Delivering Clinical Trials

in the UK NHS

National Institute for Health Research

Mr Ravi Chana

NOCRI

The UK National Health Service (NHS)

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The NHS

3

Launched 1948

Free at the point of use for UK

residents (currently more than 63.2

million people)

largest publicly funded health

service in the world

covers everything from antenatal

screening and routine treatments

for long-term conditions, to

transplants, emergency treatment

and end-of-life care

The NHS deals with over 1 million

patients every 36 hours

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UK Landscape

Political commitment to supporting life-sciences industry

Health & Social Care Act 2012 / NHS Constitution 2013

Embed clinical research in all aspects of care

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The National Institute for Health Research (NIHR)

Funded by the Department of Health to improve

the health and wealth of the nation through

research.

Key role in the Governments strategy for

economic growth

Attracting investment by the life-sciences

industries through its world-class infrastructure

for health research

Most integrated health research system in the

world

Research arm of the NHS.

The NIHR

The NIHR Infrastructure

NOCRI

NIHR INFRASTRUCTURE TO SUPPORT RESEARCH

NOCRI SUPPORTING COLLABORATION

Overview What to expect

MODELS FOR EFFECTIVE PARTNERSHIP

SUMMARY

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Structure of the NIHR System

Universities

NHS Trusts

Patients & Public

Senior Investigators

Investigators Associates Trainees

Faculty

Systems

Research Information Faster Easier Clinical Research

Res

earc

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Pro

gram

mes

R

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Sch

oo

ls

Clin

ical

Res

earc

h

Net

wo

rk

Infr

astr

uct

ure

Clin

ical

Res

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h

Faci

litie

s, C

entr

es

and

Un

its

The NIHR manages its health research

activities through four main work strands:

Infrastructure: providing the facilities

and the people to conduct first-class

research

Research: commissioning and

funding research to generate innovative

new healthcare solutions.

Faculty: supporting the individuals

carrying out and participating in research.

Systems: promoting faster, easier

clinical research through unified,

streamlined and simple systems for

managing ethical research and its outputs.

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NIHR Research Infrastructure

Invention Evaluation

> 0.5 billion p.a. investment in

relevant infrastructure to

support clinical research at all

points in development pipeline

Innovation

Late-phase clinical

research

NIHR Biomedical Research Centres

Early-phase clinical research

Evaluation Adoption

NIHR Biomedical Research Units

NIHR Clinical Research Facilities

Experimental Cancer Medicine Centres

NIHR Clinical Research Network

Healthcare Technology Cooperatives

Diagnostic Evidence Cooperatives

NIHR Collaborations for Leadership in

Applied Health Research & Care

NIHR Biomedical Research Centres Newcastle Oxford Cambridge Southampton Imperial UCLH Great Ormond St Moorfields Guys and St Thomas Royal Marsden South London and Maudsley

NIHR Healthcare Technology Co-operatives Birmingham Bradford Leeds Nottingham Sheffield Barts Cambridge Guys & St Thomas

NIHR Biomedical Research Units Newcastle dementia Leeds musculoskeletal Central Manchester musculoskeletal Liverpool gastrointestinal Nottingham hearing/respiratory/gastrointestinal Leicester cardiovascular/respiratory/nutrition Birmingham gastrointestinal Bristol cardiovascular/nutrition Oxford musculoskeletal Southampton respiratory London Imperial cardiovascular/respiratory Barts cardiovascular UCL dementia South London and Maudsley - dementia

NIHR-supported Clinical Research Facilities Alder Hay Childrens Brighton and Sussex Cambridge Central Manchester The Christie South Manchester Newcastle Leeds Oxford Royal Devon and Exeter Sheffield Birmingham Southampton Royal Marsden Guys and St Thomas Imperial Moorfields South London and Maudsley UCL

NIHR-Supported Facilities

NIHR Diagnostic Evidence Co-operatives Imperial Leeds Newcastle Oxford

NIHR Experimental Cancer Medicine Centres Birmingham Cambridge Cardiff Leeds Leicester Barts/ Brighton ICR Imperial Kings College London UCL Manchester Newcastle Oxford Sheffield Southampton

NIHR Collaborations for Leadership in Applied Health Research and Care

East of England

East Midlands

Greater Manchester

North Thames

North West Coast

North West London

Oxford

South London

South West Peninsula

West

West Midlands

Wessex

Yorkshire and Humber

Newcastle

Leeds

Sheffield

Leicester

Oxford

Bristol

Brighton

Peninsula

London

Bradford

Manchester

Liverpool

Exeter

Southampton

Cambridge

Nottingham

Birmingham

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NIHR Biomedical Research Centres (BRCs)

Imperial

Southampton

Oxford

Guys and St Thomas

Marsden*

Cambridge

Maudsley*

Newcastle upon Tyne

University College

Moorfields*

Great Ormond St*

> 800million Government

investment to support

NIHR Centres and Units -

the largest ever

commitment to early stage

health research

http://www.google.co.uk/url?sa=i&rct=j&q=nhs+uk+map&source=images&cd=&cad=rja&docid=8DUWWYQEtlPVOM&tbnid=MEY5kKq19tpUuM:&ved=0CAUQjRw&url=http://www.surgeryrecruitment.nhs.uk/&ei=cYzBUfWRK4WqOtOxgegE&bvm=bv.47883778,d.ZG4&psig=AFQjCNH6a144VknCEqrx3kpTLa1g1wLtWw&ust=1371725224297846

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NIHR Biomedical Research Units (BRUs)

Nottingham

Hearing

Gastrointestinal

Southampton

Respiratory

Oxford

Musculoskeletal

Barts & London

Cardiovascular

Bristol

Cardiovascular

Nutrition, Diet, Lifestyle

Cambridge

Dementia

Maudsley

Dementia

Newcastle upon Tyne -

Dementia

Leicester

Cardiovascular

Respiratory

Nutrition, Diet, Lifestyle

Imperial

Cardiovascular

Respiratory

University College

Dementia

Liverpool

Gastrointestinal

Manchester

Musculoskeletal

Leeds

Musculoskeletal

Birmingham

Gastrointestinal

http://www.google.co.uk/url?sa=i&rct=j&q=nhs+uk+map&source=images&cd=&cad=rja&docid=8DUWWYQEtlPVOM&tbnid=MEY5kKq19tpUuM:&ved=0CAUQjRw&url=http://www.surgeryrecruitment.nhs.uk/&ei=cYzBUfWRK4WqOtOxgegE&bvm=bv.47883778,d.ZG4&psig=AFQjCNH6a144VknCEqrx3kpTLa1g1wLtWw&ust=1371725224297846

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NIHR Experimental Cancer Medicine Centres

Translational Research network

launched in 2007

Discovery of new biomarkers and cancer

treatments

Jointly funded by CR-UK and UK Health

departments (NIHR in England)

Key areas

Target mechanisms and pathway expertise

Preclinical models, biomarkers and

pharmacodynamic endpoints

Early phase trials

Stratified medicine and screened patients

Combination therapies

Regulatory requirements

The NIHR Translational Research Partnerships (TRPs)

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NIHR Translational Research Partnerships

(TRPs)

2010/11 UK Life Sciences Strategy and Plan for Growth

Industry ask for improved access to experimental medicine and translational research in the UK

TRPs established in October 2011

Ready-to-go collaborative networks for experimental medicine and first-in-disease studies with industry

Inflammatory Respiratory Diseases

Joint & Related Inflammatory Diseases

Formal Collaboration Agreement signed by TRP centres

Common business principles and practices

Governance structure

NDA and mICRA templates agreed and readily available

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NIHR Joint & Related Inflammatory Disease

TRP

Centres and Academic Leads

Prof John Isaacs Newcastle

Dr Natasha Jordan Cambridge

Prof Ian Bruce Manchester

Prof Peter Taylor Oxford

Prof Matthew Pickering

London (Imperial)

Prof Andy Cope London

(KCL)

Prof Cos Pitzalis London (QMUL)

Prof David Isenberg London (UCL)

Prof Chris Buckley Birmingham

World-class expertise and

capabilities in experimental

medicine

Outstanding science

Patient cohorts

Study delivery

Exclusive focus on industry

collaborations

NOCRI provides single point of

contact and operational support

Internationally unique

Disease scope:

Rheumatoid Arthritis, Sjogrens Syndrome, Lupus, Psoriatic Arthritis, Ankylosing Spondylitis, Vasculitis

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NIHR Inflammatory Respiratory Disease TRP

Centres and Academic Leads

Prof. Ratko Djukanovic

Southampton

Prof. Peter Barnes London

(Imperial/Brompton)

Dr Lorcan McGarvey Belfast

Dr Ling-Pei Ho Oxford

Dr Tim Harrison Nottingham

Dr Joanna Porter London (UCL)

Dr Bibekbrata Gooptu London

(KCL)

Prof. Chris Brightling Leicester

Dr David Singh Manchester

World-class expertise and

capabilities in experimental

medicine

Outstanding science

Patient cohorts

Study delivery

Exclusive focus on industry

collaborations

NOCRI provides single point of

contact and operational support

Internationally unique

Disease scope:

Asthma, COPD, Chronic Cough, Interstitial Lung Disease, Cystic Fibrosis and other rare lung diseases

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TRP Strategic Priorities

1. Partnership with industry:

Collaboration and scientific exchange essential

Will consider commercial contracts where TRP provides scientific

leadership

2. Experimental medicine:

In depth phenotyping studies

Early phase interventional studies of new therapeutics: proof of

mechanism, proof of concept

Stratification studies

3. Academic value:

Data rich outputs breaking new ground in the assessment of disease

and treatments

4. Delivery

Quality; recruitment to time and target

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NOCRI

Belfast

Oxford

Imperial

Birmingham

Southampton

Nottingham

Leicester

Kings College

Manchester

Newcastle

Barts & London

Cambridge

University College

London

36 NHS Trusts and

University partners Single point of

contact for industry

Operational Management

Speed

Quality

Operational Advantages of the TRPs

http://upload.wikimedia.org/wikipedia/en/e/e4/CPRE_England_tranquillity_map.jpghttp://upload.wikimedia.org/wikipedia/en/e/e4/CPRE_England_tranquillity_map.jpghttp://upload.wikimedia.org/wikipedia/en/e/e4/CPRE_England_tranquillity_map.jpghttp://upload.wikimedia.org/wikipedia/en/e/e4/CPRE_England_tranquillity_map.jpg

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Flexible Collaboration

Industry Led

Collaboration

Contract

Commercial

Research

Academic

Research

Academic Led

Collaboration

Industry Collaborative Research

Each party contributes materially and intellectually and shares liabilities, IP ownership and rewards according to the relevance of their contribution

Model templates for research collaborations (mICRA) and contract research (mCTA)

Current TRP Project Portfolio

Pro

ject S

tart D

ate

2013/14

2H15

2016

Completed

Studies

Study setup

& contract Exploratory discussions (study design)

Active

Studies

Academia-sponsored

Industry-sponsored

>12M industry investment realised

1H15

RA

MoA

Early RA

ExpMed

Sjogrens

PhIb

Lupus

Pre-clin

Sjogrens

Pre-clin

Lupus

StratMed Sjogrens

PhIb

Sjogrens

Pre-clin

Tralokinumab in severe asthma

(MESOS - AstraZeneca)

Stratification study:

Biological drug for severe asthma (Novartis)

COPD/CF

Diagnostic

COPD

PhII

Asthma

MoA/PhI

I

Asthma

StratMed Asthma

PhIIa

Asthma

/COPD

PhIIa

Asthma

MoA

Asthma

Pre-clin

Asthma

Pre-clin

IPF

DDI

Ph2a PoC study

(Novartis)

Prevention study:

Abatacept in pre-RA

(APIPPRA - BMS)

Biomarkers for inadequate

response to anti-TNF

(THERAPIST - Janssen)

Respiratory TRP

Joint Inflamm TRP

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Current TRP projects and partnerships

with Novartis

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THERAPIST (J-TRP)

8 TRP sites, single collaboration agreement, 18 months recruitment period

Recruited 42/50 patients by June 2016

2014 Oct Nov Dec Jan 2015 Feb Mar 2015

Lead site "green lighted"

2/3/2015

Final Sponsorship Approval (QMUL) 9/2/2015

REC Approval

5/2/2015

REC Submission 7/11/2014

Collaboration Agreement executed 28/10/2014

13/2/2015

NHS Permission Barts Health (lead site)

TRP study delivery

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TRP summary

TRPs uniquely placed to tackle challenges of early phase

clinical development in collaboration with industry

Understanding of disease mechanisms and biomarkers combined with cutting

edge capabilities ensures optimal study design

Well characterised patient cohorts for optimally designed PoC studies

Operational support from NOCRI, including contractual agreements and

templates endorsed by BIA, ABPI and all TRP centres

Strong industry traction and project portfolio established

First industry collaborative multi-site study underpinned by a single contractual

process and agreement

Strong portfolios in Asthma, Rheumatoid Arthritis and Sjogrens Syndrome

Additional opportunities for TRPs in COPD, IPF and Lupus

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Translational Research Collaborations (TRCs)

NIHR Translational Research Collaboration in Dementia

Formed by NIHR Dementia BRUs and six NIHR BRCs with dementia related

research themes

Deep & Frequent Phenotyping study

Biomarker study in Parkinsons Disease

NIHR Translational Research Collaboration in Rare Diseases

Brings together translational research expertise and facilities in rare diseases

14 therapeutic areas, with a focus on deep phenotyping of rare disease patient

cohorts (currently >40 different rare diseases)

Successful 2015 call for industry collaborative projects:

30 expressions of interest, 14 full applications, 9 funded

Leveraged industry funding of ~1.3M

Projects include a Ph2a trial of Actemra (anti-IL6R) in PAH

NIHR Cancer and Nutrition Collaboration

Scoping areas for industry engagement

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To work with the NIHR

infrastructure contact the

team at:

nocri@nihr.ac.uk

How to engage

mailto:nocri@nihr.ac.uk