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Growing a UK Cell Therapy Industry
Delivering
Health & Wealth

Matthew Durdy, Chief Business Officer
December 2013
ct.catapult.org.uk

Catapult is a Technology Strategy Board programme
The Cell Therapy (and Regenerative Medicine)
Opportunity

*US Market data
• 
• 
• 
• 
• 
• 

http://www.cancer.org/cancer/cancerbasics/economic-impact-of-cancer
http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf
http://www.cdc.gov/heartdisease/facts.htm
http://www.pdf.org/en/parkinson_statistics
http://www.provengehcp.com/FAQs.aspx
http://www.dermagraft.com/about/efficacy/

2
Why a Catapult?

•  Learning
•  Excellence
•  Leadership
•  Efficiency
•  Risk taking
3
Assets -Facilities and Teams

•  Facilities

•  Business Team
• 

Business development

Capacity for 80-100 people

• 

Health economics

• 

Clinical research cluster

• 

Business models

• 

Global location

• 

1200 sq m on 12th floor

• 

•  Translational Labs and Team
• 

Process development

• 

Analytical development

• 

GMP process proving

•  Clinical Trial and Regulatory
Team
• 

Regulatory

• 

Clinical operations

4
Management Team and Board

Keith Thompson
Chief Executive
(Director, Scottish
National Blood
transfusion Service,
Serologicals)

Dr John Brown, CBE,
FRSE
Chairman
BTG plc, Acambis, CAT

Dr Natalie Mount

Dr Stephen Ward

Chief Clinical Officer
(Director Pfizer,
Neusentis. Cambridge,
UCL)

Chief Operating Officer
(Director, Stabilitech,
Onyvax. Southampton,
Imperial)

Matthew Durdy
Chief Business Officer
(Director, Aqix, Biotec,
CDC. Oxford, Chicago)

Professor
Johan Hyllner
Chief Scientific Officer
(Director, Cellectis,
Cellartis, Vitrolife)

Headcount: 65

Professor Marc Turner
Non-executive Director
Edinburgh, SNBTS

Professor Michael
Whitaker
Non-executive Director
NE Stem Cell Institute

Tim Edwards
Non-executive Director
Chairman, Bio Industry
Association

Dr Zahid Latif
Non-executive Director
Technology Strategy
Board

Nick Higgins
Non-executive Director
Consort Medical,
Intercytec

22/11/2013

5
Catapult Themes
Risk

Catapult is a Technology Strategy Board programme
Management of Perceived Risk

Example

Nature

Solution

EU
Regulation

Not
Understood

Expert
Advice

Economics

Not Clear

Prepare
Data

GMP

Not done

Expert
partner

Therapy

Not proven

Share

Risk?

7
Catapult Themes
Funding

Catapult is a Technology Strategy Board programme
Commercial Development Plan

?
Start
Commercial
Development
Plan

Tasks
•  Innovation
•  Quality
•  Data

Product
•  Substance
•  Process
•  Regulation
•  Information

Group
•  Identity
•  Quantity
•  Diagnostic

Need
•  Patient
•  Clinician
•  Payer
•  Seller

9
Funding for cell therapy in the UK

Govt.
Support

Medical
Charities

Commercial
Development
Plan
Financial
Investment

Corporate
Venturing

10
Successful commercialization depends on both
regulatory approval and optimal market access

Quality

Safety

Efficacy

REGULATORY APPROVAL

11

Comparative Clinical & CostEffectiveness; Budget Impact

MARKET ACCESS
Lab - Pilot - Scale

Catapult Multi Functional development Pod
Commercial Scale

Catapult GMP Proving Lab

T
e
c
h
t
r
a
n
sf
e
r

12
Collaboration

1+1 = 3

Client knowledge +
Expert capabilities =
Better outcome

Up to 80% UK Technology Strategy Board
Funding available for collaboration with SME
Partner

Project
Input

Funding
Ratio

TSB Grant

SME

£1m

60%

£0.6m

Catapult

£1m

100%

£1.0m

Total

£2m

£1.6m
80%
Sharing the outputs and opportunities

14
Partners

•  Cooperation on
manufacturing
platforms
•  Project sourcing and
funding
•  International
collaboration

15
Project Examples
•  Share of expertise
•  Support for in house projects
•  New delivery device to reduce injection
pain
•  Phase 2 clinical trials
•  Scale up, Assays, Freezing and distribution
of cells
Large Cap
Company

•  Manufacturing partner, Regulatory,
Clinical trial design and delivery
•  Immunomodulation
•  Regulatory, Clinical trial design, business
models

16
Activities
Proof of Principle
•  Scientific, clinical, regulatory, commercial

Non-clinical
•  Safety, toxicology, GMP proving, assays

Suitability
•  Commercial
Development
Plan

Clinical
•  Safety and efficacy, investible data

Platform
•  Generic issues and large collaborations

17
Working models and finance

Nature of project Paid for by:

Carried out
by:

Ownership
of outputs

Finance

Core Project

Catapult

Catapult

Catapult

£70m/
5 years

Contracted
Development

Client

Catapult

Client

£10m/
Per year

Grant or
Catapult and
partner

Catapult
and
partner

Outputs
shared

Industry
Collaboration

£10m/
Per year

18
Gateway Criteria
Building the portfolio

hESC

Blood
Bone & Cartilage
Cardiovascular
Dermatology/Wound
Healing
Diabetes
Gastroenterology
Immunology
Liver
Metabolic
Neurological
Oncology
Ophthalmology
Respiratory
Other

iPS

MSC

Immune
Cell

Other
Somatic
Outputs
Life changing therapies
Investible propositions
Industry changing innovation
Skilled leaders
UK leadership
Summary: The Cell Therapy Catapult
Strong first year of growth

Matthew Durdy
info@ct.catapult.org.uk

Laboratories and teams up and
running, 60+

http://ct.catapult.org.uk
Twitter: @CTCatapult

Large and small collaborations
Global interaction
Industry success is our success
Researchers

Industry

Cell Therapy
Catapult
NHS

Catapult is a Technology Strategy Board programme

Investment

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Growing a uk cell therapy industry delivering health & wealth, presentation by Cell Therapy Catapult Chief Business Officer Matthew Durdy

  • 1. Growing a UK Cell Therapy Industry Delivering Health & Wealth Matthew Durdy, Chief Business Officer December 2013 ct.catapult.org.uk Catapult is a Technology Strategy Board programme
  • 2. The Cell Therapy (and Regenerative Medicine) Opportunity *US Market data •  •  •  •  •  •  http://www.cancer.org/cancer/cancerbasics/economic-impact-of-cancer http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf http://www.cdc.gov/heartdisease/facts.htm http://www.pdf.org/en/parkinson_statistics http://www.provengehcp.com/FAQs.aspx http://www.dermagraft.com/about/efficacy/ 2
  • 3. Why a Catapult? •  Learning •  Excellence •  Leadership •  Efficiency •  Risk taking 3
  • 4. Assets -Facilities and Teams •  Facilities •  Business Team •  Business development Capacity for 80-100 people •  Health economics •  Clinical research cluster •  Business models •  Global location •  1200 sq m on 12th floor •  •  Translational Labs and Team •  Process development •  Analytical development •  GMP process proving •  Clinical Trial and Regulatory Team •  Regulatory •  Clinical operations 4
  • 5. Management Team and Board Keith Thompson Chief Executive (Director, Scottish National Blood transfusion Service, Serologicals) Dr John Brown, CBE, FRSE Chairman BTG plc, Acambis, CAT Dr Natalie Mount Dr Stephen Ward Chief Clinical Officer (Director Pfizer, Neusentis. Cambridge, UCL) Chief Operating Officer (Director, Stabilitech, Onyvax. Southampton, Imperial) Matthew Durdy Chief Business Officer (Director, Aqix, Biotec, CDC. Oxford, Chicago) Professor Johan Hyllner Chief Scientific Officer (Director, Cellectis, Cellartis, Vitrolife) Headcount: 65 Professor Marc Turner Non-executive Director Edinburgh, SNBTS Professor Michael Whitaker Non-executive Director NE Stem Cell Institute Tim Edwards Non-executive Director Chairman, Bio Industry Association Dr Zahid Latif Non-executive Director Technology Strategy Board Nick Higgins Non-executive Director Consort Medical, Intercytec 22/11/2013 5
  • 6. Catapult Themes Risk Catapult is a Technology Strategy Board programme
  • 7. Management of Perceived Risk Example Nature Solution EU Regulation Not Understood Expert Advice Economics Not Clear Prepare Data GMP Not done Expert partner Therapy Not proven Share Risk? 7
  • 8. Catapult Themes Funding Catapult is a Technology Strategy Board programme
  • 9. Commercial Development Plan ? Start Commercial Development Plan Tasks •  Innovation •  Quality •  Data Product •  Substance •  Process •  Regulation •  Information Group •  Identity •  Quantity •  Diagnostic Need •  Patient •  Clinician •  Payer •  Seller 9
  • 10. Funding for cell therapy in the UK Govt. Support Medical Charities Commercial Development Plan Financial Investment Corporate Venturing 10
  • 11. Successful commercialization depends on both regulatory approval and optimal market access Quality Safety Efficacy REGULATORY APPROVAL 11 Comparative Clinical & CostEffectiveness; Budget Impact MARKET ACCESS
  • 12. Lab - Pilot - Scale Catapult Multi Functional development Pod Commercial Scale Catapult GMP Proving Lab T e c h t r a n sf e r 12
  • 13. Collaboration 1+1 = 3 Client knowledge + Expert capabilities = Better outcome Up to 80% UK Technology Strategy Board Funding available for collaboration with SME Partner Project Input Funding Ratio TSB Grant SME £1m 60% £0.6m Catapult £1m 100% £1.0m Total £2m £1.6m 80%
  • 14. Sharing the outputs and opportunities 14
  • 15. Partners •  Cooperation on manufacturing platforms •  Project sourcing and funding •  International collaboration 15
  • 16. Project Examples •  Share of expertise •  Support for in house projects •  New delivery device to reduce injection pain •  Phase 2 clinical trials •  Scale up, Assays, Freezing and distribution of cells Large Cap Company •  Manufacturing partner, Regulatory, Clinical trial design and delivery •  Immunomodulation •  Regulatory, Clinical trial design, business models 16
  • 17. Activities Proof of Principle •  Scientific, clinical, regulatory, commercial Non-clinical •  Safety, toxicology, GMP proving, assays Suitability •  Commercial Development Plan Clinical •  Safety and efficacy, investible data Platform •  Generic issues and large collaborations 17
  • 18. Working models and finance Nature of project Paid for by: Carried out by: Ownership of outputs Finance Core Project Catapult Catapult Catapult £70m/ 5 years Contracted Development Client Catapult Client £10m/ Per year Grant or Catapult and partner Catapult and partner Outputs shared Industry Collaboration £10m/ Per year 18
  • 20. Building the portfolio hESC Blood Bone & Cartilage Cardiovascular Dermatology/Wound Healing Diabetes Gastroenterology Immunology Liver Metabolic Neurological Oncology Ophthalmology Respiratory Other iPS MSC Immune Cell Other Somatic
  • 21. Outputs Life changing therapies Investible propositions Industry changing innovation Skilled leaders UK leadership
  • 22. Summary: The Cell Therapy Catapult Strong first year of growth Matthew Durdy info@ct.catapult.org.uk Laboratories and teams up and running, 60+ http://ct.catapult.org.uk Twitter: @CTCatapult Large and small collaborations Global interaction Industry success is our success
  • 23. Researchers Industry Cell Therapy Catapult NHS Catapult is a Technology Strategy Board programme Investment