Measuring Innovation – a brief introduction to the REMEDiE

project

Michael MorrisonInnovative Health Technologies: health systems in transition

Barcelona 26-7 November 2009

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INTRODUCTION

REMEDiE: Regenerative

Medicine

in Europe

“Emerging Needs and Challenges in a Global Context”

FP-7 Funded European project Multi-partner, multi-country endeavour Work Package 1 = SATSU

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INTRODUCTION

What is Regenerative Medicine? A heterogeneous domain incorporating the

biological sciences, engineering, materials science, medicine, and surgery.

The aim of regenerative medicine is the restoration, maintenance, or enhancement of tissue, cell and organ function.

Materials: living tissue or cells, genes, and structural ‘scaffolding’ components including collagen matrices and synthetic polymers.

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INTRODUCTION

“This WP will map current ways in which capital is being employed within Europe and compare this to the global economy of regenerative medicine”

REMEDiE Final Project Description

“bio-capital’ research is nevertheless hampered by the low levels of financial accountability […] the traceability of private ‘bio-capital’ is limited and there are no clear figures to tell how much investment activity has been going on”

Beyond the Bull Market presentation (Kewell, 2009)

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INTRODUCTION

SO WHAT CAN WE MEASURE? ‘Universe’ of European commercial

companies involved in Regen Med Patents and the intellectual property

associated with Regen Med

EUROPEAN REGEN MED

COMPANY UNIVERSE

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EUROPEAN RM COMPANY UNIVERSE

72 active regenerative medicine companies in Europe

UK (27) and Germany (17) have by far the greatest concentration [Sweden =6]

30 companies 5-10 years old and 32 10+ yrs

Majority of companies have <100 staff

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EUROPEAN RM COMPANY UNIVERSE 2#

Commerical Focus: Cell Therapy

10

16

26

3 3

6

13

19

32

05

101520253035

StemCell

Non-stemCell

All CT

Autologous Allogenic Total

Commerical Focus: Non-cell Therapy

8

22 25

55

0102030405060

No. of Companies

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EUROPEAN RM COMPANY UNIVERSE 3#

Purpose of the survey is to provide context for the selection of a small number of case studies for in-depth analysis

Different indices not just an overview but can be used to select case studies that exemplify different aspects of commercial European regenerative medicine

Can illustrate using Gene Therapy

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EUROPEAN RM COMPANY UNIVERSE 4#

NAME LOCATION SIZE AGE (years)

DISEASE FOCUS

PRODUCTS ON MARKET

Amsterdam Molecular Therapeutics

Netherlands Small 5-10 Protein deficiency No

Ark Therapeutics

UK Small- medium 10+ Vascular disease and cancer

Five non-RM products, mainly wound dressings

Arthrogen BV Netherlands Small <5 Rheumatoid Arthritis

No

Diamyd Medical AB

Sweden Small 10+ Chronic pain Main program is therapeutic vaccine for diabetes

MolMed Italy Small 10+ Cancer No

Mologen AG Germany Small 10+ Cancer No

Oxford Biomedica

UK Small 10+ Cancer, Parkinson's’

No

Transgene France Medium 10+ Cancer vaccines No

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SUMMARY

Company Universe gives:What’s out thereWhat they’re doing (or not)Characterisation of regenerative medicine sub-sectors

PATENT DATA:

Index of Innovation?

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PATENT DATA & THE WORK PACKAGE 2#

Patent analysis can provide: A measure of the size and growth rate of a

biotechnology sub-field (Reiss & Strauss,1998; Bergman & Graff, 2007)

An index of innovative activity (Nelson, 1998)

Trace the process of ‘turning science into business’ in the bioeconomy (Oldham & Cutter, 2006)

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PATENT DATA & THE WORK PACKAGE 3#

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PATENT DATA & THE WORKPACKAGE 4#

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PATENT DATA & THE WORKPACKAGE 5#

Trends in patent activity over time Trends in choice of patent office and

applicants Most active institutions, sectors, nation

states and regions Provide a systematic overview of activity

across and within regenerative medicine sub-fields

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Data use?

Private data – hard to unpack company claims

Marshalled data – commercial data, existing surveys

Finding what can be measured Creating definitions? Of regenerative

medicine and of innovation

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REFERENCES

Bergman, K. & Graff, G.D. (2007) The global stem cell patent landscape: implications for efficient technology transfer and commercial development. Nature Biotechnology 25 pp419-424

Martin, P., Hawksley, R. & Turner A. (2009) The commercial development of cell therapy – lessons for the future? University of Nottingham, Nottingham.

Nelson, J. (1998) Analysis of patenting within gene therapy. Expert Opinion on Therapeutic Patents, 8(11) pp1495-1505

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REFERENCES

Oldham, P. & Cutter, A.M. (2006) Mapping global status and trends in patent activity for biological and genetic material. Genomics, Policy & Society 292) pp62-91

Reiss, T. & Strauss, E. (1998) Gene therapy - the dynamics of patenting worldwide. Expert Opinion on Therapeutic Patents, 8(2) pp173-179

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REFERENCES

Additional Material Kewell, B. (2009) Beyond the ‘Bull Market’:

Biocapital and regenerative medicine in a changing financial world. Presented at Beyond Pattison - Challenges for Stem Cell Translation and Policy, May 7-8, London.