0. MRC Stratified Medicine Initiative
Jonathan Pearce
Medical Research Council, Translational Programme Manager
University of Glasgow Industry Day: 24 September 2015

1. Presentation/Phenotype
Stratified medicine has the potential to deliver improved diagnoses and therapies
Input
Tools
Outputs
Value
Affected
population
Disease Strata
Diagnostics to better predict disease state, prognosis, response
Mechanism of disease leading to new therapies
Clinical
Presentation/Phenotype
Genetic /
Molecular
Therapeutic
Response
Capturing this potential requires true partnership between basic and clinical researchers, industry (BioPharma and Diagnostics) and patients. No one group has all the necessary skills/resources 1

2. Programme Coordination
… and partnership between funders, regulators, evaluators and providers
Stratified Medicine
Innovation Platform
Programme Coordination
Group 2

3. MRC Stratified Medicine Initiative
Set up in 2010/11 and represented a new way of funding from the MRC
Builds on the MRC/ABPI Inflammation and Immunology (I&I) Initiative
£60m initiative to develop disease-specific research consortia, involving industry partners
Consortia exploring predictors of response and mechanisms underpinning disease stratification, where there is evidence that therapeutically relevant strata exist 3

4. MRC Stratified Medicine Consortia
13 internationally competitive stratified medicine discovery engines
Build on NIHR and DA clinical research funding
Total investment c. £57m
3 charity co-funders (CRUK, ARUK, BHF)
32 academic and 51 commercial partners
RASP-UK
UKPBC
RAMAP-II
PSORT
MATURA-II
COPDMAP
MASTERPLANS
GAUCHERITE
MATURA-I
Auto-Immune
Respiratory
Cancer
Infections
Mental Health
Cardiovascular
Diabetes
Congenital
S-CORT
AIM HY
MASTERMIND
STOP-HCV
RAMAP-I
STRATA

5. STOP-HCV – 21 Partners; 12 Academic, 8 Industrial, 1 Governmental and Patient

6. Stratified medicine relies on an ability to integrate and interrogate multi-level data
In last 2 years ( ) MRC has invested over £100m in informatics infrastructure and capabilities
CIPHER
London
HeRC
Scotland
24 academic institutions
2 MRC Units
Medical Bioinformatics
Imperial
Oxford
UCL/Crick
Leeds
Uganda
Warwick/Swansea 6

7. Molecular pathology review
If the UK is to capture the stratified medicine opportunity, we need to be able to translate both its therapeutic and diagnostic outputs to patient and economic benefit
While much consideration has been given to the challenges faced by those developing new therapies, less work has focused on the needs of diagnostics
MRC has undertaken a review focused on these needs 7

8. Review recommendations
Path - Produce clear unified guidance setting out the critical path and required evidence for the discovery, development, approval and evaluation of tests. Address the gaps in the UK’s regulatory, evaluation, adoption and delivery system
Proximity - Establish joint research/clinical service ‘nodes’ aligned with industry and complementing NIHR, TSB and other RC and partner investments
People -
Train next generation of research leaders in molecular pathology, potential merit of guaranteed follow through clinical lectureships
Further development of UK capacity in statistics, bioinformatics and health economics
Undergraduate medical curriculum to include molecular pathology, to aid adoption and interpretation 8

9. MRC and EPSRC molecular pathology nodes call
In an initial response to recommendations, the MRC and EPSRC have launched a joint call to support up to eight molecular pathology nodes
Up to £17.5m (£15m from MRC and £2.5m from EPSRC)
Each node will be a multidisciplinary centre of innovative molecular diagnostic test discovery and development bringing together:
the research base
pathology/genetic services and
industry 9

10. MRC Stratified Medicine Consortia and MRC EPSRC Molecular Pathology Nodes
13 internationally competitive stratified medicine discovery engines
Total c. £60m
3 charity co-funders (CRUK, ARUK, BHF)
32 academic and 51 commercial partners
6 centres of innovative molecular diagnostic test development
Total c. £16m
8 academic and 21 commercial partners
Edinburgh/
St Andrews
Glasgow
RASP-UK
Newcastle
UKPBC
RAMAP-II
PSORT
Nottingham
MATURA-II
COPDMAP
Manchester
Leicester/
Loughborough
MASTERPLANS
GAUCHERITE
Auto-Immune
Mental Health
MATURA-I
Respiratory
Cardiovascular
S-CORT
Cancer
Congenital
AIM HY
MASTERMIND
Infections
Diabetes
STOP-HCV
RAMAP-I
STRATA
Node

11. The nodes will work as a network and complement partner investments
Discovery Science/
Early TRL
Mid TRL
Late TRL
Science base
MRC Stratified
Medicine
Consortia
Precision Medicine Catapult
NHS
NIHR
DECs
Nodes
EPSRC Analytical Sciences
RC Centres
MHRA
NICE
NIHR BRCs/BRUs
NHS Innovation
GEL
Discovery
Validation
Regulation
Evaluation
Adoption