Delivering the NIHR Central Commissioning Facility

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1 Delivering the NIHR Central Commissioning Facility

2 About the NIHR The National Institute for Health Research is funded through the Department of Health to improve the health and wealth of the nation through research. It is a large, multi-faceted and nationally distributed organisation. The NIHR manages its health research activities through four main work strands: RESEARCH: funding research to generate innovative new healthcare solutions INFRASTRUCTURE: providing the facilities and the people to conduct firstclass research in the NHS FACULTY: supporting the individuals leading and carrying out research SYSTEMS: promoting faster, easier clinical research through unified, streamlined and simple systems for managing ethical research and its outputs. Investment into the NIHR has driven the transformation of health research within the NHS.

3 NIHR Established in 2006 Hosted by LGC Ltd. >100 staff in Twickenham and Skipton House

4 Overview of CCF We manage research activities for NIHR and DH: NIHR Invention for Innovation Programme (i4i) NIHR Programme Grants for Applied Research Programme NIHR Research for Patient Benefit Programme NIHR Research Design Services NIHR Schools for Primary Care Research, Public Health Research & Social Care Research DH Policy Research Programme Health Innovation Challenge Fund (partnership between DH and the Wellcome Trust) NIHR Health Protection Research Units NIHR Blood & Transplant Research Units

5 Overview of CCF (2) We manage NIHR research infrastructure: Biomedical Research Centres & Units Clinical Research Facilities for Experimental Medicine Collaborations for Leadership in Applied Health Research & Care (CLAHRCs) Patient Safety Translational Research Centres Health Technology Co-operatives Diagnostic Evidence Co-operatives Other responsibilities include: NIHR Senior Investigator competitions and conferences Academic Health Science Centre designation (for DH)

6 Areas of NIHR managed by the CCF NIHR Fellowships, Professorships and other awards Integrated Academic Training Pathway NOCRI Biomedical Research Centres Biomedical Research Units Collaborations for Leadership in Applied Health Research and Care Clinical Research Facilities for Experimental Medicine Experimental Cancer Medicine Centres Diagnostic Evidence Co-operatives Healthcare Technology Co-operatives Patient Safety Translational Research Centres Academic Health Science Centres Translational Research Partnerships Dementia Translational Research Collaboration Rare Diseases Translational Research Collaboration MRC/NIHR Phenome Centre Clinical Research Network Research Capability Funding Senior Investigators Faculty World Other Performance in Initiating and Delivering Clinical Research Clinical Practice Research Datalink InfoNIHR Coordinated System for gaining NHS Permission Other Research Systems Research for Patient Benefit Programme Grants for Applied Research Programme Development Grants Invention for Innovation Efficacy and Mechanism Evaluation Health Service and Delivery Health Technology Assessment Methodology Research Public Health Research Systematic Reviews Blood and Transplant Research Units Centre for Surgical Reconstruction and Microbiology Clinical Trials Units Research Schools for Primary Care, Public Health and Social Care Health Protection Research Units Horizon Scanning Centre Research Design Services

7 Research Aim They evaluate the effectiveness and impact of new healthcare treatments, find new ways of preventing, identifying and treating ill health, and make this evidence widely available to ensure that decisions about health and social care are being informed by the best possible evidence.

8 Research for Patient Benefit Response-mode funding programme for small grants. Maximum award 350,000 for up to three years ( 250,000 for feasibility studies). Awards made to NHS bodies and other providers of NHS services in England with subcontracts to academic partners. Eight Regional Advisory Committees. Three funding competitions per year. Two stage application process. More than 650 awards made to date totalling over 145 million.

9 Programme Grants for Applied Research Response mode funding for programmes of research. No limit on funding amount or duration*. Awards made to NHS organisations in England with subcontracts to academic partners. Two funding rounds per year. 179 awards in 15 funding rounds totalling ~ 335m. *Amount and period of funding depends on nature of proposed work. Funding above 2.5 million and duration more than six years will be unusual.

10 Innovations Funding via the NIHR i4i Programme Intellectual Property Advice across NIHR Support Commercialisation of NIHR funded intellectual property Promote NIHR in the SME community

11 Invention 4 Innovation (i4i) Aims to advance the translation of healthcare technologies Funds collaborative projects involving academics, clinicians or companies working in the medtech sector i4i Product Development Awards funds projects that have strong potential for commercialisation and NHS adoption. i4i Challenge Awards are theme based and funds projects that bridge the gap between development of new medical technologies and their adoption into clinical pathways.

12 Infrastructure Aim Harness the research potential of the NHS to improve health and deliver competitive advantage for increased economic growth

13 Biomedical Research

14 Commercial engagement NIHR Health Technology Co-operatives Work collaboratively with patients and patient groups, charities, industry and academics. NHS pull for the development of new medical devices, healthcare technologies and technology-dependent interventions Focus on clinical areas and/or themes of high morbidity, which have high potential for improving quality of life of NHS patients and improving the effectiveness of healthcare services that support them

15 NIHR Office for Clinical Research Infrastructure NOCRI provides a valuable resource for the global life sciences industry - improving the quality, efficiency and success of translational research by providing: access to experimental medicine expertise and capabilities at individual NIHR centres unique multi-centre collaborations in experimental medicine enabling early-phase clinical research in selected therapeutic areas operational support of multi-centre clinical trials through the NIHR Clinical Research Network

16 NIHR Translational Research Partnerships (TRPs) Translational Research Partnerships offer an internationally unique approach to support open innovation and collaboration with the life sciences industries. Collectively they bring together formidable expertise and capabilities: Recognised experience in current exploratory development protocols, expertise in pathophysiology and disease mechanisms, expertise in modelling Enabling technologies and infrastructure, including imaging, biobanks, accredited laboratory facilities Cohorts of well-characterised patients available for clinical development studies The Partnerships are supported by streamlined and efficient business processes, using standard contracts and unified operating procedures. NIHR Office for Clinical Research Infrastructure

17 Operational advantages of Translational Research Partnerships 36 NHS Trusts and University partners Single Point of contact for industry Belfast Newcastle Nottingham Operational Management Manchester Leicester NOCRI Quality Birmingham Cambridge Oxford University College London Imperial Speed Pre-Clinical Models PoC Phase 1 PoM Southampton Barts & London Kings College Biomarkers Patient Tissue Patient stratification Point of intervention NIHR Office for Clinical Research Infrastructure

18 NIHR Rare Diseases Translational Research Collaboration (RD-TRC) Growing area of interest for industry: Patient need Model diseases for common diseases Challenge: poor assessment of natural progression of disease NIHR focus on developing deeply phenotyped patient cohorts 20M NIHR investment in Rare Diseases Translational Research Collaboration to Build capacity in rare disease research Establish deeply phenotyped patient cohorts, enabling better designed Phase 2 trials Establish a national database for rare diseases Successful NIHR open call for industry collaborative deep phenotyping studies 8 funded projects to date including A repurposing study of a marketed immuno-modulator in PAH Study co-funded by industry and NIHR - only possible through collaboration First potentially disease modifying treatment for PAH patients

19 NIHR Dementia Translational Research Collaboration The NIHR Dementia Translational Research Collaboration has been developed to pull discoveries from basic science into the clinic, with the potential to deliver real benefits for patients. The Collaboration comprises: Four NIHR Dementia Biomedical Research Units Six NIHR Biomedical Research Centres All are world leaders in dementia-related translational research and based within leading university- NHS partnerships. The Collaboration is a new and important part of the NIHR clinical research infrastructure and offers a unique opportunity to maximise the significant NIHR investment in dementia translational research. Collaboration between academia, NHS and industry is crucial in the development of new interventions to tackle dementia.

20 micra Model Industry Collaborative Research Agreement Based on Lambert agreements Each of the parties is engaged throughout the process Risk and reward are shared Reward is linked to investment Liability is linked to reward Endorsed by ABPI, BIA, research charities and UK research funders

21 NIHR Contribution to growth THE NIHR S KEY CONTRIBUTIONS TO GROWTH INCLUDE: Supporting collaborations and contract research with the life sciences industry Creating the research environment that supports the nation s international competitiveness Attracting, developing and retaining a highly skilled health research workforce Providing the clinical evidence to help the NHS and public sector to make efficient use of resources Providing the research evidence that contributes to establishing a healthier workforce and wider population

22 Collaborating with Industry Collaborative working is central to the NIHR s aim to advance treatments, new diagnostics and medical technologies for patients and to drive growth. All parts of the NIHR research system in the NHS support collaboration with industry. Collaborative working with between the NIHR and Industry contributes to growth through: Attracting investment into the UK Supporting companies based within in the UK Supporting the establishment and growth of UK SME s NIHR Office for Clinical Research Infrastructure (NOCRI) NOCRI provides the life sciences industry with a direct and simple route to a wide range of experimental medicine facilities and experienced NIHR investigators who can help companies understand the potential of their developmental drugs, devices and diagnostics, shortening cycle times for research and enabling earlier go/no go decisions. NOCRI also promotes the NIHR infrastructure to the life sciences industry, both nationally and internationally.

23 Collaborating with Industry FOCUS ON: NIHR Translational Research Infrastructure The NIHR translational research infrastructure gives industry access to word-class facilities and the opportunity to work in collaboration with expert investigators. 120 MILLION ANNUAL INVESTMENT FROM INDUSTRY The NIHR translational research infrastructure has quadrupled its annual investment by industry over the last five years from 33 million per year in 2009/10 to 130 million per year in 2014/15 582% INCREASE The number of industry studies supported by the NIHR translational research infrastructure has increased by almost six fold from 514 to 3008 studies in 2014/ PROJECTS with UK SME s 41.1 MILLION THROUGH THE EXPLOITATION OF IP The NIHR translational research infrastructure generated 41.1m from exploiting intellectual property, including the launch of six spin out companies in 2014/15. In 2014/15 the NIHR translational research infrastructure worked with SME s to support more than 864 research projects 585 STRATEGIC PARTNERSHIPS WITH INDUSTRY The NIHR translational research infrastructure had 347 existing strategic partnerships and developed 238 new strategic partnerships with industry during 2013/14

24 Underpinning International Competitiveness Each year, the NIHR invests 1billion to support the people, research, facilities and systems for health research in the NHS. This represents the most integrated health research systems in the world. Having one integrated research system within and as part of the world unique NHS, is a significant competitive advantage for attracting investment into the country. In addition, the NIHR research system strengthens the UK research environment through provision of unique offerings and creating efficiencies such as: Specialist infrastructure such as the NIHR BioResource, NIHR Biosample Centre, MRC/NIHR National Phenome Centre Enabling access to data through initiatives such as Clinical Practise Research Datalink and the NIHR Health Informatics Collaborative Funding research through targeted and needs led programme funding Filling skills gaps and creating research capacity through training

25 Underpinning International Competitiveness FOCUS ON: NIHR Clinical Research Network The Clinical Research Network (CRN) provides the infrastructure that allows high-quality research to take place in the NHS. The CRN is making a real difference to the research environment ensuring that the UK remains an internationally competitive destination for health research. 3 MILLION PATIENTS RECRUITED The CRN has hit a recruitment milestone of more than three million patients recruited to clinical research studies in the last six years, with over 600,000 patients recruited in 2013/14 ONLY 26 DAYS The CRN has reduced the median number of days to achieve NHS permissions to 26 days 35 FIRST GLOBAL PATIENTS In 2013/14, the CRN recruited 35 first global patients in commercial contract studies 99% PARTICIPATION 99% of NHS Trusts in England now take part in NIHR studies 900 COMMERCIAL CONTRACT STUDIES In 2013/14, the CRN supported 900 commercial contract studies in the NHS a 31% increase on the previous year and nearly 10 times the number in 2008/9 100% ON TARGET & ON BUDGET The CRN has more than tripled the proportion of commercial contract studies delivered to 100% time and target over the past four years. In 2013/14 73% of commercial contract studies active were recruited to time and target

26 Summary NIHR is based on the collaboration of multiple healthcare stakeholders recognising: Common goals Different needs This cross sector working delivers patient benefit and economic growth. Strengthen the UK position as a leader in Healthcare research.

27 Thank you