Transcript - Life Science Proposition

UK Experimental research and clinical trials
Working in partnership with industry
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
UK’s Life Science Strategy and
capabilities for business
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Catalysing and
empowering the UK
Life Science community to
work with international
business
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Creating focused
messaging matching UK
strengths with global
business needs
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The UK is committed to supporting the Life Sciences and
Healthcare sector both now and in the long-term future
“In December 2011 I made a firm commitment to re-establish the UK's
global leadership in the life science sector, announcing the Government's
ten-year Strategy for UK Life Sciences.”
“By more closely integrating the UK's unique strengths, I believe that we
can improve healthcare for patients, attract new investment to the UK, and
create new jobs and business opportunities in an increasingly competitive
and international industry.”
David Cameron
Prime Minister
The Strategy makes the most of the UK’s core strengths:
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Basic science in universities
Translational and clinical research excellence
Industry and supply chain
The National Health Service (NHS)
Life Science Strategy and Innovation Health and Wealth are the
UK government’s response to a global sector under pressure
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The UK Opportunity: Globally Competitive
The UK offers your company access to:
Translational research expertise with world – renowned KOLs
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World-class science, universities, and principal investigators
Globally renowned research charities committing £1bn in annual research funding
Unrivalled data and well-characterised patient cohorts
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A National Health Service (NHS) with more than 60 million patients and electronic
health records.
Clinical datasets, well-characterised patient cohorts, stratification tools, and
biobanks.
Leading translational research facilities
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In England, £500 million annually spent on National Institute for Health
Research (NIHR) infrastructure to support health research and in particular
experimental medicine research.
From complex early stage experimental research requiring innovative trial designs to
larger late stage trials, the UK can be your commercial partner.
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A business environment that supports and rewards innovation
The UK government has introduced fiscal measures to stimulate innovation and growth for companies that
opt to setup and / or operate in the UK
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
Biomedical
Catalyst = £180m
programme of
public funding for
growth
£300m
£180m
23%
corporation
tax will drop
further to
20%
Corporation Tax
10%
SUPPORTING INNOVATION
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)
PBox
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The UK research ecosystem supports innovation flow from discovery
science through to evidence generation and uptake
Early-phase clinical research
Pre-clinical research
Later-phase clinical
research
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Medical Research Council and
medical research charities.
Research funding focused on the
mechanisms of health and disease
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Translational research centres
Translating biological discovery into the clinical setting
Translational Research Centres including NIHR
Biomedical Research Centres and Units, Translational
Research Partnerships (TRPs) and Collaborations (TRCs)
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UK Clinical Research Facilities and
Experimental Cancer Medicine Centres
Expertly delivering early stage patient studies
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Clinical Research Networks
Embedded in the NHS supporting the
delivery of multicentre clinical studies
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UK Health data
In the UK, your business will have access to unrivalled, clinically-coded health data and bio- repositories
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The UK is home to world-class discovery science..
The UK has the visionary science, centres of academic and clinical excellence, key opinion leaders,
experienced partners, and the tools to help your business
Deliver engineering
and informatics
solutions
Identify patient
cohorts
Develop sensing
and diagnostic
technologies
Understand
disease biology
The UK can
help your
business..
Discover and
validate
biomarkers
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The Medical Research Council funds diseasefocused consortia of academic and industry
partners to enable and drive experimental
medicine
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The Wellcome Trust funds both basic
biomedical research and translational projects.
Develop novel 
targets for drug
discovery
The UK Health Departments fund translational
research infrastructure designed to pull
innovation from the laboratory into the clinical
setting
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Cancer Research UK and Cancer Research
Technology also provide core oncology
research funding, and offer translational funding
and expert capabilities, and support patient
engagement.
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..with translational research expertise and infrastructure to take
your innovation from discovery to the clinic
The UK is home to world-class translational research infrastructure that works in partnership with industry
Conduct fast and
efficient
experimental
research
Access to patient
samples and
biobanks
Access state of the
art technology
platforms
Conduct biomarkerled approaches to
patient stratification
The UK can
help your
business..
Develop and test
new therapeutic
targets
Access well
characterised
cohorts of patients
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NIHR Biomedical Research Centres and Units
Expert translational researchers embedded in the
leading University and hospital partnerships
across England
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Scotland Leading academic centres of
excellence in drug discovery and experimental
medicine. For example experimental cancer
research expertise at Dundee.
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Wales & NI provide industry with leading
experimental medicine centres within leading
hospital partnerships.
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NIHR Translational Research Partnerships
Structured partnerships of expert centres working
in collaboration with industry on the early and
exploratory development of new therapeutics
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Expert clinical research facilities support inpatient and outpatient
clinical research
UK Clinical Research Faculties support inpatient and outpatient clinical research studies across a wide range
of disciplines, led by investigators in both adult and paediatric specialities
Speed up the flow of
innovation from
bench to bedside
Connect to worldleading principal
investigators
Quickly identify the
right centres of
excellence for a
particular study
The UK can
help your
business..
Conduct costeffective and smarter
clinical research
Design and deliver
complex clinical
studies
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Connect to expert
research nurses
experienced at
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running early
stage trials
UK Clinical Research Facilities for
Experimental Medicine are purpose-built,
cutting-edge facilities, with specialist clinical,
research and support staff, in locations where
universities and NHS Trusts work together on
dedicated programmes of patient-orientated
experimental medicine research.
UK Experimental Cancer Medicine Centres
brings together research experts in cancer
biology with clinical oncologists and researchers
to speed up the flow of innovations from the lab
bench to the bedside. The ECMC network also
includes Scotland, Wales and Northern Ireland
through local partnership funding with Cancer
Research UK.
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The UK experimental medicine infrastructure in action
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Oxford Biomedica and the NIHR BRC at Cambridge collaborate on development of ProSavin, a
new therapy for Parkinson’s disease
o “This collaboration with Oxford BioMedica is a bold step forward not only in the use of an advanced
gene-based treatment. I’m most excited to be progressing this vital research with a UK biopharma
company.” Professor Roger Barker, Theme Lead for Dementia and Neurodegenerative
Disorders at NIHR Cambridge BRC
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The NIHR Biomedical Research Centre at Oxford University Hospitals NHS Trust and Life
Technologies Corporation is creating the first multi-gene DNA sequencing test to help predict
cancer patients’ responses to treatment.
o “With their expertise in translating genetics into clinical practice and with several commercial
partnerships with genomics technology companies successfully completed, the Oxford team were
the obvious choice.” Josephine Harada, Product Management Leader, Life Technologies
Corporation
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NIHR BRC in collaboration with Proteome Sciences and Merck Millipore conducted a 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.
o This study is a major step towards a series of simple blood tests that would facilitate the early
diagnosis and management of Alzheimer’s.” Christopher Pearce, CEO of Proteome Sciences
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The UK experimental medicine infrastructure in action
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The ECMC Combinations Alliance and AstraZeneca are collaborating on a Phase Ib/IIa clinical trial to
examine an experimental drug called AZD4547 in combination with existing therapies . The trial will be
run across the UK at ECMCs at the ICR, Imperial, Cardiff , Oxford and Glasgow.
o “We believe that collaboration is crucial to finding solutions in the fight against cancer and are pleased to
partner with others in the UK who share our dedication to bringing new medicines to patients.” Andrew
Foxley, clinical programme director for AZD4547 at AstraZeneca
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Cancer Research UK and GSK have collaborated on a phase I trial, at the Institute of Oncology at St
James’s University Hospital in Leeds and Bart’s and The London ECMC in London of GSK's 1070916A,
an aurora kinase inhibitor.
o “This deal with GSK demonstrates how Cancer Research UK and CRT can work with industry to speed
up the development of anti-cancer drugs that might otherwise remain on companies’ shelves.” Dr Keith
Blundy, chief executive of CRT
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The £4M Wellcome Trust-Wolfson Foundation Northern Ireland Clinical Research Facility (NICRF)
opened in Sept 2013 focussing on cancer, nutrition and metabolism, vision science and respiratory research.
This will allow more people than ever before to take part in clinical trials in Northern Ireland.
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UK experimental medicine and late stage clinical research:
Matching supply with demand
Selected example UK resources
Industry clinical trial
requirements
In depth understanding of disease
mechanisms and pathways
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Access to patient tissues and clinically
annotated biobanks
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Identify and validate Biomarkers for
clinical study design
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Explore and implement patient
stratification approaches
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Identify and recruit patient cohorts
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Mechanism of Action studies
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Phase Ib/IIa PoM and PoC studies
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Feasibility, set-up and delivery of multicentre clinical trials
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Experimental research can be rapidly and efficiently translated to
extensive late stage clinical research networks across the UK
Clinical Research Networks provide infrastructure to support clinical research in the NHS, giving patients access
to high quality research studies and supporting the Life-Sciences Industry to develop potential new treatments
Rapidly set up
multi-site studies
Rapidly set up
multi-site studies
Get advice on
compatibility of
protocols with
current UK clinical
practice
The UK can
help your
business..
Speed up costing
and contracting at
sites
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NIHR Clinical Research has a number of
networks with therapeutic expertise that coordinate clinical trials in Cancer, Stroke,
Mental Health, Diabetes, Medicines for
Children Dementia and Neurodegenerative
Diseases.
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From 2010 to 2012, NHS Research
Scotland (NRS) has worked with over 183
commercial clients to achieve in excess of
440 projects and 224 clinical-trial feasibility
studies. Customers found the overall
experience “good or excellent” in 90% of
cases.
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Through the Northern Ireland Clinical
Research Network and Health Research
Wales, your business can be connected to
expertise and networks to conduct late stage
clinical research in these regions
Access GCP
trained nurses
to support
patient
recruitment
Identify the right
sites drawing on
more than 1000
primed investigators
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The UK late stage clinical research infrastructure in action
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Novartis Accelerates Clinical Trials in Birmingham working within the existing NIHR Cancer
Clinical Research Network 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.
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Roche and the NIHR Medicines for Children Research Network collaborated to tackle systemic
juvenile idiopathic arthritis. Roche sponsored a global study; looking at the effectiveness of a drug
called RoActemra (tocilizumab) in children aged 2 to 17. The network recruited the entire patient cohort
for the centre to time and target. RoActemra is now licenced (and saupported by NICE) for use in the
clinic.
“The NIHR Clinical Research Network was helpful in being able to provide a research nurse to support a
very quick setup. This meant the site could focus on the study at the right time and led to successful
enrolment of eligible patients.”
Stuart Bolt, Global Studies Leader, Roche
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…supported by a single health system with unrivalled, clinicallycoded health data to drive delivery of clinical research
In the UK, your business will have access to stable unrivalled, clinically-coded health data and bio- repositories.
More than 60 million people are served by a National Health System
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Example data resources:
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UK Biobank is a unique resource of data and samples linked to
medical histories and health records from 500,000 adult
participants
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The Scottish Health Informatics Programme (SHIP) tracks real
time clinical information on all 239,000 people with diabetes in
Scotland. This has been successfully employed to recruit patients
to a range of managed clinical trials.
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NIHR BioResource enables recall to clinical studies by genotype
and phenotype and helps stratify and select patients for trials
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Clinical Practice Research Datalink (CPRD) enables
observational studies, clinical trial feasibility and protocol
optimisation, and post-market surveillance
“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
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This clinical research excellence is accessible through simplified
industry access points.
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IN NORTHERN IRELAND:
 Health and Social Care Research and
Development, funds the Northern Ireland
clinical research network:
o to support high quality clinical trials
o promote research, develop partnerships
o ensure that targets are achieved and
maintained.
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IN WALES:
 NISCHR Clinical Research Centre
(CRC) and Health Research Wales
assist companies with the feasibility
process, study setup and delivery of
commercial research in Wales.
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IN SCOTLAND:
 NHS Research Scotland Permissions
Coordinating Centre and Health Science
Scotland (HSS) collaborate as single point
of entry for multicentre permission
applications. They are dedicated in
identifying appropriate clinical trial sites,
investigators and patients
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IN ENGLAND:
 NIHR Office for Clinical Research
Infrastructure (NOCRI) ensures the
companies can rapidly engage with
multiple research centres and that studies
are set up and delivered quickly and
efficiently.
 Through NOCRI or directly through the
NIHR Clinical Research Networks, the
UK’s late-phase clinical research
infrastructure can be accessed quickly
and efficiently.
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Creating an Open and Flexible Regulatory Framework
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Government commitments:
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Opening up the NHS to collaborate with your business on research and adoption
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Ensuring that products and services are critically appraised to the highest standard
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Transparent expert advice to support decisions on access to personal health information
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A streamlined health research approvals process
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Globally-respected regulators: The UK is home to the MHRA and the EMA
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Earlier Access and Adaptive Licensing are under consideration
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An expert stakeholder group meets quarterly to discuss regulatory innovation
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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
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How UKTI can help you work with and establish new connections
in the UK
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.
 Links with centres of excellence (e.g. universities)
 Information on tax, regulatory and business planning issues
 Information on financial incentives if applicable
 Information on staff recruitment
 Site and Property search assistance
 Building key contacts – we can provide introductions to service providers, local, regional and national
government and trade organisations.
 Aftercare through on-going support
 Maximising your global potential – Once you are established in the UK, we can help your company to take
advantage of new business opportunities and branch out to new locations – both in the UK and
overseas.
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UK Experimental Research and Clinical Trials
Working in Partnership with Industry
Success Stories
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The Salford Lung Study: GlaxoSmithKline Tests the Effectiveness
of Pre-License Medicine Using Real World Data in Manchester
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A collaboration between GlaxoSmithKline, North West eHealth (NWeH), The University of Manchester, Salford
Royal NHS Foundation Trust, NHS Salford’s local general
practitioners, and local community pharmacists.
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Testing the safety and effectiveness of a new treatment for
asthma and COPD.
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Draws on Salford’s e-Health records infrastructure, a
clinical information system that provides a single,
integrated electronic patient record across primary and
secondary care.
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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 we’ve created together, our
collaborators and the health care professionals and
people of Salford.”
Dr David Leather, Medical Director of GSK’s
respiratory Centre of Excellence
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Conducting a comprehensive and robust clinical and economic
evaluation of KALYDECO™ (ivacaftor)
The first medicine to treat the underlying cause of cystic fibrosis
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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.
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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.
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Simon Lem, Country Manager, UK, Ireland and Scandinavia for Vertex
said: “We are pleased to have worked with the NIHR’s clinical
researchers and to have received the decision that the NHS will fund
KALYDECO – this is great news for patients
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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.”
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NIHR BRC in collaboration with Proteome Sciences and Merck Millipore
Successfully concludes an alzheimer’s disease biomarker validation
study:
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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.
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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.
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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.”
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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. “
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NIHR Oxford Biomedical Research Centre (BRC)
Collaborate with industry to develop the world’s first multi-gene
sequencing test for predicting cancer patients’ responses to treatment
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The world’s 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.
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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.
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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.
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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 NHS at the moment.
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Novartis Accelerates Clinical Trials in Birmingham
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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.
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Working within the existing NIHR Cancer Clinical Research Network, TAP’s
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.
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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.
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In its initial year of operation TAP has ratified nine new trials including
collaborations with eight pharmaceutical companies.
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National Centre for Mental Health in Wales Partners with IDBS
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Created a data management platform to improve the understanding of mental
health genetics and treatment
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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
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IDBS’ platform will integrate clinical, biobanking and genetic data, providing a
data management and analytics system for this and future studies
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Highlights from Scotland
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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.
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Scotland’s electronic records and ‘cradle to grave’ medical histories enable
drug safety studies, clinical trials, biomarker discovery, and tracking wellphenotyped patients over time. Example: The national diabetes register, SCIDC, tracks real time clinical information on all 239,000 people with diabetes in
Scotland, updated daily.
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Other key experimental medicine centres include:
o Drug Discovery Unit (DDU) at University of Dundee. The DDU offers
drug discovery capabilities to translate biomedical research into candidate
therapeutics.
o Kosterlitz Centre at University of Aberdeen. The centre acts as a hub
linking the biomedical sciences to biomedical imaging, medicinal
chemistry, clinical research and biopharmaceuticals.
o Rowling Centre at University of Edinburgh. The centre targets the
discovery of treatments that will slow the progression of disease such as
MS and MND.
o Wolfson Wohl Cancer Research Centre at the Beatson Institute,
University of Glasgow. This international centre of excellence in the fight
against Cancer incorporates expertise in genomics, biomarkers, target
validation, drug development, pathology and preclinical trials.
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Highlights from Scotland continued..
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Four health boards in Scotland have teamed up with Pfizer to become the
company’s second INSPIRE site driving clinical research in the UK:
o The INSPIRE programme is a strategic network of sites identified as
highly productive and effective in conducting clinical trials.
o These sites have to meet strict criteria such as running trials to the
highest standards within set timelines; ensuring dedicated, high-quality
staff and resources; and expertise in key disease areas targeted by
Pfizer’s R&D pipeline.
Working together for our nation’s health is key as we strive to achieve a
more positive environment for life sciences in the UK, and it will play a key
role in further strengthening the research culture within NHS Scotland.”
Dr David Montgomery, Oncology Medical Director,
Pfizer Oncology UK
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Farr Institute. The new institute is an interdisciplinary eHealth Informatics
Research Centre, as an integral part of the UK-wide network. The institute is
leveraging Scotland’s investment in electronic health records. Medical,
population and computer scientists will combine their expertise to interpret
large and complex health datasets in research environments that safeguard
patient confidentiality.
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Highlights from Northern Ireland
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The new Northern Ireland Centre for Stratified Medicine – the only one of
its kind in the island of Ireland:
o Puts University of Ulster and the Western Health and Social Care
Trust at the frontier of pioneering medical research into chronic
degenerative diseases.
o The £11.5m investment will facilitate research that can better identify
drugs or treatments that meet the specific needs of individual patients –
and marks a significant advancement in this strategic research area.
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In Northern Ireland a new Electronic Care Record has been developed
which will ensure that no matter where you are being treated or cared for in the
Northern Ireland Health and Social care system.
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Cardiologists from both the Royal Victoria Hospital and Ulster Hospital Belfast
can stratify patients for their suitability of a pioneering new technique.
The technique uses specialised CT imaging to map heart disease progression
which allows arteries to be visualised and determined for their suitability for
this new procedure.
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Novo Nordisk collaborates with Swansea University on eight
clinical trials in diabetes
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Novo Nordisk and Swansea have collaborated on 8 clinical trials in
diabetes. In 7 of the those trials, recruitment was on time and
target. One study was stopped early by the Company.
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In all 8 studies, Swansea was able to recruit above the UK
average number of patients per site.
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In addition, approval times for the site in Swansea were below the
national average (68 days v 85 days).
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Results indicate successful research collaboration from feasibility
and setup through to execution and delivery of results
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