Research strategy for RNOH-IOMS David Marsh Professor of Clinical Orthopaedics Institute of Orthopaedics and Musculoskeletal Science, University College London Royal National Orthopaedic Hospital Stanmore, UK Trust Board April 2008 Trust Board April 2008

A joint IOMS-RNOH academic strategy is an essential part of the Outline Business Case One of three stipulations in the letter from the SHA inviting submission: “set out a clear commitment to support the work of the university and its partners in achieving AHSC status and strengthening the Orthopaedic Institute”

Academic Health Science Centre Joint Academic Plan: –integration of UG and PG education –R&D management into IOMS –Research strategy EXCELLENCE, INTEGRATION EDUCATIONRESEARCH CLINICAL How are we going to fund this?

Research Strategy Focused on musculoskeletal system but full spectrum Five themes, building on track record and patient needs  Innovative implant design  Cell therapy and tissue engineering  Disability and improvement of quality of life  Building the musculoskeletal evidence base  Sarcoma medicine Basic science Translational Experimental Clinical trials Health services research

Tapping in to UCL Five centres in IOMS –Bioengineering –Tissue engineering –Clinical academic –Rehabilitation –Pathology Basic science Translational Experimental Clinical trials Health services research  Innovative implant design  Cell therapy and tissue engineering  Disability and improvement of quality of life  Building the musculoskeletal evidence base  Sarcoma medicine Cancer Institute Centre for Ageing Engineering Musculoskeletal Consortium

UKCC MRCNIHR Basic science Translational Experimental Clinical trials Health services research ARC, charities EPSRC BBSRC Funding

National Institute for Health Research - the new research environment Concentration of funded clinical research in fewer, larger centres –Large research teams –Epidemiology, health economics vital –Many Trusts giving up and outsourcing research management Competition with all other specialities - fierce –Priorities in cancer, neuro, endocrine, mental, children –Role of rheumatology Research governance demands tighter Transform or fade out

NIHR funding streams Comprehensive biomedical research centres Specialist BMRCs Biomedical Research Units –Musculoskeletal in Oxford, Sheffield, Leeds Local Comprehensive Research Networks HTA, RfPB, NEAT, RISC Applied Research Programme Grants Technology Support Board

MRC Translational Research Call £241m extra, most on translational research –Bottlenecks Pan-UCL bid going in –MRC Centre for Cell and Gene Therapy Stanmore hopefully to contribute cell therapy in the musculoskeletal system

Cell-based therapy Clinical trials in ACI Preclinical work on bone, collagen Regenerative Medical Systems - UK Translational teams –Bone –Tendon –Cartilage

Stanmore Clinical Research Facility At present a joint venture between RNOHT and UCLB – may change Goal is to facilitate rapid study design, costing, governance and conduct Both investigator-led and commercial –All must be fully funded Building a clinical research network is crucial –eg fragility fractures and drugs that enhance fracture healing

Research pipeline in cell-based therapy Basic science Translational Experimental Clinical trials Health services research What phenotype of cultured cells produces the best clinical response? Is it cost-effective to culture-expand cells rather than use bone marrow? Can we design new way ways of efficiently expanding stem cells? IOMSRMS-UKSCRF

Integrated Academic Training Programme Four Academic Clinical Fellows Two Clinical Lecturers

Academic Research Board Research Governance Committee Research Committee Education Committee Trust Board PPI group UCL and Partners Health Sciences Research Deanery UCL Dean and Research Vice- Provost

Research Support Staff Academic Clinical Centre of IOMS MRC Clinical Trial Unit support Chair of Musculoskeletal Epidemiology –Alex MacGregor – starting Sep 08 R&D Director and Manager (Joseph Datukasi) Nerina – Head of Academic Business Development SCRF staff IT systems for research support – Simon Grange

Research Governance MHRA inspection Duties of Principal Investigators Duties of RNOH as a sponsor Our IT solutions

MHRA Inspection

Support we can offer Training –Executive GCP training –Research Pack –Best methodological practice in musculoskeletal research Governance –Integration locally with Risk assessment –Integration with Local Comprehensive Research Network Research –Finding Research Partnerships –Developing hypotheses and designing studies –Finding funding sources

Research Governance

Clinical Trials Support Being tested by our iBSc & MSc students

Electronic Patient Record

Clinical Sen Lec My tenure Team building MSK epidemiologist Biostatistician Health economist R&D Director R&D Manager SCRF Multidisciplinary MSc Integrated Academic Training Programme IT/governance support Medical physics Regenerative Medical Systems - UK Joint academic strategy capacity building

NHS R&D UCL NIHR Applied Research Programme £2m Pfizer fracture accelerating drug 500k TSB grant 500k MRC stem cells in nonunion 300k Expenditure Grant target overheads, contributions to salary, SCRF profit