new opportunities in translational research professor stephen holgate chairman mrc physiological...
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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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Medicine became a science by combining clinical observation
with pathology and function and through the application of
chemical, biological and physical sciences
Principles and Practise of Medicine: 1892
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• 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.
Medical Research Council
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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.
The MRC mission:
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~£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
MRC funding for research
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Scientific Decision Making - Research Boards and Panels
College of Experts (CoE)
SPOG SPOGSPOGSPOGSPOG
MCMB HSPHRBPSCSB IIB NMHBCompetition
Panels
COUNCIL
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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 MRC’s 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
Challenges ahead
Post-genome Health of the Public
Individual
Understandinghealth & disease
Cell
Organ
Animal
Population
Families
‘continuum’
prevention diagnosis treatment
Genome
Environment
• Forging Partnerships• Training and retaining researchers• Research infrastructure• Development gap
funding• Engaging the public • Meeting expectations
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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 Culyer’s review, hospital
trusts had to justify amount based on research activity
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• 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
National enquiries into R & D base
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• 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 R&D Strategy: “Best Research for Best Health” – Sally
Davies, DH National Institute for Health Research
New organisation for health research
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National Institute for Health Research (NIHR)
NHS Trusts
Networks
Faculty
TraineesInvestigatorsSenior
Investigators
UniversitiesInfrastructure
Experimental Medicine Facilities
National Schools for Research
Technology Platforms
Research Networks
Programmes
Research Programmes
Research Projects
Research Units
Research Centres
Patients&
Public
Systems
Advice Service
Governance Network
ResearchEthics
Information Systems
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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
Professor Gary FordDirector, Stroke Research Network
Professor Des JohnstonDirector, Diabetes Research Network
☺
Professor David Cameron
Director, National Cancer Research Network
Professor Til WykesDirector, Mental Health Research
Network
Professor Ros SmythDirector, Medicines for Children
Research Network
Professor Martin RossorDirector, Dementias and
Neurodegenerative Diseases Research Network
Professors Janet Darbyshire & Peter Selby
UKCRN and PCRN
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 Funding
Sir 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)
• Un
der
pin
nin
g
• Ae
tiolo
gy
• Pre
ven
tion
• De
tect
ion
& D
iagn
osi
s
• Tre
atm
en
t Dev
elo
pm
ent
• Tre
atm
en
t Eva
lua
tion
• Dis
ea
se M
an
age
me
nt
• He
alth
Se
rvic
e %
20 1
0 0 10
20
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UKCRC: Research by Type
Translational Research
Health
service
Treatm
ent developm
ent
Aetiology
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Pathway for translation of health research into healthcare improvement
Basicresearch
PrototypeDiscovery &
Design
Preclinical development
EarlyClinical
trials
LateClinical
trials
HealthTechnology assessment
Health serviceresearch
Knowledgemanagement
Healthcaredelivery
MRC and Medical Charities
NIHR
NH
S
2n
d Gap
in tran
slation
1st Gap in translation
NICEMHRA
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MRC – NIHR: The joint initiative
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MRC CSR 2007 allocation
2007-08Baseline
2008-09 2009-10 2010-2011 Total End CSR07Increase
£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 lead NIHR lead
MRC
•Pharmacogenomics•Animal/human models•Regenerative medicine
•Genetics/genomics•Structural biology•Imaging•Systems medicine•Global health•Ageing: lifecourse•Stem cells•Infections•Population science
MRC activities in Developing PeopleStatistics
Microbiology
Informatics
Public health modelling
Pharmacology
Experimental medicineIn-vivo
Systems biomedicine Clinical research skills
Methodology
Multidisciplinary approaches
•ExperimentalMedicine (therapies, diagnostics, devices)•Methodology
•Public health•E-health
•HTA Trials
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•Exploratory Development Programme (new)
•Efficacy and Mechanisms Evaluations (EME) Programme – science driven (new)
•Health Technology Assessment Programme-use driven
•Global Health Programme
New Funding Schemes
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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 ResearchStrategy Committee
UK Respiratory ResearchCollaborative
Medical PractitionersOccupational physiciansBasic ScientistsLung function scientistsNursesPhysiotherapistsPharmacistsLung-related charitiesNCRINational Library
Observers:MRCUKCRC
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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
3 new MRC/Charity Clinical Training
Fellowships
Priorit
ies
for C
linica
l Tria
ls Ast
hma,
CO
PD,
Pul
mon
ary
Fibr
osis,
Lun
g Can
cer
Colla
bora
tive
link
with C
ance
r Res
earc
h UK
for i
ncre
ased
rese
arch
in lu
ng c
ance
r
New links with industry for joint initiatives
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Lung Research Moves Forward:The UK Respiratory Research Strategy Committee
Prioritisation Organisation
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Coming
TogetherRebuild
Capacity
Engage StrengthenTo prevent lung disease and improve patient care
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