Vincent Walsh MSc by Research Thesis Sept 2014 (1)

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1 Analysis of Biotechnology Cluster Drivers with Emphasis on the Atlantic Region that was Incorporated within the EU Interreg ShareBiotech Project Vincent John Walsh (BSc. Hons. Toxicology) A thesis submitted to Athlone Institute of Technology in accordance with requirements for the award of Masters of Science by Research Based on research carried out under the co-supervision of Dr. Paul Tomkins and Professor Neil J Rowan September, 2014

Transcript of Vincent Walsh MSc by Research Thesis Sept 2014 (1)

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Analysis of Biotechnology Cluster Drivers with

Emphasis on the Atlantic Region that was

Incorporated within the EU

Interreg ShareBiotech Project

Vincent John Walsh

(BSc. Hons. Toxicology)

A thesis submitted to Athlone Institute of Technology in

accordance with requirements for the award of

Masters of Science by Research

Based on research carried out under the co-supervision of

Dr. Paul Tomkins and Professor Neil J Rowan

September, 2014

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Table of Contents

Chapter 1 INTRODUCTION

1.1. Origins of Biotechnology 16- 20

1.2. The Nature & Scale of Biotechnology Research 20 – 21

1.3. Economics of the Biotech Sector 21– 25

1.4. Biotechnology Promising a Brighter Future 25 – 27

1.5. Collaboration between Universities & Industry 27 – 29

1.6. Research Infrastructure 29 – 30

1.7. Core Facilities 30– 33

1.8. Core Facilities & HEI’s 33 – 35

1.9. Laboratory Informatics 35-

1.10. Biotechnology Development in Europe 36 - 39

1.11. Industry Collaboration 39 – 41

1.12. IP & Tech Transfer 41 –

1.13. Clusters 41 – 45

1.14. The Clustering Concept 45 – 46

1.15. The Importance of Clusters 46 - 48

1.16. Clusters in Ireland 48– 50

1.17. BioPharma Cluster Ireland 50 – 51

1.18. Development of the Indigenous Biotech Sector 51– 52

1.19. Porters Theory on Clusters 52– 53

1.20. Typology of Clusters 53– 56

1.21. The Cluster Life Cycle 56 – 58

1.22. HE Networks & Clustering 58 –

1.23. Social Networking 58 - 59

1.24. Virtual Networking 59 – 60

1.25. Impact of Communication Technology 60 – 61

1.26. Transnational Collaboration ` 61 -

1.27. Tech Translator 61 –

1.28. Key Enabling Technologies 61– 63

1.29. Life Science Research that isn’t Biotech 63 – 67

1.30. Aims and Objectives of this Project 67 – 72

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1.31. Research Justification 72 –

Chapter 2 METHODS

2.1. Research Approach 74 - 75

2.2. Technology Core Facilities 75 –76

2.3. Studies and Action Plan to Reduce the Gap… 76 –

2.4. Summarised Research Surveys 76 –

2.5. ShareBiotech Companies Survey 76 – 78

2.6. ShareBiotech Research Groups Survey 78 – 80

2.7. ShareBiotech Technology Core Facilities Survey 80 – 81

2.8. Presentation of ShareBiotech Needs Report 82 -

2.9. ShareBiotech Life Sciences TCF Booklet 82 – 83

2.10. The ShareBiotech TCF Audit 83 - 86

2.11. Regional Technology Translators (Pilot Action) 87 –

2.12. Organisation of Local Technology Meetings 87 –

2.13. Selection of Local Technology Meeting Domains 87 –

2.14. Natural Products LTM 87– 89

2.15. Towards 21st Century Toxicology Framework Document 89 – 90

2.16. Expert Interviews 91 –

2.17. Dissemination of Information and Colloquia 91 – 92

2.18. Biotechnology Clusters 92 –

2.19. Transnational TCF Model 92 – 94

2.20. The CIRCA Group Consultants 94 –

2.21. The Darcy Report 95 – 96

2.22. ShareBiotech Report to Support the Growth… 96 - 97

2.23. ShareBiotech Technology and Training Offer… 97 – 98

2.24. Instruments to Foster Technology Transfer… 98 – 99

2.25. Analysis of Life Science TCF’s Business Models… 99 – 101

Chapter 3 RESULTS 103 -

3.1. ShareBiotech Biotechnology Techniques Competencies … 103 –

3.2. Biotechnology Competencies and Regional Needs Survey… 103 – 106

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3.3. Innovation in ShareBiotech Regions 106 – 108

3.4. ShareBiotech Research Groups Survey Results 109 – 131

3.5. ShareBiotech Companies Survey Results… 131 – 154

3.6. ShareBiotech TCF Survey Results 155 –

3.7. Instruments to Foster Technology Transfer… 155 – 156

3.8. ShareBiotech Technology Transfer Survey Results 157 – 159

3.9. Answers to Technology Transfer Survey Questions 159 – 172

3.10. Natural Products Companies Surveyed in Ireland 172 – 181

3.11. Local Technology Meeting Organised in Ireland 181 – 185

3.12. The ShareBiotech Private Company/BRI Audit 185 – 190

3.13. Software for TCF Management 191 –

3.13. Implementation of CIRCA Report Recommendations 191 – 197

3.14. The Darcy Report 197 – 199

3.15. Expert Interviews 200– 203

3.16. Profiles of Experts Interviewed 204 – 209

3.17. Main Points in Expert Interviews 209 – 261

3.18. Recommendations to Strengthen the Biotech… 261 – 265

3.19. Biotechnology Education & Training Needs Offer… 265 – 272

3.20. Recommendations to Improve the Offer of Training… 272 – 274

3.21. Characterisation of ShareBiotech LTM’s 275 –

Chapter 4 DISCUSSIONS

Opening 277 – 278

4.1. INTERREG IV 278 – 280

4.2. Fragmentation of Biotechnology in Europe 280 – 282

4.3. Sustainable Growth for Europe 282 – 283

4.4. ShareBiotech Activity 3 Surveys 283 – 294

4.5. Natural Products Companies in Ireland 295 – 298

4.6. Success Factors in Biotechnology Today 298 – 300

4.7. US versus European Biotechnology 300 – 301

4.8. Technology Core Facilities 301 – 305

4.9. Instruments to Foster Technology Transfer… 305 – 307

4.10. ShareBiotech E&Y TCF Report 307 –

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4.11. Expert Interviews Discussed 307 – 314

4.12. The Circa Report Discussed 314 – 316

4.13. The Darcy Report Discussed 316 – 317

4.14. University –Industry Collaborations 317 – 320

4.15. Biotechnology Education; Training …Discussed 320 – 322

4.16. The Future of Biotechnology 323 –

4.17. The Virtual Biotech Model 324 – 326

4.18. Technologies Supporting Virtual Organisations 326 – 329

4.19. A Sustainable Bio Economy for Europe 329 – 330

4.20. SME’s in Ireland and Europe 330 – 331

4.21. Conclusion 332 – 333

4.22. Future Work – Horizon 2020 333 – 335

Appendices

Appendix 1 ShareBiotech Company Survey

Appendix 2 ShareBiotech Research Groups Survey

Appendix 3 ShareBiotech Technology Core Facilities Survey

Appendix 4 ShareBiotech TCF Audit

Appendix 5 ShareBiotech Education Needs & Offer Questionnaire

Appendix 6 ShareBiotech Deliverables (1 – 15)

Appendix 7 Toxicology 21st C Agenda

Appendix 8 ShareBiotech Email Contact List

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List of Figures

Fig. Number TITLE PAGE Figure 1.1 US Biotechnologies year by year 23

Figure 1.2 Innovation capital in the US year by year 24

Figure 1.3 Irelands cluster map shows Biotechnology/Pharmaceutical clusters 49

Figure 1.4 Bio pharma and Bio-chem sector employment projections/past/future 52

Figure 1.5 Michael Porters Diamond Cluster Model. Source 53

Figure 1.6 Hub and Spoke cluster model 54

Figure 1.7 Satellite Platform cluster model 54

Figure 1.8 State Anchored / State cantered cluster model 55

Figure 1.9 The Triple Helix Model 56

Figure 1.10 The Cluster Lifecycle 57

Figure 3.1 Populations of ShareBiotech Regions 104

Figure 3.2 Economic Indicators Index 105

Figure 3.3 Employment Indicators Index in Atlantic Area 106

Figure 3.4 Innovation Indicators Index ShareBiotech Regions 107

Figure 3.5 Summary of Biotech Company Domain & Regional Location 108

Figure 3.6 Summary of Research Centre Domain & Regional Location 108

Figure 3.7 Main Specific domains of the Interviewed RG’s % Total 110

Figure 3.8 Main Scientific domains of the RG’s in ShareBiotech Regions 111

Figure 3.9 Scientist’s & Technicians employed in RG’s 111

Figure 3.10 Number of Scientists and Technicians employed in RG’s in July 2010 112

Figure 3.11 Collaboration of the RGs in 2010 with other institutions/enterprises 113

Figure 3.12 Types of Collaboration of the Research Groups with institutions/enterprises 113

Figure 3.13 Characterization of Collaboration of RGs with institutions/enterprises 114

Figure 3.14 Participation of RG’s in one or several technological networks 114

Figure 3.15 Research groups that hold registered patents 115

Figure 3.16 RG’s that do not have patents but consider patenting in the future 115

Figure 3.17 DNA/RNA Biotechnology Techniques Uses and Needs in RG’s 117

Figure 3.18 Proteins and Other Molecules Biotechnology Techniques Uses and Needs 118

Figure 3.19 Proteins and Other Molecule Techniques Internal and External Use 118

Figure 3.20 Tissue Culture and Engineering Biotechnology Techniques uses & needs 119

Figure 3.21 Tissue Culture and Engineering Biotech Techniques Int/External Use 120

Figure 3.22 Gene and RNA Vectors Biotechnology Techniques Uses and Needs 121

Figure 3.23 Gene/RNA Vector Biotechnology Techniques Internal and External Use 121

Figure 3.24 Biological Resources and Associated Facilities Uses and Needs 122

Figure 3.25 Biological Resources and Associated Facilities Internal and External Use 123

Figure 3.26 Imaging and Related Instrumentation Uses and Needs 124

Figure 3.27 Imaging technologies accessible internally & externally 124

Figure 3.28 Process Biotechnology Uses and Needs 125

Figure 3.29 Process Techniques Internal and External Use 126

Figure 3.30 Nanobiotechnology Techniques Uses and Needs 127

Figure 3.31 Nanobiotechnology Techniques Internal and External Use in the AA 127

Figure 3.32 Bioinformatics Techniques Uses and Needs within the Atlantic Area 128

Figure 3.33 Bioinformatics Techniques Internal and External Use in the RG’s 129

Figure 3.34 Training needs regarding techniques and related skills of the RG’s 130

Figure 3.35 Training needs regarding techniques and skills of the RG’s by region 130

Figure 3.36 Other needs of the research groups for the advance of R&D activities 131

Figure 3.37 Other needs of the research groups for the advance of R&D by region 131

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Figure 3.38 Main specific domains of the interviewed companies - % Total Answers 132

Figure 3.39 Main Specific domains of the interviewed companies by region 133

Figure 3.40 Number of persons employed in the companies. In July 2010 133

Figure 3.41 Number of persons employed in surveyed companies in July 2010 134

Figure 3.42 Network Membership of Interviewed Companies by Region 135

Figure 3.43 Network membership of companies by region (%) 135

Figure 3.44 Enterprise group membership of companies by region (%) group 135

Figure 3.45 Role of Biotechnology in the companies - % Total Companies 136

Figure 3.46 Role of Biotechnology in the companies- % Total by region 136

Figure 3.47 Role of Biotechnology in the companies - % Total by region 137

Figure 3.48 Geographic markets where companies sold goods/services 2008 to 2010 137

Figure 3.49 Geographic markets where companies sold goods/services 2008 to 2010 138

Figure 3.50 Geographic markets where companies sold goods/services 2008 to 2010 138

Figure 3.51 Development of R&D activities - % Total Companies 138

Figure 3.52 Means of execution of R&D activities by companies - % Total Answers 139

Figure 3.53 Intellectual Property of the companies - % Total Companies 139

Figure 3.54 Barriers to your R&D capacity - % Total Answers 139

Figure 3.55 DNA/RNA Biotechnology Techniques Uses/Needs companies 141

Figure 3.56 DNA/RNA Biotechnology Techniques Internal/External uses companies 142

Figure 3.57 Proteins and Other Molecules, Techniques, Uses/Needs companies 142

Figure 3.58 Proteins and other molecules Techniques Internal/ External Uses 143

Figure 3.59 Tissue Culture/Engineering Biotechnology Techniques Uses/Needs 144

Figure 3.60 Tissue Culture and Engineering Biotechnology Techniques Int/Ex Uses 144

Figure 3.61 Gene/RNA Vectors Biotechnology Techniques Uses/Needs companies 145

Figure 3.62 Gene and RNA Vectors Biotechnology Techniques and External uses CO 146

Figure 3.63 Biological Resources/Associated Facilities Biotech techniques U/N CO 148

Figure 3.64 Biological Resources/Associated Facilities Biotech Techniques U/N CO 147

Figure 3.65 Imaging & Related Instrumentation Biotechnology Techniques U/N 148

Figure 3.66 Imaging & Related Instrumentation Biotechnology Techniques U/N CO 148

Figure 3.67 Process Biotechnology Techniques U/ N in Interviewed Companies 149

Figure 3.68 Process Biotechnology Techniques Internal and External Uses CO 149

Figure 3.69 Nano-biotechnology Techniques U/N in Interviewed companies 150

Figure 3.70 Nano-biotechnology Techniques Internal & External Uses Companies 150

Figure 3.71 Bioinformatics Techniques Uses and Needs 151

Figure 3.72 External and internal sourcing of Bioinformatics Techniques Companies 152

Figure 3.73 Company Training Needs % 152

Figure 3.74 Company Training Needs 152

Figure 3.75 Other Needs for Advancement of R&D Activities in Companies % 153

Figure 3.76 Other Needs for Advancement of R&D Activities in Companies Region 153

Figure 3.77 Technology Transfer Survey Response by Country 157

Figure 3.78 Regional Response to Technology Transfer Survey 157

Figure 3.79 Number of people working in innovation services and technology transfer 158

Figure 3.80 Type of instruments used to facilitate TT by interviewed organisations 158

Figure 3.81 The structure of TT Survey results analysis 159

Figure 3.82 Technology Transfer through student placement 160

Figure 3.83 Technology Transfer through joint supervision 161

Figure 3.84 Technology Transfer through joint conferences 162

Figure 3.85 TT through training and continued professional development 163

Figure 3.86 TT through secondment results in ShareBiotech partner areas 164

Figure 3.87 % TT through training and continued professional development 165

Figure 3.88 TT through contract research (service supply) & consultancy 167

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Figure 3.89 TT through legislation, communication tools/incentives to support spin-outs 167

Figure 3.90 Technology Transfer through shared facilities 168

Figure 3.91 Technology Transfer through patents 169

Figure 3.92 Technology Transfer through licensing and project maturation 170

Figure 3.93 Spider web graph representing the results of the ShareBiotech audit 186

Figure 3.94 Spider graph representing the BRI AIT audit results 188

Figure 3.95 Bioscience Research Institute AIT analysis in terms of flows 189

Figure 3.96 Projected optimal staff domains for the AIT Microscopy TCF 190

Figure 3.97 BRI Management Organization Chart suggested in the CIRCA Report 195

Figure 3.98 Main organizational relationships of the TCF 197

Figure 3.99 Scope of service provision in relation to the BRI - TCF 198

Figure 3.100 Accreditation Model suggested by CIRCA for BRI compatible to ISO 13485 199

Figure 3.101 Representation of the level of agreement between the 7 core experts

regarding 32 common theme questions 202

Figure 3.102 Representation of the level of agreement between the 7 core experts

regarding Q1 to Q10 202

Figure 3.103 Representation of the level of agreement between the 7 core experts

regarding Q11 to Q21 203

Figure 3.104 Representation of the level of agreement between the 7 core experts

regarding Q22 to Q32 203

Figure 3.105 Represents the number of yes answers agreed by all 7experts interviewed 203

Figure 3.106 Number & Type of Formal Higher Education Biotechnology Degrees AA 266

Figure 3.107 Vocational courses related to Biotechnology identified per region 267

Figure 3.108 Types of vocational training offer per region 268

Figure 3.109 Classification of the Current offer in Biotechnology Courses 268

Figure 3.110 Training needs identified by research groups 269

Figure 3.111 Training needs identified by companies 270

Figure 3.112 Soft skills in the field of biotechnology requiring short-term training 272

Figure 3.113 Analysis of the uptake of ShareBiotech Mobility Grants 274

Figure 3.114 Analysis of ShareBiotech Funded LTM’s 275

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List of Tables

Table

No.

Title Page

Table 1.1 Irish BioPharma Clusters Breakdown of Irish companies per sub-sector 44

Table 2.1 Audit Questions TCF 85 -86

Table 2.2 TCF's interviewed by E&Y 100

Table 3.1 Valid Questionnaires Collected the ShareBiotech project 104

Table 3.2 Number of Students in the research groups in the Atlantic Area in July 2010 112

Table 3.3 Age of Interviewed companies in the Atlantic Area- Descriptive Statistics 134

Table 3.4 Barriers to R&D Capacity of the Interviewed Companies by Region 140

Table 3.5 Access Capacity Ratio (Total Internal and External Accesses by Total

Access) 153 - 154

Table 3.6 Irish organizations interviewed Re. Technology Transfer Survey 156

Table 3.7 Results Synthesis Table of Technology Transfer Survey 171 - 172

Table 3.8 Natural Products companies interviewed in Ireland 173- 175

Table 3.9 Biotechnology SME categories for selection of LTM’s 175- 179

Table 3.10 Brief Analysis Results of N.P. Company Telephone Interviews 180 - 181

Table 3.11 SWOT Analysis of Bioclin resulting from the TCF audit 187

Table 3.12 Audit Recommendations for Bioclin recommended by TechToolNov 188

Table 3.13 SWOT Analysis BRI resulting from the TCF audit 188

Table 3.14 The recommendations of the ShareBiotech audit of the BRI 189

Table 3.15 List of selected laboratory core facility management systems i.e. LIMS 191

Table 3.16 Consensus between Experts answers to questions 1 to 33 249 - 251

Table 3.17 Recommendations to Support the Growth of a Bio-Based Economy 263 - 265

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List of Abbreviation

3D Three Dimensional

AA Atlantic Area

AAP Atlantic Area Program

ACC Access Capacity Ratio

ADA Adenosine Deaminase Deficiency

AFBI Agri Food and Bioscience Institute

AGBR Association of German Bio Regions

Agri Agricultural

AHU’s Air Handling Units

AIT Athlone Institute of Technology

AMDeC F.I.R.S.T. Facilities, Instrumentation, Resources, and Services & Technologies

API Alimentary Pharmabiotic Centre

ARE Applied Research Enhancement

B2B Business to Business

BBSRC Biotechnology and Biological Sciences Research Council

BBT Babraham Bioscience Technologies

BBT Babraham Bioscience Technologies

BI Biotechnology Ireland

BIF Bio Incubator Forum

BMW Border midlands Western

BRC’s Biological Resource Centres

BRI Bioscience Research Institute

BSE Bovine Spongiform Encephalopathy

CAGR Compound Annual Growth Rate

CAMI Centre for Advanced Medical Imaging

CCEB County and City Enterprise Boards

CCMAR Centre for Marine Research (Portugal)

CCR Centre for Commercialization of Research (Ontario)

CCR Centre for commercialisation and Research

cDNA Complementary Deoxy Nucleic Acid

CEBR Council of European Bioregions

CEO Chief Executive Officer

CFMS Core Facility Management System

CIIMAR Interdisciplinary Centre of Marine and Environmental Research

CIT Cork Institute of Technology

CNRS Centre National de la Recherche Scientifique (France)

CO2 Carbon Dioxide

COO Chief Operating Officer

CRIA Centre for Knowledge Transfer (Portugal)

CRITT Innovation et Developpemente de la Sante en BRETAGNE

CRO Commercial Research Organisation

CSIC Consejo Superior de Investigaciones Cientificas (Spain)

CVs Curriculum Vitae’s

DABT Diplomat of the American Board of Toxicology

DBF’s Dedicated Biotechnology Firms

DCU Dublin City University

DDD Drug Discovery & Development

DETE Department of Enterprise, Trade and Employment

DIHK Committee for Industry and Research in the German Chamber of

Commerce and Industry

DNA Deoxy Ribo Nucleic Acid

DOE Department of Energy

DSC Differential Scanning Colourimetry

E&Y Ernst & Young

EC European Commission

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ECO European Cluster Observatory

ECVAM European Centre for the Validation of Alternative Methods

EFPIA European Federation of Pharmaceutical Industries and Associations

EFTA European Free Trade Association

EI Enterprise Ireland

EICFP Enterprise Ireland Commercialisation Fund Programme

EIR Entrepreneur In Residence

EITTS Enterprise Ireland Technology Transfer Supports

EOP’s Equipment Operating Sheets

ERA-IB European Research Area Industrial Biotechnology

ERA-MB European Research Area Marine Biotechnology

ERBI Eastern Region Biotechnology Initiative

ERDF European Regional Development Fund

ES Spain

ESOF Euro Science Open Forum

ETB EuroTrans Bio

EU European Union

F S National Training and Employment Agency

FDA Food and Drug Administration

Fig Figure

FISH Fluorescence in-situ Hybridisation

Forfás Ireland's Policy Advisory Board for Enterprise and Science

FP Framework Project

FR France

GC Gas Chromatography

GCMS Gas Chromatography Mass Spectroscopy

GDP Gross Domestic Product

GE Gene Expression

GLP Good Laboratory Practice

GMC’s Genetically Modified Crops

GMIT Galway-Mayo Institute of Technology

GMO’s Genetically Modified Organisms

GMP Good Management Practice

GPC Gel Permeation Chromatography

GSK Glaxo Smyth Kline

H&E Higher Education

HEA Higher Education Authority

HEI Higher Education Institute

HEIs Higher Education Institutes

HGP Human Genome Project

HIV Human Immunodeficiency Virus

HP Hewlett Packard

HPLC High Performance Liquid Chromatography

HQ Head Quarters

IBA Irish Biotechnology Association

ICT Information and Communications Technology

IDA Industrial Development Agency (for Inward Investment)

IDR Invention Disclosure Reports

IGN Spanish Instituto Geografico Nacional

IGR-IAE Institut D’administration des Enterprises de Rennes – Institut de Gestion de

Rennes

ILab Intelligent Laboratory Management

ILO Industry Liaison Officer

IMI Innovative Medicines Imitative

INMRP Irelands National Marine Biotechnology Programme

INRA Institut national de la recherche agronomique

INTERREG The Cross Border Territorial Co-operation Programme for Northern

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Ireland, the Border Region of Ireland and Western Scotland

IP Intellectual Property

IPO’s Intellectual Property Owners

IPR Intellectual Property Rights

IRAM Institute of Millimeter Radio Astronomy

IRCSET Irish Research Council for Science, Engineering and Technology

IRL Ireland

ISO International Organisation for Standardisation

IST Irish Society of Toxicology

IT Information Technology

ITB Institute of Technology Blanchardstown

ITEM Institute of Toxicology and Experimental Medicine (Munich)

ITT Institute of Technology Tallaght

JISC Joint Information Systems Committee

JPI Oceans Joint Programing Initiative Healthy and Productive Seas and Oceans

KBE Knowledge Based Economy

KET’s Key Enabling Technology’s

KET’s Key Enabling Technologies

KIC’s Knowledge and Innovation Communities

LBN London Bioscience Network

LBN London Biotechnology Network

LC MS Liquid Chromatography Mass Spectroscopy

LE Large Enterprise

LIMS Laboratory Information Management Systems

LMB Laboratory of Molecular Biology

LTD Limited Company

LTM Local Technology Meeting

MaRS MaRS Discovery District Canada

MD Managing Director

MIRC Midlands Innovation Research Centre

MMI Molecular Medicine Ireland

MRC Medical Research Council (Cambridge)

MRes Masters in Research

MRI Materials Research Institute (AIT)

MS Multiple Sclerosis

MSc. Master of Science

NBP National Biotechnology Programme

NCBES National Centre for Biomedical Engineering Science

NCBI National Centre for Biotechnology Imaging

NCBI National Centre for Biotechnology Imaging

NFWDP New Frontiers Entrepreneur Development Programme

NHGRI National Human Genome Research Institute

NIBRT National Institution for Bioprocessing Research & Training

NMR Nuclear Magnetic Resonance

NMR Nuclear Magnetic Resonamce

NUIG National University of Ireland Galway

NUTS Nomenclature of Territorial Units for Statistics

NYDC New York Development Corporation

OBIO Ontario Bioscience Innovation Organisation

OCE Ontario Centre of Excellence

OCE Ontario Centre of Excellence

OECD Organisation of Economic Co-Operation and Development

ONE Ontario Network of Excellence

OSI Ordinance Survey Ireland

P&G Procter & Gamble

PCR Polymerase Chain Reaction

PET Positron Emission Tomography

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Ph.D. Doctor of Philosophy

PHA Polyhydroxyalkanoates

PI Principle Investigator

PLA Polymer Polylactic Acid

POC Proof of Concept

POI Program in Open Innovation

Post-Grad Postgraduate Course

PT Portugal

qPCR Quantitative Real-Time Polymerase Chain Reaction

R&D Research & Development

RDA Regional Development Agency

REACH Regulation Evaluation Authorisation and Restriction of Chemicals

REF Reference

RG’s Research Groups

RI Research Infrastructure

RNA Ribo Nucleic Acid

RO’s Research Organisations

ROI Return on Investment

RTP Research Triangle Park

RT-PCR Real-Time Polymerase Chain Reaction

S&E Southern & Eastern

S&T Science & Technology

SCC Stockholm Science City

SFI Science Foundation Ireland

SiRNA Small Interfering Ribo Nucleic Acid

SME Small to Medium Sized Enterprise

SNP’s Small Nucleotide Polymorphisms

SOP Standard Operating Procedure

SPECT Single Photon Emission Computed Tomography

STEM Science Technology Engineering and Maths

TA Thermal Analysis

TCD Trinity College Dublin

TCF Technological Core Facility

TCI The Competiveness Institute

TDL Technology Development Laboratory

TOF Time-Of-Flight 9Spectroscopy

TT Technology Translator

TTO Technology Transfer Office

TTP’s Technology Transfer Pathways

UCC University College Cork

UCD University College Dublin

UK United Kingdom

UKBI United Kingdom Business Incubation

UL University of Limerick

UMIC University of Manchester Innovation Company

UniMAP University of Malaysia, Perlis

US United States

USPTO US Patent and Trademark Office

VC Venture Capital

VP Vice President

VREs Virtual Research Environments

WIT Waterford Institute of Technology

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ACKNOWLEDGEMENT

There are a number of people without whom this thesis might not have been written, and to

whom I am greatly indebted. I have had the privilege to work with many talented individuals

who have made contributions to my research experience. My supervisor, Dr. Paul Tomkins

has been, and will always remain an excellent role model for me. Despite his busy schedule,

Paul always found the time to discuss anything and instilled in me the confidence to

continue and maintain belief in the worth of this endeavour. His dedication and commitment

to science and education is truly inspiring and remarkable. Special thanks to Paul’s wife

Collette who welcomed me into their home on many occasions and extended to me

unequalled hospitality, countless dinners and cups of coffee, but most of all, her warm smile

and endless support. I offer my sincere gratitude to my other co-supervisor, Professor Neil

Rowan, for the considerate ways in which you challenged and supported me throughout the

whole of this work – knowing when to push and when to let up.

Thanks to Siobhan, Anita, and Lorna, who played very important roles along the journey, as

I tried to make sense of the various challenges I faced and in providing encouragement at

those times when it seemed impossible to continue.

This dissertation is also dedicated to my brilliant and outrageously loving and

supportive partner, Lorenza Scavino. I extend warm gratitude to my sister Colette and my

three sons, Clive, Mark, and Ian for their belief in my ability.

I wish to thank Professor Horst Domdey, Dr. Martino Picardo, Dr. Claire

Skentelberry, Dr. Mario Thomas, Dr. Tony Jones, Dr. Derek Jones, and Dr. Mary Skelly, for

agreeing to be interviewed by me. Their insight, input, and influence were invaluable to the

writing of this dissertation.

I would like to thank all the members of the ShareBiotech consortium from the four

partner regions (Spain, Portugal, France, and Ireland) whose warm welcoming cultures,

enthusiasm, and professionalism, were a breath of fresh air and made the ShareBiotech

project a pleasure to be part of.

Also, the generous financial support of the EU Interreg Sharebiotech Project and the

Bioscience Research Institute in AIT for giving me the opportunity to carry out this work

and for believing in my ability and trusting me to represent them on the European stage.

Finally and most importantly, I dedicate this work to those who are loved and sadly

missed, but never forgotten, and were pillars of strength to me; my wife Gillian, my mother

Julia, my sister Jacqueline, her loving son Ross, and my father Christopher.

Bealtaine n-anamacha a bheith ina shuí ar dheis Dé.

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Abstract

Analysis of Biotechnology Cluster Drivers identifies successful models and

strategies in Europe and throughout the world that contributed to their success and

development. This constitutes a complex and frontier study that sets out to review,

examine and experiment with factors perceived to limit the development of positive

biotechnology cluster drivers in the life science technology sector of the Alantic

area, which was addressed under the EU Interreg Sharebiotech project. This

collaborative project, in keeping with Interreg structure, was divided into 7 inter-

related activities. Although my studies are framed around specifically activity 3

(addressing studies and action plan to reduce the gap between life science technology

supply and demand) that also encompassed comprehensive interviews with leading

experts in this field (activity 7); this thesis also describes the main outputs of all 7

activities as to view in isolation would both diminish and skew interpretation and

relevance of the former. It is also relevant to convey that this author also contributed

significantly to all 7 activities during the life time of this Sharebiotech Project.

The main intention of this study, through the ShareBiotech project, was to strengthen

the biotechnology sector of the Atlantic Area, through the maximisation of the

benefits of life science research infrastructures and skills, for the economic

development of the partner regions and of the Atlantic Area as a whole. This

research endeavoured to understand the reasons behind a weaker biotechnology

sector in the Atlantic Area; to identify infrastructure gaps and needs and to analyse

the drivers for success in other areas of Europe and the US through the clustering

model. The ShareBiotech project went far beyond just conducting an inventory and

offering existing technologies: it promoted a bottom-up approach and endeavoured

in partnership with stakeholders to find appropriate technological answers by

adapting the technology offerings.

Core aspirations of the project included (a) to facilitate wider sharing of knowledge

and technology within the Atlantic Area, across life science fields (Health, Marine

research, agriculture and food) and related high-tech transversal domains

(bioinformatics, imaging, and nanotechnologies), and between academia and

industry, (b) to reinforce regional service provision of technologies for researchers

(both public and private) in line with the identified needs, (c) to create the basis of a

transnational network of Technological Core Facilities (TCFs), in order to provide

technological services at the transnational level, (d) to foster technology absorption

in the less technology-intensive sectors and companies, in particular through

explaining applications of complex and recent technologies to SMEs and (e) to in

increase the profile and the visibility of the biotechnology sector of the Atlantic

Area, in order to make it an attractive choice for networking, cooperation and

locating business.

Findings showed that collaboration between industry, government, and HEI’s is

vital to the economic future of the EU, and is vital to the recovery of Ireland’s

economy. It is anticipated that this research will elucidate a model that can be

implemented in the Atlantic Area encompassing Ireland. This study also reported on

niche specialist areas of expertise and service provision across the EU Atlantic

region.

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1 Introduction

1.1 Origins of Biotechnology

This project embraced a selected analysis of the status of aspects of biotechnology

research and associated industry across elements of the Atlantic Region of the EU,

with novel follow-on research focused on the potential benefits of collaboration

models, knowledge transfer and access to technology facilities. This unique Intereg

project reflected the current and growing importance of biotechnology to the EU in

terms of society, life quality, environment and life sciences and benefits and the

associated industry, economic, technology and knowledge impacts. Before

introducing the formal tasks and objectives of this research, it is necessary to review

aspects of biotechnology and the potential origin of the drivers of this project.

Elements of this review comply with the traditional prior project time period, but

some embrace a parallel time frame and even more recently, when appropriate.

While some basic elements of biological knowledge would inevitably have slowly

accumulated since the origins of Homo sapiens in Africa about 200,000 years ago

and indeed their predecessors, it is inevitably only since the development of human

capacity to record and retain evidence of ideas and activities that a notion of aspects

of scientific history exists. There is nevertheless evidence of oral transfer to

generations of acquired knowledge, about 10,000 years ago. Initial knowledge

drivers as a capability evolved, would have been associated with attempted self-

understanding and basic understanding of surrounding plants and animals. The

literal word ‘biology’ may have originated in the 18th

C, but initiation of the former

can be associated with ancient cultures in Egypt, Mesopotamia, India and China,

although a more structured notion of biology probably derives from the more secular

tradition of ancient Greek philosophy (Magner, 2002). The overview of biology as a

discipline embracing the knowledge of living things progressed in the 19th

C as a

precursor of current terms, such as 20th C life sciences (Agar, 2012). In all

disciplines, the acquisition of information, the analysis of complexities and

pragmatic progression of knowledge and exploitation, accelerates with the passage

of time and consequently the scale, complexity and number of definitive derivatives

17

of biology has expanded enormously over the past two decades (Buchwald & Gray

2008).

There are now at least 42 divisions of the biology domain embracing everything

from agriculture to traditional zoology and a minimum of at least 10 further sub-

divisions of some of these (Gum et al., 2004). A key life science division is

biotechnology. There are a number of definitions of biotechnology, but a commonly

cited generic definition is that of the OECD:

"The application of science and technology to living organisms, as well as

parts, products and models thereof, to alter living or non-living materials for the

production of knowledge, goods and services" (OECD, 2009). Biotechnology is

consequently in part, the deployment of biological processes, organisms, or systems

to generate products that influence or enhance life – this tends to imply

commercialisation of research. The origin of the term, ‘biotechnology’ is associated

with Kéroly Ereky in Hungary in 1919, who used it to describe a means of

generating enhanced porcine products.

As part of the history, as far back as 10,000 years, selective breeding of plants and

animals was practiced, and alcohol fermentation has been carried out for at least

6000 years. However, it was not until the middle of the 20th

century, when a number

of fundamental discoveries were made, that the potential of biotechnology to impact

greatly on human health and well-being was recognised.

In a 20th

C context, the beginnings of biotechnology are consequently

associated with farmers and the farming industry of plants and animals. However,

many reviews and discussions of biotechnology tend to reflect the history of the

discipline as originating before this formal title.1 In reality, a crucial period that

influenced the current definition of biotechnology, implying a capacity to change

integral biological systems, occurred in the 1970s and hence a modern interpretation

of the origins of biotechnology is associated with the advent of genetic engineering,

despite the prior discovery of DNA structure in 1953 (Watson & Crick, 1953). This

respected crucial 1970s development was that of recombinant DNA technology by

Cohen & Boyer (Cohen & Boyer, 1973). Recombinant DNA permitted the first

transfer of a selected section of DNA between E. coli bacteria. This effectively

1 The Biotech Industry Organizations website Bio.org, 2014

18

represented a future capacity to bioengineer cells and organisms and subsequent

protein synthesis. The contributory significance of Boyer and the VC Robert

Swanson, to the advent of biotechnology is further evidenced by his founding in

1976 of the world’s first significant and domain associated, biotechnology company,

Genentech. This company ultimately grew to a value of $47b by 2009, was

responsible for the first human gene expressed product in bacteria, somatostatin in

1977 and was eventually taken over by Hoffmann-La Roche in 2009.

While, the biotechnology industry first arose in the United States in the

1980s, subsequently, a combination of creative biologists, venture capitalism, and

the influential support of state and local governments generated a series of major

biotechnology clusters, including San Francisco, Boston, San Diego, Seattle,

Maryland, and North Carolina, although this term was not fully appreciated then.

Conversely, commercial biotechnology took longer to develop in Europe, except for

the UK. The EU emphasis on government support was important, but as per the

USA, it was recognised many years ago that significant other factors were required,

including good relations with academic departments that specialize in the life

sciences, the availability of educated venture capital, and the development of critical

masses of companies involved in biotechnology and related activities.2

Examples of other influential developments would include: field testing of

genetically engineered plants (1985); patenting of genetically modified (transgenic)

animals (1988); Animal cloning (Dolly the sheep, 1997); and the publishing of a

complete human genome sequence (2003). In recent years the five major

interdisciplinary breakthroughs, - (i) gene sequencing; (ii) developments in

recombinant DNA technologies; (iii) advances in imaging techniques; (iv) the

growth and nature of internet\we development; and (v) nanotechnology - have

played a significant role across the biotechnology sector.

Selected, additional important developments include: in 1980 the US Supreme

Court ruled that genetically altered life forms could be patented, a Supreme Court

decision that allowed the Exxon oil company to patent an oil-eating microorganism.

In 1982, Genentech received approval from the Food and Drug Administration

2 Science advertising supplement, May 7, (1999) p989

19

(FDA) to market genetically engineered human insulin. In 1985, genetic finger-

printing was used for the first time in a court room as evidence of an individual’s

presence at a crime scene. In 1990 the first gene therapy took place on a four-year-

old girl with an immune-system disorder called ADA deficiency and the Human

Genome Project (HGP), the international effort to map all the genes in the human

body was launched at an estimated cost of $13 billion between the US & UK. Kary

Mullins won the Nobel Prize in chemistry in 1993, for inventing the technology of

polymerase chain reaction (PCR).

In addition, 1977 researchers at Scotland’s Roslin Institute cloned a sheep called

Dolly from the cell of an adult ewe – the first substantial mammalian clone. 1988

saw a rough draft of the Human Genome map showing the locations of more than

30,000 genes. On 14th

of April 2003, The International Human Genome Consortium,

led in the United States by the National Human Genome Research Institute

(NHGRI), and the Department of Energy (DOE), and the Welcome Trust Sanger

Institute in the UK, announced the successful completion of the Human Genome

Project more than two years ahead of schedule.

On the 20th

of May 2010, Craig Venter created the genome of a bacterium from

fundamentals and incorporated it into a cell to make first partially synthetic life-

form. The new organism was based on an existing bacterium that causes mastitis in

goats, but at its core was an entirely synthetic genome that was constructed in vitro.

However, further advancement in full synthetic organism development has not

progressed significantly since.

To return to more fundamentals regarding this discipline, biotechnology as a

broad discipline embraces sub-disciplines, which have now become labelled as red,

white, green, and blue. Red biotechnology implies medical processes such as

biopharma, or using stem cells to regenerate damaged human tissues and the future

capacity to generate entire organs in vitro. White or grey biotechnology implies

industrial processes such as the production of new chemicals or the development of

new fuels for vehicles. Green biotechnology relates to agriculture and involves such

processes as the development of pest-resistant grains or the accelerated evolution of

disease-resistant animals. Blue biotechnology, encompasses processes in marine and

aquatic environments, including sustainability of oxygen production and control of

hazardous fresh and marine organisms (Marine Biotechnology & Developing

20

Countries, 1999). Bioinformatics is an interdisciplinary domain, which analyses

biological systems via complex computational systems and consequently is

responsible for a huge proportion of bio-data, and significantly contributed to some

of the advanced recent biotech developments, previously cited (Wang, 2012).

There is a tendency to predominantly equate biotechnology with biopharma,

but the average time required to generate a biopharma product, the risk of failure and

the subsequent regulatory process implies significant development costs despite the

potential for subsequent substantial profits and important bio-impacts. This has

reflected a greater recognition that other biotech domains must develop more and

produce commercial outputs in shorter time frames. This has particular relevance to

many elements of the Atlantic Region of Europe, where one might expect that

biotech territories such as marine, energy, food and chemicals to receive specific

focus and motivation.

1.2 The Nature & Scale of Biotechnology Research

An indication of the breadth of biotechnology, would minimally embrace the

following sub-disciplines:

Agricultural Biotechnology • Plant biotechnology

• Animal biotechnology

• Biofertilisers, biocides, biological additives, microbial pest control, hormones,

pheromones etc

Aquaculture/Marine Biotechnology • Fish health & nutrition

•Broodstock genetics & breeding

• Bioextraction & marine bioprospecting

Environment • Biofiltration & treatments

• Bioremediation, waste management, phytoremediation

• Diagnostics

Food Production and Processing • Food processing

• Functional foods, additives, nutrichemicals

Forest Products • Silviculture

• Enhanced industrial bioprocessing

21

Human Health • Diagnostics

• Therapeutics

• Gene therapy

• Genomics/ Proteomics/ Bioinformatics/ Bioprospecting – genomics & molecular

analysis

Industrial Biotech and General Biochemicals • Custom bio-synthesis of biologicals

• Bioprocessing

• Custom synthesis of fine chemicals

Medical Devices, Equipment/Supplies and Bioengineering • Equipment manufacture, instruments, consumables, reagents

• Bioengineering, large scale fermentation & contract manufacturing, down-stream

processing

Mining/Energy/Petroleum/Chemicals • microbiologically enhanced petroleum/mineral recovery – biofuels/bioenergy

• Cleaner industrial bioprocessing

Nanotechnology • New materials design, therapeutics, manufacturing processes

Specialist Service Provider • Contract research and development to the biotechnology industry

• Consulting to the biotechnology industry

Agriculture is a major focus for biotechnology predominantly because societies need

to increase food production via lower cost as population density grows. Early

biotech developments to protect the environment led to reduced use of agro-

chemicals like pesticides, fertilizers and rodenticides. More recently it has generated

environmental friendly crops such as insect-resistant, herbicide-tolerant species and

crops that can fix nitrogen. Other elements of agricultural biotech development,

particularly GM crops have of course generated fears and concerns in many

countries – issues which have still not be fully addressed (Soetan, 2011).

Within biotechnology disciplines, there is a substantial portfolio of unique

biotechnology methods as well (Jungbauer, 2013).

1.3 Economics of the biotech sector

Analysing factors and variables that influence the economic growth of the biotech

sector is now routine and indicative of the importance of this domain in many

22

developed countries (Aggarwal, 2011). In 2009, the bio-based economy in Europe

was estimated to be worth 2 trillion euros in annual turnover derived from

biotechnology related activities alone and provided 20 million jobs.3

The health and industrial sectors that either use biomass or have applications for

biotechnology accounted for 5.6% of GDP in Europe in 2004 (compared to 7.4% for

information and communication technology).

In the decade before the recent economic crisis, the US biotechnology

industry was expanding as expected. According to Ernst & Young’s annual global

biotechnology reports measured in 2008 dollars, US biotechnology revenues

increased from $20 billion in 1996 to $70.1 billion in 2008, while R&D spending in

the industry increased from $10.8 billion to $30.4 billion. In 1996 the industry had

1308 biotech firms, of which 260 were publicly listed; and in 2008, 1754 companies,

of which 371 were publicly listed. Employment in the industry increased from

118,000 in 1996 to a peak of 198,300 in 2003, before declining to 187,500 in 2004

and 170,500 in 2005, and then rising again to 190,400 in 2008 (Lazonick & Tulum

2011). An accurate comparison EU and US biotech economic status based on these

published reports is not simple. In reality, the US hosts the largest biotech sector.

The global biotechnology industry rebounded strongly in 2013, during the

time frame of the ShareBiotech project. Public companies achieved double digit

revenue growth and there was a sharp rise in funds raised. Product successes have

boosted revenues, brought in investors, and large companies have been motivated to

invest strongly in R&D. However, much of the industry’s growth was driven by a

relatively small group of commercial stage companies, which spurred on the rest of

the industry to achieve greater efficiency in their drug development efforts. In an

Ernst & Young report, several findings emerged in their analysis of key performance

indicators.4 These key findings were as follows:

Revenue climbs: Companies in the industries established biotech centres (US,

Europe, Canada, and Australia) generated revenues of US$98.8B, a 10% increase

from 2012. However, virtually all growth came from 17 US based commercial

3 Ernst & Young, 2012, “What has Europe got to offer Biotechnology Companies

4 Ernst & Young report (Beyond Borders, 2014)

23

leaders, defined as companies with revenues in excess of US$500M. European top-

line growth slowed but profits soared.

R&D spending rebounds: R&D spending rebounded forcefully, up 14% from the

previous year, mainly driven by a 20% increase in US spending. This was the first

time since the onset of the global financial crisis that R&D growth outpaced revenue

growth.

Net income slips: Net income was down by US$0.8B, driven in part by the

US$3.7B increase in R&D expenditures during the year.

Market capitalization grew considerably, by 65% to US$791B, catalysed by strong

performances from commercial leaders, which increased overall confidence in the

sector.

Figure 1.1: Funding growth: Biotech companies in North America raised US$31.6b in

2013, a sharp increase from the US$28.7b raised in 2012 and the second highest total since

2003. Fifty biotechs (in the US, Canada and Europe) debuted on the public markets in 2013,

raising US$3.5b, a 300% increase compared to 2012 and the highest one-year total since

2000. (Source: E&Y, Capital IQ, Bio Century and Venture Source)

While, the impact of the financial crisis on the biotech, and in particular, the

biopharma sector was first recognised in 2009, (Lazonick & Tulum 2011), and

despite being a core science and requiring innovative, creative and deliverable

science, as a business it is inevitably driven by money and associated profits, within

a capitalist society.

24

Figure 1.2: Innovation capital; defined as the amount of equity capital raised by companies

with less than $US500M in revenues; increased by 36% and comprised the majority of total

funding for the first time since 2010. Driven by a strong IPO market, US companies raised

US$14.8B in innovation capital in 2013, the largest amount in any year in the last decade,

and 59% of the total capital raised. Meanwhile, the commercial lenders raised US$10.5B in

2013, despite a drop in debt of nearly 50% since 2011. (Source: E&Y, Capital IQ, Bio

Century and Venture Source)

In reviewing biotech start-ups in Finland, the authors after analysis decided,

that a high profitability and low growth biotech firm is more likely to make the

transition to high profitability – effectively higher growth than a firm that starts off

with low profitability. Also, a biotech venture that demonstrates high growth but low

profitability is less likely to become a profitable firm than one that demonstrates both

low growth and low profitability, (Brannback et al., 2009).

This confirms that for biotech companies, previous growth alone is not a

reliable indicator of future performance. Consequently backing fast growing biotech

start-ups does not guarantee business success. Brannback et al., (2009) suggest that

an assessment of the company’s internal resources, capabilities and market potential

could be more useful for prediction.

The global biotech industry is characterized by its requirement for large R&D

investments sometimes associated with uncertain results and infrequent benefits.

This complexity has enforced the belief that governments should positively influence

the sector. The USA as a leader in R&D spending and its consequences, has recently

contributed to its economic recovery by investing in innovation, education and

infrastructure to create future jobs and industries, (Sohn et al., 2013). Strategies to

achieve these objectives include an increase of investment in patent management.

25

The United States has proposed to give the US Patent and Trademark Office

(USPTO) full access to its fee collections and to strengthen USPTO’s efforts to

improve the speed and quality of patent examinations through a temporary fee

surcharge and regulatory and legislative reforms. It should be appreciated as well

that Germany and Austria support SME R&D development and that the majority of

companies, small and large are privately owned, and not dependent on shareholders.

The 2008 global economic crisis has placed far more pressure on government

policies to support economic recovery. However, R&D investments by emerging

economies like China, Brazil and India are expanding at rates often higher than those

in the US, and some European cuts in R&D spending could negatively impact on EU

biotech development as well as determine the number of biotech transfer contracts in

the future. While public sector cuts may improve investor confidence, it accelerates

the decline of science and technology. Biotechnology is one of the sectors most

sensitive to economic investment, implying that it does need government support,

including in the US. A relatively simple model is that public authorities should

facilitate technology transfer from universities and public research organizations to

industry (Sohn et al., 2013).

One nature of technology start-up company change over the past two decades

is that more young and even old people are now involved in the process. A recent

US study showed more University graduates initiating companies than their

academic staff (Åstebroa et al., 2012).

1.4 Biotechnology - Promising a Brighter Future for Europe and the World

Biotechnology contributes to everyday lives, from clothes and how they are washed,

food and the sources it comes from, medicines and even the fuel for transport.

Biotech already plays, and must continue to play, an invaluable role in meeting

people needs.

From new drugs that address medical needs and fight epidemics and rare

diseases, to industrial processes that use renewable feedstock instead of crude oil to

lower the impact on the environment and crops that are able to grow in harsh

climatic conditions and ensure safe and affordable food, biotech can and will

generate economic, social and environmental merits. The development of new

technologies promises a brighter future for the EU and globally. To drive

26

biotechnology forward it needs support from policy makers that supports risk-taking

and the public need to be better informed about how biotech can create a healthier,

greener, more productive, and more sustainable economy.

Healthcare biotech is already benefiting millions of people globally through

treatment of, cardiovascular disease, stroke, multiple sclerosis, breast cancer, cystic

fibrosis, leukaemia, diabetes, hepatitis, and other rare and infectious diseases.

Healthcare biotech is estimated to account for more than 20% of all marketed

medicines and it is predicted that by 2015, 50% of all medicines will be biotech.5

Biotech will ultimately generate more “Personalised Medicine” to diagnose what an

individual patient’s problems are and apply treatment to suit the specific needs of the

patient. The European healthcare biotech comprises in excess of 1,700 companies

and has a market value of more than €17B. The provision of jobs in the healthcare

biotech sector in Europe more than doubled from 2000 to 2008, showing an increase

of 158%.6

Industrial biotech helping to minimise mans impact on the environment while

boosting manufacturing output has generated increased employment. Industrial

biotech or “white biotech” used microorganisms and enzymes in the production of

detergents enabling clothes to be washed at lower temperatures, and in the

production of paper and pulp, clothing, chemicals etc., is done in a more

environmentally, efficient way that uses less energy, less water and produces less

waste. Agricultural products and organic waste can be used to produce biofuels e.g.

bioethanol, bio-diesel.7 In the battle against “climate change”, white biotechnology

can save energy in production processes which lowers the emission of greenhouse

gasses, a reduction of between 1B and 2.5B tonnes of CO2 equivalent per year by

2030.8 Europe is a world leader in the production of enzymes, and produces 75% of

the world’s enzymes.9

5 OECD, 2012: The Bioeconomy to 2030: Designing a Policy Agenda

6 Office of Health Economics, UK

7 Europa Bio, 2008

8 WWF Denmark, 2009

9 EU Commission, 2010

27

Agricultural biotechnology or “Green Biotech” can increase the food yield

from land by 6% to 30% which helps protect biodiversity and wildlife, (Gilbert,

2010). Agricultural biotech offers built-in protection against insect damage,

resulting in a reduction of pesticide spraying. Green biotech reduces fuel use and

CO2 emissions, and less land is required enabling farmers to grow more food,

reliably, in harsher climatic conditions.10

In 2009, this was equivalent to removing

17.7 billion kg of carbon dioxide from the atmosphere or equal to removing 7.8

million cars from the road for one year.

Agro biotech plants protect themselves against weeds and pests, so there is

less soil disturbance and this increased the efficiency of water usage and will also

reduce the risks of flooding as the soil will be better able to maintain water via

absorbance.11

By offering new improved and adapted agricultural crops such as

drought or saline resistant plants, agricultural biotech can contribute to the

Millennium Development Goals on reducing poverty and can help increase food

security for a growing global population estimated to reach 10b by the year 2050.12,13

It is likely that the use of the different sectors in biotechnology as sustainable

technologies will be a major contributor to cater for an ever-growing population.

1.5 Collaboration between Universities & Industry

As expected, industrial firms use a variety of relationships with university research

centres to contribute to development. Large companies have higher intensity

knowledge transfer and research support relationships in order to strengthen skills

and knowledge and gain access to university facilities for advancing non-core

technologies. Conversely, SMEs employ technology transfer and cooperative

research relationships in order to strengthen skills and knowledge and gain access to

university facilities for advancing core technologies (Santoro & Chaktabarti, 2002).

10

www.pgeconomics.co.uk

11 Impact of Genetically Engineered Crops on Farm Sustainability in the US, 2010

12 http://www.gatesfoundation.org

13 WHO, 2010

28

In Germany, specific HEIs, particularly Fraunhofer’s are focused on working with

companies and attract a third of their funding as a consequence.

A recent PwC report14

regarding Regional Biotechnology generated a number of

recommendations, including:

KBBE Aspects (Knowledge Based Bio-Economy) - ~ 9 recommendations,

including increase funding for SMEs and creating more translational research

centres in specific KBBE domains

Funding

Incubators – create new bio-incubators at cluster or regional level

Technology Transfer (TT)

Cluster Organisations – 10 recommendations, but does not specifically

identify enhanced HE interaction or Core Facilities as issues, although there

is a previous reference to incubator facilities. A more detailed review of

cluster issues will follow.

Entrepreneurial Culture

A partial emphasis of this proposal is again linkage, networking and formal clusters,

but rather simplistically does not draw attention to the benefits of accessible

technology facilities and the potential cost savings of HEI connections. While, this

project inevitably supports and promotes the benefits of biotech industry-HEI

connectivity, it is accepted that a large proportion of HEIs in many countries have a

history of slow delivery of industry research requirements, knowledge insecurity and

lack of understanding of business needs and mode of operation.

The formal recognition of the importance of HEI-business collaboration for

innovation and subsequent exploitation did occur many years ago and Germany did

introduce the first Fraunhofer institutes in 1949. Despite the existence of vocational

orientated Polytechnics in the UK from the 1960s, the sector was converted to

standard university in 1992, with a resultant decline in industry interfacing. Other

countries such as Ireland retained its more minor equivalent, the subsequent Institute

of Technology.

The Lambert Review of Business-University Collaboration was a report

by Richard Lambert, published in the UK in 2003, which aimed at improving the

relationships between the HE science base and the business community (Lambert,

2003). The UK Lambert Review recommended significant enhancement of the scale

14

PwC 2012

29

and quality of business–university collaboration. Since the 2008 crisis, that request

has probably grown further in part associated with funding.

Networking between universities and the business community is a critical

component of an efficient innovation ecosystem (Wilson, 2012). There are several

established networking tools at national and regional levels that create links between

universities, business and research technology organisations.

The loss of manufacturing industry has encouraged countries like the UK to

promote innovation in newer areas such as biotechnology. The emergence of the

‘bioeconomy’, however, has been highly uneven, with concentrations of activity in

certain countries and particular regions in those countries. In the UK, for example,

there are four major concentrations of the bioeconomy, each of which depends on

selected types of knowledge inputs into the innovation process and physical status of

the region (Birch, 2009). These factors include - differences in public science base,

knowledge spill overs and extent and size of biotech firms. Some regions have large

firms that can provide an ‘anchoring’ effect.

Lambert very much concluded that to increase knowledge transfer requires an

increase in research activity and demands amongst the non-academic communities,

rather than increasing the supply of ideas and services from universities. Over the

following decade, the quality, quantity and nature of industry-HEI collaboration in

the UK does appear to have increased (Santoro & Chakrabarti 2002, Hewitt-Dundas

2012, Wilson 2012,). These important points have been considered retrospectively

in the context of the foundation and delivery of this research project.

1.6 Research Infrastructure

Since the advent of microprocessors and subsequent engineering and software

development, research instrumentation and infrastructure have evolved considerably

in all science domains.

It has been predicted that the 21st century will see significant growth of a

bioeconomy based on applications of biotechnology as important and influential as

the IT was at the end of the 20th century (Lex, 2008).

Research infrastructure has become a major theme of EU strategy to grow research

and its economic outputs. The ERA-NET scheme was launched in 2002 as part of

the Sixth Framework Programme (FP6). It was designed “to step up the cooperation

30

and coordination of research activities carried out at national and regional level in

the Member States and Associated States, through the networking of research

activities, including their mutual opening and the development of joint activities”. It

therefore represented one element of progression towards the creation of the

European Research Area (ERA).

Research infrastructures (RIs) are of strategic importance in the context of the

European Research Area. Excellence in research requires excellent infrastructures,

for data collection, management, processing, analysing and archiving; this is the case

in all disciplines. Infrastructures are imperative for the advancement of science and

for scientific communities; they lead scientific development in new directions, create

an attractive research environment, and support international collaboration.15

1.7 Core Facilities

HEIs have long been recognised as a source of skill sets and research technologies,

including core facilities, (Santoro & Chakrabarti, 2002). A core facility is a

centralized, shared resource that provides scientific investigators with access to

instruments, technologies, services and expertise – this is consequently sometimes

now referred to as a technology core facility (TCF), an abbreviation that will be used

in this project.

A recent analysis of selected US TCFs16

explored a number of issues that can

influence their sustainability, organisation and operation of:

1. Cutting services or raising rates

2. Growing institutional use

3. Marketing services outside of the HEI

4. Better managing equipment transactions

5. More proactively managing start-up packages

6. Exploring possible core consolidation or shut-down

7. Sharing core personnel and creating satellites

8. Developing inter-institutional core partnerships

9. Crafting more disciplined core financial arrangements.

A number of these issues arose during the conduct of this project as well, the

consequences of which will be raised in the Discussion.

15 Science Europe (http://www.scienceeurope.org/), ERA Instruments (http://www.era-instruments.eu/)

16 California Nano-Systems Institute, UCLA, 2012

31

All biotech domains within the life sciences require access to core facilities to

resource advanced research, (Janssens et al., 2010).

High throughput screening (HTS) core facilities generate large amounts of data and

it is recognised that they benefit significantly when managed by appropriate

software, (Tolopko et al., 2010). Similarly, microarray core facilities are

commonplace in biological research organizations, and need systems for accurately

tracking various logistical aspects of their operation, particularly concerning the

number of test samples and the handling of data. A simple solution is to use

Microsoft Excel for tracking the transactions, but this often requires redundant data

entry into multiple spreadsheets, and is prone to error. Lab information management

systems (LIMS) software addresses this problem by storing information in

interrelated tables with more rigorous data entry mechanisms in place to prevent

inaccuracies and reduce redundancy charges that researchers incur necessitate a

highly organized and accurate system for managing this information, (Marzolf and

Troisch, 2006)

The cost and scale of core facilities influences the need for shared access,

(Murray 2009). The concept of core facilities is now widely accepted and

increasingly recognised that a management model must be applied to ensure viable

outcomes (Haley, 2009).

Core facilities are a common base model in the design of academic, non-

profit and commercial biological research organizations as well. In this model,

multiple research groups utilize the specialized resources provided by core facilities,

such as cell culture, sequencing, and genotyping and microarray services. Often

there is a mechanism by which these facilities charge the individual research groups

for the products and services they provide to them – in such a HEI model, individual

Departments have to pay the corresponding TCF for access to resources. Managing

a core facility typically involves keeping records of consumables, tracking samples

processed, and recording charges to researchers for products and services provided to

them. The considerable number of samples processed and the substantial charges that

researchers incur necessitate a highly organized and accurate system for managing

this information

Due to the rapid and wide development of laboratory technology, the speed at

which knowledge becomes redundant is increasing, implying regular training up-

32

skill provisions. With each new testing instrument purchased and each new product

to be tested in a laboratory, the gap can be wider. In order to prove its competence

and become accredited, a laboratory must also prove their staffs are competent. In

order to keep up with changes constantly occurring, laboratories have to constantly

manage the competence of their staff. Effective and efficient management of the

staff competence, knowledge, skills, education, and training can be a very

demanding requirement of the standard, especially for those laboratories which

operate in a free market and have little or no external financial support, (Stajdohar-

Paden, 2008).

iLab Solutions Inc., an example of a company that specialises in management of

core facilities, together with some competitors was subject to a review within this

project. The company conducted an annual survey of US TCFs in 2011 to review

structure and progress.17

In total, 246 individual core managers and directors from

over 1001 institutions, representing more than 30 different core types, responded to

the survey. This study shows that business growth and utilization rates increased

from 2009 to 2010 (60% of cores with growing volume, 7% experiencing declines).

The survey also indicated a number of key issues in core operations:

Most cores charge for services (93% of cores);

Chargeback income provides the most important revenue stream (49% of

revenues);

Core managers tend to spend the largest portion of their time directly

providing services to their customers (56 hours per month);

Labour constitutes the largest area of expense (50% of expenses);

Most TCFs still rely on basic spreadsheets to manage administrative tasks;

The most common means of staying at the forefront of the core’s scientific

interest are through word-of-mouth and conference attendance;

Social media have made only limited inroads in the core community; and

Most cores do not track the publications which result from their services.

The most recent 2013 iLab survey, was based on only 60 institutions in the US, EU

and Asia Pacific and the results suggest, demand for access to TCFs continues to

rise, but this is reducing the capacity of TCFs to undertake their own research and

17

iLab 2011http://www.ilabsolutions.com/

33

pressure demands consume staff time and require adoption of new tools to manage

the process.18

1.8 Core facilities & Higher Education Institutions

Formal as opposed to traditional informal, location, resourced and managed core-

facilities are becoming a principle component of science parks and physical

interfacing between industry and HE. For example, the Daresbury Science &

Innovation Campus – Innovations Technology Access Centre (I-TAC) provides

access to some core facilities for start-ups, which emphasises the importance of cost

effective access to fundamental and advanced technology and research facilities.19

The notion of networked core facilities has evolved in many countries and the

web is a common mode of connection and interfacing. The Victorian Platform

Technologies Network (VPTN) in Australia has some correlation with ShareBiotech

objectives. The network has currently 111 facilities over 38 different Universities,

Medical Institutes and Government organisations. Monash University was one of

the main organisations involved in setting up and developing the VPTN. The

network primarily focuses on biomedical and nanotechnology facilities. VPTN

focuses on core facility management systems that will bring better access and

awareness of the networks facilities and their efficiencies. In keeping with

ShareBiotech but effectively progressing further as a real network, VPTN also

engaged with EU, US and Israeli IT companies to set-up core facility management

software that will be integrated across the State so that all the facilities in the

network are visible and can be booked from one site. This required the setup of a

web interface on the front of the software where any customer can access the

required facility. The facilities and host organisations have control over their

facilities and who they approve to access, rules and custom configuration, in return

they allow the VPTN to collect high level information (desensitized) about usage and

capacity to give back to the State government to help in planning and future

investment decisions.

In the USA, AMDeC F.I.R.S.T. ™ (Facilities, Instrumentation, Resources, and

18

http://www.ilabsolutions.com/wp-content/uploads/2013/09/20130830-BMS2013.pdf

19 www.stfc.ac.uk/itac

34

Services & Technologies) was established in 1997, as a real-time web resource

hosting up-to-date information about technology and research resources available at

biomedical core laboratories in the New York tri-state area. AMDeC F.R.S.T.

effectively networked 100 Core Facilities, 300 services, and 400 instruments listed

on AMDeC F.I.R.S.T., available for immediate use on a discounted, fee-for-service

basis.

AMDeC definitely contributed to collaborative biomedical research via team science

initiatives, member services focused on cost savings and access to innovative core

facilities, and private sector partnership with the academic biomedical research

community. However, as a not-for-profit virtual TCF, AMDeC closed in 2013 due

to financial problems.

Traditionally, the presence of experienced academics and the generation of

able graduates were always considered obvious benefits for any technology sector.

It is a simple reality that in many advanced countries over the past twenty years, as

the percentage of a population attending third level HE has increased, the standard

and quality of programmes delivered has declined, despite the introduction of greater

regulatory structures and metric records. The poorer laboratory skills of many

graduates and postgraduates can consume more time and cause problems to industry.

It is crucial that a core facility must have experienced staff and provides proper

updated training for users (Piston, 2012).

Core facilities generally as previously indicated, implies relatively advanced,

complex technology that is not easy for small companies and organisations to

procure and manage themselves, hence a need for sub-contraction or collaborative

access. However, the advent of small cheap IT technology such as Arduino and

Raspberry pi may have some positive effect in the future on the design, nature,

access and cost of some selected laboratory tools (Pearce, 2012).

Obviously, HEIs are not just involved in industry collaboration in this

context, but are a major generator directly and indirectly of companies, mainly via

spin-offs. A recent analysis suggests that the local environment where the university

spin-off process is initiated appears to influence the development of other technology

dependent business ventures, (Rasmussena et al., 2014).

The escalating scale of laboratory technology development, the increased

need for access to selected core facilities and the introduction of a variety of

35

mechanisms in the US, EU and elsewhere to facilitate this process, particularly for

SMEs, contributed to the generation of an element of this project programme.

A traditional high ranking university engages in teaching and research and

resources and funds both effectively and students engaging in undergraduate degrees

are aware of on-going research. Delivering research for industry within an HEI does

however impose different requirements and nature relative to traditional academic

research. Consequently many universities (and IoTs in Ireland) conduct mainly

teaching, while research is located in specialized institutions where there are no

students or some postgrads/postdocs registered in a traditional university, examples

being CNRS/CSIC/Max–Planck and Fraunhofer in Germany. Because of its similar

work and structure, the Max Planck Society traditionally maintains close institutional

relations with both the French Centre National de la Recherche Scientifique (CNRS)

and the Spanish Consejo Superior de Investigaciones Cientificas (CSIC). There is a

cooperation contract with both organisations to promote collaboration in the form of

cooperation projects and joint research programmes.

The Laboratories Europeens Associes (LEA; currently 6), and the

Groupements de Reserche Europeen (GDRE; currently 8) have been very successful

with work undertaken with the CNRS and the CSIC, also maintain large research

facilities, including the Institute of Millimeter Radio Astronomy (IRAM); jointly

with the CNRS and the Spanish Instituto Geografico Nacional (IGN).

1.9 Laboratory Informatics

Laboratory informatics is defined as the specialized application of information

technology to optimize and extend laboratory operations. It encompasses data

acquisition, lab automation, instrument interfacing, laboratory networking, data

processing, specialized data management systems (such as chromatography data

systems), laboratory information management systems, scientific data management

(including data mining and data warehousing), and knowledge management

(including the use of electronic laboratory notebooks). Laboratory informatics has

risen with the tide of informatics in general and is one of the fastest growing areas of

laboratory-related technology.

36

1.10 Biotechnology Development in Europe

In the late 90s, some EU members did believe that technology policy should have a

model that relates to and supports regions on the basis that many tech sectors,

particularly biotech tend to develop within relatively close geography. The German

Federal Government initiated a contest, in which Germany’s leading Biotech regions

could compete for public funding (Dohse, 2000). This implementation was in

recognition of the fact that the US and UK had developed significant biotech sectors,

while Germany still retained a substantial chemical industry, it had been slow to

progress biotechnology. In the UK, Lord Sainsbury’s 1999 report, Biotechnology

Clusters, the UK held the largest biotech sector in Europe and was 2nd

to the US,

(Sainsbury, 1999). The Report made a number of recommendations to rely on the

cluster model to increase networking and the resultant scale of the bio sector – but in

the next few years the UK biotech sector declined considerably. Despite the loss of

multiple numbers of large biotech companies, most bought up, in recent years, the

UK biotech sector has grown again, with an emphasis on biopharma and clustering.

2013 showed significant recovery by the UK biotech sector in terms of number of

start-ups, number of public companies, and growth in value of company and scale of

anticipated new products, especially drugs (Ledford, 2013).

At the time in Germany, as part of the Federal Government model, a cluster

centre eventually subject to interview by this project (see Methods & Results

sections), was funded under this regional approach. Germany’s federal status tends

to support this approach, while some EU members and Atlantic Region sectors such

as Ireland, UK and France tend to revert more to capital control. However, within

the German federal structure, inevitably selected public and private organisations

may be prevented from initiating certain technologies, if they are considered to be in

conflict with another region.

The State had a major role in 1985-1995 in stimulating the initiation of the

biotech sector in Germany, although substantive private investment was also a key

driver (Champenois et al., 2009)]. Engagement of government in biotech initiation

other than public sector research did occur in a number of EU countries, while the

US might always present as private driven, the State would contribute via policies,

funding and resources.

37

More recently, there has been interest in examining the biotechnology sector

in new EU Member States and prospective candidate countries. Hungary, the Czech

Republic, Poland and Estonia were shown to be the main new members

demonstrating biotech development (De Greef & Frei, 2009). In part, these

countries are attracting outsourced contracts from other EU countries and globally on

the basis of cost and delivery, although sustainable growth on this basis is unlikely

due to competition with China and India.

In the early 2000s, growing EU authority recognised that Europe tended to

underperform in producing globally competitive technology companies and wanted

to implement methods to address this. One such approach was the EuroTrans Bio

(ETB) programme, still in progress (Abbanant, 2004). The overall objective of

EuroTrans-Bio (ETB) is to provide the European biotech industry with a funding

program dedicated to foster cooperation of R&D&I active SMEs (R&D &

Innovation) and their academic partners across European Member States (MS). The

strategic approach towards this program is presented by focusing on two essential

components:

• Increase impact by transferring national resources into the European Research Area

(ERA)

• Leverage of FP/H2020 funds and sustainability of the ERA-NET scheme20

In the mid-2000s, an optimistic EU aimed to achieve a goal of becoming the

foremost knowledge-based economy in the world and a true ‘Innovation Union’, in

which biotech SMEs were considered vital. As is later discussed, this aspiration has

yet to be achieved. Increasing connectivity between SMEs and larger companies and

HEIs as an element of enhanced regulatory and policy framework was part of

EuropaBio’s SME Platform.

The Europa-Bio report, year 2013, 2014 cited a number of issues affecting the

biotech sector, which was defined as largely being based and dependent on SMEs.

1. Biotech is high-cost, high risk and long term. As a result, many biotech

companies remain non-profit for quite some time and this consequently

20 https://www.eurotransbio.eu/lw_resource/datapool/_items/item_71/prague_fiche_eurotrans-bio-

final.pdf

38

implies high risk for external investors compared to other disciplines such as

IT.

2. Most biotech SMEs are funded by capital, rather than by cash flow, so that

when sources of capital decline the company survival is at risk.

3. Biotech products have to undergo long and expensive development and

regulatory approval procedures and funding for these stages has been difficult

in the EU.

4. Many EU biotech companies are not traditional SMEs (less than 250

employees) but are micro-enterprises consisting of <10 staff and their

capacity to deal with administrative burdens is therefore low.

In 2008, a senior EU biotech official, Maurice Lex published a paper confident that

post FP7, and new investments in R&D and business and infrastructure will ensure

that biotech develops significantly in the EU in 21st C – this is in keeping with the

previously cited earlier 2000 aspiration (Lex, 2008). How and where and the effect

of different political governance of course cannot always be predicted.

A high proportion of European citizens in a 2010 survey were optimistic about

biotechnology (53% optimistic; 20% ‘didn’t know’). They were however even more

optimistic about brain and cognitive enhancement (59%; 20% didn’t know),

computers and information technology (77%; 6% didn’t know), wind energy (84%;

6% didn’t know) and solar energy (87%; 4% didn’t know), but were less optimistic

about space exploration (47%; 12% didn’t know), nanotechnology (41%; 40% didn’t

know) and nuclear energy (39%; 13% didn’t know) (Gaskell et al.,2010).

Time series data on an index of optimism showed that energy technologies – wind

energy, solar energy and nuclear power – are on an upward trend – what is called the

‘Copenhagen Effect’. While both biotechnology and nanotechnology had seen

increasing optimism since 1999 and 2002 respectively, in 2010 both showed a

similar decline – with support holding constant but increases in the percentages of

people saying they ‘make things worse’. With the exception of Austria, the index for

biotechnology was positive in all countries in 2010, implying more optimists than

pessimists – however, Germany joining Austria in being the least optimistic about

biotechnology and in only three countries (Finland, Greece and Cyprus) was there an

increase in the index from 2005 to 2010.21

There is nevertheless, a strong possibility that

21

Europeans & Biotechnology in 2010, EC Survey

39

positive belief in biotechnology has further enhanced since 2010, even if the majority of

citizens are not really aware of the breadth of the discipline and its potential future impact.

Prior to the initiation of ShareBiotech, it was apparent that Europe’s biotech

sector had tripled in size over the previous decade, expanding to include 2,350

companies in 2006 compared with the 700 that only existed in 1996. Post-2008,

cluster development became a major EU issue. Even in 1996, Germany’s Bio-

Regio Initiative program devoted the deutschmark equivalent of $84 million to

finance biotech cluster development with an outcome of a lot of new companies.

Maintaining success and continuous commercial innovation is not however

predictable and according to a 2007 survey conducted by the German Ministry of

Education and Research a proportion of such companies failed. The BioCluster

2021 differs from the original model in that it is specialising to seek to develop

centres of industrial expertise, such as biocatalysis, biopolymers and protein

production, (Nasto 2008).

1.11 Industry Collaboration

An analysis fourteen years ago attempted to determine what issues influenced

industry collaboration in research (Hagedoorn et al.,2000). According to this study,

companies may participate in research partnerships in order to:

Reduce transaction costs in activities subject to incomplete contracts;

Broaden the effective range of activities;

Increase efficiency, synergy, and effectiveness via the creation of networks;

Access external complementary technologies and capabilities to support new

developments with business benefits;

Promote organizational learning, internalize core competencies, and enhance

competitiveness;

Create new investment options in high-opportunity, high-risk activities;

Internalize knowledge spill-overs and enhance the exploitation of research

results, while increasing information sharing among partners;

Reduce R&D costs;

Pool risk and co-operative competition.

This analysis went on to claim that Governments have promoted and supported

research partnerships in order to:

Correct market failures in R&D investment, particularly in the context of

invalid research;

Accelerate technological innovation, aiming at increased international

competitiveness; and

Increase technological information exchange among firms, universities, and

public research institutes.

40

Despite the multiple reasons and drivers identified in this 2000 review, it also

confirmed that there can be negative effects associated with collaboration. Despite

the range of benefits, partnerships and collaborations can potentially block

competition and create various kinds of static and dynamic monopolies.

Nevertheless, this relatively early analysis states a predominant benefit that

associates with a basis for many, collaborations and networks, the desire to reduce

R&D costs. Access to advanced technology facilities and the necessary skills to

generate viable outcomes, is an increasingly accepted issue and became core

exploratory task of this project.

There is a tendency in a number of EU countries including Atlantic Region,

such as, Portugal, Italy, Austria and France, for their universities to preferentially

recruit former graduates. This model, while no doubt creates a positive internal

environment, automatically reduces connectivity with global institutions and

associated networks, and the attraction of different knowledge and experience (Niosi,

2011). Conversely, the US encourages interregional university networks and

collaborations with R&D companies and public laboratories – this culture developed

in the UK as well and more recently aspects of it were applied in Ireland. A

common language across the US is no doubt another obvious advantage to facilitate

linkage and communication. Despite, a tendency of the EU to utilise English as a

leader language, in reality it has more than 20 major languages plus many regional

ones, which accounts for basic communication difficulties and reduces mobility and

as a result, interaction between HEIs and companies across the EU (Niosi, 2011).

The fact that the majority of important global science and technology publications

are in English, imposes an information need on practising scientists, but inevitably

language and HE and business culture differences across the EU reduce

communication and mobility relative to similar scale regions in the US – this is an

issue that will decline with the passage of time. Formal EU policy to encourage

cross-country collaboration and web technologies have accelerated research and

business interactions across the EU significantly, but most European researchers still

tend to live in a region within a single European country (Eurobarometer, 2008).

In reality, bringing the best researchers, developers and resources together ultimately

benefits from global rather than just national or regional links, and this of course is a

41

practice being pursued by some key companies and HEIs. The ShareBiotech project

explored some innovative Atlantic Region mechanisms for mapping and enhancing

cross-regional networks.

1.12 IP & Tech Transfer

Patenting became a larger and more important exercise for US universities by the

early 2000s and this different strategy also occurred in the UK but probably to a

lesser extent in EU universities (Owen-Smith, 2003). By 2014, the situation is

extended in most nations. Certainly, IP is now global and biotech is a major section

of patents (Singh et al., 2009).

In recent years while the demand for patenting in biotech has increased,

achieving it has become more complex despite the actual numbers increasing

significantly in most countries. A biotech patent not only needs to be innovative, but

also highly effective and specialised (Simon and Scott, 2011). Registering a patent

usually supports the attraction of more funding and investment to progress the

commercialisation and for biotech products that require considerable development

time, this is a traditional requirement.

The biotech industry reflecting the time and cost of product development and

the fact that the latter goes through multiple stages, is prone to the generation of

many patents to secure protection and enhance company value. This has been a core

biotech model for many years (Taylor et al., 2000). In the US, where multiple

alliances with partners will be set-up by a company to secure funding and support, a

greater scale of specialist research inevitably follows (Zidorn and Wagner, 2012).

As the company progresses, more specialist research will occur (Kim, 2011).

1.13 Clusters

Biotech firms obviously have to develop new products to create business value,

(Deeds et al., 1999). The exchange of ideas across industries, when it occurs depends

on a number of activities, individuals and resources, but physical location is a

contributory factor, (Desrochers & Leppälä, 2011). Physical location maybe

facilitated by participation in a cluster structure as indicated in the previous account

of cluster evolvement and issues.

42

A cluster typically assumes a group of interconnected companies and other

institutions embracing amongst other, services, manufacturing, suppliers and HEIs

within a region (Su and Hung, 2009). Clusters are probably a common structure for

biotech, because, the time, costs and resources required for biotech product

development are frequently so large, that independent start-ups would typically have

difficulty progressing a development. Key individuals, economics and dynamic

networking no doubt influence the initiation and growth of a cluster. While,

referencing to clusters tends to cite the historical classics, Boston, Cambridge, Bay

Area (etc.), as defined by Porter (Porter 1998), there are numerous new,

‘spontaneous’ biotech clusters developing in designated areas across the world.

More extensive geographical linkages are an element of this project.

W.W. Powell of Stanford University believes three elements are critical to the

formation of productive business clusters (Powell, 2010):

•Multiple types of organizations

•A catalytic anchor tenant that protects the openness of the community and allows

multiple views to be heard.

•Cross-cutting local networks

The first and third of these are highlighted by many other analyses as well and

represent a basis of an aspect of the ShareBiotech approach.

Since 2008 there has been expanded EU emphasise on the importance of clusters and

networks for development of the biotech sector, (NetBioCluE 2008). While initial

clusters such as Cambridge, which commenced in the early 70s were occurring long

before the impact of modern networking, networking is considered an important

element and as previously stated, the EU has for some years been convinced that

clustering has positive impacts on economic development, (Ketels 2012). Ketels

report defined four network programmes with potential for economic growth and

these emphasise networking and formal cluster creation:

1. Support of networks in emerging industries and clusters

2. Establishment of national cluster platforms to provide shared services and

connect firms across regions

3. Support for networks of SMEs active in areas with positive externalities, like

innovation and exporting to new markets

4. Networks as part of more comprehensive efforts to enhance regional

competitiveness

43

The nature of networking has of course changed since the advent of the web. For

example, social networks initially linked to career mobility emerged and became an

important element of skills and idea sourcing within the San Diego biotechnology

cluster, and formal government drivers in Southern Germany (Casper, 2007). The

nature of communication in virtually all elements of human society has obviously

changed dramatically since the development and progression of internet technology

and the generation of the web. With multiple aspects of communication being

critical to the delivery and success of clusters, all standard techniques are

implemented, and not surprisingly, a cluster in Scandinavia, devoted to wireless

communication technology, employs and exploits these current and emerging

systems to facilitate the cluster (Richter & Park, 2012). This also supports the view

that a cluster must innately be a promoter, disseminator and user of new

technologies.

Since Porter’s work, there have been numerous analyses and proposed

models regarding cluster development, most of which, distinguish,: (i) spontaneous

clusters, that are the result of the spontaneous co-presence of key factors; (ii) policy

driven clusters, that are initiated and driven by the strong commitment of key

government leaders in an attempt to address industrial decline or as a deliberate

decision to generate a biotech sector. In some regions or countries, both forms of

cluster creation may exist. Biotech clusters in EU, except the UK is largely

government policy driven. The Heidelberg cluster in Germany, largely biotech had

to inevitably address survival and growth when the public funding subsequently

declined (Chiaroni & Chiesa, 2006). A decline in public funding, supportive of

cluster management and development has not since been uniformly addressed across

the entire EU.

A recent Irish report devoted to innovation did not fully embrace the funding

issues. It embraced amongst other basic topics, Knowledge Transfer, Skills Strategy,

Innovation through public procurement, regional innovation through networks,

clusters and gateways, IP. The ‘gateways’ referred to a government intention to

bring networks of towns together. The Gateway model was never implemented and

has now effectively disappeared. The report, despite the title is not innovative and

probably indicative of government knowledge deficits regarding the real world of

44

science/tech and transfer that generates innovative companies, (Innovation in Ireland

– Policy Report 2011).

The 2009 EI summary of aspects of the Irish biopharma and biotech sectors

implied the existence of clusters. Table 1 is evidence of collaboration between

selected companies, but is not indicative of a traditional cluster; evidence of

connection with HEIs not present. A number of the cited companies are SMEs and

their collaboration in effect reflects sub-contraction of work. Within the EU,

promotion of particular models tends to persuade many members to claim their

commitment to them, even if real evidence is limited.

Table 1.1: Breakdown of Irish companies per sub-sector

Source: Enterprise Ireland; Irish Bio pharma Clusters 2009

Ireland’s national biotechnology program is driven from its government’s significant

emphasis on the sector through dedicated funds targeting technology

45

commercialization, R&D infrastructure development and enhancement, and

marketing efforts looking to bring international talent and facilities in-country.

Almost every major university has resources focused on biotechnology studies due

to commitment of the government’s program for research in Third Level Institutions.

However, post “Celtic Tiger” the government embarked on a program of austerity

which saw reduced funding for research to HEI’s research projects which has done

little for Ireland to position itself as a leading European-based location for several

industries, including biotech. Among Ireland’s challenges, it must maintain its focus

in life science fields to grow and retain its related commercial base, and ensure that

academic/industry collaboration, technology transfer and commercialisation efforts

maximise investment in the biotech area. Addition efforts to gain critical mass and

clusters within the sector are needed to ensure that key portions of the R&D and

commercialization activities remain located within Ireland to develop a domestic

expertise to encourage future development, thereby creating a virtual cycle of

innovation; Department of Trade & Enterprise, (DETE, 2008).

The 2011 OBN BioCluster Report review of the Oxford biotech cluster

presents and raises some interesting points in terms of people and finance:

The scale and success of the clusters around Boston, the Bay Area and San Diego

reflects that the companies access the resources and networks that the clusters offer.

This translates into remarkable statistics; nearly 17% of residents in the State of

Massachusetts are now employed in the life sciences sector. Despite a very long

cluster history, some years ago it was pronounced that the UK would need to

stimulate innovation in biotech clusters to have a significant impact, (Rees 2011).

The Oxford cluster relative to Cambridge does appear to be interesting. The amount

of investment in the bioscience industry in Oxford increased between 2008 and 2011

from $108 million to $168 million and from $433 million to $874 million in the UK

from 2007 to 2010, respectively, despite the global financial crisis. However, in

Oxford and the UK overall, the primary biotech sector for investment continues to be

the traditional DDD (Drug Discovery & Development), rather than newer sectors.

1.14 The Clustering Concept

Cluster development also referred to as “cluster initiative or Economic Clustering “is

the economic development of business clusters. Since the cluster model was first

46

proposed by Michael Porter in 1990, it has attracted attention from governments,

consultants and academics. The cluster concept has been adopted globally by many

governments and industry and has been recognised as a means to stimulate urban and

regional economic growth. A continuing trend of cluster initiatives was adopted in

the 1990s globally. The first comprehensive global study of cluster initiatives was

reported in the “Cluster Initiative Greenbook” which was published by Orjan Sovell,

Christian Ketels and Goran Lindgvist (2003), with a foreword by Michael Porter.

The report was presented at the annual meeting of” The Competiveness Institute”

(TCI) in Gothenburg in 2003 and a follow up study in 2005 covered more than 1400

cluster initiative organisations globally.

SMEs, public or private companies and multinational organisations represent

the core of the cluster, the evolution of these elements and the relationships they

form between them shape the cluster development model; regardless of its size,

complexity and specialisation of production processes, the complexity of the cluster

is given by the number of firms that form it.

1.15 The importance of clusters

Economic agglomerations, or clusters, have captured the attention of policy advisors

worldwide. Many countries (e.g., Canada, Australia, Germany and the United

Kingdom) have adopted clustering as a preferred economic strategy for generating

higher rates of invention, innovation and economic growth (Ryan & Phillips, 2003).

Porter (1998: 197) defines clusters “as geographic concentrations of interconnected

companies, specialised suppliers, service providers, firms in related industries, and

associated institutions” (Porter, 1998). A successful or potentially successful cluster

commonly has a strong base of university and government labs and production

facilities, which provide access to expensive specialised skills and machinery, as

well as a significant amount of informational knowledge that is not visible is

embedded in the larger community – also known as tacit knowledge. The

development of a cluster is more than just co-location; it provides an environment

for relationships. As a result, the organisations that are active within a cluster both

compete and collaborate, thereby facilitating the growth of the local economy.

The analogy of the cluster ‘jig-saw’ puzzle (Martin & Sunley, 2002) may be

used to characterise a successful cluster, as it contains all the necessary ‘pieces’ –

47

actors and functions – in order to be effective. Each piece is ideally accessible within

the region but the community may need international connections in order to access

all functions needed for the economy (Phillips, 2002). A cluster, like an organism,

experiences origin, growth, and decline/reorientation. A cluster can be

“spontaneous” or “policy driven” through their life-cycles. This study addresses two

research questions: What is the success factors affecting the formation of biotech

clusters? How can we emulate the success factors that shape the configuration of a

successful biotech cluster in the Atlantic Area?

We conduct a case analysis of four clusters namely the BIOM

Biotech Cluster

in Munich, Stevenage Bio-catalyst, Biocant Portugal, and the Babraham Cluster

Cambridge UK. We also conduct in-depth interviews with the CEO of the Council

of European Bioregions (CEBR), and the director of the Ontario Centre of

Excellence (OCE). To understand the dynamics of different types of clusters is

expected to benefit both policy makers and academic researchers. These results are

crucial in the formation of a knowledge based economy. A concern regarding the

current decade EU strategy is that the priority of life science or biotechnology

contribution in the form of a bioeconomy has been diminished (EuropaBio, 2010).

The global financial crisis since 2008, negatively impacted on the end of the Lisbon

Strategy, but prior studies indicated that the EU biotech sector was not cohesive or

sufficiently mature (Wolfe & Gertler, 2004).

Clusters have been a popular research area for economists and geographers for

decades. Michael Porter (Harvard Business School) examined industrial clusters

from the perspective of business strategy and discussed the national and regional

competiveness. There remains a lack of consensus over how clusters are started and

to what extent their emergence can be set in motion by conscious design or policy

interventions (Moran, 2007). Clusters evolve as well as interact with other clusters

and with the political, entrepreneurial, and other social environments. This thesis

attempts to understand the “genetics” and “evolution” of clusters and examines

constructive directions for development of biotech clusters in the Atlantic area. We

also investigate how access to Technology Core Facilities benefits SMEs, and

ultimately plays a significant in the development of biotechnology clusters.

Clusters differ in their origins. According to Porter (Porter, 1998), the birth of a

cluster might be rooted in historical circumstances, prior existence of supplier

48

industries, or even chance. Clusters can be created by a confluence of events:

opportunity, existence of raw materials (including ideas, skilled human capital etc.),

emergence of an anchor firm, or some unexpected events, such as downsizing of the

public sector inspiring local entrepreneurs (Feldman, Francis, Bercovitz, 2004).

Chiaroni and Chiesa suggest two major forms of cluster creation in the biotech

industry: (1) spontaneous clusters that are the result of spontaneous co-presence of

key factors: and (2) policy-driven clusters, that are triggered by the strong

commitment of governmental actors whose willingness was to set the conditions for

the cluster creation, either as a response to an industrial crisis or as a deliberate

decision to foster the biotech sector (Chiaroni and Chiesa, 2005). The Biocant

Cluster in Canthanede Portugal, the first biotechnology cluster in Portugal is an

example of the emergence of a policy-driven cluster. An interview with Mariana

Brandano, technology transfer officer with the Biocant cluster elucidated the steps

taken by the regional government of Canthanede for the development of the Biocant

cluster. The ShareBiotech project aims to strengthen life sciences and the biotech

sector in the Atlantic area, create a network of biotechnology core facilities, foster

collaboration between SMEs, HEIs, Research centres and industry, improve access

to infrastructures and skills for R&D and basic research, and make the Atlantic area

an attractive choice for networking, collaboration and business.

1.16 Clusters in Ireland

There are a number of possible clusters in Ireland which involve several desirable

aspects of a national system of innovation:

1. Close linkages between industry and higher education

2. Effective knowledge flows between customers

3. Collaborative focused attention to common problems

The three major cluster groupings in Ireland are Bio/pharma, Information and

Communications Technology (ICT) and internationally traded services.

The concepts of clusters and networks are well known to Irish policy-makers. As far

back as 1992, the report of the Industrial Policy Review Group recommended the

promotion of industrial clusters focused on niches of national competitive advantage.

Additionally, a number of enterprise development support programmes highlight the

advantages of clusters as being desirable or necessary to improve productivity. Irish

49

policy-makers must recognise that successful companies draw on external influences

and internalise the benefits. The local availability of a critical mass of expertise, in

institutions and in other businesses significantly assists this process. The building of

clusters and linkages between companies, third level institutions and international

partners again, helps company’s access local, national and international knowledge

and expertise.

Figure I.3: Irelands cluster map shows Biotechnology/Pharmaceutical cluster

concentrations in the main cities of Ireland Source: ‘Knowledge and Enterprise Clusters in

Ireland’ (Department of Enterprise, Trade and Employment 2008)

Ireland can be characterised as having both a policy push and bottom-up approach to

cluster formation. There are a number of government-funded initiatives that seek to

promote the establishment of clusters. Additionally, a number of putative clusters

arose as a result of Ireland’s successful Foreign Direct Investment (FDI) policies.

Ireland has benefited both from its focus on a number of high growth sectors such as

IT and bio/pharma and its exploitation of “first-mover advantages” by which it first

50

attracted a major company in a target sector to Ireland making it easier to entice its

sub-suppliers to do likewise.

The closer integration of the two economies on the island into a rapidly

evolving all-island economy has been reflected in and reinforced by the development

of an increasing number of mutually beneficial Collaborative Business Networks in

areas such as software, digital media and healthcare.

Biomed Ireland is on an all island basis and regionally through initiatives such as the

North West Science & Technology Partnership (NWSTP) — all of which have

received facilitation and project funding from InterTradeIreland. In addition, the

Governments of the United States of America, Northern Ireland and the Republic of

Ireland have come together for a unique initiative to advance scientific progress in

fields that will have a potential positive impact on the health and economics. As part

of its overall remits to encourage both national and international collaboration, and

specifically in the context of North-South initiatives in science and technology,

Science Foundation Ireland (SFI) strongly encourages research collaboration

between SFI funded researchers and researchers in Higher Education Institutions

(HEIs) in Northern Ireland.

1.17 Bio/pharma cluster Ireland

The bio/pharma cluster incorporates a number of important sub-sectors including

pharmaceuticals, pharma, biotechnology and medical devices. Foreign direct

investment in the Irish bio/pharma sector began 40 years ago when Squibb (now

Bristol-Myers Squibb) became the first overseas pharmaceutical company to locate

in Ireland. Currently 20 of the top bio/pharma companies in the world have located

in Ireland. The Pharmaceutical sub-cluster in Ireland is supported by a sophisticated

infrastructure of serviced sites, public utilities as well as specialist support

companies and services.

There is a large congregation of pharmaceutical companies in the Cork city

area and linkages have been established with the two main HEI’s in Cork, University

College Cork and Institute of Technology, Cork. Additionally, the Cork

pharmaceutical cluster has resulted in the development service businesses’ in areas

such as plant design, construction, and supply chain and recruitment services.

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There are also smaller geographical groupings of pharmaceutical companies in the

mid-west and south-east regions. In Dublin, Wyeth, which has been operating in

Ireland since 1974, has established one of the largest integrated biopharmaceutical

campuses in the world. It is the only facility in Europe to manufacture biotech,

vaccines and small molecules under one roof.

The arrival of several large multinational companies in Galway resulted in

the development of the medical devices cluster based primarily around Galway city.

This in turn created the development of an indigenous sub-supply base and, assisted

by Enterprise Ireland, a number of these Irish-owned companies have become

significant international players in their own right within the medical device sector.

Sligo and the midlands region are also medical device “hot-spots”. The bio/pharma

cluster in Ireland is commencing a new phase of development triggered by the multi-

billion euro investment that the Irish Government is making in basic research in

biotechnology and ICT.

1.18 Development of an indigenous biotech sector

Taking into account the current state of the post-Celtic Tiger economy, it is vital to

focus on the development of the indigenous biotech sector in Ireland because

Ireland’s dependence on FDI is not conducive for the long-term development of a

strong, vibrant and sustainable economy. The present policies relating to innovative

industrial developments in the bio-sector are not working optimally (Fig. 1.4).

Reports show that the main issue undermining the development of the indigenous

biotech sector is the lack of entrepreneurial developments caused by the presence of

inter-related structural weaknesses. There has been a failure to address the issues

owing to the fragmented manner of the on-going initiatives, and the top-down

approach in which they have been conceived and implemented.

There exists an urgent need for the introduction of an all-encompassing

framework to create a support ecosystem that supports entrepreneurial and

innovative activities throughout the sectors value-chain. To achieve this initiative, a

long-term forward looking roadmap, irrespective of electoral and business cycles

needs to be implemented. There is also a need for sustainable private sector input to

develop Ireland’s indigenous biotech sector.

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Figure 1.4: Bio pharma and Bio-chem sector employment past and future projections

(Ireland) Source: EGFSN Industry estimates

1.19 Porter’s theory on Industrial Clusters

Michael Porter in his Competitive Advantage of Nations (1990), through his analysis

of the factors determining national competitiveness, stated: “The basic unit of

analysis for understanding National Competitive Advantage is the industry,

“Nations succeed not in isolated industries, but in clusters of industries connected

through vertical and horizontal relationships”, (Porter, 1998: 73).

Porter initially argued that individual nations gain competitive advantage in

particular industrial sectors that compete internationally, and that successful sectors

portray strong tendencies to concentrate within particular regions. In a revised

edition (1998), Porter adjusted his geographic focus to include non-internationally

competitive regional industries. At a national level, Porter conceived clusters as

broad industry groups linked within the overall macro economy. At the regional

level, the constituent elements share common regional locations, including urban

areas, labour markets, and/or other functional economic units (Porter, 1990, 1998).

Porter defines clusters as “geographic concentrations of interconnected companies,

specialist suppliers, and service providers, firms in industry, and associated

institutions, (e.g. universities, standard agencies, trade associations) in a particular

field that compete but also co-operate” (Porter, 1998). The interconnections are

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characterised by vertical, i.e. supply chain, and horizontal relationships, e.g. the

presence of common customers, and technology. The linkages and interdependencies

among actors in value chain activities are at the centre of the concept (Porter, 1998;

Enright & Roberts, 2001).

Porter focuses on the importance of close proximity in facilitating synergistic

interactions between actors that generate innovations and innovation by facilitating

information/knowledge and technology transfers through repeated trust based

exchanges, i.e. networks. Only through constant innovation, improvement and

upgrading, including product, process and organisational methods innovation, can

competitive advantage be attained and sustained. The nature and sources of

competitive advantage differ widely amongst industries, and cannot simply be

equated with economies of scale or labour cost differences, (De Witt, 2001).

Porter proposed a 'diamond' (Figure: 1.3) of four broad determinants of

national competitive advantage, i.e. Factor Conditions, Demand Conditions, Related

and Supporting Industries, and Firm Strategy, Structure and Rivalry.

Figure 1.5: Michael Porters Diamond Cluster Model. Source: “The Competitive

Advantage of Nations”, 1990

1.20 Typology of clusters

Hub and Spoke Cluster Model

In a hub and spoke cluster model, (Figure 2.4) a few dominant firms represent the

core of the cluster and are surrounded by smaller firms that have direct links to them.

The smaller hub-companies are mainly service provision company’s e.g. raw

materials, reagents, or have a specialized role in R&D. The small firms trade

directly with the large ones and depend on their client strategy. The hub firms define

the relation inside the cluster and its dynamics. An example of a dub and spoke

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cluster was the Detroit Automobile Cluster that was concentrated around the “Big

Three” auto manufacturers.

Figure 1.6: Hub and Spoke cluster model. Source: Markusen, 1996

Satellite Platform Cluster Model

In a satellite platform cluster (Figure 2.5) a group of branch facilities of externally

based multi-plant firms, (Markusen, 1996) are located in a particular geographic

region in order to benefit from government facilities or low costs with supplies and

workforce. One of the characteristics of the satellite platform cluster is that there are

no relations between satellite firms and they are entirely controlled by the remotely

located parent firm.

Figure 1.7: Satellite Platform cluster model: Source: Markusen, 1996

State Anchored/State Centred Cluster Model

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The last category, the state centred (He & Fallah, 2011) or state anchored cluster

(Markusen, 1996) (Figure 2.6), is defined around a public, governmental or non-

profit organisation that dominates the region and the economic relationship between

cluster members. This entity, e.g. the Cambridge Cluster in the UK, is surrounded by

numerous small firms that benefit from public-private contracts. The state centred

cluster model can be compared to a hub-and-spoke cluster model, where there is one

key dominant player that is not controlled by the private sector.

Figure 1.8: State Anchored / State cantered cluster model: Source: Markusen, 1996

/ He & Fallah, 2011

Hybrid Clusters

In some cases, the birth of a cluster is the result of hybrid processes. Two major

cases in San Diego and Milano support this. In the case of San Diego there was

already a high-tech cluster focused on ICT that grew up spontaneously in place. The

crisis of the military market brought a strong decline of the cluster, which was

converted to biotech through supporting actions of local government. Several

initiatives were created to support the process.

In the case of Milano the government actors played a key role in supporting

the management buyouts. Therefore, the small cluster that grew up in Milano was

the result of the entrepreneurial initiatives of individuals supported by the public

actors in the development of their ventures. No central actors played a role in the

process.

The Triple Helix Model

The triple helix model is based on close cooperation between the three actors:

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1. Universities and research centres are involved in projects, financed by the

private sector, to deliver technology, knowledge and to innovate; new

business can be created using spin-off technology and financial support from

private companies.

2. The business sector involves higher education in research projects and

supports private entrepreneurship.

3. Government financed research; in the US, military research facilities generate

economic clusters through outsourcing different services to private

companies: regional development initiatives and projects which support the

development of technological parks can represent the starting point for future

agglomerations that can lead to a cluster.

Figure 1.9: The Triple Helix Model: Source: (Etzkowitz, 2002)

1.21 The Cluster Lifecycle

Clusters Lifecycle

Several approaches are used to describe the dynamics of industry during different

stages of development. The industry life cycle approach explains industrial change

in analogy to the product life cycle (Vernon, 1996). An industry follows cyclical

development patterns similar to a product and Klepper (1997) distinguishes three

different stages of an industry life cycle; embryonic, growing and mature:

“In the initial, exploratory or embryonic stage, market volume is low,

uncertainty is high, the product design is primitive, and unspecialized machinery is

used to manufacture the product. In the second, intermediate or growth stage, output

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growth is high, the design of the product begins to stabilize, product innovation

declines, and the production process becomes more refined as specialized machinery

is substituted for labour. Entry slows and a shakeout of producers occurs. Stage

three, the mature stage, corresponds to a mature market. Output growth slowly, entry

declines further, market shares stabilize, innovations are less significant, and

management, marketing, and manufacturing techniques become more refined”

(Klepper, 1997:148).

Kamarulzaman, Richardson, Aziz, (2011), developed a research framework

for their study on cluster lifecycles which was an enhancement of the various cluster

lifecycles reviewed. The model has six stages – Antecedence, Embryonic Cluster,

Developing Cluster, Mature Cluster and Declining Cluster.

Figure 1.10: The Cluster Lifecycle: Source: Boja, (2011)

Six Stages in Cluster Lifecycle

1. Antecedence is the early aspect that shows or helps to provide the impetus

for clustering. It could be organic development or engineered.

2. Embryonic Cluster, the cluster shows signs of agglomeration and

economies and the actors are benefiting from it as well as beginning to

actively form linkages and networks.

3. Developing Custer’s, critical mass has been reached and linkages are active

within the cluster as well as links with external parties are being developed.

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4. Mature Clusters, the cluster has peaked and its key denominator industry or

technology has matured. Growth and performance are showing a marked

slow-down.

5. Declining Cluster, the cluster has peaked and is starting to experience slow-

down in growth and performance.

6. Transformation Stage is when the mature cluster is showing signs of new

growth. The cluster is re-entering the early stages of its lifecycle; depending

on how different the new focus is will determine at which stage the cluster

will re-enter the lifecycle.

1.22 HE, Networks & Clustering

The development of technology clusters in countries subject to recent rapid change

and are now major economies such as China and India, has attracted significant

external and internal reviews and analysis. These development approaches adopted

probably include 1) a focus on creating new knowledge in companies as well as

universities and laboratories, 2) encouragement of innovation at all levels, 3)

regional agencies were always involved, but they did experience economic

development difficulties sue to the complexity of how knowledge growth occurs.

Companies are intrinsically more focused and better equipped than public sector

HEIs to create usable knowledge to address problems, driven by commercialization.

This assumes they engage in R&D and/or are closely linked to research

organizations. Official proclamations are that Bangalore and Shanghai have great

research institutions. However, recent analysis suggests that SMEs in both Bangalore

and Shanghai that ideally would be innovative were not connected sufficiently to

research institutes for innovative knowledge access or generating innovation

themselves, (Miller et al., 2010). This implies that these country regions do need to

initiate greater network communication and sector interfacing.

1.23 Social Networking

In recent years social networks have selectively become part of the network for

linking senior managers employed in biotechnology firms in San Diego, California,

(Casper 2007). Labour mobility within the region also generated a large network

linking managers and firms.

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Social networking is inevitably involved in some version of biotech networks

in Ireland, but these are not formal cluster models (Van Egeraat & Curran, 2010).

Van Egeraat & Curran’s analysis suggests that in the Irish biotech industry, a digital

ecosystem (network) connecting key people has little impact on regional

development in terms of initiating projects that would contribute to cluster

formation. The detected number of collaborations was deemed too small. In this

context, the expectation is that a more general and effective digital ecosystem that

could connect virtually all regional biotech industry and research would contribute to

business and technology growth of a region.

Their analysis agrees that innovation is influenced by engagement with public

organisations and ‘communities’ where information exchange is relatively open.

Universities are a major member of the public sector, but despite political aspiration

and a HE desire to attract alternative funding, Ireland has relative poor HE-industry

collaboration.

1.24 Virtual Networking

The notion that a group of researchers and or developers can effectively collaborate

as parties in a single entity despite significant geographical distribution is a product

of particular EU and subsequent global partnering and the advancement of web

technology.

The virtual research environments (VREs) are still an emerging concept and

their definition is still evolving. The UK Joint Information Systems Committee

(JISC), states that “The term VRE is now best thought of as shorthand for the tools

and technologies needed by researchers to do their research, interact with other

researchers (who may come from different disciplines, institutions or even countries)

and to make use of resources and technical infrastructure” (JISC, 2010). The

advancement of web technology obviously contributes to this process (Myhill et al.,

2009).

A further 2010 JISC report, ‘The VRE Landscape Study’ aimed to

investigate international developments in Virtual Research Communities (VRCs)

and to evaluate them in relation to the activities in the JISC’s VRE programme.

The study examined programmes in a number of key countries along with significant

projects and communities as well as some countries where developments on this

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front are just beginning. There has been a great deal of activity over the past few

years in terms of prototype and demonstration systems moving into the mainstream

of research practice. Notable trends are emerging as researchers increasingly apply

collaborative systems to everyday research tasks (Carusi & Reimer, 2010). A 2011

Irish related research review expressed a positive future regarding VE (Connolly &

Wusteman, 2011).

The core element of the A5A6 programme in the project was the concept that

enhanced virtual models could permit real time connection between complementary

core facilities in diverse geographies.

There is a general acceptance that a virtual research environment (VRE)

helps research groups to manage some or all of these tasks collaboratively, online.

The JISC report believes such VREs must be customised to suit the particular

partners, (Van Till 2010). According to the JISC-commissioned VRE Landscape

Study, a VRE is an electronic web-based environment that typically serves at least

two of the following functions:

Provides access to data, tools or resources

Enables cooperation or collaboration with other researchers at the

same or different institutions

Enables cooperation at the intra – and inter-institutional level

Preserves or takes care of data and other outputs

1.25 Impact of Communication Technology

An extreme form of networking is Crowd Sourcing, a medium by which a large

number of citizens within a region or country or indeed, now globally become aware

of a request for contribution. A major form of crowd sourcing relates to agreed

access to millions of computers that are free or not engaged in demanding work,

representing connection of multiple processor power. This concept may have

initiated in the mid-1990s, but it was the SETI@home project, launched in 1999, that

first attracted the PC-using public’s imagination. This was an attempt to detect the

presence of extra-terrestrial intelligence by analysing radio signals from space.

Active crowdsourcing involves the direct participation of users rather than their

computers alone and has had some success in the commercial biotech sector. Among

life science companies, Eli Lilly of Indianapolis has been a leader in the field of

internet-led open innovation, (Sansom, 2011).

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Start-up biotech companies have been advised to join an established cluster,

(Buhler et al., 2007). Europe has become home to leading life sciences and

biotechnology industry clusters (Porter, 1998) active in medicine/healthcare,

agriculture/food and industrial/environmental areas. In Europe, life sciences and

biotechnology clusters are geographically concentrated in regions and countries with

a long tradition of life sciences research and activities in related industries such as

pharmaceutical, chemical, agro-production and medical technology. Biotechnology

clusters are contributing to the growth and development of the biotechnology

industry by ways of stimulating and fostering the academic and industry

collaborations for improved knowledge base and commercialisation of research

findings.

1.26 Transnational Collaboration

Co-authorship is one form of marker of transnational collaboration, (Hansen &

Hansen 2006). Action plans and strategies are mostly focused on trans-regional and

trans-national collaborations, improved and more efficient access to

information/collaborative networks, and technology transfer, funding programs and

finance.

1.27 Tech Translator

A recent analysis of the Irish biotech sector and associated networks recognised the

need for a technology translator type of role on a regional basis (Van Egeraat &

Curran 2010).

1.28 Key Enabling Technologies (KET’s) & R&D

The main driving force behind new innovations is key enabling technologies

(KET’s). the EU needs a strong innovative performance in order to equip itself with

all the means needed to address societal challenges such as fighting climate change,

overcoming poverty, and improving resource and energy saving. This path will

make Europe attractive for global opportunities leading to sustainable employment

with high quality jobs. KET’s are knowledge intensive and associated with high

R&D intensity, rapid innovation cycles, high capital expenditure and highly-skilled

employment. They enable process, goods and service innovation throughout the

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economy and are of systemic relevance. They are multidisciplinary, cutting across

many technology areas with a trend towards convergence and integration. KET’s

can assist technology leaders in other fields to capitalise on their research efforts (EU

Competiveness Council, 2009).

SME’s play an important role in the creation of new technologies, and they

provide inputs and innovative solutions for global companies. For an SME to

succeed it must have access to cutting-edge technologies. This should result in a

modernisation of the industrial base and in the strengthening of the research base in

Europe and the Atlantic Area. Policy makers need to put in place the right

framework conditions and support instruments for strengthening Europe’s

biotechnology capacities for the development of KET’s.

Europe has good research capabilities in some key enabling technology areas,

but Europe is weak when it comes to commercialising research results. Countries

need for KET’s are governed by the strengths and limits of their research and

industrial landscapes. What generates a critical mass in one country may not be

applicable to a different country. The EU faces significant obstacles in achieving a

wider deployment of KET’s. The EU has been less effective than the US and some

Asian countries in terms of commercialisation and exploitation of Nanotechnologies,

some aspects of photonics, biotechnology or semi-conductors. These are all areas

where substantial public R&D efforts are undertaken, however, they do not

sufficiently translate into economic or societal gains. There are several reasons for

this:

The EU does not effectively capitalise on its own R&D results (ec.europa.eu,

2009). This results in expensive research, both from public and private

sources undertaken in the EU being commercialised in other regions. This

can endanger the future research capabilities of the EU, and there is a loss of

revenue and employment. It is vital that the necessary infrastructure and

cutting edge technologies are available to SME’s to bring innovative

products to commercialisation.

Public understanding and knowledge of key enabling technologies is often

lacking. There needs to be a proactive strategy bringing stakeholders

together to address public concerns or fears to avoid delays in introducing

new technologies in the EU.

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There is a shortage of skilled labour tailored to the multidisciplinary nature of

KET’s. Europe has leading-edge research capabilities and can leverage a

substantial knowledge base in science and engineering (Eurostat, 2006).

There needs to be more emphasis on the development of science, technology,

engineering and maths (STEM) graduates. The knowledge transfer between

researchers, entrepreneurs, and financial facilitators needs to be strengthened.

Students and professors need stronger incentives to commercialise research

results to increase spin-offs from university research.

The economic slowdown has affected the flow of venture capital. Due to the

high development costs and level of uncertainty, the availability of risk-

venture capital is crucial. In comparison to the US, who concentrates their

venture capital on more advanced projects/technologies; EU research teams

need to seek venture capital at too early a stage when the risks are often too

high for both the investor and the research organisation.22

The fragmentation of the markets for innovations is a major weakness caused

by e.g. different regulations, standardisation, certification and public

procurement procedures across the Member States. Joint technology

initiatives instruments could be simplified and strengthened and the role of

technology platforms could be expanded and co-ordination among platforms

enhanced. A strong integration between experimental research, innovation

and industrial exploitation is essential.

1.29 Life Science Research that isn’t Biotech

Relationship between all areas of science/knowledge:

To return to fundamentals, science represents the acquisition of human knowledge

and understanding of their micro and macro environments, implying everything that

effectively can be defined in atomic and sub-atomic structures. The term ‘science’,

of course implies knowledge. The growth of that knowledge now extends to new

complexities such as anti-matter, dark matter and dark energy, but the formal domain

of natural sciences embraces, astronomy, biology, chemistry, Earth sciences and

physics.

22

Science, Technology and Innovation key figures report, 2005

64

The notion that life originated from the first development of nucleic acids,

probably RNA derivatives, capable of replication and hence continuity, implies

enhanced self-organisation. RNAs are now considered quite simple and efficient

replicators, despite their capacity to transfer potentially enormous amounts of data,

(Folkert, 2012). This more recent interpretation also implies that the distinction

between living and non-living materials is not as large as previously considered,

(England 2013).23

There are five branches of natural science: astronomy, biology, chemistry,

the Earth sciences and physics. This distinguishes sciences that cover inquiry into the

world of nature from humanities such as linguistics, anthropology, literary science

and from formal sciences such as mathematics and logic.

The natural sciences are the sciences that seek to elucidate the rules that

govern the natural world through scientific methods, the cornerstone of which

is measured by quantitative data. Based on formal sciences, they also attempt to

provide mathematical (either deterministic or stochastic) models of natural

processes. The term "natural science" is used to distinguish the subject from

the social sciences, such as economics, psychology and sociology, which apply

the scientific method to the study of human behaviour and social patterns;

the humanities, which use a critical or analytical approach to study

the human condition; and the formal sciences such as mathematics and logic, which

use an a priori, as opposed to empirical methodology to study formal systems.

Science represents the acquisition of human knowledge and understanding of their

micro and macro environments, implying everything that effectively can be defined

in atomic and sub-atomic structures. The term ‘science’, of course implies

knowledge. The growth of that knowledge now extends to new complexities such as

anti-matter, dark matter and dark energy, but the formal domain of natural sciences

embraces, astronomy, biology, chemistry, Earth sciences and physics. The notion

that life may have originated from the first development of nucleic acids, probably

RNA derivatives, capable of replication and hence continuity.

Life science as a discipline reflects knowledge representing physics and

chemistry, but as a level of advanced matter, it inevitably employs and displays

23

http://blogs.scientificamerican.com/brainwaves/2013/12/02/why-life-does-not-really-exist/

65

unique structures and mechanisms – the extreme complexities of which are not fully

understood. This status also relates to other recent controversial concepts such as

that previously cited, (England 2013).

Biotechnology is viewed as a life science division that tends to progress to

and reflect commercialisation of research. Since the formal status of a biotech sector

in 1979, the US has been the most successful country, but has still inevitably

witnessed aspects of business decline over the post-2008 global economic crisis that

embodies the ShareBiotech period. The public sector division of biotech declined by

~ 24% from 2008 until 2013 and the number of private companies also decreased.

The post-2012 recovery has shown changes in how start-ups progress and in funding

models.

The EU biotech decline post-2008 was less dramatic than in the US, but by

2013, it still represented fewer public and private sector biotech companies than the

US. By the early 2000’s despite the formal growth of biotech in Germany, the UK

still hosted the largest elements of biotech research and associated industry, but in

part because of political decisions, the sector subsequently declined. In the current

time, however, in part due to R&D networking and finance, the biotech sector is

undergoing recovery in the UK, while the German sector growth is reducing,

possibly due to diversions to other business domains.

There is a tendency in a number of EU countries including Atlantic Region,

such as, Portugal, Italy, Austria and France, for their universities to recruit former

graduates. This model, while no doubt creates a positive internal environment,

automatically reduces connectivity with global institutions and associated networks,

and the attraction of different knowledge and experience (Niosi, 2011). Conversely,

the US encourages interregional university networks and collaborations with R&D

companies and public laboratories – this culture developed in the UK as well and

more recently aspects of it were applied in Ireland. A common language across the

US is no doubt another obvious advantage to facilitate linkage and communication.

Despite, a tendency of the EU to utilise English as a leader language, in reality it has

more than 20 major languages plus many regional ones, which accounts for basic

communication difficulties and reduces mobility and as a result, interaction between

HEIs and companies across the EU (Niosi, 2011). The fact that the majority of

important global science and technology publications are in English, imposes an

66

information need on practising scientists, but inevitably language and HE and

business culture differences across the EU reduce communication and mobility

relative to similar scale regions in the US – this is an issue that will decline with the

passage of time. Formal EU policy to encourage cross-country collaboration and

web technologies have accelerated research and business interactions across the EU

significantly, but most European researchers still tend to live in a region within a

single European country.

In reality, bringing the best researchers, developers and resources together

ultimately benefits from global rather than just national or regional links, and this of

course is a practice being pursued by some key companies and HEIs. The

ShareBiotech project explored some innovative Atlantic Region mechanisms for

mapping and enhancing cross-regional networks.

In all countries, biotechnology is heavily dependent on public research

conducted in universities and government laboratories. Biotechnology is not a single

industry, but obviously embraces a large and very diverse range of technologies.

Many years ago, eight key issues influencing biotech development in the US, but

relevant elsewhere, where identified (Bartholomew, 1997). Some of these are still

current issues and this project engaged in analysis to confirm this relevance.

(a) The level and patterns of national funding of basic research;

(b) The linkages with foreign research institutions;

(c) The national tradition of scientific education;

(d) The degree of commercial orientation of research institutions;

(e) Labour mobility between university and industry;

(f) The venture capital market;

(g) The role of government in technology diffusion; and

(h) Technological accumulation in related sectors.

As previously highlighted, the creation of the first substantial biotech company,

Genentech in 1976, eventually led to the attraction of venture capitalists who were

experienced in information technologies to biotechnology in the 1980s.

The EU certainly believes that networking needs to expand and evolve in

nature to contribute to innovative technology development, the CReATE programme

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launched in FP7 2008 was one such initiative, which more recently became absorbed

by a German company.24

As part of numerous indicators that the European economy and scale of

innovation are not working as effectively as in the past and relevant to many other

countries, The Economist published a graph of the 3 largest internet companies in the

top 50 countries (Economist Jul 7th

, 2014). The three largest companies per country

do not embrace the full internet sector, but is a viable indicator:

USA>China>SouthAfrica>Japan>SouthKorea>Russia>Israel>UK>Sweden>German

y>Argentina>Canada>Australia>Finland>NewZealand>Ireland>Brazil>France>Ital

y>Estonia>India>Spain>CzechRepublic>Hungary>Denmark>Poland>Singapore>Sl

ovenia>Turkey>Vietnam>Taiwan>Malaysia>Belgium>Ukraine>Netherlands

These rankings implied that the EU rankings are: 8, 9, 10, 14, 16, 18, 19, 20,

22, 23, 24, 25, 26, 28, 33, and 35. The UK remained the highest despite a tradition

for the past decades of continuously selling off large companies with their frequent

subsequent loss. The internet is obviously not biotech, but now all industry employs

and benefits from internet technology and internet/web technology is continuously

influencing and changing how the business world and societies in general function.

The presence of the US and China and Japan at the top is not surprising, but the

success of South Africa is more unusual and the dominance of South Korea, Russia

and Israel over EU members. This does not equate to biotechnology, but does

clearly display how a selected technology domain displays great diversity of

development in different countries, not always, the richest.

1.30 Aims and Objectives of this Project

This selected view of biotechnology reveals the scale of and breadth of the discipline

and its substantial growth in terms of knowledge development, related industry and

impacts on the environment and all living entities, since it’s very recent birth. The

study also reveals some of the inherent impediments to faster and more effective

biotech development:

24

http://innovation.mfg. e/de/projekte/archiv/create-1.1352d

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Biotech research is generally expensive in terms of the costs of consumables,

advanced technologies, the required skill sets and the time required to complete

work.

HE biotechnology education, which in addition to the acquisition of

necessary knowledge and innovative thinking, requires substantial time and

resources devoted to laboratory work and probably more traditional markers of

effective learning. In reality, in keeping with most other disciplines, a significant

proportion of HEIs in a variety of countries have effectively reduced the level and

nature of the HE process and outcome. This will ultimately have negative impacts

on the progression of disciplines such as biotechnology.

Networking, collaboration, clustering are important mechanisms that assist

the connection of the right people, of finance attraction, of resource access,

development of new R&D and business models. The models behind these practices

need to be advanced further to ensure, access and occurrence does happen in the

optimal way.

Parts of the Atlantic Region are relatively small and consequently restricted

in what aspects of biotechnology they currently engage. EU FP funding has brought

researchers together across the EU for decades, but in the absence of a United States

of Europe, the degree of viable transnational connectivity is not as high as expected.

The nature of transnational networking, collaboration and clustering effectively

needs to be progressed.

ERA Instruments was an FP7 project that brought together stakeholders such

as funding agencies, ministries, charities and research performing organisations

across 12 countries with 16 partners with an interest in mid-sized instrumentation

and centres for mid-size research instrumentation in the life sciences. The project

included evaluation of core facility organisation in Canada and Japan and the project

outcome influenced assignment of funding in Horizon 2020 to generate new major

EU core facilities particularly in biotechnology (Guebitz, 2011). This project was to

some extent a regional version of this. Transnational biotech company mergers and

takeovers can effectively generate networks between the historical facilities and new

local connections. Such a network is dependent on key people and emphasis on

evidence of continuous R&D business benefits (Baraldi and Strömsten, 2009).

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Transnational linkage models in S&T were destined to be weak in the EU in

1999, implying a need for 21st C progression (Grande & Peschke, 1999).

The objectives of this project were in part intended to review, analyse and

experiment with ways to address some of these perceived biotech problems and as an

Interreg funded project, the work was conducted across all participating regions to

generate new baseline data regarding the status of biotechnology (A3), with

subsequent project activities devoted to post A3 analysis and some partial address

models.

1.31 Project Overview

The core project that was developed to address many of the issues raised in this introductory

chapter is briefly described in the following section. The project in keeping with Interreg

structures was divided into 7 Activities, most of which had defined sub-actions. While my

studies contributed to all 7 inter-related activities, activity 3 and 7 constitute the majority of

my efforts for this thesis that are highlighted in red below.

Activity 1 Management & Coordination of the project.

Activity 2 Communication and dissemination: raising the technological, scientific and

business profile of the Atlantic Area biotechnology sector.

Activity 3 Studies and action plan to reduce the gap between life science technology supply

and demand (Lead Partner UALG). Main focus of my research for this study.

This activity was aimed at detailing and harmonising the existing knowledge about

technology offer and needs within the partner regions and the Atlantic area, to measure the

gap between technology supply and demand and finally to effectively generate the data to

specify the action plan that will be implemented within Activity 4 and 5 to reduce this gap.

Action Nº 1

Common methodologies

This action will establish common methodologies to study the technological offers and

needs.

Action Nº 2

Evaluation of technology needs (demand side)

In each region, the methodology defined in Action 1 will be implemented to evaluate

technology needs. It will consist of analysing existing data and local stakeholders’

knowledge (e.g. clusters) and realising additional surveys to assess both public and private

R&D performers’ needs for life science advanced technologies and corresponding research

skills.

Action Nº 3

Technology resources of Partner regions (supply side)

Within Action 3, ShareBiotech Partners will produce a source book presenting technology

resources of the participating regions (supply side): mapping of TCFs (Technological Core

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Facilities), typology of TCFs (ownership, access, current types of uses and users, service

provision etc), and summary of skills (human resources and Intellectual Property linked with

TCFs).

Action Nº 4

Integration of offers and needs into an appropriate action plan

Action 4 will mainly consist in a workshop aim to: 1) precisely measure the gap between

technology supply and demand within the partner regions, and 2) propose concrete and

tailored solutions to reduce the gap (action plan).

Action Nº 5

Publication of recommendations

Activity Nº 4 Develop regional technological services, structure a transnational network and

facilitate access. (Lead Partner CRITT)

The general aim of this activity was to organise and structure commercial service supply

specially adapted to companies on the basis of partners’ Technological Core Facilities’.

Action Nº 1

Identification of best practices

Action 1 aimed at identifying best practices for technological service supply to benefit the

consortium.

Action Nº 2

Selection of relevant TCFs

Action 2 will analyse and select, in each region, the Technology Core Facilities most likely

to achieve service supply structuring during the project lifetime, and most relevant to answer

identified companies’ needs.

Action Nº 3

Set up new services

Action 3 consisted of developing services in practical terms, i.e. a comprehensive offer in

each region (service specifications, price, catalogue…). A Charter will be developed (list of

items for eligibility to the ShareBiotech network of core facilities and services in order to

comply with common quality criteria). The project will strive to give access to new services

and not to generate unfair competition with existing profit-making companies offering

services.

Action Nº 4

Improving quality of services and TCFs

Action 4 will stimulate quality improvement of TCFs and services. Partners will encourage

appropriate processes of standardisation of methods, and of quality certification of services

and/or technological facilities (e.g. ISO 9001 process) in order to ensure traceability and

good reporting.

Action Nº 5

Setting partnership “rules of the game” for transnational shared access to TFCs and

services

Action 5 is aimed at generating partnership rules for preferential access to TCFs and services

among ShareBiotech Partners. The ShareBiotech partners worked together to develop clear

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rules on how users from partner organisations (phase I) will access the TCFs and services

provided through the ShareBiotech project, focusing on providing a streamlined mechanism

that will direct users to the most appropriate core facilities.

Activity nº 5 (Lead Partner, University of Navarra)

Foster collaborative research, innovation and technology transfer by connecting people

The objective of this activity was to stimulate links between academia and industry, in order

to generate new research projects, innovation and technology transfer, notably by connecting

people from different life science fields (human health, food, marine biology,

bioinformatics, etc.) and cultures (research/business).

Action Nº 1

Regional technology translators (pilot action)

This Action explored the function of “technology translator” (or “facilitator”) within the

ShareBiotech regions.

Action Nº 2

Identify and participate in colloquia

In Action 2, Partners identified colloquia and seminars of interest for the project, about 1)

multi-disciplinary topics and approaches corresponding to research and technology needs

identified in Activity 3

Action Nº 3

Organise local technology meetings

Partners organised local technology meetings, at least 2 in each country each year (and at

least 1 in each region).

Action Nº 4

ShareBiotech training and mobility plan

In Action 4, the ShareBiotech consortium defined a training and mobility plan for

researchers, PhD and postgraduate students, innovation and technology transfer officers,

companies’ R&D staff, trainees and technicians from project partners’ personnel and related

stakeholders of the participating regions.

Action Nº 5

Action 5: Implementation of training and mobility plan

Action 5 consisted of effectively providing mobility and training opportunities to partner

regions and Atlantic Area’s stakeholders

Action Nº 6

Action 6: Identify and mobilize instruments to foster technology transfer

In order to better exploit research results and transform them into innovations that generate

growth, the Consortium proposed to provide focused information on how to implement

technology transfer on the managerial and on the financial level, in connection with the

ShareBiotech specific demand.

Activity Nº 6 (Lead Partner AIT)

Steps towards the Atlantic Area Bio-Technology Translational Centre (Capitalisation

Activity)

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The aim of this Activity was to capitalise on the core activities carried out in the

ShareBiotech project, through the experimental design of the Atlantic Area Bio-Technology

Translational Centre. The Centre was aimed at translating technology and knowledge needs

(demand) from industries and researchers into convenient, understandable and accessible

solutions. This effectively evolved into a concept of how TCFs could effectively be brought

together in effective collaborative ways to permit better access delivery – this explored

virtual models.

Activity No 7 (Lead Partner AIT). Also a core deliverable of my MSc by Research project).

Comprehensive interviews with seven selected experts to explore multiple aspects of the

fundamentals of this project (embracing more than 159 questions with sub-questions).

The project was initiated in Jan 2010 and ran for three and a half years with the final reports

effectively generated at four years.

1.32 Research Justification

There is a lot of interest in the evolution of R.I. for science over the last two

decades. Effective models are needed to allow access to facilitate research. The

evidence that this work is vital is supported by the many similar projects funded by

the EU. Analysis of the impact or R.I. access on cluster development is novel and

has not been done before. The Analysis of Biotechnology Cluster Drivers will

identify successful models in Europe and throughout the world and the different

strategies that contributed to their success and the development of the smart

economy as anticipated by the Horizon 2020 initiative. These findings will show that

collaboration between industry, government, and HEI’s is vital to our economic

future, and vital to the recovery of Ireland’s economic recovery. It is anticipated and

indeed hoped that this research will elucidate a model or part of a model that can be

implemented in the Atlantic Area, and vitally in Ireland. It is also the goal of this

research, to identify niche areas and present a proposal for funding for a follow on

project to further develop Irelands Biotechnology Industry, in particular SMEs which

account for 70% of Ireland’s employment.

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METHODS

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2 Methods

2.1 Research approach:

Denscombe, (2000) stated that qualitative and quantitative are the two major

methods that are used in social science, even though the former might be considered

the predominant one. The qualitative study is concerned with the aims of a

researcher to transform what is reported and observed in written words. The

qualitative research is helpful to transform recorded interviews into transcripts, the

descriptions of pictures in words and observations are converted into field notes. It

does not endeavour towards simplifying the problem. Quantitative research is

innately connected with data generation and analysis and deeper understanding to

solve the problem area (Saunder, 2007). The main intention of this study through the

ShareBiotech project was to strengthen the biotechnology sector of the Atlantic

Area, through the maximisation of the benefits of life science research infrastructures

and skills, for the economic development of the partner regions and of the Atlantic

Area as a whole. The hypothesis was that the biotechnology sector in the Atlantic

area has failed to evolve at the same rate as the rest of Europe and that access to

Technology Core Facilities (TCF’s) was vital to the success of early-stage start up

biotechnology companies and a driver for cluster development. This research

endeavoured to understand the reasons behind a weaker biotechnology sector in the

Atlantic Area; to identify infrastructure gaps and needs and to analyse the drivers for

success in other areas of Europe and the US through the clustering model.

The starting point of the project was to identify the needs for modern biotechnology

in the Atlantic Area resulting from the development of basic and applied research in

life sciences. The ShareBiotech project went far beyond just conducting an inventory

and offering existing technologies: it promoted a bottom-up approach and

endeavoured in partnership with stakeholders to find appropriate technological

answers by adapting the technology offerings. To reiterate, research methods were

chosen in line with the operational objectives of the ShareBiotech project, namely:

1. Facilitate wider sharing of knowledge and technology within the Atlantic

Area, across life science fields (Health, Marine research, agriculture and

food) and related high-tech transversal domains (bioinformatics, imaging,

and nanotechnologies), and between academia and industry.

2. Reinforce regional service provision of technologies for researchers (both

public and private) in line with the identified needs.

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3. Create the basis of a transnational network of Technological Core Facilities

(TCFs), in order to provide technological services at the transnational level.

4. Foster technology absorption in the less technology-intensive sectors and

companies, in particular through explaining applications of complex and

recent technologies to SMEs.

5. Increase the profile and the visibility of the biotechnology sector of the

Atlantic Area, in order to make it an attractive choice for networking,

cooperation and locating business.

2.2 Technology Core Facilities (TCF’s)

A core element of the ShareBiotech project was the recognition of the importance of

technology core facilities within a research facility and the progression of

mechanisms to disseminate them, improve their organisation and structure and make

them more accessible and collaborative, particularly to facilitate development of the

biotech industry, within the Atlantic Region. ShareBiotech notably aimed to make

access to technological core facilities easier for companies, in particular SMEs.

Definition

A Technical Core Facility is “a set of equipment and associated expertise, which

operating capacity is available to public or private organisations with a view to

offering access to high-level technologies for R&D” or “Technology Core Facilities

are a combination of laboratory instrumentation and associated skills which are

required in the performance of research and other technical functions, but which are

generally too expensive, complex or specialised for individuals and small groups of

researchers to use sustainably. TCF’s may be public or private and are generally

open to a wide range of users”.

Nature of Data

The empirical part of this Master’s thesis draws from both primary and secondary

sources. Data sources include interviews, industry studies, journals, newspapers,

websites, reports, industry statistics, conferences, and experts in the relevant fields of

biotechnology.

Primary Sources

For primary data we relied primarily on conducting in-depth interviews with

different stakeholders in the biotech industry. By conducting interviews, we took a

communicative approach, which offered the benefits of versatility and in-depth

information. The format allowed conversations to be directed towards the chosen

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theme of the study, which left respondents free to openly express their opinions. In-

depth interviews allowed us the flexibility to probe and highlight contextual issues

that might have ordinarily remained hidden.

2.3 Studies and Action Plan to Reduce the Gap between Life

Science Technology Supply and Demand This activity was aimed at detailing and harmonising the existing knowledge about

technology offer and needs within the partner regions and the Atlantic Area; at

measuring the gap between technology supply and demand, and finally at specifying

the action plan to be implemented to reduce this gap. Three detailed surveys were

commissioned by the ShareBiotech consortium to map the number of biotechnology

SMEs and multinational companies, Research Organisations (ROs), Technology

Core Facilities (TCFs) operating in the Atlantic area among the partner regions

(Ireland, Spain, France, Portugal) i.e. ShareBiotech Companies Survey;

ShareBiotech Research Groups Survey; ShareBiotech Technological Core Facilities

Survey. The surveys were developed by the European project “ShareBiotech”, with

the objective to reinforce the important contribution that Life Sciences and

biotechnology can offer towards the development of the Knowledge-Based

Economy, in the Atlantic Area (www.ShareBiotech.net). The surveys specifically

aimed at detecting the needs of companies, research organisations and TCFs in life

sciences and biotechnology sectors regarding access to TCF’s, advanced techniques

and associated expertise. The surveys also mapped existing technologies, level of

access to SME’s, duplication, training available, maintenance, risk of obsolescence

etc. In the Border Midlands & West (BMW) region of Ireland, 24 Research Groups

(RG’s) and 11 Small &Medium sized Enterprises (SME’s) were surveyed while 31

RG’s and 26 SME’s were surveyed in the Southern & Eastern (S&E) region of

Ireland. The Technology Core Facilities survey was disseminated to 54 identified

TCF’s incorporating the BMW and S&E regions. The surveys were disseminated via

email and follow on communication was used including telephone calls to encourage

a greater critical mass of respondents.

2.4 SUMMARISED A3 SURVEYS

2.5 ShareBiotech Companies Survey: (Ref. Appendix 1) The Companies Survey was directed towards the person responsible for the companies R&D. The

survey was divided into seven parts with each part having several subsections.

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Part 1 collected general information about the company under the following

headings: a) Name of the company?

b) The year the company was set up?

c) The company address?

d) The company’s main activities?

e) The main scientific domains of the company

f) The company website?

g) Was the company a member of networks

h) The number of persons employed in the company

i) Was the company part of an enterprise group?

j) In which country was the head office of the group located?

k) The contact person within the company

Part 2: Products (Goods and Services) and Interest in Biotechnology

1. A description of the company’s three main products?

2. Was biotechnology was central to the company’s activities or strategy?

3. Was the company developing products or processes requiring biotechnology?

4. In which geographical markets did the company sell goods or devices during the three years

2008 to 2010?

Part 3: R&D Activities and Collaboration

Collected general information regarding R&D activities and collaboration:

1. Did the company conduct R&D activities?

2. Describe relevant in house/collaborative projects using advanced technologies?

3. Describe outsourced R&D projects using advanced life sciences technologies?

4. Had the company registered patents?

5. Had the company bought patented rights/licenses?

6. What was the main R&D question/problem the company was currently facing?

7. How the company intended to answer/solve the identified problems?

Part 4: Barriers to R&D Activities

Collected general information regarding barriers to R&D encountered by the company

1. Cost of R&D activities, access to technology/information/skills, regulatory requirements,

public perception/acceptance, patent rights, licencing costs.

2. Explain the barriers identified?

Part 5: Specific uses and needs for biotechnology and related techniques

Part 5 consisted of 12 specific categories labelled A to L. Parts A to L was defined by OECD

categorisation. In each section of Part 5 (A to J) the OECD category was divided into two sections,

i.e. USES (which of these techniques does your company use?) And NEEDS (which of these

techniques would your company like to access?). Part 5 sections A to J., also determined whether the

suggested techniques were accessed internally or externally. In the sections A to J, under USES,

companies were asked to identify which techniques the company used and for what, and to specify if

this was a regular, or an occasional need. The companies were also asked to specify how they

accessed these techniques i.e. internal or external access; was the company a public or private

structure; was the company located in their country or abroad.

In the NEEDS section of Part 5; A to J, the companies were asked to choose from a list what

techniques they would like to access; what the company needed these techniques for, and to explain

what barriers existed in accessing these techniques?

Part 5; Question Titles A to J

Because the share biotech companies’ questionnaire was substantial, it was decided not to list all the

techniques highlighted in Part 5 Sections A to J, however, the full questionnaire was represented in

Appendix I

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A. OECD category DNA/RNA (genomics, pharmacogenomics, gene probes, genetic

engineering, DNA/RNA sequencing/synthesis/amplification, gene expression profiling, and

use of antisense technology).

B. OECD category, proteins and other molecules (sequencing/synthesis/engineering of proteins

and peptides (including large molecule hormones); improved delivery methods for large

molecule drugs; proteomics, proteins, isolation and purification, signalling, identification of

cell)

C. OECD category, Cell, tissue culture and engineering (cell/tissue culture, tissue engineering

(including tissue scaffolds and biomedical engineering), cellular fusion, vaccine/immune

stimulants, embryo a manipulation.

D. OECD category, Gene and RNA vectors (gene therapy, viral vectors)

E. Category. Biological resources and associated facilities.

F. Category, Imaging and related instrumentation DNA/RNA

G. OECD category Process biotechnology techniques (fermentation using bioreactors,

bioprocessing, bioleaching, biopulping, biobleaching, biosulphurisation, bioremediation,

biofiltration and phytoremediation

H. OECD category Nanobiotechnology (applies the tools and processes of Nano/

microfabrication to build devices for studying Biosystems and applications in drug delivery,

diagnostics

I. OECD category. Bioinformatics (construction of databases on genomes, protein sequences,

modelling complex biological processes, including systems biology)

J. Other (additional category)

K. Training Needs; do researchers, engineers or technicians from the company have training

needs regarding techniques and related skills? If the respondent answered yes, he/she was

asked to elaborate as to those needs.

L. Did the company have other needs for the advance of R&D activities? If the respondent

answered yes, he/she was asked to elaborate as to those needs.

PART 6 was optional and asked for additional information about the company.

PART 7 interviewers’ synthesis and feedback under the following headings:

Main needs as regards techniques?

Main barriers for access to specific techniques?

Main needs as regards training?

Specific needs (1 – 3) that ShareBiotech could address in its lifetime?

General comments on the information reported?

Suggestions for improvement?

2.6 ShareBiotech Research Groups Survey (Ref. Appendix 2)

Part 1 collected general information about the research group under the following

headings:

a) Name of the research group?

b) Address of the research group?

c) Main scientific domains of the research group?

d) Specific dominant scientific domain of the research group?

e) Identification of the research unit associated with the research group website of the research

group?

f) Number of persons employed in the research group-research, technical, and administration,

in July 2010, in headcount units?

g) Number of masters students in the research group in July 2010?

h) Number of Ph.D. students in the research group in July 2010?

i) Number of post-docks students in the research group in July 2010?

j) Contact details of the person interviewed?

Part 2: Uses and Needs for Biotechnologies and Related Techniques

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Part 2 of the ShareBiotech Research Groups Survey consisted of 12 categories labelled A-L. The

research groups were given a list of techniques in one column (USES) in each category and asked to

indicate if they used these techniques and if access was internal or external. In each category (A - L)

the research groups were asked what they used the specified techniques for, and how they accessed

the specified techniques i.e. internal or external access, public or private structure, nationally or

internationally? The second column (NEEDS) gave a list of techniques and asked the research groups

to indicate which of these techniques they would like to access. The research groups were also asked

what they needed these specific techniques for and what the barriers were to accessing the specified

techniques.

Part 2: Uses and Needs for Biotechnologies and Related Techniques Categories

A. OECD category DNA/RNA: genomics, pharmacogenomics, gene probes, genetic

engineering, DNA/RNA sequencing/synthesis/amplification, gene expression proofing, and

use of antisense technology?

B. OECD category, Proteins and other molecules: sequencing/synthesis/engineering of proteins

and peptides (including large molecule hormones); improved delivery methods for large

molecule drugs; proteomics, protein isolation and purification, signalling, identification of

cell?

C. OECD category, Cell, tissue culture and engineering (cell/tissue culture, tissue engineering

(including tissue scaffolds and biomedical engineering), cellular fusion, vaccine/immune

stimulants, embryo a manipulation?

D. OECD category, Gene and RNA vectors (gene therapy, viral vectors)?

E. Category. Biological resources and associated facilities?

F. Category, Imaging and related instrumentation DNA/RNA?

G. OECD category Process biotechnology techniques (fermentation using? bioreactors,

bioprocessing, bioleaching, biopulping, biobleaching, biosulphurisation, bioremediation,

biofiltration and phytoremediation?

H. OECD category Nanobiotechnology (applies the tools and processes of Nano/

microfabrication to build devices for studying Biosystems and applications in drug delivery,

diagnostics?

I. OECD category. Bioinformatics (construction of databases on genomes, protein sequences,

modelling complex biological processes, including systems biology)?

J. Other (additional category)?

K. Training Needs; do researchers, engineers or technicians from the company have training

needs regarding techniques and related skills? If the respondent answered yes, he/she was

asked to elaborate as to those needs?

L. Did the company have other needs for the advance of R&D activities? If the respondent

answered yes, he/she was asked to elaborate as to those needs?

Part 3: R&D Collaboration

Part three consisted of four subsections; A – D; relating to collaboration is with other

institutions/enterprises in biotechnology R&D. The questions asked were:

A. In 2010, did your research group collaborate with other institutions/enterprises in

biotechnology R&D; locally or regionally within your country, nationally, with other

European Union countries, EFTA or EU candidate countries, and all other countries?

B. Was the research unit, part of one or several technological networks, and if so which ones?

C. A description of one or two relevant research collaborative projects that the research group

had implemented?

D. A description of one or two technical services (outsourced R&D) that they research group

had recently requested i.e. the date, service and supplier, purpose, advantages/disadvantages?

Part Four: Patents

Part four consisted of two questions; A - B.

A. Did the research group have any registered patents?

B. If no, would the research group consider patenting in the future?

Part 5: Additional Information about the Research Group. This section was optional.

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Part 6: Interviewers Synthesis and Feedback

Each interviewer wrote a short report after every interview under the following headings:

Main needs as regards techniques?

Main barriers for access to specific techniques?

Main needs as regards training?

Specific needs (1-3) that ShareBiotech can address during its lifetime?

General comments on the information report?

Suggestions for improvement?

2.7 Technology Core Facility (TCF) Survey (Ref. Appendix 3)

This phase of the questionnaire enabled identification of TCFs within the ShareBiotech regions, their

technologies, expertise, and their access policies. A portal to this information was constructed on the

ShareBiotech website and this information was disseminated to all identified biotechnology

stakeholders in the Atlantic Area. The Technology Core Facilities were identified and located by

several means i.e., Biotechnology Ireland (www.biotechnologyireland.com); Molecular Medicine

Ireland (www.molecularmedicineireland.ie); Enterprise Ireland (www.enterprise-Ireland.com);

internet, phone interviews, HEI websites, and research. The ShareBiotech Technology Core Facilities

Survey consisted of seven sections, each part having several subsections.

Part 1: General Information about the TCF

Part 1 consisted of 18 subsections labelled A-R. The following questions were asked:

A. Name of the TCF?

B. The main purpose for which the TCF was created?

C. Year of starting operation?

D. Websites?

E. Address of TCF?

F. Main scientific domains of the TCF?

G. The domain of expertise of the TCF?

H. The main competitive advantage or distinguishing feature of the TCF?

I. The most recent equipment upgrade?

J. Host organisations of the facility?

K. Responsible Person?

L. Contact person (the interviewee)?

M. Dimensions of the premises?

N. Location i.e. single-sited or distributed, city and country, where the TCF was located?

O. Human resources i.e. people working to operate the TCF, whether full-time or part-time?

P. Identification of main equipment; date of purchase/acquisition?

Q. Quality certification?

R. Confidentiality procedures?

S. Networks i.e. was the organisation part of one or several networks, specifically,

technological networks, and if so which ones?

Part 2: Access to Techniques and Services

Part 2 consisted of seven questions A-G. The questions asked were as follows:

A. The TCF was asked to give a short description of access policies and procedures for users,

i.e. was the technique for internal use; through collaborations with external institutes; for

service provision externally; was training available on this Technology Platform.

B. Where the technology offer was available?

C. A detailed list of all services and/or products offered?

D. Did the TCF have a price list for these services and if so where was it available?

E. Who were the main clients or external users?

F. Did the TCF intend to acquire new clients or external users in the future, and if so what type?

G. A description of one or two projects for clients or external users?

Part 3: Specification of Offered Techniques and Expertise

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Part 3 was divided into 5 categories i.e. DNA/RNA, proteins and other molecules, cell and tissue

culture and engineering, Gene and RNA vectors, biological resources and associated facilities. A list

of techniques was associated with each category and respondents were asked to tick a box if they

offered the specified technique or techniques.

Part 4: Needs and Future of the TCF

Part four consisted of three questions. The questions asked were as follows:

A. Did researchers, engineers, or technicians from the TCF have training needs regarding

techniques and related skills, and if yes, to submit an explanation of the training needs

required?

B. Did the TCF have other needs for the advancement of R&D activities?

C. What were the projects of the TCF for the next few years?

Part 5: Capacity Indicators

Part five was in the form of a Table and was divided into three sections; A-C

A. Openness of the TCF: this concerned the 2008-2009 operating capacity of the TCF dedicated

to external activities in percentage of total operating capacity? The number of research

groups using the TCF from outside the host organisation? The number of companies using

the TCF from outside the host organisation? And the average 2008-2009 occupancy rate in

instrument/machine in percentage total capacity?

B. Valourisation: two or three examples of significant scientific articles in international journals

between 2008-2009-2010? Significantly, using techniques present in the TCF? The number

of spin-off companies created from the TCF since 2000? The number of contracts with

companies? The number of patents related to present techniques and in which

domains/themes?

C. Education: was the TCF involved in advanced training programs i.e. Ph.D., or Masters

Level? Was the TCF involved in continuing education?

Part 6: Additional Information about the TCF.

Part 6 was optional and related to the TCF’s infrastructure, leading research, and industry interactions.

Part 7 Interviewers Synthesis and Feedback

Part 7 was comprised of two sections, Criteria Verification and Interviewers Synthesis.

Criteria Verification: the following criteria were defined as a departure point to include a specific

infrastructure as a TCF:

a) Did the facility, collect a relevant set of high-level equipment and competencies in the

biotech field, in the view of share biotech partners and did it have the capacity to maintain a

cutting-edge level?

b) Did the facility have a decision-making capacity, i.e., a dedicated management or scientific

committee?

c) Did the facility encompass research, development, or innovation activities in the core of its

objectives?

d) Was the facility open to external users for collaborative projects or through service

provision?

Synthesis: the synthesis in English provided a short description needed for the construction of the

ShareBiotech website map. The synthesis was written under the following headings:

A summary in English of question “domain of expertise” (PART 1) maximum of 1000

characters?

A summary in English of question “competitive advantage or distinguishing feature” (PART

1) maximum of 600 characters?

A list in English of techniques/services offered (PART 2)?

Access procedures, in English?

Main needs as regards training?

General comments on the information report?

Suggestions for improvement?

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2.8 Presentation of ShareBiotech Needs Report

Data collection was performed at regional level by local ShareBiotech partners

between September 2010 and February 2011. In total 55 researches group surveys

and 37 company surveys were collected in Ireland BMW & S&E regions. A database

of the information was compiled outlining each question in the extensive

questionnaire and the answers. The information was sent to CRIA Regional Centre

for the Innovation of the Algarve Division of Entrepreneurship and Technology

Transfer, University of Algarve where statistical analysis was carried out on the

survey results collected in the four partner regions. The team led by DR. Hugo Pinto

collated the information and produced an OECD document entitled Biotechnology

Competencies & Technology Regional Needs; Final Report; “Action Plan to Reduce

the Gap Between Life Science Technology Supply and Demand” in April 2011;

(ISBN 987-989-8472-12-0) (Appendix 5). The publication outlined the results of the

Companies and Research Groups surveys within the ten partner regions.

The report was encompassed by Activity 3 “Action plan to reduce the gap between

life science technology supply and demand”. The project created a common

approach for surveying needs offers. This methodological scheme was implemented

by the ShareBiotech partners in their regions in the evaluation of biotechnology

infrastructures, competencies, and needs. The statistical analysis of the four partner

regions defined the path the ShareBiotech Project would take by providing an

informed view of the current status of the biotechnology sector in the Atlantic Area.

2.9 ShareBiotech Life Science TCF Booklet 2012

The ShareBiotech Technological Core Facilities Survey was compiled for the

purpose of gathering information about advanced techniques in life sciences and

biotechnology for R&D in order to facilitate access for companies and researchers.

Following identification of the TCF’s, a short description of each was presented on

the ShareBiotech website. A TCF booklet was published listing all the TCF’s

identified in the Atlantic Area (Ireland, Spain, France, and Portugal) and the TCF

Booklet was disseminated to stakeholders throughout the Atlantic Area. The booklet

“ShareBiotech Life Science Technological Core Facilities 2012” (Appendix 6)

gathered high-profile Technological Core Facilities in the partner regions open to

external users. The objective of ShareBiotech was to improve and promote access to

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such facilities to support research and innovation in life sciences and biotechnology.

The information was shown in a one page summary of each TCF came under the

headings:

1. Location

2. Key words

3. Address

4. Contact details

5. Domains of Expertise and Services Offered

6. Techniques and Examples of Application

7. Access Policy

The market applications of the key technologies identified came under the

headings:

1. Human Health

2. Animal Health

3. Cosmetics

4. Agriculture, Animal Breeding, Plant Science

5. Agri-food Industry Nutrition

6. Environment Energy

The following key technologies were adapted from OECD categories:

1. DNA/RNA

2. Proteins and Other Molecules

3. Cell/Tissue Culture and Engineering

4. Gene and RNA Vectors

5. Biological Resources and Associated Facilities

6. Imaging

7. Process Biotechnology Techniques

8. Nanobiotechnology

9. Bioinformatics and Biostatistics

2.10 The ShareBiotech TCF Audit

Objectives

Activity 4 of the ShareBiotech project endeavoured to help TCF’s become more

professional so that access was easier and service more satisfactory to

users/customers of the TCF. A consultancy was appointed to participate in achieving

the objective of Activity 4.25

The methodology consisted of the implementation of an

audit of the TCF’s facilities, management, competencies, access policies, etc. (Ref:

Appendix 4). A training workshop was organised in the University of Nantes to train

the ShareBiotech members selected to implement the audit.

25

D. Martin; A. Devillez; ToolTechNov, University de Nantes, France

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Ten of the TCF’s identified in Ireland (BMW Region/S&E Region) were

selected based on their technology offer, access policy, GLP/GMP (Good Laboratory

Practice/Good Management Practice), and management policy. From this list, two

TCF’s were shortlisted from each partner region to develop the pilot model for the

ShareBiotech Transnational Model of Technological Core Facilities. The relevant

person in the TCF’s was contacted and asked if they were willing to participate in

the audit. On receiving their approval an appointment was organised with the

appropriate person for completion of the audit. The completed audits were sent to the

independent experts for analysis and a report was issued at a follow up meeting in

Nantes, France. The recommendations of the independent experts were relayed to the

participating TCF’s through a face to face meeting with the ShareBiotech member

and TCF manager. The audit identified the gaps and needs within the TCF and

suggested the implementation of measures to address the deficits to improve the

professional running of the TCF. ShareBiotech funding of €18,000 was made

available to facilitate a collaborative project between the two TCF’s.

The initial audit of the BRI, AIT, and Bioclin/Intertek26

facilities supported a

TCF status but for Intertek recognised the lack of research engagement and for AIT

the obvious issues of, unsustainable funding, insufficient permanent staff, and

technical support, equipment upgrade/maintenance/replacement budget, marketing of

profile and services. A proposed A4 solution was to develop a public-private

partnership to partly address some of these issues and provide a basis for further in-

house progression. One lab in the CBBR, now branded as the Bioscience Research

Institute (BRI) would be devoted to selected bio-similar analysis work (although this

would require engagement in cell culture etc), that Intertek would manage, i.e. AIT

provides TCFs and Intertek manages and implements quality structure and

operation/maintenance budgets etc. Outcomes would transfer to Intertek for

necessary GLP repeats. There was a lot of ShareBiotech interest in this model, so

some brief statement re types of public-private sector collaboration that can mutually

enhance operation of and access to TCFs should be made. CIRCA focused on

proposals to address more fundamental aspects of TCF structure and delivery –

staffing, access, maintenance, budget etc.

26

Intertek is a UK multinational analytical company. The Athlone division is now private and restored

as Bioclin Ltd

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Table 2.1.TCF Audit Questions (Ref. Appendix 4)

Identification of the Technology Core Facility

Q1 Date of creation?

Q2 Date of audit?

Q3 Name of TCF?

Q4 Website of the TCF?

Q5 Country?

Q7 TCF main fields of activities and/or expertise?

Q8 Do you have accreditation? (Yes or No)?

Q9 Do you have standard operating procedures? (Yes or No) What are they? i.e. GMP/GLP

Q10 Do you have a quality system? (Yes or No). What are they?

Q11 Fundamental research projects? Number? Number as collaborative? Number as leader?

Q12 Applied research projects? Number? Number as collaborative? Number as leader?

Q13 Services? Number? Number as collaborative? Number as leader?

Q14 TCF manager name? Phone? Email?

Q15 Status? Public sector employee (Y/N)? Private sector employee (Y/N)

Q16 Is the TCF a legal entity? (Yes or No). Legal form of the TCF?

Q17 If the TCF is a part of broader organization, name of this organization?

Q18 Legal ease for hiring or dismissing permanent personnel for the TCF 'activities (from 1 [very

difficult] to 4 [very easy])?

Q19 Do the researchers working in the TCF consider their involvement in the TCF beneficial for

their careers? (From 1 [yes] to 4 [no])?

Governance

Q1 Does the TCF have its own: Scientific committee (Y/N)? / Management committee (Y/N)?

Since when? Number of members? Number of clients/users? Number of external experts?

Q2 Name of public entities supporting the TCF& since when? Name of private entities, including

foundations, supporting the TCF (involved in the governance of the TCF) & since when?

Q3 Name of research teams (directly and steadily) associated with TCF activities? Number of

researchers? Core competences?

Resources Allocated to the TCF

Q1 Human Resources? Researchers, PHD Students, Technicians, Administrative staff: Total

number? Public sector employee? Private sector employee? Permanent contract of

employment? Fixed term contract of employment? Grants? Other?

Tangible / Intangible Resources

Q1 Equipment owned? Risk of obsolescence by future technology (L M H)? Year of purchase?

Public finance part? Private finance part? Annual maintenance, calibration and energy costs?

Utilization rate (% in last year)?

Q2 Equipment leased? Risk of obsolescence by future technology (L M H)? Calibration and

energy costs? Contract year? Utilization rate (% in last year)? Contract term (No. of years)?

Contract clause for renewing equipment (Y or N)?

Q3 Reference number of patents and software (input required for activity of TCF) (name or

number)? Duration of license contract (No. of years)? First year annual associated cost in €?

Annual associated cost in € per year (following years? Public assignees (Y / N)? Private

assignees (Y / N)?

Main Outputs of TCF

Q1 Intellectual property generated? Patent priority document (national)? Extended and PCT

patents? Software (with an IDDN)? Brand? Design?

Other outputs In 2010, for the TCF

Q1 Turnover of the TCF? Licensing contracts on IP? Sale contracts on IP? Service contracts?

Consultancy (a known solution to be applied)? Training sessions? Research contract (public

financing)? Research contract (private financing)? Other research contracts?

Q2 In 2010 for the TCF: Free licencing on IP? Free services? Free consultancy? Free training?

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Differentiated Price Policy; Type of Expenses?

Q1 Equipment depreciation? Maintenance? Infrastructure? Accreditation? Certification? IP

costs? Training session? Human resources? Consumables? Profit margin?

Networking Activities

Q1 Workshops or seminars with international partners? Workshops or seminars with national or

regional partners? Joint conferences with private companies? Involvement in European

programs? Involvement in national / regional research programs?

Q2 NETWORKING ACTIVITIES IN THE LAST 5 YEARS: Publications in scientific

international journals produced by or through the use of the TCF? Scientific publications

through the use of TCF with acknowledgement of the TCF? Publications in professional

magazines? Involvement in foundations? Creation of spin off (legal entity)?

A Rapid Overview of TCF

Supplier/customer links? Do you think that your customers can find services and products

similar to your TCF in your country? Size of national competitors (No. of employees)? Do

you think that your customers can find services and products similar to your TCF in an

international context? Size of international competitors (No. of employees)? Standardization,

certification? Recognition strategy put in place by TCF? Belonging to a platform network?

Acknowledgement of TCF by research teams? Obsolescence of technologies implemented?

Do you have a training strategy? Utilization rate of resources? Services offered? Protection

strategy (patent)? Communication and marketing strategy? Website? Publications in

professional magazines? Future rival technology? New opportunities in the field? How do

you guarantee confidentiality?

Complementary Information

Q1 According to your expertise, what are the main difficulties for SMEs to access your TCF?

Q2 Do you have some specific requests and partnership proposals from SMEs?

Q3 Does the TCF play a strategic role in any cluster and if "yes" how can you characterise this

role?

Q4 According to your opinion what would be the three main challenges for you TCF :

At short term (for 3 to 12 months)? At middle term (for 1 to 3 years)?

2.11 Regional Technology Translators (Pilot Action)

The Regional Technology Translators (pilot action) analysed the function of

“Technology Translator” (“or facilitator”) within Ireland (BMW/S&E) regions and

France, Portugal and Spain. One person from each region was identified and was in

charge of directing a technology demand towards an appropriate answer. The

demand whether vague or complex was translated into a precise need and a

technological solution was offered. Technology Translator meetings were held every

two weeks between the ShareBiotech Regions via phone/Skype to translate identified

needs into concrete solutions.

The identified needs and answers were originally posted on The BiotechKnows

Website (http://thebiotechknows.com/); Google Spreadsheet and later on the

ShareBiotech website. The BiotechKnows was a scientific networking and

consulting platform developed by the EPISODE Project

(http://www.episodeproject.net/) that was financed by the European Commission's

Framework Programme 7 (FP7).

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2.12 Organisation of Local Technology Meeting’s (LTM’s)

Project partners were obliged to organise at least two Local Technology Meetings

(LTM’s) in each country per year and at least one in each region. The meetings took

the format of specialised colloquia/workshops to present an overview of available

technologies and their potential applications. Alternatively, the meetings could take

the format of presentations of specific technologies to a targeted audience of SME’s

or researchers identified as having special interest i.e. specific industries that had

already shown interest in accessing research and technological networks. The role of

Technology Translator (TT) was beneficial in identification of the specific

industries.

2.13 Selection of Local Technology Meeting Domains

It was decided to hold three LTM’s in Athlone Institute of Technology (AIT). To

select the themes for the LTM’s the companies and research groups surveyed were

categorised into the areas of biotechnology in which they specialised. The following

domains were identified:

1. Biotechnology SME’s Antimicrobial/Biocides

2. Biotechnology SME’s Controlled Environments

3. Biotechnology SME’s, Miscellaneous

4. Biotechnology SME’s Veterinary

5. Biotechnology SME’s/Drug Development

6. Biotechnology SME’s/ Health Care/Tests And Biotechnology SME’s/

Healthcare/Bio-products

7. Biotechnology SME’s/ Medical Devices

8. Biotechnology SME’s/ Drug Delivery And Biotechnology SME’S/ IT

9. Natural Products

2.14 Natural Products LTM

The meeting was focused on SME members of the Natural Products Biotechnology

Sector in Ireland and endeavoured to clearly identify company perceptions of deficits

regarding partnership, collaboration, and access to core facilities, required skills,

training, and effective networking within Ireland, the Atlantic Area of Europe and

beyond, finance and investment etc.

To proceed with the Natural Products LTM it was necessary to identify companies

and stakeholders in this area. The majority of companies identified were involved in

the harvesting of seaweed and other sea vegetables for the production of

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biopharmaceuticals, cosmetics, health foods, animal feeds, Bio-fuels, and other

domains. Companies were identified using; Biotechnology Ireland Directories,

Enterprise Ireland Directories, The Marine Institute NUIG, Internet Websites, and

phone calls. Emails were sent to companies with a cover letter detailing the

ShareBiotech project and to establish the willingness of companies to engage with

the project and participate in phone interviews to identify specific needs in their

industry that could be addressed in the life-time of the ShareBiotech project.

A table of companies was drawn up detailing the company name, specific activities,

summary of identified needs, address and contact details (Ref. Table 3.8). A survey

was compiled to ascertain the gaps and needs of the companies regarding R&D,

access to technology core facilities, regional and National Government support,

access to training and skills, and funding. The interviews were conducted by phone,

where a description of the ShareBiotech Project was given, and its possible benefits

for the companies as well as the questions. Each interview lasted approximately

thirty minutes. Following analysis of the interviews, the concerns expressed by the

companies were tabulated to identify common themes among the answers. The

identification of commonalities focused the areas which could be addressed in a half-

day meeting, and the identification of experts who could suggest solutions to the

problems highlighted during the interviews. This information also facilitated the

mapping of the Natural Products Biotechnology Sector in Ireland.

The Natural Products LTM was planned to take place on May 3rd

in AIT

2012. However, when potential attendees were contacted, it emerged that this date

was not suitable for the majority of SME representatives and would have resulted in

low attendance. It was decided to reschedule to a later and more suitable date for all

concerned.

Two LTM’s were rescheduled to take place on September 3rd

and 4th

2012 in

Athlone Institute of Technology. The theme for the first meeting was “Natural

Products: Technology Needs” (Appendix 7) and was scheduled to run from 12:30

pm to 05:00 pm. Again, the speakers identified for the original meeting were

contacted and asked if they were available to present on the new date. Most of the

original speakers agreed to give presentations and some new speakers were

identified. The meeting agenda was disseminated to the same attendee base

originally identified in the phone interviews.

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The theme for the second LTM “Decontamination: Technology Needs” (Appendix

8) took place on September 4th

in the same venue and over the same time frame. The

meeting focused on SME’s in the hygiene and disinfection sector and sought to

address needs identified in the original phone interviews. Speakers were also chosen

on this basis both nationally and internationally. The meeting agenda was

disseminated to the already identified potential attendees in the natural products

sector. Both meetings were video recorded and uploaded to U-Tube and the link was

disseminated to all ShareBiotech partners and stake holders in the natural products

sector which facilitated broad access to the meeting presentations and

recommendations.27

2.15 Towards 21st Century Toxicology (November 4th/5th 2011)

A major international toxicology conference was held at Athlone Institute of

Technology (AIT) on Thursday and Friday, 3-4 November (Appendix 9). The

conference, entitled, “Toward 21st Century Toxicology”, represented a collaboration

between the Irish Society of Toxicology (IST, and the EU ShareBiotech project as

initiated by the AIT ShareBiotech team.

This conference attracted some very significant researchers and leaders in

this field from across Europe and the US. Prof Thomas Hartung of John Hopkins

University Bloomberg School of Public Health and former head of ECVAM

(European Centre for the Validation of Alternative Methods) who was involved in

the implementation of the US National Research Council vision document “Toxicity

Testing in the 21st Century – a vision and a strategy”.

Dr Eckhard von Keutz, the Senior VP, Head of Global Early Development, in

Bayer Healthcare, responsible for their toxicology and committed to effectiveness

and efficiencies. Dr David Dix, Deputy Director of the National Centre for

Computational Toxicology in the US described some of their innovative and

significant robotic and IT toxicology developments. Dr Richard Brennan of DABT

27

http://www.youtube.com/watch?v=AG5Iut7dmuA),

(http://www.youtube.com/watch?v=6z6hZ_41Uds

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(Diplomat of the American Board of Toxicology) of Thomson Reuters in San Diego

in the US was involved in development of software under systems biology for

applications in toxicology. Prof Richard Walmsley of Gentronix Ltd and the

University of Manchester had developed new approaches for genotoxicology

screening and Dr Annette Bitsch from the ITEM Fraunhofer in Hannover in

Germany discussed the evolving regulatory impact on toxicology development and

adoption. Dr Sophie Rocks of the University of Cranfield in the UK presented

research conducted in the new and challenging area of nanotoxicology, while Dr

Olivier Kah, a Research Director in the University of Rennes described new

advances in in-vivo approaches. The conference hosted presentations by AIT

researchers and overlap between toxicology testing methods and modern

biotechnology in-vitro analysis methods, and the possible impact of the

ShareBiotech transnational translational network of Technical Core Facilities on the

toxicology sector. The REACH Project (Regulation on Registration, Evaluation,

Authorisation, and Restriction of Chemicals) was implemented in 2007. One of

the main reasons for developing and adopting the REACH Regulation was that a

large number of substances have been manufactured and placed on the market in

Europe for many years, sometimes in very high amounts, and yet there has been

limited information on the hazards that they might pose to human health and the

environment. It was considered that there was a need to fill these information gaps

which would help to ensure that industry was able to assess hazards and risks.

Posters from researchers in AIT, NUIG, and UCD were exhibited. A member of the

AIT ShareBiotech team gave a presentation entitled “Core Facilities Impact on

Toxicology-ShareBiotech” illustrating the identity and implementing the necessary

risk management measures in order to protect human health and the environment.

Dr. Paul Tomkins gave a presentation on 3D cell toxicology models. The REACH

project supports implementation of the 3Rs (Replacement, Reduction, Refinement)

to reduce testing of substances on animals, and promotes the use of Omics

technologies i.e. genomics, transcriptomics, proteomics etc., biotechnology

techniques as alternatives to animal testing. During the presentation some of these

alternative technologies were highlighted.

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2.16 Expert Interview

As part of the overall project and in particular, the Transnational TCF Model, a

series of extensive interviews with experts that were involved in biotech sector

partnering, collaboration and networking were undertaken. All selected experts in

addition to their current role had a long history of participating in innovative

biotechnology development – full profiles were included in the interview report.

The experts were contacted by email and briefed on the ShareBiotech Project and

asked if they were willing take part in interviews and asked to provide dates when

they would be available. Once the experts were recruited questions were then drawn

up that corresponded to their area of expertise in the biotechnology sector. Although

some questions were generic the main body of questions varied from expert to

expert. The questions were emailed to the interviewees at least one month prior to

interview. The interviews were carried out via face-to-face meetings, telephone, and

Skype. The following people agreed to be interviewed:

Prof Horst Domdey (MD of BioM Biotech Cluster Development GmbH

Munich, Germany), Dr. Martino Picardo (Dir Stevenage Bioscience Catalyst,

London, U.K.), Mary Skelly (MD Microbide Ltd Ireland/USA), Dr. Mario

Thomas (Dir Ontario Centre of Excellence, Ontario, Canada), Dr. Terry Jones (Dir

One Nucleus, London, U.K.), Derek Jones (Dir Babraham Bioscience Technologies

Ltd, London, U.K.), Dr. Claire Skentelbery (Head of Council for European Bio

Regions (CEBR), Belgium).

A full list of the presented questions is given in Appendix ??

2.17 Dissemination of information and colloquia

An email list of approximately 400 contacts was created (Appendix 10) containing

organizations and people (companies, research groups, core facilities, academics,

experts in biotechnology, clinicians and biotechnology stakeholders) that were either

directly or indirectly involved in biotechnology. Members from industry and national

organizations e.g. Enterprise Ireland were invited to form part of the ShareBiotech

steering committee. The ShareBiotech newsletter (Appendix 11) was published

every 3 months and contained contributions from the four partner regions such as;

latest developments in the ShareBiotech project, SME success stories, events,

meetings, conferences, links to services, etc. The newsletter was disseminated via

email to all contacts. ShareBiotech meetings were held approximately every 3

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months in one of the partner regions to update partners on the progress of the project

and to plan the next steps. These meetings were attended by representatives of all the

partner regions and stakeholders from the Atlantic Area and outside were

encouraged to attend meetings and conferences to present successful biotechnology

models. Workshops were organized during meetings to tease out problems related to

the project as they arose. The “ShareBiotech Mobility Grant Scheme” (Appendix 8)

facilitated travel expenses and living costs for attendees. A study visit by partners

from France, Spain and Portugal was organized, where a delegation visited centers of

excellence in Ireland. The study group visited the Conway Center in UCD, CAMI in

St James’s Hospital, Shannon ABC, NCBES in Galway NUIG, and Intertek in

Athlone.

2.18 Biotechnology Clusters

As the ShareBiotech Policy evolved it became clear that the concept of clustering,

first identified by Maskell (2001) and Porter (1998) in relation to the development

and success of biotechnology could not be overlooked. Much literature was studied

in relation to clustering and biotechnology clusters of different types

(spontaneous/policy driven) and at different stages of evolution were identified in the

U.S, U.K. Europe and Asia. CEO’s of successful clusters were interviewed and

asked what made them successful and asked for their opinions on the global

biotechnology industry and its potential contribution and benefit to mankind. Experts

were also asked for their views on the development and potential of the Irish

biotechnology industry. Experts were asked whether the ShareBiotech Model of

Transnational TCF’s was a viable model that would foster collaboration between

member states and positively impact the development of the Knowledge Based

Economy (KBE).

2.19 Transnational TCF model

One of the objectives of the ShareBiotech project was to develop a pilot

transnational network of Technological Core Facilities within the partner regions.

Initially, Potential TCF’s were identified, ten in total, and two were ultimately

selected to engage with the development of the transnational network of TCF’s. The

organisations selected were Bioclin; a subsidiary of Intertek Athlone and the

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Bioscience Research Institute (BRI) located at the East campus of the Athlone

Institute of Technology (AIT).

Prof Dominique Philippe Martin, Dr. Arnaud Devillez, and Dr. Audrey

Tremeau of IGR-IAE Rennes conducted the TCF audits of assigned facilities of all

partners and issued a long term diagnosis at the University of Nantes meeting in

April 2012. The analysis took cognisance of fundamental variables that influence

viable and sustainable operation – status of core facilities, projects, funding, human

resourcing, access and utilisation rates, and cost models. The final form of analysis

presents data in two forms, action and status flow chart and a table of linked

strengths and weaknesses.

The results were relayed to both TCF’s and funding of €18,000 was made

available for a small collaborative project. Unfortunately, at this time, Bioclin was

taken over by Intertek and a change in policy prevented the progression of the

collaborative project. It was decided to take on board the audit analysis and set about

upgrading and improving the service provision of the BRI.

Technology Core Facilities (TCFs) as a progression of the term core

facilities, refers to laboratory instrumentation required by many investigators to

conduct their research, but are generally too expensive, complex or specialized for

individual and small group researchers to provide and sustain themselves. The scale

of impact of such technologies grow further when SMEs and other industry domains

are included – their R&D can benefit considerably from access to advanced

technologies, but this generally must occur via some collaboration model, frequently

with public sector research centres. The increase in costs, enhanced skills sets,

knowledge, research impact and data generation and reduced shelf life of many core

facilities over the past decade has been recognised in many countries and has

reflected the generation of specialist research centres and enhanced collaboration

models and media. The necessary skill sets, service and funding model and

accelerated need for equipment updating or replacement due to accelerated

technology development all contribute to significant annual costs and readily

distinguish those research facilities that can professionally achieve these objectives

from those who cannot. This sector of Activity 4 in ShareBiotech was devoted to

developing a positive outcome to the prior selected TCF analysis.

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The prime objective of this element of Activity 4 was to undertake work that

would address the findings and related matters of the audit, to positively impact on

the future nature of technology core facilities in AIT research centres.

2.20 C.I.R.C.A. Group Consultants

A tender went out for a consultant to review the capacities of AIT to identify those

services which were likely to become viable Technological Core Facilities of

relevance to the ShareBiotech concept. For each of these services, but particularly

for the Centre for BioPolymer and BioMolecular Research, the consultant was

required to do the following:

1. Review of TCF audit and plan

2. Designation of TCF Instruements

3. Pilot TCF selection

4. Management software review

5. Development of organisational model

6. TCF SOP documentation

7. Designation of support staff roles

8. Selected quality approval

9. Designation of access criteria

10. Operation cost calculation and budget

11. Identified training needs and courses

12. Review of Public Private Sector models

13. Maintenance costs and budgets

The review consisted of investigating:

The Technology Core Facilities plan and the definition and selection of its core

equipment and instrumentation.

The organisation of the management of the facility including quality control

procedures, calibration and maintenance programs

The core personnel and support staff, and their training programs

The financial system including budgets ,costs and accounting control

Other aspects that included facility and instrumentation access, and prior

successful activities in Public Private partnerships

The long-term aim of the TCF was to create a resource of activity which would

enhance the reputation of AIT as a centre for research and training in the midlands

region, and which would also develop collaborative linkages between AIT and

regional and national industry. However, it was also necessary to develop a plan for

equipment replacement and enhancement, and for skill development and acquisition.

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2.21 The Darcy Report

Following on from the recommendations of the TechToolNov Audit, Darcy

Consultancy Services were engaged to review the recommendations of the audit and

to suggest a TCF model (i.e. BRI, AIT) that was fit-for-purpose to embrace

public/private collaborative projects and was capable of interfacing with SME’s on

several levels. The “ShareBiotech TCF Report” was published in 2012 (Appendix

21). The work carried out by Darcy Consultants was in the following 14 areas:

1. Review of TCF audit plan (TechToolNov): 2. Designation of TCF instrumentation: The key input into this work package

element was understanding the business needs for specific instrumentation

and the degree of customisation required. The possibility of short-term rental

or provision of instrumentation as a demonstration facility was explored with

providers.

3. Pilot TCF selection: 4. Management software review: A review was undertaken as to software

requirements mecessary to meet stakeholders expectations e.g. management

software including project management software, LIMS (Laboratory

Information Management Software), bridging software to integrate

istrumentation software into LIMS, and software related to operational

software management e.g. temperature, and humidity monitoring aswell as

data-prodcessing software.

5. Development of organisational model: The organisational model was

developed to ensure the maximum potential for the centre by means of a

review of core skills required specifically from an instrumentation and

analytical perspective e.g. validation, maintenance and calibration.

6. TCF/SOP documentation: Equipment Operating procedures (EOPs) were

prepared, approved and controlled as part of an overall documentation control

system. Existing procedures were revised to ensure compliance with selected

industry standards.

7. Designation of support staff roles: Support personnel will be identified in

areas such as calibration, maintenance (both facility and instrument) as well

as software validation. It pas planned to supply contracts to specify

requirements and other elements of the service provision where external

contractors were required for specialised services.

8. Selected quality approval: The quality certification route were assessed

based on the needs of the stakeholders, e,g ISO 13485 Quality management

systems compliance would be sufficient for medical device/ diagnostics

research and development but some pharma and medical device companies

performing validation studies or similar would require certification to ISO

17025.

9. Designation of access criteria: Access to the laboratory facilities and use of

the instrumentation were determined so as to ensure that firstly the safety of

all personnel was ensured. In addition it was essential to safeguard the

integrity of the facility and the instrumentation in terms of both the

competence of the users and also the materials being brought into the facility.

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Policies were developed regarding access, working restrictions e.g after

hours/alone and a pre authorisation process were developed for materials

being brought into the facility as well as the disposal of such materials.

10. Operation cost calculation and budget: A costing model was proposed for

approval in terms of intial capital expenditure, preparation of operational

budget and lifecycle costing on instrumentation.

11. Identified training needs and courses: A training matrix including training

needs was prepared as part of this element of the work package. This

document served as record of training performed internally on SOPs , EOPs

and other policy documentation as well as external training.

12. Review of public/private secdtor models Data was presented in relation to

other Public Private sector models e.g Teagasc, Moorepark where access was

available to industry to highly specialised instrumentation and processing

facilities for research and development work as well as pilot batch production

on a Toll basis. Other models were also be reviewed.

13. Maintainance costs and budgets: Costings were prepared for annual

calibration and maintenance of the instrumentation as well as revalidation

requirements e.g of the Water system, AHU (Air Handling Units) as

applicable. Also consumable costs e.g filters, were included.

2.22 ShareBiotech Recommendations to Support the Growth of a

Bio-Based Economy (APPENDIX 6)

The report “ShareBiotech Recommendations to Support the Growth of a Bio-

Based Economy” was compiled by Bruno Sommer Ferreira Data Collection and

Revision: ShareBiotech Consortium Partners. All partners were asked to forward

relevant data from their own regions regarding instruments in place for the

development of a Bio-Economy. The report was published in November 2012.

First the required data to assess the fit between the existing research infrastructure

and the needs identified at local, national, and transnational level was sourced. The

information collected by the Activity 3 ShareBiotech Survey, namely the mapping of

“Biotechnology Competencies and Technology Regional Needs” was used together

with publically available information on the local economy of the various regions in

the project, including businesses for which biotechnology is not the core activity but

can benefit from biotech-based tools, processes, or products. Additionally, a

questionnaire was sent to local experts of each region participating in the

ShareBiotech Project. Further information on existing biotech clusters and bio-

businesses was used. Also, the short to long-term EU policies and available financial

instruments for inter-regional, transnational, and inter-sectorial cooperation were

taken into account.

97

Each region participating in the ShareBiotech project was profiled. These

profiles aimed to briefly characterise the economy of the regions, the research and

innovation support initiatives, both public and originating from the private sector,

and provide a brief assessment of the innovation landscape in biotechnology and

related sectors. Local experts were interviewed to get the most up-to-date critical

assessment to provide in-depth regional insight.

For the purpose of this analysis, the regions of the same country were grouped

together, since the influence of the national strategies, policies and economic

environment remained determinant, although regional specificities were mentioned

whenever relevant. As such, Pays de la Loire and Bretagne were referred as French

regions, Border, Midland, and Western and Southern and Eastern were referred as

Irish regions, and Algarve, Centro, and Norte, were referred as Portuguese regions.

Only one region from Spain was involved, which was Navarra. Each region was

surveyed under the headings, (1) Economy (2) Policy (3) Access to finance (4)

Clusters and (5) Snapshot of the Biotech Ecosystem. A report entitled

“ShareBiotech Recommendations to Support the Growth of a Bio-Based

Economy” was organised by Biocant Technology Transfer Organisation and

prepared by Bioingenium Lda in November 2012. (www.sharebiotech.net).

2.23 ShareBiotech Biotechnology Education “Training Offer &

Needs in the Atlantic Area”

One of the objectives of ShareBiotech was to stimulate links between academia and

industry using several instruments one of which was to connect people from different

life science fields, and cultures through training and mobility and development of

workshops i.e. LTM’s (Local Technology Meetings). Following in-depth research

the report “Training Offer & Needs in the Atlantic Area” was published by the

ShareBiotech consortium in 2013 (www.sharebiotech.net). All partners contributed

to the publication of the report. In the context of the European strategies and

recommendations to improve Education and training in Life Sciences as a base for a

sustainable Bio-economy, the report aimed to identify the skills and training needs in

the area of biotechnology in the Atlantic Area and to provide recommendations to

improve the training offer and education in this area.

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The research was divided into 5 parts; (1) Snapshot of the ShareBiotech Regions,

(2) Biotechnology Training Offer in the Partner Regions, (3) Biotechnology Training

Needs and Deficits (Gap Analysis), (4) The Contribution of ShareBiotech to Biotech

Training in the Partner Regions, and (5) Main Conclusions and Recommendations to

Improve the Offer.

A questionnaire “Questionnaire on Biotechnology Education Needs &

Offers” (Appendix 12) was compiled; containing questions that traversed several

different aspects encompassed by the training report was directed to relevant

participants of the project consortium. The analysis of the answers to the

questionnaire is presented in the results section of the thesis. The questionnaires

were completed by a total of 15 people belonging to organisations such as local

universities, research centres, vocational schools, entrepreneurs, innovation and

technology transfer agencies and technology parks. All answers were compiled and

analysed and were represented in graphical format.

2.24 Instruments to Foster Technology Transfer in Life Sciences

Technology Transfer is the process of transferring “skills, knowledge, know-how,

technologies, manufacturing methods, manufacturing samples, among governments

or universities, and other organisations to ensure that scientific and technological

developments are accessible to a wider range of users, who are then able to further

develop and exploit the technology into; new products, processes, applications,

materials, or services”.

An “Educational Needs Questionnaire” containing 12 questions (Appendix 6)

was compiled by the ShareBiotech consortium with the objective to identify

instruments – and more particularly incentives that have been developed for the

implementation of technology transfer at regional, national, or European level. To

this end, the ShareBiotech partners interviewed local, national, and European

organisations in their regions that supported technology transfer to identify the

instruments/incentives they were using e.g. (call for projects, grants, contests, prizes,

web tools, fairs, and innovation and technology meetings, networking activities etc.).

These were organisations such as Technology Transfer offices in universities,

research centres, technology parks, innovation centres, funding agencies, clusters,

and any organisations that develop or used incentives to foster technology transfer. A

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total of 50 organisations associated with technology transfer were contacted within

the ShareBiotech partner regions, 12 of which were Irish Organisations.

The questionnaire went through 12 questions referring to the transfer

channels or pathways listed below, and defined in the article “Innovation: a

knowledge transfer perspective” (Alexander. A., Childes, 2011). The identification

of technology transfer instruments via the questionnaire allowed for the comparison

of technology transfer strategy between the ShareBiotech Regions.

Technology Transfer Pathways (TTP’s):

1. Student placements/Graduate employment

2. Joint supervision

3. Joint conferences

4. Training & Continuing Professional development

5. Secondment (simultaneously working for public and private organisations)

6. Collaborative research

7. Contract research& Consultancy

8. Spin-outs

9. Shared facilities

10. Patents

11. Licences

2.25 Analysis of Life Sciences Technology Core Facilities Business

Models in Europe

State-of-the-art technology is a crucial asset for actors in the biotechnology domain,

who need to commit considerable financial resources, to own, operate, and renew

their equipment. TCF’s are a set of laboratory instruments and their associated skills

which are required in the performance of research and other technical functions, but

which are generally too expensive, complex, or specialised for individual and small

groups of researchers to provide and sustain by themselves. TCF’s may be public or

private and are generally open to a wide range of users.

The ShareBiotech consortium contracted Ernst & Young to conduct a study

on the business models of European TCF’s. The aim was for ShareBiotech to obtain

an overview of the various business models adopted by TCF’s and an analysis of

their obvious strengths and weaknesses and to inform ShareBiotech partners and

TCF managers of business and management practices as well as suggested

development strategies. Fifteen TCF’s across Europe were sampled and various

aspects of their organisation such as: activity, partnership, governance, staff

organisation, IP management, and marketing and promotion strategy were

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considered. The 15 TCF’s were chosen from a list of 110 TCF’s suggested by the

partner regions. Among the 15 TCF’s, three categories of TCF’s emerged based on

the focus of their activities.

Profit Orientated TCF’s (N=5) maximise profit by providing a highly specialised

service offer to private and public clients

Local Innovation Support TCF’s (N=6) participate to the regional or national

economic development by giving access to cutting-edge technologies to both

researchers and SME’s, or start-up companies.

Research Community Focused TCF’s (N=4) supporting the development of

research activities and the enlargement of the community knowledge basis by

providing easy and affordable access to state-of-the-art equipment, mainly to the

global academic community.

The business models of all TCF’s were analysed on a “Cartesian Space”

(access policy v service offer) which allowed the clustering of the TCF’s. In order to

guarantee a wide range of structures and business models the selection of TCF’s

included a broad range of scientific infrastructures from spin-off companies to TCF’s

integrated into a Bio-park. The following organisations were interviewed:

Table 2.2 TCF's interviewed by E&Y

TCF Location Contact Title

Animascope France Mr. Christ Serra Business Developer

AROS Applied Biotechnology Denmark Mr. Thomas Thykjaer CEO

Barcelona Science Pk Spain Mr Jesus Purroy Scientific director

Biocant Portugal Prof. Carlos Faro Scientific director

Biocentre Oulu Finland Dr. Pirkko Huhtala Centre Coordinator

Cell Imaging Unit Portugal Mr. Jose Feijo Director

CIMNA France Mr Regis Josien Scientific director

Fondaziene Filatete Italy Mr Mario Selarno Business Director

Genoscrene France Frederic Antigny Business Director

GIGA Belgium Mrs Christina Fransen Business Director

MPI-CGG Germany Mr Ivan Baines CEO

TIC Strathclyde University Scotland Catherine Breslin Development Mngr

Biotec Centre University Oslo Norway Elisa Bjorgo Project Manager

Spinovation Netherlands Mr Fredrick Girard CEO/Founder

UCD Conway Centre Ireland Mr Brendan Professor

101

To achieve the objectives of the survey, E&Y adopted a methodology based on

bibliography and interviews as follows:

Review of literatures regarding business issues of TCF’s

Expert selection of criteria to ensure a good approach to the study

Interview with 2 experts in academic research and industry

Interviewed 15 managers/directors/coordinators of selected TCF’s

Analysis of information gathered via conference calls

The criteria used for the selection of TCF’s consisted of:

Geographic location

Ownership (public/private/hybrid)

Experience i.e. broad potential application versus specialised

Type of activity i.e. collaboration, training, R&D, service

Type of users i.e. public, private, SME, start-up, industry

Existence of partnership i.e. public, private entity, CRO, equipment supplier

On the basis of the selected criteria, 18 European TCF’s were contacted via email to

arrange a phone interview and 15 accepted.

A list of analysis criteria was drawn up to identify the main items required to

comprehensively investigate and determine the business models operated by the

TCF’s:

Objective of the TCF

Governance

Legal structure

Ownership, financing & budget (public, private, hybrid, grants, self-financed)

Activity and service offer

User and client portfolio

Staff and organisation

Structure of pricing and fees

Partnership and collaborative projects

IP and confidentiality management

Development strategy

Key success factors

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RESULTS

103

3 Results

3.1 ShareBiotech Biotechnology Competencies and Techniques

Regional Needs Survey (Activity 3)

This section of the results chapter highlights the results of the three surveys used to

map the current trends and infrastructures in the biotechnology sector in the Atlantic

Area, i.e. the Companies Survey, Research Groups Survey, and Technological Core

Facilities (TCF’s) Survey. The surveys were generic across the four member states.

The information gathered was vital in determining the future direction and activities

of the ShareBiotech project to develop an action plan to strengthen the biotechnology

sector in the Atlantic Area. The results were published in the OECD document

entitled Biotechnology Competencies & Technology Regional Needs; Final Report;

“Action Plan to Reduce the Gap Between Life Science Technology Supply and

Demand” (Pinto, Cruz, 2011) in April 2011; (ISBN 987-989-8472-12-0).

3.2 Biotechnology Competencies and Regional Needs Survey

Results

The document resulting from the Biotechnology Competencies and Regional Needs

Survey suggesting an action plan to reduce the gap between life science technology

supply and demand was prepared by CRIA, Regional Centre for the Innovation of

the Algarve; Division of Entrepreneurship and Technology Transfer, University of

Algarve. The work was carried out by the ShareBiotech consortium within the

ShareBiotech project co-financed with the support of the ERDF (European Regional

Development Fund) – Atlantic Area Program (AAP).

The results were part of ShareBiotech Activity 3, which aimed to establish an

action plan to reduce the gap between life science technology and demand. The

challenge of this activity was to improve current methodologies of surveying

technology requirements. In this activity a common methodology was established for

surveying needs and offers (document available online at (www.sharebiotech.net)

and was implemented by ShareBiotech partners in their regions in order to catalogue

biotechnology infrastructures, competencies and needs. The ShareBiotech supply

and demand analysis included NUTS ΙΙ level (Nomenclature of Territorial Units for

104

Statistics) in the Atlantic Area (Figure 3.1). This work also fostered another

ShareBiotech deliverable; the “Strategic Recommendations and Action Plan to

Reduce the Gap between Life Science and Technology Supply and Demand”

Table 3.1: Valid Questionnaires Collected the ShareBiotech project

Regions Research Groups Companies

ES – Comunidade de Navarra 13 11

FR – Pays de la Loire 5 13

FR – Bretagne 26 29

IE – Border, Midlands & Western 24 11

IE – Southern & Eastern 31 26

PT – Norte 18 3

PT – Algarve 28 10

PT – Centro 40 28

PT – Lisbon - 11

TOTAL VALID INTERVIEWS 183 143

Data collection was carried out at regional level by ShareBiotech partners between

September 2010 and February 2011. In total, 183 valid research groups’

questionnaires were collected and 141 valid company questionnaires (Table 3.1).

The following section shows the results of the ShareBiotech company and research

centre surveys in graphical format.

Populations of ShareBiotech Regions

Figure 3.1: Populations of ShareBiotech Regions Source: Personal Elaboration based in EUROSTAT data

In terms of population (Ref: Figure 3.1) there was a large discrepancy between

regions with some having more than 3 million inhabitants (Bretagne, Pays de la

105

Loire and North Portugal) and others around half a million inhabitants. Similar

discrepancies occurred between regions for population density.

ShareBiotech Regional Economies

Figure 3.2: Economic Indicators Index Source: Personal Elaboration based in EUROSTAT data

In relation to economic indicators (Ref. Figure 3.2) both Irish and French regions

had stronger performances in GDP level compared with the Portuguese regions. The

Portuguese regions faced a problem of difficulty to catch-up. Irish regions were the

best performers in relation to economic growth, but the World economic crisis (2009

to present) has had a dramatic impact in the Atlantic Area regions particularly in

Ireland.

106

Employment in ShareBiotech Regions

Figure 3.3: Employment Indicators Index in Atlantic Area Source: Personal Elaboration based in EUROSTAT data

Regarding employment (Fig 3.3), the employment rate was higher in Centro region

Portugal, Algarve Portugal and SE Ireland. Employment in high-technology sectors

and Human resources in S&T in Irish and French regions were clearly higher than

other ShareBiotech regions. Navarra had a very strong graph in human resources in

S&T but had less in high-technology sectors indicating significant potential existed

for stimulating uptake of technology and innovation by companies.

3.3 Innovation in ShareBiotech regions

In the area of innovation and R&D (Ref. Figure 3.4) Navarra lead all other

ShareBiotech regions and had a higher R&D expenditure as a percentage of regional

GDP and Bretagne followed close behind. Navarra and SE Ireland were the regions

with the highest proportion of their population aged 25-64 educated to tertiary level

107

followed by Bretagne and Algarve, Portugal had the lowest level. This Spanish

region was a runner-up in patents where Bretagne was the most relevant region with

an annual average of 309.1 patents by million inhabitants. The Algarve was the

weakest ShareBiotech region in this kind of indicator; in fact, Portuguese regions

were in general poorer performers.

Figure 3.4: Innovation Indicators Index ShareBiotech Regions Source: Personal Elaboration based in EUROSTAT data

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Regional Location & Operational Domain of Surveyed Companies & Research Centres

2 21

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Figure 3.5 Summary of Biotech Company Domain & Regional Location

Figure 3.5 depicts the regional location and operational domains of research centres

and companies in the Irish BMW & S&E regions

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Figure 3.6: Summary of Research Centre Domain & Regional Location

Figure 3.6 displays the domain and regional location of surveyed research centres.

109

3.4 ShareBiotech Research Groups Survey Results

The analytical unit of R&D demand was the research group. A research group was

defined as a “stable group sharing scientific objectives led by one or more scientists

and contains several members, both senior and young researchers and technical

support staff”. The group is usually a sub-division of a broader organization, a

research unit, and is responsible for the development of specific research lines. Even

if the group has scientific autonomy it answers to the research unit director. Groups

developed specific projects in research, development, and innovation with particular

resources, infrastructures, and equipment. Research groups were selected in

preference to research units as one of the analytical units in the ShareBiotech

evaluation because generally they were more homogeneous in their technology needs

and research lines. The research groups participating in the questionnaire were

selected in the partner regions by identifying: i) research units receiving funding to

carry out bioscience-related research and/or development activities, ii) research

institutes in relevant fields, iii) university departments that had an interest in

bioscience, and/or iv) research units in hospitals. Each local partner sent the

questionnaire to a sample of research groups, as defined using the criteria and search

techniques outlined. However, it is important to note that the survey responses were

not necessarily representative of the weight and importance of research groups in

each region. In total 183 research groups were surveyed by the ShareBiotech

consortium. In the following pages the main results of this survey are analysed in

detail.

General Presentation of Interviewed Research Groups

The first part of the questionnaire was dedicated to the characteristics of the research

groups. One of the questions was aimed at identifying the main domains of activities.

Each research group chose as many research domains as necessary to describe their

activity.

110

3.4.1 Domains of Activity of Interviewed Research Groups

Figure 3.7: Main Specific domains of the Interviewed research groups - % Total

Answers

The main scientific domain of interviewed research groups in ShareBiotech was

from Human Health (25.5%). In addition, Environment (11.3%), Bioinformatics

(9.1%) and Marine Sciences (8.9%) were also well represented (Figure 3.5).

Some regional differentiation occurred in the relative importance of the research

domains in ShareBiotech regions, Human Health was the main focus. The exception

was (Figure 3.6) Bretagne where research in Environment and Human Health

predominated; in North Portugal research in Animal Health and Environment

predominated and, finally, in the Algarve research in Marine Sciences and the

Environment predominated.

The large healthcare area of biotechnology in most regions was driven by the

Biopharma/diagnostics/biologics sectors. The drug migration to large molecules was

still very much in progress and the inherent need and demand for healthcare with a

growing aging population in Europe and eventual advent of personal medicine etc.

will continue to ensure the growth and dominance of this sector.

111

Figure 3.8: Main Scientific domains of the research groups in ShareBiotech regions

- % Total Answers

Size of Interviewed Research Groups

Figure 3.9: Number of scientists and technicians employed in research groups in

July 2010 – Percentage of the % Total Number of RGs responding to the

questionnaire

The most frequent (40.8%) size class of RGs was 0-10 employees (Figure 3.9) and

over 82.8% of the RGs had no more than fifty members. The exception was Ireland

in which a significant percentage of RGs had more than fifty members, followed by

BMW with 66.7% and S&E Ireland with 52.0% (Figure 3.10).

17.5%

23.8%

17.7%

37.7%

43.3%

14.0% 12.3%

32.0%

15.0%

4.8% 4.8% 5.7% 5.0%

.0%

11.0% 9.0%

5.0%

14.3% 11.3%

9.4% 8.3% 10.0%

8.2% 11.0%

.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

35.0%

40.0%

45.0%

ES - ComunidadForal de Navarra

FR - Pays de laLoire

FR - Bretagne IE - Border,Midland and

Western

IE - Southern andEastern

PT - Norte PT - Algarve PT - Centro

Human Health Animal health, Veterenary

Agriculture (including animal breeding), aquaculture and silviculture Agri-food (including beverages)

Nutrition, nutraceuticals Cosmetics

Environment Marine Science

Industrial processing Bioenergy

Bioinformatics Other

40.80%

24.30%

17.80%

17.20%

0 →10 10→25

25→50 >50

112

Figure 3.10: Number of Scientists and Technicians employed in RG’s in July 2010 -

% of the Total Number of RG’s responding to the questionnaire per region

The dimension of the RG’s in Ireland impacted positively on the numbers of Masters

and PhD. Students and employed Post-doctoral Scientists. However, the financial

collapse since 2008 negatively impacted on trained MSc and PhDs and higher

education (H&E) metrics. Other ShareBiotech regions in which over 50% of

research groups contained greater than 10 members were Centro-PT, North-PT, and

Navarra (Table 3.2). While research groups in BMW and S&E regions of Ireland

had a similar range of scale, there were significantly more centres and groups in the

S&E and mean post graduate numbers per group were higher in S&E, (Table 3.2).

Table 3.2: Number of Students in the research groups in July 2010

Regions Master’s students PhD students Post-doc students

Min. Max. Mean Min. Max. Mean Min. Max. Mean ES - Comunidad Foral de

Navarra 0 40 6.92 0 57 8,75 0 6 2,58

FR - Pays de la Loire 1 5 2.8 0 10 4,6 0 2 0,6

FR - Bretagne 0 10 3.21 1 12 4,36 0 4 1,46

IE - Border, Midland and

Western 0 5 1.86 0 80 17,53 0 180 19,47

IE - Southern and Eastern 0 16 5.83 1 250 30,47 0 120 17,92

PT – Norte 0 18 4,53 1 13 4,78 0 7 3

PT – Algarve 0 7 2,56 0 10 2,62 0 9 1,73

PT – Centro 0 42 7,46 0 54 7,11 0 38 2,89

ShareBiotech Total Sample 0 42 4,8 0 250 8,98 0 180 5,36

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Collaboration activities of interviewed research groups

(Figure 3.11) illustrated the geographical scope of collaborations of RGs with other

institutions/enterprises. This analysis unmasked the highly collaborative nature of

biotechnology and a high level of collaboration occurred at the national level (84%

of RGs responded positively to this level of cooperation that represented 30% of the

total number of collaborations registered).

Figure 3.11: Collaboration of the RGs in 2010 with other institutions/enterprises in

biotechnology R&D - Percentage of the Total Number of RGs responding to the

questionnaire on a Geographical Scale

Figure 3.12: Types of Collaboration of the Research Groups with

institutions/enterprises in biotechnology R&D - % Total Answers

The intensity of cross frontier collaboration also gave an indication (Figure 3.12) of

internationalization of RGs in the ShareBiotech regions and was very similar for all

81.7

84.0

72.2

48.0

18.3

16.0

27.8

52.0

.0 20.0 40.0 60.0 80.0 100.0

Local/Regional

National

Other European Union (EU) countries, EFTA, or EUcandidate countries

All other countries No

Yes

29.20%

30%

25.80%

15%

Local/Regional

National

Other European Union (EU)Countries, EFTA, or EUCanditate countries

All other countries

114

regions. PT-North, Navarra and Bretagne are slightly ahead of other ShareBiotech

regions in this respect

Figure 3.13: Characterization of Collaboration of RGs with institutions/enterprises

in biotechnology R&D - % Total Answers in each region

The internationalization of RGs may have been aided by technological networks and

more than two thirds of those responding to the questionnaire indicated that the

research units they were part of participated in technological networks (Figure 3.14).

This further highlighted the value of networks as a means of stimulating

communication, technology transfer and their importance in generating a critical

mass across Europe.

Figure 3.14: Participation of research units in one or several technological networks

- % Total Answers

69.30%

39.70% No

Yes

115

Intellectual Property

Intellectual Property (IP) rights are commonly identified as a critical subject in the

area of biotechnology. There was significant pressure to patent biotechnology

inventions, products and processes, to protect potentially economic valuable

knowledge. Commonly, the creation of new companies in this domain began with

researchers patenting their inventions and starting spin-off ventures. Slightly more

than half of the research groups who participated in the survey had registered patents

(Figure 3.15) and of those not holding patents 76% confirmed their interest in

patenting in the future (Figure 3.16). The number of patents leading to a

commercially relevant, exploited product yielding a financial return was not

quantified in the survey. Similarly, the relative importance of patenting versus

publication was not established nor was the factors that led R&D performers to

advance with patenting. However, there were several negative aspects related to

patenting, which included the fact that IP protection delayed or impeded research

collaborations, the EU lacked a common patent model and Higher Education

Institutes (HEI) needed a liberal policy to facilitate collaboration and development.

Figure 3.15: Research groups that hold registered patents - % Total Research

Groups

Figure 3.16: Research groups that do not have patents but consider patenting in the

future - % Total Research Groups

52.80% 47.20% Yes

No

76%

24% Yes

No

116

Confronting Needs and Biotech Capabilities (Uses) in Research

Groups In this section Needs (capacities which the research groups wished to acquire) and

Uses (were the existing biotechnology capacities in research groups) of RGs were

compared. One objective of this section was to establish the RGs perceived

technology needs and pre-existing capabilities and give them a regional and

transnational dimension. To this end in the following series of figures indicated side

by side technology capabilities and needs for each specific technique considered in

the questionnaire.

Approach taken to analyse data: The data represented a multiple response

approach, i.e., the total number of responses included multiple responses to the same

question by each group and was used to sum one hundred per cent for each category.

Regarding external and internal the percentages should be read as follows; the total

regards the sum of all uses (or needs) that sums 100% evidencing simultaneously the

specific techniques that were more relevant to total and the internal and external

access importance. In the end of this section, a table was presented that assumed a

different point of view, the relevance a particular type of access (internal or external)

to the total use of a specific technology.

The “specific techniques needs and uses” surveyed were defined using an

established OECD proposal and then adapting it to create a more complete list-based

definition that met the requirements of the ShareBiotech consortium objectives. The

techniques section of the questionnaire aimed to establish what were currently the

most used and needed techniques in the ShareBiotech regions and encompassed: 1.

DNA/RNA, 2. Proteins and other molecules, 3. Cell/tissue culture and engineering,

4. Gene and RNA vectors, 5. Biological resources and associated facilities and 6.

Imaging and related instrumentation

117

Category 1 – DNA / RNA

Figure 3.17: DNA/RNA Biotechnology Techniques Uses and Needs in the Research

Groups - % Total Answers

Regarding the category DNA/RNA the most used techniques are PCR and

Sequencing. The most notable needs were associated with access to antisense

(silencing RNA) technology and transcriptomics with DNA/RNA microarrays the

most needed technique and a substantial gap occurs between capabilities and needs

(Figure 3.16).

Analysis of the mode of access to DNA/RNA techniques revealed that the

expensive cutting-edge techniques requiring large specialised equipment such as

sequencing and transcriptomics (including DNA/RNA microarray) was frequently

covered by external facilities (Ref. Figure 3.17).

Considering the Biotech field in general the majority of sequencing was

performed by contract companies and it appeared that there were adequate numbers

available to meet demand in the EU, US and more recently China and the recent

reduction in costs have significantly increased accessibility. Gene Expression (GE)

analysis in the biotech area in general was increasing and while some labs employed

cDNA arrays, the dominant technology was affymetrix both in user HEIs/companies

and service providers. Although not a factor specifically analysed in the survey a

general problem with this research domain was associated with the quality of GE

analysis and also generally high costs and means of data analysis. Needs in this area

17.4%

14.7%

10.3%

10.4%

11.2%

13.2%

7.9%

8.3%

6.6%

11.2%

13.3%

10.7%

14.5%

14.5%

9.8%

13.5%

10.7%

1.9%

.0% 5.0% 10.0% 15.0% 20.0%

PCR / qPCR / RT-PCR

Sequencing

Genotyping

Transcriptomics

DNA / RNA microarray

Northern and Western blots

Antisens technology (SiRNA)

Gene Probes (e.g. FISH technology)

Other Needs

Uses

118

were also closely linked to lack of capacities in the area of bioinformatics an

essential component of GE.

Category 2 – Proteins and Other molecules

Figure 3.18: Proteins and Other Molecules Biotechnology Techniques Uses and

Needs

In the category of Proteins and Other molecules) (Figure 3.19) the most commonly

used techniques were Monoclonal and Polyclonal antibodies and Protein isolation

and purification. Metabolomics, Proteomics, and Sequencing of proteins and

peptides were the most needed techniques.

Figure 3.19: Proteins and Other Molecule Techniques Internal and External Use

In common with the category DNA/RNA, techniques for proteins and other

molecules were high tech and expensive and tended to be required by RGs with

119

intermediate frequency to respond to specific scientific questions and required a high

level of technical expertise, access to very specific installations and instrumentation.

For these reasons, production of Monoclonal and Polyclonal antibodies, synthesis

and engineering of proteins/peptides and sequencing of proteins/peptides was

frequently carried out in specialized external facilities (Figure 3.19)

The surveys highlighted that a great number of interviewed research groups

used and also needed cell and/or tissue culture systems. This was not surprising as

numerous scientific domains made use of this technology. Moreover, this trend was

likely to intensify in coming years because of the increasing regulatory burden,

which is becoming more and more restrictive for animal testing. Therefore, it was

foreseen that in the medium to long-term cell and tissue systems will progressively

replace animal models. Moreover, the number of available cell lines and specialized

mediums and culture systems (such as, 3D) is constantly increasing making the use

of in vitro cell culture relevant for an ever wider range of “testing” situations

Figure 3.20: Cell Tissue Culture and Engineering Biotechnology Techniques Uses

and Needs

120

Figure 3.21: Cell Tissue Culture and Engineering Biotechnology Techniques

Internal and External Use

With regards to the other techniques in the category, cell/tissue culture and

engineering (Figure 3.20) the uses and needs were quite similar excepted for

embryo manipulation, which was mastered by relatively few of the RGs surveyed in

each of the ShareBiotech regions.

With the exception of cell / tissue culture, all the techniques of this category were

equally used internally or in external facilities (Figure 3.21). The relatively easy

accessibility of these techniques, notably regarding cost of instruments and the

frequency and “core” use of cell culture to rapidly test hypothesis and elaborate new

experimental paradigms, could explain the frequent internal access. The survey did

not determine the factors that lead some group to access external resources.

However, it may be a consequence of a number of factors which may include the

need for access to high throughput screening methods or specialized imaging

techniques and additionally the fact that a number of scientists such as

bioinformaticians and chemists need biological data coming out from cell and tissue

models and did not have the training and / or expertise to realize experiments

themselves.

Category 4 – Gene and RNA Vectors

The category of Gene and RNA Vectors (Figure 3.22) covered a wide range of

techniques that encompassed manufacture of vectors and also their application for

transgenesis of a wide range of organisms.

121

Figure 3.22: Gene and RNA Vectors Biotechnology Techniques Uses and Needs

In the category of Gene and RNA vectors, the most used technologies corresponded

to micro-organism transgenesis, synthetic vectors and viral vectors (Figure 3.22).

The frequent usage of such technologies was unsurprising as numerous research

groups performed molecular biology experiments that encompassed steps of micro-

organisms transgenesis. Concerning synthetic and viral vectors, these technologies

were used routinely to introduce nucleic acids in cells in vivo and in vitro, and

consequently were common methods for research groups studying genes expression

and performing molecular biology experiments. An interesting observation in this

category was that relatively few research groups surveyed had the capacity to

perform vegetal (plant) transgenesis (i.e. genetic modification of plants), and

numerous RGs responded that they would like to have access to this technique. It

seemed that the public perception and legislation were important barriers for access

to this technique and these factors were cited by several of the researchers who were

interviewed.

Figure 3.23: Gene/RNA Vector Biotechnology Techniques Internal and External

Use

122

Access to Gene and RNA vector techniques was approximately half internal and

half external (Figure 3.23). The most frequently out-sourced technology

corresponded to animal transgenesis which was a lengthy process that normally was

infrequently required by research groups and required a high level of know-how and

skills and also specialized facilities. Moreover, there was evidence of a strong market

offer with specialized facilities retaining transgenic animal lines for “off the shelf”

purchase.

Category 5 – Biological Resources and Associated Facilities

This category covered access by research groups to specialised experimental

facilities for experiments with animals and plants, access to curated collections (e.g.

DNA, RNA, fixed specimens, blood samples etc.) and to model organisms.

Figure 3.24: Biological Resources and Associated Facilities Uses and Needs

The most important items highlighted in the category Biological resources and

associated facilities, both for uses and needs, corresponded to (i) biological

resources centers (BRC), (ii) housing and facilities for animal experimentation, (iii)

micro-organisms models and (iv) animal models (Figure 3.24). These four items

were clustered in one type of use (or need): “biological materials and associated

facilities”. A relevant aspect was that this general need could partially be

addressed by ShareBiotech through improving the visibility and access to BRCs

and related facilities.

123

Figure 3.25: Biological Resources and Associated Facilities Internal and External

Use

As expected, the majority of interviewed research groups accessed biological

resources and animal models in facilities that were external to their research unit

since relatively few of them maintained and administered collections of biological

samples or animal models (Figure 3.25) Interestingly the majority of research

groups working on plant breeding had access to experimental facilities and this was

probably related to the relative facility of their maintenance. In contrast specialized

animal facilities and experimental farms were accessed external to the research units

by 50% of the research groups of the survey.

Category 6 – Imaging and related Instrumentation

Imaging techniques have undergone a significant advance in the last decade and this

section of the survey assessed use of traditional methods of optical microscopy as

well as modern highly advanced and specialized methods.

124

Figure 3.26: Imaging and Related Instrumentation Uses and Needs

In the category, ‘Imaging and related instrumentation’, all techniques displayed a

similar profile for uses and needs with the exception of confocal and fluorescence

microscopy that were more widely used by research groups (Figure 3.26) It

appeared that such imaging techniques, despite the cost of instrumentation and

maintenance, were becoming more routinely utilized by research groups. In general

the survey highlighted an approximately similar need for methods that required

access to expensive, high maintenance equipment such as, radiography, ultrasound,

electron microscopy, SPECT, positron emission tomography, computed tomography

and magnetic resonance imaging, which reflected the potential of such methods to

address a series of research questions.

Figure 3.27: Imaging technologies accessible internally & externally

6.7%

5.0%

5.5%

4.7%

8.6%

16.2%

14.0%

8.8%

12.7%

5.2%

4.7%

6.4%

1.5%

8.6%

7.5%

7.7%

7.5%

9.2%

8.6%

9.9%

8.2%

14.4%

7.2%

6.8%

3.3%

1.0%

.0% 5.0% 10.0% 15.0% 20.0%

Magnetic resonance Imaging

Computed Tomography

Positron Emission Tomography (PET)

SPECT: Single Photon Emission…

Optical Imaging: bioluminescence

Optical Imaging: fluorescence

Optical Imaging: confocal imaging

Optical Imaging: (multi)photonic imaging

Electronic microscopy

Ultrasounds

Radiography

Infra-red imaging

OtherNeeds

Uses

6.1% 5.7% 5.9% 5.4%

10.2% 17.4%

12.5% 9.0% 8.6%

6.1% 5.9% 6.3%

.8%

10.0% 3.9%

4.4% 3.3%

4.4% 10.0%

16.7% 5.6%

20.6% 5.0%

6.1% 8.3%

1.7%

.0% 10.0% 20.0% 30.0% 40.0%

Magnetic resonance Imaging

Computed Tomography

Positron Emission Tomography (PET)

SPECT: Single Photon Emission Computed…

Optical Imaging: bioluminescence

Optical Imaging: fluorescence

Optical Imaging: confocal imaging

Optical Imaging: (multi)photonic imaging

Electronic microscopy

Ultrasounds

Radiography

Infra-red imaging

OtherInternal Use External Use

125

Electron Microscopy, Confocal Microscopy, and Nuclear Magnetic Resonance

(NMR) were mainly used in external facilities (Figure 3.27) most likely because of

the extremely high cost of instrumentation and the specific expertise required

mastering these techniques. Other techniques were little externalized.

Category 7 – Industrial Processes

Figure 3.28: Process Biotechnology Uses and Needs

The category Industrial Processes encompassed several different areas Bioenergy,

Biocatalysts, and Fermentation. In the category Industrial Processes, it was

interesting to notice that Fermentation was much more used by researchers to

produce enzymes than to produce active compounds or food and beverage (Figure

3.28). This technology was indeed necessary for the production of numerous

microorganisms’ enzymes that were either studied or used as biological tools by

researchers. Besides, the most needed technique corresponded to fermentation for the

production of active compounds. Finally, fermentation for the production of

biomaterials and bio-based building blocks were barely used by researchers but were

needed as much as other techniques of the category;Fermentation for biomaterial

production and Fermentation for Bio-based building blocks production.

126

Figure 3.29: Process Techniques Internal and External Use

The analysis of access ratio for industrial processes indicated that the majority of

researchers conducting fermentation for food or beverage or producing their

enzymes by a fermentation process used the equipment of their own research unit

(Figure 3.29). In contrast, for the production of active compounds, most of the

research groups externalized this process. The latter may be a consequence of a

number of different factors, related to the nature of compounds to be extracted,

capacity to scale-up production, the purification processes which may have required

specific facilities with know-how and appropriate instrumentation.

Category 8 – Nano-Biotechnologies

Nano-biotechnology was identified as a relatively recent research area that has

rapidly been adopted by Pharma and had relevance for the medical devices sector.

Associated research involving nano-biotechnology was in the field of risk

assessment, toxicity and monitoring. All techniques from the nano-biotechnology

category were used and needed similarly, although nano-encapsulation of bioactive

products was the technique most frequently used and access was internal. (Figure

3.30)

17.2%

26.6%

12.5%

3.1%

3.1%

14.1%

12.5%

10.9%

7.1%

14.3%

21.4%

.0%

7.1%

14.3%

14.3%

21.4%

.0% 10.0% 20.0% 30.0% 40.0% 50.0%

Fermentation for food or beverage production(traditional fermentation)

Fermentation for enzymes production

Fermentation for active compounds production

Fermentation for biobased building blocks production (succinic acid, propanediol,

butanol, glycolic acid …)

Fermentation for biomaterials production (PHA, PLA, …)

Biocatalysis : enzymatic hydrolysis orenzymatic organic synthesis

Bioenergy : 1st, 2nd , 3rd generation

Other

Internal Use External Use

127

Fig. 3.30: Nano-biotechnology Techniques Uses and Needs

Fig. 3.31: Nano-biotechnology Techniques Internal and External Use in the Atlantic

Area

Concerning access to the Nano-biotechnology techniques, internal and external

accesses were quite similar. The most externalized technique was the

characterization of Nano-particles probably as a consequence of the need for

specialized equipment more typical of materials sciences coupled to expertise and

know-how in the area (3.31). Although not visible in the data presented the numbers

14.5%

13.3%

7.8%

12.7%

10.8%

14.5%

12.0%

13.3%

1.2%

17.1%

12.2%

12.2%

9.8%

7.3%

19.5%

9.8%

7.3%

4.9%

.0% 10.0% 20.0% 30.0% 40.0%

Nanoencapsulation of bioactive products

Nanoparticle formulation

High trough-put experimentation, micolabs,microrobotics

Active coumpond delivery methods(vectorisation)

Nanostructures

Characterization of nanoparticles

Incorporation of chemical ligands to thenanoparticle surface

In vitro citotoxicity evaluation ofnanoparticles

Other

Internal Use External Use

128

of RGs involved in Nanobiotechnology was relatively small compared to more

conventional research areas such as DNA/RNA, proteins.

Category 9 – Bioinformatics

Figure 3.32: Bioinformatics Techniques Uses and Needs within the Atlantic Area

The most used and needed item of the category Bioinformatics corresponded to

Data Analysis and Biostatistics (Figure 3.32). However, the surveys revealed that

the other bioinformatics disciplines were also considered important and both used

and also needed. With the development of high throughput biology techniques

(genomics, proteomics, metabolomics, etc.), bioinformatics became a crucial tool for

data interpretation.

13.3%

9.7%

16.4%

12.6%

8.4%

6.6%

8.8%

6.6%

7.8%

9.2%

.5%

10.3%

10.3%

12.1%

9.6%

8.6%

8.0%

10.0%

9.2%

10.2%

10.5%

1.1%

.0% 5.0% 10.0% 15.0% 20.0%

Data storage

Construction and management of databases

Data analysis and biostatistics

Sequence analysis

Structural analysis, molecular modelling

Insilico tests (virtual screening)

System modelling (biological processes,ecosystems,etc.)

Integrative biology

Software development

Computing power (calculation)

OtherNeeds

Uses

129

Fig. 3.33: Bioinformatics Techniques Internal and External Use in the Research

Groups

Interestingly, despite the relative accessibility of bioinformatics tools, approximately

50 % of bioinformatics analyses were externalized (Figure 3.33). This may be the

consequence of a number of different factors not evident from the analysis but

identified by the project participants; I) many biologists were not trained in the use

of bioinformatics tools and had to outsource the analysis of their results to

specialized platforms, ii) the large datasets generated by next generation sequencing

required significant computational power and computing know-how to handle very

large data sets and convert raw sequence data to assembled genome/transcriptome, or

conduct digital counts of transcript abundance. In fact, part of the offer with next

generation sequencing which was frequently conducted out of house included data

assembly and preliminary data analysis to allow verification of sequencing quality.

Moreover, the high cost of informatics infrastructures that required informatics

expertise and maintenance and the general policy of data release into the public

domain via established public databases e.g. National Centre for Biotechnology

Imaging (NCBI) generally did not favor the development of onsite computing

resources.

14.3%

10.6%

17.8%

14.4%

7.2%

6.5%

8.0%

5.6%

7.4%

7.8%

.6%

12.5%

10.4%

15.3%

11.1%

9.0%

6.9%

8.3%

6.9%

5.6%

13.2%

.7%

.0% 10.0% 20.0% 30.0% 40.0%

Data storage

Construction and management of databases

Data analysis and biostatistics

Sequence analysis

Structural analysis, molecular modelling

Insilico tests (virtual screening)

System modelling (biological processes,…

Integrative biology

Software development

Computing power (calculation)

Other

Internal Use External Use

130

Training Needs in Biotechnology of Research Groups

The majority of research groups highlighted the need for training in relation to

specific Biotechnology skills (Figure 3.34).

Figure 3.34: Training needs regarding techniques and related skills of the research

groups - % Total RG

The need for training varied in the ShareBiotech regions, for example, over 90% of

the Irish research groups involved in the survey indicated that they had specific

training needs while only 58% of research groups in Navarra identified training

needs in the area of Biotechnology (Figure 3.35).

Figure 3.35: Training needs regarding techniques and related skills of the research

groups in each region - % Total by Region

Other needs were not so well detected by RGs in general (Figure 3.36). A much

bigger proportion of Ireland RGs highlighted the fact there were problems. Algarve

RGs (57.7%) also highlighted the existence of problems limiting research that were

in addition to training needs (Figure 3.37)

78.10%

21.90% Yes

No

131

Figure 3.36: Other needs of the research groups for the advance of R&D activities

Figure 3.37: Other needs of the research groups for the advance of R&D activities in

each region

3.5 ShareBiotech Companies Survey Results: Needs for advanced

techniques in Life Sciences

Companies

A company was defined as a private organisation that developed specific business in

order to supply products, goods, or services. It had functional autonomy and judicial

personality. The Organisation for Economic Co-Operation and Development

(OECD) analysis suggested the firm-level as the adequate scale to understand the

behaviour of the private sector (OECD, 2005; A Framework for Biotechnology

Statistics, OECD, and Paris). The ShareBiotech project focused companies with

particular interest in biotechnology. Detecting such companies was not easy. The

partnership followed referred methods to locate these companies (Statistics New

Zealand (2010), New Zealand’s Bioscience Survey 2009) searching particular

keywords in the legal and/or trading names such as:

60%

40% Yes

No

50.0

40.0

30.8

95.5

93.3

35.3

68.2

42.9

50.0

60.0

69.2

4.5

6.7

64.7

31.8

57.1

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

ES - Comunidad Foral de Navarra

FR - Pays de la Loire

FR - Bretagne

IE - Border, Midland and Western

IE - Southern and Eastern

PT - Norte

PT - Algarve

PT - Centro

Yes No

132

1. Bioinformatics, Bioprocessing, Bio reagent’s, Biotechnology,

Biotransformation’s, Chromatography, Clonal, Concentrates, Extract,

Extraction, Fluid Extraction, Functional Foods, Genetics, Genomics,

Industrial Microbiology, Monoclonal, Neutraceuticals, Proteomics,

Supercritical, Transgenic

2. Biotechnology national associations lists

3. Firms from other surveys that reported biotechnology activities

4. Firms on the national and bio products association lists

5. Companies operating in economic activities that are users of particular

streams of biotechnology

6. Firms receiving funding to carry out bioscience-related research/or

development activities

In total 143 companies were surveyed by ShareBiotech and 37 of total were

surveyed in the Ireland BMW and S&E regions. The main specific domain of

interviewed companies (Figure 3.3) was Human Health similar to research groups.

In contrast, Animal Health and Agri-food were more represented in companies. In all

ShareBiotech regions, Human Health was the most represented domain. A total of

nine regions in the Atlantic Area were surveyed (Table 3.2). The biotechnology

domains of interest identified in the ShareBiotech Regions were as follows:

Human Health; Agri-food including beverages; Cosmetics; Marine Science;

Bioenergy, Other; Agriculture including animal breeding, aquaculture and

silviculture; Nutrition, neutraceuticals; Environment; Industrial processing;

Bioinformatics; Animal Health, Veterinary (Figure 3.36).

Figure 3.38: Main specific domains of the interviewed companies - % Total

Answers

133

Figure 3.39: Main Specific domains of the interviewed companies - % Total

Answers by region

The large majority of companies interviewed were small to medium sized enterprises

(SME’s). The research showed that 74.6% of the companies had no more than fifty

workers. Larger companies, with more than 250 employees represented 9.8% of the

total companies surveyed (Figure 3.39).

Figure 3.40: Number of persons employed in the companies. In July 2010 – Total

Answers

South East Ireland, Navarra, and Pays de la Loire were the regions that surveyed the

greatest number of companies with > 250 employees in addition to companies with

fewer employees. Compared with other ShareBiotech regions Portuguese companies

generally had < 25 employees (Figure 3.41).

.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

35.0%

40.0%

45.0%

ES -Comunidad

Foral deNavarra

FR - Pays dela Loire

FR - Bretagne IE - Border,Midland and

Western

IE - Southernand Eastern

PT - Norte PT - Algarve PT - Centro PT - Lisboa

Human HealthAgriculture (including animal breeding), aquaculture and silvicultureAgri-food (including beverages)Nutrition, nutraceuticalsCosmeticsEnvironment

59% 15.60%

15.60%

9.80%

0-25

25 - 50

50 - 250

> 250

134

Figure 3.41: number of persons employed in surveyed companies in July 2010 by

region

The age of companies is often used as an indicator of experience. The ShareBiotech

average year of setting up a company was identified as 1994. French and Irish

companies were in general older than this, and Portuguese and Spanish companies

were younger, which gave some insight for the sectors maturity in the different

regional contexts (Table 3.2).

Table 3.3: Age of Interviewed companies - Descriptive Statistics

Regions Year of Setting - up

Minimum Maximum Mean ES – Comunidade de Navarra 1963 2010 1998

FR – Pays de la Loire 1933 2008 1989

FR – Bretagne 1927 2010 1993

IE – Border, Midlands & Western 1969 2005 1996

IE – Southern & Eastern 1967 2008 1994

PT – Norte 1987 2010 2000

PT – Algarve 1986 2009 2002

PT – Centro 1852 2010 1989

PT – Lisbon 1995 2009 2005

ShareBiotech Regional Average 1852 2010 1994

Of the companies surveyed 73.7% participated in Networks and 36.2% were parts of

enterprise groups (Figure 31).

135

Figure 3.42: Network Membership of Interviewed Companies by Region

French and Irish companies were found to have more participation in networks, i.e.,

clusters, scientific parks, company associations, and other forms of intensive

collaboration (Figure 3.43).

Figure 3.43: Network membership of companies by region (%)

The participation in enterprise groups was very variable across the ShareBiotech

regions and ranged from 0% in the Algarve (PT) and 15% in Pays de la Loire

(France) to 100% in the North of Portugal (Figure 3.44).

Figure 3.44: Enterprise group membership of companies by region (%) group

136

Biotechnology played a central role in company activities and strategy and 79% of

the companies that responded to the survey indicated that they were developing

products or processes that required the use of biotechnology (Figure 3.45).

Figure 3.45: Role of Biotechnology in the companies - % Total Companies

Biotechnology was found to have a central role in the majority of the companies

surveyed. However, in the Algarve, BMW (Ireland) and Navarra a significant

number of companies surveyed did not have biotechnology intergrated into their

central strategy (Figure 3.46).

Figure 3.46: Role of Biotechnology in the companies- % Total by region:

biotechnology is central to your company activities or strategy?

137

Figure 3.47: Role of Biotechnology in the companies - % Total by region: Is your

firm currently developing products or processes that require the use of

biotechnology?

National markets were considered to be most important to the companies which

responded to the survey. In parallel, there were a very expressive percentage of

European and International exports (Figure 3.48).

Figure 3.48: Geographic markets where the companies sold goods or services from

2008 to 2010 - % Total Companies for Each Geographical Market

National sales represented 29.2% of total trading by companies (Figure 3.49) No

significant differences were registered in national patterns between the ShareBiotech

regions (Figure 3.50).

138

Figure 3.49: Geographic markets where the companies sold goods or services from

2008 to 2010 - % Total Answers

Figure 3.50: Geographic markets where the companies sold goods or services from

2008 to 2010 by region - % Total by region

Almost all companies surveyed (95.8%) indicated that they developed R&D

activities (Figure 3.51). The high rate of R&D was expected as a large proportion of

interviewed companies had activities in the biotech area and R&D intensive activity.

Even the regions such as Navarra and the Algarve that included in the survey

companies not classified as having biotechnology as a principal activity also

indicated they had significant R&D activity. Of the R&D activities, 41.5% were

performed in-house, 39.3% were outsourced and 19.2% by collaborative R&D

projects (Figure 3.52).

Figure 3.51: Development of R&D activities - % Total Companies

25.80%

29.20% 25.30%

19.70% Local/Regional

National

Other European Union (EU)Countries, EFTA, or EUCanditate countriesAll other countries

0% 20% 40% 60% 80% 100%

ES - Comunidad Foral de Navarra

FR - Pays de la Loire

FR - Bretagne

IE - Border, Midland and Western

IE - Southern and Eastern

PT - Norte

PT - Algarve

PT - Centro

PT - Lisboa

Local/RegionalNationalOther European Union (EU) countries, EFTA, or EU candidate countriesAll other countries

95.80%

4.20%

Yes

No

139

Figure 3.52: Means of execution of R&D activities by companies - % Total

Answers

Figure 3.53: Intellectual Property of the companies - % Total Companies

IPR was a strategic domain for companies operating in biotech and related fields and

this was reflected in the responses to the survey as 61.9% of companies held

registered patents and 45.5% had bought patent rights (Figure 3.53).

When questioned about the main barriers to conduct R&D, companies indicated that

cost was the main inhibitor of such activities. Other very significant barriers were

access to technology and regulatory requirements (Figure 3.54).

Figure 3.54: Barriers to your R&D capacity - % Total Answers

41.50%

39.30%

19.20% In-house R&D activities

Collaborative projects

Outsourced R&D activities

140

Cross-referencing R&D barriers and the regions in which the companies were

located the main barriers per region were identified (Table 3.3). Costs were always

the most relevant aspect inhibiting R&D, but had differing degrees of relevance

across the ShareBiotech regions. In Navarra, access to skilled human resources was

also considered a constraint for R&D, in Pays de la Loire, Bretagne and Algarve

regulatory requirements were highlighted as a crucial limitation, in Centro and BMW

easy access to technology constrained R&D. Patent rights were also considered a

limiting factor for R&D in companies in BMW and the North of Portugal.

Table 3.4: Barriers to R&D Capacity of the Interviewed Companies by Region

Costs to

conduct

R&D

activities

Access to

technology

Access to

information

Access to

skilled

human

resources

Public

perception/

acceptance

Regulatory

requirements

Patent rights held by

others/high licencing

costs

o

t

h

e

r

ES –

Comunida

de de

Navarra

■■■■ ■■ ■■ ■■■ ■■ ■■ ■■ -

-

-

FR – Pays

de la Loire

■■■■ ■■■ ■■ --- --- ■■■ ■■ ■

FR –

Bretagne

■■■■ ■■ ■■ ■■ ■■ ■■■ ■■ ■

IE –

Border,

Midlands

& Western

■■■ ■■■ ■■ ■■ ■ ■■ ■■■ ■

IE –

Southern &

Eastern

■■■ ■■ ■■ ■■ ■ ■■ ■■ ■

PT – Norte ■■■■ ■■■ --- --- ■■■ --- ■■■ -

-

-

PT –

Algarve

■■■■ ■■ ■■ ■■ --- ■■■■ --- ■

PT –

Centro

■■■■ ■■■ ■ ■■ ■■ ■■ ■■ ■

PT –

Lisbon

■■■■ ■■ --- ■■ ■■ ■■ ■■ ■

(Legend: ■0% - 5%; ■■ 6% - 15%; ■■■ 16% - 25%; ■■■■ > 25%)

Confronting Needs and Uses in Companies to Research Groups

This section briefly reviewed the perceived needs and uses in companies of the main

biotechnology methods highlighted in the survey and compared this to the research

groups. The approach taken to analyse needs and uses was similar to that applied to

141

research group’s analysis and permitted direct comparison of trends in both groups

of stakeholders.

Category 1 – DNA/RNA

In common with the research groups, the surveys highlighted that:

1. The most used techniques of the DNA/RNA category were PCR and

Sequencing

2. The most important need was DNA/RNA microarray (Figure 3.55).

A reason cited to explain companies need for microarray was the complexity of the

technique that meant it was still not adapted for routine experiments.

Figure 3.55: DNA/RNA Biotechnology Techniques Uses, and Needs in Interviewed

Companies [Uses N = 408; Needs = 289]

In common with research groups in companies the most externalised techniques of

the DNA/RNA category corresponded to sequencing. This was probably because of

the high cost of the instrumentation and the ease of access to the relatively cheap,

good quality external services (Figure 3.56). Routine techniques such as antisense

technology and northern blots were used internally in common with what occurred in

research groups, but PCR analysis, a fairly common technique was often provided by

external suppliers, according to the interviews.

142

Figure 3.56: DNA/RNA Biotechnology Techniques Internal and External Uses in

Interviewed Companies – [Internal Use N= 282; External Use N= 126]

Category 2: Proteins and Other molecules

Surveys revealed that interviewed companies had similar uses and needs of all

techniques in the proteins and other molecules category. Therefore, no particular

technique was highlighted in this category as more important or relevant.

Figure 3.57: Proteins and Other Molecules, Techniques, Uses and Needs in

Interviewed Companies – [Uses N= 399; Needs N= 343]

Surveys revealed that interviewed companies had similar uses and needs of all

techniques in the proteins and other molecules category. Therefore, no particular

technique of this category was highlighted as more important/relevant (Figure 3.58)

0.00% 2.00% 4.00% 6.00% 8.00%10.00%12.00%14.00%

Other

Matabolomics

Monoclonal & polyclonal antibodies

Improved delivery methods for large-…

High through-put screening and…

Structural analysis

Proteomics

Protein isolation and purification

Synthesis & engineering of proteins &…

Sequencing proteins & peptides

Needs

Uses

143

Figure 3.58: Proteins and other molecules Techniques Internal and External Uses

Cutting edge techniques such as structural analysis, proteomics or sequencing of

proteins were more used in external facilities (Figure 3.58). The techniques require

either sophisticated instrumentation (e.g. Mass Spectrometry) or specific techniques

that encourage companies to perform their experiments in specialised facilities

(TCF’s). Some techniques like metabolomics’ and monoclonal/polyclonal antibodies

were not frequently externalised. It is possible that the response to the question

might have been misinterpreted and that some companies perceived, - “Do you use

antibodies?” with “Do you produce antibodies?” If the response was to the first

option, this could explain why access to monoclonal/polyclonal antibodies was

mainly internal. Although a strict methodology was used to implement the

questionnaire and to train interviewers, it was not possible to rule out issues relation

to interpretation of questions.

Category 3 – Cell/Tissue Culture and Engineering

In this category, cell/tissue culture techniques were more used and needed than other

techniques (Figure 3.59). The same observation was made for research groups

because there are numerous scientific domains in which this technology can be used.

This trend should be reinforced in coming years as these techniques substitute animal

testing, which has become more heavily regulated. Therefore, it was estimated that

cell and tissue culture will progressively replace animal models and the number of

cell lines available had greatly increased.

144

Figure 3.59: Cell Tissue Culture and Engineering Biotechnology Techniques Uses

and Needs in Interviewed Companies [Uses N= 192; Needs N= 159]

Figure 3.60: Cell Tissue Culture and Engineering Biotechnology Techniques

Internal & External Uses in Interviewed Companies [Internal Use N= 155; External

Use N=46]

The majority of techniques in Cell/Tissue Culture and Engineering were used

internally (Figure 3.60). The only technique that was significantly externalised

corresponded to cell/tissue culture which was in contrast to the situation in research

groups. The latter was thought to result from the specific infrastructure requirements

needed for cell culture which were costly to maintain and required dedicated space

and possibly encouraged companies to perform their experiments in external

facilities.

Category 4 – Gene and RNA Vectors

Except for plant transgenesis Genetically Modified Organisms (G.M.O.s), all

techniques in this category were used and needed (Figure 3.61). The most used

techniques corresponded to vectorization methods and to microorganism

11%

4.50%

11%

12%

15%

11%

37%

15%

2.50%

13%

15%

16%

12.50%

27%

0% 5% 10% 15% 20% 25% 30% 35% 40%

Other

Embryo manipulation

Cellular therapy, stem cells

Recombinant vacine

Vaccine/Immune stimulant

Tissue engineereing (e.g. medical…

Cell/tissue culture

Needs

Uses

18%

10%

18%

19%

32%

23%

90%

16%

5%

14%

16%

18%

10%

34%

0% 20% 40% 60% 80% 100%

Other

Embryo manipulation

Cellular therapy, stem cells

Recombinant vacine

Vaccine/Immune stimulant

Tissue engineereing (e.g. medical…

Cell/tissue culture

Internal use

External use

145

transgenesis. This was thought to be a consequence of the numerous molecular

biology experiments that encompassed steps of microorganism transgenesis.

Synthetic and viral vector technologies were also used to routinely introduce nucleic

acids into cells in-vivo and in-vitro, and were used by a lot of companies interviews

that studied gene expression and performed molecular biology experiments. An

interesting result in this category was the observation that few companies performed

plant transgenesis (i.e. G.M.O.s) although many expressed a need for the technique.

It was presumed that public perception and legislation were important barriers to

accessing this technique.

Figure 3.61: Gene & RNA Vectors Biotechnology Techniques Uses & Needs in

interviewed companies [Uses N= 155; Needs N= 177]

The surveys demonstrated that numerous companies externalised their vectorization

experiments to specialised facilities (Figure 3.62). This may be explained by the

fact that manipulation of viral vectors required specific labs compliant wit safety

regulation. Therefore. Technological Core Facilities (TCFs) or Contract Research

Organisations (CROs) having specialised technologies and with appropriate

infrastructure could facilitate this need. For example, in France, the Biogenouest

TCFs network had two platforms specialised respetively, in viral vectors and

synthetic vectors. Animal trangenesis was performed mainly internally in companies

in contrast with research groups. The quality standards required in companies (GLP,

etc) was suggested as a reason for the lack of externalisation in public animal

transgenesis facilities.

146

Figure 3.62: Gene and RNA Vectors Biotechnology Techniques and External Uses

in Interviewed Companies [Internal Use N= 136; External Use N= 11]

Category 5 – Biological Resources and Associated Facilities

In the category Biological Resources and Associated Facilities the surveys revealed

almost the same pattern for research centres and companies (Figure 3.63). The four

most needed items corresponded to (1) B.R.C.s, (2) housing and facilities for animal

experimintation, (3) micro-organism models, (4) animal models. This was an

interesting observation since ShareBiotech aimed to improve the visibility and access

to B.R.C.s and related facilities.

Figure 3.63: Biological Resources & Associated Facilities Biotechnology

Techniques Uses & Needs in interviewed companies [Uses N=290; Needs N= 236]

0% 10% 20% 30% 40% 50% 60% 70% 80%

Other

Synthetic vectors

Viral vectors

Micro-organism transgenesis

Vegetal transgenesis

Animal transgenesis

Gene therapy

Internal Use

External Use

0% 5% 10% 15% 20% 25%

Other

Biological Resource Centres, Banks,…

Animal breeding

Housing facilities for animal…

Plant models

Needs

Uses

147

Figure 3.64: Biological Resources & Associated Facilities Biotechnology

Techniques Uses & Needs in interviewed companies [Internal Uses N=214; External

Needs N= 105]

With the exception of Micro-organisms models (widely used for molecular biology

experiments), the four most needed items indicated in (Figure 3.64). were mainly

accessed in external facilities reinforcing the potential role of ShareBiotech in

increasing the visibility of B.R.C.s and related facilities.

Category 6 – Imaging and related Instrumentation

In the Imaging and related Instrumentation category, the most used technologies

corresponded to Electron microscopy and Optical imaging techniques (Figure 3.65).

This was not surprising since these techniques were used to characterise numerous

matrices in various fields of activity (e.g. observation of emulsions in cosmetics, of

microorganisms in the food industry, of human cells in medical companies, etc.).

Other imaging techniques (i.e. non-microscopic techniques) were less used but were

of great interest since numerous needs were registered by the surveys. The majority

of techniques in this category were initially devoted to medical applications,

(Radiography, Ultrasound, Tomography and Nuclear Magnetic Resonance) but were

widely applied in other activities such as agriculture (e.g. N.M.R. can be used to

characterise the structure and presence of water in vegetables.

0% 10% 20% 30% 40% 50%

Other

Experimental items

Biological Resource Centres,…

Plant breeding

Animal breeding

Housing and facilities for plant…

Housing facilities for animal…

Micro-organism models

Plant models

Animal models

Internal Use

External Use

148

Figure 3.65: Imaging & Related Instrumentation Biotechnology Techniques Uses &

Needs in Interviewed Companies [Uses N=369; Needs N= 389]

Electronic and Confocal microscopy were mainly used in external facilities likely

because of the extremely high cost of instrumentation and the specific expertise

required in operating these techniques (Figure 3.66). Other optical imaging

techniques were less externalised due to the fact that numerous companies have

invested in optical microscopes and robots.

Figure 3.66: Imaging & Related Instrumentation Biotechnology Techniques Uses &

Needs in Interviewed Companies [Internal Use N= 190; External Use N= 90]

2%

6%

6%

6.60%

12.50%

10.20%

14%

10%

5%

6%

6%

7.50%

1%

8%

7.50%

7.30%

9%

9.50%

9.50%

7.50%

7%

8%

8%

8%

0% 2% 4% 6% 8% 10% 12% 14% 16%

Other

Infra-red imaging

Radiography

Ultrasound

Electronic microscopy

Optical Imaging (multi) photonic…

Optical Imaging, Fluoresence

Optical Imaging, Bioluminesence

SPECT. Single Photon Emission…

Positron Emission Tomography (PET)

Computed Tomography

Magnetic Resonamce Imaging (MRI)

Needs

Uses

3%

10%

10%

4.50%

29.50%

22%

37%

24%

5%

4%

8%

6%

3%

5%

5%

2.80%

8.50%

15%

19%

16%

4%

3%

5%

14%

0% 5% 10% 15% 20% 25% 30% 35% 40%

Other

Infra-red imaging

Radiography

Ultrasound

Electronic microscopy

Optical Imaging (multi) photonic…

Optical Imaging, Fluoresence

Optical Imaging, Bioluminesence

SPECT. Single Photon Emission…

Positron Emission Tomography…

Computed Tomography

Magnetic Resonamce Imaging (MRI)

Internal Use

External Use

149

Category 7 - Industrial Processes

In the category of Industrial Processes, fermentation techniques to produce active

compounds, enzymes and food/beverage were much more uses and needed than

other techniques (Figure 3.67). The survey results showed that Technological Core

Facilities (T.C.F.s) that specialised in fermentation technology were needed in the

Industrial Process Category.

Figure 3.67: Process Biotechnology Techniques Uses and Needs in Interviewed

Companies [Uses N= 86; Needs N= 49]

Except for fermentation techniques for biomaterials and enzyme production, most of

the Industrial Process Category was almost equally used in internal and external

facilities (Figure 3.68). This was probably linked to the interviewed companies

structure and objectives (R&D or production of goods), which meant that a step of

the R&D or industrial process was often externalised, such as, the development of

the process (before scale-up) or the mass production (i.e. small size production was

performed internally).

Figure 3.68: Process Biotechnology Techniques Internal and External Uses in

Interviewed Companies [Internal Use N=62; External Use N=26]

7%

6%

10.20%

8%

6%

25%

3%

6.50%

6.50%

0%

6.50%

37%

0% 5% 10% 15% 20% 25% 30% 35% 40%

Other

Bioenergy: 1st, 2nd, 3rd generation

bBiocatalysts: enzymatic hydrolysis…

Fermentation for Biomaterial …

Fermentation for Biobased building …

Fermentation of active compounds…

Needs

Uses

15%

12%

12%

20%

10%

53%

29%

49%

6%

4.40%

4.40%

4.40%

6%

26%

21%

27%

0% 10% 20% 30% 40% 50% 60%

Other

Bioenergy: 1st, 2nd, 3rd…

bBiocatalysts: enzymatic…

Fermentation for Biomaterial …

Fermentation for Biobased …

Fermentation of active…

Fermentation for enzyme…

Fermentation for food and…

Internal Use

External Use

150

Category 8 – Nano-biotechnologies

In common with what occurred with the research groups, it was difficult to identify

companies’ specific needs and uses for the techniques in the Nano-biotechnology

category (Figure 3.69).

Figure 3.69: Nano-biotechnology Techniques Uses and Needs in Interviewed

companies [Uses N= 35; Needs N= 25]

Figure 3.70: Nano-biotechnology Techniques Internal & External Uses in

interviewed companies

2.50%

11%

14%

12.50%

8%

8%

11%

17%

15.20%

3%

12.50%

11%

14%

13%

12%

12%

13%

12.50%

0.00% 5.00% 10.00% 15.00% 20.00%

Other

In-vitro cytotoxicity evaluation ofnanoparticles

Incorporation of chemical ligands tothe nanoparticle surface

Characterisation of nano-particles

Nanostructures

Active compound delivery methods(vectorisation)

High through-put experimentation,microlabs, microbiotics

Nanoparticle formulation

Nanoencapsulation of bioactiveproducts

Needs

Uses

151

Despite the cutting edge character of Nano-biotechnologies, the surveys revealed

that all the techniques of this category were used in internal facilities (Figure 3.70).

However, techniques such as in-vitro cytotoxicity evaluation of nanoparticles and

Nano encapsulation of bioactive products were externalised

Category 9 - Bioinformatics

Surveys revealed that all bioinformatics techniques are used and needed by the

interviewed companies (Figure 3.71). The most used and needed techniques

correspond to sequence analysis and data analysis and biostatistics and also to

construction and management of databases and data storage. In common with

research groups, companies had significant volumes of data that could not be

managed without bioinformatics tools.

Figure 3.71: Bioinformatics Techniques Uses and Needs

All techniques in bioinformatics were used approximately equally internally and

externally (Figure 3.72). Significant demand existed for bioinformatics from both

Companies and research groups. The ShareBiotech project clearly could contribute

to “fill the gap” by reinforcing bioinformatics in participating TCFs and also through

the organization of training sessions to enable more companies (and researchers) to

internalize a part of their analyses.

152

Figure 3.72: External and internal sourcing of Bioinformatics Techniques for

companies was more or less equal

Company Training Requirements

75% of companies were identified as having training needs (Figure 3.73) but a

relevant regional diversity exists (Figure 3.74).

Figure 3.73: 25% of companies interviewed did not have training needs while 75%

expressed a need for training

Figure 3.74 The need for training in companies interviewed was higher in all regions

than not

75.0

25.0

Yes No

80.0

84.6

79.3

80.0

96.0

66.7

66.7

53.6

62.5

20.0

15.4

20.7

20.0

4.0

33.3

33.3

46.4

37.5

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

ES - Comunidad Foral de Navarra

FR - Pays de la Loire

FR - Bretagne

IE - Border, Midland and Western

IE - Southern and Eastern

PT - Norte

PT - Algarve

PT - Centro

PT - Lisboa

Yes No

153

Other needs were not so easily detected by companies (Figure 3.75) where a

disparity of regional answerers was evident (Figure 3.76).

Figure 3.75: Other Needs for the Advancement of R&D Activities in Interviewed

Companies

Figure 3.76: Other Needs for the Advancement of R&D Activities in Interviewed

Companies

Using the quotient between internal and external uses and total used techniques it

was possible to calculate an Access Capacity Ratio (ACP) (Table 3.4) for each one

of defined categories and by region. Even if sometimes limited by the short number

of answers, this indicator reflected the percentage of used techniques that were

covered by internal or external access.

Table 3.5: Access Capacity Ratio (Total Internal and External Access)

OECD

Category Regions Internal Access External Access

DNA/RNA

ES - Comunidad Foral de

Navarra

77.6% 28,6% FR - Pays de la Loire 25.0% 75,0% FR - Bretagne 68.3% 46,7% IE - Border, Midland and

Western

72.9% 21,0% IE - Southern and Eastern 88.2% 6,2% PT - Norte 81.4% 52,5% PT - Algarve 87.5% 32,8% PT - Centro 72,9% 50,6%

Proteins and other molecules ES - Comunidad Foral de

Navarra

51,3% 48,7% FR - Pays de la Loire 45,5% 72,7%

154

FR - Bretagne 48,8% 58,5% IE - Border, Midland and

Western

66,1% 17,0% IE - Southern and Eastern 100,0% 3,9% PT - Norte 65,4% 73,1% PT - Algarve 55,8% 58,1% PT - Centro 74,7% 41,8%

Cell tissue culture and

engineering

ES - Comunidad Foral de

Navarra

100,0% 0,0% FR - Pays de la Loire 50,0% 50,0% FR - Bretagne 96,4% 7,1% IE - Border, Midland and

Western

100,0% 29,4% IE - Southern and Eastern 100,0% 17,4% PT - Norte 100,0% 22,2% PT - Algarve 86,7% 20,0% PT - Centro 88,2% 17,6%

Gene and RNA vectors

ES - Comunidad Foral de

Navarra

100,0% 7,7% FR - Pays de la Loire 50,0% 50,0% FR - Bretagne 94,4% 22,2% IE - Border, Midland and

Western

98,6% 29,2% IE - Southern and Eastern 100,0% 9,1% PT - Norte 100,0% 25,0% PT - Algarve 100,0% 8,3% PT - Centro 66,7% 28,6%

Biological resources and

associated facilities

ES - Comunidad Foral de

Navarra

92,3% 12,8% FR - Pays de la Loire 33,3% 75,0% FR - Bretagne 51,7% 70,7% IE - Border, Midland and

Western

69,3% 30,7% IE - Southern and Eastern 100,0% 27,8% PT - Norte 93,8% 9,4% PT - Algarve 83,3% 24,1% PT - Centro 80,6% 19,4%

Imaging and related

instrumentation DNA/RNA

ES - Comunidad Foral de

Navarra

53,1% 50,0% FR - Pays de la Loire 62,5% 37,5% FR - Bretagne 62,7% 47,0% IE - Border, Midland and

Western

75,3% 16,1% IE - Southern and Eastern 100,0% 15,0% PT - Norte 60,9% 30,4% PT - Algarve 48,9% 51,1% PT - Centro 51,5% 43,9%

Process biotechnology

techniques

ES - Comunidad Foral de

Navarra

100,0% 14,3% FR - Pays de la Loire 100,0% 0,0% FR - Bretagne 90,0% 30,0% IE - Border, Midland and

Western

81,8% 0,0% IE - Southern and Eastern 100,0% 15,4% PT - Norte 100,0% 50,0% PT - Algarve 84,6% 38,5% PT - Centro 80,0% 20,0%

Nanobiotechnology

ES - Comunidad Foral de

Navarra

88,5% 11,5% FR - Pays de la Loire 50,0% 50,0% FR - Bretagne 100,0% 0,0% IE - Border, Midland and

Western

47,5% 0,0% IE - Southern and Eastern 60,9% 18,4% PT - Norte 25,0% 50,0% PT - Algarve 66,7% 33,3% PT - Centro 75,8% 19,7%

Bioinformatics

ES - Comunidad Foral de

Navarra

73,1% 38,5% FR - Pays de la Loire 93,8% 6,3% FR - Bretagne 83,1% 31,7% IE - Border, Midland and

Western

57,3% 18,9% IE - Southern and Eastern 50,0% 8,0% PT - Norte 100,0% 17,0% PT - Algarve 88,7% 19,4% PT - Centro 91.8% 23.5%

Table 3.4 displays the total access capacity, both internal and external within the

ShareBiotech regions to OECD nominated biotechnology needs.

155

3.6 ShareBiotech T.C.F.s Survey Results

The ShareBiotech Technology Core Facilities Survey was developed by the

European project ShareBiotech with the objective to reinforce the important

contribution that Life Sciences and Biotechnology could offer towards the

development of the Knowledge-based Economy, in the Atlantic Area

(www.sharebiotech.net). The questionnaire aimed to gather information about the

existing offer in advanced techniques in life sciences and biotechnology for R&D, in

order to facilitate access for researchers and companies. It was based on the TCF

concept: “a TCF is a set of equipment and associated expertise, which operating

capacity is available to public or private organisations, with a view to offering access

to high-level technologies for R&D”. The questionnaire enabled identification of

TCFs within the ShareBiotech regions. Earlier studies gave a partial view of

technology offers and needs but failed to provide a precise and homogeneous view.

A great quantity of inventories and/or directorates already existed within the

participating regions and these were used as a starting point in implementing the

survey. The TCF Survey aimed to provide the appropriate information for the

purpose of the ShareBiotech initiative: common inventory criteria, mapping of

TCF’s, typology of TCF’s (ownership, access, openness, current types of uses and

users, service provision etc.), and summary of skills (human resources and

Intellectual Property linked to TCF’s). A short description of each TCF was

presented on the ShareBiotech website. A TCF Source Book was produced in a hard

copy and was available on-line. The Technology Core Facilities were identified and

located by several means i.e., Biotechnology Ireland

(www.biotechnologyireland.com); Molecular Medicine Ireland

(www.molecularmedicineireland.ie); Enterprise Ireland (www.enterprise-

Ireland.com); internet, phone interviews, HEI websites, and research.

The ShareBiotech Technology Core Facilities Survey consisted of seven sections,

each part having several subsections. The ShareBiotech Technology Core Facilities

Survey can be referenced in (Appendix 3).

3.7 Instruments to foster Technology Transfer in Life Sciences

The objective of this action was to identify instruments and incentives that have been

developed for the implementation of technology transfer at regional, national or

156

European level. To this end the ShareBiotech partners interviewed the local,

national and European organisations in their region that supported technology

transfer, in order to identify the instruments/incentives used (e.g. call for projects,

grants, contests, web tools, networking activities etc.) The interview questionnaire

went through 12 questions referring to the transfer channels or pathways. The

identification of technology transfer instruments via the questions allowed for the

comparison of technology transfer strategy between ShareBiotech regions.

Technology Transfer pathways:

Student placements / Graduate employment

Joint supervision

Joint conferences

Training & continued personal development

Secondment (simultaneously working for private and public organisations)

Collaborative research

Contract research & Consultancy

Spin-outs

Shared facilities

Patents

Licences

Table 3.6: Irish organizations interviewed Re. Technology Transfer Survey

Interviewed Organisations Website

Athlone Institute of Technology www.ait.ie

Cork Institute of Technology – Industry

Liaison Officer www.cit.ie/industry_innovation

Institute of Technology Blanchardstown www.itb.ie

Institute of Technology Carlow www.itcarlow.ie

Institute of Technology Tallaght www.it-tallaght.ie

Invent DCU www.dcu.ie/invent Irelands National Marine Biotechnology

Programme (INMRP) www.marine.ie/biotech

Molecular Medicine Ireland www.molecularmedicineireland.ie

Science Foundation Ireland (SFI) www.sfi.ie

Shannon ABC www.shannonabc.ie

University of Limerick Technology Transfer

Office http://www2.ul.ie/web/WWW/services/research/t

echnologytransferoffice

Waterford Institute of Technology www.wit.ie

157

3.8 ShareBiotech Technology Transfer Survey Results

Figure 3.77: Geographic location country

The number of organisations having responded to the survey was comparable for

Ireland (12), France (18) and Portugal (15). However, only four organisations from

Spain responded (Figure 3.77).

Figure 3.78: Regional response to survey

Figure 3.78 shows the regions to which the organisations who responded to the

survey belong. For France and Portugal, some of these are bi-regional. (Source:

ShareBiotech “Instruments to Foster Technology Transfer, 2012)

12

18

15

4

0 5 10 15 20

Ireland

France

Portugal

Spain

Technology Transfer Survey Response by country

158

Figure 3.79: The number of people working in innovation services and technology

transfer in interviewed organisations in the Atlantic Area; France had the highest

number in the region of o to 10 with Ireland having the least. France was also highest

in the 10 to 24 and the 25 to 50 category. Ireland had the greatest number working in

the innovation services and technology transfer in the > 50 category (Source:

ShareBiotech “Instruments to Foster Technology Transfer, 2012)

Figure 3.80: The pie chart shows the type of instruments used to facilitate

Technology Transfer by interviewed organisations. The bar chart details the

instruments cited in each country (Source: ShareBiotech “Instruments to Foster

Technology Transfer, 2012)

159

Figure 3.81: The structure of results analysis

These two charts present the answer to the following type of question “Does your

organisation use instruments or incentives to implement technology transfer through

(e.g. student placement, collaborative project support etc.)” The greyscale pie chart

represents the results for the overall consortium, i.e. the number of organisations

interviewed by ShareBiotech partners answering “yes” or “no” to the question asked.

The coloured bar chart details the results by country, i.e. the number of organisations

interviewed that answered “yes” or “no” in France, Spain, Portugal or Ireland.

(Source: ShareBiotech “Instruments to Foster Technology Transfer, 2012)

3.9 Answers to Technology Transfer survey questions

Question 1: Does your organisation use specific instruments (e.g. communication

tools) or incentives (e.g. grants, fiscal incentives) to encourage student placement

and new graduate employment in companies?

160

Figure: 4.82 Technology Transfer through student placement / graduate

employment; there was little difference between Ireland, France, and Portugal at 15,

20, and 16 respectively with Spain registering the lowest score (5) for this method of

Technology Transfer

Only 45% of the structures supporting innovation set up resources to reinforce this

transfer pathway. Even organisations having direct links to research groups did not

systematically use this transfer channel, since only 70% of them responded

positively to this question. At a national level, Irish organisations were twice as

active in these fields as their Portuguese counterparts. Most of the tools allowing

students and young graduates to be placed in companies corresponded to various

forms of assistance (grants, tax incentives etc.). All the regions targeted by the

survey organised events that allowed companies to be introduced to students except

Spanish regions. A few examples taken from Irish survey response answers to

question 1 were:

The Employment-based Graduate Programme was identified as a new

and exciting initiative offering an employment-focussed postgraduate

experience that offered researchers the opportunity to complete a Master’s or

PhD degree while employed by a private company or public organisation

based in the Republic of Ireland. (http://www.research.ie/scheme/employment-

based-postgraduate-programme)

Enterprise Ireland is the state agency responsible for supporting the

development of manufacturing and internationally-traded services

companies. It provides funding and supports for companies and college-

based researchers to assist in the development, protection and transfer of

technologies into industry via licensing or spin-out companies.

http://www.enterprise-ireland.com/, http://www.enterprise-ireland.com/

en/Researchers/The-business-or-research.pdf

Athlone Institute of Technology’s annual careers fair on campus

organised by the Careers and appointments Service, which combines

careers advisory work with students and helps employers come into direct

56

20

16

15

5

0 10 20 30 40 50 60

ShareBiotech Consortium…

France

Portugal

Ireland

Spain

Technology Transfer through student placement/graduate

employment

ShareBiotech Consortiumtotal responseFrance

Portugal

Ireland

Spain

161

contact with students, for recruitment purposes

(http://www.ait.ie/informationforcurrentstudents/careersoffice/).

Question 2: Does your organisation use specific instruments (e.g. communication

tools) or incentives e.g. specific grants) to encourage or allow the joint

supervision of people in charge of a research project (e.g. Masters, PhD) by both

academic and industrial partners?

Figure 3.83: Technology Transfer through joint supervision; Portugal, France, and

Ireland registered 7, 13, and 11 respectively for TT through joint supervision with

Spain lowest at 2

A moderate number of responses were collected for this transfer channel (33). Half

of the organisations surveyed used this transfer channel, regardless of country of

origin. This transfer channel used a few specific instruments, but mobilised tools

which were used both for student placements and for setting up collaborative

projects between academics and companies. These were mainly funding tools, but

surprisingly, very few events were organised to encourage this transfer channel. In

Ireland, a number of programmes specifically designed for joint project supervision

were identified e.g.

The Employment-based postgraduate programme was identified as a new

and exciting initiative offering an employment-focused postgraduate

experience. The programme offered researchers the opportunity to complete

a Masters or PhD while employed by a private or public organisation based

in the Republic of Ireland. (http://www.irchss.ie/eapp/index_set.php).

The Inter Trade Ireland – fusion “business, academic, graduate

partnership” allowed joint supervision of research projects and provided

part-funding for projects with companies. This technology transfer

programme, FuSion, helped companies bolster the bottom line of their

business, and enabled them to get ahead of the competition. The partnership

33

11

13

7

2

0 10 20 30 40

ShareBiotech Consortiumtotal Response

Ireland

France

Portugal

Spain

Technology Transfer through jount supervision

ShareBiotech Consortiumtotal Response

Ireland

France

Portugal

Spain

162

included a third-level institution with a specialist expertise, and a high-calibre

science, engineering or technology graduate. The graduate was employed by

the company and based at the company throughout the project, with

mentoring from the academic partner and an Inter Trade Ireland FuSion

consultant (http://www.intertradeireland.com/fusion).

IrcSET’s Embark Initiative awarded scholarships at postgraduate level on

an annual basis through a competitive process

(http;//www.ircset.ie/Default.aspx?tabid=63)

Question 3: Does your organisation participate in or organise joint conferences

between companies and academic partners, or use specific instruments (e.g.

communication tools) or incentives? (e.g. Mobility grants, networking activities) to

promote attendance at such meetings

Figure 3.84: Technology Transfer through joint conferences; joint conferences were

most popular in France (34) with Portugal and Ireland even at (16) each, while Spain

used this method least at (7)

There were 73 responses to question 3. The results indicated that technology transfer

through joint conferences was a popular transfer channel. These events allowed

academic and private researchers to meet and discuss ideas to come up with joint

projects. Expert interviews revealed that this channel was extensively used by Tony

Jones as a method of technology transfer to grow the Babraham cluster in the UK. It

was thought that more intimate working groups on specific themes with, which

gathered fewer participants were more likely to allow the development of

collaborative joint projects than congress organised events with broad themes. The

following technology transfer channels were identified in the Irish survey:

Athlone Institute of Technology’s and the University of Perlis Malaysia (UNIMAP) Annual Business, Science and Engineering International

Symposium –a two day international symposium on science, engineering and

73

34

16

16

7

0 20 40 60 80

ShareBiotech Consortium…

France

Portugal

Ireland

Spain

Technology Transfer through joint conferences

ShareBiotechConsortium ResponseTotalFrance

Portugal

163

business

(http://www.ait.ie/aboutaitathlone/newsevents/pressreleases/2011pressrelease

s/title-9498-en.html)

Applied Research Enhancement (ARE) Centre – Industry Days. Client

companies presented their projects and case studies at annual events hosted at

ARE Centres. (http://www.enterprise-ireland.com/en/Research-

Innovation/Companies/Collaborate-with-companies-research-

institutes/Applied-Research-Enhancement-Centres-.html)

Irish Society of Toxicology (IST) Conferences – The IST is a professional

organisation of scientists from academia, government and industry,

representing a broad cross-section of those involved in toxicology in Ireland.

The IST has committed to creating a safer and healthier environment by

advancing the science of toxicology.

(http://www.toxicologyireland.com/home.php)

Question 4: Is your organisation involved in the setting up of training session

/programmes that allow companies to keep their professional knowledge up to date

with new developments developed by academics or use specific instruments (e.g.

communications tools) or incentives (e.g., grants) to promote attendance at such

training events?

Figure 3.85: Respondents to Q4 in the Atlantic Area; France and Ireland favored TT

through training and continued professional development (13 to 11) respectively

with Portugal and Spain using this method least at (5 to 3) respectively.

A moderate number of responses were collected for this transfer channel; 32 in total.

Fewer than half the organisations surveyed used this method to technology transfer.

It was noted that in Ireland, the on-going training offer for companies was more

often on offer. The most used instruments were events and communication efforts

32

13

11

5

3

0 10 20 30 40

ShareBiotech ConsortiumTotal Response

France

Ireland

Portugal

Spain

Technology Transfer through training &continueing

professional devedlopment

ShareBiotech ConsortiumTotal Response

France

Ireland

Portugal

Spain

164

by organisations for their promotion. The following technology transfer instruments

in this category were identified in Ireland:

Intellectual Property and Technology Transfer training events were

organised for client companies of the Cork Institute of Technology business

incubator.

(http://www.cit.ie/industry_innovation/entrepreneurswhipandbusiness/).

Shannon ABC Open Days included tours of laboratories, workshops on

current equipment and techniques. (http:/www.shannonabc.ie/)

Institute of Technology Blanchardstown custom training sessions for

companies (http://www.itb.ie/industryinnovation/industrytraining.html).

Question 5: Does your organisation use specific instruments (e.g. legislation,

communication tools) or incentives (e.g. specific grants) to encourage or allow the

members of a company or research group to work for another organisation at the

same time? (For example, in France, legislation allows academic researchers to work

up to 6 years in a start-up company, exploiting their research).

Figure 3.86: Technology Transfer through secondment results in ShareBiotech

partner areas; Spain did not use secondment as a driver of TT and use was low in

Portugal and Ireland at (2 to 5) respectively with France at (12) was the biggest user

of this method.

Only 25% of the organisations respondent to the survey used this technology transfer

channel which allowed researchers to work in an academic laboratory and a

company at the same time. Organisations interviewed in Navarra (Spain) made no

mention of this technology transfer channel. In Ireland, academic researchers were

allowed to work in any organisation providing they had the funding in place to do so.

They could engage in research with a company to develop a product or service as

long as they delivered the agreed workload to the company and this did not conflict

19

12

5

2

0

0 5 10 15 20

ShareBiotech Consortium…

France

Ireland

Portugal

Spain

Technology Transfer through secondment

ShareBiotech ConsortiumTotal Response

France

Ireland

Portugal

Spain

165

with their academic employment contract. In France, this transfer channel was

highly regulated and a law was passed in 1999 which governed the conditions

allowing an academic researcher to work within a private company. Some examples

in Ireland were as follows:

University Leave of Absence Scheme: Leave of absence was recognised as

unpaid leave that was granted for a minimum period of 2 weeks and a

maximum period of 12 months. If leave of absence was granted, the

employee’s position was held open, or filled on a temporary basis. This

policy was operated in the University of Limerick. (http://www.ul.ie/).

Researchers at the Cork Institute of Technology could “buy out” time to

become involved in start-up companies.

(http://www.cit.ie/industry_innovation).

Question 6: Does your organisation use specific instruments (e.g. communication

tools) or incentives (e.g. call for projects, specific grants) to encourage collaborative

research between academic partners and industry?

Figure 3.87: The graph indicated that (19) organizations in Ireland used training and

continuing professional development as a tech transfer channel which was the same

as Portugal, while France at (51) used TT through collaborative research more than

all the ShareBiotech regions with Spain the lowest at(8).

Almost all the organisations surveyed used this transfer channel. A total of 97

responses were given by the organisations surveyed which indicated widespread use

of this channel. From the data, it was concluded that the European Union was well

aware of the significance of this transfer channel in bring innovative projects to

fruition. More than 50% of the instruments used corresponded to project funding.

This funding was available in the form or innovation vouchers used extensively in

AIT who provided services to ~900 companies, and minor funding to support major

97

51

19

19

8

0 20 40 60 80 100 120

ShareBiotech ConsortiumTotal Response

France

Ireland

Portugal

Spain

Technology Transfer through collaborative research

ShareBiotech ConsortiumTotal Response

France

Ireland

Portugal

Spain

166

innovative strategic projects. Some examples of this transfer channel identified in

Ireland were as follows:

Enterprise Ireland Innovation Voucher Scheme: The Innovative Voucher

Scheme was developed to build links between Irelands public knowledge

providers (i.e. Higher Education Institutes (HEI’s); public research bodies)

and small businesses. Innovation vouchers worth €5,000 were available to

assist companies to explore a business opportunity or problem with a

registered knowledge provider. The Innovative vouchers initiative was

available to SME’s in Ireland with less than 50 employees.

(http:www.enterprise-ireland.com/en/Research-Innovation/Companies/

Collaborate-with-companies-research-institutes/Innovation-

Voucher.shortcut.html). The programme originated in Holland.

Science Foundation Ireland Research Centres Programme: SFI invested

in academic researchers and research teams who were most likely to generate

new knowledge, leading-edge technologies and competitive enterprises in the

fields of science and engineering underpinning three broad areas: 1)

biotechnology, 2)Information and communication technology, 3) Sustainable

and energy-efficient technologies. (http:www.sfi.ie/funding/finding-calls/

open-calls/).

SFI Infrastructure Call: This programme was established to facilitate

established multi-PI groups to engage in exploratory collaboration with

another party – such as another research centre or an industry partner

company with a view to developing a long-term collaboration

(http:www.sfi.ie/funding/finding-calls/open-calls/).

Question 7: Does your organisation use specific instruments (e.g. communication

tools) or incentives (e.g. specific grants, networking activities) to encourage service

supply & consultancy between academic partners and industry?

There were 63 respondents to this question across the ShareBiotech consortium.

Communication was the instrument most used for the development of service

provision between academics and companies. A large volume of websites were

created to present the various offers and technological platforms available to

companies. Nevertheless, the majority of these existing databases tended to render

the information difficult for companies to read. The ShareBiotech consortium used

the platform “The Biotech Knows” to post technology demands from SME’s in the

Atlantic Area with a view to bridging the technology gap.

167

Figure 3.88: Technology Transfer through contract research (service supply) &

consultancy was highest in France at (28) with Ireland and Portugal even at (15), and

Spain lowest at (5).

Examples of this technology transfer pathway identified in the Irish ShareBiotech

Technology Transfer survey were as follows:

Strategic Consultancy Grants: The SME Consultancy Grant supported the

cost of hiring Strategic Consultants to assist in the development and/or

implementation of strategic initiatives in the SME. It was designed to

facilitate business growth: consultants acted as coaches, mentors, facilitators,

analysts, negotiator and/or operator for the company. (http:www.enterprise-

ireland.com/en/Funding-Supports/Company/Establish-SME-

Funding/Strategic-Consultancy-Grant.html)

Research Institutes Websites: The websites presented the competencies of

their own laboratories and platforms e.g. Shannon ABC

(http://www.shannonabc.ie); Athlone Institute of Technology

(http://www.ait.ie); Institute of Technology Blanchardstown

(http://www.itb.ie).

Question 8: Does your organisation use specific instruments (e.g. legislation,

communication tools) or incentives (e.g. call for projects, specific grants) to support

the creation of spin-outs?

Figure 3.89: Technology Transfer through legislation, communication tools or

incentives to support spin-outs was highest in France at (19), and even in Portugal

and Ireland at (14) each, while lowest in Spain at (7).

63

28

15

15

5

0 20 40 60 80

ShareBiotech Consortium…

France

Ireland

Portugal

Spain

Technology Transfer through contract research (service supply)

& consultancy

ShareBiotech Consortium TotalResponse

France

Ireland

Portugal

54

19

14

14

7

0 10 20 30 40 50 60

ShareBiotech Consortium…

France

Ireland

Portugal

Spain

Technology Transfer through spin-outs

ShareBiotech ConsortiumTotal Response

France

Ireland

Portugal

168

Almost 60% of the organisations surveyed used the creation of spin-outs as a transfer

channel. Spin-outs occur when a corporation breaks off parts or divisions of it to

form a new corporation. In all surveyed countries, systems were identified to assist

the creation of innovative companies arising out of academic research e.g. incubators

offered support in the form of training, consultancy and seeking finance. Incubators

also made office and wet-lab space available to young companies. Some technology

transfer through spin-outs instruments identified in Ireland was as follows:

Enterprise Ireland Start-up Incubation Space: Enterprise Ireland funded

both business and bio-incubation centres on college campuses across Ireland,

which provided an ideal environment for start-up companies. More than 200

companies employed more than 1,000 people were based in Irish incubation

centres funded by EI (httpp://www.enterprise-

ireland.com.en/Researchers/Spin-Outs/Start-Up-Incubation-Space.html).

New Frontiers Entrepreneur Development Programme (NFWDP): New

Frontiers Ireland was developed as Ireland’s national entrepreneur

development programme. It was delivered at local level by the Irish

Institutes of Technology. The New Frontiers Ireland Programme

entrepreneurs who were planning to develop a concept by starting a new

company with support to accelerate the business development and equip it

with the skills and contacts needed to successfully start and grow the

company (http://www.enterprise-ireland.com/en/Start-a-Business-in-

Ireland/Supports-for-High-Potential-Start-Ups/New-Frontiers-Entrepreneur-

Development-Programme.html).

Question 9: Does your organisation use specific instruments (e.g. legislation

communication tools) incentives (e.g. specific grants) to support the creation of

shared facilities between academic partners and companies?

Figure 3.90: Technology Transfer through shared facilities; this method was similar

in Spain, Portugal, and Ireland at (4, 5, & 6) respectively while France was the

biggest user of this method at (28).

28

13

6

5

4

0 5 10 15 20 25 30

ShareBiotech ConsortiumTotal Response

France

Ireland

Portugal

Spain

Technology Transfer through Shared facilities

ShareBiotech ConsortiumTotal Response

France

Ireland

Portugal

Spain

169

Half of the organisations researched cited the existence of research structures that

were shared between academic and industrial partners. The objective of this was to

systematically create technology transfer by setting up mixed structures to allow

regular exchanges between these actors, and ultimately move from fundamental

research to applied research. It was also envisaged that this would enable a given

sector the ability to respond faster to a market need. Identified examples of

technology transfer through shared facilities in Ireland were:

Science Foundation Ireland’s Infrastructure Call; This initiative

encouraged the efficient use, renewal, and development of existing national

research infrastructures whilst also recognising the need for continued

investment in cutting-edge research equipment. The emphasis in this

research infrastructure call was placed on collaborative efforts and liaison

with industry, with the goal of sustaining and strengthening Ireland’s

research base for all stakeholders (http://www.sfi.ie/funding/funding-calls).

Question 10: Does your organisation use specific instruments (e.g. communication

tools) or incentives (e.g. specific grants, call for projects) to support industrial

protection of research results (e.g. with patent)?

Figure 3.91: Technology Transfer through patents was most popular in France at

(19) with Portugal and Ireland scoring (17 & 13) respectively while least popular in

Spain at (5).

Two thirds of the organisations surveyed used patents to facilitate technology

transfer. The study revealed that patents were the preferred instrument used by

academics to protect their innovations. The following technology transfer through

patents initiatives were identified in Ireland through the ShareBiotech technology

transfer survey:

54

19

13

17

5

0 10 20 30 40 50 60

ShareBiotech Consortium…

France

Ireland

Portugal

Spain

Technology Transfer through patents

ShareBiotech ConsortiumTotal Response

France

Ireland

Portugal

170

Enterprise Ireland Technology Transfer Supports (EITTS): The

National Technology Transfer System was created to enable the transfer of

commercially valuable research outputs to industry. Funding sources

included Enterprise Ireland, The Higher Education Authority (HEA), Science

Foundation Ireland (SFI) and others. This support enabled researchers in

higher education institutes to invent new technologies, and develop solutions

in challenging areas such as healthcare, transport, energy, engineering, food,

software, and telecommunications. It was hoped that solutions and inventions

would form the basis for new companies, or could be used by existing

companies to develop new products and services to open up new markets.

The technology transfer system played a significant role in bringing new

initiatives to a commercial reality. (http://www.enterprise-

ireland.com/en/Researchers/Technology-Transfer-Support-System/)

Invention Disclosure Reports (IDR): These were available in all

universities, research centres, and institutes of technology. They facilitated

decisions to be made as to whether patent protection should be sought in

relation to a particular invention.

Technology Institutes / Centre Grants and Support for IP: The Institute

of Technology Tallaght provided patent filing services, expertise and

financial supports in relation to IP; Shannon ABC provided grants for

funding IP costs and organised meetings relating to IP. They provided

assistance to companies through all stages of IP protection. (http://www.it-

tallaght.ie/technologytransferoffice);

(http://www.shannonabc.ie/intellectualproperty.php).

Question 11: Does your organisation use specific instruments (e.g. communication

tools, websites) or incentives (e.g. grants to help proof of concept) to support

licencing activities or project maturation?

4.92: Technology Transfer through licensing and project maturation was highest in

France and Ireland scoring (21 & 16) respectively with Portugal scoring (7) while

Spain did not register using this method.

44

21

16

7

0

0 10 20 30 40 50

ShareBiotech Consortium…

France

Ireland

Portugal

Spain

Technology Transfer through licencing & project maturation

ShareBiotech ConsortiumTotal Response

France

Ireland

Portugal

171

There were a total of 44 respondents to survey question 11. It was noted that 53% of

organisations were fostering licencing and maturation stages and 65% were fostering

patent applications. More than 60% of identified transfer channels related to project

financing and engineering. The maturation phase for patented technologies in the

field of life sciences demanded input from innovation support structures as well as

significant levels of investment. The presentation of patented technologies to

industry likely to obtain licences required the use of communication tools (e.g. B2B

meetings, internet portals, newsletters, etc.). Transfer pathways relating to question

11identified in Ireland were as follows:

Enterprise Ireland Commercialisation Fund Programme (EICFP): The

aim of the Commercialisation Fund was to improve the competiveness of the

Irish economy through the creation of technology-based start-up companies

and the transfer of innovative technologies developed in higher education

institutes and research centres to Irish industry. Funding was available to

support the development of technologies throughout all phases of the

commercial pipeline. (http://www.enterprise-ireland.com/en/funding-

suports/Researcher/Funding-to-Commercialise-Research/Commercialisation-

Fund-Programme-Commercial-Case-Feasibility-Grant.html).

Table 3.7: Conclusion: Results Synthesis Table records each countries average

percentage, lowest yes count, and highest yes count for each method of TT used and

records each country’s most common type of instrument to foster TT. The total

numbers of instruments cited are also shown. Q

No.

Transfer channels % of organisations answering Yes Total No. of

instruments

cited (may

be identical)

Most common

types of

instruments

Average

for the

consortium

%

Country

lowest

yes

count %

Country

highest

yes

count %

Q1 Student

placement/Graduate

employment

45% Portugal

33%

Ireland

58%

56 Funding

Q2 Joint supervision 49% France

39%

Ireland

58%

33 Funding

Engineering

Q3 Joint conferences 76% Portugal

67%

83% 73 Meetings

communication

Q4 Training and

professional

45% Portugal

27%

Ireland

67%

32 Meetings

172

development

Q5 Secondment 27% Spain

0%

Ireland

42%

19 Engineering

Q6 Collaborative

research

90% Spain

75%

Ireland

100%

97 Funding

Engineering

Communication

Q7 Contract research &

consultancy

67% Spain

50%

Ireland

73%

63 communication

Q8 Spin-outs 59% Spain

25%

France

Ireland

67%

54 Funding

engineering

Q9 Shared facilities 51% Portugal

40%

Spain

75%

28 All

Q10 Patents 65% Portugal

60%

Ireland

75%

54 all

Q11 Licencing 53% Spain

0%

Ireland

83%

44 Funding

Engineering

communication

3.10 Natural Products Companies surveyed in Ireland

Thirty one Natural Products Companies whose activities included biotechnology

were surveyed. The companies were selected using search engines e.g. the

Biotechnology Ireland website, internet searches and Molecular Medicine Ireland

(MMI). The companies were contacted via email and telephone to raise awareness

about the ShareBiotech Project among the N.P. companies and to establish the

willingness of the companies to partake in a telephone survey aimed at identifying

problems perceived in the normal day-to-day running of their businesses, e.g. access

to cutting edge technologies, funding, access to government agencies, technology

transfer among other topics. Ten questions covering ten areas relative to

ShareBiotech project aims were drafted (Methodology). The companies identified

who confirmed their willingness to be interviewed are shown in (Table 3.7). The

companies were also asked if they were willing to attend Local Technology

Meetings (LTM’s), the agendas which would be decided following analysis of the

surveys and the classification of all biotechnology companies interviewed into

common categories. The companies were grouped into 10 categories decided by their

173

area of business (Ref Table 3.8). In total 132 SME’s were surveyed which

comprised biotechnology companies, NP companies, research centers and TCF’s. It

was observed that some companies belonged to two or more themes which caused

overlaps in certain areas.

Table 3.8 Natural Products Companies comprising mainly of SME’s in the marine

sector; generally involved in harvesting of seaweed and sea vegetables, for

processing into bio-products, i.e. health foods, Bio-pharma, cosmetics, etc.

Interviewed in Ireland

NATURAL PRODUCTS LOCAL TECHNOLOGY MEETING

(SHAREBIOTECH) COMPANY ATTENDEE

NAME

EMAIL PHONE SERVICES

PROVIDED

Microbide

Ltd.

Mary Skelly [email protected]

[email protected]

01 480

0563

Aldehyde biocide

formulations

DTL Biotech

Ltd

Denis Looby Pharmaceuticals

Life Scientific Nicola

Mitchell

[email protected] 01 283

2024

Developing &

registering plant

protection products &

provision of

bio/pharmaceutical

analytical development

services

Trustwater

Ltd

Edmond

O’Reilly

[email protected] 052

6170818

Water & general

disinfection

technologies

AlgAran Ltd Rosaria

Piseri

[email protected] 074 973

8961

Researches Irish

seaweed extracts

Arramara

Teoranta

Noreen

Breannach

[email protected] 095 33404

095 33417

State owned company

harvesting seaweed for

production of alginates,

seaweed meal for

agriculture,

horticulture, and

aquaculture industries

Bio-Atlantis

Ltd

John T

O’Sullivan

[email protected] 066 711

8477

Development &

production of

neutraceutical

ingredients for plant,

human and animal

markets from seaweed

Blath Na

Mara

Mairtin

Concannon

[email protected] 087 618

3841

Harvesting macro-

algae (seaweed)

Brandon

Products Ltd

Henry Lyons [email protected] 087 2608

482

Biotechnology

company that develops

and commercialises

products derived from

Marine Raw Materials

Cybercolours

Ltd

[email protected] 021 437

5755

Food ingredient

company specialising

in sourcing, research,

development,

manufacture,

promotion and

marketing of natural

174

food colours

Irish

Seaweeds Ltd

Gus Heath [email protected]

+44 (0)

289061

7512

Hand harvesting

seaweed and sea

vegetables for the

seaweed market in

Ireland

Irish seaweed

processors

Ltd

Tony Barrett [email protected] 0909 749

071

Glasrai Mara

Port Lairge

Nicholas

Paul

058 46168 Harvests sea vegetables

for culinary use

LoTide Fine

Foods

Seamus

Moran

[email protected] 098 42616 Harvests Atlantic sea

vegetables for supply

into speciality food

shops

Matigot Ltd Michael

Ryan

[email protected] 021

4378377

Seaweed harvesting

On The Wild

Side

Oliver

Beaujouan

[email protected] 066 713

9028

Collects seaweed to

make a selection of

speciality foods

available in markets

Quality Sea

Vegetables

Manus

Mc’Gonagle

[email protected] 074 954

2159

Seaweed harvesting to

produce dried seaweed

and grinds and blends

seaweed to produce

seaweed condiments

Roaringwater

Bay Seaweed

Co-op

Diana Pitcher [email protected] 028 38483 The Co-op harvests

seaweed, and supplies

to the food,

pharmaceutical, beauty

and live-stock

industries

Spanish Point

Sea

Vegetables

Gerald Talty [email protected] 085 1648

648

065 708

7395

Harvesting sea

vegetables

Carabay

Seaweed

Health

Products

Graham

Casburn

[email protected] 091

773370

Seaweed harvesting

Carraig

Fhada

Betty Melvin

Frank Melvin

[email protected] 096 49042 Hand harvesting

seaweed and drying for

supply to health food

shops

Cleggan

Seaweed

Company

John King [email protected] 095 44649 Harvesting seaweed for

supply to health food

shops, also, producing

“Sea Pickle”

Erin Seaweed

and Shellfish

Gerald

Heneghan

097 84976 Sustainable harvesting

of seaweed

Ri Na Mara Deirdre Ui

Chathmhaoil

[email protected] 091 55307 On-going R&D

program into organic

products (seaweed) ,

development of

products for

distribution

Nationally&

Internationally, with

FDA approval

Seavite

Bodycare Ltd

Patrick

Mulrooney

[email protected] 091

521351

investigating the

healing properties of

sea produce

VOYA

Products Ltd

Neill Walton [email protected] 071 916

8956

Hand harvested

seaweed, to produce

speciality skin care

175

products

Seaweed

Ireland Ltd

Ria Peters [email protected] 083

4087040

027 74808

Marine product

research

Gaia Biotech

Ltd

Stephen

Kavanagh

[email protected] 040

229316

Research, development

and marketing of

marine bioactive

substances for food and

cosmetic industries.

Research

commercialisation of

natural health products

Westgate

Biological

Mark

Clifford

[email protected] 023 54944 Natural Antimicrobial

Biocide Production

Xenith

Biomed

- - - -

Table 3.9 Shows the grouping of surveyed SME’s, & N.P. companies into categories

according to their area of expertise for the purpose of organizing Local Technology

Meetings

(1) BIOTECHNOLOGY SME’s ANTIMICROBIAL/BIOCIDES SME LOCATION CONTACT PHONE EMAIL

Westgate

Biological

Dublin2 Ireland Mr. Mark

Clifford

+353 23

54944

Email:[email protected]

Xenith Biomed Galway, Ireland Mr Kulwant

Singh

+091-

593900

[email protected]

CeBec Group

Ltd.

Galway, Ireland. Sean Daly

+353 91 443

913/4

[email protected]

Microbide Ltd Dublin Dr. Deirdre

McDonnell-Lee,

+353 (0)1

480 0563

moc.ediborcim@ofni

Life Scientific

Ltd

Dublin. Ireland. Nichola Mitchell

+353 1

2832024

[email protected]

Trustwater Ltd Clonmel, Ireland Edmond

O’Reilly

+353 52

6170818

[email protected]

(2) BIOTECHNOLOGY SME’s CONTROLLED ENVIRONMENTS SME Location Contact Phone Email

Ardmac Dublin, Ireland Gwen O'Brien + 353 (0)1

894 8800 [email protected]

Airmid

Healthgroup Ltd

Dublin. Ireland Angela

Southey

+ 353

(0)1633 6820

Clearsphere Cork, Ireland. David Tipping 353(0)21

4371175

[email protected]

Ardmac Dublin, Ireland. Ronan Quinn 353 (0)1

8948800

[email protected]

(3) BIOTECHNOLOGY SME’s VETINARY SME Location Contact Phone Email

IdentiGEN Dublin Ireland Ciaran

Meghen

+ 353 1

6770221

[email protected]

Enfer Naas, Ireland Martin

Crowley

+353 45

983800

[email protected]

Tridelta

Maynooth

Ireland.

Brian Hett

+353 1

6290635

[email protected]

176

Bimeda Dublin Ireland Brendan

Smith

+353 1

4515011

[email protected]

Ovagen

Group Ltd

Ballina,

Ireland.

Catherine

Caulfield

+353 96

75579

[email protected]

Protectas

Health LTD

Dublin David

Crimmins

+353 1

2541841

[email protected]

Chanelle

Veterinary

Galway,

Ireland

Breda

Mc'Cormack

+353

(0)91

841788

[email protected]

The Irish

Equine

Centre

Naas, Ireland Mark Sherry

+353 45

866266

[email protected]

(4) BIOTECHNOLOGY SME’s/DRUG DEVELOPMENT SME Location Contact Phone Email

New Vistas

Healthcare

Limerick.

Ireland

Martin

Murray

+ 353(0) 61 334455 [email protected]

EirGen Pharma

Ltd.

Waterford

Ireland

Patsy Carney +353 (0)51 591944 [email protected]

Azur Pharma

Limited

Dublin

Ireland

Mr. Seamus

Mulligan

+353 (1) 634 4183

AGI

Therapeutics

Ltd.

Dublin

Ireland

Dr. John

Devane

+353(0)1449 3250 [email protected]

HiberGen Bray

Ireland.

Greg

McGuinness

+353 (0)1 276 9898 [email protected]

Crescent

Diagnostics

Limerick,

Ireland

Ernest Poku +353 (0)1 433 3096 [email protected]

Genable

Technologies

Ltd

Dublin

Ireland

Professor

Jane Farrar

+353(0)1 896 3390 [email protected]

Janseen Ireland

Ltd

Dublin,

Ireland

+ 353 (0)1 620 2300

The Centre for

Human

Proteomics

Dublin Derek

Murphy

Ph.D.

+353 (0)1 402 8518 [email protected]

Amarin

Corporation

Dublin

Ireland

Joseph S.

Zakrzewski

+353 (0) 1 6699 02

Thrombogenics Dublin

Ireland

Professor

Désiré Collen

+353 (0) 1 63911 78 [email protected]

Reliance Gene

Medix plc.

Tullamore,

Ireland.

Conor O'Dea +353 5793 235 72 c.odea@genemedix

Genzyme

Ireland Ltd.

Waterford,

Ireland

Mr Michael

Walsh

+353(0)51 594147/Mob

087 9056643

[email protected]

Elan/Arkimas Athlone,

Ireland.

Yvonne

Kennedy

+353(0) 90649 5000 [email protected]

Xeolas

Pharmaceuticals

Dublin

Ireland

Damien

Flynn

+353(0) 1

7007468/Mob 353 86

8097219

[email protected]

Vysera

Biomedical Ltd.

Galway,

Ireland

Tony

keavney

+353(0)91 8622 02 [email protected]

Sigmoid

Pharmaceuticals

Dublin Ivan S.

Coulter,

+353 (0)1

7007511/Mob 087

4186087

[email protected]

Pharmatrin Ltd. Dublin

Ireland

Neil Frankish +353(0)167098 65 [email protected]

177

Opsona

Therapeutics

Dublin

Ireland

Jeremy

Skillington

+35(0)1 89684 99 [email protected]

Merrion

Pharmaceuticals,

Ltd.

Dublin

Ireland

Jonathan

O'Connel

+353(0)16423300 [email protected]

Alimentary

Healthcare Ltd

Cork,

Ireland

Brian Barrett 353 (0)21 42991 04 [email protected]

(5) BIOTECHNOLOGY SME’s/ HEALTH CARE/TESTS SME Location Contact Phone Email

Allergy

Standards Ltd

Dublin

Ireland

Andrea Richardson

+353 (0)1 675

5678

andrea(at)allergystandards.com

Biotrin Dublin,

Ireland.

DesmondO'Leary +353 (0)1

2831166

[email protected]

Trinity Biotech

Ltd

Bray Ireland Rachael O'Shea

+ 353 1

2769800

[email protected]

Argutus

Medical

Dublin,

Ireland

Joe Keenan

353 1

6708576 Ext:

201

[email protected]

Audit

Diagnostics

Cork, Ireland Michael

O’Donovan

+353 21

4533652

[email protected]

Megazyme

International

Ireland Ltd.

Bray, Ireland.

Barry McCleary

+353 1

2861220

[email protected]

Biomonitor A/S Galway,

Ireland

Arsalan Kharazmi

+353

091862664

[email protected]

Anecto Ltd Galway.

Ireland.

Yvonne Kearney +353 91

757404

[email protected]

(6) BIOTECHNOLOGY SME’s/ HEALTHCARE/BIOPRODUCTS SME Location Contact Phone Email

Mednova Galway

Ireland

+353

91758026

Embricon Ltd Galway,

Ireland

Marto Hoary +353 91

585599

[email protected]

Innocoll Ltd Athlone,

Ireland

Denise Carter

+353 9064

86834

[email protected]

Beeline

Healthcare Ltd

Dublin

Ireland

Jerry Finn

+353 (1) 457

50 11

[email protected]

Proxy

Biomedical.

Galway,

Ireland

Peter Mulrooney

+353

(0)91896900

[email protected]

(7) BIOTECHNOLOGY SME’s/ MEDICAL DEVICES SME Location Contact Phone Email

EnBIO Dublin Ireland Joe O’Keeffe +353 (0)1

525 3305

[email protected]

Audit Diagnostics Cork, Ireland Michael

O’Donovan

+353 (0)21

4533652

[email protected]

Biosensia Dublin Ireland Diarmuid

Flavin

+353 (0)1

7163650

[email protected]

Enzolve

Technologies Ltd

Dublin 4,

Rep. Ireland

Stuart

Cramer

+353 (0)1

7163633

[email protected]

Smurfit Institute of Dublin Ireland Gearóid +353 (0)1 [email protected]

178

Genetics, Tuohy 608 3390

Innicoll Ltd. Athlone,

Ireland

Denise

Carter

353 (0)9064

86834

[email protected]

Genzyme Ireland

Ltd.

Waterford,

Ireland

Mr Michael

Walsh

+353 (0)51

594147

[email protected]

Proxy Biomedical. Galway.

Ireland

Peter

Mulrooney

+ 353 (0) 91

896900

[email protected]

Stokes Bio Limited Limerick,

Ireland

Professor

Mark Davies

+ 353 (0)

61506200

[email protected]

Mavaro Medical

Devices

Galway,

Ireland

Chris Davey +353 (0)91

759 301

[email protected]

Clada Medical

Devices

Galway

Ireland

Ray Blowick + 353 (0)91

572040

[email protected]

Serosep Ltd. Limerick.

Ireland

Dermot

Scanlon

+ 353 (0)61

440207

[email protected]

Creganna Ltd Galway

Ireland

Graeme

Reese

+ 353 (0)91

757801

[email protected]

Sigma-

Aldrich Ireland Ltd

Wicklow,

Ireland

Nicola

McCarthy

1800 200

888

[email protected]

(8) BIOTECHNOLOGY SME’s/ DRUG DELIVERY SME LOCATION CONTACT PHONE EMAIL

EnBIO Ltd Dublin Ireland. Joe O’Keeffe + 353 (0)1 525

3305

[email protected]

Sigmoid

Pharmaceuticals

Dublin. Ireland Ivan S.

Coulter,

+353 (0)1

7007511/ [email protected]

Vysera Biomedical

Ltd.

Galway, Ireland Annette

Mullally

+ 353 (0)91

862202 [email protected]

Innocoll Ltd Athlone, Ireland Denise

Carter

+ 353 (0)9064

86834 [email protected]

Cytrea Dublin Ireland Raphael

Darcy

+ 353 (0) 716

2317 [email protected]

(9) BIOTECHNOLOGY SME’s/ IT SME Location Contact Phone Email

Automsoft Dublin

Ireland

Paraic

O’Toole

+353(0) 1

4491100 [email protected]

Campbell

Informatics

Ltd

Cork,

Ireland

Maura

Connolly

+353

(0)214291336

[email protected]

Clinical

Trial

Endpoint

Ltd

Dublin

Ireland

Stephen

Dorman

+353(0)1

4637346

[email protected]

Compucal

Software

Solutions

Cork

Ireland.

Matthew

Dornan

+353 (0)21

4524682

[email protected]

(10) BIOTECHNOLOGY SME’s , MISCELLANEOUS SME Location Contact Phone Email

Celtic Catalysts Dublin

Ireland.

Brian Kelly +353 (0)1

7163610

[email protected]

Enzolve

Technologies

Ltd

Dublin,

Ireland

Stuart

Cramer

+353 (0)1

7163633

[email protected]

Luxcel

Biosciences Ltd

Biotransfer

Cork,

Ireland.

Fred Klok +353 (0)21

4901447 [email protected]

(Enzyme Technologies)

Sensl Cork, Carl +353 (0)21 [email protected]

179

Technologies

Ltd

Ireland Jackson 4350442

BCD

Engineering

Cork,

Ireland

Richard

Keays

353(0) 86

8370523

[email protected]

Biotector

Analytical

systems Limited

Cork,

Ireland

Miriam

Fitzgibbon

353 (0)21

4374237

[email protected]

BSM Ireland Ltd Galway

Ireland.

Maurice

Hannon

+353 (0)91

746900

[email protected]

Chemstore Ltd. Limerick,

Ireland

Noel

Conolin

+353 (0)61

327792 [email protected]

(Chemical storage)

Stokes Bio

Limited

Limerick,

Ireland

Professor

Mark

Davies

+ 353 (0)

61506200 [email protected] (genetic analysis

enhanced plant breeding)

The Centre for

Human

Proteomics

Dublin

Ireland

Derek

Murphy

Ph.D.

+353 (0)1 402

2261 [email protected]

(Genetics)

Genable

Technologies

Ltd

Dublin

Ireland

Professor

Jane Farrar

+353 (0)1 896

3390 [email protected]

(gene medicines)

Biostór Wexford,

Ireland.

Peadar

Mac

Gabhann

+353 (0)53

9161398 [email protected]

(high purity liquid processing)

OVAGEN

GROUP Ltd

Ballina,

Ireland.

Catherine

Caulfield

+353 (0)96 75

579

[email protected]

Technopath Ballina,

Ireland

Dave

Sullivan

+ 353 (0)61 33

5844

[email protected]

LUXCEL

BIOSCIENCES

Ltd

Cork

Ireland.

Fred Klok +353 (0)21 490

1447

[email protected]

(Food sensors/

Instrumentation food safety)

Carl Stuart Ltd Dublin

Ireland

Stuart

Smith

+353 (0)1452

3432

[email protected] (Chromatography

consumables)

Biosensia Dublin

Ireland

Diarmuid

Flavin

+353 (1)716 3650 [email protected] (In-vitro

diagnostics/point-of-care)

Audit

Diagnostics

Cork,

Ireland

Michael

O’Donovan

353 (0)214533

652

[email protected] (Liquid

ready to use reagents)

Opsona

Therapeutics

Dublin

Ireland

Jeremy

Skillington

353 (0)18968499 [email protected] (Modulating

human innate immune system)

IdentiGEN Dublin

Ireland

Ciaran

Meghen

+ 353 (0)1 677

0221

[email protected]

(DNA traceability solutions food)

EnBIO Dublin

Ireland

Joe

O’Keeffe

+ 353 (0)1 525

3305

[email protected] (technology for

medical implant surface modification)

Embricon Ltd Galway,

Ireland

Marto

Hoary

+ 353(0) 91

585599 [email protected]

(clinically identified opportunities into

commercially available products)

Berand Ltd. Dublin

Ireland.

Andrew

Foley

+353(0)17163540

+353(0)17163542

[email protected]

(autism & obesity/algae)

Biotrin Dublin,

Ireland.

Mr.

Desmond

O'Leary

+ 353 (0)1

2831166 [email protected]

(diagnostic tests for novel viruses)

180

Table 3.10 Results of N.P. Company Telephone Interviews: This table contains

brief summaries and main points of the interviews conducted with the CEO’s of

selected Natural Products SME’s.

COMPANY COMMENTS / NEEDS IDENTIFIED CyberColloids Ltd

Areas that need to be addressed included development of entrepreneurship,

business angels, and finance. It was challenging to access research groups and large

companies and partnership with IT’s were needed. Networking was important but

there was a fear of collaboration among Irish food SME’s. Shannon ABC was not

helpful and difficult to engage. Need to look at Biomass and Biorefineries and

anaerobic digestion. Brainstorming and forward thinking were needed.

Spanish Point Sea-

Vegetables

Funding was an issue as was the need to move to online sales and expertise in E-

Marketing. Technology was needed for testing nutritional value in seaweed and

extraction of nutrients from seaweed.

Lo-Tide-Foods Having invested €200,000 and built an ISO standard facility the company could not

another €50,000 to continue their business plan. The company has an operating

facility in Denmark where dealing with government is more favourable unlike

dealing with Irish government officials. The company exports seaweed to

Denmark, Sweden, and Japan. The company was unable to access technology to

extract fibre from seaweed at NUIG. Seamus would like to extract MSG from

seaweed because Irish seaweed contains a much healthier form of MSG. Japan uses

vast amounts of MSG in cooking especially soups. Due to the tsunami, Japans

coastline is contaminated and will remain so for the next 100 years. Seamus says if

he could attract more capital, he could employ up to 100 people locally, or have

access to necessary technology. He has not found E.I. helpful and the banks only

play lip-service, and he does not want to see another consultant anywhere. Seamus

has used €5,000 innovation vouchers from NUIG.

Glasrai Mara Port

Lairge

The company has difficulty accessing technology to extract nutrients present in

seaweed. E.I. has not been helpful because the company is located in the Gaeltacht

he is forced to deal with the regional authority Udaras Na Gaeltachta who has not

been very helpful. The company has tried to deal with pharmaceutical companies

but found privacy and protection of I.P. a huge issue.

AlgAran Ltd

Analysis is expensive and difficult to access and results are not standard from one

facility to another. AlgAran have huge demand for seaweed from foreign

companies but cannot meet the demand due to lack of investment in technology and

expense of acquiring such services. AraMara are selling out to Canada or France.

This will ruin the Irish Seaweed industry as the seaweed will not belong to Ireland.

Ireland’s seaweed is the best in the world, not polluted, and the industry should be

developed. Government don’t listen to SME’s and E.I. can’t help because we are

forced to deal with Udaras Na Gaeltacha. Japan’s seaweed industry is

contaminated; Japan is buying seaweed from France because Irish seaweed is too

expensive. AlgAran has packaging technology, and offers service to other

companies, making it a potential CRO/TCF but the industry needs reliable

inexpensive analysis.

Ri Na Mara The main issue identified was lack of funding. The company is forced to rely on

Udaras Na Gaeltacha because B.I.M. has pulled funding to the seaweed industry

and Board Bhia doesn’t help with funding. There is no support for R&D.

Blath Na Mara

Funding is a big issue and the company doesn’t bother with Udaras Na Gaeltachta,

not worth the effort. We can’t meet demand due to lack of facilities and our

business could improve if we could access new technology. Efficient effective

seaweed drying machined are difficult to access. We need to develop on-line-sales

and E-marketing. The Japanese market wide open but can’t take advantage//France

has best technology.

New Vista Healthcare

Legislation dictates that his company do “Regulated Chemical Testing” but there

are no guidelines as to exactly what is needed. There is a need to access validation

technology because products are not validated, BIM will not approve products.

Technology transfer is a big problem; we are 20 years behind other countries. We

need access to high quality testing facilities.

181

Arramara Teoranta

There is a need for networking to get people together to break down barriers.

Company needs added value; company used to export dried seaweed to Scotland

for worldwide distribution. The Scottish link is gone and now the company is 100%

owned by Údarás na Gaeltachta. The company needs a lift, i.e. produce new

products and find a niche in the market. Company has collaborations with I.T.

Tralee and NIUG, for research. Reports produced but knowledge transfer between

HEI and company needs interpretation or tweaking towards end-product. Need

focused technology to develop new products for company to move forward. The

company needs to work closely with researchers and need technology offer and

better knowledge transfer. Next step is production of liquid seaweed as opposed to

dried seaweed, but other companies are years ahead in development, technology

and experience.

3.11 Local Technology Meetings Organized

Towards 21st Century Toxicology

The collaborative conference organised between the ShareBiotech consortium and

the Irish Society of Toxicology (IST) was hosted in Athlone Institute of Technology

(AIT) on the 3rd

and 4th

of November 2012. The conference represented a new

collaborative model between the IST and the AIT associated EU project.

ShareBiotech was devoted to collecting information and proposing new strategies for

developing and managing core technologies within biotechnology – this includes

organising advanced research technology meetings. Toxicology is a multi-domain

discipline, but a major component embracing cell and molecular biology falls within

biotechnology. As a discipline focused on chemical and material evaluation to ensure

safety, toxicology has traditionally been quite conservative regarding the

development, validation, and adoption of new methods and technologies. Towards

the end of the 20th C, there was a wide appreciation that toxicology would inevitably

have to advance considerably in the 21st C to ensure human and environmental

safety and minimise failures on the part of the pharma and medical device sectors –

the label of 21st C toxicology has therefore been widely deployed in Europe, the US

and Japan.

To ensure this conference seriously addressed, presented and provided a forum to

discuss critical elements of current toxicology failures and emerging solutions, it was

necessary to attract a number of key researchers and providers from across the world.

These included:

Prof Thomas Hartung of John Hopkins University Bloomberg School of Public

Health and former head of ECVAM (European Centre for the Validation of

Alternative Methods) who is currently involved in the implementation of the US

182

National Research Council vision document “Toxicity Testing in the 21st Century –

a vision and a strategy”. Dr Eckhard von Keutz, the Senior VP, Head of Global Early

Development, in Bayer Healthcare, responsible for their toxicology and committed

to effectiveness and efficiencies. Dr David Dix, Deputy Director of the National

Centre for Computational Toxicology in the US, which is a member of the US 21st

C Toxicology programme. Dr Richard Brennan of DABT of Thomson Reuters in

San Diego in the US is involved in development and application of software under

systems biology for applications in toxicology. Prof Richard Walmsley of Gentronix

Ltd., and the University of Manchester has developed new approaches for

Genotoxicology screening and Dr Annette Bitsch from the ITEM Fraunhofer in

Hannover in Germany, is an expert in regulatory toxicology. Dr Sophie Rocks of the

University of Cranfield in the UK has a history of evaluating approaches to address

crucial nanotoxicology problems, and Dr Olivier Kah, a Research Director in the

University of Rennes, France has developed remarkable transgenic animal models.

Paul Tomkins, covered AIT research that has been devoted to the development of 3D

cell culture models, which are accepted as a next generation approach for in vitro

partial, tissue simulation. The conference also hosted presentations by AIT and UCD

researchers and posters from researchers in AIT, NUIG, and UCD. Vincent Walsh a

member of the AIT ShareBiotech team, along with Dr Paul Tomkins, gave a

presentation entitled “Core Facilities Impact on Toxicology” covering the overlap

between toxicology testing methods and modern biotechnology in-vitro analysis

methods, and the possible impact of the ShareBiotech transnational network of

Technical Core Facilities on the toxicology sector.

The conference was attended by ~ 80 people from H.E., government agencies and

industry. Charles River, a major international toxicology CRO contributed to

sponsorship of the meeting. There was a vocal attendee view that the meeting had

permitted the dissemination of new, important, and exciting data and information.

Intrinsic deficits in some core toxicology were clearly defined and the need and basis

for mechanistic focused solutions presented. The application of substantive robotic

technology and generation of complex multivariate data demanding sophisticated

systems biology type analysis presented real evidence of accurate predictive

toxicology over a very short time frame with world-wide multi user access. At the

beginning of the conference, the notion of 21st C toxicology may have been

183

considered rather aspirational, while at the end it was effectively considered

achievable.

Developing a Natural Products Business

The LTM was held on September 3rd

2012 at the Midlands Innovation Center, AIT.

The objective was to develop, facilitate and engage with SME’s in the Agri-bio/

Agri-food sectors. The LTM was organised by the Office of Research at AIT and

held in the Midland Innovation and Research Centre. In addition to the academic

meetings, attendees toured the research facilities at AIT. It is hoped that such

networking will be followed up, and exploited, to enable greater cross fertilisation of

research themes.

It was identified during telephone interviews that the small N.P companies had

difficulty attending meetings due to low staffs numbers and company commitments;

therefore; the meetings were videoed and posted on YouTube under “ShareBiotech”.

Although 68 invites were sent to the sectors of interest, a total of 12 people attended

the meeting; however; a total of 355 hits were recorded on YouTube. The attendees

came from Ireland, UK, and Spain.

Five speakers presented on their technologies, these being:

Ross Campbell, (Cybercolloids Ltd.) spoke on applications of hydrocolloids

in Food.

Ines Del Campo (U. Navarra) outlined her facility’s biofuel production

capabilities.

Simon Faulkner (Ocean Harvest Ltd.) spoke of how his company exploits the

rich resource that is the Atlantic Ocean.

Margaret Patterson (A.F.B.I., N.I.) showed how her institute is developing

high pressure technology to produce novel food stuffs.

Paul Murphy (NUIG) explained how nature provides a rich pallet of natural

products and the hurdles to their commercialisation.

While the opportunities for networking were many, the critical issue remained the

means by which live commercial projects could be cycled through so that a rapid

viable response to the SME was elicited. The assembly of a Knowledge Toolbox

comprising the technologies outlined in the talks could be quickly brought to bear to

meet these SME’s needs. For this to happen require a recognised forum that allows

dissemination and discussion of such technology needs. It was suggested that

184

laboratories could combine their offerings for the advancement of solutions

benefiting SME’s.

The actions suggested during the meeting that might be beneficial to SME’s were as

follows

1. Continue to probe the biotech and agri-bio sectors for means by which

TCF’s can better satisfy R&D needs.

2. Highlight and facilitate access by SME’s to TCF’s.

3. Identify R&D funding streams accessible to SME’s

4. Ensure project roadmaps, timelines and budgets are explained upfront.

5. Put in place a process for managing expectations

Decontamination Technology Needs

An LTM was held on 4th

of September 2012 focusing on the theme of

“Decontamination Technologies”. The objective was to facilitate and engage with

SME’s in the agri-bio/agri-food sectors. A total of 68 invitation letters were

disseminated to organisations in this domain and related domains. On the day of the

conference, 13 invitees attended from a variety of sectors i.e. HEI’s, Industry, and

research institutions from France and Ireland. The meeting was videoed and posted

on YouTube for maximum dissemination.

Considering technology gaps and needs identified in telephone interviews and in the

Activity 3 interviews (companies, research institutions, TCF’s), five speakers who

are experts in their areas gave presentations outlining their technologies and access

policies. The speakers were:

Jim Lyng (UCD) spoke of the application of pulsed electric field in the

disinfection of perishable foods.

Colin Hill (UCC) equally outlined how bacteriocins were being exploited for

food preservation purposes.

Thierry Benezech (INRA) highlighted the means by which a sterile

production plant could be achieved. INRA is the leading European

agricultural research institute and the second largest public research institute

in France.

Dr. Mary Garvey (AIT) showed how Pulse UV was being employed to

ensure safe potable water.

Dr. Kieran Murray (AIT) gave a talk on opportunities with Gamma-

irradiation.

Euro Science Open Forum (ESOF)

In 2012, Dublin was the European City of Science and hosted ESOF2012 from the

11th

to the 15th

July. The event brought together over 5,000 scientists, business

185

leaders, government officials, policy-makers, and international scientific media

representatives to discuss the best of European science and to address all of the

current major global scientific challenges, including Energy, Climate Change, Food,

and Health.

ESOF is an interdisciplinary, Pan-European meeting held under the auspices of

Euroscience which aims to showcase the latest technologies in science, promote a

dialogue on the role of science and technology in society and public policy and

stimulate public interest in science.

The event is unique in the diversity of delegates who attend; top researchers from the

natural sciences, social sciences, business leaders, senior EU and government

officials, as well as the international scientific media.

ShareBiotech and AIT rented a science booth for a period of 3 days to disseminate

the ShareBiotech project and showcase technologies and services available to

industry in the Bioscience Research Institute (BRI) where the aim was to engage

industry and partners in collaborative projects. A presentation entitled “Analysis of

Biotechnology Cluster Drivers Incorporating the ShareBiotech Project” was

delivered by Vincent Walsh. Over the 3 days there was much interest shown in the

ShareBiotech model and over 400 visits to the science booth were recorded. Each

visitor was given an information pack detailing the project and TCF’S open for

business in AIT.

3.12 The ShareBiotech Audit of Private Company and the

Bioscience Research Institute AIT

As part of Activity 4 in ShareBiotech, the collective bioscience and polymer research

facilities were defined in detail and subject to an analytical audit to identify potential

operative issues Prof Dominique Philippe Martin, Dr. Arnaud Devillez, and Dr.

Audrey Tremeau of IGR-IAE Rennes conducted the TCF audits of assigned facilities

of all partners and issued a long term diagnosis at the University of Nantes meeting

in April 2012. The analysis took cognisance of fundamental variables that influenced

viable and sustainable operation – status of core facilities, projects, funding, human

resourcing, access and utilisation rates, and cost models. The final form of analysis

186

presents data in two forms, action and status flow chart and a table of linked

strengths and weaknesses.

ShareBiotech Audit Results Private Company

Figure 3.93: Spider web graph representing the results of the ShareBiotech audit.

Source:TechToolNov™ Audit

Interpretation of the Spider graphs

Opening of potential market segments

Score of 100: market segment is clearly identified for at least one offer of the TCF.

This offer helps to differentiate clearly the core competence of TCF from other

competitors in the same market segment. The criterion also takes into account the

opportunity in the field, the IP portfolio of the TCF and the position of the TCF on

the market segment.

Score of 0: no market segment identified for the offer of TCF.

Intensity of competition

Score of 100: a lot of competitors are present in the identified market segment. It is

very easy for customers to find other public or private actors offering the same

products or services.

Score of 0: monopolistic situation of the TCF in the identified market segments. It is

difficult for customers to find other providers.

Legitimacy of TCF

Score of 100: TCF benefits from a wide recognition in the academic environment.

This is a support for research programs. Human resources are associated to

publications signature. Furthermore TCF has a current practice of supplier/customer

relation with quality procedure.

Score of 0: It is very difficult for the TCF to benefit from a recognition mark in the

academic field and there is no practice of supplier/customer relation

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Availability of human resources

Score of 100: human resources have time for setting up new projects more or less

close to the core competences of TCF.

Score of 0: human resources have no time for developing new projects and to take

time for the supplier/customer relationship.

Availability of material resources

Score of 100: equipment is available for new services and/or new partnerships. The

equipment is maintained and upgraded in order to propose the best technological

offers in comparison with the latest technological development proposed by the

builder of equipment in the field. Association with equipment builder can be a

positive appreciation for this criterion.

Score of 0: there is no availability for using the equipment. There is a risk of

obsolescence of equipment despite maintenance and upgrading. We also look at the

risk of future rival technology proposed by the equipment builders.

Knowledge of functioning costs

Score of 100: all the resources mobilized for performing the service, technological

developments, supporting research programs are systematically evaluated and well

known.

Score of 0: there is no knowledge about the cost of resources mobilized for the use

of TCF resources.

Ability for recovering costs

Score of 100: the business model allows recovery of all the functioning costs. There

is no partial price computed. Complete cost is the basis of negotiation with

commercial partners.

Score of 0: standard practices of TCF are free access and free service. It is

impossible to integrate the cost of mobilized resources in the price of TCF offers.

Communication strategy

Score of 100: all communication tools are implemented: catalogue of packaged

offers, website, and professional brochure

Score of 0: no communication tool for prospects.

Table 3.11: SWOT Analysis of private company resulting from the TCF audit

Strengths: Certification and quality proceeding; Marketing and communication;

Financial ROI with benefits in short term; Best state of the art technologies and

equipment; Links with Intertek

Weaknesses: Relationship with academic research teams even for financing of

applied research projects; Ability to regenerate portfolio of research activities High

utilization rate of resources; Protection strategy

Opportunities: New norm as REACH

Threats: Future rival technologies identified (long-term)

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Table 3.12: Audit Short-term Recommendations for Private Company recommended

by TechToolNov

Short Term Recommendations Knowledge and cost mastering Nothing

Internal Process - HR To develop and reinforce links with research

teams

Develop partnership contracts with equipment

builders

Communication and legitimacy of TCF To participate in the standardization process in

the field of core competencies of TCF

Market To develop specific offers for SME’s

Audit Bioscience Research Institute (BRI) AIT Results

Figure 3.94 This spider graph represents the BRI AIT audit results

Source:TechToolNov™ Audit

Table 3.13: SWOT Analysis BRI resulting from the TCF audit

Strengths: Diversity in the portfolio of activities; Links with research teams; IP

portfolio with private assignees; Leadership in research programs Weaknesses: Age of some equipment; no user on the management committee

Opportunities: Low rate utilization of equipment; To develop some activities with

SME’s; To use IP portfolio to generate royalties

Threats: Turnover of human resources; Ability to have some grants for PhD

students

The subsequent risks and strengths analysis was largely in keeping with internal self-

analysis of the research infrastructure, human resourcing, business model, and

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research and service projection. Bioscience at AIT had grown significantly over the

past 20 years, but the institute is relatively small and had not embraced a comparable

understanding of research and education H.E., needs, standards, academic autonomy

and a non-market driven future.

Table 3.14: The recommendations of the ShareBiotech audit of the BRI

Short Term Recommendations Knowledge and cost mastering Nothing

Internal Process - HR Integrate customers into the committee

Develop partnership contracts with technology

suppliers to offset technology obsolescence

Consider hiring PhD students from SME’s/Firms

Communication and legitimacy of TCF Organize workshops with leading SME’s/Firms

Market To develop specific offers for SME’s

Figure 3.95: Bioscience Research Institute AIT analysis in terms of flows. Source: Tech

ToolNov™ audit

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The predicted status is that of a Centre with a viable scale of capable researchers with valid

academic and selected business outputs, but suffering from poor governance model,

inadequate equipment sustainability and an insufficient number of core projects (Figure

3.94).

Audit results and recommendations for the AIT Microscopy TCF

In a typical imaging facility, much of the equipment is I.T. connected for image

capture and processing. This was recognized as a deficit in many of the current AIT

facilities. In an institution where microscopy is a priority and ample funding is

available, additional equipment will include duplicate systems. A collection of such

equipment requires maintenance, and thus the operational costs of an imaging

facility are considerable. A major expense is the maintenance contract on the larger

systems. The risk is too high to operate without such support, since the repair cost of

a single major breakdown can exceed the cost of a yearly service contract.

Figure 3.96: Projected optimal staff domains for the AIT Microscopy TCF

ACTIVITY TASKS

Researchers in management roles will be permanent with relevant profile & history; Technician support; Annual maintenance budget; Formal training provided; System part of technology management structure; Dedicated IT support

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3.13 Software for TCF management

The audit looked at Laboratory Information Management Systems (LIMS) as an

aspect of professional organisation or the BRI. Historically, LIMS were developed

to manage experimental results that related primarily to quality testing, sample

characterisation, and tracking. The audit suggested possible LIMS that could benefit

the TCF. A list of LIMS is shown in Table 3.14.

Table 3.15: List of selected laboratory core facility management systems i.e. LIMS

Software Type URL

OpenCoral Open source http://opencoral.org/

Idea Elan Commercial http://www.ideaelan.com/public/index.aspx

Cirklo Open source http://www.cirklo.org/agendo.php

iLab Commercial http://www.ilabsolutions.com/

BookIt Commercial http://bookit-lab.com/

Stratocore Commercial http://stratacore.com/

3.14 Implementation of the CIRCA Report recommendations

AIT/BRI as part of the ShareBiotech consortium engaged the professional services

of The CIRCA Group to develop a report on the Technology Core Facilities in the

Athlone Institute of Technology. A draft report was delivered on the 25th

of

September 2012. AIT offered a combination of expertise in the defined areas, and

access to relevant equipment. The report found that the accumulated value of the

equipment offer in the BRI AIT would be very difficult and expensive for any Irish

enterprise or organisation to develop a similar resource internally. AIT therefore

offered a centre of competence which was unique in the midlands region and

available in only a limited number of facilities nationally.

The AIT offer was for customized access to the equipment and expertise base.

Depending on need, clients could use the equipment and expertise within the TCF to

whatever extent was required for their needs. At its simplest, this included short-

term basic consulting by TCF staff without use of equipment; or direct use of TCF

equipment by client staff without use of TCF expertise. However, the major

objective was to conduct long-term collaborative R&D projects which would use a

range of AIT expertise and equipment.

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The TCF plan was seen in the context of AIT as an educational establishment whose

primary purpose was the training and education of primary and post-graduate

students in technology fields. The long-term aim of the TCF was to create a

resource of activity which enhanced the reputation of AIT as a centre for research

and training in the midlands region, and which also developed collaborative linkages

between AIT and regional and national industry. Such linkages supported the

mission of AIT, which was “to contribute to the technological, scientific,

commercial, economic, industrial, social, and cultural development of the state, with

particular reference to the midland region, through the provision of a balanced

education to the highest international standard founded in accessibility, mobility,

collaborative links, and research excellence.”

The report suggested that the provision of the services must therefore either directly

or indirectly support this mission. Direct benefits could include participation of

students in research or service projects; while indirect benefits might include the

enhancement of AIT staff knowledge through their participation in such projects; or

provision of funding which could be used for educational purposes. A further

potential benefit was exposure of students to real industrial issues, and exposure of

potential employers to AIT students. The report noted that AIT was not a

commercial operator and was not solely interested in the provision of commercial

services. This qualification could impact some of the terms and conditions under

which the services might be made available.

Target Market

The report stated that the target markets for the service were (a) companies which

required technical services for their product development, for product accreditation

or for other technical purposes; and (b) research organisations and academic

research groups which required TCF inputs to their research projects. The BRI-TCF

had relevance in many other sectors including diagnostics, cosmetics, veterinary

products, animal feed etc. It also had significant relevance to the industries which

supplied reagents, raw materials and some of the types of equipment which were

used by the pharmaceutical, food, agriculture, and medical device sectors.

The competition for AIT in this market was primarily from other Academic institutions.

However, it was almost certainly the case that no single Irish competitor had precisely the

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same combination of skills and equipment as the TCF. Several, however, offered some of

the individual services listed above. For instance:

Microscopy Services were offered by several Irish groups coordinated by the

National Bio-Photonics and Imaging Platform Ireland (www.nbipireland.ie).

Cell culture and Bioreactor-related services were offered by the National Institute

for Bioprocessing Research and Training (NIBRT), by Shannon ABC and others.

Scanning Electron Microscopes were available, and available for collaborative

research and for services, within many institutions including:

Institute of Technology Tallaght Dublin (ITTD)

University College Dublin (UCD)

University of Limerick (UL) M

Waterford Institute of Technology (WIT)

Athlone Institute of Technology (AIT)

Dublin Institute of Technology (DIT)

Trinity College Dublin (TCD)

Galway-Mayo Institute of Technology (GMIT)

In short, AIT was not a unique provider of any of the services offered, and the report

recommended that it must differentiate itself from the competition by other factors,

such as the quality of service, the convenience of its location, or the terms and

conditions offered.

Future Development

The report stated that while the TCF services were currently fully in line with current

technology needs, they would not remain so indefinitely. It also noted that

continuing investment must be made in the equipment base, and in the skills of the

associated researchers. Some of this investment would come from basic and applied

research grants obtained by BRI and AIT from non-TCF activities. However, it will

also be necessary to develop a plan for equipment replacement and enhancement,

and for skill development and acquisition. This process must be done in liaison with

wider AIT skill and equipment needs.

Management & Staffing

The CIRCA report found that the TCF management had several internal challenges

which needed addressing within the structure devised for its operation. These

included:

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1. The ShareBiotech unit shared space and equipment with other services

operated by AIT (Chemistry Platform, and Contract Analytical Services) and

must therefore had close liaison with these services so as to ensure optimal

access to equipment for all parties.

2. Training of staff and students on all technologies needed to be sustainable

and on-going

3. The TCF would not have its own marketing staff. Promotion would be

conducted both by TCF-associated staff and also by AIT Research Office.

Clear information on the current TCF offer must be available at all times as

availability of staff and equipment will change.

4. TCF Equipment and expertise will also be required by AIT staff and students,

whose needs are a priority.

The report suggested that the management must therefore reflect the need for

extensive liaison with other groups within AIT, and also the need for external

consultation on sectoral, regulatory and technology trends which will affect the

relevance and value of the TCF offer. This was obviously not a revelation.

Accordingly, a management structure was proposed which had the following

elements:

Management Committee:

This is the central management group for the TCF, to which the Director reports. It

would meet on a monthly basis. The suggested membership was:

Head of BRI (Chair)

TCF Director

Representative of AIT Management

Member of Research Office and/or Midlands Innovation and Research Centre

Steering/Advisory Committee

This group would be designed to provide guidance to the Management Committee

on external issues affecting its activities. It would meet on an occasional basis and

discuss issues, including (a) Industry developments or trends which may become

threats or opportunities (b) Changes in equipment, regulatory environment,

competitors, funding regimes etc. It would also monitor and advice on the terms and

conditions for TCF services, collaborations etc. The membership should include:

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Chair of TCF

TCF Director

Representative of each relevant sector (Food, Pharmachem, Device) ideally

from within a regional company

Equipment expert

Hub Management Committee

It was suggested that the overall management of some issues could not be effectively

conducted at TCF level. These included issues which affected all of the equipment

and staff in the building (e.g. Health & Safety; Training; Equipment maintenance,

replacement and use scheduling etc.). This group could also usefully consider

issues related to the marketing of AIT services. Much of this was already in place,

such as joint promotions, websites, company visit monitoring etc. These issues

should be discussed centrally within the Hub with inputs from all of the operators

and interests involved. The TCF should have a formal input to this committee or

group.

Figure 3.97: BRI Management Organization Chart suggested in the CIRCA Report

The specific roles within this are:

TCF Director: General Management of TCF

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Unit Head: Manager of a specific technology unit e.g. Toxicology, BioReactors

and for coordination of activities related to provision of related services. The Unit

head will be the main contact person for ongoing projects.

Laboratory Staff: Scientists designated to specific projects within each unit. These

may be part-time or full-time commitments depending on the nature of the project.

Equipment Manager. It was understood that a person was recently appointed to

coordinate all of the equipment within the Hub, and to ensure its maintenance and

use scheduling. This person would be a fundamental part of TCF activities and

would report to the TCF director in relation to those items of equipment which were

solely used by the TCF. Reporting structure in relation to equipment shared with

other internal users should be addressed by the Hub Management Committee.

Development of organisational model

The diagram below indicates the main organisational relationships of the TCF, and

the partners and associates whose needs must be considered:

AIT: the staff of the TCF were academic members of AIT primarily engaged in the

education and training of students. Interaction with AIT was fundamental to its

operation and was required in coordination of equipment and facility needs (ideally

through a ‘Hub management committee as proposed above); in coordination of

training of AIT students (through active involvement of AIT staff and students in

TCF activities); in promotion of TCF services (through active involvement of AIT

research office staff); and in administration and staffing of TCF (through active

interaction with AIT budget and HR departments).

ShareBiotech: ShareBiotech as a project to bring multiple Atlantic Region partners

together to develop methods to address some major biotech deficits, it may have a

positive impact over the coming years – this will obviously be raised in Discussion.

Midlands Gateway Research Campus: The creation of a Midlands Gateway

Research Campus was a significant component of the strategic plan for AIT (2009-

2013). It was being developed in partnership with regional and national research

and industry stakeholders, it will house high-tech industry R&D space, phase two of

the Midlands Innovation and Research Centre (MIRC), as well as an auditorium. It

was also anticipated that the Research Campus will host the Institute’s existing three

research institutes – the Software Research Institute (SRI), the Materials Research

Institute (MRI) and the Bioscience Research Institute (BRI). The Research Campus

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will be the focus of AIT’s submission to PRTLI V. Interaction of the TCF with this

initiative was another consideration for TCF management

Figure 3.98: Main organizational relationships of the TCF, and the partners and

associates whose needs must be considered

Clients: If a TCF was to be successful as an outreach activity, it must be aware of

client needs and sensitive to changes in these needs. This could be achieved through

active involvement with existing clients; and through appropriate interaction with the

proposed Steering Committee.

Public Research Funders: It was very unlikely that the TCF was capable of

sustaining itself from income generated from client activities. The future

development of the TCF, including skills development, equipment renewal etc. must

be subsidised by research funding from the usual range of public research funders

(EI, SFI, EU etc.). The TCF must therefore be continually aware of the opportunities

available for public funding and of the changing demands of public funding agencies

both in terms of thematic areas, and also new funding mechanisms (e.g. Innovation

Vouchers and Technology Gateways being recent examples of changes in funding

mechanisms).

3.15 The Darcy Report

Darcy Consultancy Services were contracted to analyse the potential of the BRI to

engage industry in collaborative projects. The consultancy was acting on the

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TooltechNov diagnosis and short term recommendations for Technological Core

Facilities selected in the frame of European project ShareBiotech. The report

highlighted two areas for corrective action.

1. The age of some of the equipment

2. The lack of users in the management committee

Following on from these audit findings and having discussed the scope of the

equipment and the potential for utilization of the existing equipment the following

structure was developed as an indication of the type of applications which could be

performed with the existing instrumentation. (Figure 3.95)

Figure 3.99: Scope of service provision in relation to the BRI - TCF Source “Adapted from the ShareBiotech Darcy Report” 2013

The Darcy Report proposed a TCF model based on existing AIT personnel,

expertise, and equipment and was based on commercial potential given the

requirements of medical device companies. The model was also applicable for

Pharma companies as well as those companies operating in the diagnostic space.

Additional specific analytical services may be requested from companies as the

service provision develops and this may require the purchase of instrumentation to

meet this need, but the report found that there was sufficient resources present in

AIT to launch an initial service offering that was attractive to a reasonable number of

customers.

The report also concluded that the success of the proposed TCF would be

reasonably dependent on the regulatory certification process and investment in this

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from AIT as while initially some service offering may be provided outside this

scope, in order to capture a customer for the longer term the expectation will be for

the service to be certified. Most medical device companies operate a quality

management system compliant to the requirements of ISO 13485 which is a fully

operational quality system covering all elements from design control, product

realisation, sterilisation, and delivery. However, AIT would not be operating as a

manufacturer of finished products, the performance of contract R&D work could

benefit from the implementation of a design control system (Figure 3.96) that would

be compliant to ISO 13485 while not necessarily certified. This level of compliance

would provide customers with a level of assurance that they would feel comfortable

with given the compatibility of AIT’s system with their own internal processes. An

outline of the typical design control module is shown in (Figure 3.96). The complete

report can be viewed in Appendix 21.

The report suggested that the initiation of an R&D project with an internal or

external partner could be constructed in such a way as to comply with a design

control system which would be tailored to meet ISO 13485 (EU Specific) and also

FDA requirements. As a consequence the availability of SOP’s to regulate the design

and development process would allow AIT’s service provision to stand out as unique

as this level of compliance while not difficult to achieve, is not routinely employed

and would create a niche for AIT.

Figure 3.100: Accreditation Model suggested by CIRCA for the BRI compatible to

ISO 13485 while not necessarily certified. (Source: Adapted from “The ShareBiotech Darcy

Report” 2013)

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3.16 Expert Interviews

A range of highly regarded experts in the Biotechnology sector and related areas

such as networking, cluster management and development, services, a start-up CEO,

were identified in Canada, the UK, Germany, Brussels, and Ireland, and

subsequently asked if they would partake in interviews directed towards their area of

expertise. Face-to face interviews were carried out with Mary Skelly; CEO of

Microbide in Ireland, Derek Jones, director of the Babraham Institute in Cambridge,

UK; Dr. Martino Picardo, MD of Stevenage Biocatalyst, Hertforshire, UK; Tony

Jones, CEO One Nucleus, a cluster networking organization located in London, UK;

And Professor Horst Domdey, director of the BioM Cluster in Munich Germany. A

telephone interview was conducted with Dr. Claire Skentelbery, CEO of the Council

of European Bio Regions (CEBR) in Brussels and written interview was conducted

with Dr. Mario Thomas, director of the Ontario Centre of Excellence (OCE) in

Canada. The questions were designed to target the expert’s area of knowledge while

also encompassing a generic element. The questionnaires were emailed to all

respondents approximately one month prior to the interviews taking place. This

broad range of experts from different jurisdiction’s identified successful models of

biotechnology clustering and endeavored to map their route to success. It was hoped

that valuable lessons could be learned and adopted into the Atlantic Area

biotechnology sector to progress the development of biotechnology and address the

imbalance that existed between the Atlantic Area and the rest of Europe.

A short profile of each expert is given in this section followed by a summarized

version of the Questions and Answers. All interviews were digitally recorded and

transcribed verbatim. The full transcripts are available on request from the author.28

The first interview was conducted with Tony Jones of One Nucleus. One Nucleus is

a membership organisation for international life science and healthcare companies. It

is based in Cambridge and London UK, the heart of Europe’s largest life science and

healthcare cluster. It has been established that networking is vital in any industry and

even more-so in the biotech sector as investors and stakeholders are in constant

demand due to the expense and length of time it takes to get a drug or innovation to

market. One Nucleus organises conferences and other events designed to bring

28

[email protected]

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people in the biotech sector together. Tony believes that it is vital to get people

talking to each other, and said the most important part of a conference is the coffee

break, where people can interface in an informal manner. Derek Jones of BBT had

the same view as Tony and stressed that creativity was probably one of the best

assets in an employee. Derek believed in collaboration among companies and part of

the tenancy agreement in the Babraham Institute was that companies would work

together where possible.

A two and a half hour face-to-face interview was conducted with Professor Horst

Domdey in Munich at the BioM Cluster. Professor Domdey explained how a change

in federal funding policy a declining pharma sector resulted in HEI’s forming

collaborative links with industry which helped the birth of Germany’s biotech

industry. Horst did not agree with HEI’s providing TCF’s unless it was a niche area

and could not be accessed elsewhere because this constituted interference with the

market. The German Biotech industry evolved mainly as a result of sustainable

government funding and private investment. Martino Piccardo who successfully

developed the Manchester bio-cluster creating 1600 jobs over 10 years applied a

policy of “Open Access” to Stevenage Biocatalyst in Cambridge London. Open

Innovation, also known as external or networked innovation, is focused on

uncovering new ideas, reducing risk, increasing speed and leveraging scarce

resources. With a better understanding of “what is out there”, a company is able to

lower risk by combining external capabilities with internal innovation resources. The

old question of “Why reinvent the wheel?” clearly applies, as Open Innovation

enables a company to connect with someone who has already developed the

technology in need or who is further along the development path. During the

interview Martino stressed the theme of “not re-inventing the wheel” and focusing

on what you were good at. Martino suggested that in his opinion, Ireland’s expertise

lay in the food sector. Mary Skelly believed that Irelands model or the Enterprise

Ireland model of support for SME’s was not fit for purpose. That was why Mary did

most of her R&D in the US as the US model was geared towards developing and

growing SME’s with no stigma attached to failure. Mary did not believe that NIBRT

should be attached to UCD or that a national incubator should be managed by an

academic institution because they did not have the relevant experience to interface

with industry. Claire Skentelbery held the same view regarding SME’s trying to

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access academic TCF’s. Claire shared the view expressed by all the experts, that

academic organisations were driven by the need to publish papers and that a one-

size-fits-all technology transfer model did not work. DR. Mario Thomas of the OCE

believed that SME access to core facilities was vital to the development of the

biotech sector in Ontario Canada. There was consensus among all experts

interviewed on many points as shown in the results section.

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Figure: 3.101: Representation of the level of agreement between the 7 core experts

regarding 32 common theme questions as a proportion of the total of 158 questions

actually presented (inclusion of sub-questions exceeds 158)

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Figure 3.102: Representation of the level of agreement between the 7 core experts

regarding Q1 to Q10 common theme questions as a proportion of the total of 158

questions actually presented (inclusion of sub-questions exceeds 158)

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Figure 3.103: Representation of the level of agreement between the 7 core experts

regarding Q11 to Q21 common theme questions as a proportion of the total of 158

questions actually presented (inclusion of sub-questions exceeds 158)

Figure: 3.104 Representation of the level of agreement between the 7 core experts

regarding Q22 to Q32 common theme questions as a proportion of the total of 158

questions actually presented (inclusion of sub-questions exceeds 158)

Figure: 3.105: Represents the number of yes answers agreed by all 7experts

interviewed

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3.17 Profiles of Experts Interviewed

Professor Horst Domdey, BioM Munich Germany

Horst Domdey, a trained biochemist, received his PhD from the University of

Munich in 1979. He held research positions at the Max Planck Institute for

Biochemistry in Martins Reid (Germany), the Swiss Institute

for Experimental Cancer Research in Epalinges (Switzerland),

the University of California, San Diego, La Jolla (USA), the

California Institute of Technology in Pasadena (USA), and the

Gene Centre of the University of Munich (Germany), before

he became there Associate Professor for Biochemistry in

1994. In 1994 he co-founded MediGene, one of the first

biotech companies in Germany. In 1996 he successfully led

the Munich Biotech Initiative into the German BioRegions

Competition. Since 1997 he has been the Managing Director of BioM, the cluster

development and management organization of the Munich Biotech Cluster. Since

2006 he also manages the Bavarian Biotechnology Cluster.

Since 2003, he is the scientific director of the Bavarian Genome Network Bay Gene,

since 2011 the coordinator of the Bavarian Centre for Molecular Biosystems

BioSysNet. Horst Domdey is cofounder of BIO Deutschland, of the Association of

the German BioRegions and of the Council of the European BioRegions (CEBR). He

is also member of the Committee for Industry and Research in the German Chamber

of Commerce and Industry (DIHK).

In 2010 the Munich Biotech Cluster became - under his leadership - one of the

winners in the German Leading Edge Cluster Competition

Dr. Martino Picardo

Chief Executive Officer, Stevenage Bioscience Catalyst

Dr Martino Picardo is the first CEO of the Stevenage Bioscience Catalyst. With a

PhD in Biochemistry, he has more than 20 years’ experience in the pharmaceutical

and biotechnology sector and is a board member of

UKBI. Dr Picardo joined Amersham International in

1991 and subsequently went on to manage the R&D

Technology Transfer Group, based in Cardiff,

developing high throughput screening technologies for

the pharmaceutical sector. Following the merger of

Amersham with Pharmacia Biotech, he became the

Science Director for the Cardiff site, looking to acquire

and develop next generation technologies for the company.

More recently, he was Managing Director of the University of Manchester

Innovation Company (UMIC), a company set up by the university to manage all

incubation facilities. In this role, Dr Picardo oversaw its development into a venture

that housed in excess of 80 small and medium enterprises and start-up companies,

generating more than 500 jobs in the process. In addition to his role as CEO for

Stevenage Bioscience Catalyst, he is also acting Chairman for a start-up company,

SRi Forensics Ltd and has previously been on the Board of Cartesian Technologies.

He is also a non-executive Director for Queen Mary Bioenterprise Ltd.

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Mary Skelly CEO Microbide Ltd

Mary Skelly is the Senior Company Executive of start-

up company Microbide. Mary has substantial

multinational and start-up business development

experience. She has specific interest in the start-up /

formative life science company area with a focus on

intellectual property, research & development,

commercial development, contract drafting and

negotiation Chief Executive Officer Microbide Limited August 2008 – Present (5

years 7 months) Microbide Ltd is developing novel anti-microbial technologies for

use in a number of product sectors. Founder of Angel Bioventures Ltd

February 2006 – Present (8 years 1 month) Virtual consulting company for the Life

Science industry: Formed the "Bio-Angel" network of consultants to address the

specific needs of start-up and growth phase companies in the life sciences.

Founder of Irish BioVentures International Ltd

1998 – September 2005 (7 years)

Strategic Consulting, including business plan, company strategy and product

development/registrations advising new business on business plan, company strategy

and product development. Advising new businesses on business structures, alliances,

negotiation, drafting and structuring of commercial transactions. Generated new

development deals for start-up companies and universities focussed on commercial

licensing and research alliances.

T4 - Regulatory & Clinical Development

The Procter & Gamble Company

Public Company; 10,001+ employees; PG; Consumer Goods industry

1988 – 1996 (8 years)

Regulatory Manager for the analgesics and respiratory product lines within the

HealthCare Division. Managed the US interface with FDA and within the P&G

organization within these product areas.

Dr. Mario Thomas

Senior Vice-President - Ontario Centres of Excellence

Managing Director - Centre of Excellence for

Commercialization of Research

Dr. Mario Thomas is an accomplished senior executive with

impressive international credentials in the management of

innovation. He brings extensive experience filled with

achievements driving successful development collaborations

and financial ventures. With over 30 years in leadership roles

directing corporate development and commercialization, he

creates remarkable value for all stakeholders.

Dr. Thomas is the founding chairman of the recently created

International Commercialization Alliance (ICA). He holds the

dual role of Senior Vice-President, Ontario Centres of

Excellence, and Managing Director, Centre of Excellence for

Commercialization of Research.

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His previous experiences include partner in the venture firm T2C2 CEO and co-

founders of two start-up companies; and senior level positions in business

development, marketing and scientist. He holds a PhD in chemistry and a BSc from

Université Laval in Quebec City, as well as a diploma in business administration

from École des Hautes Études Commerciales of Université de Montréal. He is also a

Chartered Director with the ASC designation in board governance.

The Ontario Centres of Excellence (OCE) not-for-profit program was formally

established in 1987 with seven independent centres that evolved and amalgamated

into the Ontario Centres of Excellence Inc. in 2004. Twenty-five years ago, the

traditional economic foundation for the province, and for Canada, was shifting from

a North American-focused and commodities-based economy to one that is globally

oriented and knowledge-based. Prior to the creation of OCE, there was limited

connection between universities, colleges, research hospitals, and industry.

Consensus was that these academic and research institutions were producing quality

research that was not being utilized to its full potential by industry. OCE was

designed to bridge that gap and create productive working partnerships between

university and college research departments, research hospitals, and Ontario

industry.

Today, OCE drives the commercialization of cutting-edge research across strategic

market sectors to build the economy of tomorrow and secure Ontario’s and Canada’s

global competitiveness. OCE focuses on areas and projects that will deliver not only

the greatest economic benefits but those that will have a positive social impact in

communities across the province. OCE fosters the training and development of the

next generation of innovators and entrepreneurs and is a key partner with Ontario’s

industry, universities, colleges, research hospitals, investors, and governments. OCE

is funded by the Government of Ontario, is a member of the Ontario Network of

Excellence (ONE), and is a key partner in delivering Ontario’s Innovation Agenda.

OCE, through its Centre for Commercialization of Research (CCR) – an initiative

financially supported by the federal government – also acts as a catalyst that allows

innovative businesses to grow and achieve sustainable, commercial success and

global competitiveness.

Dr. Tony Jones, One Nucleus

After completing a PhD in Biochemistry (1992) from the University of Southampton

UK, Tony Jones undertook several years of post-doctoral research in the oncology

field, primarily with the Imperial Cancer Research

Fund taking novel neuropeptide antagonists into Phase

1. In 1977 he moved into Technology Transfer with

the Medical Research Council and moved to

University College London, where he was business

development manager at the Wolfson Institute for

Biomedical Research until November 2003.

He then took up the post of director of Biotechnology

& Healthcare at London First, managing the London

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Biotechnology Network and promotion of London’s excellence in healthcare

research and delivery, moving the LBN from a primarily inward looking London

group to an outward facing business network. In May 2010 Tony took London

Biotechnology Network into the merger with ERBI (now One Nucleus) seeing this

as the best manner in which to continue assisting their respective member companies

in developing their business.

One Nucleus is a membership organisation for international life science and

healthcare companies. It is based in Cambridge and London UK, the heart of

Europe’s largest life science and healthcare cluster.

DEREK JONES

Babraham Bioscience Technologies (BBT) has appointed Derek Jones, as its new

CEO. Formerly Chief Business Officer of BBT, Derek has brought a wealth of

experience to the Babraham Research Campus - over

20 years' in the pharmaceutical industry as both a

scientist and in business development, with first-hand

experience of establishing biomedical ventures.

Initially a medicinal chemist with Merck, Derek

moved into business and corporate development at

Chiroscience, successfully negotiating several multi

million pound licensing agreements. In 2000, he co-

founded his first company, BioWisdom, an IT/Drug

discovery company.

Derek was appointed COO at DanioLabs in 2002, a therapeutics company using

zebrafish as a model organism for drug discovery, where he grew the company from

4 to 34 employees and raised around £10 million for VC backed companies, before

selling DanioLabs to Vastox, now Summit Plc, for £15 million in 2007.

Acknowledged as a leader of research and innovation for the UK, home to both

world-class academic research and commercial biomedical companies, the

Babraham Research Campus has established itself as a hub of bioscience innovation

at the heart of the Cambridge cluster. With world-class facilities and a vibrant

research community, the Babraham Research Campus continues to

expand. Following the award of £44M to support bioscience innovation, as part of

the capital/infrastructure investment for science announced by Government in the

2011 budget, developments have been moving at a pace on the campus. The opening

of Babraham’s fifth Bioincubator Building earlier this year underscores Babraham’s

continuing commitment to nurturing early-stage enterprises and supporting

biomedical innovation in the region.

At the cornerstone of the campus is the internationally regarded Babraham Institute,

which receives strategic funding from the Biotechnology and Biological Sciences

Research Council (BBSRC) and underpins government’s national responsibilities for

life sciences research and training. Research is focussed on generating new

knowledge of the biological mechanisms underlying ageing, development and the

maintenance of health. The Institute also aims to promote knowledge exchange and

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to facilitate partnerships to translate innovative science into viable ventures.

Discoveries are commercialised through the Institute’s commercial arm - Babraham

Bioscience Technologies (BBT) Ltd - an example being the creation of the spin- out

company Crescendo Biologics Ltd.

Dr. Claire Skentelbery Council of European Bioregions (CEBR)

Claire Skentelbery started her career with a PhD in plant biochemistry, before

moving into scientific communication and marketing which in turn led to a role as

National Contact Point in FP5 for biotechnology SMEs

in the UK.

She then combined a freelance role as technical writer,

including Framework applications, with a growing role

in cluster development. She worked extensively within

the Cambridge biotechnology cluster, growing the

ERBI biotechnology network and creating links across

Europe with other clusters. Her increasing international work, led to the formation of

the Council of European BioRegions (CEBR), as a joint initiative between clusters

across Europe who wanted to work more closely together in the support of SME and

cluster development and in the defragmentation of biotechnology in Europe. She has

been CEBR Network Manager since its launch, with over 50

clusters/biocommunities in Europe working together. She combines this with her

role as Secretary General of the European Biotechnology Network, which networks

all actors in biotech, from universities, SMEs, Pharma and service providers across

all biotech applications.

CEBR was launched in 2006 through an FP6- funded project intended to network

biotechnology clusters across Europe. The project objective was to create a long

term sustainable network through which biotechnology in Europe and its support

infrastructure became more harmonised. The network was launched in June 2006

and has gathered strength and members since then, with over 100 Full and

Associated Members joining at launch.

January 2008 saw the launch of a financially independent network, supported by low

cost membership and participation in EC-funded projects. CEBR operated as a ring-

fenced activity of ERBI Ltd (now One Nucleus) in Cambridge and worked towards

sufficient strength to create a stand-alone legal entity.

The CEBR mission is to build a competitive European biotechnology sector on the

world stage through networking, collaboration, recommendations for policy and

sharing best practice between regional biocommunities.

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CEBR aims to:

Reduce fragmentation of companies and regions in Europe

Create a level playing field for company operation

Transform competitiveness to cooperation between regions

Create a platform for EU biotechnology initiatives, including EC-funded

projects

In 2013, CEBR ASBL was created in Belgium as a non-profit association and

operates in Brussels, supported by a Board of Directors from across Europe.

3.18 Main Points in Expert Interviews

The full recording of all interview answers was translated to a 100% identical written

document amounting to 92 pages and XXX words, which is accessible for a full

review at, (Ref Appendix 19). The following section in results, while including key

statements indicated by inverted commas, is a formal summary and initial analysis of

core answers and associated information.

1. Do you find that getting access to third level institution Technology

Core Facilities is difficult and challenging; and if so can you give

reasons for your answer?

Tony Jones stated that cutbacks in University funding should make it easier to

leverage their core facilities on a service level but not on an R&D level. The

universities look for a trade off in IP for the company to get derivative results and the

company needs a value proposition to collaborate with the university core facility.

Often, technology lies idle in university labs because it was bought with a specific

funding stream, e.g. cancer UK, and cannot be used for other research projects. Tony

stated that you need technicians to run services well and that university TCF’s

cannot interface with industry if they are not managed as a proper facility. This

would encourage SME’s to access University TCF’s rather than outsourcing to

external entities. University TCF’s are not run as a business and that mind-set needed

to change. This point was also highlighted by Derek Jones from the Babraham

Institute in Cambridge U.K. This made it problematic for companies to access

university cores and to change this situation was challenging especially as the

number of companies increased.

Derek stated that the challenge he had with collaborating with universities

was that they were driven by publications because that was how they were measured

and not by helping companies. Derek stated that there was a need to build a culture

that embraced supporting companies to develop innovative novel products and not

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solely the publication of the next paper; “we need to build a culture that says; it’s

the job of the universities to help companies”. He stated that universities had a

culture of not wanting to share their facilities in the UK and that universities could

run their core facilities as services, but a stumbling block to this was that they might

have to pay VAT and that was a challenge. A similar view was expressed by Martino

Picardo of Stevenage Biocatalyst in the U.K. in relation to accessing University core

facilities. He stated that the model of accessing a university core facility was a

nightmare and virtually impossible to run; “you are limited to use when it suits the

university”. Martino stated that reliance on university core facilities will never

facilitate alignment between what they can offer and what the company wants. The

model has been tried for years and it does not work; “you need to put a quasi-

commercial entity between the university and the company who speaks the business

language, is able to charge and provide quality accreditation”. “You are always just

held to ransom by Prof wonderful and his team and he will always have priorities

over others and there will never be an alignment between what they can offer and

what the company wants”. Martino stresses that work carried out in universities in

the UK is not GMP/GLP accredited and that if big pharma purchase IP from the

universities, they have to do all the work again in a quality controlled environment;

“universities could set up a service business but to grow its business globally it

needs accreditation in place”. Martino stated that there were a lot of cutting-edge

technologies in academic institutions not being utilised to its full potential that could

be shared and used to benefit SME’s but that’s not happening because the process is

too difficult. Martino was setting up a model in collaboration with GSK whereby

GSK were locating some core facilities in the Stevenage incubator and providing

technical services around the equipment in an accredited quality controlled way.

Another collaborative model was with technology vendors who were going to locate

next generation technologies in the Stevenage incubator for use by start-up

companies. Martino also cited a collaborative model in New House in Scotland

where by millions of pounds worth of cutting-edge technologies were being made

available to the growing community of SME’s at reasonable prices. “The provision

of TCF’s and access to them is necessary to attract companies into a cluster. Part of

the tenancy in Stevenage includes free access to TCF’s e.g. Flow Cytometry, NMR,

LC MS, and Microscopy etc.” Martino also stated that academic groups should not

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provide commercial services unless there is an interface with real commercial people

with real commercial experience.

Mary Skelly indicated that US International companies would use academic

core facilities if there was a business friendly model in place and that academic core

facilities should be designated as tax-free zones. However, Professor Domdey stated

that BioM, the network agency that manages the Munich BioCluster would only

support an academic core facility if it was novel and specialised, otherwise he

viewed it as unfair competition and interfering with the market. He stated that unless

the innovation or idea generated from the university; they were not interested in

developing it; it had to be invented there. Claire Skentelbery (CEBR) stated that the

Cambridge cluster developed independently from Cambridge University because the

university simply was not open for access. “The university has so much money; it

still does not have to dirty its hands with too much commercial interaction.”

“Access to research infrastructure i.e. core facilities would unlock a lot of things but

the challenges involved in that include the professionalization of access to university

cores and getting companies to engage with the universities”. The individual

academic approach is that it does not have to change if it does not want to and while

you might get academic researchers who do a great job, others will see it as

secondary to their academic work. “There are individuals who prevent access to

university core facilities to specific organisations and block the route forward to

collaboration and that comes down to the character of the person”. This is where

the key problems are and it is the attitude of a single individual that can prevent you

speaking to an entire university and that is not an acceptable business model. “There

should be much more flexibility in how universities interact externally”. Claire

related to me that while giving a lecture in Kent at a network of the sectors that

several business people indicated to her that while dealing with universities; they

were tired of running into closed doors where the formal person they were supposed

to go to or contact was non-contactable with no substitute, and this was not

acceptable from a business perspective.

Tony Jones stated university core facilities could not interface with industry without

professional management. Universities need to capitalise on their core facilities by

interfacing with industry which could reduce outsourcing by SME’s to commercial

entities, and by sharing underutilised resources you make the biotech sector more

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cash efficient. “SMEs should be able to access University core facilities rather than

outsourcing to commercial entities if the University core facilities were properly

run”. Professor Domdey would disagree with this model stating that it interferes

with the market. “We have an activity here organised by Bio Deutschland to limit

the availability and marketing of TCFs by universities, because German use of

University TCFs does not take into account technology funded by the state, so prices

are not calculated on a full cost basis. This is affecting CRO’s and in my opinion is

unfair competition by undercutting the market because a company has to write off

their technology each year”. On the other hand Horst supports TCFs in universities

for their own use, but not when they are entering the public market”. Many of

Horst’s answers were governed by this opinion.

“The objectives of the ShareBiotech project are very interesting and I support this

kind of effort because it highlights the possibilities and limitations”. As a cluster

manager, Horst said he represented the entire biotech activities of BIO-M, especially

SMEs. “But if we had a start-up company in the incubator that offers a service and a

core facility in the Max Planck Institute offering the same service at half the price we

will object to this on the grounds of unfair competition”. Also BIO-M has provided

seed funding for the SMEs.” So Horst Domdey disagrees with the Share Biotech

model of universities offering core facilities to industry on the grounds of unfair

competition and interfering with the market unless the university is offering a core

facility that is unique and not available elsewhere. “Connection to the University can

be counter-productive and we have found that if the idea did not generate in the

University, then they don’t want to collaborate. This is typical of universities”. The

mind-set that academia is solely where research, knowledge and publications are

produced needs to change. Tony jones agreed with this stating; “University look

towards academic collaborations; the intellectually stimulating side but it does not

fund itself that way”

Claire Skentelbery says for a long time she been very frustrated with the lack of

ability to go in and tell a University that it is not professional enough and there needs

to be a will to go in and critically assess their services. “By ruthlessly formalising

everything and bringing in very unrealistic expectations in terms of contracts,

publication rights, and things like that you stifle any spontaneity of research that

could be done between private and public entities”. Claire believed there should be

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much more flexibility in how universities interact externally. “Literally this comes

down to the individuals within the different parts of the University”. “Claire stated

that Cambridge University did not provide research infrastructure locally because

they were simply not open for access. Rarely have I seen members of a university

actively involved in cluster development; it’s that old Ivory Tower thing again.”

“You can’t walk into Cambridge and borrow a piece of technology”. Claire

highlighted a case of a young cluster in Israel that approached the university to act as

a specialist service provider. Acknowledging that the university had very specialised

skills they decided rather than trying to persuade the university to provide services,

they built a new stem-cell institute to provide services and allowed the university to

provide academic research in the institute. This model reverts the university into a

professionally run facility rather than trying to revert professional services into the

university. Apparently; the Israeli Institute of Nanotechnology also embraces this

model and runs professional contracts with industry all over Israel. Claire believes

that it is extremely difficult to create a professional platform in a university. In the

OCE the Centre for Commercialisation and Research (CCR) organised access to core

facilities in the areas of industry, university interactions, and single entity facilities.

2. Do collaborative models facilitate better access to TCF’s for SME’s?

Dr. Mario Thomas of the Ontario Centre of Excellence said access to TCF’s was

central to their success and that collaboration was one mechanism for facilitating

status and organisation and access to core facilities. The Centre for

Commercialisation of Research organised and facilitated collaborations and access to

core facilities in the areas of industry, university interaction and single entity

facilities. The model embraced in the state of Ontario was that the province was

managed as one network with 14 regional innovation offices and staffed by serial

entrepreneurs and stakeholders with tangible business skills and possessed the

expertise to interface with industry at the highest level for the benefit of the state.

“Support is directed towards public/private sector collaborations as well as

regional, national and transnational collaborations through our Centre for

Commercialisation and Research”. Prior to the creation of OCE, collaboration

between industry and the province’s academic institutions (universities, colleges,

research hospitals) was limited. There was a noticeable disconnect between the

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quality and quantity of research being produced and the level of commercialization

resulting from it. The role of the OCE was to bridge that gap and create productive

working partnerships between Ontario’s industry and academia. Today, OCE drives

the commercialization of cutting-edge research across strategic market sectors to

build the economy of tomorrow and secure Ontario’s and Canada’s global

competitiveness. “The OCE focuses on areas that will deliver the greatest social and

economic benefits through more and better jobs across the province”. Mario stated

that the provision and access to TCF’s is considered important drivers of technology

clusters particularly regarding start-up companies a view also shared by Derek Jones,

Claire Skentelbery and Martino Picardo.

Claire Skentelbery stated business models are evolving constantly. Access to TCFs

and selective research and development activities has a huge effect because an

investor is not interested in a company unless the company displays competency to

deliver a product.

Horst Domdey stated that a major part of the research at Bio-M was Personalised

Medicine. “We support collaborations between universities and industry. We bring

people from industry, research centres, and clinicians together for companies; a kind

of speed dating where each person does a seven or eight minute’s presentation”.

Horst stated that the most valuable work is done during the coffee breaks.

“Sometimes the important thing is not the result but its how you get there”.

3. What are your views on the US model of cluster development in

comparison to the European model? Should Europe adopt the US

model?

Claire Skentelbery stated that in terms of differing cluster structures between the US

and Europe, it depended on where you were looking. The smaller clusters are more

similar in structure to the EU in that public money is being invested enabling the

start-up of clusters around big organisations. “The US is more market-driven in its

attempts at cluster development.” Clusters have developed spontaneously because

they got more money earlier than Europe did. The level of funding you can get in the

US is much higher than in Europe enabling an SME to get further down the pipeline

before it runs out of money. US companies can get bigger faster because investors

are likely to put in large sums of money, “it’s a basic difference; it’s very

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fundamental; this is hard-core basic finance”. In the UK the government is starving

the SME’s of public finding an expecting the private sector to pick up the slack.

Claire believes that SMEs are a very large section of the biotech industry. “Europe

seems to have resigned itself to having more early stage exit companies rather than

maturing along the pipeline”. Claire also stated that the US notion of a cluster was

more about connectivity as opposed to a formal cluster structure.

Tony Jones stated that the US system was such that they supported a lot of

business plans and if 20% of them were successful and created jobs. This meant tax

revenue to recoup money. However, he believed this method could attract the wrong

businesses which would use up government incentives and when the money dried

up, the companies would close down or re-locate. Derek Jones stated “we need to

stop comparing ourselves to the US because we are not the US, we would be better

off comparing ourselves to France or Germany or Spain; we are not as big as the US.

It’s like comparing Ireland to the UK”.

Horst Domdey stated that despite all the success of the German biotechnology

industry, it is still in its infancy compared to the US and Switzerland. “Germany has

some very big biotech companies such as Octavian and Qiagen”. “Some promising

German biotech companies relocated HQ to the Netherlands, Switzerland, and

Austria because of lower tax levels. Germany’s government needs to revise its tax

laws because being located in Central Europe it is very easy to move to another

country with lower tax levels”.

4. What is needed to develop a university/industry (public/private)

collaborative model that embraces commercialisation?

OCE is a key partner in delivering Ontario’s Innovation Agenda and are funded by

the Government of Ontario and a member of the Ontario Network of Entrepreneurs

(ONE). Claire Skentelbery stated that there was a continuing struggle to

professionalise assesses to RI as well as getting companies to use those RI’s, and it’s

very unlikely to be done without some kind of financial incentive or cost reduction.

“Europe needs the political will to do it and will require implementing, rather than

trying to come to a general consensus”. “Once you’ve sought consensus from the

universities, SMEs, legal companies, you have a terrible mishmash where you are

trying to please everybody and actually end up in a very unprofessional result.”

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Professor Domdey explained how a 50% cut in funding to HEI’s in Germany

increased commercialisation. State funding was cut by 50%, to encourage academia

to develop collaborations with industry. This led to innovation and

commercialization of research which in essence was the start of the biotechnology

industry in Germany and many spin-off companies were born. “All biotechnology in

Europe is academic based”. “It is very important to support the companies offering

the core facilities, but we do not support them as competitors”. We invite core

facilities from universities because they have some technologies that cannot be

accessed anywhere else. But we differentiate what can be done by a company and

what can be done by the University and a core facility. “Less sophisticated work can

be done by companies but we recommend that more specialised work is done by core

facilities”. We rely on the context that the scientists, the clinicians here are on the

international level with the many contacts of their own.

Martino Picardo said that Academia should interact more with people in industry and

there should be an industry presence on university campuses. There are not enough

people in the university technology transfer offices or incubators with industrial

experience. Not having academic engagement with industry is a recipe for disaster -

the incubator is the best place for industry/academic interface when the incubator is

run properly. Just because it’s great science does not always transfer to a commercial

opportunity. Universities could set up a service business to provide services. But to

grow its business globally it needs accreditation in place.

5. Should large companies engage SME’s in collaborative projects enabling access to cutting-edge-technologies?

Martino Picardo stated that a lack of collaboration was just the nature of business

and people forget that these businesses are driven by people and people have their

own ways and are reluctant to engage with others that they might see as competition.

When I was managing the Manchester Bio Incubator, we had three stem cell

companies located close to each other and we hoped they would collaborate, but it

never happened. He stated that Stevenage was not an academic environment where

sharing for publications are common, but that Stevenage was a business creation

environment. “Companies who locate in Stevenage come here knowing that there is

an expectation of them to engage in open innovation and collaboration; this is one of

our unique selling points”. “Unless there is a value proposition to their business,

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then they are actually taught as they go through the journey of business school,

growth, and business creation; there is as much competition as collaboration and

whether or not they are able to sustain a value proposition that allows them to grow

without collaborating with others”. As part of a collaborative model, GSK were

providing some TCF’s and technicians skilled in new technologies to SME’s located

in Stevenage. Derek Jones noted that it was important to get clinicians and the big

pharmaceutical companies on board stating that Babraham had collaborations with

Cambridge University, the Sanger Centre, Granta Science Park, and other centres of

excellence. They also had collaborations with Pfizer and GSK who wanted to help

small companies and were willing to share their experience e.g. running an

experiment. The multinationals needed the SME’s for innovations an open

innovation model was encouraged. Before companies locate in Cambridge they are

told “If you don’t want to be part of the community here and be willing to

collaborate you should not come here”. However, having access to technologies

where people had to travel was not going to work. Mary Skelly said “companies

should collaborate on projects in line with their skill sets” companies needed to

eradicate competition and collaborate with some profit-sharing agreement in place.

This would lessen the duplication of products and services and reduce costs. She said

that pharmaceutical companies should put their needs into academic research, but

that academic research did not meet the need of the day. Also, academia should

collaborate with the pharmaceutical companies to define research via virtual

networks. Tony jones held the view that companies needed a value proposition to

collaborate with university TCF’s and that university looked towards academic

collaborations; the intellectually stimulating side but did not fund itself that way.

Tony did not differentiate between industry and academia believing that there was

good and bad science in both camps. “We need to develop a collaborative model

whether it is open innovation or whatever and we need to find a way of working

together with multiple parties to get into the value chain”. Mario Thomas the OCE

supported public/private sector collaborations, regional collaborations as well as

national/transnational collaborations through the Centre for Commercialisation and

Research. Other provinces in Canada were not as successful as Ontario because of

duplication and rivalry. “The Centre for commercialisation of research organises

and facilitates collaborations and access to core facilities in the areas of industry,

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University interactions, and single entity facilities. The MaRS District is an example

of this”.

Horst Domdey said that Germany recognised the need for collaboration to

build a successful biotechnology industry so they formed the Association of German

Bio Regions where they exchanged and created novel ideas. In the late 1990s the

German government reduced funding to academic institutions for research which

forced the academics to look to companies for collaborative projects that drove

innovation and ultimately develop tangible commercial products and create

employment. This also created an environment that supported entrepreneurship; the

pharmaceutical pipelines were weak and they began looking towards biotechnology

SME’s for new innovations thus creating collaborative models. BioM suggested

setting up a portal for industry/industry and industry/academia collaborations where

people could come together to share ideas but the university would not share their

server. BioM collaborates with different Technology Transfer Organisations and

provides financial support to technology translators involved in personalised

medicine projects to keep everyone in the same boat. BioM brings the different

sectors of the Munich Bio Cluster together keeping the multiple stakeholders abreast

of technologies available within the campus with a view towards collaborative

engagement.

Claire Skentelbery stated that Biotechnology gets by on collaboration. “A single

technology that starts a company is not going to be that successful because

technology is only 5% of the story; it’s how you enable the technology to be

delivered”.

6. What contribution does cluster membership and access to

infrastructures make to SME’s and ultimately economic development?

Claire Skentelbery expressed the view that cluster networks and structures had a

massive impact on economic development; biotechnology companies found it

difficult to excel in isolation; “the clustering effect has a massive impact on the

speed at which technologies and companies are delivered”. Claire believed that for

Europe to generate economic returns from its biotechnology it needed to happen

from within a cluster environment because the cluster environment provided a higher

concentration of core skills and rapid access to the correct additional external skills

and services. “You have an environment of innovation and professional management

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of science, which seems to be the biggest bottleneck for every stage of cluster

development. If you don’t have that environment it’s very hard to then make it if you

haven’t got seeds to grow it from”. Research equipment obviously constitutes a key

element of research infrastructure. “This permits specialised focused research to

occur at multiple levels from postgraduate education to confidential business. Major

core facilities exist in the public sector and private sector and access varies from

both as do quality standards. Cluster networks and structures have a huge impact on

the way companies are facilitated in Europe”.

Mario Thomas said that cluster based companies generate results that

members would not achieve in single non-cluster structures.

Claire believes that clusters create a gravitational effect; “if you reach a

critical mass people will move towards you”. Claire stated that business models were

evolving constantly and access to TCFs and selective research and development

activities had a huge effect because investors were not interested in a company

unless the company displays competency to deliver a product.

According to Claire the critical point in the development of the Cambridge

cluster was when the service providers started to move in, such as law firms, patent

offices; “these are indicators that the cluster is growing strong and the cluster

grows bigger because it becomes a place where companies know they can get

services on their doorstep”. “50% of the Cambridge cluster is service providers.

Dedicated Biotech Companies (DBF’s) are not the measure of a cluster”.

Derek Jones stated that small companies that run into financial difficulty and

cannot afford to pay rent; he can come to alternative agreements like equity in lieu of

rent because loosing companies is not how the cluster gets measured. “Our business

is creating companies and jobs and that happens within a cluster environment”. We

have two multi-billion companies in Cambridge; Arm Technologies and Hewlett

Packard (HP), and Microsoft is building their R&D headquarters here because they

have access to the skills they need here. “We have relationships with the Pfizer’s and

GSK’s who say they want to help SME’s”. Tony stated that the Technology

Development Laboratory (TDL) was accessible by companies both on and off site.

“Established to support innovation in biotechnology and biomedical fields, the TDL

is a fully-equipped biology and chemistry laboratory. Companies, entrepreneurs and

academics can hire bench space and equipment in the TDL on a flexible basis”. The

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TDL also offers scientific research services on a fee-for-service basis. Areas of

expertise include molecular biology, protein biochemistry, cell biology, and

synthetic chemistry. “We have a unique TCF here which is the animal house which

houses nearly 50,000 mice, but you have to be in the cluster to use it due to ethical

regulations in the UK”. Derek believes that bioscience can play a huge role in

European economic recovery, but Europe has to de-leverage the manufacturing of

science, be more innovative and make money from it, and prevent it disappearing to

China where it is ten times cheaper to manufacture. “We need to keep it in Europe”.

Professor Domdey stated that in many German clusters you find that everybody

knows the clusters are supporting industries, but people also realise that science is

being supported at the universities because their spin-off activities are supported and

clusters are an important partner for them and the clusters are unique in that they are

connecting science, business, and clinics. Tony Jones believed that companies want

to be part of a cluster like Cambridge because they have access to the right talent

they need and London is a good example of that. “Clusters are like a nursery ground

where you get lots of spin-off companies growing”.

7. What role do big companies play within clusters?

Claire Skentelbery stated that large companies had different relationships within

clusters. She gave Cambridge as an example noting that large companies existed

within the cluster but their level of participation was minimal. “Large companies are

more likely to view the cluster as a positive source of staff recruitment because

successful clusters attract a skilled talent pool; however, they could attract talented

people from all over the world”.

8. What attracts companies to locate in a cluster?

Professor Domdey believes that the excellent science available in BioM and

government investment was the basis for everything. Access to TCF’s and expertise,

favourable tax and employment laws, Technology Transfer Organisations, logistical

infrastructure, incubator space, cluster networks, start-up companies, innovation,

entrepreneurs, hospital clinicians, universities, research institutes, venture capitalists

and investors, banks, political decision makers, service providers and a well-

educated work force, cluster location and amenities i.e. leisure and shopping, schools

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and health providers were important. “You need a multi-disciplinary approach”.

“We have attracted four companies from abroad to settle here. They settled here

because they have access to all the services they need”. Derek Jones mentioned all

the above points as well as having niche TCF’s like their animal facility. “If you are

going to start a company with four or five people you don’t need big buildings, so an

incubator offering 500 ft2/600 ft

2 is ideal and as the company grows, access to

bigger buildings allows companies to stay in the cluster”. BioM built an industrial

village in Martins Reid in Munich with bigger buildings so that companies that

outgrow BioM can re-locate close to the cluster. Companies locating in Babraham

automatically become members of “One Nucleus” a cluster network organisation as

do companies locating in the Munich bio-cluster become part of the BioM network.

Also, members of the Babraham Cluster can avail of group purchasing schemes and

other incentives. Derek stated that companies did not like to travel to access services

and that communication breaks down over a very short distance. Claire Skentelbery

echoed the points stated by Derek and added that companies benefit from being in a

cluster because they can attract staff. Horst and Derek pointed out that cluster

membership gave companies a “critical mass” which enhanced their visibility and

attractiveness on the national and international playing field.

9. What are the main drivers of cluster success?

Claire Skentelbery says clusters need a strong support strategy. Strong cluster

management and networks are important drivers. While Claire believes that

proximity to universities is an important driver of cluster development, she does not

believe that Cambridge University was crucial to development ‘of the Cambridge

cluster. “Rarely have I seen active members of a university very actively engaged in

cluster development. The cluster is there despite the university and not because of

it”. “People have left the university and created a cluster, but they have to leave the

university to do that”. However, according to Horst Domdey; BioM encourages

university staffs who want to spin out companies to stay at the university and take

shares or equity because there are enough qualified people within BioM to develop

the company. He believes that academics do not have the industrial experience and

that clusters should be driven by business people. Government stability is important;

too often when government changes, investment strategy changes. “In Germany if

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you invest in something you want you are still investing in it 10 to 15 years later

which is the minimum amount of time it takes to bring a biotechnology drug to

market”. However, Horst stated “the German education system had no specific

effect on cluster development. There are no Fraunhofers that are working directly in

the biotechnology field. In the past they didn’t do any science. They do provide

human resources but have no direct effect on cluster development”. Horst stated that

location and proximity to service is really important in cluster development. “We

have similar science parks in Northern Bavaria. They built an incubator in another

German University in Bavaria, just 15 minutes from the campus and it does not work

and people go there but reluctantly”. Derek Jones also stated that companies did not

want to travel long distances to access TCF’s.

Claire stated that there needed to be a 20 year roadmap in place to capture the best of

the previous UK manufacturing capability, or design capability or engineering

capability. Claire said “cluster success is driven by sustained government policy,

investment and the right people on the ground and understanding the strengths of the

region”. “There is no point in George Osborne giving somebody €40M to spend in

12 months; that’s not a sustainable investment strategy. You might be able to build a

€40M building, but what’s the point if you can’t afford to turn the lights on”. Claire

believed that there need to be an entrepreneurial culture and the presence of serial

entrepreneurs. “Cambridge is a great example of a cluster because the people who

set it up, the original entrepreneurs are still active in it 25 years later”. Claire stated

that clusters and companies that were reliant on public funding to stay alive would

fail as soon as the funding dries up.

Claire stated “cluster development is almost entirely based on market forces.

Cambridge and Oxford were lucky to reach critical mass before the money ran out”.

“The UK government underestimates the impact of not having public support for

biotechnology companies”. Claire also stated that Public support is vital to cluster

development.

“Having high-profile champions, companies, researchers, and a skilled cluster

manager who communicates with the people through the cluster network is vital to

creating the clustering effect. A cluster is people talking to each other all the time

because through that deals are exchanged, new jobs are created, and new ideas are

born”. Claire says that a cluster is not going to develop where it is not nice to live;

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this point was agreed by Derek Jones and Marianna Bradanno of the Biocant cluster

in Portugal, the first policy-driven biotechnology cluster in Portugal. The Biocant

cluster in Cantanhede was a partner in the ShareBiotech project consortium. Claire

stated that the most important thing was “human capital” and this was agreed by

Tony Jones of One Nucleus and Derek Jones of the Babraham Cluster. Claire

believed that clusters are defined by small companies who tend not to move around a

lot. “Once a cluster becomes established and it becomes enabled to be commercially

competitive then it keeps on rolling because it will be good enough for the

companies to survive. That’s why Cambridge survived; in hard times it has enough

internal energy itself”. Claire stated that key clusters were defined by the presence of

serial entrepreneurs. “They are people who are active in the local community; they

start up company after company, not one-trick ponies who have one molecule that

they have taken out of the lab. This does not make a cluster; it makes one company”.

“It’s the flow of people skills and companies; it’s the life-cycle of all those things

inside that cluster that actually makes it a cluster”.

Claire believes that another driver of cluster success is sustained government policy,

investment and the right people on the ground and understanding what the strengths

of the regions are. “You can’t make a cluster out of an area you have never worked

with before. It’s important to have clusters validated by someone working in the

territory”. Claire stated that it was exceptionally difficult to predict how

biotechnology clusters will evolve because new financial, clinical, regulatory,

societal, and scientific factors come into play all the time.

Claire also stated that the establishment of a cross country legal entity that could

harness different skills in the same area would benefit cluster development. Another

point raised by Claire was futures-research in terms of what’s coming down the line;

in terms of influential information would have an effect on cluster development “all

information stimulates the imagination and forearmed is forewarned and with this

information you could choose to do things differently”.

Mary skelly believes that people in charge of biotech should essentially be

biotechnology entrepreneurs. “Clusters should be built using their own staff as

opposed to outsourcing to prevent loss of skills”. Mary also stated that the cluster

model should be built from a bottom up approach i.e. consumer, patient etc. clusters

should be managed by a totally independent team and not branded by an academic

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organisation. When Mary was asked about cluster development in Ireland she stated

“Ireland’s cluster models are polluted by government”.

Tony Jones believes that TCF’s are the drivers for any cluster and also underlying

academic strength, skill-sets and talent. “Available money’s are the pillars that need

to be there in one shape or another for a cluster to develop”. Tony believes that you

can orchestrate a cluster if the public sector bodies in academia or policymakers, and

the funding bodies are in place. Tony believes that TCF’s should be run by business

people and not academics because academics do not factor in overheads and do not

have the necessary skills. “The core facilities that shape a lot of companies based

themselves in biotech clusters or technology clusters”.

“The academic base helped to create Babraham but the presence of TCF’s is what

brought the companies in and they are crucial to SME’s”. Tony stated that

proximity to a large city with investors, venture capitalists, e.g. Babraham’s

proximity to London is a success factor, and that physical infrastructure’s limit the

development of a cluster. “It’s very difficult to create a cluster in a remote area”.

Clusters should be developed according to their environment because what works in

one place will not necessarily work in another “it’s not a one-size-fits-all model”.

“You can’t be good at everything so work out what you are good at and that has to

be the cluster driver”. This point was reinforced by Martino Picardo, Derek Jones,

and Claire Skentelbery.

Mario Thomas of the OCE stated “the right people with the right skills are critical to

cluster development and it is also dependent on broad and deep networks”. Martino

agreed that a cluster should reflect its environment, “you can learn from leading

clusters but you need to find what you can do better than anyone else and know your

strengths and your weaknesses”. This point was agreed by all the experts

interviewed. Martino believes the components of cluster development are “people-

people-people, investment, IP, and ideas. This view was expressed by all

interviewees. “Having joined-up thinking facilitates creating a hub around which a

cluster can generate. You need a pragmatic view of what is and is not achievable

and an in-depth knowledge of the local environment”. He stated that long-term

planning will determine success or failure of a cluster, a point emphasised by Claire

Skentelbery stating that a 20 year road map was needed in the UK if it was going to

realise its full potential in the European biotechnology sector. Horst Domdey stated

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that consistency of policy was crucial in the development of Germany’s

biotechnology industry. According to Martino “If you want to develop a cluster;

don’t build something that is of no use to your community, do extensive mapping,

survey SME’s to see what they want and you have to sell the SME’s a vision that

says, “if we build this will you use it and what services would you be interested in?”

“If a cluster is based entirely around real biotechnology i.e., IP based, drug

discovery, drug development and biologics, it’s a 15 year program and you need

long-term sustainable funding”.

Derek Jones stated that geographical location, access to funding, access to academic

institutions, a vibrant V.C. community, social capital a pool of talent and social

infrastructure are all drivers of Babraham’s success. “You can’t build a cluster just

by throwing money at it, it’s not a case of; if I build it they will come, you need to

organically grow what you have to get to critical mass”. As an example he quoted

the Singapore Bioscience Cluster where millions of dollars were pumped in but now

that cluster is in decline and never achieved critical mass. This point was also

mentioned by Claire Skentelbery. Derek stated that one of the biggest drivers was

that Babraham was close to world-class science and a talent pool. “Biotechnology

companies will take 5 to 10 years to start showing results; therefore, long term

planning is needed”. Derek said that successful cluster development is not a one-

size-fits-all and you need to find your niche area and know what companies you are

trying to support.

Horst Domdey indicated that the idea of government funding support for cluster

formation resulted in a strong German biotechnology industry. The formation of the

Association of German Bio Regions (AGBR), which fostered co-operation between

regions, was a driver for cluster formation. Germany applied a top-down approach to

cluster development but the clusters developed using a bottom-up approach. “In

many German clusters everybody knows that we are supporting industry, but we are

also supporting science at the institute because we support their spin-off activities, so

we are connecting science and business, and also lately clinics. This

multidisciplinary approach and network is an important cluster driver”.

The German government has a system in place to keep people in work when times

become difficult financially. The employee is kept on for 40 hours per week at 70%

of their normal wage and when the financial situation improves they are restored to

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full income. This prevents loss of skilled personnel and this helps to drive cluster

success. Horst says that you need to be creative at all times and creativity must be

rewarded to keep people incentivised.

10. Technology Transfer refers to the provision of a service that addresses

technology needs by linking them to a solution e.g. SME with an R&D

facility. How important is Technology Transfer and having access to

experienced Technology Translators in cluster development?

According to Horst Domdey all biotechnology comes from an academic base in

Germany; from the universities, the Max Planck Institute, from the Helmholtz, so

Technology Transfer is very important. “We are in close collaborations with

different technology transfer organisations and we support some of them financially

in our personal medicine projects”. Martino believes that there are not enough

people in the university technology transfer offices or incubators with industrial

experience. Mario Thomas stated that technology transfer in Ontario is implemented

through a network of partners who themselves have TCF’s. Mario stated that the

OCE annually funds four major networks for technology transfer in 20 universities,

for people, infrastructures, and proof of principle projects.

Tony Jones stated “anything that enables one side of a collaboration or

contract to translate to the other side, to articulate it in a different way than the

originator has to be a good thing”. Tony stated that technology transfer needs to be

implemented by a team of experts; the regulatory advisors, the technology translators

are not enough individually.

Mary Skelly stated that “a Technology Transfer Officer with a one-size-fits-all

little black book does not work”; “you need more than a hired hand from the state”.

Mary believes that technology translators should be connected to the right people

and the right networks. “In Ireland the wrong people are appointed to the

Technology Translator role and most do not have the relevant experience. This is an

Irish culture issue”.

Claire Skentelbery stated that the universities were not professional enough

regarding technology transfer and it did not seem to be changing. “A Technology

Transfer Office or a facility could promise you the earth but in reality they don’t do

anything”. There needs to be a will to go in and critically assess those services”.

Claire quoted a model operating in Heidelberg Germany that links up traditional

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industry problems with biotechnology solutions. The program is run by Ralph

Kindervarter; its government subsidised, and basically Ralph goes into big industries

in Germany e.g. Damer, Bosch , and works out where they have technology

challenges in their production process and then he approaches biotechnology

companies to solve those problems. It’s a very expensive program to run because he

has a team of highly talented technology finders. “You would not run it with an idiot

on a string, so it’s a massive investment but the economic impact on the company

has been significant”. The program works astonishingly well and it pays back a

thousand times over but it requires significant public effect upfront. “You need a

significant team of highly skilled people to run it”. Claire says that a Technology

Transfer Officer is a key person. “Ralph is the Technology Translator; he has

significant access to networks, and he has a dedicated team to work those

networks”. The investment in that program paid off for the companies, “but if you

are going to do something to address a European problem you need to plan it, fund

it, and wait for it to deliver”. Derek Jones also stressed this point of long-term

planning.

Mario Thomas of the OCE said Technology Transfer is implemented through a

network of partners who themselves have core facilities. “The OCE annually funds

four major provincial networks for Technology Transfer in 20 universities, for

people, infrastructure, or proof of principle projects”. Mario believes that focus on

the business issue faced by the nascent companies has shown tremendous economic

outcomes.

11. What impact do cluster networks like One Nucleus and BioM have on

cluster development? Does being a member of a cluster network pay

dividends?

Claire believes that it is difficult to measure the impact of cluster networking

organisations like One Nucleus. It did not create the Cambridge Cluster; it’s

basically a network that operates in clusters so it has an important part to play. One

Nucleus was created in response to demand from companies; it’s simply a

commercial response to a need within a cluster. Claire states that what Tony Jones

and Derek Jones are doing is similar to what the CEBR Cluster Network does; “they

talk to companies within a cluster nationally and the CEBR talks to Clusters on an

International level”.

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Mary Skelly said that a Technology Transfer Officer with a one-size-fits-all

black book does not work “you need more than a hired hand from the state. “You

need a large group of Technology Transfer Officers in different specialisations”.

Claire agreed with this saying that one person cannot hold all the information in their

head regarding technology transfer. Mary said that Enterprise Ireland (E.I.) was a

large hold-back organisation and that everything has to have the E.I. brand to get

approved and developed. E.g. DCU Hothouse is controlled by E.I. Technology

Translators need to be connected to the right people and the right networks and in

Ireland the wrong people are appointed to the Technology Translator role and most

do not have the relevant experience. Mary says “this is an Irish culture issue”.

Tony Jones who runs the One Nucleus cluster network says talking to people is very

important but you have to invest some effort. “Nobody wants to pay for networks

and this is a world-wide view that needs to change”. Tony believes that cluster

networking organisations should be government funded because it’s just something

that should be provided to enable engineers, entrepreneurs, scientist’s and inventors

to meet to create value and they can pay back in spades creating companies together.

One Nucleus is funded by membership income because the government do not

provide that sort of funding. The CEBR is wholly funded by membership fees. Tony

stated “if we could add up the cost of all the companies who paid us from

membership, we could go to the government and say; give us this amount of money

and we will provide free networking for everybody; it would pay back because

everybody is engaged just by being in the right catchment area”. Tony believes that

people align themselves with something they feel comfortable with i.e. the One

Nucleus Network in London. When Tony was asked how One Nucleus has benefited

the biotechnology sector he said that it provided a focal point for like-minded people

to come together and talk to each other. We also operate a group purchasing scheme

that helps companies to save money. The network gives companies access to

employees, quality knowledge sharing, and with a greater critical mass companies

were enabled to talk to other, international clusters, and multinational organisations

to discuss collaborative projects. Tony claimed that One Nucleus gave added value

to companies, “you need to meet the right people who know the right things and One

Nucleus facilitates that”.

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Mario Thomas spoke about Ontario Bioscience Innovation Organisation (OBIO),

Ontario’s bio-cluster network organisation, which is a private sector membership-

based organisation, and is Ontario’s leading advocate for the life sciences sector.

OBIO engages in policy and government relations activities and enabled the

successful development and commercialisation of Ontario’s life science technologies

through investment, strategic alliances, stakeholder engagement, and industry

promotions.

Derek Jones believed that being part of a cluster network was beneficial to

clusters and companies. “Companies that locate here automatically become

members of One Nucleus and have access to all networking events”. Derek said that

One Nucleus also acts as a portal for job opportunities and companies could source

employees through this and they provide a directory of companies giving exposure to

potential clients.

Horst Domdey supported cluster networks. “Through membership of the

Council of European Bio Regions (CEBR) an international cluster networking

organisation of which Claire Skentelbery is the CEO; we have made strong

connections with clusters throughout Europe e.g. Barcelona and Belgium”.

12. Networking and community have been identified as being a critical

factor in cluster success. How important is networking and

community?

Horst Domdey believes seminars, shows, trade fairs are very important. “The most

important thing is the coffee break and get together after the meal where people can

talk. You always have to invent something new”. We have used roundtables in pubs

where people get together and drink beer, e.g. CEOs, clinical directors, HR people

and people like that. We have asked companies to sponsor dinners and when they

know or think the other CEOs are going; they come too because they don’t want to

miss something. We invite guest speakers and once we hired a comedian who made

fun of the guest speakers. You need to build up the pressure before planning an event

and be inventive.

When Horst was asked about the importance of community and networking

in cluster development he said, "Once I was asked by a Minister of Economic

Affairs; “what is the best way we can support you”? I said; “the best thing would be

to fund one big party per week where people come together”. “In a conference

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environment the most important thing is the coffee break you get after the meal.”

Horst says creativity is important when bringing people together “you must always

invent something new”. “You have to find different ways to bring people together”.

“You can have the best computers in the world but at the end of the day you need to

meet with people because the computer does not make contact or have a couple of

beers in the evening; its people who do that”. Tony Jones runs an event whereby

company CEO’s go to the pub to network three times a year. Horst would organise

all kinds of conferences and meetings where contracts between industry and

academia were supported. One model he used was bringing people from industry,

research units, research institutes, and clinicians together for a type of speed-dating.

Horst says that people have to meet people to talk, people have to exchange ideas,

and through this completely new things are born.

Horst stated that knowledge of the local activities is very important in order

to support them. An example of this is Bio-Technica a networking event which takes

place in Hanover every two years. Horst decided to run a smaller, more locally

focused event called Bio M Technica. This was a platform to promote our brochure

and our bank of resources and how to access them and also the University core

facilities. BioM made a list of 50 SME’s, 50 research companies, and university core

facilities and advertised their access policy. “Our brochure highlights 1500 life

science research groups in Bavaria”. BioM organise “Pharma Days” where

pharmaceutical companies are invited and informed about the region’s products and

technology services. “This told us that the Pharmaceutical sector was not interested

in the SMEs or the University but it gave us the opportunity to ask what they

needed”.

Horst believes that it is important to engage in transnational networking

events. As an example, BioM showcase their companies to pharmaceutical

companies such as, GSK, Novartis and other major players at an event in Boston,

US, called “Bio Pharma America”. “Last year we signed an agreement with the

Osaka Biotechnology Fortecture in Consa West Japan with 200 pharmaceutical

companies. The agreement gave us immediate access to the pharmaceutical

companies. These Pharma companies need innovation because there is not a strong

biotechnology industry in the region.”

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Horst also organised a delegation of 18 Munich/Bavarian-based

biotechnology companies to travel to Bio-Japan which took place in Yokohama

Tokyo. “This allows us to study their business model. In one case a contact was

made and a licence agreement to take over one company. The delegation visit was

80% funded by the German Ministry of Research”. BioM are also connected to the

Boston Biotech Area; “we exchanged some ideas with them, and this opens doors”.

Derek Jones says clusters are all about community “it’s all community driven”.

Babraham run conferences like the Bio Investment Forum to showcase the local

community nationally and internationally which keeps us on the radar. We have had

companies locate here because they liked what they saw at the conference. Derek

stressed that people need to understand that success does not happen over-night and

just because an event did not work you don’t give up, a point agreed by Tony jones

and Horst Domdey. “You need to give it sufficient time to get going”. We also run

networking events like dinners, breakfasts, and coffee and doughnut mornings. “The

idea of getting people to talk to each other is crucial. We also encourage people

from other local science-parks and multinationals like GSK and Pfizer to attend”.

Discovery 12 is a networking event run by the OCE in Canada, whereby

industry interfacing meetings give access to investors and a large amount of access

to researchers. Mario Thomas says “interface meetings with industry gives access to

potential collaborations, innovative staffs and innovative ideas”, All stakeholders

are in attendance, investors, industry, inventors, students and government and the

meeting takes place in one large room which encourages interaction. “Covering all

sectors of innovation creates a convergence of technologies and impact is gauged by

the attendance, new and repeat, and a satisfaction survey”.

Tony Jones believes that community is the important bit; to know that you

are only one or two phone calls away from getting advice whether it’s a business

plan or projects etc. “Lots of things happen best locally; information that you can get

over a cup of tea or coffee or a glass of wine perhaps because people are physically

close to each other”. Tony believes that the cluster and the community impact is

really people interaction, a type of symbiotic relationship. Tony noted the

importance of integrating new companies into the local community and the local

cluster. “Then they become in-bedded in that community and the community

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benefits”. One Nucleus organises pub night-outs three of four times a year because

as Tony said “so there’s a lot of people going for a beer and there is nothing wrong

with that, it’s really important that you get them away from their desks sometimes”.

Claire Skentelbery believes that if a company identifies itself as part of a cluster, it

should contribute to that cluster because this is critical in creating the clustering

effect. “The clustering effect is just community; it’s pretty much what a cluster is,

just people talking to each other all the time and because of that, deals are

exchanged, new jobs are found and new ideas are had. A collection of organisations

in a region is not a cluster really until they communicate and work together”

13. The EU now views Cluster Managers as formal roles of a very

important nature to the success of a business cluster, including

biotech. Is it difficult to find efficient cluster managers, and how does

the role they play benefit cluster development?

Claire Skentelbery believes the job of the cluster manager is enabling access to skills

but it is difficult for a cluster manager to enable access to finance. Claire said that

early-stage clusters have to have access to experienced management whether it is

technological, maturation, clinical innovation and believed that any aspect of cluster

development came down to skilled individuals. “The cluster manager has the

advantage of being able to reach into other clusters and find other models that are

working and if the information is valuable he can relay the information to his

tenants; that is really their role”. Claire believes that the cluster manager should

create an environment of openness and collaboration and facilitate access; “that is

the manager’s job done”. “They are not business advisors in their own right”.

Claire stated that cluster managers are highly diverse people and some of them have

been biotechnology business managers. “It’s not a job where you stay for a few

years and then leave; in the CEBR we have only seen three face changes in five

years”. “If you have an endless succession of civil-servants in the job that don’t

know the sector they you have weak cluster management”. Cluster iterated that

cluster managers need to be passionate and know a huge amount about the sector. “I

think a lot of what Europe has struggled with when it gets a policy driven approach

to cluster development; you don’t get the right people to implement that policy”.

Claire says the best people she has seen do not have a scientific background; rather,

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they are great people-people. The remit of the cluster manager should be defined by

local government rather than a European thing.

Claire has found that there exists a very strong relationship between the

cluster managers and their cluster, and in the CEBR it is rare to see face changes.

“If a cluster is to maintain productivity and growth you need a strong, proactive

cluster management team who are interested in the team of the cluster. It comes

down to the skills and enthusiasm of the individual and it needs to be policy driven”.

Mario Thomas believes that the right cluster managers with the right skills are

crucial to cluster development. The model adopted by the OCE is such that the

province is managed as one network with 14 regional innovation offices staffed by

entrepreneurs.

Martino Picardo believes that you need to have the right incubator and cluster

manager who can create the right environment that leads to open innovation. The

companies that locate in Stevenage do so knowing that there is an expectation of

them to engage in open innovation and collaboration. Horst Domdey believes that

creativity is one of the most important qualities a cluster manager can have and the

ability to think outside the box.

14. The pharmaceutical sector model of collaboration with SME’s has

been described as being out-dated. With several pharmaceutical drugs

coming off patent and a slowing R&D pipeline; does this model need to

change?

Claire Skentelbery sees the pharmaceutical sector a very slow and old-fashioned in

their approach to collaboration, “they seem to view things more like a sub-contract

rather than collaboration”. Claire stated that the pharmaceutical sector needs to

change their research methods. “Big Pharma do work with small companies but their

pipelines are not growing because they are too conservative”. Claire believes that

the desire of pharmaceutical companies to be in control makes it difficult for them to

engage within a cluster. Claire stated that pharmaceutical companies need a cultural

change and that ultimately healthcare is suffering because governments don’t have

the money for new drugs and companies are finding it more expensive to make drugs

and the industry is overregulated making it more expensive to get a new drug to

market. According to Claire, SMEs have to move further down the pipeline to attract

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a partner so they have to have the basis of a clinical trial before a pharmaceutical

company will engage them

15. The world is becoming increasingly virtual and with the onset of the

financial crisis, companies have less money to spend mobility. Do you

see the development of virtual communications technology as a viable,

sustainable option?

Horst stated that BioM were not so good at communications and they need to

improve. “I would like to see the development of a web portal where everybody

could get in and exchange ideas and also have intimate forums where people could

get new ideas. We need to improve our server so I asked the University if we could

use their server but they refused. We discussed using Facebook but all these Internet

things like LinkedIn take too much time”.

Claire Skentelbery said that most of the CEBR’s communication is on-line. Claire

stated that in her experience; during the early stages of a project there is a need for

face-to-face meetings but as projects proceed, there is not as much cash available.

She also said that people would much rather have a meeting from their own office

via video conferencing or Skype rather than having to travel.

16. The rate of technology development is changing all the time. What was

cutting-edge technology one day is being replaced the next year by

faster, smaller, and newer technology. This is a problem for SME’s to

stay up to date. How can we offset technology obsolescence?

Derek stated that technology independence was very important. “Government funds

us every five years, but we have autonomy over when the money is spent and what it

is spent on”. “We are not focused on a particular technology; we do blue skies

research”. “If you buy a mass spectrometer one year and this is replaced by a faster,

smaller, and cheaper model the next year”. Derek said that Babraham was

dependent on the science that they do and the advantage was that its academic

research and there is not the competitive commercial threat.

Horst Domdey stated that Germany had a lot of funding, and they have the

best people and they get the latest technology. “It is not a problem because if one

technology is obsolete it is because they already have the next one”. Horst believes

having staff turnover and staff coming from abroad is important. “It is important to

have young postgrads going to Europe and to the USA where they learn new

technologies, but is even more important that they come back”. Germany sends

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delegations e.g. the president of the Max Planck’s Institute, the president of the

German Academy Of Sciences who go to the USA to attract American science

students to study in Germany. “We don’t want a brain drain but we promote a brain

gain. All this contributes to never having a gap in technology”. Horst stated that this

was not the case with companies and that due to lack of funding companies found it

difficult for to keep up with technology.

Martino Picardo believed to offset technology obsolescence companies

needed to develop relationships with the vendor’s who are building the next

technologies. “Build relationships with vendor so that you have the capability for

today, but it’s not fixed for the next three years. They need to have flexibility so you

can bring in the next generation of technologies or platform, the next instrument or

detection platform so you don’t become a mausoleum”. Martino said that companies

need to create a virtual network around them. Martino also believes in running

seminars and workshops, “don’t make them exclusive, show the vendor is that you

have a captive audience”. Martino relayed that when he put the bid in for the Core

Technology Centre in Manchester, Lord Sainsbury, the then minister for science told

him that he loved the concept and told him that he would approve the £25M for

funding but he would hold back the £5M funding for equipment and said; “by the

time I have signed off on the cheque and you have bought the equipment; it will

already be obsolete”.

Mario Thomas stated that the accelerating rate, cost, and scale of research

infrastructure development and associated new technologies had the potential to

create R&D deficit issues in countries and regions. To offset this the OCE have

created the International Commercialisation Alliance with intermediary

organisations from 22 countries involved. The Canadian intermediary organisations

connect through the Canadian Commercialisation Consortium Claire Skentelbery

stated that the open-innovation model could help to offset technology obsolescence.

17. How important is knowledge exchange for start-up companies?

Horst said that knowledge exchange was an important aspect of BIO-M especially

with new companies who need to get to know the system. “We introduce companies

to contacts in the universities who can help them to write proposals”. As an example

Horst spoke of an American bio-marker company who located in BioM; “we

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introduced them to the people doing diagnostics and to clinicians. We helped them to

write a grant application and they received €1M from the German government. We

cannot do this for all companies but we do it for new companies. We get them into

the system by a hands-on approach at the very beginning so they get a good start”.

This approach is also used by Derek Jones to help start-up companies get off to a

good start in Babraham.

18. Open innovation in other sectors has shown benefits for all parties.

While the concept of inter-company collaboration in R&D has been

around for some time, the term ‘open innovation’ and related research

into its practice has been developed extensively by Professor Henry

Chesbrough, Executive Director of the Program in Open Innovation (POI) at the University of California, Berkeley. What is your view on

the benefits of open innovation?

I would say that open-innovation is one of the most important aspects of BIO-M. I

have learned from the past that all the technology is there but you have to know how

to access it. In 1997 when we started BIO-M one of the major components of our

concept were shared technologies. It proved difficult due to too much competition.

So now the TCFs are part of our network, e.g. University cores and companies. It is

very important to support the companies offering the core facilities, but we do not

support them as competitors. There are so many technologies available and so much

know-how, but we don’t know who has it, and we have to develop a good system

that can deliver the information about what is available. Bio-M run high and low-risk

projects and this is possible through technology transfer and open-innovation. Horst

stated “open-innovation is one of the major tools we use here”. We have a lot of

people here at BIO-M and the longer that they are here I can give them more and

more help. The longer they are here the more connections they make. This this is

why events that bring people together are invaluable because when people talk,

knowledge is exchanged and people learn from each other and the network of

knowledge grows. You can have the best computers in the world but at the end of the

day you need people because computers do not connect our contact or have a couple

of beers in the evening; it’s the person who has to do that”.

Claire Skentelbery did not think that open innovation is a model for success

in biotechnology because when pharmaceutical companies open up something like

the 9 Sigma platform, it’s more subcontracting than a collaborative development.

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Tony Jones believed in the concept of open innovation but said that people were

resistant to changes. They say; “show me how it works, and I have not yet seen an

example of it. This is the Stevenage model and it comes from the USA”. Tony

believes that open innovation forces the discussion that says; “where does this fit,

which was probably the case 20 years ago when someone said you can do high

throughput chemistry. There is always room for an unreasonable man”. Tony

believes that open innovation will work if there are TCFs and funding for those types

of hubs and believes that something has got to become a hub of what brings people

together.

Derek Jones described open-innovation as “it’s just a naff word for something that

has been around for quite some time”. Derek stated that open-innovation was a

valuable model for biotechnology SME’s and could speed-up the time it takes to get

a product from bench to consumer.

19. How important is sustainable government funding in developing

successful biotechnology clusters?

I would say that our success is down to the excellent science we have here and

sustainable Government funding has played a big role. “That level of support may

not exist everywhere in Germany, but here in Munich the Federal Government was

very supportive and happy that we were using science to create innovation and

commercialisation. So the companies became an integral part of the community

here”. We have built up relationships with many clinical institutes. Horst stated that

Bio-M fill a gap that industry needed to fill and they do things to promote industry

and the Bavarian Government recognises that. “This makes things easier for our

scientists because they want to come here because they know they will get the

support to do their work”.

20. Government funding policies can change when power changes hands.

What effect does change in funding policies have on cluster

development and the biotechnology sector in general?

Horst agreed that government funding for biotechnology was declining and that

funding was likely to go to projects pertaining to renewable energy and the study of

climate change. “That is true but in other parts of Germany support for biotech

clusters has fallen down the cause biotech is no longer the focus of the German

government. New topics like climate change and alternative energy have replaced

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biotechnology. I believe the focus of the 21st century should be general biology

because healthcare is declining and this is being taken for granted. Now the German

government supports of biotechnology to a much lower level approximately €20

million per year which is nothing when you consider all the biotech companies”.

Horst stated that many of the ministers who supported biotechnology have left the

Ministry so new people with new visions drive research in different directions.

Claire Skentelbery stated that this was one of the major problems in the UK and that

there needed to be consistency in government funding policy. Horst said “the new

people want to support more academic activities because they come from academia.

We need another new idea that makes biotechnology interesting to policymakers

again”. This change could be very negative for biotech unless it has effectively

become sustainable, but as he says this is dependent on innovation.

Horst was asked if he thought research into rare diseases would drive

innovation but he stated; “this is an old story; we need something new. Maybe the

next step would be to merge our activities with Med Tech, Pharma and biotech, and

in this way the German government would see us doing something new and this

could secure funding for another 10 years. You have to be creative and you always

have to invent new things. You cannot rest on your laurels. This has been the

problem in the pharmaceutical industry that they did not adopt a new mind-set. We

rely on personalised medicine and companion diagnostics; this is reducing the

market but it does not matter if you are the front-runner”.

21. Some experts believe that incubators should not compete with each

other, should not be manages by academic organisations, and need

long-term planning to develop. Would you agree with this point of

view?

Martino Picardo believed that incubators should not compete with each other. “When

I was in Manchester we did not compete with Bio City and they did not compete with

London”. Martino highlighted the UK Bio-Incubator Forum as a model that

analyses what technical services are available in incubators across the UK to

encourage industry to interface with the incubators.

Derek Jones said that when “Bio Incubator Forum” (BIF) was set-up they

implemented an agreement whereby incubators do not compete with each other.

Horst Domdey also echoed this sentiment and started while he supported the core

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facilities in the incubator, he did not support incubators competing with each other.

The Bio-M incubator began with 800M2

and it was a modular building so sustainable

government funding was available when the incubator needed to be expanded. Now

the incubator is 10% funded by government and the rest of the finance comes from

bank loans which was made possible by long-term planning.

Martino stated that incubators should not be run by academic organisations.

On public funding, Martino said that if public funds were being used to fund the

incubator that there needed to be a clear view on the goals and objectives. Martino

stated that incubators did not get built in the UK without some kind of contribution

from private funds. “Usually incubators are about job creation and they are a long-

term project. To successfully develop an incubator you need to have a long-term

plan and have some metrics in place to project where you will be in one year, three

years, five years and so on because what little I know about the UK landscape

people are less than honest about what is achievable in the first 2 to 3 years of

business incubation”. Martino believes it will take the best part of 12 to 18 months

to get to 70% or 80% occupancy and stated he knew of incubators around the UK

were it took them three years to get to 50% or 60% occupancy. When Martino was in

charge of the Manchester Bio Incubator, 1600 jobs were created over 10 years and

£200M was accessed in VC funding. “It’s not just enough to get the £20 million or

£30 million to build the building, you have got to put some revenue funding in to

make sure that it is able to run before it gets to sustainability and you need a

pragmatic view of what is and what is not achievable and an in-depth knowledge of

the local environment”. “It won’t be Cambridge; you won’t have the level of

entrepreneurship and investment, and the level of big companies coming into the

environment like Pfizer”. Martino stated that the incubator is the best place for

industry/academic interface when the incubator is run properly and that an incubator

that competes with another should not get public funding. “Having joined-up

thinking and non-competition leads to public finding being pumped in, in the right

way and this creates a holistic view of incubation business and supports, and

prevents local-parochial thinking”..

When asked about an incubator model for Ireland, Martino suggested not

filling the building with equipment but rather bring in service providers to provide

the services. Another model suggested was to engage a CRO or build a network of

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CRO’s. “I am just so against academic groups providing commercial services; you

either put an interface in there with real commercial people, with real commercial

experience or you bring in a CRO or a service provider”.

In his closing statement on the topic of incubation, Martino stated “It’s not in my

interest as a champion of incubation in the UK to have a failure on my doorstep

because failure just breeds government resistance to incubation in general and

therefore a lack of appetite for funding”.

Mario Thomas stated that the MaRS Discovery District is unique as the

largest innovation incubator in the world. “This is where science, technology, and

serial entrepreneurs get the help they need. All kinds of people meet to spark new

ideas and a global relationship for innovation is being earned one success story at a

time”

Derek Jones stated that Babraham provided self-contained units offering office

and lab-space to companies ranging from one person to 30 or 40 people and were in

the process of building follow-on space for companies that needed their “hands held

a little longer”. The objective of the incubator is to facilitate access to expensive

technology for SME’s that they would otherwise be unable to access.

22. One objective of the ShareBiotech project is to analyse the viability of

a Transnational Biotechnology Cluster Model. Do you think that such

a model would be viable?

Martino stated that you need to know the demand for this first before funding is

approved; so what is the demand for a Transnational TCF model? “You need to see

the supply chain, unique selling point, clear differentiation, potential for long-term

success, and not some knee-jerk reaction because you have some funding to use up”.

Derek jones stated the idea of distributed technology is a challenging idea because

people want close access to what they need; they don’t want to travel. He quoted a

survey that was done during the 70s to determine how far people need to be apart

before communication levels dropped or were lost and the result was hundreds of

meters. Derek stated that some of what the ShareBiotech Project was trying to

promote regarding a Transnational Model had been tried at the regional level in

England and was not successful. He quoted a model developed by the Regional

Development Agency (RDA), whereby funding was pumped into Babraham,

Norwich, and Stevenage to develop science parks to provide cutting-edge-

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technology for companies. “The idea was that if a company comes along and needs

some technology they can go to Norwich for it because we fund that technology.

Norwich is 50 miles away; nobody is going to Norwich, nobody is going to do that;

it’s too much of a barrier”. Tony stated that he struggled to get people into the

university which was only 3 miles away and visa-versa. “I think it’s really

challenging because people will find an easy way of doing it” “Having access to

technology where people have to travel is not going to work”. Again this is further

evidence that transnational models will not be easy, and one must assume that easy

advanced real time video communication is critical

Claire said it would be great if you could create something as massive as a

Transnational Cluster but she was not sure how to go about something as big as that.

Claire believed that if you could create a centre of excellence in three specific areas

across three countries that each group would want recognition inside their own

country. Claire said that you would need to create a legal entity across all three areas

and a single point of access; build a community around this entity so that you have

dedicated PhD’s across all three things and business development meetings across all

three regions. She stated “a label means nothing unless you can do something

around it. So I would use practical terms in producing a wider, deeper pool of

scientific excellence using those three organisations. If I was going to try and do

that across three research centres, even three different countries and create a formal

legal entity that spanned all three companies I would have is Professorship of the

legal entity. I would have studentship of the legal entity. You create, you have to

invest in it and create reality from something like that”. Claire also stated that a

long-term planning and funding policy was needed; “you would need a secretary at

first, you would need to invest in it properly. It’s like a business entity; just putting a

sign on the door does not make you open to business”.

23. Communication technologies and the development of the internet

make it possible for companies to engage with each other without the

expense of travelling. How important are virtual models of

communication?

Mary Skelly Microbide is a virtual model giving access to all parts of the US. “It is

vital to have access to key people with credibility e.g. Microbide has a US expert

from the FDA, a credible surgical expert etc. on their board of directors”. Mary

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believes that future would embrace virtual technologies because’ intergalactic

‘marketing is now possible. Mary thought that academia should collaborate with the

pharmaceutical sector to define research via virtual networks.

Tony jones stated that “Networking is vital; talking to the right people and virtual

networking, virtual discussions is possible with the technology available today”.

Claire Skentelbery thought that a network needed an active facilitator and it

should not be a passive search engine for core facilities. “It needs to produce real

linkages of people talking to each other, virtual matchmaking teams, online

networking between facilities and not just as a directory of services. Any other model

is not a commercially viable activity”.

CEBR have moved heavily towards online communication platforms because

their members simply don’t have the money to travel. “When people are in projects

they are contractually obliged to have face-to-face meetings, and when people are

out of projects they would much rather have a 90 minute webinar a than travel a day

to sit around a table”. Claire stated huge amounts of money could be spent on a web

platform for communication like “Tools of Science”, but unless you had somebody

oiling the wheels inside it does not get used. Claire said that the intranet quality is

not good enough for an entire online theme so there was no point in having very

expensive communications technology if the bandwidth did not allow it to be used

properly; “you can have the video conferencing technology in every University in

Europe but unless you have a formal infrastructure, a legal entity, there is little point

in having it”.

Claire believed that small companies needed very expensive communication

technology and the CEBR used an array of free online technology like Google

Documents or Skype. “The webinar series we are running now, we are just using

free webinar software and low-cost conference calls”. Claire agreed that there is a

drastic need for a new reliable web based technology but there is a lot of stuff out

there that people can use now.

24. Do you engage in a mixture of high and low risk projects?

Horst Domdey thinks it’s important to have a mix of high risk projects and low risk

projects. “With higher risk projects the failure rate is higher but the success might

be higher also”.

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Mario Thomas stated that the OCE allocate funding based on the potential for

economic outcomes which means a blend of low risk and high risk projects.

Claire believes that there is no such thing as a low-risk biotechnology project.

25. What is your definition of a TCF?

Horst would define a TCF as “In general a core facility is technologies providing a

service. It is not just to provide equipment but you need to provide the personnel to

use this equipment”. Mario Thomas defines a TCF or a research core facility as an

incubator of enterprise.

26. How difficult is it to secure private funding for cluster development

and R&D?

Mario Thomas said that funding of research and development by the private sector in

Canada is a huge challenge because 90% of all companies are SMEs resulting in

80% funding by the public sector.

27. Porter argues that the role of locations has been long overlooked in the

age open global markets, pointing out that “the enduring competitive

advantage in a global economy lie increasingly in local things-

knowledge, relationships, motivation-that distant rivals cannot

match”. Do you agree with his view?

Derek Jones stated that the local environment, quality of accommodation, schools,

hospitals and shopping centres and leisure and amenities are drivers for attracting the

people we need so cluster of location is important. Derek said that being located so

close to high-profile universities, science parks and hospitals and London played a

significant role in the clusters success. “There was some work done by the New York

Development Corporation (NYDC) that asked companies “why do you go to where

you go?” Tax benefits, all that sort of stuff is really low on their list. “The biggest

driver is you’ve got to be close to world class science and you’ve got to be able to

get a talent pool, that’s what is going to drive you to do it”.

Claire Skentelbery believed the geographical location of the cluster plays a

big role in its ability to attract companies. Investors will travel to a well branded

cluster where they can see 10 companies in one day and not to an isolated or remote

area where they will see one early stage company in a day. “In terms of facilities it’s

much tougher when you have to travel to access them. “You need to factor in the

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human factor like low-cost accommodation nearby, access to other facilities as well

to make it attractive for people to travel”.

Tony Jones expressed the view for all the things that the community cluster

bit works for “I don’t think that it’s necessarily to do with the innovation. I think

people fire off each other and you get that buzz and it attracts talent because you’ve

got lots of funding there and I think it fuels people to come there, but again it comes

down to this lifestyle thing, some people want to live in the South East of the UK

where the roads are crammed up and its expensive and other people will quite

happily choose to live in the valleys or in Ireland or where it’s a different quality of

life altogether”.

Tony believes that if the individual is innovative with one area of science, one

disease area, or one technology; it’s much easier to be networked to everyone else on

your network at that point, virtual discussions as much as you have physical ones,

28. How important is it to have a culture of government support for the

biotechnology industry? How supportive is the government of the

biotechnology industry in your country?

Derek the UK government are trying to build a good bioscience infrastructure. “If

you generate taxable revenue from IP you pay a lower rate of tax”. As an example

Derek said GSK were building a big manufacturing site in the UK and they will pay

a lower rate of corporation tax because they will use IP created in the UK, and this

helps to keep the IP in the UK. Derek states that the policies being put in place will

take 5 to 10 years to start showing results therefore long term planning is needed.

“The government can’t be seen to be giving soft money. They did this in Germany

but it was all a bit of a disaster”. Claire Skentelbery also commented on Germany’s

method of creating their biotechnology industry, but at the end of the day their policy

worked as agreed by Claire. When Germany decided on a model to develop its

biotech sector, there was ~ 60% company failure but 40% generated the biotech

sector and these results were considered good

Derek stated that the BBSRC; the government agency funding science have a

budget of £350M per year of which a lot goes to universities and research institutes;

the Babraham Institute receives £12M per-annum from the BBSRC. In the 2011 UK

budget the Babraham Institute was awarded £44M. Derek said that it is all about jobs

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and growth and the UK government are happy for Babraham to continue what it is

doing.

In April 2013 the UK Government introduced the Patent Box; Derek explained the

principle of the Patent Box is “that if you have generated taxable revenue from

intellectual property you pay a lower rate of tax on it so the idea is because

historically we have been very good at coming up with bright ideas but not actually

making any money out of it; if you can keep it in the country it’s cost-effective. So

GSK have announced are going to build a big manufacturing site because they will

pay lower rates of corporation tax because they use intellectual property that has

been created in the UK. There are loads of hoops that you have to go through; the

Dutch have been doing it for years and the UK Government has just introduced that

now”.

The UK Government also introduced Tax Credits where companies doing

R&D can claim back tax and national insurance paid. The government has

introduced a scheme called “Bridging the Value Debt” to assist start-ups who have

difficulty getting funding. “The Technology Strategy Board (TSB) has put quite a lot

of money into this. They have set up a cell therapy Centre in London; at King’s

Cross North London they are just building the Crick centre; the Crick centre is £1

billion I think; so that’s between the medical research Council, the Welcome Trust

and Cancer Research UK”. The unit being built there and that’s headed up by Paul

Nurse who was president of the Royal Society and he was a Nobel Prize winner also.

Derek also said; “the government are apparently; I’ve been told this comes right

from the very top; this comes right from David Cameron; he is very supportive of

bioscience and science in general. They think that this is the way we are going to get

out of the mess that we are in”. Derek stated that the general consensus was that the

government were putting their money where their mouth was; while guarding against

giving soft money away because when the soft money was gone, it is difficult to get

proper money.

Another issue raised by Derek was that the UK Government were looking at

licencing products prior to Phase 3 completion. “I think the idea is that you

approach the EMEA when you have decent Phase 2 results and seek permission to

launch before prior to getting Phase 3 data and the idea is to accelerate the process

of getting drugs to market and changing the clinical trials structure”.

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Claire stated that the UK government underestimates the impact of not having public

support for biotechnology companies. “Public support is vital to cluster

development. Cluster development lacks government strategy to support them”.

Claire believes that the closing of the Regional Development Authorities in the UK

eroded any strategic support for start-ups to now companies that are less likely to

start-up and survive.

29. Cluster development has been inextricably linked to the quality of the

personnel working in and managing the cluster. How difficult is it to

attract the right people?

Derek Jones stated that since the UK tightened its regulations on immigration rules it

is very difficult to get scientists into the country. “We need to be open to people

coming here from other countries. You make sure that you are getting the right

people and you don’t care where they have come from as long as they are creating

wealth for where they are living”.

Horst stated that it was not easy to get the right people; “it takes time and you

need to build up trust”. We have built up very good connections with the State of

Bavaria, the Ministry Of Economic Affairs and they have supported us through the

bad times. Creativity is vital to attracting the right people and one of the most

important characteristics of people you hire is creativity. It is very important that

they see the results of their creativity. “This keeps enthusiasm high and everybody is

trying to do the next best thing”. You need to have flexibility, and exchange of

people is a good thing. I have the freedom to hire somebody I know is right for the

position even though I may not have the budget to pay him, but I know some women

will go on maternity leave and some will not come back and this approach works.

30. How effective is the EU funding model in terms of supporting and

developing biotechnology and the development of the Smart Economy?

Claire Skentelbery believes that there needs to be better use of the current EU

funding models. “Europe tends to ignore the reality of its biotechnology sector and

prefers the sales pitch. Europe should fund fewer companies, provide seed funding

for 10 companies with a payment by milestone achievement rather than funding 50

companies most of which will not survive because they never reach sustainability”.

Claire stated that EU funding is all minimal risk and this sends out a message that

says; “something innovative and a bit far out will not be funded” and she also

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believes there is no such thing as a lower risk biotech product. Tony Jones and

Professor Domdey also stated that there is a need to fund novel ideas. Professor

Domdey quoted the example of Eckard Wolfe who was looking for government

funding to develop a large animal model veterinary facility, namely pigs because of

their close physiology to humans, to study rare diseases. However, he did not secure

government funding even though BioM wrote the proposal. “We supported this TCF

and wrote the proposal because at the time it was probably the only one of its kind in

Germany and it would be good to have such a facility in the cluster”. Eckard secured

private funding and built a €5M stable. He is now in collaboration with the European

pharmaceutical industry and he does not even need to advertise. He has developed a

model for Cystic Fibrosis and Muscular Dystrophy and also a model for studying

Diabetes. Tony Jones poignantly stated that “there is always room for an

unreasonable man”. Claire said governments are not reaching forward enough for

companies. “The funding models are broken where private funding is moving down

the fat end of the pipeline and it is not moving backward down the pipeline”. This is

a very important point.

Claire believes that Europe’s funding strategy is to fund five biotech

companies to sustained growth. “During the boom years Germany and Japan would

fund e.g. 100 companies and if only five were successful they would create jobs and

create tax payments on wages. Either way they both ended up with successful

biotechnology clusters”. Claire stated that the reason this model worked was during

the boom-years they had enough money to throw at it and government did not

change every four years. “The problem with government change is that a new

government drives their own ideas, and if existing ventures do not fit in there, they

are in danger of disappearing due to the electoral cycle”. Claire believed that

another reason Germany and Japan were successful is that they always look long

term and are not looking at share price values and thinking beyond the corporate

public sector. Indeed, all the experts agreed that developing a sustainable biotech

sector needed long-term planning independent of government electoral cycle

changes.

Claire was in favour of the Euro Tran’s Bio or Eurostar Projects and believed

they had huge potential in that it’s the logical way to fund international

collaborations by using existing research budgets. However; the main disadvantage

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of Eurostar is that if you have a brilliant proposal between e.g. Germany, Spain, and

France; if one of the countries has only a tiny amount of money available for that

call, then the project will not be funded even if the other countries meet the required

financial quota.

Claire stated that “a few years ago CEBR tried to set up a Joint International

Seed Fund but the critical stall point was that people did not want to spend money

outside of their own region or country. “Countries are afraid that the benefit will be

felt elsewhere which is ridiculous. The mission of CEBR is defragmenting

biotechnology, its healthy competition and cooperation”.

Claire was critical of government funding strategy because it changes with

the electoral cycle which impacts greatly on deliverables making it very difficult to

achieve consistency. This was the general consensus across all the expert interviews.

“Regions like Catalonia have done better because they have had consistency of

policy despite government change. Government needs to be more cross-border and

cross party on developing science. The delivery time is too long to be felt in one

political term”. According to Claire when people can’t get what they want from their

government they have to go somewhere else. She believed here should be a much

more formal EU planning process linking together facilities. “For example, we could

link the development stages of Ireland on some new antibody to the facilities in

Europe that sit next to each other in the different stages of implementing and

developing antibodies by creating a logical pipeline. Waiting for countries to do

those them is not viable because it will never happen”. Mary Skelly stated this point

also and highlighted it as a model for progression of drug development and reduction

in delivery time stating that “companies with compatible specialities should

collaborate” i.e. dividing phases 1, 2, and 3 and coming to a profit sharing

agreement.

Claire stated if EU money was granted for state facility development,

legislation should be in place that the facility is open at European level and that it

formally goes into a structure of open access. As an example Claire quoted the EU

Water Quality Directive which improved the water quality across Europe. “This

would never have been implemented by National Government. The EU Commission

makes unpleasant decisions forcing better quality at national level. It’s ironic that

the current financial crisis is going to bring us more uniformity across Europe

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because it has to if we are going to achieve economic stability. The commercial

payback for Europe implementing a European strategy for biotechnology and cluster

development is so huge it’s massive”.

31. During the course of interviews, many experts have expressed

dissatisfaction with the current model of accessing HEI TCF’s. How

would you address this issue and what model would encourage

industry to use academic TCF’s?

Claire Skentelbery stated that academic institutes like Cambridge do not provide

research infrastructure locally. This of course disagrees with Derek Jones of the

Babraham Institute and Tony Jones of One Nucleus. Claire believes that access to

research infrastructure would unlock a lot of things but there are two challenges

involved. “Number one is the continuing struggle to professionalise access to

research infrastructure. Number two is getting companies to use those research

infrastructures”. Claire believed that the voucher scheme could be used to develop

this and felt it was unlikely to be done without some kind of financial initiative or

cost reduction.

Clair indicated that the problem with giving vouchers to SMEs to have some

work done is that they would prefer if a company did it because they are more

aligned to timelines, whereas HEI’s were not. Claire expressed the view that

companies expect a €5000 voucher to buy them €50,000 worth of work within an

academic institution, and the feeling was that an academic researcher might see the

work as secondary to his own work. This view was also expressed by Derek Jones

of the Babraham Institute and Martino Picardo of the Stevenage Biocatalyst

Claire reverted to a meeting she had with the manager of a new cluster in Israel

who stated that rather than using the University facilities he was building a new

Stem Cell Institute that will be run for professional service provision and academic

research will then take place in the Institute. “He is reverting the University into a

professionally run facility”. Claire stated that the Institute of Nano biotechnology

has also adopted this model and runs professional contracts with companies all over

Israel. Claire was in favour of the Caltech Georgia model and the Fraunhofers model

as an effective way of directly interfacing with industry and indicated that in general

universities were not professional enough to interface with industry; also Tech

Transfer offices need to be critically assessed.

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32. The pharmaceutical industry model has been described as old

fashioned and outdated. Do we need to develop a model where

pharmaceutical companies work with SME’s?

Claire was supportive of pharmaceutical companies setting up innovation centres to

work with SMEs and felt it was a very attractive model. “The centres are purely

private sector funded and they know the right language to talk and what to do and

what is needed, more so than government organisations or universities. Stevenage is

probably the closest model we have to that in the UK because of their links with

GSK. GSK offer consultancy to companies in partnership with them and the GSK

supply a specialist to work with the company”.

Individual questions for Professor Horst Domdey

1. How important is it for the cluster management to have autonomy over

the running of the cluster?

Horst believes that you need the freedom to run your organisation;” your hands

cannot be tied by bureaucracy. If we want to do something entirely new we have the

autonomy to do it and that is one of the key elements of Bio M. We are not a Cluster

Management Organisation; we are a Cluster Development Organisation because we

want to develop. We decided to enter a competition called the Leading Edge Cluster

Competition in accordance with the Ministry of Research. We won and the federal

government gave us another €40 million which was matched by local companies.

The Bavarian government are very happy with us and gave us another €20 million so

we had €100 million because we decided to enter this competition. We didn’t need

permission; we just did it and use the money to work on personalised medicine. The

decision to research personalised medicine brought the clinicians and the

pharmaceutical companies into BIO-M, something we had tried to do for years. Big

Pharma was only interested if we had phase 2 or phase 3 drugs and the clinicians

said,” You are biotechnology, we treat patients”. “This gave BioM an official

platform where we could cooperate with the clinicians and the Pharma industry. And

most importantly we were supported by the Federal Ministry of Research and the

Bavarian Ministry of Economic Affairs. It is very important to build a strong

network with big Pharma, clinicians and the government”.

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2. What benefits have you derived from engagement in transnational

collaborations?

“We strongly support transnational activities. There is an event in Boston called bio

Pharma America where we present our companies to big pharmaceutical companies

such as GSK, Novartis and other major players. Last year we signed an agreement

with the Osaka Biotechnology Fortecture in Consa West Japan with 200

pharmaceutical companies. The agreement gave us immediate access to the

pharmaceutical companies. These Pharma companies need innovation because there

is not a strong biotechnology industry in the region. We are planning a delegation

visit by 18 Munich/Bavarian-based biotech companies to Bio Japan which takes

place in Yokohama Tokyo. This allows us to study their business model. In one case

a contact was made and a licence agreement to take over one company. The

delegation visit was 80% funded by the German Ministry of Research. We are also

connected to the Boston Biotech Area; we exchanged some ideas with them, and this

opens doors. Through membership of the CEBR we have made strong connections

with clusters throughout Europe e.g. Barcelona, Star column, and Belgium.

Connection to the University can be counter-productive and we have found that if

the idea did not generate in the University, then they don’t want to collaborate. This

is typical of universities”.

3. Under what circumstances would you approve industry use of academic

TCF’s?

“In 1997 when we started BIO-M one of the major components of our concept were

shared technologies. It proved difficult due to too much competition. So now the

TCFs are part of our network, e.g. University cores and companies. It is very

important to support the companies offering the core facilities, but we do not support

them as competitors. We are part of the incubator and there we have 30 to 40

companies who offer their services. We invite core facilities from universities

because they have some technologies that cannot be accessed anywhere else. We

recommend cores in the Max Planck’s Institute. But we differentiate what can be

done by a company and what can be done by the University and a core facility. Less

sophisticated work can be done by companies but we recommend that more

specialised work is done by core facilities”.

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“We sent in a proposal here for funding to set up a core facility for veterinary

medicine using large animal models, namely pigs, whose physiology is very similar

to that of humans. The federal government did not give funding but the professor

whose idea it was got finance to build a €5 million pig stable. He started

collaborating with pharmaceutical companies internationally. We supported this

TCF because it was novel and probably the only one of its kind in Europe. We put 2

man months into writing this proposal. This man’s name is Eckhard Wolf and he

already has developed a model for diabetes. He doesn’t need to advertise because he

is heavily involved with the big Pharma”.

4. How would you define a TCF in BioM

“In general a core facility is technologies providing a service. It is not just to

provide equipment but you need to provide the personnel to use this equipment.

Again I come back to the point; we support core facilities as soon as they are

specialised as long as they do not interfere with the market”.

5. How important is it to have full time technicians? (discussion)

“I don’t see the turnover of staff as a bad thing; about one third of our staff here are

technicians. In the USA you don’t find as many technicians and this makes running a

TCF more difficult. Here the technicians play a big role in keeping the technology

in-house. In the University technicians have permanent positions and are involved in

training students”.

6. Do you think that proximity of TCF’s is a factor in cluster success?

“This is the kind of science Park we have here. We located the Department of

Pharmacy and the Department of Chemistry on the campus. We decided then to

build an incubator starting with 800 m² and now it is grown to 25,000 m². We fully

support this incubator but we do not run the incubator ourselves because that is

another business and we did not want to be diverted from our main goal which was

to build the type of science Park we planned. We have attracted four companies from

abroad to settle here. They settled here because they have access to all the services

they need. Location and proximity to service is really important in cluster

development. We have similar science parks in Northern Bavaria. They built an

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incubator in another German University in Bavaria, just 15 minutes from the

campus and it does not work and people go there but reluctantly. Other universities

say they would like to locate a group here because they could learn from others. We

have a waiting list of 5000 m²”. This would suggest that transnational clusters only

work if the basics are local and they offer something unique on top.

7. How important is thinking outside the box to address novel research

questions?

“It is very important that you have the possibility of electronic communication but

the campus, the cluster effect plays a very important role. People need to interact for

new ideas to emerge. What I saw in Harvard Medical School; I remember a guy who

was doing some work on frog’s legs in conjunction with a hospital orthopaedic

Department; so the more novel the idea the better the chances of getting funding. It

is also important to support some strange ideas because they may result in some new

innovations. If some scientist is researching exceptionally rare disease, you need to

look outside the box. Sometimes people only see what was done before and they see

no new possibilities. A modern scientific approach is essential to answer the

exceptional problems”.

8. In BIO-M what is the breakdown between public/private sector

infrastructures?

“Public sector is 90%; the companies do not have enough money to finance good

research so they have to rely on the research institutes. In the 90s companies had a

lot of money to do this type of research which resulted in a lack of success because

this was just academic research for University professors. This resulted in new

innovations coming from the University”. This implies again that academics that

understand industry and are not just self-focused is crucial in making TCF access

useful. Also to some extent it is in conflict with Horst’s view that HE TCFs

represent unfair competition.

9. Is it difficult for TCF’s in Germany to access sustainable funding?

“The problem with these core facilities is that they have to support themselves at the

end of the day and that is difficult. This is also a problem within university core

facilities. You need some infra-mural financing structures otherwise it does not

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work. The reason why we do not have so many core facilities in Munich is because

we have so many service companies who can do equally the same work or even

better. In specialised areas like microscopy which is very specialised and not offered

by many companies, people do it on a more research collaboration basis but not so

much a TCF. The University of Regensburg has some very specific technology but

they are not organised as a core facility and they are run by the Department Of

Research. They collaborate with other HEI’s and can charge other institutes for the

service. The Max Planck’s Institute here has a much specialised sequencing facility

but if they need fast results they contract out to a company”.

10. Employment laws and culture differs across Europe and the US. Do

these cultural differences cause problems for foreign companies thinking

of locating in Germany?

“The employment policy in most of Europe and the USA is such that if you have a

problem you hire somebody to fix it and when it’s fixed you can let them go. That is

not the situation in Germany. If you hire a person in Germany they are hired for

good so it’s not a hire and fire situation and this can be a real problem for a new

company is starting. They would hire staff for the research stage and five years later

you could be in the development stage, but you cannot fire the research staff. This is

not a problem if the company is growing you can hire new people. But usually the

company does not have enough money and the people you are hired for research do

not know how to do the development. I remember the case of a biotech company; I

was sitting on the board of directors. The company had a lack of money and the

American investors suggested making 80% of the staff redundant. But this was not

possible because if you lay off the workers you have to pay them so much in

redundancy that your money is gone any way which resulted in the American

investors saying that they would never invest in Germany again. This is one of the

major reasons why companies do not invest in Germany because restructuring

companies is so difficult here. This is why consultancies and universities offer one-

year contracts only. This is perhaps a general problem for Europe. One instrument

in Germany to combat this is that the company keeps the staff on a 40 hour week and

the government pays 70% of their salary and then when the company goes into profit

everything revert back to the original contract. This means you keep all the good

people you have”.

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11. To what do you attribute the success of BIO-M? How big a role has

sustainable government funding played?

“I would say in our success is down to the excellent science we have here and

sustainable Government funding has played a big role. That level of support may not

exist everywhere in Germany, but here in Munich the Federal Government was very

supportive and happy that we were using science to create innovation and

commercialisation. So the companies became an integral part of the community

here. We have built up relationships with many clinical institutes. We fill a gap that

industry needed to fill and we do things to promote industry and the Bavarian

Government recognises that. This makes things easier for our scientists because they

want to come here because they know they will get the support to do their work”.

12. What effect do company mergers or take-overs have on cluster

development and how are take-overs and mergers viewed by the German

Government?

“It’s not a bad thing when a company is taken over if the company can stay in the

home country. If a company is taken over and its assets and IP are acquired and the

company is closed down then this is bad for cluster development. If the buyer is only

interested in one product then the company can be sold back to the shareholders and

continue under a different name. Another example where a takeover is good for a

cluster development is if the buyer uses the company to expand its presence in

Europe. So the company continues under the same name and its products are sold by

the buyer. The German government would prefer if new companies were developed

and become profitable by themselves. I support service companies being taken over

but where you have two CRO’s doing the same thing I support mergers or

collaborative joint ventures that produce better products for clients such as

pharmaceutical companies”.

Individual Questions Martino Picardo

1. Could you define a successful incubation model for Ireland?

“Each incubator should deal with its own environment and its own deal flow and its

own people. There needs to be an awareness of what’s going on in NIBRT, the

Conway Institute and Trinity College because Ireland is not big enough for

duplication of facilities unless somebody can convince me that the investor appetite

and the people and the IP and the deal flow are there”. This in theory has been the

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policy in Ireland for some time, although numerous examples of politics intervention

etc.

2. What is needed to create a successful biotechnology cluster in Ireland?

Martino believes that before you build an incubator, Science Park or centre, you

need to map what’s already in place “what have we got? Where are we strong?

Where are we weak? What do we need next? To get venture capital support in

Ireland, you need to convince the global market that there is something in Ireland

that you cannot get anywhere else. If you have joined-up thinking, it leads to public

money being pumped in and joined-up thinking facilitates creating a hub around

which a cluster can develop. Ireland does not have much in the way of drug

development or drug discovery which is real biotechnology. No country can be the

best at everything e.g. inflammatory diseases, respiratory, cardiovascular, oncology

etc. so a country needs to focus on what it does best. There is no pharmaceutical

research and development in Ireland. You need to join up what you have to see what

is already there. The bulk of what is in Ireland is medical technologies and services.

Ireland strengths lay in medical technology, CRO’s, analytical services. Whatever

clusters you develop, needs to be based on demand and cannot be seen as local

parochial. What can you provide to the outside world that starts in Ireland, then

goes to Europe and the UK and then globally?

As regards incubators; if public funds are being used to fund an incubator, you need

to be clear on your objectives and your goals. Usually incubators are about job

creation and they are a long-term project. To successfully develop an incubator you

need to have a long-term plan and have some metrics in place to project where you

will be in one year, three years, five years and so on. The Manchester bio incubator

created 1600 jobs over 10 years and received £200 million in VC funding. It’s not

enough to just have the money to build an incubator, you need the money to fund it

and it becomes sustainable and you need a pragmatic view of what is and is not

achievable and an in depth knowledge of the local environment”.

Individual Questions Mary Skelly

1. Your company is located in Ireland but you do most of your research

and development in the US. How have you found doing business in

Ireland v the US?

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Mary Skelly believes cultural differences are a major stumbling block when

comparing doing business in Ireland v America. When engaging in new business

ventures in the US the culture is such that entrepreneurs are encouraged to be

adventurous and there is no shame attached to failure. “In Ireland you are

questioned as to why you are so brilliant”. Mary believes that the Irish culture is

geared towards people with wealth or belonging to a certain social background.

“Public/private structures are more accessible in the US”. As an example, Mary

named Kentucky as one of the Poorest states in the US, but it provides $30,000 for

legitimate companies to present a credible business plan and the prospect of creating

employment that does not have to be repaid. “Once the premises are located and a

one year contract is signed a repayable grant of $75,000 is given”. Mary also said

that “the Federal Agencies in the US have a willingness to support SME’s and that

50% of technology is from non-academic facilities. This means that unlike the EU, a

lot of the TCF’s are in the private sector. US university facilities are shared and

access is available to external users. NIBRT should be managed by a totally

independent team and not be branded by UCD/DCU”

“The Research Triangle Park (RTP) is one of America’s most successful clusters

that was started almost 40 years ago and has continued to grow even during the

recession due to strong support from state leaders and continued state investment in

high tech worker training”. Mary stated that the RTP had maintained the ability to

change and work with SME’s; several of which had grown into large companies.

Mary stated that the US support program for SME’s “bends over backwards to

prevent failure”. Mary finds that US companies and the people who run them are

accessible no matter what position they hold, whereas is Ireland it’s difficult to get

business leaders to converse with you. Europe also fails in not providing adequate

funding for start-up companies, “€15,000 - €30,000 is not enough for biotech start-

ups and does not support export capacity”. Mary stated that people in charge of

biotechnology in the US are essentially biotechnology entrepreneurs and that

Enterprise Ireland needed to adopt this model and be more accessible. “Ireland

needs to offer more than tax credits to companies. All academic core facilities

should be tax-free zones. This allows job creation in providing wages and each wage

has a tax attached”.

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Individual Questions for Tony Jones

1. There is virtually no R&D in Ireland and we are reliant on

manufacturing. How do you develop a model that embraces R&D and

the growth of indigenous industries?

“It’s easy to have a negative view on research and development and say; we can’t

compete with Asia or China or the US. Look at the bits of research and development

you can do by creating your own IP. This would produce far more high-value

research. Ireland has some excellent academic institutions and if you look at their

publication record there is a lot of innovation there. There needs to be a mind-set of

investment in innovation, and a willingness to go down the innovation pipeline.

Derek Jones believes Ireland’s strength lies in high-tech food processing”.

2. What model would you like to see developing for biotechnology going

forward?

“We have to develop a collaborative model whether its open innovation or whatever

and we need to find a way of working together with the multiple parties to get into

the value chain. A lot of time companies are academics they don’t have the money

but they have the capacity, so it’s about trying to match capacity gaps. A sense of

ownership has to happen and that can only happen at the community level. By

sharing underutilised technology you make the sector more cash efficient!

Individual Questions for Claire Skentelbery

1. What is your view of the EU Commission introducing quality standards

for clusters?

“There is a huge shift from the enthusiastic start-up of a cluster to serious

assessments of what they are doing and how they are managed. There should be a

quality standard for clusters but the plan being implemented by the EU Commission

is not feasible because many clusters already have very strict policies in place. The

plan being proposed is just a ticket for consultants who are not experts on cluster

development and management to make a lot of money. I think cluster managers will

be very cynical because their job is not cluster development”. This is of course

different to Horst Domdey’s opinion. “Clusters can benefit from training but it has

to be from a trusted person. This quality standard will not impact on what a lot of

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clusters do and they want to spend money on it if there is no added value. That is

why the EU Commission is making it mandatory to access cluster funding”.

2. Innovations seldom end up in the cluster where they were born – is this

true?

“The development pipeline for a technology never stays in the same cluster. It must

go somewhere else. This makes it difficult to measure growth even if it’s in shifting

markets”.

3. What is the benefit of CEBR membership and how are you funded?

“I would say CEBR has a positive effect on cluster development; we have a network

of 50 clusters across Europe. We are totally self-funded by membership fees and

sponsorship. Being part of this CEBR network gives access to technology transfer

offices, consultancies, hospitals and anybody else who is interested in work to

support a cluster and make it grow. CEBR is the primary point of contact for

companies in their community. CEBR is drawing a map of our network to identify

and fill identified gaps. In 2013 we will be a legally independent entity and we will

try to cement our position as the network for Europe. The mission of CEBR is

defragmenting biotechnology, its healthy competition and cooperation”.

4. What are your views on cluster development in Ireland?

“Companies need to look at their niche areas and developed the environment that

they have. Country should look at what made them strong in the first place and

remember the legacy that created economic power. It’s redefining your capabilities

and we don’t have to be like Germany, only Germany is like Germany. Clusters are

almost impossible to replicate and that is why you should do what works for you.

When plans lose momentum, when the government cycle changes, it halts progress.

NIBRT should have become a high profile centre of excellence located in Athlone

and interfacing with industry, but because of bureaucracy and government change

the budget was lost and it ended up being a facility half of its original size and linked

to an academic organisation. This stifles industry interface and promotion on a

global scale leading to less investment and had a definite of the development of the

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Irish biotechnology sector. . You have got to control things very carefully and

implement a long-term sustainable budget”.

Table 3.16 Consensus between Experts answers to questions 1 to 33 - Short

answers to individual questions

Questions Experts Initials

Q HD CS MP MT MS TJ DJ 0/0 %

1 × × × × × × × 7/7 100

2 × × × 3/7 42.85

3 × × × 3/7 42.85

4 × × × × 4/7 57.15

5 × × × × × × 6/7 85.7

6 × × × × 4/7 57.15

7 × × 2/7 28.6

8 × 1/7 14.3

9 × × × × × × × 7/7 100

10 × × × × × × 6/7 85.7

11 × × × × × 5/7 71.43

12 × × × × × 5/7 71.43

13 × × × 3/7 42.85

14 × 1/7 14.3

15 × × 2/7 28.6

16 × × × × 4/7 57.15

17 × × 2/7 28.6

18 × × × × 4/7 57.15

19 × 1/7 14.3

20 × 1/7 14.3

21 × × × 3/7 42.85

22 × × × 3/7 42.85

23 × × × 3/7 42.85

24 × × × 3/7 42.85

25 × × 2/7 28.6

26 × × × × 4/7 57.15

27 × × 2/7 28.6

28 × × 2/7 28.6

29 × × 2/7 28.6

30 × × 2/7 28.6

31 × 1/7 14.3

32 × 1/7 14.3

INDIVIDUAL QUESTIONS HORST DOMDEY

1 Cluster managers need autonomy over decision making in their cluster

2 Transnational collaborations are important for cluster development

3 Academic TCF’s can offer technologies to Industry only when they are novel

4 A TCF provides technologies and expertise in a service capacity

5 Full time technicians are vital for provision of services and maintaining skills

6 Proximity of TCF’s is vital to cluster development

7 It is important to be creative because novelty enhances acquisition of funding

8 90% of companies in Germany are in the public sector

9 Public and private TCF’s have difficulty achieving sustainability

10 The employment laws in Germany are not conducive to attracting foreign investment

11 Our success is down to excellent science and sustainable government funding

12 Company mergers and take-overs can have a negative or positive on cluster

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development, depending on whether the I.P. stays in Germany. The German

Government would prefer to see companies growing in Germany and staying in

Germany.

INDIVIDUAL QUESTIONS CLAIRE SKENTELBERRY

1 The plan being proposed is just a ticket for consultants who are not experts in cluster

development or management to make money, and cluster managers will be very cynical

2 The development pipeline for a technology never stays in the same cluster

3 The CEBR has a positive effect on cluster development; our aim is to defragment

biotechnology

4 Companies need to look at their niche areas and develop the environment they have

INDIVIDUAL QUESTIONS TONY JONES

1 Ireland’s strength lies in high-tech food processing, but there needs to be a mind-set of

investment in innovation and a willingness to go down the innovation pipeline

2 Develop a collaborative model; whether it’s open-innovation, and find a way of

working together with multiple parties to get back into the value-chain

INDIVIDUAL QUESTIONS MARY SKELLY

1 The cultural differences, lack of government investment, and attitude of appointed

officials make developing a sustainable business in Ireland difficult in comparison to

the US

INDIVIDUAL QUESTIONS MARTINO PICCARDO

1 An incubator should deal with its own environment, deal-flow, and its own people

2 To build a cluster in Ireland you need to map what you have, do SWOT analysis, have a

unique offering globally, have joined-up thinking, and have sustainable funding and

long-term planning

HD = Horst Domdey BioM - CS = Claire Skentelbery CEBR - MP = Martino Picardo Stevenage -

MT = Mario Thomas OCE - MS = Mary Skelly Microbide - TJ = Tony Jones One Nucleus - DJ =

Derek Jones Babraham

3.19 Recommendations to Strengthen the Biotechnology Sector in

the Atlantic Area The report “Recommendations to Support the Growth of a Bio-Based Economy” was

published in November 2012 by Bruno Sommer Ferreira, general coordinator, data

collection, and revision for the ShareBiotech consortium of partners. Table 3.9 is a

summary of the recommendations, and the “Issues column” is the views of the thesis

author. The full 61 page document can be accessed on www.sharebiotech.net under

the press/publications tab. The full text of recommendations can be accessed in

(Appendix 6).

The study analyzed the technology landscape in the ShareBiotech Regions and gave

recommendations to technological networks and Policy makers in the Atlantic Area

to support the growth of a bio-based economy.

The resulting report presented a short profile of the ShareBiotech regions, which

focused on the economy of each region, the existence of policies to foster the

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development of biotechnology as a sector (central and regional policies, biotech-

specific or not), the financial resources available for research, innovation, and for the

creation of businesses (public and private, financial and corporate investment), the

clustering initiative, and finally gave a short overview of the biotech landscape for

each region.

The analysis showed a patchwork landscape which reflected the fact that the regions

belonged to different countries, with different economic and social environments,

administrative organizations, policies and strategies, different investment practices,

international outreach and priorities. However, common aspects were found such as

a specialization in health and well-being applications of biotechnology, well in line

with the European average reality, but limiting the differentiation potential. Also,

common barriers to R&D, lack of specialized competencies in-house (mainly for

small companies or for companies working in areas which interface different areas of

knowledge) and the lack of human resources experienced in for senior positions of

management, science and engineering. In addition to those barriers, the difficulty to

find partners, such as specialized service providers, scientific research groups,

investors or other companies, and the cost and lack of know-how require effective IP

protection were mentioned across various regions.

Recommendations were proposed in order to enhance the cooperation between the

regions participating in ShareBiotech, building on the existing capacities and

potential synergies, and in order to address some of the innovation barriers that were

identified. The main recommendations were:

1. Deploy one large-scale transnational collaborative project on Marine

Biotechnology, a strategic topic in which the Atlantic Area can compete at

global scale and actively participate in initiatives being launched on that

topic, such as ERA-NET on Marine Biotechnology (ERA-MB).

2. Establish a permanent collaborative network for technology share and

transfer to more effectively source information, better match demand and

offer of technology, and share best practice.

3. Improve the visibility of academic competences and promote stronger

linkages within the innovation system by repositioning the strategy and

increase pro-activity of technology transfer and liaison officers at publically

funded institutions, including the creation of a position for business

development, and intensify the interaction between the relevant actors

(regional authorities, university and research institutes or national

laboratories,, business associations and financing institutions).

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4. Correct some infrastructural deficiencies, such as providing adequate

facilities in incubators with wet-labs, or set up a specialized bio-incubator

when the dynamic of the local region justifies it.

5. Set up a limited number of open access integrated multi-purpose pilot scale

facilities for industrial bio-processes (e.g. to support the development of bio-

refinery activities)

6. Set up a network of Biological Resource Centers (BRC’s) within the

ShareBiotech regions.

7. Map and access the capacity and integrate the best possible “Omic”

platforms available within the ShareBiotech regions to create a network of

diversified (Omic)” platforms with the capacity to serve the needs of the

ShareBiotech regions, and offer those capabilities outside the network. All of

the recommendations are presented in (Table 3.9).

Table 3.15: Summary of Recommendations to Support the Growth

of a Bio-Based Economy (Appendix 6)

Recommendation Issues

Cover the operating expenses of the infrastructures and up-

grade existing ones

A more extensive and frequent funding

programme for handling updating of

capital infrastructure and contributing

to operating costs would be very

useful, but this of course won’t be

applicable to all TCFs

Current curricula should be revamped in order to include a

diversified set of transferable skills

The creation of new real world applied

courses is important, but such

curricular content is unlikely to be

incorporated into all programmes.

Masters in Research (MRes) etc. could

address this

One University from each region should get involved in the

Life Science, Marine and Agricultural Universities Forum

Marine research should be a significant

domain for the Atlantic Region.

Presume this engagement would be

useful

Synergies should be sought for establishing life-long

training structures, for example the (above)-mentioned

biopharmaceuticals and biomedical production training

Facilities offering e.g. bioprocessing

training are being selectively

developed, e.g. NIBRT. There are

options for ShareBiotech partners to

develop such programmes with

industry engagement

Marine biotechnology should be elected as a strategic topic

for ShareBiotech regions; deploy one large-scale

collaborative project

Marine biotech is a necessary core

domain for the region. Debatable

regarding the desired number and

nature of projects

All ShareBiotech regions are recommended to take part in

the future ERA-NET marine Biotechnology

Yes, should happen in partnership

Take part in the JPI Oceans

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Set up of Knowledge and Innovation Communities (KIC’s)

devoted to Atlantic Marine Biotechnology stimulated by

the partners of the ShareBiotech regions, or consider the

integration in the Marine KIC initiative

Private company or public facility? As

a driver of innovation, yes important &

should be connected with other planned

marine bio research

Establish collaboration network/partnership in the fields of

biomaterials, cell therapies and regenerative medicine

All substantial & growing fields but

tend to have large establishment in

non-Atlantic regions. Networks exist,

but options for new models exists

Establish collaboration network/partnership in the fields of

biorefineries

Low scale of biorefinery work

currently on-going – need to increase.

Will become very important with

further decline of oil industry. Costs

need to be addressed. Target should be

key chemicals, not biofuels to reduce

impact on food production. Biofuel

requires alternative plant sources, e.g.

reactor growth

Promote stronger linkages within the innovation system Important need, but requires serious

customisation to deliver new benefits

and outcomes

Visibility and advertisement of the academic competences

need to be dramatically improved

There is substantive dissemination of

academic competence and history, but

perhaps greater need for applied

focused institutions such as

Fraunhofers etc.

Establish a permanent collaborative network in order to

share best practice and to more effectively source

information and perform the matching between demand

and offer of technology

Formal progression of TCF network

with enhanced collaboration, access

models, interfacing, communication,

task delivery, training etc. is important

Each node of the above mentioned network should create a

position for business development (without duplication of

work...)

Design and operation of such networks

needs to be finalised, but assumes

strong capacity for supporting SMEs

and facilitating tech transfer

It is recommended that some existing infrastructure

deficiencies are corrected (e.g. Bioincubator...)

Biotech parks usually include company

accessible core facilities such as bio-

incubators – structure do need be

planned and extended

Set up a limited number of open accesses pilot scale

facilities (biorefineries, fermentation…)

It represents a risk, but creation of

competent specialist TCFs with cheap

access, would be very useful and a

practical contributor to innovative

company & R&D development. Some

smaller more basic facilities may

extend to community access – Living

Lab/Science Shop

Set up an on-line bioinformatics collaborative platform to

gather and share bioinformatics capabilities of the network

Significant bioinformatics data

platforms already exist for those in a

position handle such data.

Bioinformatics competence and

necessary resources are an important

element of any biotech network

engaged in genomics / proteomics etc.

Map and asses the capacity of the available "omic"

platforms

Yes, necessary to extend TCF map to

include more info regarding company

links and commercialisation research

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and particular domains such as “omics”

Set up a network of biological resource centres within the

ShareBiotech region

Instruments to Mobilise Life Science Infrastructures

Mobilize INTERREG/European Territorial Cooperation Important to continue and evolve

Interreg programmes

Structural funds Emphasis on EU research

infrastructure

Mobilize FP7/Horizon 2020 An inevitable major source of

transnational funding

ERA-Net Of value

Eureka Eurostar Employ as selected model for Atlantic

Region TCF access models

3.20 Biotechnology Education “Training Offer & Needs in the Atlantic Area” (Appendix 6)

The Lisbon European Council set up an ambitious strategic goal in 2000 “to become

the most competitive and dynamic knowledge-based economy in the world capable

of sustainable economic growth and more and better jobs and greater social

cohesion” (Lisbon European Council, 2000). ShareBiotech – Sharing life science

infrastructures and skills to benefit the Atlantic Area biotechnology sector and aimed

to promote transnational networks of innovation and entrepreneurship which focused

on knowledge transfer between research centres and firms. Technological, scientific,

and organisational breakthroughs were generally generated at the interface of a

variety of disciplines and approaches. One of the objectives of ShareBiotech was to

stimulate links between academia and industry using several instruments, one of

which was to connect people from different life science fields (human, health, food,

marine, biology, bioinformatics, etc.) and cultures (research/business) through

training and mobility and development of workshops, i.e. Local Technology

Meetings, (LTM’s). ShareBiotech activities funded 170 mobility grants and 41

LTMs that were attended by more than 1600 people. The overall impact of

ShareBiotech on providing training was fairly modest, although this was

unsurprising as this was not a key axis of the project. The actions of ShareBiotech

served to reinforce the notion that more actions are needed to develop an appropriate

offer for training needs but that short term mobility’s for training were an effective

means of specialised training and networking. However, alternative training models

are required to attract SMEs and to offer what they require. Overall, significant gaps

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in the Biotechnology training offer exists in the Atlantic Area and it will be

important in the future to focus on the development of Biotechnology training in

order to reinforce the sustainability of this sector.

In the context of the European strategies and recommendations to improve Education

and training in Life Sciences as a base for a sustainable Bio economy, a report

(Biotechnology Education; Training Offer and Needs in the Atlantic Area) was

commissioned to identify the skills and training needs in the area of Biotechnology

in the Atlantic Area) within the ShareBiotech partner regions) and to provide

recommendations to improve the training offer and Education in this area. This

report was published in 2013 (wwwsharebiotech.net).

Formal Higher Education Degrees

A wide range of University degrees in Life Sciences, which can serve as the basis for

specific training for the Biotechnology sector were identified in higher education

(HE) institutions in all partner regions. However, only degrees strictly related to

Biotechnology were collected during the investigation summarized in (Figure 3.).

Figure 3.106: Number & Type of Forman Higher Education Biotechnology

Degrees identified per ShareBiotech region (Source: Biotechnology Education Training

and Needs in the Atlantic Area)

Higher Education Degrees in Biotechnology were identified in all ShareBiotech

regions and there was substantial variation in the offer of specific Biotechnology

degrees in H.E. Systems of the regions. The North of Portugal had a high level of

BSc and MSc in biotechnology followed by the BMW region (Ireland), Bretagne

(France), and the centre of Portugal. Three of the partner regions, Navarra, Spain,

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Algarve and North Portugal also offered training in biotechnology at PhD level.

Some courses in the S&E region of Ireland were available as a distance learning

option.

Figure 3.107: The number and type of vocational courses related to Biotechnology

identified per region (Source: Biotechnology Education Training and Needs in the

Atlantic Area)

Some regions (e.g. Portuguese regions Algarve and Centro) offered almost

exclusively only short and occasional/infrequent types of training mainly short

courses/workshops. The S&E region of Ireland had a very high offer of short

courses/workshops. The vocational training offer in Ireland tended to be either short

courses/workshops or tertiary vocational degrees with nothing in between. In

addition, the two Irish regions offered several BSc/BSc honours degrees that

conferred professional certification. Navarra had a broad distribution of vocational

training courses that were offered with a well-established frequency at both

secondary and tertiary levels. French ShareBiotech regions had no secondary

education level vocational studies in biotechnology but had a rich offer in both short

term and longer duration tertiary vocational studies.

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Figure 3.108: Types of vocational training offer per region (Source: Biotechnology

Education Training and Needs in the Atlantic Area)

Figure 3.00 shows the percentage of courses per region offered only occasionally, in

contrast to frequent courses, and those available as “Distance-Learning” options or

supplied “on demand” to companies. The regions with the best offer of courses on

supplied “on demand” to companies or available as “distance-learning” options were

Navarra and the two Irish regions (BMW/S&E).

Figure 3.109: Classification of the Current offer in Biotechnology Courses (Source:

Biotechnology Education Training and Needs in the Atlantic Area)

Most of the people responding to the questionnaire (Appendix 18) considered the

offer of Biotechnology education in their region as insufficient, but overall good or

very good in their country or Europe in general (Figure 7). Overall the results

indicated that there was a weak, ad-hoc vocational training offer in Biotechnology in

the ShareBiotech partner regions. S&E Ireland had the broadest training offer in the

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training category and together with Navarra they were the only regions offering

distance training modules.

The “Biotechnology Competencies and Technology Needs Final Report, 2011”

(www.sharebiotech.net) collected the answers from 143 research groups and 183

companies, which allowed the identification of the main training needs in this sector.

It was established that training needs were identified by 78.1% of the interviewed

research groups and by 75% of interviewed companies.

Figure 3.110: Shows the training needs identified by research groups. It was clear

the training needs in Bioinformatics (18.4) was the domain most frequently

mentioned followed by Proteomics training needs (5%). (Source: Biotechnology

Competencies and Technology Regional Needs Final Report; ShareBiotech, April

2011)

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Figure 3.111: Training needs identified by companies (Source: Biotechnology

Education Training and Needs in the Atlantic Area)

The training needs identified by interviewed companies (Figure 3.00) were mainly

connected to the Bioinformatics domain; namely, biostatistics and data analysis

(16.1%). However, a greater dispersion of needs was shown with Next-generation

sequencing (6.5%) and PCR/qPCR/RT-PCR (6.5%) also identified as important

needs.

Training Needs and Limitations Identified

The report found that a key aspect for the success of any sector was the availability

of well trained and motivated personnel and although H.E. in the ShareBiotech

partner regions offered formal University Education in Biotechnology, it was unclear

if graduates fulfilled the requirements of the SME sector. The education

questionnaire aimed to identify the lacunae that existed in the preparation of

biotechnology graduates and also other limitations.

Most Important Training Needs for Biotechnology Graduates

Identified in the report

1. Solid science background (e.g. Maths, chemistry, I.T.)

2. Laboratory experience (practical/project work components in cell culture,

molecular biology etc.)

3. Research skills (experimental design, critical interpretation of results,

scientific writing and communication

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4. Expertise in cutting-edge technologies (e.g. sequencing data generation,

bioinformatics, systems biology)

5. Marketing, entrepreneurial and technology transfer skills (IP, Licencing,

know-how, confidentiality, market survey, etc.)

6. Communication, team work, problem solving and innovative thinking

Limitations in existing education training programs in

Biotechnology, at national and regional levels 1. Lack of dissemination towards the interested targets and awareness of needs

2. High cost and uninteresting themes for SME’s

3. Lack of enough practical training (experimental projects)

4. Weak links between H.E. and the biotech industry (potential solutions invited

lecturers from industry professionals, training of students in industry,, events

to bring H.E. and SME’s together)

5. Weak bioinformatics, information technologies content and skills

6. Need to extend H.E. in future important biotechnology domains (e.g. bio-

energy, bioreactor cell culture, etc.)

7. Lack of formation of science graduates in “complementary” skills (e.g.

entrepreneurship, project management, public speaking)

Types of training offer in Biotechnology that should be provided or

improved as recommended by the report 1. Invest in “e-learning” and “blended learning” (that would allow to increase

the level of the lecturers, optimise the “virtual learning infrastructure” reach

the interested targets)

2. Increase formation in practical issues (e.g. scientific paper writing, result and

data analysis)

3. Increase cross-talk/integration between universities and companies

4. Offer short courses directed to companies, e.g. on specific needs or

techniques (e.g. cloning, sequencing, clinical diagnosis)

5. Integrate “company vision/reality” into the courses (project tutorial, lectures

from biotech companies, training industry).

Main conclusions and recommendations to improve training and

needs offer in the Atlantic Area 1. There was a strong and well organised HE training offer in Life Sciences

including Biotechnology that included BSc, MSc, PhD, in the ShareBiotech

regions

2. Information on higher degrees was in general easily accessible and common

nomenclature for HE qualifications in Europe was found for the identified

biotechnology degrees

3. In contrast, information on the vocational training offer was not readily

accessible and common nomenclature of course types and qualification

systems were heterogeneous and based on the recovered data it appeared that

the number and type of vocational courses offered in the biotechnology area

varied between partner regions.

4. Key limitations identified were the failure of the current Biotechnology

training offer to meet needs of SME’s; the lack of enough practical training

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components in HE courses; practical training opportunities inside companies

and the need for better interactions between HE and SME’s.

Figure 3.112: Soft skills in the field of biotechnology requiring short-term training

(Source: Biotechnology Education Training and Needs in the Atlantic Area)

3.21 Recommendations to Improve the Offer of Biotechnology

Training in the Atlantic Area

Capitalisation of ShareBiotech initiatives; identification of new solutions and

recommendations to optimise the biotechnology education and training offer in the

Atlantic Area were obtained by analysing the results from section 2 to 4, the answers

from the questionnaire (Appendix 12).

Main recommendations arising from the study:

1. Improve the offer of vocational training to meet the needs of SME’s in the

Biotechnology sector at an affordable cost and with an appropriate duration

and training model

2. Improve offer dissemination by publicising detailed information (type,

duration, targets, qualification and certification levels) and diversify the types

of offer (e.g. distance learning, courses on demand) to reach the interested

targets

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3. Continue the process to adapt national qualification levels to the European

qualification framework, in order to standardise the vocational education

offer in EU member states and also its mutual recognition by different

European countries.

4. Increase the practical training components, collaboration, and integration in

the biotech industry (e.g. lecturers from biotech companies, hands-on training

projects in company environments. And develop on-the-job training offer.

5. Increase the offer in the following fields, inside biotech courses or as full

specialist programmes; Bioinformatics and Biostatistics, Integrative Biology

and other cross-disciplinary education programmes, Future important biotech

domains such as Bioenergy – Biosynthesis - Bioreactor cell cultures, Non-

Academic skills such as Marketing - Entrepreneurship - Technology Transfer

- Intellectual Property - Project Management - Bio-economy, etc.

6. Organise transnational business and science training network programmes,

taking advantage of the established network of higher education, research and

industry partners from the different regions developed under the

ShareBiotech project.

The constraining factors relating to HE/SME interaction identified were similar to

those identified in the Expert Interviews Section of this thesis.

Constraining Factors to HE/SME Interaction

1. Lack of funding, human resources and time in universities and research

institutes to organise short courses that must meet SME needs and be offered

at below real cost.

2. High cost of the technology, materials, and specialised human resources for

efficient biotech training.

3. Difficult interaction between industry and academia and low exploitation of

synergies.

4. Lack of interest and time by SME’s that are normally small companies in the

sector and in the participating regions.

5. Lack of business culture in universities and Research Institutions and

difficulty in communicating to SME’s the benefits of interaction with such

organisations.

6. Administrative and policy-breaks in inter-regional projects due to high

numbers of institutions e.g. universities and research institutions.

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3.22 Characterisation of ShareBiotech funded Mobility Grants

Figure

3.113: Analysis of the uptake of ShareBiotech Mobility Grants (Source:

Biotechnology Education Training and Needs in the Atlantic Area)

The report found that the project failed to engage strongly with SME’s and

consequently failed to take full advantage of the mobility grants as indicated by the

awarding of only 15% to this group. A further issue was that only 37% of the

mobility grants involved training. This analysis suggested that the contribution of

mobility grants for training was modest and highlighted the need to identify

additional models and instruments for the implementation of training in

biotechnology.

ShareBiotech funded 41 LTM’s that were organised in the Atlantic Area regions by

ShareBiotech partners. The objective of the LTM’s were to connect people and

institutions from different types of organisation and partner regions, in the field of

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3.23 Characterisation of ShareBiotech Local Technology Meetings

(LTM’s)

Figure 3.114: Analysis of ShareBiotech Funded LTM’s (Source: Biotechnology

Education Training and Needs in the Atlantic Area)

biotechnology, to stimulate exchange of scientific, technological and business

between participants.

More than 1600 people participated in ShareBiotech funded LTM’s with an

average of 41 participants per event with a maximum of 189. The majority of

attendees were from Universities or Research Centres (67%), industry (13%), or

from education and training centres (6%), (Figure 3.105), with the remaining 14%

belonging to Public agencies, National, Regional and local authorities or others.

Most of the organised LTM’s consisted of workshops related to the different areas of

biotechnology (44%), but only six of these involved training. A total of 41% of

LTM’s were seminars, conferences, and forums in which different types of

knowledge were presented, mainly related to advances in the biotechnology fields

and to showcase the biotechnology platforms in the Atlantic Area. The remaining

LTM’s (15%) were meetings between people from different types of organisations,

including SME’s, research centres, and local producers.

The overall impact of ShareBiotech in responding to the training needs

identified in Activity 3 was modest; however, this was not the key axis of the

project. Overall, significant gaps in the training offer exist in the Atlantic Area and it

is important to focus of the development of biotechnology to reinforce the

sustainability of the sector

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DISCUSSION

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4 Discussion

The scale of this project is no doubt visible at this stage, embracing 10 partners over

3.5 years and a budget of €2.4M. However, the Methods, Results, and now

Discussion chapter only describe and relate to the work that I as a member of the

AIT partner, actually engaged in and delivered. The substantial expert interviews,

which will be discussed in this section, were of course unique to my engagement.

The biotechnology sector tends to require a large amount of public investment in any

country, (Niosi & Reid 2007). But public investment is obviously not the only

requirement. Countries with insufficient R&D facilities will not necessarily expand

their biotech despite large investment – in reality, the presence of large investment

usually reflects access to resources to deliver.

Despite the impact of the post-2008 financial crisis and the US business

culture to be driven solely by profit, there still remains a significant difference in

scale of the biotech sector in the EU versus the US. The US probably still

employees about twice the number in the biotech sector compared to Europe

(195,000 against 82,000) (Niosi, 2010).

The Atlantic Region within the EU, in embracing coastal regions inevitably

possesses important natural resources for the biotech sector, while inclusion of whole

countries, UK, and Ireland represent significant full-time resources. The

commonality among the Atlantic Area regions is undoubtedly marine biotech, and

this area should be significantly developed. Ireland has over 400 different types of

seaweed and sea vegetables, some of which are now present anywhere else in the

world. When conduction the survey of the Natural Products companies in Ireland,

the consensus was that they were mainly SME’s, employing two to ten people, and

these SME’s had the potential to develop, but they lacked resources such as funding,

access to TCF’s, marketing, packaging, and up-to-date technologies, mainly dryers.

These SME’s felt marginalised and insignificant at the lack of support for this

natural resource that could generate employment and revenue to an area of Ireland

that was badly hit by the 2008 recession.

Within the biopharma sector, it takes on average >10 years to develop a biotech

medicine or a plant improved through agricultural biotechnology from its inception

to regulatory approval and finally to market launch. The average, fully capitalised

cost of developing a new medicine has been estimated at $1.2B and a new

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biotechnology derived plant product at approximately $136M (Pharmaceutical

Research & Manufacturers of America, 2013).

While this project has been analysing and employing methods to facilitate enhanced

connectivity in biotech across the Atlantic Area, the right people and resources are

rarely uniformly distributed, but always limited to specific locations. A classic

indicator of this is that currently in the US, 63% of their patents are developed by

people living in just 20 metro areas, representing 34% of the country’s population.

Furthermore, 92% of US patents are concentrated in only 100 large metropolitan

areas, employing just 59% of the population. Examples are these large areas are San

Jose, Burlington, Rochester, Corvallis, and Boulder. This of course doesn’t

contradict that scientific and technical research is increasingly collaborative in the

US and globally, and this contributes to more valuable patents and publications.29

4.1 INTERREG IVC

Intereg IVC provides funding for interregional cooperation across Europe. It is

implemented under the European Community’s territorial co-operation objective and

financed through the European Regional Development Fund (ERDF). The

Operational Programme was approved in September 2007 and the period for Intereg

IVC and lasted from 2007-2013. This programme followed on from the Intereg IIIC

programme which ran from 2002-2006. The overall objective of the Intereg IVC

Programme was to improve the effectiveness of regional policies and instruments. A

project builds on the exchange of experiences among partners who are ideally

responsible for the development of their local and regional policies.

The areas of support are innovation and the knowledge economy,

environment and risk prevention. Thus, the programme aimed to contribute to the

economic modernisation and competitiveness of Europe. Intereg IVC was linked to

the objectives of Lisbon and Gothenburg agendas. Typical tools for exchange of

experience are networking activities such as thematic workshops, seminars,

conferences, surveys, and study visits. Project partners cooperate to identify and

transfer good practices. Possible project outcomes include for example case study

collections, policy recommendations, strategic guidelines or action plans. Intereg

29 htpp://www.brookings.edu/”/media/research/files/reports/2013/02/patenting%20prosperity%20rothwe

ll/patenting%20prosperity%20rothwell.pdf

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IVC also allows light implementation or piloting, but only if these complement the

exchange of experience activities.

Intereg Europe brings an indirect contribution to the achievement of the

Europe 2020 targets. It does so by offering regions the opportunity to participate in

policy learning and knowledge transfer and thereby bring an important contribution

by improving the effectiveness of the Europe 2020 related policies and projects. The

main contribution of the specific programme objectives focuses on smart and

sustainable growth, while only a small contribution to inclusive growth is seen.

Likewise the contributions to social, economic and territorial cohesion are of an

indirect nature.

The core of Intereg Europe’s purpose is to increase the capacities of all

regions in delivering better results of policies and programmes, which is why the

programme targets both socio-economic and territorial cohesion. However, the main

focus lies within economic cohesion. Furthermore the programme supports territorial

cohesion, although at a more variable scope. The programme does not bring any

significant contribution to social cohesion.

Key lessons are that Intereg Europe must step up its effort to ensure that

supported activities do in fact lead to tangible policy changes in the partner regions.

Projects should be geared to preparing the actual implementation of actions based on

the exchange. This implies that relevant local stakeholders in each partner region

need to be more systematically involved from the start of all supported activities.

Opportunities for “implementation-related activities”, e.g. pilot actions should also

be provided, as part of this stronger orientation to prepare implementation of actual

policy changes.

To strengthen the multidimensional learning and capitalisation processes, the

programme should also develop new forms to reach the wider target group of

regional policy actors in Europe, and allow them to have easy access to and learn

from the thematic knowledge and experience gathered in other regional policies and

programmes.

ShareBiotech was an Intereg IVB Atlantic Area Project which contributed to the 1st

priority of the program aiming to promote transnational, entrepreneurial, and

innovation networks. It aimed to develop knowledge transfer between companies

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and research centres. ShareBiotech’s main objective was to strengthen the

biotechnology sector within the Atlantic Area. The project was led by French

organisations, and was implemented by a consortium of 10 partners from 4 member

states (France, Spain, Portugal, and Ireland) and 7 regions. It is difficult to gauge the

impact of ShareBiotech on the biotechnology sector in Europe. It was unusual that

the project did not incorporate the leading biotechnology centres in Europe like

Germany and the UK. Having transnational collaborations in Europe is difficult in

comparison to the US because ~ 200 languages are spoken in Europe and many

different cultural differences exist. The US is one country with many cultures but the

common language is English. One would think that since Europe has a common

currency that there would be more emphasis on developing English as a common

language. The establishment of a United States of Europe would enhance the

development of collaborative projects and possibly put Europe on a par with the US.

4.2 Fragmentation of Biotechnology in Europe

Performance in R&D and innovation varies markedly across the EU Member States

(MS) and regions. The Regional Innovation Scoreboard (2012) shows that most

European countries have regions at different levels of innovation performance.

Regions that qualify as ‘Innovation leader’, mainly in the centre and north of Europe,

can be found directly next to weaker innovation regions, even within one MS. EU

regions have different strengths and weaknesses in their innovation systems,

reflected by differences in the performance for their so-called innovation ‘enablers’

e.g. education levels of the labour population and public R&D investments. R&D

resources are concentrated in a few leading regions mainly in the ‘European science-

based area’, where R&D spending can be as high as 7% of GDP, while they can be

very low (under 1%) in others.14

. A region’s investment in human capital also supports its ability to be

innovative. There is evidence that in weaker regions, mainly in parts of eastern and

southern Europe, the share of population holding a tertiary degree has a higher

impact on regional production than R&D expenditure has15

. This regional diversity

calls for regional innovation support programmes tailored specifically to the needs of

individual regions. One of the instruments available to MS and regions is to develop

smart specialisation strategies to concentrate resources for innovation support on key

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areas of intervention, clusters or sectors which represent a competitive advantage and

support the delivery of innovation in those key areas throughout the innovation

chain. Information and Communication Technologies (ICT) contribute importantly

to smart growth, as enablers of innovation, knowledge creation and e-commerce and

employment. Today the differences in quality of ICT infrastructures and e-commerce

use are mainly between countries rather than regions, with a clear north-west –

south-east divide with the north-west of Europe being most advanced. The regional

distribution of ICT employment shows an urban-rural divide with concentrations of

people working in ICT in metropolitan regions16. Interregional cooperation can

contribute to smart growth by enabling European regions to improve their regional

policies and programmes for innovation and R&D support. Experience exchange and

policy learning in key areas like, for instance, cluster support, research-to-business

technology transfer, skills development, innovation in SMEs and innovation

infrastructures will enable regions to accelerate and improve the implementation of

their regional growth policies.

ERA-Instruments is a European project bringing together funding agencies,

ministries, charities and research performing organisations to aid in establishing

centres for mid-size research instrumentation that meet the needs of the scientific

community. ERA-Instruments has surveyed and analysed the current situation of

research instrumentation in the life sciences in the context of the ongoing and

intensifying European discussion on research infrastructures. Mid-size facilities and

networks of regional centres as they are typical for the life sciences are very different

from the single-sited large scale facilities that are mostly known from the field of

physics including astronomy.

The OpenLabTools initiative aims to provide a forum and knowledge centre

for the development of low cost and open access scientific tools, with an emphasis

on undergraduate and graduate teaching and research.

Biotechnology is geared at enhancing our quality of life and responding to society’s

grand challenges such as an ageing and ever increasing population, healthcare choice

and affordability, resource efficiency, food security, climate change, energy

shortages and economic growth. Biotechnology can be found in the clothes we wear,

the products we use to wash them sustainably, the food we eat and the sources it

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comes from, the medicines we use to keep us healthy and even the fuel we use to

take us where we need to go.

Until now, biotechnology has also been a cornerstone of Europe's

competitiveness in terms of research and innovation as well as in terms of industrial

growth, number of jobs and new companies created in Member States. Today

however, we risk turning Europe into the world's biotech research hub and not

reaping the benefits of the products and services provided by this key enabling

technology (EuropaBio Biotechnology Industry Manifesto, 2014 – 2019).

Expert interviews were carried out for the purpose of this research in Canada,

UK, Germany, US, and Brussels. All the experts chosen had extensive knowledge of

the biotech sector and had significant input into the development of biotech clusters

in their respective countries and regions. The objective of these interviews was to

study the models used by these experts, and determine if these models could be

applied to the Atlantic Area. There was a clear consensus on the drivers of successful

biotech cluster development.

4.3 Sustainable Growth for Europe

Creating sustainable growth in the EU requires the creation of a strong climate for

business and enterprise. SMEs account for over 99% of businesses in Europe,

providing two thirds of all private employment and 80% of new jobs created across

the EU. However during the years of economic crisis since 2008 many SMEs

suffered and over 3 million jobs in SMEs have been lost17

. SME value added and

employment growth are slowly recovering since, and have returned to their 2008

levels in several MS in the central and northern parts of Europe. Interestingly, SME

growth rates (number of enterprises, employment, value added) in the EU12 (‘new’

Member States) outperformed those of the EU15 (‘old’ Member States) before the

crisis. However, their fall was also much bigger in 2009 than that of the EU15. Both

groups of Member States follow a similar growth pattern from 2010 onwards18

.

To support SMEs as drivers for growth and employment in Europe, several

challenges and obstacles need to be addressed in priority. These include the need to

encourage entrepreneurship, to give SMEs better access to finance, to improve SME

internationalisation, both in the EU internal and global markets19

. All this calls for

better rules, support and facilities for SMEs and this is where regions all over Europe

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have a role to play. Sustainable growth also requires policymakers to engage with the

challenges of climate change.

4.4 ShareBiotech Activity 3 Surveys (Appendix 1, 2, & 3)

As part of Activity 3 of the ShareBiotech project, a broad survey of technology uses

and requirements by research groups and companies within the ShareBiotech partner

regions was implemented (Pinto et al., 2011). The survey proved difficult to

implement due to its size and scope, and it was difficult to collect information from

every biotechnology player in each region, especially as biotechnology was not the

core discipline of all organisations, but may had formed a unit thereof (Pinto & Cruz,

2011); however, the survey provided a wealth of up-to-date data. A spreadsheet was

created in the analysis of the responses to the company and research groups surveys.

In a follow-up meeting to discuss the survey results, all consortium partners implied

that the survey was too long and complicated and did not make it attractive for

stakeholders to complete. In Ireland, a total of 300 questionnaires were circulated

between research groups, companies, and TCF’s. When it became apparent that the

response matrices were very low, the websites of each group were thoroughly

researched and relevant answers were input to the questionnaires. The partially

completed surveys were then sent to the corresponding groups, acknowledging the

time consuming nature of the survey, and they were asked to look over the partially

filled survey, and asked to fill in information not available through public sources.

This seemed to be the only viable method to glean the necessary information within

the time parameters of Activity 3. The company response excel spreadsheet

consisted of 31 rows and 446 (QD) columns and the research group’s excel

spreadsheet had 47 rows and 427 columns (PK). However, it must be taken into

account that the sample may not be statistically meaningful in representing the

diversity of the companies and research groups in each region as the percentage of

coverage between regions may differ considerably (Pinto & Cruz, 2011).

It is not unusual in hindsight to realise that elements of the project could have been

addressed differently. Preliminary studies of the Atlantic Areas biotechnology

industry, namely SME’s, Research groups, and TCF’s, would have provided

valuable information on the gaps and needs of biotechnology stakeholders, and this

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would have led to a more tailored surveys instead of relying on OECD

biotechnology categories and a one-size-fits-all approach.

The data was analysed to establish singularities and complementarities between

regions and assess if a fit existed between the technology offer in each region and the

needs of the local economy. Of the 143 companies and 183 research centres (Table

3.1) responsive to the survey each were individually asked to state one or a number

of domains to describe their activities from the following list.

Human Health

Animal Health, Veterinary

Agriculture (including animal breeding) aquaculture and silviculture

Agri-food (including beverages)

Nutrition, neutraceuticals

Cosmetics

Environment

Marine science

Industrial processing

Bioenergy

Bioinformatics

These domains were clustered in order to reduce fragmentation of the analysis and to

facilitate the comparison to available statistical data from other sources. All of the

respondents active in nutrition were also active in cosmetics (Figure 3.7 & 3.8).

83% of the respondents who were active in cosmetics and 76% of the respondents

who were active in nutrition were also active in human health, which was expected

given the unifying action of growing fields of research e.g. nutrigenomics. A further

73% of respondents active in animal health were also active in human health. The

domains of Human Health, Animal Health, Veterinary, Nutrition, Neutraceuticals,

and Cosmetics were clustered into a new domain referred to as “Health and

Wellbeing”. Bioinformatics was considered as a technology rather than a domain.

For this discussion, the domains considered were:

Health & Wellbeing

Agriculture (including animal breeding) aquaculture and silviculture

Agri-food (including beverages)

Environment

Marine science

Industrial processing

Bioenergy

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Research Groups

It was worth noting that in excess of 70% of the research groups in the ShareBiotech

region were in some way involved in the health and wellbeing domain (Figure 3.7 &

3.8), with some regions showing high specialisation in this domain, namely Pays de

la Loire, the BMW/S&E regions Ireland and Centro significant number of research

groups were active in the nutrition and cosmetics sub-domains in Pays de la Loire.

The research groups of Navarra were more focused in the agriculture, agri-food and

environment domains, as well as the bioenergy and industrial processing domains

(Figure 3.8). This was supported by the presence of an agri-food cluster. Only 22%

of the research groups were active in marine science, mainly in the Portuguese

regions Algarve and Norte and also Bretragne (Figure 3.8). It would seem logical

that legislators would see the Atlantic Area as a niche biotechnology sector for

development. It is a vast natural resource that could play a major role in economic

recovery; yet it is vastly underexploited. However, SME’s along the western

seaboard are set to benefit from a one million euro EU initiative aimed at helping

small firms in the marine biotech sector to grow and develop internationally. The

Ryan Institute – Marine Biotechnology Coordination Unit, at NUI Galway, in

partnership with WESTBIC are partners in ‘AtlanticBlueTech’, a transnational

Interreg project aimed at helping small firms along Atlantic regions of Europe

develop innovative research and development collaborations to take advantage of

opportunities from the Blue Economy.

In July 2012, the Irish Government launched ‘Harnessing our Ocean Wealth’,

an Integrated Marine Plan for Ireland, which sets out a framework that will help the

country to exploit the vast potential of its Ocean Economy. The Plan has identified

Marine Biotech as an emerging sector within the industry and has set a turnover

target of €61m for the Marine Biotechnology and Marine ICT sector by 2020. This

new field requires further R&D investment to help realise commercial return for

firms in areas such as Food, Health and Well Being, Cosmetics and Bio-Energy

fields. AtlanticBlueTech will contribute to this goal. Twenty eight percent of

respondent research groups were active in the environment domain, mainly in the

French regions and Norte. Considering the European emphasis on industrial

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processing and bioenergy, very few research groups were active in these domains

and the Navarra region was the only area with significant activity (Figure 3.8).

Companies

The health and wellbeing domain was the main focus of 73% of responsive

companies with as few as 4% active in the bioenergy domain (Figure 3.38 & 3.39).

In general the domains of research of the companies were in line with those of

research groups of the same region with some noteworthy deviations. In Bretagne,

the companies were more focused on the health and wellbeing domain than the

research groups. In the two French regions a significant number of companies were

active in the industrial processing domains, which were virtually absent from the

mentioned activities of respondent research groups. Conversely, the research groups

of these regions were actively involved in the environment domain. The

environment domain was less populated by companies in these regions. In the

BMW/S&E regions the company focus was more on the health and wellbeing

domain than their neighbouring research groups and agriculture was the only other

domain in which some company activity was detected. The respondent companies

of the Portuguese Centro region were more focused on health, but there was

significant activity in the agri-food sector. There were few companies active in

biotechnology sectors but those who were, were active in the health, environment,

and industrial sector domains. Animal health and nutrition contributed significantly

to the health and wellbeing domain in Pays de la Loire, while in Bretagne, nutrition,

and cosmetics were as important as human health. (Ref. Figure 3.39).

Current use and expressed wish to access OECD category technologies

Another surveyed area, was the current use, and expressed wish to access different

technologies that were distributed under the following OECD categories (Pinto et al.,

, 2011) (Ref. Figure 3.15).

DNA/RNA (PCR, qPCR, RT-PCR, sequencing. genotyping, transcriptomics,

microarrays, northern and western blots, antisense technology, gene probes).

Proteins (sequencing of proteins and peptides, synthesis and engineering of

proteins and peptides, protein isolation and purification, proteomics,

structural analysis, high-throughput screening and synthesis, improved

delivery methods for large molecule drugs, monoclonal and polyclonal

antibodies, metabolomics).

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Cells/Tissues (cell culture, tissue engineering, vaccine/immune stimulant,

recombinant vaccine, cellular therapy, stem cells, and embryo manipulation).

Gene/RNA vectors (gene therapy, animal transgenesis, vegetal transgenises,

microorganism transgenesis, viral vectors, synthetic vectors).

Biological resources (animal models, plant models, microorganism models,

housing and facilities for animal experimentation, housing and facilities for

plant experimentation, animal breeding, plant breeding, biological resource

centres (BRC’s), banks, collections, experimental farms).

Imaging (Magnetic Resonance Imaging (MRI), tomography, optical imaging,

electronic microscopy, ultrasound, radiography, infrared imaging).

Process biotech (fermentation, for production of food or beverages, enzymes,

active compounds, bio-based building blocks, bio-materials, bio-catalysis, 1st,

2nd

& 3rd

generation biofuels)

Nanobiotech (nanoencapsulation of bioactive products, nanopartical

formulation, high-throughput experimentation, microlabs, micro-robotics,

active compounds delivery methods, nanostructures, characterisation of

nanoparticles, incorporation of chemical ligands to the nanoparticle surface,

in-vitro cytotoxicity evaluation of nanoparticles).

Bioinformatics (data storage, construction and management of databases,

data analysis and biostatistics, sequence analysis, structural analysis,

molecular modelling, in-silico tests, systems modelling, integrative biology,

software development, computing power).

Research groups

With the exception of nanotechnology, most of the Irish research groups used

technologies from all the considered categories, either internally or through external

access. (Ref. Figure 3.30 & 3.31). In other regions the range of technologies was

either less diversified or each research group specialised in a more limited number of

technologies than in the Irish regions. This may have been due to the fact that Irish

groups were mostly focussed in the health and wellbeing domain, specifically human

health, which was extremely research-intensive and required an ever-growing arsenal

of cutting-edge technology. In the Irish regions, more than 50% of research groups

had more than 50 members, in contrast to Navarra where most groups had between

25 and 50 members and the remaining regions the membership of research groups

was between 1and 10 members (Ref. Figure 3.8). The Irish research groups had an

increased critical mass and this explained their need for an increased diversity of

technologies.

In most Atlantic Area regions, process biotechnology was identified as a needed

technology more than a used one, which indicated a possible unmet need in the

ShareBiotech regions (Ref. Figure 3.28 & 3.29). Bioinformatics was a technology

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that was in demand and in Bretagne, all surveyed research groups used

bioinformatics (Ref Figure 3.32 & 3.34). This was likely due to the cross-

fertilisation of biotechnology and ICT, which was fostered by the local clusters.

Research groups in Bretagne, Ireland, and the Algarve were showing an increased

interest in nanotechnology (Ref. Figure 3.20 & 3.31).

Companies

On observation of the survey data, the range of technologies used by the companies

was that the companies had a less intensive use of technologies than research groups

except for those in the Irish regions (Ref. Figure 3.44 & 3.45). In contrast to the

research groups, the use of need to use process biotechnology was limited with the

exception of Pays de la Loire. In Bretagne and the BMW region, the number of

companies that wished to use process technology was higher than those who were

already using it (Ref. Figure 3.55 & 3.56). The findings of Activity 3 showed that,

1) over 50% of companies had less than 25 staffs and were created between 2000

and 2010 (Ref. Fig 3.39), and had not reached the scale of maturity that was required

for them to increase their scale of operations, 2) the step to process R&D and process

implementation was often externalised (Ref. Figures 3.58, 3.60, 3.62, 3.64, 3.66,

3.68, 3.70, 3.72), (Pint et al., 2011), such as the development and scale-up of the

process or the production of samples or commercial batches of product. Many of the

surveyed companies were academic spin-offs, and the transition from the research

laboratory to process development or production may have been a significant hurdle,

since it required significant investment and infrastructure, and/or a different mind-set

in the management of the company and structure of company operations. In

Bretagne, the activity was not related with human health only but was diversified e.g.

cosmetics and food, and in the BMW a significant part of the health and wellbeing

domain related to the development of technologies for the medical devices market,

which had lower development times than pharmaceutical applications, therefore, it

was likely that in those regions some companies presented a more mature technology

development which was closer to commercial-scale applications. In the BMW

region, nanobiotechnology was gaining significant interest and this was most likely

due to the presence of the medical devices regional cluster in Galway (Ref. 3.69 &

3.70). The companies in Navarra, Centro, and Algarve showed a significantly lower

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average of technological maturity and readiness than the remaining ShareBiotech

regions.

Main challenges to performing R&D

The Activity 3 surveys identified some of the major challenges companies

encountered in the performance of R&D activities within the ShareBiotech regions

(Ref. 3.75 & 3.76). Many companies mentioned the cost of R&D and the lack of

available funding, especially the respondent companies in Navarra and Portugal.

This was most likely due to the current scarcity of financial resources due to the

macroeconomic environment. The financial environment was identified as a key

pillar for the growth of biotechnology SME’s (Porter, 1998). Most companies were

very small and required specialised competencies which were not available in-house.

Most companies lacked all the required expertise in-house and did not have the

financial resources to outsource. The majority of companies expressed the need to

find partners in the form of business angels, or venture capitalists to take a stake in

the company and finance projects, specialised service providers such as, technology

centres or contract research organisations (CRO’s); partner companies or research

groups to engage in collaborative R&D work (Ref. Figure 3.54, 3.12, 3.11, 3.13,

3.51, 3.52), mainly through publically co-financed initiatives or established clusters.

Many companies complained that it was difficult for them to find the right partners

and to get public funding, both national and European, for their R&D projects. A

significant number of companies cited the need to find experienced human capital,

such as senior level managers, scientists and engineers who had experience in

biotechnology and this may have been due to the fact that biotechnology was a

relatively young business sector in the ShareBiotech regions. Other problems such

as, the cost and know-how required for effective IP protection (Ref. Figure 3.15 &

3.16) and difficulty in fulfilling training needs for their staffs, both in technical areas

as well as business support areas such as, regulatory issues, project management and

legal aspects of technology transfer (Ref. Figure 3.73, 3.74, 3.75).

When companies were asked to identify barriers to access specialised core facilities,

financial constraints topped the list in almost al ShareBiotech regions (Ref. Table

3.3). Collaborative projects with research centres and academic labs were

problematic for companies in the areas of IP and confidentiality and difficulties in

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matching timings and focus of research because companies had a higher sense of

urgency to obtain results than their academic partners. This point was also stated

during expert interviews with Derek Jones (Babraham), Martino Picardo (Stevenage)

and Claire Skentelbery (CEBR). For companies and research groups, access to

technology, services, and specific techniques were constrained by lack of funding as

well as lack of equipment and facilities.

Infrastructures and equipment

In most ShareBiotech regions a continued effort was undertaken in the last decade to

build State–of-the-art research infrastructures. In the Irish regions new

biopharmaceutical research centres were set up; in Pays de la Loire, in addition to

the new biomedical research facilities, the Bio-practice training centre was

inaugurated; in Bretagne the “Institut de Recherche Santé Environnement et Travail”

(IRSET) was created in 2009 and offered training facilities and expertise in

environment and health; in Navarra, CIMA, the infrastructure bridging fundamental

research with clinical application and product development for diagnostics and

therapies was founded in 2004; in Centro the first biotechnology park (Biocant)

opened its doors in 2005, expanded since then and plans to build a new biotech

research building were put in place.

However, some regions needed further investment. For example, the Algarve

region lacked wet-lab-space to host new Dedicated Biotechnology Firms (DBF’s).

The availability of wet-lab space was one of the key elements supplied by the

Babraham Institute for the development of young start-up biotech companies as well

as access to TCF’s and expertise and ultimately a driver of cluster development. In

some regions where lab space was available for start-ups within university

infrastructures, a true bio-incubator did not exist. The hosting of start-up companies

in bio-incubators was identified as being of extreme importance in changing the

mind-set from scientific academic research to business-orientated research and the

exposure of start-up companies to a community of companies that co-exist and

interact in the same infrastructure, sharing specialised equipment, while at the same

time having their own private office and lab space. This principle was identified as

paramount to the success of start-ups in expert interviews with Professor Horst

Domdey (BioM Munich) and Derek Jones (Babahram, Cambridge London). At the

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time of this research, an important infrastructure such as a national incubator was

still missing in Ireland, despite an otherwise positive entrepreneurial ecosystem.

Activity 3, Technologies emerging as unmet needs across the Atlantic Area

For both research groups and companies; DNA/RNA microarrays and

fermentation capabilities, and integrative biology and systems modelling

were highly externalised.

For research groups; antisense technology, transcriptomics were highly

externalized while metabolomics, vegetal transgenesis, housing and facilities

for plant experimentation, and high-throughput experimentation were mainly

externalised.

For companies; nanostructures, active compound delivery methods and

nanoparticle characterisation and in-vivo cytotoxicity were all significantly

externalised.

BRC’s were highly used by both research groups and companies and mostly

externalised.

Many of the unmet needs related to bioinformatics. It was speculated that this

provided the opportunity for a network-wide collaboration that could be provided at

relatively low infrastructural cost through setting up an on-line collaborative

platform. An array of “omics” technology was identified as not being available by

research groups (Ref. Figure 3.17 & 3.18). These techniques lent themselves to

equipment sharing within collaborative networks. A thorough inventory, mapping

and capacity of the available “omic” platforms at the research infrastructures of the

ShareBiotech regions was suggested to identify specialised nodes within the

network, and if required, upgrade the available platforms at those nodes and foster

their interface with networks in each country at the European level.

Several nanotechnologies were identified as needs by companies, particularly in

relation to biomedical or biopharmaceutical applications (Ref. Figure 3.69 & 3.70).

The expressed need for these technologies was mainly from the biopharmaceutical

and medical devices companies in the Irish regions

In addition to purely technological infrastructures, significant needs were

identified, for both research groups and companies that should have been dealt with

by other supporting infrastructures, such as technology transfer offices and business

liaison offices that existed across the ShareBiotech regions. The following list was

used to identify the aspects that were most frequently mentioned during the

implementation of the Activity 3 surveys and expert interviews in the region:

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Difficulties in the negotiation of IP rights with public research institutions,

particularly relevant to the creation of spin-offs.

Lack of specialised professional services, e.g. patent writing, negotiation of

licenced deals, technology watch, and competitive intelligence etc.

Normally, academics, technology transfer offices, and start-ups only had a

superficial knowledge of the market, in particular, disruptive technologies.

Claire Skentelbery also raised this point and quoted a successful model

initiated by Ralph Kindervarter in Germany (Ref. Expert Interviews, Claire

Skentelbery).

Confidentially management issues by academic partners.

Lack of human resources with entrepreneurial and business development

experience.

A different mind-set between academics and companies caused difficulties

for setting up and managing joint research activities, even if on a contract

research basis.

Involvement of bureaucracy in incentive programmes to collaborative

research between industry and academia was often a discouraging obstacle,

particularly for SME’s. This issue was stressed by Mary Skelly of Microbide,

one of the experts interviewed in Ireland when talking about difficulties

encountered during the start-up phase of an SME, and her reasons for moving

her company to the US.

Companies referred to the difficulty of finding information regarding funding

instruments, new technologies, and local scientific events. During expert

interviews with Tony Jones (One Nucleus), he stated that networking was

vital to the success of small companies and cluster initiatives such as One

Nucleus were important for the provision and dissemination of real time

information where it was needed. Derek Jones (Babraham) used coffee and

doughnut mornings weekly to encourage company CEO’s to meet and

network, while Professor Horst Domdey stated that held round tables in pubs

and that much business was dome over a friendly pint or two.

Imaging Technologies

Imaging techniques underwent a significant advance in the last decade; however, the

ShareBiotech survey assessed the use of traditional methods of optical microscopy as

well as modern, highly advanced, and specialised methods (Ref. Figure 3.26 &

3.27). In companies all techniques displayed a similar profile for uses and needs

with the exception of confocal and fluorescence microscopy that was more widely

used by research groups (Figure 3.26). It appeared that such imaging techniques,

despite the cost of instrumentation and maintenance, were becoming more routinely

utilized by research groups. In general the survey highlighted an approximately

similar need for methods that required access to expensive, high maintenance

equipment such as, radiography, ultrasound, electron microscopy, SPECT, (Single

Photon Emission Computed Tomography) and MRI (Magnetic Resonance Imaging),

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which reflected the potential of such methods to address a series of research

questions.

For companies, the most used technologies corresponded to Electron

Microscopy and Optical Imaging Techniques (Figure 3.65 & 3.66). This was not

surprising since these techniques were used to characterise numerous matrices in

various fields of activity (e.g. observation of emulsions in cosmetics, of

microorganisms in the food industry, of human cells in medical companies, etc.).

Other imaging techniques (i.e. non-microscopic techniques) were less used but were

of great interest since numerous needs were registered by the surveys. The majority

of techniques in this category were initially devoted to medical applications,

(Radiography, Ultrasound, Tomography and Nuclear Magnetic Resonance) but were

widely applied in other activities such as agriculture (e.g. N.M.R. can be used to

characterise the structure and presence of water in vegetables).

Training needs in biotechnology research groups and companies

The majority of research groups highlighted the need for training in relation to

specific Biotechnology skills (Figure 3.34 & 3.35). The need for training varied in

the ShareBiotech regions, for example, over 90% of the Irish research groups

involved in the survey indicated that they had specific training needs while only 58%

of research groups in Navarra identified training needs in the area of Biotechnology

(Figure 3.35). 75% of companies were identified as having training needs (Figure

3.73) but a relevant regional diversity existed (Figure 3.74). Sustainable training and

maintenance of skills was identified as a major driver for the development of a Bio-

based economy as set out in the Lisbon Treaty. Since the economic downturn in

2008 – 2009, Ireland has been haemorrhaging skills with the onset of mass

emigration of graduates in search of better working conditions and increased

remuneration. There needs to be a policy-driven effort to halt the brain-drain and

resources put in place to upskill the existing workforce and new graduates if we are

to remain a credible country for companies to locate their businesses.

Entrepreneurship needs to be fostered for the development of an Irish indigenous

biotechnology industry to reduce reliance on multi-national companies from the US.

The pharmaceutical industry is receding with many block-buster drugs e.g. Lipitor

coming off patent and as a result, job losses have already been seen. Investment is

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needed to foster and encourage the development of R&D to reduce reliance on

manufacturing. While pharmaceutical manufacturing and export is worth €50B in

revenue to Ireland yearly the development of sustainable indigenous biotechnology

companies would progress the development of the Bio-based smart economy.

Bioinformatics

The surveys revealed that all bioinformatics techniques were equally needed by

interviewed research groups and companies (Ref. Figure 3.32, 3.33, 3.71, 3.72). The

most used and needed techniques corresponded to sequence analysis and data

analysis and biostatistics and also to construction and management of databases and

data storage. In common with research groups, companies had significant volumes of

data that could not be managed without bioinformatics tools. The research indicated

that a policy needed to be put in place to contribute to “fill the gap” by reinforcing

bioinformatics in participating TCFs and also through the organization of

training sessions to enable more companies (and researchers) to internalize a part of

their analyses.

Approximately 50 % of bioinformatics analyses were externalized and several

factors may have been responsible for this (Ref. Figure 3.33, 3.72). The research

showed that many biologists were not trained in the use of bioinformatics tools and

subsequently had to outsource the analysis of their results to specialized platforms.

The large datasets generated by next generation sequencing required significant

computational power and computing know-how to handle very large data sets and

convert raw sequence data to assembled genome/transcriptome, or conduct digital

counts of transcript abundance. The high cost of informatics infrastructures that

required informatics expertise and maintenance and the general policy of data release

into the public domain via established public databases, for example, in Ireland the

National Centre for Biotechnology Information was set up (NCBI) generally did not

favor the development of onsite computing resources. To progress the development

of modern biotechnology in Ireland and the Atlantic Area, there needs to be

substantial investment, both public and private, in the development of bioinformatics

platforms.

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4.5 Natural Products Companies in Ireland

A unique activity of this research was the surveillance of the Irish natural products

industry, namely seaweed harvesting and aquaculture and its link to the biotech

sector. Seaweed has been harvested since the 8th

century in Ireland. The majority of

harvested seaweed is mainly used for food & agriculture. The industry started in

1947 with the establishment of Arramara Teoranta who began operations in 2

locations; Donegal & Galway. Seaweed industry production peaked in the 1970s

with over 100.000t of seaweed harvested annually.

Commercial seaweed harvesting takes place in 35 countries worldwide. The

global seaweed industry uses 8 million tonnes of wet weed annually. Over 90% of

the seaweed used is cultivated. Ireland has an estimated national harvest of 25,400

tonnes per annum. 100% of the seaweed used is wild. The Irish seaweed industry

employs circa 185 full time equivalents. Agricultural products account for nearly

100% of the raw material used and 70% of the value generated. Cosmetics and

therapies account for circa 1.0% of the raw material used and 30% of the value

The food sector consists mainly of micro enterprises employing five employees or

less, with very limited automation in harvesting, drying or processing. Most

enterprises operate on manual harvesting from spring to late autumn, with the

majority of harvesting done at low tide, particularly during spring tide periods.

In total 30 telephone interviews were held with seaweed harvesting companies. The

bigger companies e.g. did not report any major difficulties; however this was not the

case with the small micro-enterprises consisting of between one and five persons.

The micro-enterprise sector reported that they felt marginalised and that any

assistance available went to the bigger companies. When asked if they would attend

a LTM, the majority said they would not have time as they had in some cases, only

one of two staff and could not afford to take time off. They stated that they could

how companies like Arramara Teoranta could attend because it was a state-run

company and did not have to make a profit and staff wages were secure and they got

paid to attend conferences.

When asked about technology needs there was a consensus when it came to

seaweed dryers; they could not afford to purchase the dryers needed to take out the

required percentage of moisture from the seaweed, and the dryers they had were

inefficient, expensive to run and time consuming as it took two days to dry one batch

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of seaweed. For every 100kg of wet seaweed the return was 20kg of dry product.

This lack of cutting-edge technology and packaging facilities prevented micro-

industries from growing their businesses and creating employment in their local

areas. The effects of the 2008 recession have been strongly felt on the West coast of

Ireland and mass immigration has resulted from this area due to lack of employment.

The main problem that persists is the requirement of processors to handle the

material extensively during the drying stage; this delays the process and adds

significantly to the labour cost. In order to increase the attractiveness of the seaweed

sector to new entrepreneurs, it is an absolute requirement that automated processes

be transferred or developed to reduce the labour and energy costs of processing

seaweeds. BIM recently stated in a report “A Market Analysis towards the Further

Development of Seaweed Aquaculture in Ireland” that “the Seafood Development

Centre (SDC) in Clonakilty, intends to work with the industry and with qualified

engineers and food processing technicians, to improve existing processing

techniques and to identify transferable processing technologies from other sectors,

particularly for drying and packaging of edible seaweeds”. This would be a

welcome initiative but there was no evidence of any new incentives for micro-

enterprises at the time of these interviews in August 2012.

When asked about funding the general consensus was that Enterprise Ireland,

Board Iasca Mhara (BIM), and Uduras na Gaeltachta were only interested in the

bigger companies and offered little in the way of financial assistance or any kind of

support for the small industries; there was evident anger in this area. A report by

BIM entitled “A Market Analysis towards the Further Development of Seaweed

Aquaculture in Ireland” stated (at present, BIM, MI, Udaras na Gaeltachta (UnaG),

QUB and NUIG provide a wide range of financial, technical and scientific support

to interested parties throughout the island of Ireland). This was not evident when

speaking to stakeholders in the seaweed industry. When asked if they had ever used

the services of NUIG or received any assistance from the Marine Institute, the

answer was no.

Interviewees stated that there was a gap in the provision of training courses in

the areas of, food hygiene and food processing, e-commerce, product packaging and

innovation workshops, marketing, IT/communications, and business management.

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Stakeholders felt that to compete on a global market and grow their businesses; they

needed education in the areas stated. BIM recently stated in a report that “In order to

secure the future of the Irish seaweed industry, it will be necessary that new

opportunities in functional foods, health and well-being products and high value

added cosmetic products are pursued by Irish companies. The existing model used

by seaweed processors will not be suitable for such markets. Therefore there must be

a move away from rudimentary processing and anecdotal claims for the benefits of

seaweed”. This, no doubt, would help to grow and professionalise the Irish Seaweed

Industry. In today’s market, provenance and source of raw material must be backed

up with scientific data. Organic accreditation should be investigated with the relevant

agencies, to enhance consumer awareness and appeal.

In the last four to five years, commercially relevant seaweed research has

reflected global trends and commercial interests, for example, research into biofuels,

bioactive compounds for medicine and extracts for ‘functional’ food production.

Ireland has a vast natural resource and the potential to develop the marine

biotechnology sector. There appears to be a lack of support for the smaller seaweed

industries or a lack of communication between stakeholders and policy makers.

There needs to be an all-inclusive effort to develop the Irish marine biotech sector

for all stakeholders. There is a strong case for mechanisation of the industry with

due-diligence applied to preserve the natural marine ecosystem. It is also important

that the industry remains indigenous and those large areas of the coastline are not

licenced off to foreign investors.

Efforts should be made by relevant agencies to identify and transfer handling,

processing and other labour saving techniques and equipment from other countries.

France, Canada and Israel all have comparable labour and energy costs and all have

advanced macro-algal and micro-algal industries.

Ireland’s industry may be larger than many countries in terms of production

volumes; however, with the exception of a few operators, it is a relatively

technologically backward seaweed industry. Automation, particularly in the areas of

drying processing and packaging, must be improved in Ireland in order to reduce

labour costs and production times; many seaweed processors have expressed

dissatisfaction with existing processing techniques due to their inefficiency and high

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labour costs. Technology such as rotary drum dryers, fluid bed dryers and freeze

dryers must be integrated into the Irish seaweed processing industry.

It is self-evident that the purchase cost, running cost and scale of a great deal of

modern processing equipment are outside of the reach of all but a few seaweed

processors, therefore it may be necessary to coordinate and facilitate the industry to

access contract manufacturers or to provide a suitable pilot plant that can be

employed by several enterprises. There is a need for technical development in the

manufacture of high quality extracts for food, pharmaceutical, cosmetic and

biotechnology applications. Universities and other institutes such as BIM and

Teagasc could take a lead in developing pilot plants or facilitating the use of under-

utilized existing plants in order to develop the means and technical know-how within

the sector.

4.6 Success Factors in European Biotechnology Today

The Atlantic Area is quite heterogonous and this was quite clear also when analysing

the technological landscape in the field of biotechnology and the life sciences in the

ShareBiotech regions. However, differences in focus of the research groups, in start-

up companies and in the regional economies provided some interesting opportunities

of collaboration, learning, and value creation. The commercialization of

biotechnology research results depends on the specific economic and institutional

structure of the specific ecosystem, e.g., how much absorptive capacity the industrial

sector has in order to adopt new technologies, the financing conditions, including the

investment community, their research institutions (including their international

network and commercial orientation), and policies in place for research and

innovation.

Biotechnology policy is complex because it involves the interplay between

many different agents such as universities, research and technology centres,

financing bodies and investors, government and regulatory agencies, corporations,

and consumers. Governments, both local and national or supranational bodies, create

biotechnology programs through the founding of public laboratories, new business

R&D funding programs, policies for academic research, venture capital, science

parks, and incubators. Too often when the face of government changes, so also do

their policies towards who should receive funding and where investment should go.

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Claire Skentelberry stated that this was one of the major problems in the UK and

stressed the need for consistency in government funding. Horst Domdey was in

agreement with Claire and stated that many ministers that supported biotechnology

had left the Ministry and that new people with new visions drive research in different

directions.

Biotechnology is recognised as a driver of economic recovery, but this cannot

be achieved in one government term. There needs to be a 20 year roadmap in place

to develop a successful, sustainable biotechnology industry; an industry that has

positively impacted the economies of many countries. Both Claire Skentelberry and

Derek jones also stressed this point. It takes on average 15 years to develop a new

biotechnology drug with an investment of nearly $US1B. Investors don’t like

waiting this long to generate return on investment (ROI) so promising molecule are

bought up by bigger companies and the generating SME is sold or broken up; this

does little for the development of an indigenous biotech company. Derek Jones

stressed that something needed to be done to address the European problem and that

biotech development needed planning, funding, and it should be given the time to

deliver. In Ontario, 90% of biotech companies are SME’s, while expert interviews

revealed that the figures for the UK and Ireland were approximately 80% and that

SME’s accounted for the largest section of employment in Europe, Canada and the

US. In general, SME’s are a very large section of the biotech industry, but Europe

seems to have resigned itself to having more early-stage exit companies rather than

maturing along the pipeline. Having the cutting-edge infrastructure in place attracts

major investment both national and international and becomes a platform from

which economic recovery and development can be launched.

Universities became, perhaps too recently, aware of the new potential source of

income, and created offices of technology transfer, university-industry liaison offices

and intellectual property offices. However, often universities resist these changes, or

adopt them using their pre-existing hiring, research, and publication routines, which

may create obstacles to academic mobility, patenting, interaction with industry or to

the launching of academic spin-offs. Such inertia has been shown to slow down the

building of the complex biotechnology innovation system (Noisi, .2011). Recently,

three key factors were put forward which were deemed to be affecting the

competitiveness of European biotechnology: the limited availability of risk capital, a

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fragmented patent system, and environments that do not foster a connection between

science and business (Nasto, 2008). For a sustainable European model of

biotechnology to evolve, legislators, investors, and biotechnology stakeholders need

to look to successful models that have brought economic stability and prosperity to

countries like the US, Germany, France, Canada to name but a few.

4.7 USA versus European Biotechnology

The US venture capital firms not only had more funds to invest, partially due to a

better policy incentive system, but they were also more experienced and benefited

from more exit avenues than their European competitors. Overall, the venture capital

market in the US was estimated as being about 5 times bigger than the European

venture capital market (E&Y, Beyond Borders, 2012). One would have to agree with

the view of Claire Skentelberry when she stated that the US is more market driven in

its attempts at cluster development. The fact that the US biotech sector was better

developed than their European counterparts was that they got more money earlier

and this allowed SME’s to get further down the pipeline before they ran out of

money. This is the basic difference between the US and Europe; it’s very

fundamental; this is hard-core basic finance.

The difference was even more dramatic when comparing the angel investor

funds, which complemented the private funding of the new biotechnology firms, and

US angel investor funds were 50 times greater than in Europe (Noisi, .2011). This

point was echoed by Mary Skelly, CEO of Microbide. A point raised by Mary was

that cultural differences were a major stumbling block when comparing doing

business in the US and Ireland. She felt that in the US, there was no shame attached

to failure whereas in Ireland the stigma of failure was alive and well. Entrepreneurs

need support, not just financially, but also morally. Is there an element of snobbery

attached to the Irish culture of doing business? Mary believed there was, and that

when looking for financial support, the Irish culture was based on wealth and to a

degree social background. It was difficult to get an appointment to see a high-

ranking official while in the US, this was not the case. In Kentucky, one of

America’s poorest states, when a legitimate business produced a viable business

plan, they received a $30,000 non-repayable loan and once a premised was located

and a one year contract signed the company received a $75,000 repayable loan.

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Europe fails in providing adequate funding for start-up companies and €15K or €30K

is not enough for biotech start-ups and does not support export capacity. In the US,

there was a willingness on the part of the Federal Agencies to support SME’s and

50% of technology needed came from non-academic institutions, so, unlike the EU,

a lot of TCF’s are in the private sector. Also, US university facilities are shared and

access is available to private users. Mary believed that NIBRT should not be

managed by UCD, but should be managed by a totally independent team of

professionals from the private sector comprising of entrepreneurs and experts with

the ability to interface with industry. There was a consensus among all experts

interviewed on this point. It is essential to maintain the ability to change and work

with SME’s for them to grow into large companies and have a positive impact on a

countries reputation and economy.

The size of angel investment funds varies from country to country, but

normally are only suited to the seed phase of biotechnology companies. As a result,

although Europe had more dedicated biotechnology firms than the US, the American

biotechnology sector had twice the number of employees compared to Europe,

highlighting the over-fragmentation of the sector in Europe. This fragmentation was

also observed in the academia and research centres, which were normally of small

size and often not enough focused. Further, in Europe the university system was

somewhat endogamic, with academic inbreeding high in France and exacerbated in

Portugal and Spain (Horta et al., 2010), and the competition between universities for

faculty and students hardly existed (Noisi, 2011), and most academics had not

experienced any other environment but the academic environment since they

enrolled in their graduation studies, with few if any contacts with the industry.

To summarise, although EU had leading productivity indicators concerning scientific

publications; investment was also made in incubators, science and technology parks,

funding programs for new biotechnology firms; when it came to commercial

applications, the results were often disappointing.

4.8 Technology Core Facilities

There is currently a movement within the European Union towards an improved

organisation of life science research facilities and infrastructures (ESFRI Roadmap,

FP7, and Horizon 2020) which today tend to be fragmented and multi-sited. The

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challenge was to ensure cohesion and to attain a critical mass. Given its dimensions,

if R&D in the Atlantic Area is to become competitive and a driver for economic

development, accessibility to and networking of existing mid-sized TCF’s, as well as

infrastructure sharing needs to be a priority. The ShareBiotech project aimed to meet

this challenge by the creation of a network of TCF’s accessible to researchers from

both the public and the private sectors. Resulting from the Activity 3 survey, a

booklet entitled “ShareBiotech Life Science Technology Core Facilities 2012” was

published. At its simplest, the booklet was a directory of TCF’s in the Atlantic Area

partner regions (Ireland, Spain, France, and Portugal), identifying their location,

access policy, specialities and applications, and contact details. In total, 143 TCF’s

were identified of which 49 were located in Ireland.

All experts interviewed stated the importance of access to TCF’s for

companies, especially enabling access to cutting-edge technologies for start-up

companies. There was a consensus among experts that it was difficult to access

TCF’s in Academic Institutions for many reasons which will be discussed in the

Expert Interviews analysis. TCF’s are generally provided by academic institutions,

research centres, incubators, or Commercial Research Organisations (CRO’s), e.g.

PPD, Intertek, etc.

Technology Core Facilities (TCFs) as a progression of the term core

facilities, refers to laboratory instrumentation required by many investigators to

conduct their research, but are generally too expensive, complex or specialized for

individual and small group researchers to provide and sustain themselves. The scale

of impact of such technologies grow further when SMEs and other industry domains

are included, and their R&D can benefit considerably from access to advanced

technologies, but this generally must occur via some collaboration model, frequently

with public sector research centres. The increase in costs, enhanced skills sets,

knowledge, research impact and data generation and reduced shelf- life of many core

facilities over the past decade has been recognised in many countries and has

reflected the generation of specialist research centres and enhanced collaboration

models and media. The necessary skill sets, service and funding model and

accelerated need for equipment updating or replacement due to accelerated

technology development all contribute to significant annual costs and readily

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distinguish those research facilities that can professionally achieve these objectives

from those who cannot.

State-of-the-art technology was a crucial asset for actors in the biotechnology

domain, who needed to commit considerable financial resources to own, operate,

maintain, and renew their equipment. TCF’s “are a combination of laboratory

instrumentation and associated skills which are required in the performance of

research and other technical functions, but which are generally too expensive,

complex, or specialised for individual and small groups of researchers to provide and

sustain by themselves” (Tomkins 2013). TCF’s may be public or private and are

generally open to a wide range of users. TCF’s deliver an extensive range of services

according to the access policy agreed with the users. When access is through

membership, the user can utilise the full range of services available in the TCF, from

simple access to equipment, training, and routine analysis, up to highly customised

services such as tailor-made research, research projects, and consulting. When

access is through a licence agreement, the user utilised the TCF for a specific

research project that exploited or operated IP. In many cases, TCF’s operated in

some middle ground between both approaches and engaged with clients of the basis

of “fee for service”. The fees varied depending on the type of use and the nature of

the user i.e. companies, researchers, internal or external users. This point was

elucidated on analysis of the TCF surveys. Due to the economic downturn and the

drying up of financial subsidies, most TCF’s became flexible in their business offer

in order to increase their business volume.

The main recommendations for TCF have to meet their clients expectations include:

1. Service-oriented activity

2. Simplification of service offer

3. State of the art facilities

4. Stringent confidentiality

5. Standards of practices certified

6. Sound management

7. Competitive pricing policy

8. Clear access policy

9. Clear visibility

10. Compatibility with local environment

Instrumentation in the life sciences has been growing since the 90’s as a

consequence of the fast scientific evolutions. Getting access to state-of-the-art

technology has become crucial for biotechnology SME’s but not so easy considering

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the considerable financial resources required to buy or lease cutting-edge

technologies, hire qualified personnel to operate the technology, and interpret results,

and invest continuously to offset technology obsolescence. Some experts interviewed

said that they established relationships with technology vendors and this enabled

them to have access the latest technologies. Derek Jones said that BBT did not have

to worry about having the latest technologies because Cambridge University had so

much money that it was not an issue. Academic institutions, although they would

like to have novel technologies, did not need the latest technologies as most of their

research was “Blue-Skies-Research. However in current times with funding not as

freely available, it would make sense for HEI’s to develop collaborative R&D

capability with industry to bring in much needed revenue. As a result, sharing

research facilities in the biotechnology sector was identified as one option enabling

the performance of effective R&D. Consequently, the highly capital intensive

biotechnology sector has seen the expansion of the pooling of expensive

technologies through TCF’s.

Academic institution TCF’s with the purpose of providing a wide access to

cutting-edge technologies to the international research world at a low cost, and to

develop a centre of expertise for research were generally open to all types of users

(academics, SME’s, private firms) with activities taking mostly the form of R&D

collaborative projects. Offering a service was often secondary and was generally

implemented to generate revenues paying for equipment maintenance or wages. The

funding source for this type of TCF was normally based on public or private grants.

The consensus among the experts interviewed regarding SME’s engaging academic

TCF’s was that academic TCF’s were not professional enough to interface with

industry and that they were more interested in their next publication because that was

how they were measured. It was suggested that the management board of academic

TCF’s should include members with industrial experience to create added-value.

Academic TCF’s did not generally employ full-time technicians, and while post-

graduate researcher developed skills in relation to their research; when they finished

their studies and graduated, the skill sets were lost.

Most start-up biotechnology companies preferred to engage the services of a

company or CRO to progress the route to commercialisation of an innovative drug or

technology because these commercial entities were generally accredited and the

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research was carried out in a GMP/GLP facility, whereas most academic TCF’s were

not accredited and did not provide a GMP/GLP environment, meaning that research

had to be repeated in a commercial facility. Access to technologies in a CRO was

generally expensive and outside the reach of early-stage SME’s. However, expert

interviews revealed that accessing academic TCF’s was difficult and academic

TCF’s were not set up to efficiently interface with industry when it came to the

commercialisation of new innovations.

4.9 Instruments to Foster Technology Transfer in Life Sciences

(Appendix 6) “Technology Transfer is the process of transferring skills, knowledge, know-how,

technologies, manufacturing methods, manufacturing samples, among Governments

or universities, and other organizations to ensure that scientific and technological

developments are accessible to a wider range of users, who are then able to further

develop and exploit the technology into new products, processes, applications,

materials, or services”.

Collaborative projects were the means most used to stimulate technology

transfer. They allow a response to needs, as well as joint objectives for academic and

private partners. In the same way, the spin-offs from these collaborative projects

benefit both parties. This explains why we found many instruments allowing the

construction and financing of these projects, whether at regional, national, or

European level. The organisations of joint conferences had the advantage of allowing

the creation of meeting spaces propitious to the emergence of collaborative projects,

services, or licence contracts. In the “Expert Interviews”, there was a consensus that

the organisation of joint conferences was a driver of cluster development and

innovation because they brought people together and this personal interface was

necessary. Because corporate culture is different from that of academic research, it is

vital that these two worlds get to know one another better, to exchange ideas on their

shared themes and concerns.

Where research bodies provided services to companies, companies gained

access to leading-edge expertise. Indeed, innovative SMEs leading R&D projects did

not always have access to the material, financial and human resources they needed to

internalise all of their analysis, and therefore resorted to subcontracting. Major

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groups, however, did have the means to internalise most of the equipment they

needed and solicited external competences for niche problematic areas (specific

expertise, equipment that was too costly, one-off needs that failed to justify the

purchase of tools, time efficiency). For mature technologies, companies turned first

to private subcontractors, whose manner of operation was best adapted to their

constraints. Recourse to a public-sector structure was envisaged because of the

researcher’s competences, mainly for technologies that were still fairly immature.

The European ShareBiotech project was thus constructed by Biogenouest, the

network of life sciences platforms in Western France, in order to develop the

opening of technological platforms. The main purpose of this project was to increase

the visibility of these platforms, and help them adapt their offer to the needs of

businesses. Often, these last test platforms’ aptitude to their needs via low-strategic-

level service provision. Once their confidence had been earned, they sometimes

entrusted riskier projects within a collaborative project framework.

Two-thirds of the organisations surveyed used patents to grow technology transfer.

Patents were the method most commonly used by academics to protect their

inventions. Since a few years ago, researchers have, thanks to awareness-raising

efforts by technology transfer structures, become aware of the importance of

protecting their discoveries, because they have a value that is not just scientific but

also economic, to industrial players. Yet the number of patent applications was not

an indicator of the appeal of these discoveries in the eyes of the industrial world.

However, the number of patents in use (i.e. patents that lead to the signature of

licences), was a strong indicator. Today, it is essential to develop new instruments in

order to support this last stage. In the face of significant mobilization of instruments

concerning the set-up and upstream management of projects, and on the application

for patents, lesser importance is placed on networking strategies (placement of

students, secondment) and on transfer via publications or training – even though

these various practices could gradually lead to the building of trusting relationships

between partners. It should be noted that one question, concerning the publication of

articles in professional journals, was removed from the analysis, given that the level

of response to it was close to zero.

This document illustrated the wealth and diversity of instruments used in

Europe to stimulate the transfer of technology. It listed a certain number of practices

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which could be picked up and adapted in the various different countries and at

European level.

4.10 ShareBiotech E&Y TCF Report (Appendix 6)

In reality there were no apparent novel findings in the E&Y analysis and report.

Was the selection of 17 TCF’s and interview of 15 TCFs fully representative of the

type of TCF/Centres that existed? One would have expected a range of business

orientated facilities in the UK, but they only engaged with one in UK; the new

emerging major facility in Strathclyde. An even more substantive facility was being

built in London; the Francis Crick Research Institute ( http://www.crick.ac.uk/),

which, while having state funding did have some new approaches to interfacing with

the public and research community and no doubt industry. E&Y analysis indicated

that there were only 3 fundamental TCF business models (based on their selected

interviews) but this was not substantiated. Are there more?

1. Profit Oriented TCF

2. Local Innovation Support TCF

3. Research Community Focused TCF

Very strangely, they only interviewed and analysed a Max Planck TCF in Germany.

For ShareBiotech, one would think that a Fraunhofers model was much more useful

and relevant to analyse – here, ideally funding is divided into 3 sources – 1/3

government (state/regional), 1/3 project research funding - and 1/3

industry/commercial funding. The simple Fraunhofers model that ~ 60 specialist

TCFs are set-up with autonomy and without being subject to HEI administration/

management, that with core funding can cover key staff, equipment and maintenance

and use the additional 2/3 budget to cover contract staff, postdocs, specific projects,

travel, marketing etc. – was potentially a very good model for progression in biotech

in ShareBiotech regions with procured government agency support. Fraunhofers

make a significant contribution to IP and company start-up and industry

development.

4.11 Expert Interviews Discussed

As part of the overall project and in particular, the Transnational TCF Model, a

series of extensive interviews was conducted with specialist experts that were

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involved in biotech sector partnering, collaboration and networking. The

associated report and analysis was published as a stand-alone document, but with

specific relevance to transnational models, some key opinions and findings were

included in this section. Analysis of expert interviews was based on sub-section

questions into common themes, common questions and specialist questions as all

experts were specialists in unique areas.

Expert List and Specialisation

All selected experts in addition to their current role had a long history of

participating in innovative biotechnology development – full profiles were included

in the interview report.

Table 4.2: List of Experts Interviewed

Name Organisation Position

Prof Horst Domdey BioM Biotech Cluster Development

GmbH MD

Dr. Martino Picardo Stevenage Bioscience Catalyst Director

Mary Skelly Microbide Ltd MD

Dr. Mario Thomas Ontario Centre of Excellence (O.C.E.) Director

Dr. Terry Jones One Nucleus Director

Derek Jones Babraham Bioscience Technologies Ltd Director

Dr. Claire

Skentelbery

Council for European Bio-Regions

(CEBR)

Head of CEBR

A selected number of key points and an interpretation, analysis and connection with

ShareBiotech Atlantic Region are given below

Some key points

All parties obviously supported and recognised the crucial importance of access to

Technology Core Facilities (TCFs) as part of biotech development. However

the view in Germany was that HEIs offering lab services and access to TCFs based

on State funding represented unfair competition for Commercial Research

Organisations (CROs) and therefore was only permitted, when the HEI

possessed unique technology that was not accessible in the private sector. It was

true that despite the quality of TCFs and the knowledge of academics, given a

choice, many companies preferred to engage with a viable CRO or R&D department

of another large company, but for an SME, such costs were too high. In

recognition of innovative research deficits, large pharmaceutical companies in all

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countries were now more willing to collaborate with HEIs, although inevitably

this only tended to relate to the small number of world leading HEIs. Science

Parks/Clusters provided the TCF support for SMEs and these again worked, where

the right groups came together.

An eventual reduction in State funding for biotech research in

universities encouraged Higher Education (H.E) scientists to collaborate with

industry generating start-ups. Due to the current economic environment this was

true in Germany and was happening in all Atlantic Regions.

Funding was obviously a major driver of biotech companies and was included

in a refined format within A6A5 criteria and as a good example, BioM set up its

own investment agency to fund start-ups. Mainstream investment in biotech

SMEs in Germany has since declined and VCs addressed other sectors, so the

BioM model contributed significantly to the growth and sustainability of the cluster.

The Association of German Bioregion’s ensured that clusters did not compete

with each other, but rather cooperated and exchanged ideas. Within a country

or region, it was an accepted model that clusters should not compete for company

attraction, but rather complement and collaborate. This again supported the notion

of interaction between complementary TCFs to provide resources and competence

not available individually. This view was strongly expressed in the expert interviews

with Professor Domdey, Martino Picardo, Tony Jones, Derek Jones, Claire

Skentelbery and Mary Skelly. This view has not changed among Biotechnology

leaders since it was proposed by porter in his “Triple Helix Model” (Porter, 1990).

Germany has had companies relocate HQ to other countries due to tax differences

and this factor should be appreciated in the context of enhanced biotech

collaborations across the Atlantic Region.

A successful cluster required a mixture of high risk and low risk projects

ranging from direct tech transfer to open innovation models. It was the case, which

for many HEI engagements with the biotech sector, this diversity of funding

interaction, did not occur. Open innovation implies very extensive dissemination of

information and easy communication, to which advanced conference communication

technologies can contribute. The area of extensive dissemination of information

using advanced conference communication technologies was researched to

determine how it would complement and enable the setting up of the pilot

“Transnational Model of TCF’s”.

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All parties believed a sense of community was vital for cluster development and web

services were an important technology that supported and enhanced this working

environment.

German TCFs retained high technician numbers and this was a metric that

inevitably varied across the Atlantic Region partners. Where a TCF had good

human resourcing with advanced capability, it was more likely to cope with

company approaches seeking work and meeting preferred timelines. H.E. TCFs in

much of the Atlantic Region did not possess such effective staff numbers and

inevitably with current public sector funding cutbacks, this issue became worse.

A key driver of a transnational TCF facility was recognised to be the provision of

facilities and research competence that did not currently exist, but was predicted to

be needed based on survey analysis. For example in Munich Eckhart Wolf set up a

specialist TCF (porcine) for the pharmaceutical sector following discussion with

them. New TCFs could therefore impact on biotech and were not being effectively

addressed.

In Germany, logistics were important for cluster development with evidence that

SMEs did not access facilities far away, e.g. A Science Park was very effective.

This was negative for transnational TCFs, unless such a model could diminish the

logistics issue. The use of advanced conference communication technologies was

seen as a potential solution to logistical concerns. Claire Skentelbery stated that in

her experience, most stakeholders would prefer an alternative method of

communication to travelling and that although face to face meetings were necessary,

they were not necessary for every communication and that in today’s financial

downturn, many small companies could not afford expensive travel. However,

BioM was very positive about attracting the best researchers/experts from abroad

and this related to effective networking. This sentiment was echoed by all

interviewed experts. Derek Jones was unhappy about current UK decisions on

emigration and stated that the Babraham Institute was a melting-pot of cultures.

Derek stated that it was difficult to bring good scientists to the UK from the US,

Australia, etc. Derek said that it didn’t matter where they came from as long as they

were contributing to economic development and to the community.

Germany tended to adopt long term business models, compared to the more

traditional finance driven models in the UK and US. Benefits of stable government

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policy and long term rather than short term financial status had a particularly

advantage for the biotech sector, which normally took a long time to generate a ROI.

This was a model that should be incorporated in the Atlantic Region. This view was

again expressed by Claire Skentelbery who stated that much valuable policy relating

to biotechnology development was lost in the UK due to a change of government and

that there should be a policy of continuing R&D funding to the biotechnology sector

regardless of a change of government leadership. “There needs to be a continuation

of successful policy to develop the biotechnology sector and this also applies to

Ireland”.

In the UK, the main components of cluster development were considered to be:

1. The right people

2. Investment

3. IP

4. Ideas – pre IP and exploitation of IP

5. Avoiding unnecessary competition between facilities

Potential complementary companies did not usually collaborate, but maintained

competition. Derek Jones acknowledged the “why should they collaborate” view but

insisted that unless companies were willing to collaborate, Babraham was not the

right cluster for them to locate. To get good knowledge transfer as open innovation,

it was recognised that a good cluster led by the right people who could ensure

effective communication and engagement with follow-up delivery was a desirable

requisite.

A cultural difference between H.E. and industry was an accepted problem:

Knowledge exchange was suited to the academic environment and blue skies

research for publication purposes

Academic research was far removed from the commercial and business world

It was suggested that academia should interact more with people in

industry and there should be an industry presence on university campuses

An industry perspective was that HE Tech Transfer offices usually had the wrong

staff and HE metrics such as number of spin-outs did not necessarily reflect long

term development. This was in keeping with much feedback in the ShareBiotech

project that suggested that for an HEI to effectively interact with industry, it needed

to set-up a different entity that was effectively a part- company itself to ensure that

traditional academic and university governance drivers and culture were not in place.

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Again, the UK supported that a new TCF model needed to offer something not

currently available, i.e. novel and it ideally should integrate with other related

resources and research policy; ideally to find a niche area in the market.

Companies and Cluster/Science Parks can provide good and very

modern technologies, e.g. Bio City, Stevenage, GSK. Companies cannot rely on

university access to address problems because academic research was far removed

from the need to deliver the required accredited results within a commercial timeline

and that some academic researchers will put their own research before the

commercial research, or that access to the desired technology will take second place

and at a time that may not be suitable. Martino Picardo of Stevenage expressed the

view that he did not want to be dependent on the whim of “Professor Wonderful” for

access to cutting-edge technologies.

As a consequence, the ShareBiotech surveys of SMEs and TCFs should ideally

have been more focused on asking what they really wanted & needed to confirm this

differential and indicate what needs to be done to address it. It is not unusual to

recognise deficits at the end of a project, which are consequently addressed in a

follow-on study. Dr. Picardo raised the following points:

The US put a lot of sustainable state funding into start-ups – far more than

EU and the support services try and ensure success

Biotech entrepreneurs tended to run organisations in the US, i.e. have the

right history and experience

Lots of different Tech Transfer experience was required.

Control of Tech Transfer by a single organisation like EI (Ireland) did not

work

A TCF should be Tax free

Cluster/Science Park/TCF should be driven by the people directly

involved, not managers or politicians

These points extended beyond the UK and were relevant to how shared resources

could be best funded, managed, and accessed and rationale for collaborative TCFs

including transnational collaborations.

The implication was that transnational network of current TCFs organised as

a single entity model, should be focused on the development of new TCF facilities

required in specific regions that would complement each other and access shared

money in different countries. Communication technology became a crucial part of

the access process and effective but novel models needed to be reviewed.

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Funding in addition to actual investment in biotech companies and update of TCFs

became an issue for SMEs regarding their capacity to cover operational costs,

including access to TCFs. The Netherlands introduced a low value Innovation

Voucher programme some years ago to facilitate SME start-up, development,

collaboration, and outcome delivery. The model has since progressed to Ireland,

parts of the UK and Germany. In practice, many of AIT pre- cited TCF access

projects (Tech Translation) were funded by such Innovation Vouchers. A version of

this practice was now being evaluated in the French Atlantic Region. While this did

facilitate SME access to TCFs, it must be accepted that it supported SME-HE

interaction, when many SMEs might have a preference for other company linkages,

where there was no competitive conflict.

The EU would support clusters becoming transnational and international

where benefits accrued, but while the favoured view was that viable clusters have to

embrace close logistics, there was evidence particularly in biotech, for acquisition of

network benefits that were across countries, and these benefits included fundamental

R&D (Hendry & Brown 2006). This latter understanding was largely in keeping

with ShareBiotech findings, although some key experts were more focused on

regional cluster issues and were not in conflict with a tendency for physical location

to be always regional – an extreme example being the relocation of Astra Zeneca

R&D to Cambridge. What these findings confirmed was the importance of the

nature, relevance for innovation and complementarity for a network to be functional

and beneficial. A critical element of this was again the effectiveness of

communication. In the ShareBiotech project, the concept of a transnational model

related to two distinct deliveries and outcomes, i. Transnational Technology

Translator Network, and ii, transnational collaboration of complementary core

facilities presenting as a single entity. The former arose as a product of regular Tech

Translator representative communication and engagement, a review of special web

sites set up to provide and transfer Tech Translator knowledge (Tools of Science1,

BiotechKnows2) and recognition of the benefits of tech translation delivered by a

complementary group rather than an individual. The latter was a consequence of

analysis of TCFs across the Atlantic Region and a need to facilitate greater access to

novel resources. The EU under Horizon 2020 will continue to fund the set-up of new

substantive TCF resources, but these are effectively of global status. It was

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recognised that regions, particularly from an SME perspective needed greater access

to TCFs and associated research competence. The drivers for a potential

transnational TCF model were identified as a product of ShareBiotech research

in the initial phase of A6, and these were drivers of A6A5, though not of equal

delivery, (Tomkins 2011).

Location of the cluster was also seen as key to success of biotechnology

development. In an interview with Mariana Bradano, Technology Transfer Officer

with the Biocant Cluster, the first policy-driven biotechnology cluster in Portugal,

and recently appointed to the board of the CEBR; when asked why the cluster was

located in Biocant she stated that the location was chosen for the following reasons:

Proximity to the University of Canthanede

Access to an educated workforce

Proximity to schools and shopping amenities and hospital facilities and

recreation amenities

Available housing

A nice place to live with a pleasant climate

Reliable transport infrastructure

Access to venture capital organisations and other funding mechanisms

Availability of incubation and wet-lab space for start-up companies

Service provision

There is nothing new in in the reasons expressed by Marianna; indeed, the same

points were expressed by all the experts interviewed, and these very same reasons

have been expressed by cluster development experts since the cluster model was first

envisioned e.g. Porter, Maskell, Powell etc.

4.12 The CIRCA Report Discussed

In addressing an element of the TCF concept, the initial proposed A4 project, was to

develop a public-private partnership between the AIT CBBR laboratories and a

private biotech service company with collaborative focus on specific technology -

biosimilars. The company was originally an Irish spin-out from a large pharma

company, but had recently been absorbed by a UK multinational (ironically,

currently, this company has reverted back to an Irish SME). One lab in the CBBR

would be devoted to selected biosimilar analysis work (although this would require

engagement in cell culture etc), that the private company would manage, ie AIT

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would provide TCFs and the company would manage and implement quality

structure and operation/maintenance budgets etc. Outcomes would transfer to the

company for necessary GLP repeats. A full detailed proposal of this division of the

project was generated (Tomkins, Burke & Walsh 2011). There was a lot of

ShareBiotech interest in this model, in part because public-private sector

collaboration could innately enhance operation of and access to TCFs, counter to the

general scale of public-private sector collaborations being poor.

Silicon Valley is often presented as an example of where collaboration between

industry and HEIs occurred with the generation of numerous innovative outcomes.

Conversely, it is accepted that HEI-industry collaboration across most of Europe,

including Ireland is generally very poor, in terms of numbers and scale, (Edmonson

et al., 2012). A university needs to develop a specific pragmatic culture and

structure to work effectively with industry. MIT and the University of Georgia are

examples of US Universities with substantial infrastructure and relevant skilled staff

in place to facilitate working with companies. In Germany, Fraunhofer’s obviously

represent a diverse series of very dedicated HEIs focused on delivering industry

research. The ShareBiotech group were aware of the deficiency in HEI-industry

collaboration in the Atlantic Region and the proposed AIT-company collaboration

project represented a positive means of developing and evaluating mutual partner

beneficial models. Unfortunately, the sale of the SME company to a UK based

global multinational inspection, product testing and certification company,

effectively resulted in a reversed decision and the corporate abandonment of the

proposed project. The company would continue to implement biosimilars analysis

resources and methods, but via the skills and experience of another division of the

multinational.

With a short time frame now available, the replacement project was restricted to

further enhancement of AIT TCF management and structure, by transfer of analysis

of TCF deficits to two external consultancy groups.

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CIRCA were post-audit how to implement TCF’s into academia; because the

collaborative model AIT and Bioclin could not progress; it was really a review of the

audit; audit analysis highlighted AIT shortfalls. This report was valuable but in

essence, it did not highlight any areas that were not already evident. However, the

report did result in an evaluation of the BRI and its potential to develop a TCF model

that was more attractive to companies and other sectors in the research area. Several

changes in the management and running of the BRI were implemented, including:

1. A research officer was appointed

2. All SOP’s were reviewed

3. An audit of methods of purchasing consumables which resulted in setting up

a central fund that created added value

4. The AIT/BRI website was significantly upgraded; creating a portal making

access policy, pricing, turn-around-time, technology and expertise available

etc. clear to potential clients

5. A management committee which comprised internal staff, PhD. Students,

a postgraduate representative, Industry leaders, was set up

6. Professor Neil Rowan was appointed Head of the BRI Dr. Damien Brady was

appointed assistant director of the BRI

7. All safety procedures were reviewed and changes implemented where

necessary

The implementation of the findings of the CIRCA report added value to the offering

of BRI and made it an attractive Centre of Excellence for industry to engage with.

The appointment of Dr. Jim Ryan and Tony Forde was a good decision as both men

had extensive professional experience in the biotechnology industry as attested by

their relative C.V’s. (Appendix 14).

4.13 The Darcy Report Discussed

The Darcy report highlighted two areas for corrective attention in their review of the

BRI-TCF, namely; the age of some of the equipment and the lack of users on the

management committee. The age of the equipment is due to lack of funding for

HEI’s from official sources, however, this can be offset by proper maintenance of

existing by a “qualified person” and the presence of a technology maintenance

budget. However, if the technology was maintained, companies would be likely to

avail of services, which in turn could generate income for upkeep. Literature and

expert interviews highlighted the need for an industrial presence on academic

research committees. Research also highlighted those academic research facilities, in

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Ireland, the UK, and in general across the Atlantic Area, did not have sufficient

input, and interface with industry. This made it difficult for industry to engage with

academic research centres, and is an area that needs to be addressed in the short-

term. The report suggested six areas where the BRI could engage industry (see

results section the Circa Report) in relation to research undertaken and the needs of

the local environment. The Enterprise Ireland Innovation Voucher Scheme was well

utilised by the BRI, and was a platform to showcase its technological ability to

industry, thus enhancing the good reputation of AIT.

The report raised the issue of accreditation and the absence of a quality

system e.g. ISO17025, Irish Medicines Board (IMB) approval, FDA registration, and

Environmental Protection Agency (EPA) approval. Again, this point was mentioned

during expert interviews, but research showed that it was difficult to find any HEI in

Ireland with core facility accreditation in place. 1SO accreditation is expensive and

HEI institutes cannot afford the expense without sustainable funding. However,

early-stage proof-of-concept does not necessarily need accreditation.

Laboratory Information Management Systems (LIMS) facilitates the receipt,

logging, tracking, and security of any sample being processed in a research facility.

While having a LIMS capability would give added value to an academic research

facility; a basic package costs approximately €30,000 and is not a viable proposition

for cash-strapped HEI institutions.

The recommendations of the Darcy Report, along with the CIRCA Report

highlighted issues that were generally already known and these issues would have

been rectified if a sustainable budget was in place. However, as a result of the

report’s a qualified person, namely a Research Officer was recruited and the BRI

benefited considerably from the report’s recommendations, which in-turn created

added-value for companies using the facilities, and postgraduate students also

benefited significantly.

4.14 University – Industry Collaborations

University research and research-related activities contribute in many important

ways to the national economy, notably through increased productivity of applied

R&D in industry due to university-developed new knowledge and technical know-

how, provision of highly valued human capital embodied in faculty and students,

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development of equipment and instrumentation used by industry in production and

research, and creation of concepts and prototypes for new products and processes.

These benefits are enabled primarily through publications, conferences, information

exchange via consulting and collaborative research, and hiring of trained students.

It is widely known that university-industry research interactions and collaborations

have grown substantially over the past several decades. Collaborations take many

forms, ranging from university licensing of inventions based in federally funded

research, to industry participation in major federally-funded university-based

research consortia, to direct industry support of university-based research projects.

New companies also are frequently formed around innovations based on university

research (spin-off companies). Private firms increasingly have recognized that

research partnerships with universities provide a wide range of benefits, only some

of which take specific economic forms such as new and improved products,

processes, and services; other benefits are access to students and graduates with

specialized knowledge who can be interns, employees, or consultants. While only a

fraction of industry-university research collaborations result in intellectual property

(IP) that is successfully commercialized by private firms, universities also own

intellectual property rights to inventions derived from billions of Euros of

Government funding. They seek to maximize the public benefits of this research by

licensing these discoveries to private firms to ensure maximum access to the

technology by the general public. There is a substantive history of HEI-HEI, HEI-

SME, HEI-MNE etc. collaborations across Europe, the US and beyond. Yet, this

research has shown that industry finds it difficult interface with academia in

collaborative projects and access to academic TCF’s is a model that has been tried

and tested, and it does not work. The view of industry is that academic TCF’s are not

professional enough to interface with industry, and that academia is driven by the

need to publish and collaborative research with industry takes second place.

The direct commercial value of knowledge generated from university research is

only one of a wide range of outputs that have economic significance. In a synthesis

of prior research, Goldstein, Maier, and Luger (1995) list eight outputs of research

universities that can lead to economic impacts:

1. Generation of new knowledge;

2. Creation of human capital;

3. Transfer of existing know-how (tacit knowledge);

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4. Technological innovation;

5. Capital investment;

6. Regional leadership;

7. Production of knowledge infrastructure; and

8. Influence on the regional milieu.

Sampat (2003) provides a similar but shorter list that focuses more sharply on the

more readily recognized and assessed economic outputs of university research:

1. Creation of economically useful scientific and technological information,

which helps increase the efficiency of applied R&D in industry;

2. Provision of skills or human capital to students and faculty members and

helping to create networks of scientific and technological capabilities;

3. Development of equipment and instrumentation used by firms in

production or research;

4. Creation of prototypes for new products and processes

Sampat noted that the relative importance of the different channels through which

these outputs diffuse (or are “transferred”) to industry has varied by industry and

over time. Such channels include hiring of students and faculty, consulting

relationships between faculty and firms, publications, conference presentations,

informal interactions with industry researchers, university start-up companies, and

licensing of university patents. Recent studies show that both faculty and private

firms in most industries consider the primary channels through which learning

occurs to be publications, conferences, and informal information exchange (Cohen et

al., 2002; Agrawal and Henderson, 2002). Also, several studies of the benefits that

companies derive from membership in National Science Foundation-funded

university-industry research centres (e.g., Engineering Research Centres,

Industry/University Cooperative Research Centres) show that access to students and

faculty and to new ideas and research results, rather than technology per se, are

consistently the most frequently cited benefits of centre membership (Feller et al.,

2002; Roessner, 2000).

Despite the “ivory tower” label sometimes attached to universities, this is now a

gross misrepresentation of reality. In fact, our research universities have been among

the most important economic institutions of the twentieth century (Atkinson &

Blanpied, 2008).

“Most economic historians agree that the rise of American technological and

economic leadership in the post-war era was based in large part, on the strength of

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the American university system (Sampat, 2003)”. Many other countries viewed the

university-industry collaborations found in the United States as a competitive

advantage and sought to duplicate the underlying conditions supporting these trends

(Neal et al., 2008).

If the Atlantic Area is to create added value in its H.E. Research Institutes, it needs

to learn from universities in the U.S. and adopt sustainable research models by

developing collaborative research projects with industry that have commercialisable

end-products. There needs to be a lot more interface with industry and a greater

presence of industrial leaders on university research management committees. This

research has shown that industry finds it difficult to engage with the current

university research model in the Atlantic Area, and that the “ivory-tower” mentality

is alive and well. However, as history has shown; over time things change and

evolve to match current needs, and this has to happen in a Europe with huge

economic problems that have seen funding cut to many research organisations.

While “blue-skies” research is vital for new developments and the advancement of

knowledge, there needs to be a paradigm shift whereby H.E. research institutes

derive income from services provided and thus, begin to sustainably fund

themselves, and through their discoveries contribute to the development of the

European Smart-Economy.

4.15 Biotechnology Education; Training Offer and Needs in the

Atlantic Area Discussed Technological, scientific, and organisational breakthroughs are usually generated at

the interface of a variety of different disciplines and approaches. One of the

objectives of ShareBiotech was to stimulate links between academia and industry

using several instruments, one of which was to connect people from the different life

science sectors through training, mobility, conferences, workshops, and LTM’s. The

study revealed that there was a strong and well organised training offer for a wide

range of University degrees in life sciences in the Atlantic Area. The main barrier

identified to HE student mobility was the offer of training in the language of the

country offering the training. This would suggest that there should be more

emphasis on learning a popular foreign language at primary and secondary and

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tertiary levels of education across the Atlantic Area and more emphasis on learning

English in countries where English is not the mother tongue.

Another limitation identified was the failure of current Biotechnology

training to meet the needs of SME’s, particularly limitations including the lack of

practical training. Traditionally, IOT’s were geared towards delivering practical

hands-on skills in comparison to their University counterparts. However, this metric

has changed significantly with the reduction of laboratory training hours due to

reduced availability of funding caused by the economic downturn. If we are to

recover from this recession and meet the human capital skill-set demands of

biotechnology companies now and in future recovery, this deficit needs to be

addressed to avoid the scenario of “throwing the baby out with the bath-water”.

Even with the availability of mobility grants, the ShareBiotech project failed to

engage strongly with SME’s and only 37% of the mobility grants involved training.

It is true that the main objective of the mobility grants was to connect people in order

to generate new projects, this did not happen. the main organisations that benefited

from the mobility grants were HEI’s, Universities, and research centres, with only

15% of the grant recipients belonging to companies and 10% belonging to other

types of organisations such as national or regional education organisations,

Technology Transfer Offices, and Innovation Centres. The lack of SME presence

was obvious at meetings and it seemed as if the organisers were struggling to make

up the numbers. Many of the meetings could have been held using virtual

communication systems which would have allowed SME’s to participate. Many of

these SME’s have a small number of staff and cannot afford to spend two or three

days away to attend a meeting. Precious funding could have been saved using virtual

communications technologies and deployed to other, more productive activities to

benefit SME’s. The analysis suggested that the contribution of mobility grants to

training was modest and highlighted the need to identify additional models and

instruments for the implementation of training in biotechnology.

Possible Education Models to look at

Two possible education models could be looked at:

1. Application of advanced real time high quality, low cost video conferencing

technology to lecture delivery, student engagement, and assessments. Such a

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system could also potentially deliver elements of remote training regarding

practical techniques etc. MOOCS (massive open on-line courses) have

already grown significantly in a short time period with high profile HEIs

such as Harvard and Stanford delivering them. Cambridge University

recently stated that MOOCS will change the HE system in countries, but it

won’t have much effect on them because of their specialised academic-

student interaction. The proposed A6A5 transnational model in terms of

communication would allow regular face-to-face interactions with students.

With course fees rising dramatically in the UK and other countries (Ireland,

heading to €3k), standard and quality of education declining and the number

of students registered on postgrad programmes rising (masters & PhD etc.)

and hence career impact declining, there is a strong environment for new

options and models (very large numbers of Indian, Chinese people etc. are

engaging in MOOCS with US delivery).

2. Industrial Doctorate Programme – the Atlantic Region needs to progress

development of the biotech sector and part of this will recognise the novel

benefits of the region regarding natural products, marine biology, bio E etc.

Generation of entrepreneurial researchers can facilitate the process and the

Industrial Doctorate model is one that the UK (EPSRC) and Denmark have

been running for a while. These usually involve centres set up in specific

universities that have a capacity to handle relevant applied research in a

specialist area, e.g. bioprocessing (obviously NIBRT would do that in

Ireland). In the Atlantic Region, there may be potential to again involve a

transnational model that brings together complementary knowledge, skills

and resources to more effectively manage such a degree. The degree contract

would be with a company – in the UK and Denmark, they do contribute

funding, but only a small amount. For a transnational model, 2 or 3 agencies

including infamous EI would have to come together to co-fund, but would

only do so for mutual benefits for their regions. The postgrad spends time in

the company and the HEI. Not an easy one to progress, but worth discussion.

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4.16 The Future of Biotechnology

The first commercial ventures based on synthetic biology, such as Synthetic

Genomics Inc and Amyris Biotechnologies, are already operational.30,31

Over the

next few years, we are likely to see several new ventures applying the principles of

gene circuit engineering to enable a variety of solutions in agricultural,

pharmaceutical, environmental, industrial and energy related biotechnologies. It

certainly seems that in a few years biotechnology will have incorporated many ideas,

devices and systems built using the foundations of synthetic biology. Perhaps there

will be no distinction between biotechnology and “applied” synthetic biology. It

would be a stretch to say that synthetic biology is the future of biotechnology;

however, there is no denying that synthetic gene networks will have a significant

impact on the biotechnology of the future (Bhalerao, 2009).

For the future, the ultimate promise of biotechnology is for combinations of

biomarkers to provide so much guidance to doctors that drug care can become so

targeted it could even one day become personal, with each patient receiving a

medicine or combination of treatments that have been tailor-made for their condition

and their genetic make-up. Biotechnology offers new hope to medical research as

scientists seek to unravel the pathways through which a disease advances so its

progress can be slowed or halted. This greater understanding not only opens up the

possibilities of new drugs, it also enables physicians to know which sub-set of

patients each drug will be most effective for, as suggested by a biomarker or, even

one day, a combination of biomarkers. Any variable in the human body has the

potential to be a biomarker, be it pulse or blood pressure or a certain gene. So long as

it can be measured and clinically demonstrated to predict better outcomes for

patients, it can be used to ensure drugs are given to those who will benefit the most

and the cost and possible side effects of unnecessary treatments are avoided.

30

http://www.syntheticgenomics.com

31 http://www.amyrisbiotech.com

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4.17 The Virtual Biotech Model

Biotechnology leaders and their financial backers have embraced the virtual model

as a way to save money on workers and lab facilities. Nearly every biotechnology

and pharmaceutical company conducts aspects of product development through

contractors. But a virtual company outsources almost every step of its research and

development chain. A virtual company can be agile, shifting from drug formulation

to toxicity testing without having to build facilities or hire staff. And a slimmed-

down business can entice pharmaceutical companies shopping for smaller firms to

restock drug pipelines. These attributes are all the more appealing in the wake of the

financial crisis, as the high risk involved in backing young biotechnology companies

over the long timelines of product development makes investors wary of the sector.

That pressure has already forced firms to become more efficient. “This movement is

really born of necessity,” says Hal Broderson, managing director of the consulting

firm Rock Hill Ventures in Wynnewood, Pennsylvania. “It's like a nuclear winter out

there for early-stage medical-technology companies.”

The Virtual Organisation is a flexible network of independent entities linked

by telecommunication and computing technologies to share skills, knowledge and

access to expertise in non-traditional ways. It is a form of cooperation involving

companies, institutions and/or individuals delivering a product or service on the

basis of a common business understanding. Units participate in the collaboration and

present themselves as a unified organisation (Peng, 2001).

The distributed and pervasive nature of the Internet, and the ease with which

institutions can now communicate across great distances, have made new forms of

organizing possible for institutions. These various forms of organizing have

attractive benefits for institutions, including cost savings and increased flexibility.

As institutions have taken advantage of these new technologies to distribute their

work and workers, and to re-shape information flows in the pursuit of mission,

strategy, and business objectives, they have moved towards being virtual

organizations.

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A virtual organization can bring together, often temporarily, independent

entities in partnering or outsourcing arrangements, enabling them to share expertise,

resources, and cost savings until objectives are met and the network is dissolved.

Virtual organizations are virtual, not only in the sense that they exist largely in

cyberspace, but also in that they are unconstrained by the traditional barriers of time

and place. The ultimate goal of the virtual organization is to provide innovative,

high-quality products or services instantaneously in response to customer demands.

Working at a virtual biotechnology company requires a special skill set, notes

David Cavalla, founder of Numedicus, a virtual pharmaceutical firm in Cambridge,

UK. “You need to have somebody who has a 30,000-foot view of the whole process

of drug development,” he says. “They need to be able to look at the next step and

say, 'This is what I'm going to need in 18 months'.” Virtual firms are often designed

to be bought by pharmaceutical companies, giving investors a chance to recoup their

funds without waiting for the decade or more that it can take to bring a drug to

market.32

Bruce Register, Ph.D., founder and CEO of Register Consulting & Executive

Search, said at a Nov. 14 forum sponsored by the Association for Corporate Growth

San Diego that the old biotechnology model was just as unstainable as the dot-com

boom. With less to show for risking $500 billion over 20 years than they had

expected, Register said most venture capitalists and large pharmaceutical and

biotechnology companies are now holding back. “Companies need to generate a

return on investment and do what’s needed in order to move in that direction. The

biotech industry needs to be restarted,” he said.

Gail Naughton, Ph.D., chairman and CEO of Histogen, has first-hand

experience with the leaner virtualized model. Histogen, a San Diego-based company,

is developing health products based on replicating the regenerative capacity of new-

born cells grown under embryonic conditions. Its hair-growth formula called

ReGenica is scheduled to present preliminary mid-trial results of the first human

clinical evaluation. The trials are intended to evaluate ReGenica’s safety in its use to

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http://lifescivc.com/2014/06/biotechsvirtual-reality/

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elicit hair regrowth. The company has only 22 full-time employees. Histogen uses

use a clinical research organization (CRO) to do the majority of clinical monitoring.

Virtual biotech groups have embraced new software to tackle the complexity

of discovering useful compounds as well as the management of the moving parts of

R&D programs. By most definitions of virtual biotech, the lean operations lack wet

labs and large staffs. They can't be too reliant on manpower, and technology helps

them fill some of the gaps.

Outsourcing the early stages of R&D is a growing trend among young biotech

firms in the UK, a new report reveals. Researchers at Cass Business School in

London tracked 68 university and public service laboratory spin-outs as part of a

larger Engineering and Physical Sciences Research Council (EPSRC) project on

high-tech business organization. The study revealed that up to one-third of these

firms have embraced an innovative ‘virtual biotech’ business model to help reduce

the time taken to reach clinical trials and build up a pipeline of early stage products.

According to Dzidziso Samuel Kamuriwo, the report’s author, this business model

has flourished among fledgling bioteches thanks to a combination of local policies

that favour the industrialization of public science, multiple sources of funding and

high-quality science conducted in public labs. The advantages of going ‘virtual’

include flexibility and few or no capital costs, which helps reduce expenditure (Nat.

Biotechnol, 2009).

4.18 Technologies Supporting Virtual Organisations

Basic technologies supporting VOs include the Internet and the World Wide Web,

telecommunications, electronic mail, groupware such as Lotus Notes, and video

conferencing. There is also a substantial focus on knowledge management (KM)

technologies that support virtual organisations. KM has been defined by the

International Centre for Applied Studies in Information Technology as "a conscious

strategy of getting the right knowledge to the right people at the right time and

helping people share and put information into action in ways that strive to improve

organizational performance."

KM technologies supporting Virtual Organisations include:

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Collaborative technologies

Extensible mark-up language (XML)

Intranets and extranets

Personal devices

Wireless technologies

Virtual reality (VR)

Portals

Collaborative technologies are divided into two groups--asynchronous and

synchronous. Asynchronous collaboration tools include document sharing software,

group calendaring and newsgroups. Synchronous tools include virtual meeting

rooms (group support systems), shared whiteboards, and application sharing and

video/audio conferencing.An interesting combination of both can be found in what is

called integrated collaboration. An example is MITRE's Collaborative Virtual

Workspace (CVW), which provides a persistent virtual space within which

applications, documents and people are directly accessible in rooms, floors and

buildings. To a user, a CVW is a building divided into floors and rooms, where each

room provides a context for communication and document sharing. The

ShareBiotech Project engaged a company named RealSim to provide highly realistic

interactive and 3D simulation of the BRI located at Athlone Institute of Technology

as part of Activity 6, similar to the CVW model. CVW allows people to gather in

rooms to talk through chat or audio/video conferencing and to share text and URLs

with one another. For privacy, users can lock rooms and communicate privately

within and between rooms. Rooms are also used for document sharing. Users can

place different documents into a room, allowing anyone else in that room to read the

document. Examples of documents include whiteboards, URLs, notes and other

documents edited through the user's local applications.

Extensible mark-up language (XML) is meta-mark-up language for describing

structured data in that environment, whereas hypertext mark-up language (HTML) is

for displaying data and graphics over the web. XML is evolving to be the common

structure for data interchange among disparate heterogeneous systems. It will have a

tremendous impact in the sharing of data and for supporting increased functionality

(e.g., searching for information).

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Intranet is a network of networks contained within an enterprise and protected from

outside intrusion through firewalls. Intranets permit the sharing of company

information and computing resources among managers and employees. Examples of

intranet applications include manuals, procedures, internal job offerings, documents,

employee information, schedules and calendars, databases and project management.

Extranets permit further accessibility. In an extranet, the intranet is extended to

external stakeholders such as customers, suppliers and trading partners. Examples of

extranet applications include collaboration, data sharing, project management, news

and training.

Personal devices include personal digital assistants, cell phones, e-mail wireless

devices and Internet appliances. These devices enable employees to have an office

anywhere and an expanded reach to both management and clients. There is a

growing trend toward a convergence of functionalities onto one device.

Wireless technologies include Bluetooth, which is a computing and

telecommunications specification that describes how mobile phones, computers and

personal digital assistants can seamlessly connect with each other using a short-range

(10-meter) wireless connection via a radio frequency. The technology requires that a

low-cost transceiver chip be included in each device. Another wireless technology,

wireless local area network (LAN), allows a user to connect to a network through a

wireless radio connection. IEEE 802.11 specifies the technologies for wireless

LANs.

Virtual reality; there are various types of virtual reality:

Immersive experience--The user visits a world through a wearable device

(e.g., head tracker and helmet, glasses, goggles or a data glove) and interacts

with that world as though he/she were actually a part of it. This form of VR is

the most popular version and the one with the most exposure.

Desktop systems--They are at the lower end of the spectrum in terms of cost

and are worlds that are not immersive and that run on regular personal

computers without additional hardware. These worlds still allow the user to

be interactive within the world, but not immersive.

329

Mirror world or second person experiences--The user is represented by a

figure or avatar inside the computer. The user manipulates this avatar within

the world and interacts indirectly with the world. By controlling this

electronic image of his or herself, the user can interact extensively within the

world.

Telepresence technology--The user remotely controls a mechanical

manipulator to perform some action or explore some aspect of a world. For

example, the user might steer the Mars rover across the terrain, explore under

Antarctica or perform surgery remotely. Most of the time the user is wearing

some sort of headset to project him or herself into the mechanical

manipulator in an immersive manner.

CAVE (cave automatic virtual environment)--It consists of a multiple screen

environment, which surrounds the user. Many CAVE setups have multiple

users involved. The user steps into the CAVE and enters a virtual world on

all sides. Although probably the most expensive type of VR setup, the CAVE

is growing in popularity rapidly because of the ability to project a realistic

experience for multiple users at once.

The number of partnerships and interorganizational alliances among different firms

has grown steadily and is expected to increase as part of need to gain competitive

edge and new customers. These collaborative efforts can be facilitated via the VO

structure (Bhalerao, 2009). The ShareBiotech transnational model of TCF’s is a

viable future project, but it will only be sustainable and attractive to stakeholders

through the use and development of virtual technologies and a paradigm shift

towards virtual organisations.

4.19 A Sustainable Bio-economy for Europe

The European Commission published a communication on the Bio-economy

(European Commission, 2012) to pave the way for a more innovative, resource-

efficient and competitive society that reconciles food security, sustainable use of

renewable resources for industrial processes and environmental protection. The

development of the bio-economy throughout Europe will require actions at both EU

and national level, notably: Development of a policy framework and effective

330

governance and coordination to encourage private investment and better align EU

research and innovation funding to relevant sectoral policies (European Commission,

2012)

Research and innovation actions to implement the European Bio-economy, in

particular, support research into industrial applications and foster industrial

involvement in research and innovation projects.

Support bio-based markets, economic growth, and sustainable employment

by improving access to finance for research and innovation and propose

incentives for industries trying to take innovative bio-based products to the

market.

Develop engagement with society and foster social innovation in the Bio-

economy, e.g. by promoting communication and dissemination of

information on advantages and risks of the Bio-economy and by

dissemination information on bio-based products.

The communication on a sustainable Bio-economy for Europe (European

Commission, 2012), provided a blueprint to maximize policy coherence in the EU

and to bring research and innovation to the mainstream of socio-economic

development. Its successful development, including the extent to which it meets

societal expectations will depend on the European Commission and Member States,

but also on regional authorities, Industry, farmers, NGO’s, consumer associations,

and others (New Biotechnology, 2012). (European Territorial Cooperation

Operational Program, Atlantic Area - Transnational Cooperation 2007-2013)

4.20 SME’s in Ireland and Europe

The European Union faced challenging economic conditions in 2011/2012.

Throughout the downturn, however, SME’s have retrained their position as the

backbone of the European economy, with some 20.7 million firms accounting for

more than 98% of all enterprises, of which 92.2% are firms with fewer than 10

employees. For 2012, it was estimated that SME’s accounted for 67% of total

employment and 58% of gross value added (GVA) 1. These figures point to a stand-

still as compared to the previous year, 2011. With more than 87 million people

employed in EU SME’s, they continue to be the backbone of the EU economy.

2013 is likely to mark a turning point for the EU SMEs. After five years of an

uncertain economic environment, 2013 was expected to be the first year since 2008

with a combined increase in aggregated employment and value-added of EU’s

SMEs. The total employment in the EU SMEs was expected to increase by 0.3% and

331

value-added by 1% as compared to 2011. Preliminary forecasts expect the positive

developments further accelerating in 2014. These promising projections were backed

up by other positive signals. Over the last three years, an increasing number of

Member States have seen their small business sectors returning to an expansion of

employment and value-added, or at least a petering out of the decline. If the

macroeconomic conditions hold, this development would mark the end of the most

challenging crisis the European SMEs have experienced in the recent history.

European SMEs were significantly more resilient than large enterprises to the

2008 crisis, particularly in employment terms. However, after the crisis it has been

more difficult also for them to recover. After 2009, large enterprises were leading the

recovery in terms of output (gross value added), but as of 2012 they have surpassed

SMEs – albeit only slightly - also in terms of employment. Thus, by 2012, large

enterprises managed to regain almost 1.1 million of the 1.6 million jobs lost in 2009.

The SMEs, which lost comparatively fewer jobs in preceding years, went through a

rough patch in 2012.

Viewed against the unparalleled depth and complexity of the crisis, such a

turn-around is a remarkable testimony to the resilience of the EU SMEs. While in

2008-2011 the SMEs resisted the crisis better than large enterprises, in 2012 SMEs

suffered a loss of jobs in the order of 610,000 jobs or a 0.7% decrease compared to

2011. Moreover, SMEs’ contribution to GDP declined by 1.3% from €3.44 trillion in

2011 to €3.39 trillion.

Small businesses play a vital role in the Irish Economy. Across Europe nearly

99% of all European companies are SME's employing almost 81 million people,

providing 66% of Europe's total employment. In Ireland, almost 200,000 small and

medium sized enterprises employ over 655,000 people. Therefore it is recognised

that small businesses are a key contributor to the economy and are crucial for growth

and employment. Biotechnology SME’s does only excel in R&D if they have access

to finance and cutting edge technologies. There needs to be a defragmentation of

biotechnology across the EU, with a focus on development in underdeveloped areas

of the Atlantic Area. If Europe is to compete on a global scale it needs to do so as a

critical mass and not as a fragmented sector with areas of high development and

large areas of low development.

332

4.21 Conclusion

The focus of ShareBiotech was modern biotechnology and implicitly a

multidisciplinary approach. The starting point of the project was to identify the needs

for modern biotechnology resulting from the development of basic and applied

research in life sciences. The project aimed to promote a “bottom up” approach and

in partnership with stakeholders to find appropriate technological answers through

adaption of the technology offering. Transnational models must be implemented

across different jurisdictions with all the inherent differences and distinction between

the partners, impacting on organization and operation. However the view of experts

interviewed was that the ideas of a transnational network of core facilities would be

difficult to implement for several reasons. These included cultural differences

between countries and even regions within countries, differences in tax and

employment laws, and research has shown that people do not want to travel even

short distances to access technologies. The cluster model appears successful in

addressing logistical barriers. In parallel there is also a substantive history of

transnational corporations, running a business across a number of countries. The

latter has attracted growing business analytical research in recent years, but it would

still be true, that no full comparative understanding of these transnational entities

exists to a level that an automatic recommendation can be made, when any new

partner structure is initiated. All evidence to date supports the view, that despite

more than two decades of EU effort to drive transnational collaboration networks,

logistics, and language and culture all influence probability of success and therefore

any proposed ShareBiotech model must accommodate flexibility to handle partner

differences and issues. In terms of working with current research infrastructure as

opposed to initiating new facilities, the former has proved easier in the past for EU

models.

The operating environment for biotech companies in Europe is becoming less

attractive than in other geographical areas. In addition to high energy costs, Europe

has less predictable and science-based regulatory frameworks than those of other

geographies, lacks the funding and tailored market-pull offered by other parts of the

world, and needs to ensure faster and more equitable access to biotech products and

processes for patients, farmers, and consumers. Europe should fully embrace the

333

virtual organisation’s model in environments where it will give best added value.

Significant improvements in wireless technologies are on the horizon. For example,

third-generation (3G) wireless networks will offer high-speed, packet-switched

mobile voice/data networks. The 3G standards, which are being defined by working

groups within the International Telecommunications Union (ITU), will be deployed

to support significantly higher bandwidth over wireless communications. This

increased mobile bandwidth will open up a whole new generation of applications to

wireless subscribers such as collaborative and multimedia services. With the right

environment, Europe’s biotech industry can continue to play a leading role in

tackling major European problems in energy, environment, food security, health,

international competiveness, local job creation, and security. Europe can be at the

forefront and contribute to Europe’s industrial renaissance. The next five years will

be critical for Europe, and they will also determine the success of Europe’s biotech

industry.

Networking and a sense of community was recognised as very important to

sustainable cluster development. A social aspect as simple as having a cup of coffee

during conferences was an excellent method of networking. Government funding

needed to be sustainable and long-term irrelevant of government cycle changes.

When developing a cluster it was important to work within the niche areas of the

community. There needed to be a change of mind set by policy makers regarding

biotech ant it was important to provide information to the public to educate people

about the benefits of biotechnology.

Strong cluster management was a key driver of sustainable cluster development with

an entrepreneurial input. A policy of joined-up thinking should be development and

encouraged among all biotech stakeholders, policy makers, investors and the public.

4.22 Future Work – Horizon 2020

Horizon 2020 is the European Union’s new research programme, which will succeed

FP7 in 2014. Horizon 2020 is the financial instrument implementing the Innovation

Union, a Europe 2020 flagship initiative aimed at securing Europe's global

competitiveness.

Running from 2014 to 2020 with an €80 billion budget, the EU’s new programme

for research and innovation is part of the drive to create new growth and jobs in

334

Europe. Horizon 2020 will tackle societal challenges by helping to bridge the gap

between research and the market by, for example, helping innovative enterprise to

develop their technological breakthroughs into viable products with real commercial

potential.

This market-driven approach will include creating partnerships with the private

sector and Member States to bring together the resources needed. Horizon 2020 will

be complemented by further measures to complete and further develop the European

Research Area by 2014. These measures will aim at breaking down barriers to create

a genuine single market for knowledge, research, and innovation. The ShareBiotech

project addressed access to TCF’s for SME’s through sharing technologies and

accessing the feasibility of a Transnational Network of TCF’s. Horizon 2020 can

build on the work done by the ShareBiotech project.

Horizon 2020 promises to raise the level of excellence in Europe’s science base and

ensure a steady stream of world-class research to secure Europe’s long-term

competiveness. It will support the best ideas, develop talent within Europe, and

provide researchers with access to priority research infrastructure, and make Europe

an attractive location for the world’s best researchers.

Horizon 2020 will:

Support the most talented and creative individuals and their teams to carry

out frontier research of the highest quality by building on the success of the

European Research Council (ERC)

Fund collaborative research to open up new and promising fields of research

and innovation through support for Future and Emerging Technologies (FET)

Provide researchers with excellent training and career development

opportunities through the Marie Skiodwska-Curie Actions.

Ensure Europe has world-class research infrastructures (including e-

infrastructures) accessible to all researchers in Europe and beyond.

Biotechnology will be embedded throughout Horizon 2020. Biotechnology will be

at the core of “Food security”, sustainable agriculture, marine and maritime research

and the Bio-economy, notably in the development of “Sustainable and competitive

bio-based industries”. Biotechnology has been identified as one of the Key Enabling

Technologies (KET’s) and will focus on three major areas:

Boosting cutting-edge biotechnologies as future innovation drivers with the

aim of laying the foundations for the European biotechnology industry to stay

at the front line of innovation, both in the medium and long term.

335

Biotechnology-based industrial processes enabling European bio-industry to

develop new products and processes meeting industrial and societal demands,

including replacing established ones based on other technologies and

harnessing the potential of biotechnology for detecting, monitoring,

preventing, and removing pollution.

Developing innovative and competitive platform technologies that would

generate leadership and competitive advantage in a wide number of economic

sectors.

Biotechnology in Horizon 2020 brings together a top-down approach through the

societal challenges on bio-economy and supporting sustainable and competitive bio-

based industries, and a bottom-up approach with KET on biotechnology.

336

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