic Resonance
    Imaging (DT-MRI) in the human heart.
  • Director of Cardiovascular Magnetic Resonance,
    Professor Dudley Pennell has said As a leading
    innovator in cardiovascular MR, the NIHR Royal
    Brompton Cardiovascular BRU is helping to gain a
    further understanding into a condition that still
    poses a great threat to high-risk, potential
    sufferers. Our collaboration with Siemens has
    translated into outstanding results constantly
    leading to better knowledge of how to diagnose,
    predict and manage hypertrophic cardiomyopathy.

25
UNLOCK YOUR GLOBAL BUSINESS POTENTIAL
  • Imaging excellence through a unique academic
    partnership
  • Imaging is fast becoming one of the most
    effective means of detecting disease and tracking
    progression, even in the earlier stages. The UK
    offers imaging expertise, facilities, and
    clinically-annotated datasets to enable patient
    selection, clinical trials, and diagnostic
    development.
  • Imanova is a unique partnership between the
    Medical Research Council, Imperial College,
    University College London and Kings College
    London. Building on current strengths in
    neuroscience and cancer imaging and developing
    novel applications, Imanova is a national hub
    with world-class imaging facilities and a focus
    for academic and commercial collaborations.
  • Our Company is developing novel imaging probes
    to investigate key disease pathways in dementia
    and oncology, such as neurodegeneration and
    apoptosis, which will provide invaluable
    information for the development of new drugs and
    patient stratification. New imaging tools could
    transform the drug development process in these
    debilitating diseases.Kevin Cox, CEO Imanova

26
UNLOCK YOUR GLOBAL BUSINESS POTENTIAL
  • Novel targets and drugging the undruggable The
    SyntheTx technology partnership with Horizon
    Discovery and H3 Biomedicine
  • UK-based Horizon Discovery and USA-based H3
    Biomedicine (a subsidiary of Eisai), recently
    launched SyntheTx, a technology partnership to
    screen up to 50 currently undruggable but key
    cancer-driving genotypes to identify a range of
    novel targets.
  • The programme capitalises on Horizons precise
    genome editing technology (GENESIS) to validate
    targets.
  • By revealing the genetic dependencies of cancer
    cells in vitro, SyntheTx aims to uncover points
    of vulnerability in the genomes of the cancer
    cell lines screened, and then confirm these
    vulnerabilities in wider cell panels.
  • SyntheTx is looking for additional industry
    partners.

27
UNLOCK YOUR GLOBAL BUSINESS POTENTIAL
  • NIHR Oxford Biomedical Research Centre (BRC)
  • Collaborate with industry to develop the worlds
    first multi-gene sequencing test for predicting
    cancer patients responses to treatment
  • The worlds first multi-gene sequencing test for
    predicting cancer patients responses to
    treatment on the NHS has been launched in
    Oxfordshire in a partnership between Oxford
    University Hospitals NHS Trust and the University
    of Oxford.
  • The development of the test, which looks at 46
    genes, has been co-funded by the TSB through a
    grant to NIHR Oxford Biomedical Research Centre
    (BRC), with other funding from Life Technologies
    Corporation, AstraZeneca and the Johnson
    Johnson company Janssen Research Development. 
  • The test is performed on tumour tissue using Life
    Technologies Ion Personal Genome Machine at the
    BRC Molecular Diagnostics Centre lab in Oxford. 
    The test costs around 300 but will save the cost
    of using expensive drugs in patients who will not
    respond. 
  • A version of the test that involves around 150
    genes is now being considered and it is hoped
    will be rolled out the 46 gene test more widely
    in the NHSatment.

28
UNLOCK YOUR GLOBAL BUSINESS POTENTIAL
  • Medical Research Council funds three new
    stratified medicine
  • Medical Research Council funds three new
    stratified medicine disease consortia in
    rheumatoid arthritis, hepatitis C, and Gaucher
    disease with multiple UK and international
    industry partners
  • In December 2012, MRC announced that it would
    fund three disease consortia in rheumatoid
    arthritis, hepatitis C, and Gaucher disease.
  • The three consortia combine 34 academic groups
    and 20 industry partners with charities and
    patients to 1) determine why many patients dont
    respond to hepatitis C treatment 2) look for
    biological and genetic markers in rheumatoid
    arthritis and 3) stratify Gaucher patients by
    the nature of their disease to better target
    therapeutic intervention.
  • There are a large number of international
    industry partners for these three consortia,
    including Amgen, United Therapeutics, Janssen
    Diagnostics, Gilead, Complete Genomics, Genentech
    and Pfizer.
  • MRC previously funded pilot disease consortia in
    rheumatoid arthritis, chronic obstructive
    pulmonary disease, and diabetes.

29
UNLOCK YOUR GLOBAL BUSINESS POTENTIAL
  • National database of tumour genetic information
    and demonstrate a hub-and-spoke model for
    clinical tumour profiling
  • Cancer Research UK, AstraZeneca, Pfizer, and
    other partners build a national database of
    tumour genetic information and demonstrate a
    hub-and-spoke model for clinical tumour profiling
  • The Cancer Research UK (CRUK) Stratified Medicine
    Programme is a partnership between government,
    charity and commercial organisations to help the
    NHS adopt new targeted therapies, as well as
    making the UK a better place for research into
    more personalised cancer treatment.
  • Core funding for the programme is provided by
    CRUK, AstraZeneca and Pfizer with investment from
    the Technology Strategy Board and co-ordinated
    with other organisations including the NHS.
  • The first phase has two main objectives 1) to
    improve molecular profiling and 2) to capture
    clinical and genetic research data, forming
    cohort datasets of mutations, treatments and
    outcomes.
  • Phase I is now complete, and the eight clinical
    hubs have consented analysis of 7,229, patients
    across six major solid tumour types and a range
    of biomarkers. Phase II started in Q1 2013 with a
    focus on integrating Phase I learning into
    broader practice in the NHS.

30
UNLOCK YOUR GLOBAL BUSINESS POTENTIAL
  • Optimal Medicine develops personalised clinical
    decision support and chronic disease management
  • Optimal Medicine is a UK-based personalised
    medicine company dedicated to improving
    healthcare through state of the art software,
    initially focused on mental health.
  • The company has developed a personalised clinical
    decision support system, mehealth, integrated
    with remote self-monitoring applications. These
    apps can be configured to offer tailored support
    to patients between appointments and a visual
    journal of the patients status.
  • Mehealth provides point-of-care decision support
    for a wide spectrum of clinical decisions from
    diagnosis to chronic disease management.

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UNLOCK YOUR GLOBAL BUSINESS POTENTIAL
  • Novartis Accelerates Clinical Trials in Birmingham
  • Led by Leukaemia Lymphoma Research, the Trials
    Acceleration Programme (TAP) gives haematological
    oncology patients in the UK accelerated and wider
    access to early stage trials.
  • Working within the existing NIHR Cancer Clinical
    Research Network, TAPs dedicated centralised
    management at the University of Birmingham
    minimises red tape to establish trials and
    deliver accelerated results via patient
    recruitment across 13 UK centres.
  • Early results from Novartis Pharmaceuticals UK
    Ltd show a 50 per cent reduction in set-up time
    and significant reduction in costs per patient.
    Importantly, for the first time ever in its
    Oncology Unit, Novartis UK managed to secure the
    first visit by the first patient enrolled in the
    trial ahead of all centres participating
    globally.
  • In its initial year of operation TAP has ratified
    nine new trials including collaborations with
    eight pharmaceutical companies.

32
UNLOCK YOUR GLOBAL BUSINESS POTENTIAL
  • National Centre for Mental Health in Wales
    Partners with IDBS
  • 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

33
UNLOCK YOUR GLOBAL BUSINESS POTENTIAL
  • Almac offers next generation sequencing and
    companion diagnostics
  • Almac, headquartered in Northern Ireland,
    partners with the biopharmaceutical industry to
    provide biomarker discovery and development
    solutions ranging from preclinical biomarker
    discovery, through to full companion diagnostic
    development
  • Also offers biomarker clinical trial management
    and clinical test delivery.
  • Recently launched a next-generation sequencing
    service to support clinical trial enrichment and
    companion diagnostics
  • Announced a collaboration with industry partner
    Aeterna Zentaris to develop a companion
    diagnostic tool for a Phase II drug for LHRH
    receptor positive ovarian and endometrial cancers

34
UNLOCK YOUR GLOBAL BUSINESS POTENTIAL
  • Highlights from Scotland
  • Beijing Genomics Institute (BGI), recently signed
    a memorandum of understanding with the University
    of Edinburgh to enable personalised medicine
  • DestiNA Genomics, a spinout of the University of
    Edinburgh, is commercialising a revolutionary
    chemical-based system to detect nucleic acids and
    single nucleotide polymorphisms. The technology
    is unique and distinguishable from all existing
    enzymatic methods.
  • Scotlands electronic records and cradle to
    grave medical histories enable drug safety
    studies, clinical trials, biomarker discovery,
    and tracking well-phenotyped patients over time.
    Example The national diabetes register, SCI-DC,
    tracks real time clinical information on all
    239,000 people with diabetes in Scotland, updated
    daily.
  • The Division of Signal Transduction Therapy at
    the University of Dundee / MRC Protein
    Phosphorylation Unit has attracted 50 million in
    funding from the pharmaceutical industry (six
    leading pharma companies) to accelerate the
    development of specific inhibitors of kinases and
    phosphatases for the treatment of disease, as
    well as for the study of cell signalling.

35
UNLOCK YOUR GLOBAL BUSINESS POTENTIAL
  • University of Warwick and Bosch Healthcare Launch
    Research Facility
  • The Institute of Digital Healthcare (IDH) at the
    University of Warwick and Bosch Healthcare have
    launched a major research facility to develop
    digital healthcare technologies for people with
    life-threatening and chronic illnesses
  • IDH Learning Lab will design and trial novel
    digital healthcare technologies and aim to
    understand and evaluate the effectiveness of
    digital programmes in the health service

This approach is at the very heart of our
healthcare products, which connect patients to
services and assist them in having more control
over their own wellbeing. It is therefore, very
exciting for Bosch to be a founding partner of
the IDH Learning Lab, which will enable new
technology to be developed and tested and we look
forward to the results it will produce. Peter
Fouquet, President of Bosch, UK
36
UNLOCK YOUR GLOBAL BUSINESS POTENTIAL
  • Structural Genomics Consortium and University of
    Oxford Creating a Cluster of Biotechs
  • The Structural Genomics Consortium (SGC) is based
    at the University of Oxford
  • Has attracted 21 million of investment from 8
    industry partners for drug discovery in the UK
    (Pfizer, Novartis, Eli Lilly, GlaxoSmithKline,
    Abbott, Takeda, and two more leading global
    pharma companies)
  • SGC has plans to create a cluster of local
    biotechs on the basis of the consortiums
    extensive portfolio of innovative scientific and
    technological outputs

37
UNLOCK YOUR GLOBAL BUSINESS POTENTIAL
  • Structural Genomics Consortium and University of
    Oxford Creating a Cluster of Biotechs
  • 1998 Solexa was spun out of technology developed
    at the University of Cambridge, on the basis of a
    breakthrough in DNA sequencing.
  • 2006 Illumina acquired Solexa for 600 million.
  • Today Scientists worldwide read billions of
    bases and decode human genomes every few days,
    and Solexa Sequencing has decreased the time it
    takes to read a genome by 10,000 times compared
    to previous technologies.
  • Bright future In 2010, Illumina launched the
    companys European Headquarters on the old
    Solexa site at Chesterford Research Park near
    Cambridge
  • Home to Illuminas sequencing research, powered
    by a team of over 150 staff
  • Research group focuses on sequencing chemistry,
    enzymology, recombinant
  • DNA technology, computational data analysis, and
    genomic applications
  • Manufacturing makes Illuminas reversible
    terminators, while the
  • Commercial team supports a workforce across
    Europe, Middle East Africa

38
UNLOCK YOUR GLOBAL BUSINESS POTENTIAL
  • Proteus Digital Health and Lloydspharmacy monitor
    medication usage and patient wellness
  • US-based Proteus Digital Health and UK-based
    retail pharmacy chain Lloydspharmacy have teamed
    up to launch Proteus first commercial pilot,
    Lifenote
  • Includes sensor-enabled marker pills taken with a
    patients existing medication, an adhesive sensor
    patch worn on the body, and a mobile health app
  • Gives individuals with complex medication
    regimens and long term health conditions the
    opportunity to record and track their daily
    health habits
  • Metrics can be combined to provide useful
    information for patients and carers to manage
    wellness.
  • Lloydspharmacy will offer Lifenote as part of a
    service that includes personalized medication
    adherence packs assembled by pharmacists for each
    individual customer.
  • Leverages Proteus digital health feedback
    system, which has a CE mark in Europe and FDA
    clearance in the US. The system underpins a suite
    of products in development for both the US and UK
    markets.

Proteus and Lloydspharmacy share a common vision
of how advancements in technology can be captured
to improve the well being of patients struggling
with complex medication regimes and health
issues. The intimate knowledge that
Lloydspharmacys healthcare teams have of their
communities, patients and families makes the
company a perfect partner with which to introduce
a patient-focused service like Lifenote - Andrew
Thompson, Chief Executive Officer, Proteus
Digital Health
39
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