The document outlines the UK’s strategy for advancing stratified medicine, highlighting a £200 million investment over five years by key partners to enhance diagnostic test and drug development. It emphasizes the importance of collaboration between government, healthcare providers, and researchers to improve patient outcomes and foster economic growth by 2025. Key themes include patient recruitment, data management, regulatory standards, and the importance of intellectual property rights in promoting innovation.

1. Driving Innovation
Stratified Medicines
Innovation Platform
Graham Bell
Lead Specialist Stratified Medicine

2. Driving Innovation
New strategy launched 2011

3. Driving Innovation
Challenge Lead Innovation

4. Driving Innovation
Challenge Statement
• How to place the UK at the centre of a
new era of stratified medicines:
• Approach: to help accelerate the
development and uptake of treatments
based on the combination of diagnostic
test and drugs
... to benefit the healthcare industry
... to improve patient outcomes
... and for wider UK economic benefit

5. Driving Innovation
Programme Partners
• Technology Strategy Board
• Department of Health
• Scottish Government Health Directorate
• National Institutes for Clinical Excellence
• Medical Research Council
• Cancer Research UK
• Arthritis Research UK

6. Driving Innovation
Stratified Medicine Innovation Platform
Together the partners will invest over £200
million over a 5 year period will be invested
to accelerate Stratified Medicine in the UK.
The aim is to bring the government,
researchers and business together in a
major initiative that will place the UK at the
centre of a revolution in the diagnosis and
treatment of disease.

7. Driving Innovation
First calls
• Tumour Profiling & Data Capture (£5.8m)
– Working along side CRUK programme
– Funded 6 projects
• Inflammatory Biomarkers (£4.3m)
– Working along side MRC:ABPI programme
– Funded 4 projects
• Business Models and Value Systems (£0.9m)
– Funded three projects

8. Driving Innovation
Technology Roadmapping
• Build a UK vision for stratified medicine
– ..... that the UK can deliver
– ...... supported by the SMIP and PMG
• Build a community of people who will help
• Take a strategic view of investment options
– Identify the barriers
– Programme activity to overcome them
– Investments in support of the programme activities

9. Driving Innovation
Vision for 2025
• The UK should be the best place to develop, and have adopted, stratified medicine. This will
benefit patients, provide cost-effective solutions for the NHS and other healthcare providers and
create opportunities for business
• There should be an increased collaborative culture throughout the sector based around shared
resources, and systems should be in place for effective data collection, sharing, governance and
use across sectors (including NHS, business, academia, regulators and NICE)
• It should be quicker and less expensive to develop new drug-diagnostic combinations and have
them licensed, and success should be reflected in increased UK economic growth
• It should be possible for all NHS patients to be involved in medical research if they wish, including
through use of patient information and records, in order to inform the next generation of successful
therapies
• There should be a smooth reimbursement process for stratified therapies and diagnostics, and an
intellectual property (IP) framework that encourages innovation
• The UK health system should have established stratified care pathways, and evidence should be
available to show that patient outcomes are improved where stratified medicine is used

10. Driving Innovation
Key Themes
• Incentivising adoption
• Increasing awareness
• Patient recruitment – consents and ethics
• Clinical trials
• Data – collection, management and use
• Regulation and standards
• Intellectual property
• Bio-banks and biomarkers
• Increasing the impact of R&D investment

11. Driving Innovation
Incentivising adoption
Key message:
Adoption of products into the healthcare
system was seen key during the
workshops.
There are many activities ongoing in this
area reflecting it’s importance to both
Industry and health service
Sound demonstration of value for money
for products is seen as the key
deliverable

12. Driving Innovation
Increasing awareness
Key message:
Need to develop a sound information
base and ensure that professionals
and public are provided with evidence
and a rational for Stratification.
For professionals proof of effectiveness
and value
For public avoid the message that
stratification is a form of rationing

13. Driving Innovation
Patient recruitment – consents and ethics
Key messages:
Often patient consents are restrictive and
do not allow use in research projects
beyond the immediate study. Broader
consents are preferred.
Ethical consideration needs to be given to
later incidental findings particularly in the
area of whole genome screening.

14. Driving Innovation
Clinical trials
Key messages:
Delays around identifying the appropriate
patients and recruiting into trials is one of
the key bottle necks in development.
Any systems to pre-identify patient
cohorts could save significant resource.
New types of trial design will need to be
discussed and approved by regulatory
agencies

15. Driving Innovation
Data – collection, management and use
Key message:
There is a significant quantity of highly
relevant data already in existence within
the NHS and in Pharma companies.
Finding some way to share this data
appropriately could benefit all.
Will require significant effort in data
standardisation to enable open sharing.

16. Driving Innovation
Regulation and standards
Key message:
Regulation is a key gatekeeper in drug
development, all products must be safe
and effective (but how should trials be
designed to show efficacy in preselected
groups)
There was a desire for more regulatory
guidance around both trial design for
stratified products and in the validation of
tests and test protocols.

17. Driving Innovation
Intellectual property
Key message:
This was raised as a concern by diagnostic
companies who were concerned that
“homebrew” tests did not face a level
playing field.
Quality systems being implemented
nationally may help to improve this but
companies would like to see strong IP
protection for tests.

18. Driving Innovation
Bio-banks and biomarkers
Key messages:
There is a recognition that access to
appropriate samples with clinical
annotation is key and that having linked
Bio-banks with standardised systems
would help
Clarity or standardisation around what
information is required to “validate” a
biomarker

19. Driving Innovation
Increasing the impact of R&D investment
Key message:
The desire is to increase the impact of
everyones R&D spend, public, private
and third sector
There was a widespread acceptance that
no single organisation could make a
difference alone. The key is coordinated
activity in multiple areas simultaneously.
Only by working together

20. Driving Innovation
Summary
There was a widespread acceptance that
no single organisation can make a
significant difference working alone. The
key is coordinated activity in multiple
areas simultaneously.

21. Driving Innovation
Where Next?
Adverse Events and Non-Responders
( up to £7.5m)
• Developing tests to predict risk of suffering
adverse events, or non response to
current therapies.
– Phase 1: Health economic valuation of product
and impact on clinical care pathway
– Phase 2: Funding of development of most
successful projects from phase 1
– SBRI in partnership with Dept of Health

22. Driving Innovation
Contact details
• Dr Graham Bell (graham.bell@tsb.gov.uk)
• Dr Alasdair Gaw (alasdair.gaw@tsb.gov.uk)
• https://ktn.innovateuk.org/web/stratified-medicines-
innovation-platform