1. Stratified Medicine –
Opportunities for Business
24th January 2013

2. Session 1 – Setting the Scene
09:40 Welcome Address
– Toby Reid, BioCity Nottingham
09:50 National Vision for Stratified Medicine
– Dr Alasdair Gaw, Technology Strategy Board
10:10 Keynote Speech
– Colin Callow, NHS National Innovation Centre
10:30 Leicester Diagnostic Development Unit
– Professor Tim Coats

3. Welcome Address
Toby Reid
BioCity Nottingham

4. Welcome
STRATIFIED MEDICINE EVENT
UNIVERSITY OF LEICESTER
TOBY REID
DIRECTOR - BIOCITY NOTTINGHAM

5. Welcome
Summary of the regional strengths
BioCity Nottingham
Latest News
Question/Challenge
2 Footer Title

6. Regional Overview
10 Higher Education Institutes
60,000 Students
(Science/Engineering)
10,000 PhD Students
Over 500 companies
>20,000 employees
8 Hospital Trusts
>100, 000 employees

7. Regional Strengths
Medical Technology Companies
Drug Delivery
›50% of all companies
Reproduced from HM Government’s Strength & Opportunity Report 2011

8. Regional Strengths
Life science research power
Research Power
=
University Research Strength
+
Level of Start Up Activity
77% concentrated in 4 regions
Reproduced from BioCity’s UK Life Science Start-Up Report 2010

9. Nottingham Science Sector
1 in 5 jobs in a science-related sector
20% growth in life sciences sector between
2000-2010
Currently 15% of people employed in
Nottingham work in health related careers
Sector is forecast to continue to grow in line
with national trends up to 2026

10. BioCity – Introduction
129,000 sq ft of office and laboratory space
3 buildings

11. BioCity – Story so Far
2002 – Site donated to NTU
2003 – Opened Innovation Centre
2006 – Opened Stuart Adams Building
2008 – Opened Laurus Building
2012 – Opened BioCity Scotland

12. BioCity – Story so Far
Growth in Occupancy (sq ft)
120,000
100,000
80,000
60,000
40,000
20,000
‐
2003 2004 2005 2006 2007 2008 2009 2010 2011

13. BioCity – Story so Far
Start-up population based in UK bioincubators
18
16
14
12
10
8
6
4
2
0
2005‐2009 2006‐2010

14. BioCity – Business Model
Existing Companies
+££’s
Accommodation
Growth Companies
Rental Income
+££’s
Access to Finance
Other Services
Financial +££’s Additional Income
Investment
-££’s +££’s
Business Support
Time/Resource
-££’s Investment
New Companies

15. Companies at BioCity
3 Types of Company
Business support
• PR, Bookkeeping, Regulatory Affairs, Patent Attorneys
Science as a service
• Contract Research Organisations
IP developers
• One or series of products on patented IP

16. Companies at BioCity
Business Support – Corporate Sponsors
CRO/CMO’s
Notable successes – Sygnature/R5
Focus Group
IP Based
Haemostatix, Monica Healthcare, Critical Pharmaceuticals,
Pharminox, Cellaura, Petscreen, Platelet Solutions

17. BioCity – Now
Largest Bio-Incubator in UK – interactive community
70 companies employing 500 people
£35m of external venture capital
Mobius Life Sciences Fund
Author of UK Life Science Start Up Report

18. Nottingham Creative Quarter
Nottingham’s City Deal:
£10m Nottingham Technology
Grant Fund
£40m Venture Capital Fund
£1m Accelerator programme
£1m Creative Quarter Loan Fund

19. BioCity Focus - 2013
Sustaining the environment for business success
Improving the environment for business conception
Focus is often on investment readiness
Start-up readiness and increased birth rate
- The reality is that we have a low rate of IP based
start ups compared to the number of patent
applications
16 Footer Title

20. Constituent Parts Business Stages
Hospitals/NHS
- clinicians, practitioners Investors
- Access to finance 1. Generating Ideas
Universities/Space IDEAS
- technologies, expertise Incubators 2. Commericalising +
- Environment for business launching
Business Schools
- entrepreneurial talent Business Support 3. Executing + Scaling
- Dedicated programmes
Large Corporates - Experienced management
- customer, funder, exit
17 Footer Title

21. Challenge
How do we pull it all together to help generate more,
better formed business opportunities and create a
local environment in which they are more likely to be
successful?

22. National Vision for Stratified
Medicine
Dr Alasdair Gaw
Technology Strategy Board

23. Stratified Medicine Innovation Platform
Imaging as an enabling technology
Dr Alasdair Gaw Lead Specialist
www.innovateuk.org

24. The Technology Strategy Board
The UK Innovation Agency
•Promoting technology-enabled innovation for
• Business benefit, economic growth,
and quality of life
Investment Criteria
• Does the UK have the capability?
• Is there a large market opportunity?
• Is the idea ready?
• Can the Technology Strategy Board make a difference?

25. Priority Themes
Sustainability
Built Food Transport Healthcare
Energy
Environment
Development
High Value Manufacturing
Digital Services
Electronics,
Advanced Photonics and
ICT Biosciences
Materials Electrical
Systems

26. http://www.innovateuk.org/
COMPETITIONS _CONNECT SBRI
Technology Strategy Share knowledge through Develop innovative
Board funding KTNs and other networks products to meet
competitions government needs
CATAPULTS KTP SMART
A network of world-leading Partner with academics to (Grant for R&D)
technology and innovation develop new business Innovation funding for SMEs
centres capability

27. SMART: Grant for R&D
Proof of Market Proof of Concept Prototype Development
This grant enables companies to A grant to explore the technical This funding is used by
assess commercial viability, feasibility and commercial companies to develop a
through: potential of a new technology, technologically innovative
• market research market testing product or process: product, service or industrial
and competitor analysis • initial feasibility studies process:
• intellectual property position • basic prototyping • small demonstrators
• initial planning to take the project • Specialist testing and/or • intellectual property protection
to commercialisation, including demonstration to provide basic • trials and testing, including clinical
assessing costs, timescales and proof of technical feasibility • market testing
funding requirements. • intellectual property protection • marketing strategies
• investigation of production and • identifying routes to market
assembly options. • product design work
It also includes pre-clinical research • phase 0 pre-clinical studies for
studies for healthcare technologies medicines.
and medicines, including target
identification and validation.
Duration – up to 9 months Duration – up to 18 months Duration – up to 2 years
Maximum grant – £25k Maximum grant – up to £100k Maximum grant – £250k
Funding proportion – up to 60% Funding proportion – up to 60% of Funding proportion – up to 35%
of total project costs total project costs of total project costs for medium
enterprises; up to 45% for small
and micro enterprises

28. UK Capabilities
• Very strong in Commercial Life Sciences
– In vitro diagnostics
• -200 companies 4000 FTE, £1.1billion
– Pharma /Biotech
• >42billion pa, 67,000 FTE 20% of top 100 drug
– 4% of GDP
• Very strong Medicine & Life Science base
– 2 of top 3 in World rankings
• 20% of all medical science publications from UK
– 20 world leading institutes in disease
• Cancer, Respiratory & Inflammatory disease, Diabetes,
Neurological disease, Cardiovascular
– 37 Nobel Laureates in medicine physiology and chemistry
– £10 billion investment 2009

29. The Changing Face of R&D
• Precompetitive Public-Private Partnerships & Open
innovation platforms
– Shared costs, establish widely acknowledged standards,
Provide adequate weight of evidence, faster achievement
– Understanding Core Disease
• Biomarker specific benefits
– (Inter) National consensus on the means to identify disease
manifestations in subsets of patients
– Qualified biomarkers and patient-centered outcomes for patient
stratification and assessment of efficacy
• Cross industry and academic acceptance
• Improved clinical studies, rigorous methods,
• More effective data packages for Regulatory Bodies
– Makes Stratified Medicine a reality

30. Stratified Medicine
• Choice of effective therapy dependent on either
– A companion diagnostic test
– A clearly identified group of patients defined by
• in vitro diagnostics
• Biomarkers
• Defined algorithms
• Clinical responses
• Clinical Imaging/non-invasive detection
– A molecular level understanding of the disease
– Availability of both tests and drugs to clinicians
Right Treatment, Right Patient, Right Amount, Right Time
Optimal Benefit

31. Stratified Medicine Innovation Platform
• Launched October 2010
• Accelerate Development and Uptake of Stratified Medicine
– Improve Patient Outcomes
– Provide Cost Benefit to the NHS and The Healthcare Industry
– Deliver wider UK economic benefit
• Key Partners
– Department of Health, Scottish Government Health Directorate
– NICE, Medical Research Council, Technology Strategy Board
– Arthritis Research UK, Cancer Research UK
• Consultation and Advice
– MHRA, NIHR
• The combined 5 year Investment amounts to £200 Million
Putting UK healthcare at the heart of a revolution
in the diagnosis and treatment of disease

32. SMIP supporting the UK economy
• Pharma attracted to and remains in the UK
– Growth of the industry
– UK leads in drug discovery and development
• Med Tech companies remain and grow in the UK
• Smaller Biotechnology companies strengthened
• International sales of tools for stratification (diagnostic
systems, endoscopes, tests, medical devices etc)
• Clinical trials carried out in the UK benefits:
– Contract research organisations
– The NHS and patients
• A fertile ground for innovation across multiple sectors
The potential Global Sum of the UK parts
is considerably greater than the parts
Life Science = £1billion inward investment in 2012

33. 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
https://ktn.innovateuk.org/web/stratified-medicines-innovation-platform

34. Stratified Medicine Innovation Platform
• £50 Million TSB (£200Million partners)
• Round One £9.5 million:
– Development Business Models
• Biobanks, Companion Diagnostics
– Inflammatory Biomarkers
• Rheumatoid arthritis, Osteoarthritis, COPD
– Tumour Profiling
• Oncology multi screen assays
• Round Two: £6.5million TSB +£1Million DH
– Adverse Effects and Non responders
• Patient trials for regulatory acceptance

35. SMIP Round Three: £7.5m TSB + co-funding
Advancing in-vivo imaging as an enabling technology
Scoping workshops
Clinical customer focused workshop - 15 Nov 2012
Provider orientated workshop - 11 Dec 2012
Plan:
• Briefing documents published and competition opens
March 2013
• Events at Innovate and NHS Expo March 2013
PHOTONICS COMPETITION: Anticipated for imaging in healthcare 2013

38. Keynote Speech
Colin Callow
NHS National Innovation Centre

39. Supporting the development
of pioneering healthcare innovation

40. Innovation
The intentional introduction and application
within a role, group, or organization, of ideas,
processes, products or procedures, new to the
relevant unit of adoption, designed to
significantly benefit the individual, the group,
or wider society
[West, 1990]

41. “For the foreseeable future NHS must meet
increasing demands within ever constrained
resources and at the same time continuously
improve quality”.

42. Unprecedented Healthcare Demands
 a growing population with an
extending lifespan
 an increase in its own
capability, fuelled by advances
in knowledge, science and
technology
 ever-increasing expectations
from the public it serves.

43. Current NHS Health & Social Care System
• Services struggling to keep pace with demographic
pressures, the changing disease burden, rising expectations.
• Too much care is still provided in hospitals & care homes,
and treatment services continue receive higher priority
than prevention.
• The traditional dividing lines between GPs and hospital-
based specialists and services mean that care is often
fragmented and integrated care is the exception rather than
the rule.
• Society and technologies are evolving rapidly & changing
the way patients want to interact with service providers.
Current models of care appear to be outdated
• Care still relies too heavily on expensive individual
professional expertise despite patients and users desires to
play a much more active role in their care and treatment

44. Current health and social care delivery system
• Failing to keep pace with the
population's needs and expectations.
• Incremental changes to existing
models of care will not be sufficient in
addressing these major challenges
• A much bolder approach is needed to
bring about innovative models that
are appropriate to the needs of the
population that are :
– high quality,
– sustainable
– offer value for money.

45. Policy Implications
• Simply doing more of what has always
done is no longer an option.
• the need to do things differently by
radically transform the delivery of
services.
• Innovation is now considered the way
– the only way – to meet these
challenges.
• Innovation must become core
business for the NHS.

46. Translating Policy into Action
NHS leaders need to take a strategic view
rather than focusing on short-term fixes
designed to preserve existing services.
IHW is a policy initiative that will :
– decommission outdated models of care;
– support NHS organisations to innovate and
adopt established best practices;
– recognise the potential of new providers
as an important source of innovation;
– develop a culture that values peer support
for learning and innovation;
– encourage development of infrastructure
at the local level to develop & support
innovation and new models of care.

47. Innovation in the NHS
• NHS recognised as a world leader at
invention
• Spread of those inventions has
been slow , with even the best of
them failing to achieve widespread
use
• Increasing recognition that
innovation has a vital role to play

48. Why is it currently difficult to innovate in the NHS ?
•Diffusion of new ideas in
large, disaggregated
organisations like the
NHS remains difficult
•Urgent need to
systematically identify
and overcome barriers
and develop and spread
the very best ideas

49. Factors affecting the diffusion of innovation
• How well it fits into the culture or
operational style of a health
organisation or practices,
• How it affects workflow and work
processes,
• What other technologies or services will
it displace or change,
• How easy it is to implement
/maintain/sustain,
• What the mechanism for
reimbursement?

50. Realising the benefits from innovative solutions
• Change gurus and researchers tell us
that up to 75% of change initiatives fail
to achieve their objectives
• Our leaders tackle many change
priorities simultaneously in different
ways
• Every leader has a different set of
experiences and ideas about critical
success factors
• NHS often fails to identify and make
best use of available resources, skills
and knowledge to support a systematic
www.changemodel.nhs.uk approach to implementation

51. Recipes for success ?
4 common denominations that determine outcomes :
• Performance integrity
• Duration
• Commitment – Leadership / Participants
• Effort – the 10% rule
Harold Sirkin et al , HBR, 1000 global case studies

52. Effort
• There is an NHS tendency to launch major
innovation and improvement initiatives
without taking account of the extra
responsibilities for innovation projects on top
of busy operational jobs.
• If anyone’s workload increases >10% as a result
of the initiative, it is likely to run into problems.
• Organisations need to calculate the extra time
and effort required to execute the change and
create the space for it to happen

53. Commitment
• There must be active, visible backing
for the change from the most
influential senior leaders
• In addition, the innovation is unlikely
to succeed if it is not enthusiastically
supported by the people working
within the new structures and
systems that it creates.
• Staff need to understand the reasons
for change and believe it is
worthwhile

54. Duration
• Common belief that NHS innovation
projects need to execute change
quickly.
• What really matters is having formal,
senior management-led, review
processes.
• A long innovation project, reviewed
frequently and effectively is more
likely to succeed

55. Performance Integrity
• Selecting the right mix of team
members to deliver the change
• Selecting the most results-orientated
people with credibility and influence
and effective change skills.

56. Adopting the right mindset when
measuring the impact of innovation
What mindset do
you bring about
performance
measurement?
Reference: L Solberg, G Mosser and S McDonald (1997) The Three Faces of Performance Measurement:
Improvement, Accountability and Research, Journal on Quality Improvement, 23 (3): 135 - 147.

57. Performance Integrity – Impact Measurement
Renewed interest in effective
measurement and evaluation :
– The challenge is the nature
and accuracy of its
development
– Process often seems
confusing with a
plethora of models,
formulas and statistics
– Misunderstanding of the
evaluation process and
misuse by some
organisations

58. Performance Integrity – Demonstrating value
A more formal, consistent and rigorous approach to
the planning, measuring and reporting impact
• Formal review and validation of assumptions
• Prospective analysis using appropriate data agreed in
advance by front line clinicians
managers and commissioners
• Greater clarity about aims and
objectives
• Greater clarity with regards to
the perspective from which any
evaluation is assessing

59. Framing the innovation case
How to convince the Chief Executive to support
an innovative solution?
Clinical Case Financial Case Management Case
Unmet need Your assumptions Articulate the problem and
Benefiting Population Baseline comparison proposed solution
Current Clinical Practice No of patients Impact on operations
Expected Outcomes affected/benefit Relevant impact indicators
Business Model Impact on pathways and
Proposed Clinical Practice Baseline costs services
Evidence base Savings forecast Barriers to adoption
Clinical Champion ROI/BCR Key risks

60. The Clinical Case
The intention of the clinical case should
be to present the:
• Innovative solution and the core
claims in relation to intended clinical
benefits
• target patient population that will
benefit
• the current clinical practice that will
be impacted by the innovation
• the proposed clinical practice and
outcomes

61. The Financial Case
• Explanatory notes and assumptions
underpinning the savings forecast
• The impact of the innovation against
a baseline that truly represents
current practice
• No. of patients whose care would be
affected and the number that would
benefit
• Baseline costs that drive the current
clinical practice (e.g. staff costs,
procedure specific costs, etc)
• Savings forecast, at the level of the
NHS

62. The Management Case
• Description of the problem and the
solution aligned to strategic priorities
• Overview of the clinical and financial
benefits taken from the Clinical and
Financial Case
• Key impacts on care pathways, staff,
training, decommissioning, facilities,
other departments and other services
• Key impacts resulting from adoption ,
e.g. shifting care from one staff group
to another, or from one organisation to
another
• Key risks to the realisation of the
claimed benefits

63. Drivers for Successful Innovation Adoption
 Common language and success
metrics
 Urgency and pressure for
innovation and change
 Appropriate / compensating
rewards
 Organisational cultures supportive
of experimentation and new ideas
 Capacity and capability to promote
and lead innovation and change
 Effective validation data
 Effective risk management

65. www.nic.nhs.uk

66. Leicester Diagnostic
Development Unit
Professor Tim Coats
Leicester Royal Infirmary

67. Leicester Diagnostics Development
Unit
Tim Coats
Professor of Emergency Medicine
University of Leicester , UK
tc61@le.ac.uk

68. Emergency Medicine
 Risk Stratification
 Bayesian Decision Making
 Threshold for action depends on balance of risk
 Two people experience risk:
- The patient
- The doctor
 Depends on having biomarkers

69. DDU Concept
 Could novel detection methods identify new biomarkers
for risk stratification?
 Technology transfer from space science and
atmospheric chemistry
 Collaboration:
- Cardiovascular Sciences / EMAG
- Space Science
- Atmospheric Chemistry
 Industry
- Intelligent Fingerprinting – TSB funded

70. Facility
 Take the technology out of the lab to the patient
 Create a unique facility which allows the study of
critically ill emergency patients
 Bridge the ‘valley of death’ of technology development
 Bring experience of clinical efficacy testing to device
development

72. Equipment
• IR Imager: temperature distribution
• Hyperspectral imager (2nm resolution): spectral features
• Context Colour Imager
• Mass Spectrometer: Breath Analysis
• Nitric Oxide Analyser: Breath Analysis
• Respiratory Function
 Cardiovascular State via:
• Thoracic Impedance Monitor
• Supra-sternal doppler
• Deep tissue oxygenation
• Transcutaneous oximetry

73. Current Status
 Equipment integrated and running
 Database design completed
 Data automation complete
 Initial study underway (40 of 505 patients)
 Initial cardiovascular data from Infection and
Breathlessness

74. Staff
 Coats / Sims / Monks
 PhD students x3 (2 from chemistry, one from physics)
 Research Nurse / CRO 3.0 WTE (CLRN funded)
 BSc student
 Technician

75. Project Map

76. Development pathway for a Biomarker within the Leicester DDU

77. Stratification
 Sepsis patients after resuscitation – by conventional
measurements all look the same, and have a 20% in-
hospital mortality.
 Using deep tissue oxygenation by Near Infra-Red
Spectroscopy – if <70% there is a 2/3 chance of death.
 Next stage – we can stratify according to risk, but does
intervention in the high risk group make a difference to
outcome?

78. Summary
 Emergency care is risk stratification
 Good emergency physicians are good Bayesian
thinkers
 New biomarkers are required
 Leicester DDU gives a unique conjunction of emergency
care and technology

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