Risk-sharing in pharmaceutical R&D collaborations: the case of out-licensing
Gespeichert in:
| Beteilige Person: | |
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| Format: | Hochschulschrift/Dissertation Buch |
| Sprache: | Englisch |
| Veröffentlicht: |
2005
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| Schlagwörter: | |
| Links: | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=014281256&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| Umfang: | XVII, 296 S. graph. Darst. |
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Datensatz im Suchindex
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| adam_text | Index
1 Introduction 1
1.1 Motivation and Goal 1
1.2 Terms and Definitions 18
1.3 Research Concept 22
1.4 Structure of Thesis 25
2 Key Issues in Managing Pharmaceutical Innovation 29
2.1 Increase in R D Risks 29
2.2 Increase in R D Collaborations 49
2.3 Summary 62
3 Risk sharing as New Paradigm in Pharma R D Collaborations 65
3.1 Traditional Approaches to Risk sharing 67
3.2 Out licensing as Novel Approach to Risk sharing 75
3.3 Summary 87
4 Case Studies on Risk sharing in Pharma R D Collaborations 89
4.1 Out licensing at Novartis 90
4.2 Out licensing at Schering 103
4.3 Out licensing at Roche 114
4.4 Summary 125
iv Index 5 Characteristics of Risk sharing in Pharma R D Collaborations 131
5.1 Attributes of the Licensor 131
5.2 Attributes of the License 145
5.3 Attributes of the Licensee 162
5.4 Summary 177
6 Theoretical Basis for Risk sharing in Pharma R D Collaborations 183
6.1 The Theory of Adverse Selection 185
6.2 Adverse Selection Applied to the Case of Out licensing 186
6.3 Summary 200
7 Managerial Recommendations for Risk sharing in Pharma R D
Collaborations 203
7.1 Product Coverage 205
7.2 Price Setting 215
7.3 Performance Presumption 226
7.4 Summary 238
8 Conclusion 245
8.1 Implications for Management Practice 245
8.2 Implications for Management Theory 256
Contents
Preface i
Abstract ii
Index iii
Contents v
List of Figures x
List of Tables xiv
List of Abbreviations xv
1 Introduction 1
1.1 Motivation and Goal 1
1.1.1 Relevance of research subject 1
1.1.2 Deficits in current research 4
1.1.3 Research objective 17
1.2 Terms and Definitions 18
1.3 Research Concept 22
1.3.1 Research classification 22
1.3.2 Research methodology 24
1.4 Structure of Thesis 25
2 Key Issues in Managing Pharmaceutical Innovation 29
2.1 Increase in R D Risks 29
2.1.1 Risk of growth attainment 29
2.1.2 Risk of increasing complexity 31
2.1.3 Risk of technology investment 34
vi Contents
2.1.4 Risk of high attrition 40
2.1.5 Risk of blockbuster reliance 41
2.1.6 Risk of market timing 44
2.1.7 Risk of product differentiation 46
2.1.8 Risk of regulative force 48
2.2 Increase in R D Collaborations 49
2.2.1 Relevance of R D collaborations 51
2.2.2 Evolution of R D collaborations 52
2.2.3 Classification of R D collaborations 57
2.2.4 Reasons for R D collaborations 60
2.3 Summary 62
3 Risk sharing as New Paradigm in Pharma R D Collaborations 65
3.1 Traditional Approaches to Risk sharing 67
3.1.1 Research alliance 67
3.1.2 In licensing 69
3.1.3 Co development 72
3.2 Out licensing as Novel Approach to Risk sharing 75
3.3 Summary 87
4 Case Studies on Risk sharing in Pharma R D Collaborations 89
4.1 Out licensing at Novartis 90
4.1.1 Company profiles 90
4.1.2 Description of the out licensing strategy 93
4.1.3 Structure of the out licensing collaboration 98
4.1.4 Capabilities of the out licensing partner 99
4.2 Out licensing at Schering 103
4.2.1 Company profiles 103
Contents vii
4.2.2 Description of the out licensing strategy 106
4.2.3 Structure of the out licensing collaboration 110
4.2.4 Capabilities of the out licensing partner 113
4.3 Out licensing at Roche 114
4.3.1 Company profiles 115
4.3.2 Description of the out licensing strategy 118
4.3.3 Structure of the out licensing collaboration 120
4.3.4 Capabilities of the out licensing partner 123
4.4 Summary 125
5 Characteristics of Risk sharing in Pharma R D Collaborations 131
5.1 Attributes of the Licensor 131
5.1.1 Out licensing approach 131
5.1.2 Out licensing organization 136
5.1.3 Out licensing process 140
5.2 Attributes of the License 145
5.2.1 Appropriability regime 146
5.2.2 Bargaining range 150
5.2.3 Compensation structure 155
5.3 Attributes of the Licensee 162
5.3.1 Business strategy 162
5.3.2 Corporate flexibility 167
5.3.3 Entrepreneurial setting 170
5.4 Summary 177
6 Theoretical Basis for Risk sharing in Pharma R D Collaborations 183
6.1 The Theory of Adverse Selection 185
6.2 Adverse Selection Applied to the Case of Out licensing 186
viii Contents 6.2.1 Demand for licensing contracts 189
6.2.2 Supply of licensing contracts 190
6.2.3 Probability that the licensee cannot execute 191
6.2.4 Definition of an equilibrium in the licensing market 191
6.2.5 Equilibrium with identical licensees 192
6.2.6 Equilibrium with two classes of licensees 194
6.2.7 Discussion of the underlying assumptions 198
6.3 Summary 200
7 Managerial Recommendations for Risk sharing in Pharma R D
Collaborations 203
7.1 Product Coverage 205
7.1.1 Relevant parameters 205
7.1.2 Impact on risk transferability 209
7.1.3 Managerial implications 210
7.2 Price Setting 215
7.2.1 Relevant parameters 216
7.2.2 Impact on risk transferability 219
7.2.3 Managerial implications 220
7.3 Performance Presumption 226
7.3.1 Relevant parameters 227
7.3.2 Impact on risk transferability 229
7.3.3 Managerial implications 232
7.4 Summary 238
8 Conclusion 245
8.1 Implications for Management Practice 245
8.1.1 Central statements and recommendations 245
Contents ix
8.1.2 Future directions and trends 252
8.2 Implications for Management Theory 256
8.2.1 Contribution to research 256
8.2.2 Open research questions 259
References 263
Appendix 291
List of Figures
Fig. 1. Declining productivity in pharmaceutical R D 2
Fig. 2. Literature streams related to risk sharing in pharmaceutical R D
collaborations 8
Fig. 3. Basic principles to manage risks 20
Fig. 4. Exploratory research as an iterative learning process 23
Fig. 5. Structure of thesis 26
Fig. 6. The failing attempt to achieve growth in the pharmaceutical
industry via M A activity 30
Fig. 7. R D process in the pharmaceutical industry 32
Fig. 8. Attrition rates in pharmaceutical R D by phase 40
Fig. 9. Breakdown of drug R D expenditures 41
Fig. 10. Contribution of blockbuster sales to ethical sales in 2002 42
Fig. 11. Time spent by a drug candidate in the clinical and approval phases 45
Fig. 12. Restructuring of pharmaceutical R D departments and resulting
interaction with external partners 50
Fig. 13. Development of alliances in the pharmaceutical industry 52
Fig. 14. Potential of outside innovation in the pharmaceutical value chain 54
Fig. 15. Classification of partnerhips in pharmaceutical R D activities 57
Fig. 16. Changing nature of interaction with outside innovation 63
Fig. 17. Different types of collaboration in pharmaceutical R D
(perspective: pharmaceutical company) 67
Fig. 18. Rising proportion of sales from in licensed products 71
Fig. 19. Growth in alliances of top 20 pharma companies (1988 to 2002) 76
Fig. 20. Out licensing as a strategy to gain complementary assets for the
utilization of a company s own technology 77
Fig. 21. Product responsibility of the business development licensing
departments at pharmaceutical companies regarding out licensing 78
Fig. 22. Out licensing as a way to dispose risks and open new markets 80
List of Figures xi
Fig. 23. Causes of failure pre deal closure for out licensing 83
Fig. 24. Causes of failure post deal closure for out licensing 84
Fig. 25. Expectations sometimes or rarely met with out licensing 85
Fig. 26. Out licensing process at Novartis 95
Fig. 27. Out licensing collaboration between Novartis and Speedel 99
Fig. 28. Comparison of clinical development time: Speedel (substance:
Aliskiren), big pharma with CRO, and big pharma without CRO 100
Fig. 29. Out licensing process at Schering 108
Fig. 30. Out licensing collaboration between Schering and Intarcia 111
Fig. 31. Organizational integration of out licensing within Roche 118
Fig. 32. Out licensing collaboration between Roche and Actelion 121
Fig. 33. Proactive vs. passive out licensing approach of the licensor 135
Fig. 34. Embedded vs. undefined out licensing organization of the licensor 139
Fig. 35. Process responsibilities of the business development licensing
departments at pharmaceutical companies regarding out licensing 141
Fig. 36. Exemplary out licensing process 142
Fig. 37. Structured vs. fuzzy out licensing process of the licensor 144
Fig. 38. Attributes of the licensor and their impact on risk transferability 145
Fig. 39. Tight vs. loose appropriability regime of the license 150
Fig. 40. Bargaining range of the license 152
Fig. 41. Share of expected NPV in a traditional licensing deal 154
Fig. 42. Large vs. small bargaining range of the license 155
Fig. 43. Average deal terms regarding upfront and milestone payments in
pharmaceutical R D collaborations 157
Fig. 44. Success based vs. fee based compensation structure of the license 160
Fig. 45. Attributes of the license and their impact on risk transferability 161
Fig. 46. Segmentation of the global blockbuster market in 2002 164
Fig. 47. Industry performance of specialty pharma companies compared to
established pharmaceutical companies 166
xii List of Figures Fig. 48. Focused vs. broad business strategy of the licensee 167
Fig. 49. Speedel s dependency and integration into other companies
innovation processes 168
Fig. 50. High vs. low corporate flexibility of the licensee 171
Fig. 51. Venture capitalists as providers of capital for high risk development
tasks 172
Fig. 52. Strong vs. weak entrepreneurial setting of the licensee 176
Fig. 53. Attributes of the licensee and their impact on risk transferability 177
Fig. 54. Entities and their attributes involved in an out licensing
collaboration 181
Fig. 55. The partner firm s projected revenues in the case of out licensing 189
Fig. 56. Equilibrium in the market for out licensing with identical licensees.... 193
Fig. 57. Non existence of a pooling equilibrium in the out licensing market.... 195
Fig. 58. Equilibrium in the out licensing market with two classes of
licensees 196
Fig. 59. Parameters for finding an equilibrium in the out licensing market 204
Fig. 60. Impact of increasing the product coverage on finding an equilibrium
in the out licensing market 211
Fig. 61. Impact of reducing the product coverage on finding an equilibrium
in the out licensing market 213
Fig. 62. Impact of changes in the product coverage on the ability to find an
equilibrium in the out licensing market 215
Fig. 63. Impact of increasing the upfront payment on finding an equilibrium
in the out licensing market 222
Fig. 64. Impact of reducing the upfront payment on finding an equilibrium
in the out licensing market 223
Fig. 65. Impact of changes in the upfront payment on the ability to find an
equilibrium in the out licensing market 225
Fig. 66. Impact of targeting a high risk licensee on the ability to find an
equilibrium in the out licensing market 234
Fig. 67. Impact of targeting a low risk licensee on the ability to find an
equilibrium in the out licensing market 236
Fig. 68. Impact of changes in the performance presumption on the ability to
find an equilibrium in the out licensing market 238
Fig. 69. Management framework for out licensing as a method for risk
sharing in pharmaceutical R D collaborations 240
Fig. 70. Summary of changes in the product coverage, price setting and
performance presumption on finding an equilibrium in the out
licensing market 242
List of Tables
Table 1. Overview of empirical data set 25
Table 2. Top 10 pharmaceutical companies in R D spending worldwide 31
Table 3. Average cost structure of a newly developed drug 32
Table 4. Out licensing offerings at Schering (as of November 2004) 109
Table 5. Characteristics of the analyzed out licensing collaborations 125
Table 6. Compensation and deal structure of key licensing deals in 2002 158
Table 7. Therapeutic focus of the analyzed partner firms 164
Table 8. Selected newly founded NRDOs 173
Table 9. Specifications of the attributes of the analyzed case studies 179
Table 10. Overview of underlying assumptions of the theoretical model 198
|
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| indexdate | 2024-12-20T12:26:16Z |
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| spellingShingle | Reepmeyer, Gerrit Risk-sharing in pharmaceutical R&D collaborations the case of out-licensing Pharmazeutische Industrie (DE-588)4045696-1 gnd Forschung und Entwicklung (DE-588)4017897-3 gnd Risikomanagement (DE-588)4121590-4 gnd Forschungskooperation (DE-588)4236001-8 gnd Lizenzvergabe (DE-588)4167986-6 gnd |
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| title | Risk-sharing in pharmaceutical R&D collaborations the case of out-licensing |
| title_auth | Risk-sharing in pharmaceutical R&D collaborations the case of out-licensing |
| title_exact_search | Risk-sharing in pharmaceutical R&D collaborations the case of out-licensing |
| title_full | Risk-sharing in pharmaceutical R&D collaborations the case of out-licensing by Gerrit Reepmeyer |
| title_fullStr | Risk-sharing in pharmaceutical R&D collaborations the case of out-licensing by Gerrit Reepmeyer |
| title_full_unstemmed | Risk-sharing in pharmaceutical R&D collaborations the case of out-licensing by Gerrit Reepmeyer |
| title_short | Risk-sharing in pharmaceutical R&D collaborations |
| title_sort | risk sharing in pharmaceutical r d collaborations the case of out licensing |
| title_sub | the case of out-licensing |
| topic | Pharmazeutische Industrie (DE-588)4045696-1 gnd Forschung und Entwicklung (DE-588)4017897-3 gnd Risikomanagement (DE-588)4121590-4 gnd Forschungskooperation (DE-588)4236001-8 gnd Lizenzvergabe (DE-588)4167986-6 gnd |
| topic_facet | Pharmazeutische Industrie Forschung und Entwicklung Risikomanagement Forschungskooperation Lizenzvergabe Hochschulschrift |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=014281256&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
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