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http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/99193Full metadata record
| ???org.dspace.app.webui.jsptag.ItemTag.dcfield??? | Value | Language |
|---|---|---|
| dc.contributor.advisor | 胡凱焜 | zh_TW |
| dc.contributor.advisor | Kae-Kuen Hu | en |
| dc.contributor.author | 劉昱彣 | zh_TW |
| dc.contributor.author | Yu-Wen Liu | en |
| dc.date.accessioned | 2025-08-21T16:45:16Z | - |
| dc.date.available | 2025-08-22 | - |
| dc.date.copyright | 2025-08-21 | - |
| dc.date.issued | 2025 | - |
| dc.date.submitted | 2025-08-03 | - |
| dc.identifier.citation | Book
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| dc.identifier.uri | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/99193 | - |
| dc.description.abstract | 細胞與基因治療（CGT）作為當代醫療創新的關鍵技術，具備根治罕見疾病與重大疾病的潛力。然而，其研發與商業化過程仍受到臨床不確定性、法規審查與支付機制限制的挑戰。本研究採用混合研究方法，結合專利分析、臨床試驗數據、國際制度比較與專家訪談，選取腺相關病毒（AAV）、嵌合抗原受體T細胞（CAR-T）、常間回文重複序列叢集關聯蛋白（CRISPR）、間質幹細胞（MSC）、自然殺手細胞（NK cell）與誘導性多能幹細胞（iPSC）等六種代表性技術，建構細胞基因療法的發展分類與成熟度評估架構。
透過美國、歐盟與日本的制度比較，本研究揭示不同法規與支付設計在CGT產品核准的偏好及產業發展的影響。最後特別聚焦於台灣現行雙軌制制度，並提出兼顧產業誘因與發展之建議。研究認為，影響CGT普及的關鍵並非僅止於技術發展，更取決於法規彈性、支付體系成熟度與整體政策前瞻性。 | zh_TW |
| dc.description.abstract | Cell and gene therapies (CGTs) represent a new frontier in biomedical innovation, offering curative potential for diseases once considered intractable. However, the development and delivery of CGTs remain constrained by uncertainties in regulation, reimbursement, and clinical translation. This study establishes an integrated analytical framework combining patent analysis, clinical trial mapping, and international policy comparison to examine six representative CGT modalities: AAV, CAR-T, CRISPR, MSC, NK cell, and iPSC. The analysis reveals differentiated technology trajectories and clinical maturity levels, which are used to develop a strategic group typology of CGT development. A cross-jurisdictional comparison of the United States, the European Union, and Japan further uncovers the heterogeneous structures of approval pathways and payment mechanisms.
Particular attention is paid to Taiwan’s dual-track regulatory system and its implications for local innovation. The study proposes strategic recommendations for Taiwan’s CGT governance, including regulatory alignment, HTA reform, data stewardship, and global standard integration of delivery capabilities. The findings suggest that beyond technology, institutional readiness and policy foresight are decisive in shaping the future of CGT accessibility and affordability. | en |
| dc.description.provenance | Submitted by admin ntu (admin@lib.ntu.edu.tw) on 2025-08-21T16:45:16Z No. of bitstreams: 0 | en |
| dc.description.provenance | Made available in DSpace on 2025-08-21T16:45:16Z (GMT). No. of bitstreams: 0 | en |
| dc.description.tableofcontents | 論文口試委員審定書 i
致謝辭 ii 中文摘要 iii ABSTRACT iv CONTENTS v LIST OF FIGURES ix LIST OF TABLES xii Chapter 1 Introduction 1 1.1 Research Background and Motivation 1 1.2 Research Objectives and Questions 4 Chapter 2 Literature Review 6 2.1 Technologies of CGT 6 2.1.1 The Definition of CGT 6 2.1.2 Gene Therapy 8 2.1.3 Cell therapy 15 2.2 Challenges of CGTs to the Current System 20 2.2.1 Clinical Uncertainty and Safety Challenges 21 2.2.2 Manufacturing, Supply Chain, and Delivery Constraints 23 2.2.3 Payment and Reimbursement Mechanisms 25 2.3 Global Responses to CGT Payment Challenges 26 2.3.1 The Innovative Payment Models for CGT 27 2.3.2 The United States 30 2.3.3 The European Union 36 2.3.4 Japan 41 2.4 Multilevel Frameworks of Technology Management 44 2.4.1 Technological Evolution: Life Cycles, Paradigms, and Discontinuities 45 2.4.2 Organizational Capabilities and Strategic Positioning 48 2.4.3 Institutional Environment and Innovation Policy 49 Chapter 3 Research Method 51 3.1 Study Design Overview 51 3.2 CGT Technology Landscape 52 3.2.1 Patent Analysis 52 3.2.2 Clinical Trials Analysis 56 3.2.3 Strategic Grouping 57 3.3 Comparative Analysis from a Regulatory Perspective 57 3.3.1 Country Selection and Data Sources 57 3.3.2 Analytical Framework: Regulation and Payment 57 3.4 Semi-Structured Expert Interviews 58 3.4.1 Interview Design and Scope 58 3.4.2 Participant Selection and Process 58 Chapter 4 Discussion and Results 60 4.1 The Development of CGT Modalities 61 4.1.1 The Technology Life Cycle of CGTs 63 4.1.2 Patent Citation Network Analysis 79 4.1.3 Therapy Indications and Technologies 125 4.1.4 The Strategic Group of CGTs 132 4.2 The Landscape of CGT Approvals and Pricing: Case Study of the US, EU, and Japan 138 4.2.1 Current Approved CGTs and Their Prices 138 4.2.2 The Analysis of the Approved CGTs and Their Prices of The Three Systems 159 4.2.3 The Mapping of Technologies and Regulatory Systems of CGTs 162 4.3 CGTs in Taiwan 167 4.3.1 The Regulatory Evolution of CGT 167 4.3.2 The Development of CGTs 173 4.3.3 The Payment and The Reimbursement State of Taiwan’s CGT 178 Chapter 5 Conclusion 183 5.1 Study Findings 183 5.1.1 The Establishment of a Systematic Structure for CGT Analysis 183 5.1.2 The Heterogeneous Global Environment of CGT 187 5.1.3 A New Strategic Pillar in Biotechnology for Taiwan 188 5.2 Strategy Suggestions 189 5.2.1 Different CGT Modality and Payment System 189 5.2.2 Shaping the Future of CGT in Taiwan 191 5.3 Study Limitations and Recommendations for Future Research 196 REFERENCES 198 Appendix A 233 Appendix B 234 | - |
| dc.language.iso | en | - |
| dc.subject | 細胞與基因治療 | zh_TW |
| dc.subject | 再生醫療 | zh_TW |
| dc.subject | 支付制度 | zh_TW |
| dc.subject | 法規體系 | zh_TW |
| dc.subject | 專利分析 | zh_TW |
| dc.subject | 台灣 | zh_TW |
| dc.subject | payment system | en |
| dc.subject | cell and gene therapy | en |
| dc.subject | regenerative medicine | en |
| dc.subject | Taiwan | en |
| dc.subject | patent analysis | en |
| dc.subject | regulatory system | en |
| dc.title | 細胞與基因治療的技術發展與支付體系探討 | zh_TW |
| dc.title | A Study on the Technology Development and Payment System of Cell and Gene Therapy | en |
| dc.type | Thesis | - |
| dc.date.schoolyear | 113-2 | - |
| dc.description.degree | 碩士 | - |
| dc.contributor.oralexamcommittee | 何佳安;何俐安;阮大同 | zh_TW |
| dc.contributor.oralexamcommittee | Ja-An Annie Ho;Li-An Ho;Ta-Tung Yuan | en |
| dc.subject.keyword | 細胞與基因治療,再生醫療,支付制度,法規體系,專利分析,台灣, | zh_TW |
| dc.subject.keyword | cell and gene therapy,regenerative medicine,payment system,regulatory system,patent analysis,Taiwan, | en |
| dc.relation.page | 239 | - |
| dc.identifier.doi | 10.6342/NTU202502665 | - |
| dc.rights.note | 同意授權(全球公開) | - |
| dc.date.accepted | 2025-08-06 | - |
| dc.contributor.author-college | 進修推廣學院 | - |
| dc.contributor.author-dept | 生物科技管理碩士在職學位學程 | - |
| dc.date.embargo-lift | 2025-08-22 | - |
| Appears in Collections: | 生物科技管理碩士在職學位學程 | |
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|---|---|---|---|
| ntu-113-2.pdf | 5.63 MB | Adobe PDF | View/Open |
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