Effects of firm’s alliances on new drug development time|RISS 상세보기

다국어 초록 (Multilingual Abstract)

Introduction: Alliances between firms are becoming more common for drug development; however, it is not clear how these alliances affect the time spent on drug development. This study analyzes the effect of firm’s alliances on the clinical development time of new drugs by controlling for related factors.

Methods: Datasets of the new drug development program in which the first human trials were started between 2000 and 2015 were constructed using the Evaluate Pharma database. These datasets included the initiation date of clinical Phases 1, 2, and 3, and the approval phase, as well as the firm’s alliances and related influencing factors. Using these datasets, a multiple regression analysis was performed to determine the effect of firm’s alliances on the new drug development time at each stage of development, after adjusting for the origin of substances, therapeutic indications, drug designation, and firm size. Subgroup analysis was performed based on key variables.

Results: A firm’s alliance significantly increased the development times of clinical Phases 1, 2, and 3 by 549.3 days, 617.3 days, and 232.0 days, respectively. However, there was no statistically significant effect on the development time of the approval stage.

Conclusion: As a firm’s alliance significantly increases the drug development time in the early clinical stages, companies developing new drugs through alliances in the early clinical stages need to make more efforts to reduce the development time.

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목차 (Table of Contents)

Chapter 1. Introduction 1
1.1. Background 1
1.1.1. Importance of New Drug Development Time 1
1.1.2. Importance and Effects of Firm’s Alliances 1
1.2. Alliances and Innovation Speed 2

Chapter 1. Introduction 1
1.1. Background 1
1.1.1. Importance of New Drug Development Time 1
1.1.2. Importance and Effects of Firm’s Alliances 1
1.2. Alliances and Innovation Speed 2
Chapter 2. Literature Review 4
2.1. Previous Studies on New Drug Development Time 4
2.1.1. Definition and Measurement of New Drug Development Time 4
2.1.2. Studies on New Drug Development Time 6
2.1.3. Studies on Clinical Development Phase, White Space, and its Reduction 10
2.1.4. Influence Factors of New Drug Development Time 15
2.2. Previous Studies on Firm’s Alliances 20
2.2.1. Definition and Measurement of Firm’s Alliances 20
2.2.2. Motivation, Effects, and Challenges of Firm’s Alliances 27
2.2.3. Studies on Firm’s Alliances and Drug Development Time 30
Chapter 3. Objective 32
3.1. Controversial Effect of Firm’s Alliances on New Drug Development Time 32
3.2. Needs for Study on Effect of Firm’s Alliances on New Drug Development Time 32
Chapter 4. Method 34
4.1. Data Acquisition 34
4.2. Definition of Variables 35
4.2.1. New Drug Development Time 35
4.2.2. Firm’s Alliances 38
4.2.3. Control Variables 41
4.3. Statistical Analysis 47
4.3.1. Multiple Regression Analysis 47
4.3.2. Kaplan-Meier Analysis 48
Chapter 5. Results 49
5.1. Descriptive Analysis of Subject and Observation 49
5.2. Analysis of New Drug Development Time 52
5.2.1. Analysis by Development Phases 52
5.2.2. Analysis by Alliance/non-Alliance 52
5.2.3. Analysis by Alliance’s Type 55
5.2.4. Analysis by Top20/non-Top20 58
5.2.5. Analysis by Origin of Substances 60
5.2.6. Analysis by Orphan drug/non-Orphan drug 62
5.2.7. Analysis by Priority Review/Standard Review 64
5.3. Main Analysis: Multiple Regression 66
5.3.1. Analysis by Development Phases 66
5.3.2. Subgroup Analysis 69
5.3.2.1. Biological drug vs. Chemical drug 70
5.3.2.2. Top20 vs. non-Top20 71
5.3.2.3. Orphan drug vs. non-Orphan drug 72
5.3.2.4. Priority review vs. Standard review 73
5.4. Kaplan-Meier Analysis 76
5.4.1. Analysis by Alliance/non-Alliance 76
5.4.2. Analysis by Time Periods of Alliance Occurrence 77
Chapter 6. Discussion 80
6.1. Summary and Discussion 80
6.1.1. Main Analysis 80
6.1.2. Subgroup Analysis 85
6.2. Strength 88
6.3. Limitations 90
Chapter 7. Conclusion 93
References 95
Appendix 101
<Appendix 1> Biological drug vs. Chemical drug 101
<Appendix 2> Top20 vs. non-Top20 105
<Appendix 3> Orphan drug vs. non-Orphan drug 109
<Appendix 4> Priority Review vs. Standard Review 113
<Appendix 5> Time Distribution on Origin of Substances 117
<Appendix 6> Time Distribution on Top20/non-Top20 119
<Appendix 7> Time Distribution on Orphan drug/non-Orphan drug 121
<Appendix 8> Time Distribution on Priority Review/Standard Review 123
Korean Abstract 125

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