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The UK Opportunity: what is experimental medicine?UNLOCK YOUR GLOBAL BUSINESS POTENTIALLate stage clinical trialsExperimental medicine

#1The UK Opportunity: Globally CompetitiveThe UK offers your company access to:UNLOCK YOUR GLOBAL BUSINESS POTENTIAL1.2.3.

Translational research expertise with world renowned KOLs

Unrivalled data and well-characterised patient cohortsLeading translational research facilities co-located within the hospital setting

#2The UK research ecosystem supports innovation flow from discovery science through to evidence generation and uptake

Translational Research CentresTranslating biological discovery into the clinical settingTranslational Research Centres including NIHR Biomedical Research Centres and Units, Translational Research Partnerships (TRPs) and Collaborations (TRCs)Clinical Research NetworksEmbedded in the NHS supporting the delivery of multicentre clinical studiesUK Clinical Research Facilities and Experimental Cancer Medicine CentresExpertly delivering early stage patient studiesMedical Research Council and medical research charities.Research funding focused on the mechanisms of health and disease UNLOCK YOUR GLOBAL BUSINESS POTENTIALUK Health dataIn the UK, your business will have access to unrivalled, clinically-coded health data and bio- repositories

#3The UK has the visionary science, centres of academic and clinical excellence, key opinion leaders, experienced partners, and the tools to help your businessThe UK is home to world-class discovery science..Text comes hereText comesIdentify patient cohorts Develop sensing and diagnostic technologiesDiscover and validate biomarkersDeliver engineering and informatics solutionsUnderstand disease biology Develop novel targets for drug discoveryThe UK can help your business..UNLOCK YOUR GLOBAL BUSINESS POTENTIAL

The Medical Research Council

The Wellcome Trust

Cancer Research UK and Cancer Research Technology

#4The UK is home to world-class translational research infrastructure that works in partnership with industry..with translational research expertise and infrastructure to take your innovation from discovery to the clinic

NIHR Translational Research PartnershipsNIHR Biomedical Research Centres and Units Scotland Leading academic centres of excellence in drug discovery and experimental medicineWales & NI provide industry with leading experimental medicine centres within leading hospital partnerships.

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Text comes hereText comes here Access to patient samples and biobanksAccess state of the art technology platformsAccess well characterised cohorts of patientsConduct fast and efficient experimental researchConduct biomarker-led approaches to patient stratification Develop and test new therapeutic targetsThe UK can help your business..

#England

TheNIHR Biomedical Research Centres (BRCs)

BRCs drive progress on innovation and translational research in biomedicine into NHS practice.

The Centres, based within the most outstanding NHS and University partnerships in the country, are leaders in scientific translation. They receive substantial levels of funding to translate fundamental biomedical research into clinical research that benefits patients and they are early adopters of new insights in technologies, techniques and treatments for improving health.

The BRCs:

Drive innovation in the prevention, diagnosis and treatment of ill-healthTranslate advances in biomedical research into benefits for patientsProvide a key component of the NHS contribution to our nations international competitiveness by making the best BRCs even better.

TheNIHR Biomedical Research Units (BRUs)

TheNIHR Biomedical Research Units (BRUs) undertake translational clinical research in priority areas of high disease burden and clinical need.The BRUs are based in leading NHS organisations and Universitiesenabling some of our best health researchers and clinicians to work together to develop new treatments for the benefit of patients.

TheBRUs:

Drive innovation in the prevention, diagnosis and treatment of ill-health.Translate advances in medical research into benefits for patients.Provide a key component of the NHS contribution to our nations international competitiveness by building on the best research leaders and their teams and enabling their host institutions to achieve or further develop critical mass in a priority research area:supporting the further development of NHS/University partnerships with existing critical mass in the priority research areas, 'building on the best';enablingexcellent, but comparatively small, research groups (comprising a relatively small number of research leaders, working in one of the priority areas, who are at the forefront of their field internationally) to achieve critical mass.

Scotland

Wellcome Trust Scottish Translational Medicine and Therapeutics Initiative (STMTI): a collaboration between the four Scottish Academic medical centres, funded by the Wellcome Trust, and Pfizer Pharmaceuticals in a PhD programme to create a new cadre of academic clinicians with expertise in translational medicine.

Edinburgh BioQuarter: The Edinburgh Bioquarter is a key centre of experimental medicine regrouping the Royal infirmary, the University of Edinburgh School of Medicine, the Queen Medical Research Institute, the Institute for Regenerative Medicine, the Clinical Research Imaging Center and an associated incubator (with now 13 tenants). The Bioquarter which already regroups over 1,000 researchers will also be the future home of the Sick Children Hospital and of a centre of the Farr Health Institute.

Stratified Medicine Scotland Innovation Center: The 20m Stratified Medicine Scotland Innovation Centre (SMS-IC) at the new South Glasgow Hospitals Campus involves a consortium of universities, NHS Scotland, and industry partners (Life Technologies, Arhidia...). SMS-IC has two primary objectives: 1) to create a new innovation hub with industry partners that becomes a leading global centre for specialist stratified medicine clinical trials, and 2) to develop new global translational informatics outputs that enable the effective delivery of stratified medicine, and care pathways at the patient, clinician and health system level.

Wales

Wales has three NISCHR funded Biomedical Research Units (BRU):Advanced Medical Image Analysis and Visualisation Unit Cancer Genetics Biomedical Research Unit Haemostasis Biomedical Research Unit

5UK Clinical Research Faculties support inpatient and outpatient clinical research studies across a wide range of disciplines, led by investigators in both adult and paediatric specialitiesExpert clinical research facilities support inpatient and outpatient clinical research

Text comes hereText comes here Quickly identify the right centres of excellence for a particular studyConduct cost-effective and smarter clinical researchDesign and deliver complex clinical studiesConnect to world-leading principal investigators Speed up the flow of innovation from bench to bedsideConnect to expert research nurses experienced at running early stage trialsUNLOCK YOUR GLOBAL BUSINESS POTENTIALUK Clinical Research Facilities for Experimental Medicine

UK Experimental Cancer Medicine Centres

The UK can help your business..

#Clinical Research Facilities

England

The NIHR funds Clinical Research Facilities (CRFs) for Experimental Medicine to help speed up the translation of scientific advances for the benefit of patients. CRFs 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.

Since its establishment in 2006 the NIHR has worked in partnership with other major funders under the umbrella of the UK Clinical Research Collaboration (UKCRC) to facilitate the translation of scientific advances into benefits for patients through the establishment of dedicated purpose-built CRFs. Capital funding for buildings and equipment has been provided by the UKCRC partners, including the NIHR. The NIHR funded the necessary recurrent NHS infrastructure costs of these CRFs such as clinical research nurses, technicians, and facility running costs, via a number of schemes.

Scotland

A network of Clinical Research Facilities within Scotland provide a purpose-built environment for patient-oriented research providing access to cutting-edge clinical facilities to enable the translation of scientific advances into real benefits for patients. Thefacilities provide significant opportunities for research scientists to work closely with clinical researchers, thus enabling the development of new therapies and treatments. By encouraging collaborations between basic and clinical scientists, the clinical research facilities help to ensure that advances in biomedical research feed through to benefit the healthcare of patients.

Clinical Research Facilities in Scotland include:

Aberdeen Clinical Research FacilityDundee Clinical Research FacilityEdinburgh Clinical Research FacilityGlasgow Clinical Research FacilityHighlandsClinical Research FacilityBeardmore Centre for Health Science at the Golden Jubilee

Wales

Health Research Wales provides a clinical trial feasibility service which distributes feasibility information (protocols and feasibility questionnaires) to each NHS Organisation in Wales. Requests for feasibility may be received directly from companies or via the NIHR Clinical Research Networks in England. Health Research Wales uses its Commercial Research Register and other software resources to identify sites with the appropriate research expertise and also works very closely with R&D offices to identify researchers new to commercial research who might be interested in taking part in the clinical trial. This service also aims to increase the commercial research portfolios of Welsh Health Boards that have traditionally not been involved in commercial research on a regular basis. Companies are offered the opportunity to sign Master Confidentiality Agreements which are not study specific and will cover all feasibility requests sent to Health Research Wales. Similar confidentiality agreements have been signed between Health Research Wales and each Welsh NHS Organisations and some universities.Health Research Wales employs three industry managers who distribute feasibility requests to NHS Organisations and follow up with physicians who received the feasibility information to collate responses and ensure that they are received by the deadline.Health Research Wales is presently developing a plan to identify specific patient populations and services that are available for clinical research in the NHS and universities. A project has recently started to review the potential of the SAIL (Secure Anonymised Information Linkage) database, which is hosted by Swansea University, to identify patients in primary and secondary care who might be eligible to participate in clinical trials and other research.

Northern Ireland

The Northern Ireland Clinical Research Facility allows for research involving healthy volunteers, hospital outpatients and day cases, and Belfast Health and Social Care Trust in-patients. The building links directly with all patient care areas and with state-of-the-art imaging and cardiology centres.

Four main research themes are being addressed:nutrition and metabolism vision science cancer respiratory research

Experimental Cancer Medicine Centres

Experimental Cancer Medicine Centres (ECMCs) play a leading role in speeding up the process of cancer drug development and the search for cancer biomarkers molecules present in blood or tissue - that can be used to diagnose cancer, predict the aggressiveness of the disease, or show whether a drug will be effective in a specific patient and at what dose.

TheECMCsmeet the costs of research infrastructure (via the Cancer Research UK element of funding to the University partner) and the costs of NHS infrastructure for research including NHS Support Costs (via the NIHR element of funding to the NHS partner).This funding provides vital infrastructure that is not readily supported through other early phase cancer trial funding in the UK.

The ECMCs work together as a network to combine their collective strengths and collaborate to drive new discoveries more effectively.

6Clinical 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 treatmentsExperimental research can be rapidly and efficiently translated to extensive late stage clinical research networks across the UK NIHR Clinical Research Network in England

Scotland has clinical research networks in Diabetes, Dementia and Cancer.

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

Text comes hereText comes here Speed up costing and contracting at sites Trouble shoot support from inside the NHS to keep study on trackIdentify the right sites drawing on more than 1000 primed investigatorsRapidly set up multi-site studiesGet advice on compatibility of protocols with current UK clinical practice Access GCP trained nurses to support patient recruitmentThe UK can help your business..UNLOCK YOUR GLOBAL BUSINESS POTENTIAL

#England

The NIHR Clinical Research Networkmakes it possible for all patients and health professionals across England to participate in relevant clinical trials.

The aims of the NIHR Clinical Research Networkis to:

Ensure patients and healthcare professionals from all parts of the country are able to participate in and benefit from clinical researchIntegrate health research and patient careImprove the quality, speed and co-ordination of clinical researchIncrease collaboration with industry partners and ensure that the NHS can meet the health research needs of industry.

A number of networks co-ordinate clinical trials for specific conditions. These are:

CancerStrokeMental HealthDiabetesMedicines for ChildrenDementias and Neurodegenerative Diseases

A Primary Care Research Networkfocuses on health areas for which primary care has particular responsibility, including disease prevention, health promotion, screening, early diagnosis, and the clinical management of long term conditions.

In addition to these networks, the NIHRhasestablished a ComprehensiveResearch Network to encourage clinical trials in all areas ofdiseases and clinical need within the NHSother than the specific conditions above.

The work of all the networks is coordinated by the NIHR Clinical Research Network Coordinating Centrethrough local recruitment and management centres.

Scotland

The Scottish clinical research networks are:

Scottish Cancer Network: Established in late 2003, this network has more than doubled patient recruitment to Scottish clinical research studies in cancer.Scottish Dementia Network(SDN): This network aims to improve care of patients with dementia through the provision of high quality, evidence-based clinical research.Scottish Diabetes Research Network(SDRN): The aim of this network is to raise the quantity and quality of diabetes research in Scotland.Scottish Medicines for Children Network(SMCN): The aim of this network is to improve the evidence base by facilitating appropriate research and helping to expand the number of licensed products and formulations for children.Scottish Stroke Research Network(SSRN): The SSRN has a Glasgow-based coordinating centre, operates across Scotland and is closely linked with the Stroke Research Network in England.Scottish Mental Health Research Network(SMHRN): The goal of this network is to facilitate the conduct of multi-centre randomised controlled trials in mental health in Scotland and across the UK by collaborating with the networks in England and Wales.Scottish Primary Care Research Network(SPCRN): This network was formerly known as the Scottish Practices and Professionals Interested in Research (SPPiRE). Its key aim is to facilitate national research activity in primary care, undertaking projects with other Scottish networks and colleagues in England.

Wales

There are three late-stage clinical networks based in North, South East and South West Wales that strive to ensure the delivery of high quality research studies in primary, secondary and social care settings. They provide a range of support to researchers including:

Obtaining patient and service user consent for participation; Ensuring compliance with research management and governance, ethical and GCP requirements; Identifying and recruiting patients, service users and collaborators; Collecting data for studies; Supporting Registered Research Groups and researchers to set up and co-ordinate studies; Database searches and notes screening.

Northern Ireland

The Northern Ireland Clinical Research Network aims to:

Enhance the ability of patients and Health care professionals to participate in and benefit from clinical researchEnhance the quality of clinical research undertaken within HSCImprove the speed of delivering research outcomesEnhance the regional coordination of clinical research across Trusts and academic organisationsImprove local integration of clinical research within HSC structures and services

This managed, comprehensive network has a coordinating centre based at the Belfast Royal Hospitals site and comprises nine NICRN areas of interest. These are networks of clinicians and other professionals with a critical mass of research interest in specific disease areas and with access to a sufficiently large patient population to enable recruitment. The NICRN areas of interest are:

CardiovascularChildrens diseasesCritical CareDementiaDiabetesPrimary CareRespiratoryStrokeVision

7In the UK, your business will have access to stable unrivalled, clinically-coded health data and bio- repositories.

supported by a single health system with unrivalled, clinically-coded health data to drive delivery of clinical research More than 60 million people are served by a National Health SystemExample data resources:

UK Biobank The Scottish Health Informatics Programme (SHIP) NIHR BioResource Clinical Practice Research Datalink (CPRD)

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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#Unlocking Data to Drive Innovation

The NHS routinely collects data on patients as they receive care, which is a rich source of information about how disease and treatments work. The information collected includes data on biomarkers, diagnosis, treatment and clinical outcomes. This information is vital to understanding how the NHS and Social Care system can improve outcomes for patients

UK life science is informed by real world data and information, from bioresources to anonymised patient records, clinical practice, and outcomes data. Enabled by the National Health System and Anonymised electronic patient records, your business will have access to unrivalled, clinically-coded health data, including linked datasets offering a unique opportunity to understand care pathways.

The UK Biobank is a unique resource of data and samples linked to medical histories and health records from 500,000 adult participants, available to researchers in academia and industry from anywhere in the world. Advanced imaging and genotyping of UK Biobank participants are underway.http://www.ukbiobank.ac.uk/

Clinical Practice Research Datalink and data from England, Scotland, and Wales: The Clinical Practice Research Datalink (CPRD) enables observational studies, clinical trial feasibility and protocol optimisation, and post-market surveillance. The Clinical Practice Research Datalink (CPRD) research, clinical trial feasibility and protocol optimisation in England. CPRD can also connect to data from Scotland, Wales and Northern Ireland. http://www.cprd.com/intro.asp

The NIHR BioResource is being scaled into a national cohort of healthy volunteers and patients who wish to participate in clinical research and are willing to provide clinical information and samples. This resource enables recall to studies by genotype and phenotype and can help study sponsors stratify and select patients for trials.http://bioresource.nihr.ac.uk/

Health and Social Care Information Centre: Englands central, authoritative source of health and social care information for frontline decision makers. The information centre provides healthcare information to enable the improvement of healthcare decision making, patient outcomes and the identification of efficiency savings. http://www.hscic.gov.uk/

Health Episode Statistics (HES): The national statistical data warehouse for England of the care provided by NHS hospitals and for NHS hospital patients treated elsewhere. HES is a unique data source, whose strength lies in the richness of detail at patient level . HES includes data on hospital admissions, outpatient appointments and A&E attendances for all NHS trusts in England.

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We have had a very productive relationship with the Cambridge Bioresource (CBR) over the last 2-3 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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