NIHR partnering with industry

Anthea Mould Business Development Manager (commercial)NIHR Clinical Research Network

• 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

Supporting innovation: Study design and delivery

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

A whole research system

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

NIHR facilitiesIn 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

Infrastructure partnerships and collaborations 2015/16

• 1378 collaborations with SMEs

• 576 partnerships with industry

• Resulting in £149.7m funding through industry collaborations and contracts

• 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

Number of new commercial studies added to the NIHR CRN Portfolio

Increased volume

A 125% increase over the last six years

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.

Our clinical research infrastructure Partnering with industry

Dr Ian Newington, Senior Programme ManagerNIHR Invention for Innovation (i4i) Programme

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).

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

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

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.

• 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

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

Invention for Innovation (i4i) ProgrammeFunding novel technologies, devices or interventions

Mr Martin Hunt, Programme Director NIHR Invention for Innovation (i4i) Programme

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 devicesActive implantable devicesIn vitro diagnostics.We de-risk projects for follow-on investmentFrom 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. 

Tackling MedTech ‘Valley of Death’

Innovation Project teamIP & 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 planValue for money

Patient and public involvement

The Graveyard of Good Ideas

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 systemReduced time burden, improved survivalEstimated NHS cost savings at £15k per patient per year

Compact dialysis machine

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

Unique technology to enhance sight, detects and displays nearby objects.

University of Oxford, £548k over 3 yearsCollaborators: Oxford University Hospitals NHS Trust, Royal National Institute of Blind PeopleHuge impact on quality of life and independenceWon 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

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

Efficacy and Mechanism Evaluation (EME) &

Health Technology Assessment (HTA)

Mr Robert Gray, Research FellowNIHR Efficacy and Mechanism Evaluation (EME) Programme

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?”

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?”

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.

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 therapiesFOCUS4 is supported by collaborations with pharmaceutical companies:• Providing study drug• Matched placebo

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

• 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