Navigating England s clinical research infrastructure. How NOCRI helps simplify access to accelerate discoveries

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1 Navigating England s clinical research infrastructure How NOCRI helps simplify access to accelerate discoveries

2 2» The National Institute for Health Research (NIHR) Clinical Research Network recruited 595,000 patients studies to its portfolio in 2012 a doubling of patient numbers over the past five years» The NIHR Clinical Research Network recruited more than 630,000 patients to clinical studies in 2012/13, a 7% increase on the previous year» At the end of 2012/13, the NIHR Clinical Research Network was supporting more than 4,200 studies in the NHS, a 12% increase on the previous year» Over 13,000 patients recruited to NIHR Biomedical Research Centre (BRC) research studies during 2011 / 2012» The NIHR BRCs operated 4,682 active research projects during 2011 and 2012 a 20% increase on the year before Contents Foreword 3 Introduction 4 Accelerating clinical development and de-risking investment 5 Addressing study requirements and expert guidance 6 NIHR Clinical Research Network Feasibility Services 7 NIHR clinical research infrastructure 8 Clinical research case studies 10 NOCRI staff 14 Useful links 15 Foreword Mark Samuels Managing Director, NIHR Office for Clinical Research Infrastructure (NOCRI) Many biotechnology companies have already profited from working with the National Institute for Health Research. This booklet shows how companies have benefitted from support in terms of the speed of patient recruitment and trial setup, and the de-risking of investment through the shortening of cycle times and earlier go/no go decisions. Funded by the Department of Health in England, the NIHR is the most integrated health research system in the world. The NIHR supports world-leading scientists in world-class facilities, embedded in the NHS. They develop and deliver patient-focused research. NOCRI works closely with companies to make it quicker and easier to access this research infrastructure. Through NOCRI, the NIHR is committed to supporting biotechnology companies in their research. With continued support from the BIA, I hope that more companies will work with us in the NIHR. This is important, because such research is needed to translate scientific discovery into new therapies for patients. Steve Bates Chief Executive, BIA The UK possesses world leading clinical infrastructure and expertise within the health service that can accelerate research and development activities and speed products to patients. Successive governments have invested to build, maintain and enhance this capacity. For bioscience companies, particularly small and emerging businesses, navigating this landscape has not historically been straight forward whether conducting early phase research or in the latter stages of clinical trials. That is where NOCRI can help, acting as a research SatNav directing you to the most appropriate NIHR skills and resources for your particular programme. This bespoke offering enables bioscience companies to access what you need in a timely fashion, reducing cash burn whilst maintaining the highest quality. This booklet acts as an introductory guide and provides some case studies to demonstrate how your peers have already made use of the offering. I encourage you to engage with NOCRI to see how they might simplify and accelerate your development. 3

3 4 5 Introduction Timely access to high quality clinical infrastructure is a critical success factor for biotechnology companies. The contributions made by NIHR and the Institute of Cancer Research to Chroma s research highlight the significant benefits of tapping into the UK s clinical capabilities. Richard Bungay, Chief Executive Officer, Chroma Therapeutics. The UK has one of the strongest and most productive life sciences sectors in the world, generating turnover of over 50 billion and employing 167,500 people in over 4,500 companies. The value of biological medicines in development within the UK represents approximately 24billion 1. Hosting four of the world s top 10 universities and one of the world s three major financial centres, the UK is already a major supporter and funder of collaborative medical research2. The UK also possesses a world-leading clinical research infrastructure which bioscience companies can access via NOCRI. NOCRI and the BIA have jointly produced this booklet to showcase this resource across the country and to illustrate key examples of successful collaboration between the global biotechnology industry, and the worldclass NIHR clinical research infrastructure. Accelerating clinical development and de-risking investment The importance of speed when setting up a clinical study and reducing cash burn cannot be underrated. Setting-up a clinical study includes steps, which can be time consuming if not managed efficiently:» planning and designing the study» developing protocols and risk assessments» confirming trial feasibility» locating a collaborative partner» obtaining regulatory approval» recruiting patients. This booklet highlights how the NIHR clinical research infrastructure can work with industry partners to accelerate their clinical outcomes and help to de-risk investment. The NIHR works to speed up the development of clinical trials in this country by:» Providing access to well-characterised cohorts of patients within the 60 million people who use the NHS» Improving the quality, speed and co-ordination of clinical research by removing barriers to research in the NHS» Strengthening research collaboration with life sciences industries to ensure that the NHS can meet the health research needs of industry» Supporting clinical investigators in the development of high quality research proposals through the NIHR Research Design Service. 1

4 6 Addressing study requirements and expert guidance NOCRI, working together with partner organisations such as the BIA, can help companies address study set up requirements. NOCRI provides the tools and processes to support collaborative research with the world-class NHS infrastructure, embedded within the NHS. With a unique overview of the clinical research landscape, NOCRI is able to support biotechnology companies by offering a fast, easy and consistent single point of entry to the NIHR clinical research infrastructure, including its world-leading investigators and world-class facilities. This single point of access enables NOCRI to speed up engagement with the NIHR by rapidly connecting biotech companies with the right experts in the best research centres to support and progress their clinical development programmes. NOCRI is not a grant funder and does not provide grants to companies to undertake research. For further information on current funding opportunities interested parties can contact the BIA. NOCRI works with industry partners to help them navigate the clinical research environment and to set up collaborations with NIHR centres in a streamlined and efficient way. One example of this is how NOCRI provides structured collaboration models such as the NIHR Translational Research Partnerships in Inflammation. De-risking investment is a crucial part of NOCRI s services to the UK s biotech industry. As well as reduced cash burn through accelerated clinical development set-up, NOCRI connects companies to NIHR experts who understand the potential of developmental drugs, devices and diagnostics and can enable earlier go/no go decisions. Being able to understand whether a drug or device is viable ultimately saves not only time, but valuable finance which may be better spent on an alternative research project. NOCRI can introduce industry partners to the most experienced and relevant experimental researchers, using the latest equipment and facilities, to help ensure that a project s investment correlates to the most effective results, in the shortest of times. In 2011, NOCRI launched the model Industry Collaborative Research Agreement (micra) The micra is designed to support clinical research collaborations involving the pharmaceutical and biotechnology industries, academia and NHS organisations across the UK. The micra has been responsible for making a major contribution to improving the speed, ease and efficiency of negotiating contract terms. Welcomed by the BIA, the micra provides template clauses which can be brought together to form a contract. This includes a range of options for handling the ownership of any intellectual property rights resulting from the collaboration. The use of the micra improves the speed, ease and efficiency of negotiating the terms under which individual collaborations are conducted. This simplified and managed agreement thereby helps to ensure the initiation of the collaborative study is not subject to unnecessary delays. NIHR Clinical Research Network Feasibility Services In June 2013, the NIHR Clinical Research Network launched a feasibility service to help the lifesciences industry to complete their studies successfully within the NHS in England. Features of the new service include:» A single online Industry Application Gateway for all industry studies. Companies upload their application material once, and it is triaged out to the relevant part of the Clinical Research Network, making it simpler for industry to access the right support» A clear set of services for life-sciences companies, which can be tailored to the level of support each company requires for a particular study. The services include early feedback on study deliverability at protocol development stage, including expert clinical guidance to support a decision to place a study in the UK; site intelligence to validate and enhance the company s own site selection propositions; and a full site identification service to identify all/additional sites with the expertise to deliver a particular study» A streamlined, faster process for applications. Confirmation of eligibility for Network support and initial feasibility feedback now takes just 15 working days - an improvement of 50 per cent on the previous average turnaround» A central Industry Information Centre to provide information and advice to help commercial life-sciences companies to use the Network service effectively. 7 No matter what stage a biotechnology company is at in its clinical development pathway, NOCRI can provide the most appropriate sign-posting and support. To ensure industry partners are provided the best options at study start-up, the NIHR Clinical Research Network has developed a route map designed for commercial companies intending to sponsor and fund clinical research studies. This NIHR route map provides clear signposting to all necessary approvals and permissions required to commence a study in England. See the route map here: Life+sciences+industry/Set-up/study_start_up_routemap

5 8 9 NIHR clinical research infrastructure NOCRI provides a single point of entry to the world-class NIHR clinical research infrastructure, helping deliver research support to time and target. The below diagram highlights some of the leading NIHR research facilities, indicating where each sit within the innovation pathway. These NIHR facilities support the NHS to deliver first class research that results in high-quality care for patients and the public. Further detail can be found at: Invention Evaluation Adoption Pre-clinical research Early-phase clinical research Late-phase clinical research Biomedical Research Centres Biomedical Research Units Experimental Cancer Medicine Centres Clinical Research Facilities Translational Research Partnerships and Collaborations Healthcare Technology Co-operatives Clinical NIHR Office for Clinical Research Diagnostic Evidence Co-operatives Research Network Infrastructure (NOCRI)

6 10 11 Case study one Cancer collaboration proves success in epigenetics study A collaboration between the NIHR, the Institute of Cancer Research and Chroma Therapeutics, has proved the success of a new type of cancer drug one that exploits the emerging field of epigenetics by inhibiting an enzyme that regulates gene expression. This drug targets a series of chemical switches within our genes to determine whether specific cancer-forming genes or cancer-suppressing genes are turned on or off. The biomarker analysis was financed by Chroma Therapeutics and linked with world class investigators at the NIHR Biomedical Research Centre at the Royal Marsden NHS Foundation Trust and The Institute of Cancer Research (NIHR Royal Marsden BRC). The cost of development of the assay and validation was supported by UK academic funding streams and infrastructural funding was sourced from the NIHR Experimental Cancer Medicine Centre Network (NIHR ECMC) and the NIHR Royal Marsden BRC. Case study two 300 multi-gene sequencing testing A collaboration between researchers at the NIHR Biomedical Research Centre at Oxford University Hospitals NHS Trust and the University of Oxford (NIHR Oxford BRC) and Life Technologies Corporation is seeking to create the first multi-gene DNA sequencing test to help predict cancer patients responses to treatment. Part funded by the Technology Strategy Board through a grant to the NIHR Oxford BRC, Life Technologies Corporation, AstraZeneca, and Janssen Research & Development, established a collaboration which was the first to introduce a multigene diagnostic test for tumour profiling in the NHS. The collaboration is seeking a test that uses the latest DNA sequencing techniques to detect a wide range of mutations in a wide range of genes. This new 46 gene test is a significant and positive step forward in cancer treatment, moving research from the conventional sequencing of single genes towards more comprehensive genome sequencing. The test potentially offers significant savings by helping prescribe patients with the most effective drugs straightaway. The NIHR Oxford BRC is an internationally-recognised centre in cancer research with world-class facilities and internationally recognised oncologists who lead multi-centre clinical trials including genetic biomarker led trials. For partners it boasts established links to global biopharmaceutical companies. Undertaking the study in collaboration with the NIHR brought the study significant benefits: The NIHR infrastructure has allowed the de-risking of investment enabling and encouraging further investment in clinical trials within the NHS in England.» The study met recruitment targets - The NIHR and the NIHR ECMC provided the infrastructure to facilitate effective collaboration between the various tumour units involved» Chroma Therapeutics relied upon the bespoke pharmacodynamic assays provided as part of the NIHR Royal Marsden BRC s drug discovery programme. This is a valuable service to biotech companies who have single drugs on a given pathway. The cost to develop such assays independently can sometimes be highly restrictive. Working with the NIHR and the Institute of Cancer Research, Chroma Therapeutics was able to access expertise, accelerate clinical development and move the product through the clinical pathway from bench to bedside in a study that improved patient outcomes. 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, Medical Sciences for Life Technologies Corporation

7 12 13 Case study three - Developing new disease-modifying treatments for relapsing remitting multiple sclerosis Case study four - Blood test - a simple diagnosis for Alzheimer s? Industry partners Biogen Idec and Elan collaborated with researchers at the NIHR University College London Hospitals Biomedical Research Centre (NIHR UCLH BRC) to help develop two disease-modifying treatments for relapsing remitting MS: natalizumab and dimethyfumarate. Using world-class facilities within the NIHR UCLH BRC, NIHR researchers led the primary outcome analysis of multicentre proof-of concept (PoC) trials to determine the efficacy of these potential disease modifying therapies. The team followed up these PoC studies by providing centralised analysis in subsequent large, multinational phase three trials that provided the clinical evidence required for regulatory approval.» The NIHR s studies, supported by grant funding from the UK MS Society, were crucial to show that blood-brain barrier breakdown is a key early event in new lesion formation in relapsing remitting MS The NIHR is collaborating with industry partners in biomarker research that has significant potential to form the basis of simple blood tests for the diagnosis and management of Alzheimer s. In March 2012, the NIHR Biomedical Research Centre at the South London and Maudsley NHS Foundation Trust and King s College London (NIHR Maudsley BRC), in collaboration with industry partners Proteome Sciences and Merck Millipore, successfully concluded a 1,000 sample Alzheimer s disease biomarker validation study. The collaboration has successfully tested biomarker panels of between 11 and 16 proteins in a very large replication study. These biomarkers have significant potential to form the basis of a series of simple blood tests for the diagnosis and management of Alzheimer s.» NIHR research played a leading role in defining protocols for the use of Magnetic Resonance Imaging in proof-of concept trials of potential new diseasemodifying treatments, generating evidence for further research» Expertise at the NIHR UCLH BRC ensured clinical development challenges identified during the trial could be overcome. This NIHR / industry collaborative research programme was crucial in demonstrating that both treatments improved patient outcomes worldwide. The study:» Represents a major step towards a series of simple blood tests to facilitate early diagnosis and management of Alzheimer s addressing a major unmet need» Used internationally-renowned skills and experience» Accessed a large cohort of patients from within the NHS access that was expedited through partnership with the NIHR, reducing delays and cost. Analysis of the study data will determine whether individual markers and defined marker panels have diagnostic and prognostic utility, providing benefits for patients and families suffering from the devastating effects of Alzheimer s.

8 14 15 NOCRI staff The NOCRI team is highly skilled and experienced in making it easy for industry partners to access the UK s clinical research infrastructure. To contact any of the below NOCRI team members, please Mark Samuels Managing Director, NOCRI As Managing Director of NOCRI, Mark s role is to make sure the Department of Health benefits from its 0.5billion/year investment in world-leading science, worldclass facilities and the country s best scientists. Additionally, Mark ensures that NOCRI provides the global life sciences industry with a single point of access to the NIHR clinical research infrastructure. Mark is a member of the Chief Medical Officer s Strategy Board for the NIHR. Mark formerly worked in industry, latterly at Roche Diagnostics. Representing the diagnostics industry, he co-chaired the Evaluation Pathway programme with Sir Andrew Dillon, which established a way for NICE to evaluate medical devices and diagnostics. Dr Oliver Rausch Head of Industry, NOCRI Programme Director, NIHR Translational Research Partnerships Oliver brings a vast amount of industry experience to NOCRI, having spent the past 15 years working at pharma companies across Europe. He was most recently Vice President, Biology at Cellzome and has further experience as Director, New Chemical Entities, Biology at UCB and as an investigator with GlaxoSmithKline. Oliver is strengthening the development of the NIHR s Translational Research Partnerships and underpins NOCRI s commitment to clear and streamlined access to the UK s worldleading clinical research infrastructure. Dr Matthew Hallsworth Head of External Relations, NOCRI As Head of External Relations for NOCRI, Matthew works with companies to highlight the opportunities for collaboration with the wide range of expert investigators and research infrastructure funded by the NIHR to support research from early-phase translational medicine studies through to later-phase and multi-centre clinical trials. Prior to joining NOCRI, Matthew was Head of Communications at the UK Clinical Research Collaboration a partnership of government, charities, industry, the NHS, academia, regulators and patients focused on improving the clinical research environment in the UK. Matthew has also held a number of research management roles in the charity and NHS sectors and prior to this pursued a research career in respiratory medicine. Dr Lucy Allen Head of Research Infrastructure, NOCRI As Head of Research Infrastructure for NOCRI, Lucy works with the NIHR-funded clinical research infrastructure to identify key strengths, expertise and opportunities to develop collaborations with the life-sciences industry. Lucy also ensures that the expert individuals, research facilities and cutting-edge technologies the NIHR funds work in a coordinated way to support high quality clinical research. Prior to joining the NOCRI team Lucy was a Department Manager and senior scientist at GE Healthcare. Lucy has worked across all phases of discovery from early stage research through development, driving lead candidates into clinical trials and First-In-Man imaging studies. Useful links National Institute for Health Research (NIHR) - The BioIndustry Association (BIA) - NIHR Office for Clinical Research Infrastructure (NOCRI) - NIHR Clinical Research Network - NIHR Translational Research Partnerships - NIHR Research Programme Hub - NIHR Industry Application Gateway - NIHR Clinical Research Network Feasibility Services - _feasibility/eligibility_and_feasibility_home.htm UK Clinical Research Collaboration Experimental Medicine Resource Finder -

9 The National Institute of Health Research Since its establishment in 2006, the NIHR has made major investment in clinical research infrastructure in the National Health Service to support high quality health research for patient benefit. The NIHR clinical research infrastructure provides world class facilities and brings together a wide range of individuals with the expertise to design, develop, deliver and support world-class research studies and clinical trials. Supporting industry research is paramount to the NIHR. The NIHR Office for Clinical Research Infrastructure (NOCRI) has been established to help research partners navigate their way through the research environment in England and establish mutually beneficial partnerships with the NIHR clinical research infrastructure. NOCRI aim to improve the quality, efficiency and success of translational research by:» providing structured collaboration models such as the NIHR Translational Research Partnerships in Inflammation» providing rapid connection to expert investigators and cutting edge technologies» providing necessary tools and processes to support collaborative research» speeding up patient recruitment through effective use of well-established patient cohorts» connecting industry partners with only the most experienced NIHR experimental researchers in the best facilities, to establish collaborative research studies and de-risk investment. For further information, please visit The Bioindustry Association Founded over 20 years ago at the infancy of biotechnology, the BioIndustry Association (BIA) is the trade association for innovative enterprises involved in UK bioscience. Members include emerging and more established bioscience companies; pharmaceutical companies; academic, research and philanthropic organisations; and service providers to the bioscience sector. The BIA represents the interests of its members to a broad section of stakeholders, from government and regulators to patient groups and the media. Our goal is to secure the UK s position as a global hub and as the best location for innovative research and commercialisation, enabling our world-leading research base to deliver healthcare solutions that can truly make a difference to people s lives.

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