Title Page
Contents
Abstract 16
Chapter 1. Introduction 18
1.1. Background 18
1.1.1.Importance of New Drug Development Time 18
1.1.2. Importance and Effects of Firm's Alliances 18
1.2. Alliances and Innovation Speed 19
Chapter 2. Literature Review 21
2.1. Previous Studies on New Drug Development Time 21
2.1.1. Definition and Measurement of New Drug Development Time 21
2.1.2. Studies on New Drug Development Time 23
2.1.3. Studies on Clinical Development Phase, White Space, and its Reduction 27
2.1.4. Influence Factors of New Drug Development Time 32
2.2. Previous Studies on Firm's Alliances 37
2.2.1. Definition and Measurement of Firm's Alliances 37
2.2.2. Motivation, Effects, and Challenges of Firm's Alliances 44
2.2.3. Studies on Firm's Alliances and Drug Development Time 47
Chapter 3. Objective 49
3.1. Controversial Effect of Firm's Alliances on New Drug Development Time 49
3.2. Needs for Study on Effect of Firm's Alliances on New Drug Development Time 49
Chapter 4. Method 51
4.1. Data Acquisition 51
4.2. Definition of Variables 52
4.2.1. New Drug Development Time 52
4.2.2. Firm's Alliances 55
4.2.3. Control Variables 58
4.3. Statistical Analysis 64
4.3.1. Multiple Regression Analysis 64
4.3.2. Kaplan-Meier Analysis 65
Chapter 5. Results 66
5.1. Descriptive Analysis of Subject and Observation 66
5.2. Analysis of New Drug Development Time 69
5.2.1. Analysis by Development Phases 69
5.2.2. Analysis by Alliance/non-Alliance 69
5.2.3. Analysis by Alliance's Type 72
5.2.4. Analysis by Top20/non-Top20 75
5.2.5. Analysis by Origin of Substances 77
5.2.6. Analysis by Orphan drug/non-Orphan drug 79
5.2.7. Analysis by Priority Review/Standard Review 81
5.3. Main Analysis: Multiple Regression 83
5.3.1. Analysis by Development Phases 83
5.3.2. Subgroup Analysis 86
5.4. Kaplan-Meier Analysis 93
5.4.1. Analysis by Alliance/non-Alliance 93
5.4.2. Analysis by Time Periods of Alliance Occurrence 94
Chapter 6. Discussion 97
6.1. Summary and Discussion 97
6.1.1. Main Analysis 97
6.1.2. Subgroup Analysis 102
6.2. Strength 105
6.3. Limitations 107
Chapter 7. Conclusion 110
References 112
Appendices 118
〈Appendix 1〉 Biological drug vs. Chemical drug 118
〈Appendix 2〉 Top20 vs. non-Top20 122
〈Appendix 3〉 Orphan drug vs. non-Orphan drug 126
〈Appendix 4〉 Priority Review vs. Standard Review 130
〈Appendix 5〉 Time Distribution on Origin of Substances 134
〈Appendix 6〉 Time Distribution on Top20/non-Top20 136
〈Appendix 7〉 Time Distribution on Orphan drug/non-Orphan drug 138
〈Appendix 8〉 Time Distribution on Priority Review/Standard Review 140
Korean Abstract 142
Table 1. Definitions of Innovation Speed 21
Table 2. Advantage and Disadvantages of Development Speed 22
Table 3. Characteristics of each Clinical Development Phase 24
Table 4. Previous Studies for Drug Development Time 26
Table 5. Comparison of Trial Duration to Phase-Change Duration (years) in Key Disease Areas, 2013-2022 29
Table 6. Characterization of COVID-19 Vaccine Trial Changes 30
Table 7. Influence Factors for New Drug Development Time 34
Table 8. Definition and Classification by Alliances Agreement Type 40
Table 9. Definition and Classification by Alliances Governance 41
Table 10. Definition and Classification by Alliances Objective 42
Table 11. Previous Studies of Alliances with Independent, Dependent and Controlling Variables 43
Table 12. Drug Development Process 53
Table 13. Operational Definition of each Development Phases 54
Table 14. Definition of Alliance Types 56
Table 15. Definition of Origin of Substances 58
Table 16. Definition of Therapeutic Cass 59
Table 17. Drug Designations by US FDA 60
Table 18. The World Top 20 Companies in 2015 63
Table 19. Descriptive Statistics of Variables of each Dataset 67
Table 20. Descriptive Statistics of Variables of each Dataset 68
Table 21. New Drug Development Time on Firm's Alliances at Each Development Phase 70
Table 22. New Drug Development Time on each Alliance Type at Each Development Phase 73
Table 23. New Drug Development Time on Top20/non-Top20 at Each Development Phase 75
Table 24. New Drug Development Time on Origin of Substances at Each Development Phase 77
Table 25. New Drug Development Time on Orphan/non-Orphan drug at Each Development Phase 79
Table 26. New Drug Development Time on Priority/Standard Review at Each Development Phase 81
Table 27. Effect of Firm's Alliances on New Drug Development Time 85
Table 28. Coefficient of Alliance by Origin of Substances 87
Table 29. Coefficient of Alliance by Top20/non-Top20 88
Table 30. Coefficient of Alliance by Orphan drug Designation 89
Table 31. Coefficient of Alliance by Review Status 90
Table 32. Coefficient of Variables on each Subgroup at Each Development Phase 91
Table 33. Development Time on Alliance/non-Alliance (years) 93
Table 34. Development Time on each Time Period of Alliance Occurrence (years) 96
Table 35. Effect of Firm's Alliances on New Drug Development Time by Biological drug vs. Chemical drug: Phase 1 118
Table 36. Effect of Firm's Alliances on New Drug Development Time by Biological drug vs. Chemical drug: Phase 2 119
Table 37. Effect of Firm's Alliances on New Drug Development Time by Biological drug vs. Chemical drug: Phase 3 120
Table 38. Effect of Firm's Alliances on New Drug Development Time by Biological drug vs. Chemical drug: FDA Review 121
Table 39. Effect of Firm's Alliances on New Drug Development Time by Top20 and non-Top20: Phase 1 122
Table 40. Effect of Firm's Alliances on New Drug Development Time by Top20 and non-Top20: Phase 2 123
Table 41. Effect of Firm's Alliances on New Drug Development Time by Top20 and non-Top20: Phase 3 124
Table 42. Effect of Firm's Alliances on New Drug Development Time by Top20 and non-Top20: FDA Review 125
Table 43. Effect of Firm's Alliances on New Drug Development Time by Orphan and non-Orphan: Phase 1 126
Table 44. Effect of Firm's Alliances on New Drug Development Time by Orphan and non-Orphan: Phase 2 127
Table 45. Effect of Firm's Alliances on New Drug Development Time by Orphan and non-Orphan: Phase 3 128
Table 46. Effect of Firm's Alliances on New Drug Development Time by Orphan and non-Orphan: FDA Review 129
Table 47. Effect of Firm's Alliances on New Drug Development Time by Priority Review vs. Standard Review: Phase 1 130
Table 48. Effect of Firm's Alliances on New Drug Development Time by Priority Review vs. Standard Review: Phase 2 131
Table 49. Effect of Firm's Alliances on New Drug Development Time by Priority Review vs. Standard Review: Phase 3 132
Table 50. Effect of Firm's Alliances on New Drug Development Time by Priority Review vs. Standard Review: FDA Review 133
Table 51. Development Time of Chemical Drug on Alliance/non-Alliance (years) 134
Table 52. Development Time of Biological Drug on Alliance/non-Alliance (years) 135
Table 53. Development Time of non-Top20 on Alliance/non-Alliance (years) 136
Table 54. Development Time of Top20 on Alliance/non-Alliance (years) 137
Table 55. Development Time of non-Orphan Drug on Alliance/non-Alliance (years) 138
Table 56. Development Time of Orphan Drug on Alliance/non-Alliance (years) 139
Table 57. Development Time of Standard Review on Alliance/non-Alliance (years) 140
Table 58. Development Time of Priority Review on Alliance/non-Alliance (years) 141
Figure 1. Study Frame for Data Acquisition and its Process 52
Figure 2. Defined Duration of each Development Phase 55
Figure 3. Median New Drug Development Time on Firm's Alliances at Each Development Phase 71
Figure 4. Mean New Drug Development Time on Firm's Alliances at Each Development Phase 71
Figure 5. Median and Mean New Drug Development Time on Alliance Type at Each Development Phase 74
Figure 6. Median and Mean New Drug Development Time on Top20/non-Top20 at Each Development Phase 76
Figure 7. Median and Mean New Drug Development Time on Origin of Substances at Each Development Phase 78
Figure 8. Median and Mean New Drug Development Time on Orphan/non-Orphan drug at Each Development Phase 80
Figure 9. Median and Mean New Drug Development Time on Priority/Standard Review at Each Development Phase 82
Figure 10. Kaplan-Meier Curve on Alliance/non-Alliance 94
Figure 11. Definitions for Time Periods of Alliance Occurrence 95
Figure 12. Kaplan-Meier Curve on each Time Period of Alliance Occurrence 96
Figure 13. Kaplan-Meier Curve on Chemical Drug 134
Figure 14. Kaplan-Meier Curve on Biological Drug 135
Figure 15. Kaplan-Meier Curve on non-Top20 136
Figure 16. Kaplan-Meier Curve on Top20 137
Figure 17. Kaplan-Meier Curve on non-Orphan Drug 138
Figure 18. Kaplan-Meier Curve on Orphan Drug 139
Figure 19. Kaplan-Meier Curve on Standard Review 140
Figure 20. Kaplan-Meier Curve on Priority Review 141