NOCRI simplifies access to the UK’s world-leading clinical research infrastructure. NOCRI simplifies access to the UK’s world-leading clinical research infrastructure NOCRI is helping bring to life the Government’s ‘UK Health and Life Sciences’ vision Foreword Collaborative research accelerates the development of new treatments, devices and diagnostics to tackle complex healthcare needs. Creative engagement between the NHS, universities and industry forms a powerful alliance to drive translational medicine. This alliance is vital. It ensures that advances in basic science progress swiftly into benefits for patients and the economy. NOCRI makes this collaboration easy, accelerating the development of solutions to meet real patient needs. Companies’ research programmes are already benefitting from this way of working – contact the NOCRI team now to understand how they can help you. Professor Dame Sally C Davies Chief Medical Officer and Chief Scientific Adviser, Department of Health In the foreword to the publication ‘Investing in UK Health and Life Sciences’, the Prime Minister said: “The old ‘big pharma’ model is becoming more difficult to maintain. In its place is a new focus on translational medicine – more early stage clinical trials with patients, more external innovation, more collaboration” He went on to say: “This is an ambitious strategy to join up life sciences in the UK: to open up universities and business to more collaboration; to invest in the best British ideas at an early stage; to tear down the regulatory barriers you face; to open up the NHS to new innovations and new clinical trials” 3 Introduction to NOCRI What we do Benefits for industry The NIHR Office for Clinical Research In early-phase clinical research, NOCRI- Infrastructure (NOCRI) makes it easy sourced expertise helps companies to access the UK’s clinical research understand the potential of their infrastructure. This includes world-leading developmental drugs, devices and science, world-class facilities and the diagnostics. This enables earlier go/no-go country’s best investigators with access to decisions. We expedite the research process well characterised groups of patients within and ensure delivery on target. the 60 million people who use the National Health Service in the UK. knowledge, enabling the generation of NOCRI is a unique resource for the global new ideas and leaps in research. We have a life sciences industry – improving the quality, clear, managed approach to collaborations. efficiency and success of translational This meets the needs of industry, helping research. We enable this by providing: companies to achieve their translational • fast and easy access to the UK’s clinical research infrastructure • rapid connection to expert investigators and cutting edge technologies • a managed process for collaborative research. We are focused on successful outcomes – from making rapid introductions through to supporting collaborations to ensure delivery. 4 NOCRI facilitates an exchange of research objectives. Collaborations between industry and the NIHR infrastructure benefit UK research, by ensuring that we stay at the forefront of knowledge and expertise. The recent £800 million Government investment to support NIHR Biomedical Research Centres and Units is the largest ever commitment to early-phase health research Our place within the NHS NOCRI is part of the National Institute for The recent £800 million Government Health Research (NIHR). Together, NIHR investment to support NIHR Biomedical people, facilities and systems represent the Research Centres and Units is the largest most integrated clinical research system ever commitment to early-phase health in the world – propelling research from research. This was followed up by an bench to bedside for patient benefit. NOCRI additional £102 million for NIHR Clinical contributes to this vision by helping public, Research Facilities. charity and industry research funders collaborate with the NIHR infrastructure. NOCRI also ensures that NIHR-supported infrastructure works effectively to help drive the flow of innovative research forward. The NIHR provides the National Health Service (NHS) with the support and infrastructure it needs to carry out firstclass research. This has established the NHS as an internationally recognised centre of research excellence. The UK Government, and partners in industry and the charity sector, funds this research. NOCRI’s reach encompasses the £0.5 billion annual Government investment in relevant infrastructure to support clinical research at all points in the development pipeline. 5 Research The UK is responsible for more than 14 percent of the world’s most highly-cited research papers Introduction The UK contributes one percent of the world’s population, attracts three per cent of global funding for research, and is responsible for more than 14 percent of the world’s most highly-cited research papers1. For translational research in particular, the UK offers world-class science in world-leading facilities complemented by access to ethnically-diverse, well-characterised cohorts of patients. This is a unique resource that can help industry improve the quality, efficiency and success of clinical translational research programmes. NOCRI can help tailor the breadth of the NIHR research infrastructure to suit the needs of industry. Overall, the NIHR is responsible for more than £0.5 billion p.a. investment in relevant infrastructure to support clinical research at all points in the development pipeline. 1 Evidence Ltd (2009). International comparative performance of the UK research base. Department for Business, Innovation and Skills: London, UK; OECD (2009). Main Science and Technology Indicators (MSTI): 2009 Edition. Organisation for Economic Cooperation and Development: Paris, France; Science and Engineering Indicators 2010. National Science Foundation: Arlington, VA, USA. 7 Research infrastructure The NIHR funds a range of facilities focused on translating findings from the laboratory into the clinic, and ultimately into new treatments across the spectrum of disease and therapeutic areas. NOCRI provides a rapid route of access to these facilities and works with companies to direct them to the most appropriate centres to meet their research needs. NIHR Biomedical Research Centres and Units The NIHR supports 19 Clinical Research (BRCs and BRUs) translate fundamental Facilities (CRFs) that are purpose-built, biomedical research into clinical research. cutting-edge facilities with specialist clinical Competitively chosen, NIHR BRCs and BRUs research and support staff. They offer host formidable expertise and cutting edge industry help with the research process – equipment that is available to industry for from study design to data collection collaborative research. and management. NIHR Biomedical Research Centres The NIHR supports 14 Experimental are large investments in early phase Cancer Medicine Centres (ECMCs) across infrastructure, embedded within NHS Trust- the country in close partnership with the University partnerships. These include 5 leading cancer charity, Cancer Research BRCs that host research themes in multiple UK. Working closely with industry partners, therapeutic areas, as well as specialised ECMCs play a leading role in speeding up BRCs at London’s Royal Marsden (cancer), the process of cancer drug development Moorfields (ophthalmology), Maudsley and the search for cancer biomarkers (mental health) and Great Ormond Street through the design and execution of early (paediatrics) hospitals, plus Southampton phase trials. (nutrition) and Newcastle (ageing). NIHR Healthcare Technology NIHR Biomedical Research Units Co-operative (HTC) funding enables NHS are 20 more focused investments by organisations to act as centres of expertise therapeutic area, including musculoskeletal, that focus in clinical areas or themes of gastrointestinal, respiratory, dementia, high morbidity and unmet need for NHS nutrition diet and lifestyle, deafness and patients. Working collaboratively with hearing, plus cardiovascular diseases. industry, they develop new medical devices, healthcare technologies or technologydependent interventions, which improve treatment and quality of life for patients. 8 The NIHR Clinical Research Network helps the life-sciences industry deliver leading-edge research across the NHS. The Network provides a range of tools and services that are designed to improve the performance of research and help the delivery of studies, especially later phase multi-site studies, on time and to target. Services include site identification, study feasibility and performance management. Study start-up route maps, costing Online Resource Finder The UK Experimental Medicine Resource Finder is a unique resource, providing information about UK early phase translational research infrastructure, including further details of individual NIHR BRCs, BRUs, CRFs and ECMCs. It provides an optimum entry point for companies seeking information about the NIHR infrastructure. templates, model contracts and milestone It contains up-to-date information schedules are available to support industry about over 80 major facilities with studies with the NHS. details of expertise, resources, techniques For more information, visit www.crncc.nihr.ac.uk and technologies. Site users can search for facilities by location, health or disease research topic or skills and equipment available. For more information, visit www.ukcrcexpmed.org.uk 9 Industry partnering Introduction NOCRI uses its knowledge of the UK’s The TRPs are supported by streamlined and clinical research landscape, as well as its efficient business processes, using standard unique position in the NIHR, to connect contracts and unified operating procedures. industry to relevant research expertise and capacity in the NHS. There are various models for partnering. These vary from established groupings of centres of excellence in defined therapeutic areas to bespoke collaborations that are responsive to the needs of individual companies. A leading example of the former are the NIHR Translational Research Partnerships (TRPs). Underpinned by relevant NIHR infrastructure, the Partnerships bring TRPs are strongly positioned to ensure scientific ideas are applied to patient need earlier than would otherwise have been possible, by concentrating expertise and fast-tracking ideas. There are currently two in operation: • NIHR TRP in Inflammatory Respiratory Disease – including, asthma allergy, COPD, respiratory infection • NIHR TRP in Joint and Related together the UK’s leading academics and Inflammatory Diseases – the life sciences industry, in order to drive including rheumatoid arthritis, translational research in defined therapeutic osteoarthritis, synovitis. areas. Typically, this happens through phase I and II proof of concept clinical drug trials, and other well designed studies for medical technology and diagnostics applications. Their scope also includes earlier stages of translation from the laboratory to the clinic, including discovery, optimisation of biomarkers and preclinical models of disease. Study design is informed by Translational Research Partnerships are strongly positioned to ensure scientific ideas are applied to patient need earlier than would otherwise have been possible, by concentrating expertise and fast-tracking ideas. Research centres that make up the TRPs have been selected to work together based on their proven ability to deliver in experimental medicine and translational research. As members of a Partnership, each centre has committed to work with industry through NOCRI – their consistent, single point of contact. formidable expertise and capabilities: • cutting edge expertise in exploratory development protocols, biomarkers, pathophysiology, disease mechanisms and in modelling • enabling technologies and infrastructure, including advanced imaging, biobanks and dedicated research facilities • cohorts of well-characterised patients available for clinical development studies. 11 Translational Research Partnerships TRPs bring a unique breadth of expertise to industry’s translational research questions, packaged in a streamlined operational model Inflammatory respiratory disease Expertise Principal Investigator Facility • Acute lung injury Professor Peter Barnes Imperial Academic Health Science Centre (NIHR Respiratory BRU) • Airway inflammation • Allergy Professor Christopher Brightling University Hospitals of Leicester NHS Trust / University of Leicester (NIHR Respiratory BRU) Professor Ratko Djukanovic Professor Stuart Elborn Dr Tim Harrison Dr Ling-Pei Ho University Hospital Southampton NHS Trust / Professor Wisia Wedzicha • Chronic cough BRU) • Chronic obstructive pulmonary disease Belfast Health and Social Care Trust / Queen’s (COPD) University Belfast • Cystic fibrosis Nottingham University Hospitals NHS Trust / The • Idiopathic pulmonary fibrosis University of Nottingham • Interstitial lung disease Oxford University Hospitals NHS Trust / The • Lymphangioleiomyomatosis (LAM) King’s Health Partners Academic Health Science • Pleural diseases (malignancy and infections) Centre (NIHR BRC) • Primary ciliary dyskinesia University College London Partners Academic • Pneumonia Health Science Centre (NIHR BRC) Professor Ashley Woodcock • Bronchiectasis University of Southampton (NIHR Respiratory University of Oxford (NIHR BRC) Professor Tariq Sethi • Asthma Manchester Academic Health Science Centre (NIHR Respiratory Clinical Research Facility) • Respiratory infection- fungal and non-fungal pathogens • Respiratory failure • Sarcoidosis 12 • Tuberculosis. Joint and related inflammatory diseases Expertise Principal Investigator Facility • Ankylosing spondylitis Professor Ian N Bruce Manchester Academic Health Science Centre (NIHR Musculoskeletal BRU) • Behcet’s syndrome • Bone and cardiovascular comorbidity Professor Christopher Buckley University Hospitals Birmingham, Sandwell and West Birmingham Hospitals, Dudley Group of Hospitals NHS Trusts / University of Birmingham Professor Andrew Cope Professor Hill Gaston • Crohn’s disease King’s Health Partners Academic Health Science • Inflammatory bowel disease Centre (NIHR BRC) • Inflammatory skin disease Cambridge University Hospitals NHS Foundation • Juvenile Idiopathic arthritis Imperial Academic Health Science Centre (NIHR BRC) Professor John Isaacs • Chronic pain syndromes (NIHR BRU) Trust / University of Cambridge (NIHR BRC) Professor Dorian Haskard in inflammatory arthritis Newcastle upon Tyne Hospitals NHS Foundation Trust / Newcastle University (NIHR BRC) • Juvenile myositis • Myositis • Osteoarthritis • Psoriasis • Psoriatic arthritis Professor David Isenberg University College London Partners Academic Health Science Centre (NIHR BRC) Professor Costantino Pitzalis Barts and The London NHS Trust / Queen Mary, University of London (NIHR BRU) Professor Peter C Taylor Oxford University Hospitals NHS Trust / University of Oxford (NIHR BRC) • Rheumatoid arthritis • Scleroderma • Sjögren’s syndrome • Synovitis • Systemic lupus erythematosus (SLE) • Ulcerative colitis • Vasculitis. 13 NOCRI provides access to NIHR’s world-leading infrastructure for translational research. The four NIHR Biomedical Research Units in Dementia, together with six NIHR Biomedical Research Centres with dementia themes, provide a network of infrastructure for translational research in neurodegeneration. Dementia Translational Research Collaboration Centre Director / Theme Lead Together the NIHR Dementia NIHR Cambridge Dementia BRU Professor Peter St George-Hyslop, Director Translational Research Collaboration NIHR Cambridge BRC Dr John Bradley, Director offers world-leading expertise in: Professor Roger Barker, Dementia and Neurodegeneration Research Theme Lead NIHR Imperial BRC Professor Jonathan Weber, Director Professor David Brooks, Neuroscience Research • Late-onset dementias, including Alzheimer’s Disease, Vascular Disease and Lewy body dementia Theme Lead • Young-onset dementias Professor Eric Aboagye, Imaging Theme Lead • Frontotemporal dementia with NIHR Maudsley Dementia BRU Professor Simon Lovestone, Director NIHR Maudsley BRC Professor Simon Lovestone, Director NIHR Newcastle Dementia BRU Professor David Burn, Director NIHR Newcastle BRC Professor Patrick Chinnery, Director NIHR Oxford BRC motor neuron disease • Parkinson’s Disease, including progression to dementia Professor Ian McKeith, Ageing Brain Research • Neuroinflammation Theme Lead • Huntington’s Disease. Professor Keith Channon, Director Professor Peter Rothwell and Dr Sarah Pendlebury, Dementia and Cardiovascular Disease Research Theme Leads Professor Peter Brown, Functional Neuroscience and Neuroimaging Theme Lead Professor Kia Nobre, Cognitive Health Programme NIHR Queen Square Dementia BRU Professor Martin Rossor, Director NIHR UCL BRC Professor Bryan Williams, Acting Director Professor John Collinge, Neurodegeneration Research Theme Lead Professor Tar ek Yousry, Neuroimaging Research 14 Strengths and expertise The NIHR Dementia Translational Research Collaboration offers internationally recognised strengths in: • Patient stratification through biomarkers • Discovery, development and delivery of innovative disease modifying therapies • Identification of new diseasecausing genes • Extrapolation of discoveries in Theme Lead, young onset dementia to older Professor John Duncan, Neurodiagnostics patient groups. Research Theme Lead NOCRI brings together clinical expertise from around the UK in a managed way, creating unique research partnerships. We can improve the quality, efficiency and success of translational research programmes by connecting you to the UK’s world-leading scientists, working in world-class facilities with access to well-characterised patient cohorts. If you would like to know more about how NOCRI can help you to establish academic-NHSindustry collaborations, please contact us at nocri@nihr.ac.uk. Mark Samuels Managing Director, NOCRI For further information visit: www.nihr.ac.uk/nocri NIHR Office for Clinical Research Infrastructure (NOCRI) A305, Richmond House 79 Whitehall London SW1A 2NS