New opportunities in translational research

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• New opportunities in translational research

Professor Stephen Holgate Chairman MRC
Physiological Systems and Clinical Sciences
Board University of Southampton

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Principles and Practise of Medicine 1892
Medicine became a science by combining clinical
observation with pathology and function and
through the application of chemical, biological
and physical sciences
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Medical Research Council

• Established in 1913 as the Medical Research
  Committee by Christopher Addison (Prof of Surgery
  in Sheffield) to tackle TB and illness related to
  poor housing and other socioeconomic
  inequalities.
• Supporting medical research across the full
  spectrum of biological sciences.
• 25 Nobel prizes and major medical advances
  penicillin, DNA, MRI imaging, link between
  smoking and cancer, benefits of cholesterol
  lowering drugs.
• Largest non-commercial funder of clinical trails
  in UK. Major contributions to clinical practice
  and public health.

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The MRC mission

• Discovery Science for Health
• Encourage and support high quality research with
  the aim of maintaining and improving human
  health.
• Produce skilled researchers.
• Advance and disseminate knowledge and technology
  to improve the quality of life and economic
  competitiveness in the UK.
• Promote dialogue with the public about medical
  research.

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MRC funding for research

• 500m
• 50 of funding is directly to MRC research
  establishments - 3 Institutes, 29 Units
• 50 of funding is in response mode
• - 9 Centres, research grants, training awards
  and fellowships
• 50m pa on training and career development
• People
• Employs over 3300 staff in UK and overseas
• Supports 3000 staff on research grants
• 350 research fellows and 1400 students

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Scientific Decision Making - Research Boards and
Panels
COUNCIL
MCMB
HSPHRB
PSCSB
IIB
NMHB
CompetitionPanels
College of Experts (CoE)
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MRC gross spend by scientific area in 2004/05

• Health Services and Public Health Research
• 61.9m (13)
• Molecular and Cellular Medicine
• 180.8m (39)
• Neurosciences and Mental Health
• 82.1m (17)
• Infections and Immunity
• 77.3m (16)
• Physiological Systems and Clinical Sciences
• 72.6m (15)

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Board engagement remains vital

• Boards are pivotal in helping shaping the MRCs
  Strategy and Delivery Plan
• Examples where PSCSB has led strategic priority
  setting
• Integrative mammalian biology (12m total MRC
  2m, 2005)
• Mouse models of disease (mutagenesis 4m, 2006)
• Experimental Medicine (I and II - 30m, 2006/08)
• Biomarkers qualification (17m total MRC 8m,
  2007)

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Board engagement remains vital

• Interim Strategy Portfolio Group and Council
  Delivery Plan and Board budget discussions.
  Boards have delegated authority to award grant
  funds.
• Current PSCSB priorities
• Musculoskeletal, respiratory, obesity, drug
  safety,
• Integrative Physiology, ageing
• Future opportunities
• Environment and health, nutrition strategic
  review
• Lifelong health and wellbeing

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Research is changing

• Evidence-based medicine need for trials.
• Need to harness molecular revolution.
• Move from taking things apart to understanding
  complexity.
• Funding arrangements Research Assessment have
  separated NHS and academic research.
• Training in research methods now more
  professional.
• Involvement of patients.
• Research ethics and governance complex.

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Biomedical Research
Post-genome
Health of the Public
continuum
Challenges ahead
Individual

• Forging Partnerships
• Training and retaining
• researchers
• Research infrastructure
• Development gap funding
• Engaging the public
• Meeting expectations

Understanding
Animal
Families
health disease


prevention
Organ


diagnosis
Population


treatment
Cell

Genome
Environment
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DH Research and Development

• R D Directorate established in 1990 following a
  HOLSC enquiry into medical research.
• Led by Sir Michael Peckham, a series of Regional
  R D Centres were established. Held local
  budgets.
• National Centres established Reviews
  Dissemination, Health Technology Assessment,
  Primary Care, Information Technology, Cochrane
  Centre.
• Funded largely by top-slicing Regional finance
  and some central resource.
• Intrinsic budget supported cost of research in
  teaching hospitals
• (previously SIFTR) and under Sir Anthony
  Culyers review, hospital trusts had to justify
  amount based on research activity

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National enquiries into R D base

• Major concerns about the state of clinical
  research in the UK
• Pharmaceuticals Industries Competitiveness Task
  Force (PICTF) 2001
• Biosciences Innovations Growth Team (BIGT) 2003
• Academy of Medical Sciences (AMS) 2003
• Sir David Cooksey Report 2006
• Establishment of Research for Patients Benefit
  Working Party

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New organisation for health research

• From a base of 540DHm p.a., announcement March
  2004 (Dr Sally Davies) extra 100m p.a. by 2008
  for research (in England) building on successful
  model for cancer research.
• Targeted research funding
• Medicines for Children
• Diabetes
• Dementias and Neurodegenerative Disease (DeNDRoN)
• Stroke
• Cancer
• Mental Health
• Clinical Research Network model (UKCRN).
• UK Clinical Research Collaboration (UKCRC).
• NHS RD Strategy Best Research for Best Health
  Sally Davies, DH National Institute for
  Health Research

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National Institute for Health Research
(NIHR)
Universities
NHS Trusts
Networks
PatientsPublic
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What is the UK Clinical ResearchNetwork?

• UKCRN consist of a managed set of Clinical
  Research Networks to facilitate the conduct of
  randomised trials and other well designed
  studies.
• Research projects funded by both commercial and
  non-commercial organisations will be
  incorporated.
• 6 initial priority areas Cancer (NCRN), Mental
  Health (MHRN), Medicines for Children (MCRN),
  Diabetes (DRN), Stroke (SRN) and Dementias and
  Neurodegenerative Disease (DeNDRoN). Each has a
  small Coordinating Centre.
• UKCRN is being extended to cover full spectrum of
  disease and clinical need through Comprehensive
  Clinical Research Network.
• Links with developments in Scotland, Wales and
  Northern Ireland.
• Aim to provide a world-class health service
  infrastructure to support clinical research.

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UKCRN Coordinating Centres
Professors Janet Darbyshire Peter SelbyUKCRN
and PCRN
Professor Gary FordDirector, Stroke Research
Network
Professor David Cameron Director, National
Cancer Research Network
Professor Ros SmythDirector, Medicines for
Children Research Network
Professor Til WykesDirector, Mental Health
Research Network
Professor Martin RossorDirector, Dementias and
Neurodegenerative Diseases Research Network
Professor Des JohnstonDirector, Diabetes
Research Network ?
www.ukcrn.org.uk
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What is a Comprehensive Local ResearchNetwork
(CLRN)?

• Primary vehicle for providing infrastructure to
  support study delivery (set-up, recruitment,
  follow-up, data collection, publicity)
• Primary, secondary and tertiary care (and social
  care)
• All appoint Clinical Lead (p/t) and Network
  Manager (f/t)
• A typical LRN will include
• Appropriate NHS staff costs research nurses,
  data managers, secretarial support
• Appropriate infrastructure in the primary care
  setting practice nurse time, receptionist time,
  manager time
• Appropriate diagnostic test or clinical services
  costs pharmacy, pathology, radiology
• Essential running costs
• Must be embedded into clinical care provision

www.ukcrn.org.uk
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Local Elements of CLRNs

• Coverage across England
• Covers all areas of healthcare
• Within SHA boundaries - 25 CLRNs
• Natural catchments primary, secondary and
  tertiary
• One to four per SHA minimum essential
• Local capacity and expertise important
• Flexible per capita funding

UK Clinical Research Network (UKCRN)
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How do clinical research studies become UKCRN
studies?

• Studies funded by a UKCRC partner who awards
  funds in open national competition
• Exceptionally, studies not funded by a UKCRC
  partner are adopted
• Commercial trials and studies after adoption.

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A Review of UK Health Research FundingSir David
CookseyDecember 2006
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Research Spend versus Disease Burden
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Proportion of combined total UK spend by research
activity as of total spend(UKCRC Research
Analysis 2005)

• Detection Diagnosis

• Treatment Development

• Disease Management

• Treatment Evaluation

• Health Service

• Underpinning

• Prevention

• Aetiology

20 10 0 10 20
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UKCRC Research by Type
Health service
Treatment development
Aetiology
Translational Research
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Pathway for translation of health research into
healthcare improvement
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MRC NIHR The joint initiative
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MRC CSR 2007 allocation
2007-08 Baseline 2008-09 2009-10 2010-2011 Total End CSR07 Increase
543m 605m 658m 707m 1971m 30.1

• Average increase of other Research Councils 17
• Values include 80 FEC
• Funding includes specific allocation of
• 25m/44m/63m for OSHRC related strategy
• translational and public health research
• 30m for collaboration with TSB

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OSCHR Delivery Plan
OSCHR
MRC
MRC lead
NIHR lead

• Genetics/genomics
• Structural biology
• Imaging
• Systems medicine
• Global health
• Ageing lifecourse
• Stem cells
• Infections
• Population science

• Experimental
• Medicine
• (therapies,
• diagnostics,
• devices)
• Methodology

• Pharmacogenomics
• Animal/human models
• Regenerative medicine

• HTA Trials

• Public health
• E-health

Multidisciplinary approaches
MRC activities in Developing People

Statistics
In-vivo
Microbiology
Experimental medicine
Public health modelling
Systems biomedicine
Clinical research skills
Methodology
Pharmacology
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New Funding Schemes

• Exploratory Development Programme (new)
• Efficacy and Mechanisms Evaluations (EME)
  Programme
• science driven (new)
• Health Technology Assessment Programme
• -use driven
• Global Health Programme

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Targeted calls and initiatives

• Patient-based cohorts (November 14th)
• Well-characterised patient cohorts for patient
  stratification studies
• Tissue banks
• Population-based cohorts (e.g. birth cohorts) to
  provide control data
• Models (Mid December)
• Pathways of disease to identify potential
  treatable targets
• Animal and human models of disease
• In silico modelling, including predictive
  toxicology
• Biomarkers (Mid January)
• Activity/mechanism
• Surrogate end points
• Toxicology
• Methodology Research
• Increased support for investigator-led and
  commissioned research

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UK Respiratory Research Strategy Committee
UK Respiratory Research Collaborative
Medical Practitioners Occupational
physicians Basic Scientists Lung function
scientists Nurses Physiotherapists Pharmacists Lun
g-related charities NCRI National
Library Observers MRC UKCRC
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UK Respiratory Research Collaborative

• Using a joint funding model increase capacity for
  lung research in all areas PhD Studentships,
  Postdoctoral and Clinical Training Fellowships.
• Establish a support group for new research
  trainees.
• Seek support and establish clinical trial
  networks.
• Coordinate the bringing together of birth and
  other cohorts for biobanks.
• Explore ways of engaging industry and DH as
  members of UKRRC.

21 new PhD Capacity Building Studentships for
2007- 8
Collaborative link with Cancer Research UK for
increased research in lung cancer
Priorities for Clinical Trials Asthma, COPD,
Pulmonary Fibrosis, Lung Cancer
New links with industry for joint initiatives
3 new MRC/Charity Clinical Training Fellowships
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Lung Research Moves Forward The UK Respiratory
Research Strategy Committee
Organisation
Prioritisation
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Capacity
Coming
To prevent lung disease and improve patient care
Engage
Strengthen
Together
Rebuild
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