NIHR partnering with industry
•Als PPTX, PDF herunterladen•
2 gefällt mir•654 views
Delivered by the National Institute for Health Research Day Two, Pop-up University 7, 14.00
Empfohlen
Empfohlen
Weitere ähnliche Inhalte
Was ist angesagt?
Was ist angesagt? (20)
Andere mochten auch
Andere mochten auch (20)
Ähnlich wie NIHR partnering with industry
Ähnlich wie NIHR partnering with industry (20)
Mehr von Health and Care Innovation Expo
Mehr von Health and Care Innovation Expo (10)
Kürzlich hochgeladen
Kürzlich hochgeladen (20)
NIHR partnering with industry
- 1. NIHR partnering with industry Anthea Mould Business Development Manager (commercial) NIHR Clinical Research Network
- 2. • Political commitment to supporting life-sciences industry • Health & Social Care Act 2012 / NHS Constitution 2013 – Embed clinical research in all aspects of care The right environment
- 3. Supporting innovation: Study design and delivery
- 4. The National Institute for Health Research (NIHR) is funded by the Department of Health to improve the health and wealth of the nation through research. The NIHR plays a key role in the Government’s strategy for economic growth, attracting investment by the life- sciences industries through its world-class infrastructure for health research. Together, the NIHR people, programmes, centres of excellence and systems represent the most integrated health research system in the world. The NIHR is the research arm of the NHS. The NIHR
- 5. A whole research system
- 6. Innovation Late-phase clinical research NIHR Biomedical Research Centres Early-phase clinical research Evaluation NIHR Collaborations for Leadership in Applied Health Research & Care NIHR Biomedical Research Units NIHR Clinical Research Facilities Experimental Cancer Medicine Centres NIHR Healthcare Technology Co-operatives NIHR Diagnostic Evidence Co-operatives NIHR Clinical Research Network • > £0.5 billion p.a. investment in relevant infrastructure to support clinical research at all points in development pipeline NIHR research infrastructure
- 7. NIHR facilities In 2015/16, the NIHR infrastructure received £1.15bn of funding from all sources, resulting in: • Conduct of 11,243 studies • 321,985 patients recruited • 10,169 publications • 94 licences • 5 registrable and 62 non- registrable IP products • 15 spin-outs
- 8. Infrastructure partnerships and collaborations 2015/16 • 1378 collaborations with SMEs • 576 partnerships with industry • Resulting in £149.7m funding through industry collaborations and contracts
- 9. • 100% of National Health Service (NHS) organisations now research-active through the support of the Network • 74% are delivering commercial contract research studies Percentage of NHS Trusts participating in commercial contract studies NHS engagement
- 10. Number of new commercial studies added to the NIHR CRN Portfolio Increased volume A 125% increase over the last six years
- 11. Join dementia research Nearly 35,000 people were supported to participate in clinical research associated with dementias and neurodegeneration – a 62 % increase from 2014/15.
- 12. Our clinical research infrastructure Partnering with industry Dr Ian Newington, Senior Programme Manager NIHR Invention for Innovation (i4i) Programme
- 13. SensiumVitals® monitoring patch Major surgery has a high complication rate. Patients are currently monitored by a nurse, every few hours. • The SensiumVitals® System is a light patch that is applied to the patient’s chest to measure heart rate, breathing rate and temperature every two minutes. • It sends alerts by email, SMS or pager to the nurse if the vital signs become abnormal. • The patient can move around freely. • SensiumVitals® has received FDA clearance (2011) and CE marking. • SensiumVitals® has been shown to improve patient outcomes by enabling early intervention, thereby avoiding more serious conditions and higher treatment costs, and to reduce the average length of stay by four to six bed days (St John’s pilot study, 2013).
- 14. • SensiumVitals® is being trialled by St James's University Hospital, part of the Leeds Teaching Hospitals NHS Trust in a collaboration between the NIHR Colorectal Therapies Healthcare Technology Co-operative (HTC) and Sensium Healthcare co-funded by the Health Foundation and the NIHR Doctoral Research Fellowship Programme. • The trial will investigate the clinical benefits of the system, its health economic impact and the patients’ perspective and will take place initially in two colorectal surgery wards to monitor patients following major abdominal surgery. “The SensiumVitals® system will be compared with standard hospital monitoring to determine if it allows earlier detection of post-operative complications. If successful, the project will inform larger studies involving the SensiumVitals® technology throughout the NHS.” Professor David Jayne, Director, NIHR Colorectal Therapies HTC SensiumVitals® monitoring patch
- 15. Validating a regional model of Familial Hypercholesterolaemia diagnostic and cascade testing Collaborative project – x10 North East Cardiovascular Network Clinics, x13 CCGs, Northern Regional Genetics Services, NewGene Ltd, AHSN, NIHR DEC Newcastle, AstraZeneca, British Heart Foundation Objectives – to implement and evaluate a novel two-stage diagnostic testing strategy for patients with suspected FH in the North East and Cumbria region. Innovative testing strategy – `chip and sequence’ 1. Chip test for commonly occurring regional mutations – quick and inexpensive If no mutation found, 2. Consider full gene sequencing – more expensive and requires larger batches
- 16. Impact and adoption Service developments as a result of project: • Roll-out of regional pathway for FH genetic diagnosis and family cascade testing • Clinical Commissioning Groups agreement to continue to support FH testing • Adult and paediatric cascade clinics established throughout the region DEC Newcastle’s evaluation to date: • Two stage testing strategy is less costly compared with full gene sequencing at the current mutation detection rate of 35% or higher • Identification of a number of opportunities to refine selection criteria for testing which can be incorporated into the FH test request form to improve the mutation detection rate. Second version of the chip is being developed to include mutations most commonly found in UK wide patients.
- 17. • used to identify and severity grade frailty using routine health data in primary care • calculated using existing electronic data and doesn’t require an additional clinical assessment • made up of 36 deficits comprising around 2,000 Read Codes and presented as a score. CLAHRC West Midlands provided independent external validation using The Health Improvement Network (THIN) database. Enabling GPs to identify the frailest people CLAHRC Yorkshire and Humber partnered TPP in the application of software SystmOne to develop, validate and implement an electronic frailty index (eFI): Development of an electronic frailty index (eFI) for informing care decisions
- 18. For researchers, eFI enables: • identification of older people (OP) with frailty for research into health, disability and QOL trajectories to inform better targeting of interventions • increased research capacity in primary care and specialty areas where OP are core users • modelling of resource use at population level to inform strategic priorities/service needs. For the NHS, eFI is: • embedded in SystmOne and EMISWeb = availability to GPs caring for 90% of UK population • being used to inform new models of care for OP, for example: GPs at NHS West London CCG using eFI to risk stratify patients according to severity grade of frailty, forming part of a whole system approach in developing personalised, well- coordinated and seamless pathways of care across all sectors. Contact: Dr Andrew Clegg a.p.clegg@leeds.ac.uk http://www.improvementacademy.org/improving-quality/healthy-ageing.html eFI - Implementation and impact
- 19. Invention for Innovation (i4i) Programme Funding novel technologies, devices or interventions Mr Martin Hunt, Programme Director NIHR Invention for Innovation (i4i) Programme
- 20. Who we are and what we do • We are a translational funding scheme. • We support collaborative R&D and clinical adoption. • We want to fund innovative healthcare technologies in any area of existing or emerging clinical need: – Medical devices – Active implantable devices – In vitro diagnostics. • We de-risk projects for follow-on investment • From April 2010 to March 2016, NIHR i4i has invested £67,354,916 in 95 projects. – In 50 projects (53%), an SME was an applicant. – In 10 projects, an SME was the lead applicant.
- 21. Tackling MedTech ‘Valley of Death’ Innovation Project team IP & commercial strategy NHS adoption plan Technology that is attractive to follow-on funders and investors for commercialisation Proof-of- concept Clinical need Basic research produces proof of concept data Project plan Value for money Patient and public involvement The Graveyard of Good Ideas
- 22. For 95% of patients, haemodialysis is performed in hospitals, which is time-consuming and disruptive to patients‘ lives. • Quanta Dialysis Technologies Ltd awarded £548k over 3 years (2010) • Collaborators: St James’ Hospital Leeds, Newcastle University and the National Kidney Foundation • CE-marked home dialysis machine (2015) • Compact, user-friendly, simple cartridge system • Reduced time burden, improved survival • Estimated NHS cost savings at £15k per patient per year Compact dialysis machine
- 23. • In June 2015 Quanta treated its first patient. • Quanta are currently carrying out clinical validation. • Launch of the machine is planned for 2018 in the UK, with FDA clearance and additional EU markets to follow soon thereafter. • Quanta secured £45m of VC funding. • Throughout 2015 Quanta appointed a number of highly experienced individuals to its Company Board and Medical Advisory Board. • Quanta has also been awarded further i4i funding: over £1.85m to develop a new solution for nocturnal dialysis (2015). Compact dialysis machine
- 24. Unique technology to enhance sight, detects and displays nearby objects. • University of Oxford, £548k over 3 years • Collaborators: Oxford University Hospitals NHS Trust, Royal National Institute of Blind People • Huge impact on quality of life and independence • Won Google Impact Challenge (£500k) "As the i4i grant enabled the development of the prototype, it also put the team into a position to generate further funding for the final steps towards commercialisation." Source: RAND Low-cost visual aid
- 25. • The University of Oxford have recently created a new spin-out, OxSight Ltd, to exploit IP created during the project and a previous i4i project on blindness. • OxSight has subsequently raised £2m in seed funding to further develop the technology and build commercial prototypes. • RNIB continue to collaborate and will help promote the technology for UK adoption. • First product launch in the UK market expected in 2017. Low-cost visual aid
- 26. Efficacy and Mechanism Evaluation (EME) & Health Technology Assessment (HTA) Mr Robert Gray, Research Fellow NIHR Efficacy and Mechanism Evaluation (EME) Programme
- 27. What is the EME Programme? • Supports translational research into a wide range of new or repurposed interventions. • Supports clinical studies in man which test the efficacy of interventions. – Exploring new scientific or clinical principles • Encourages hypothesis-driven mechanistic studies, integrated within the efficacy study. • Welcomes collaborations between academia, clinical groups, industry and charities. Efficacy and Mechanism Evaluation (EME) Programme EME supports: “Does it work?” “How does it work?”
- 28. Health Technology Assessment (HTA) Programme • Evaluates clinical effectiveness, costs and broader impact of healthcare treatments • This includes all interventions used to promote health, prevent or treat disease, improve rehabilitation or long-term care • Supports key evidence users, which include decision/policy-makers, eg. – Clinical commissioning groups – Service managers What is the HTA Programme? HTA supports: “Is it worth it?”
- 29. The FOCUS4 Trials Programme • University of Oxford, £3.5million over 7 years • Joint-funded with Cancer research UK • Adaptive platform design • Multi-arm, multi-stage (Phase 2-3) • Molecular stratification • Efficacy study of several drugs against placebo or monitoring Targeted cancer therapies Novel and repurposed drugs for the treatment of inoperable and metastatic colon cancer.
- 30. What next? • The trial design has been published in the Journal of Clinical Oncology – It is being adopted by other large trials, eg. The pharma-sponsored MODUL trial. • Potential for new arms to test promising new drugs • Evidence will support treatment of bowel cancer Targeted cancer therapies FOCUS4 is supported by collaborations with pharmaceutical companies: • Providing study drug • Matched placebo
- 31. Respiratory dialysis for extracorporeal CO2 removal. An alternative or supplement to mechanical ventilation. • The Queen’s University of Belfast, £2.1M over 5.5 years • Phase 3, pragmatic clinical and cost- effectiveness trial • 1120 patients across at least 40 UK ICUs The REST Trial Sparing mechanical ventilation
- 32. • Providing Hemolung RAS equipment – Allowing 25% extra • Service, installation and technical support of devices • On-site clinical training REST is supported by a collaboration agreement with ALung… Sparing mechanical ventilation Project impact • The Hemolung RAS is currently approved in 34 countries • Study results will be published in full in the NIHR HTA journal • Evidence is likely to inform treatment guidelines
Hinweis der Redaktion
- Data range: Financial year 2015/16 (1 April 2015 to 31 March 2016) £149.7m of funding refers to money paid to NIHR facilities by industry Partnership: streams of work under the umbrella of one agreement, including many projects Collaborations: Individual projects
- At the end of Feb 2016 JDR had 16,047 volunteers, enrolled 4698 people into studies, and has 70 studies open at one or more sites.
- Saint John’s Health Center is in Los Angeles, California.
- Motivation - NICE Quality Standard (QS41 August 2013) Familial Hypercholesterolaemia FH services in the NE were not equipped to deliver this standard of care. E.g. there was no centralised disease register for adult FH patients, no specialised nurses, no regional infasturcture but more importantly, there was no access to DNA mutation testing for new FH patients. FH project in the North East of England - AHSN funding. Broad aims for the project - To set up regional service for diagnosis and family cascade testing for FH, to deliver NICE Quality standards to the NE of England Refine current criteria for identifying people at higher risk for monogenic FH Develop a testing strategy with high sensitivity (pick up causative gene for patients with FH) and high specificity (patients who do not have FH will not receive a positive result). Timely delivery of results In a cost-effective manner Images – Two high through-put, modern technologies available at NewGene SEQUENOM™ MALDI-TOF Stage 1 targeted mutation testing Illumina MISEQ next generation sequencer Stage 2 Complete gene sequencing The rationale behind the two step approach was to use a rapid, low cost targeted genotyping assay (incorporating 52 mutations) as the first stage test to identify patients with common FH mutations, and to reserve the more expensive CGA, using next generation sequencing, as a second stage test for those with a strong clinical phenotype a high likelihood for having monogenic FH but none of the common mutations. Diagnostic Evidence Co-operative (DEC) Newcastle’s role in the project: Evaluate the accuracy and cost-efficiency of the two step process Identify opportunities for increasing the prior probability before genetic testing (refining current selection criteria for testing). Too many collaborators to put on slide! MDT – Multidisiplinary team North East Cardiovascular Network LSAG (10 clinics) • Northern CCG Forum (13 CCGs) • Northern Regional Genetics Service (genotyping) • NewGene Ltd (genotyping) • Academic Health Sciences Network (AHSN) (genetics) • Newcastle NIHR Diagnostic Evidence Co-operative (DEC) • AstraZeneca Ltd (PASS software licences) • City Hospitals Sunderland (CHS FT, nurses host Trust) British Heart Foundation Support for FHG Nurses secured!
- The NIHR DEC Newcastle identified which refinements could be made to the current phenotypic thresholds for testing. This has resulted in modifications to the current diagnostic testing request form. The study team have gained funding to embark on the second stage of the project which involves the redesign and refinement of the diagnostic panel. The second version of the panel will contain 50 mutations, most commonly found in UK patients with monogenic FH together and combine these with an LDL-C genetic risk score based on 12 single nucleotide polymorphisms (SNPs). This SNP score has been shown to discriminate between polygenic and monogenic forms of FH. Following the refinement of the chip to include the most commonly occurring mutations in the whole of the UK, we will be in a position to embark on roll out of the service to the rest of the UK.
- The Collaborators: CLAHRC Yorkshire & Humber researchers Andrew Clegg and John Young, from the Academic Unit of Elderly Care & Rehabilitation, University of Leeds, collaborated with Chris Bates and John Parry at TPP. Plus an external validation led by Tom Marshall and Ronan Ryan from West Midlands CLAHRC, using THIN database, demonstrating evidence of cross-CLAHRC linkage. The eFI: - developed using the cumulative deficit model of frailty. - validated using data from around 500,000 patients in ResearchOne. - frailty defined on the basis of the accumulation of a range of deficits: clinical signs (e.g. tremor); symptoms (e.g. breathlessness); diseases (e.g. hypertension); and disabilities. consists of 36 deficits which have been constructed using around 2,000 primary care clinical codes (Read codes). calculates a frailty score by dividing the number of deficits present by the total possible. E.g. if a patient has 9 out of 36 deficits, the eFI score is 0.25. This score is a robust predictor of people at greater risk of adverse outcomes (e.g. care home admission, hospitalisation and mortality). has been implemented into the SystmOne and EMISWeb electronic health records, so is available for use by around 90% of UK GPs.
- ResearchOne: - eFI was developed & validated using ResearchOne - a database available to researchers & containing anonymised data from approx. 6 million SystmOne pt records is a health and care research database developed by TPP in partnership with the University of Leeds and the UK Government’s Technology Strategy Board. The database consists of de-identified clinical and administrative data drawn from the electronic patient records currently held on the TPP SystmOne clinical system. The research records contain linked data from a wide variety of settings across both primary and secondary care key message: is that academic/NHS/industry partnership has enabled remarkably rapid progress in translating research findings into clinical practice. In around 2 ½ years we have: developed, internally and externally validated the eFI implemented the eFI across the UK, enabling free availability to GPs caring for around 90% of the UK population enabled the development of evidence-based, new models of frailty care, including complex whole-systems change at population/CCG level Research: eFI enables identification of older people with frailty for research into health, disability and quality of life trajectories in older age to inform better targeting of interventions to improve outcomes. eFI increases research capacity in primary care, and in specialty areas where older people are core users, including cardiovascular medicine, oncology, surgery, anaesthetics/ICU, renal medicine, etc. Also enables modelling of resource use at population level to inform strategic priorities/service needs. NHS: A major advance to embed eFI in SystmOne and EMISWeb which enables free availability to GPs caring for 90% of the UK population. eFI is being used to inform new models of care for older people e.g. the improvement academy (http://www.improvementacademy.org/improving-quality/healthy-ageing.html where CLAHRC YH are working with a large number of CCGs across the country. 1 example is the NHS West London CCG model (case study 8 on website), which highlights the national spread, uptake and engagement. NHS West London CCG are developing personalised, well-coordinated and seamless pathways of care across health, social care and the voluntary sector with the aim of delivering holistic care to support older people’s wellbeing, while shifting activity to community and primary care settings. Care will be delivered in hubs, in GP practices and in patients’ homes. The GP practices will use the eFI to risk stratify patients according to severity grade of frailty.
- Essential requirements: R&D must be in scope A minimum of two organisations must be involved Lead applicant must be based in England Projects must have progressed beyond basic research and must have demonstrated proof-of-concept
- Project title: Patient-centric haeodialysis machine to facilitate home treatment Lead applicant: Prof Clive Buckberry Lead organisation: Quanta Fluid Solutions Ltd Funding amount: £547,560 Contact: enquiries@quantafs.com Background Haemodialysis is required when the kidneys are unable to perform their function of removing toxins from the body. The cost of chronic kidney disease was £1.45 billion per year in 2009 (~1.3% of all NHS spending). For 98% of patients, haemodialysis is performed in hospitals, which is time-consuming and disruptive to patients‘ lives. Studies have shown that 30-40% of patients would be capable of performing self-dialysis. Advantages of home-based haemodialysis are reduced time burden as no need to travel to and from dialysis centres, dialysis regimes that suit patients‘ lifestyle, improved survival upon home-based haemodialysis as shown by increasing evidence. Hospital-based haemodialysis costs £35,023 per patient per year, while home-based haemodialysis costs £20,764 per patient per year. The potential saving per patient is therefore £14,259 per patient per year. Current state of the art home dialysis machines are generally large and cumbersome, require specialist products to be delivered to patients and are complex to use. Project Quanta Fluid Solutions is an SME based in the West Midlands developing solutions for haemodialysis patients. They collaborated with St James‘ Hospital Leeds, Newcastle University and the National Kidney Foundation for this project. Quanta developed a CE-marked device which offers a drastically simplified solution, due to dramatically reduced size and ease of operation of the cassette-based system which does not rely on delivery of reagents.
- For these two programmes, industry can be the lead applicant, co-applicant or may support a project with a collaboration agreement.
- Joint-funded by the MRC and Department of Health These can be diagnostic or prognostic tests, decision making tools, therapeutics, psychological treatments, medical devices or public health initiatives delivered in the NHS Efficacy of interventions: may accept a well-validated surrogate as an outcome. Mechanisms : might explore the mechanisms of action of the intervention or the disease, the cause of differing responses or improve understanding of adverse affects. Science driven questions, with an expectation of substantial health gain.
- Remit includes drugs, devices, procedures, settings of care and screening The programme supports both primary research, as well as evidence synthesis. Eg. Technology appraisal reports. Key evidence users, from the perspective of translation of these technologies, includes decision-makers What makes an HTA question is where a technology is available and the question ”is it worth it”
- These are drugs where there is currently insufficient evidence to conclude a benefit. As such there is equipoise for a phase 2 study against placebo/control. Rapidly changing area, this trial brings flexibility and adaptability Can be thought of as a programme of individual RCTs Arms of the study which are found not to be effective can be dropped New arms can be added The EME programme and CRUK have set up a scientific sub-board to oversee this
- Collaborations Bayer and AZ are providing support to two existing arms of the study. Other companies are in discussions. Impact The innovative study design has had an impact on other research. in a rapidly moving area, this project provides the platform to expedite testing of new marker-drug combinations phase 2 studies may lead seamlessly into a phase 3 for successful arms, to inform treatment guidelines and adoption EME studies which complete at phase 2 might typically be expected to seek further funding from the HTA programme for this stage, if necessary
- An active HTA trial Allows the de-escalation of invasive, mechanical ventilation, which is known to be protective in respiratory failure, but associated with lung damage. The technique of extracorporeal CO2 removal dates back to the late 1970s and is known to be efficacious in removing CO2. However, various studies had failed to conclusively demonstrate a reduction in mortality. With the production of safer and more efficient apparatus, the question around cost-effectiveness and the size of clinical effect remained. NICE guidelines therefore called for more clinical trials for these devices. This is the largest trial of the technology to-date
- ALung are providing support with a value of several million pounds. The device is approved in 34 countries It is currently on the FDA Expedited Access Pathway in the US The results of this landmark, high-quality research are likely to inform clinical guidelines. Will be published in full, Results may support or oppose costly widespread adoption of the treatment.