1. The NIHR NIHR@Leeds; drivers of change Professor Stephen Smye
Acknowledgements;
Professor Dame Sally Davies FRS, Chief Medical Officer
Professor Chris Whitty, Chief Scientific Adviser, DH
Dr Louise Wood, Director of Science, Evidence and Research
Dr Jonathan Sheffield, CEO, NIHR CRN
Professor Peter Bower, NIHR CRN National Specialty Lead for HSR
Exciting environment
Expanding research environment
Primary, seconday, end of life care as well as community setting

2. Building on 10 remarkable years
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.

3. NIHR@Leeds; drivers of change
Science
Distribution of research
Training
System & Process
ODA
Life Sciences Industry
Exciting environment
Expanding research environment
Primary, seconday, end of life care as well as community setting

4. Emerging science & health
(Gen)omics
Stratified medicine
Regenerative medicine
Government’s 8 Great Technologies – 2 have direct links to DH priorities (genomics & regenerative medicine).
All these (and more) are relevant aspects of converging science & technology for health – no single technology but potentially important improvements to current approaches to prevention, diagnosis and treatment.
DH Strategy Unit leading some work considering :- sensors & wearables; 3D printing; Robotics; Implantable / ingestible technology; synthetic biology, nanotechnology; blockchain & distributed ledgers.
(Gen)omics – all genes, proteins and other biomarkers in a patient or even their microbial flora. Dependent on advances in gene sequencing, big data and computing to understand “systems biology”. Applications include:
Large population genomics initiatives like 100,000 Genomes Project to embed genomic medicine in routine healthcare
Liquid biopsy / single cell sequencing (cancer, prenatal diagnosis)
Lab-on-a-chip, rapid near patient testing for AMR, diagnostics & drug prescribing
Microbiomics - links between (gut) microflora and chronic health conditions including obesity
Regenerative medicine – new advances in stem cells, gene therapy and gene editing to repair & replace tissues, applications include:
Treating rare / degenerative disease, improved joint & limb repairs, artificial tissues & organs (3D printing)
Immunotherapy for cancer – CAR-T cells are showing huge promise
Gene editing – huge breakthroughs for basic science, adult gene therapies BUT debate over embryo research and germline therapies
Stratified/Precision Medicine – A move away from ‘one size fits all’ medicine to diagnostic tests, genomic technologies and data analytics to target therapies to achieve the best outcomes in the management of a patient’s disease or predisposition to disease
Improved understanding of diseases mechanisms
More precise diagnosis involving panels or tests
Therapies based on rules – likely response
Pharmacogenetics - right dose, right drug, first time
Deliver more targeted, predictable and effective outcomes

5. National Institute for Health Research: research infrastructure
Invention
Evaluation
Adoption
Early-phase clinical Research
Late-phase clinical Research
NIHR Biomedical Research Centres
EM infrastructure in matched to excellent infrastructure
Simplify
NIHR Clinical Research Facilities
Experimental Cancer Medicine Centres
Med Tech and IVD Cooperatives
Bench to bedside and back.
Supporting life sciences industry, whether CRO, pharma, med tech- small or large.
The whole infrastructure is there to support the product lifecycle.
NIHR Clinical Research Network
Collaboration for Leadership in Applied Health Research and Care

6. Trials Adaptive N-of-1 Real world
“..an adaptive design clinical study is defined as a study that includes a prospectively planned opportunity for modification of one or more specified aspects of the study design and hypotheses based on analysis of data (usually interim data) from subjects in the study”
N-of-1
“ a key component will be transforming everyday clinical care into solid N-of-1 trials”
Schork NJ 2015 Nature 520,
Real world
Exciting environment
Expanding research environment
Primary, seconday, end of life care as well as community setting

7. Applied Health Research - New Models of Care
Multispecialty Community Providers
- moving specialist care out of hospitals into the community
Integrated primary and acute care systems
 - joining up GP, hospital, community and mental health services
Acute care collaboration
- local hospitals working together to enhance clinical and financial viability
Enhanced health in care homes
 - offering older people better, joined up health, care and rehabilitation services
Urgent and emergency care
 - new approaches to improve the coordination of services & reduce pressure on A&E departments.
Charles Tallack, NHS(E)

8. Public health Exciting environment Expanding research environment
Primary, seconday, end of life care as well as community setting

9. Must take account of distribution of need
Must take account of distribution of need. Dementia in women (L), heart disease (R)

10. Population 85 and over: 1992, 2015, 2033 (ONS).

13. The NIHR: Public
“Around three-quarters of the public say they would be willing to share their anonymised medical records, or their anonymised genetic information, for the purposes of a medical research study. The primary concern among those who are unwilling relates, perhaps
unsurprisingly, to confidentiality and privacy…..”
Exciting environment
Expanding research environment
Primary, seconday, end of life care as well as community setting

14. Methodological expertise Precision Medicine Research Infrastructure
The Leeds Centre for
Personalised Medicine and Health
Dissemination& Adoption
Clinical Efficacy & Utility
Safety & Clinical Validity
Preclinical & Measurement Validity
“The Push”
New Technology
Drugs
Devices
Diagnostics
“The Pull”
Clinical Need
NHS
Academia
Industry
Stakeholders
Early Modelling (Commercial and NHS opportunity)
Patient Benefit
Economic Value
Methodological expertise
Health Economics, Health Informatics, Medical Statistics, Metrology, Systems Biology, Quality Management, Artificial Intelligence
Precision Medicine Research Infrastructure
Patient Cohorts, Biobanks, “Big Data”, Analytical Platforms (e.g. Omics), High Performance Computing
Cost-Effectiveness & Market Approval
Data Science