李吉仁臺灣大學：商學研究所碩士在職專班高階公共管理組蘇經天Su, Ching-TienChing-TienSu2007-12-032018-06-292007-12-032018-06-292007http://ntur.lib.ntu.edu.tw//handle/246246/63829健康照護產業可以說是最昂貴的服務業。產業中許多次產業，像是醫藥產業與生技產業一直以來的互相依存的競合關係，常常是實務界及學術界共同注意的研究議題。 這篇論文想由生技公司的觀點，尋求一個系統化的方式，來探討其在與大藥廠進行技術交易時，是否能在策略上達到交易價值的極大化，並討論當此價值極大化發生時所應具備的前提條件與情況。 文章中以一家擁有世界級產品潛力的台灣生技公司之新藥產品線為闡述的基礎，並鋪陳可應用至其他領域的產業驅動力來貫穿全文。由於生技公司新藥開發之主要商業模式為授權與被併購，文中亦針對上述價值極大化時於不同商業模式的取捨與決策判斷的條件加以論述。Healthcare industry is possibly the most expensive service industry in the world. To cope with technology changes and innovation challenge, pharmaceutical companies have to engage R&D collaborations with biotechnology companies and develop co-opetition relationship with each other. The smaller biotech companies always have the dilemma to either license-out (to big pharma) or launch the product on their own during collaborative processes. This thesis illustrates systematically those intrinsic driving forces underlying the co-developing relationship and maps out a strategic scheme for smaller biotech companies to maximize their potential value proposition in dealing with their pharmaceutical counterparts. The schematic model, which focuses on the new perspectives such as intrinsic and extrinsic factors from both biotech and pharmaceutical industries, could be used as an empirical tool in formulating corporate strategies. Finally, a case study using a new drug product pipeline from a Taiwan based biotech company demonstrates a potential best practice deducted from the above scheme.CHAPTER 1 OVERVIEW OF THE THESIS 1 1.1 Introduction 1 1.2 Specific Aims 2 1.3 Structure of the Thesis 2 CHAPTER 2 EMERGING LANDSCAPE OF HEALTHCARE INDUSTRIES 3 2.1 Introduction 3 2.1.1 Healthcare Industry 3 2.1.2 Pharmaceutical Industry 4 2.1.3 Biotechnology Industry 6 2.2 Drug Paradigm Shifts: The Evolving Relationships between Biotechnology and Pharmaceutical Industries 9 2.2.1 From Blockbuster To Personalized Medicine 9 2.2.2 From small molecule based drug to biologics 11 2.2.3 From In-House R&D to Product In-Licensing 12 2.3 Drug Development 13 2.3.1 Pre-clinical Studies: Target Identification and Lead Optimization 14 2.3.2 Clinical Trial 16 2.3.3 Post-Market Management 18 2.4 Strategies to Maximize the Legal and Regulatory Protection 18 2.4.1 Patent Protection 19 2.4.2 Market Exclusivity 20 2.4.3 Cured or Treated – The True Meaning of “Indication” 21 2.4.4 Orphan Drug and Pediatric Usage Status 21 2.4.5 Generic Drugs 22 2.5 Product Lifecycle Management 23 2.5.1 Indication Expansion 24 2.5.2 Reformulation 24 2.5.3 Launch of Derivative Product Line 25 2.5.4 Path to OTC 25 2.6 Pharmaceutical Product Launch Strategies 26 2.7 Summary 29 CHAPTER 3 LITERATURE REVIEW 31 3.1 Introduction 31 3.2 The Trend of Healthcare Industries 31 3.2.1 The co-opetition in pharmaceutical and biotech industry 31 3.3 The Importance of Strategic Alliances and M&A 33 3.3.1 Value Creation through Strategic Alliances in Pharmaceutical Industries 34 3.3.2 Alliance Management Process 34 3.4 Determinants of Strategic Alliances 36 3.4.1 Key Determinants for Strategic Alliances 36 3.4.2 Creating Successfully Alliances 38 3.5 Summary 39 CHAPTER 4 METHODOLOGY 40 4.1 Introduction 40 4.2 A Systematical Approach towards the Match Making Strategies for Biotech Companies 40 4.2.1 Market Dynamics: 41 4.2.2 Pharmaceutical Lifecycle Management: 41 4.2.3 Pharmaceutical Portfolio Management: 42 4.2.4 Biotechnology Project Management: 42 4.2.5 Criteria to maximize potential transaction value in the biotech-pharmaceutical match making process: 43 4.3 Valuation Approaches of International Asset Valuation Standards 43 4.3.1 Market Method 44 4.3.2 Cost Method 44 4.3.3 Income Method (DCF method) 45 4.4 Summary 47 CHAPTER 5 PHARMACEUTICAL PORTFOLIO MANAGEMENT & BIOTECH PROJECT MANAGEMENT 48 5.1 Pharmaceutical Portfolio Management 48 5.1.1 Key Drivers of Pharmaceutical Portfolio Management 48 5.1.2 Pharmaceutical Portfolio Management and Corporate Strategy 50 5.1.3 Growth by Portfolio Management and Project Management 52 5.2 What does Pharmaceutical Portfolio Management Mean to Biotech Companies? 55 5.2.1 Licensing and M&A Strategies by Pharmaceutical Giants through Portfolio Management 57 5.2.2 Pharmaceutical Project Management V.S Biotech Project Management 58 5.2.3 Project Evaluation 60 5.2.4 Project Valuation 60 CHAPTER 6 BIG PHARMA’S PORTFOLIO MANAGEMENT TOWARDS ALZHEIMER’S DISEASE 62 6.1 Market Analysis of Alzheimer’s Disease 62 6.1.1 Alzheimer’s Disease 63 6.1.2 Alzheimer’s Disease Impact 65 6.1.3 Current Solution Providers of Alzheimer’s Disease 66 6.1.4 Potential Entrants Analysis 67 6.1.5 Market Dynamics among Major Players 68 6.2 Meeting Pharma Partner’s Portfolio Management Criteria through Project Management 71 6.2.1 Pfizer’s Portfolio Management 71 6.2.2 Revenue Analysis of Pfizer 72 6.2.2 Risks Caused by Patent Expiry 74 6.2.3 Pfizer’s Current Pipelines 76 6.2.5 Potential Shortfalls Demonstrated by Portfolio Management Analysis 80 CHAPTER 7 RESULTS OF CASE ANALYSIS FOR A TAIWAN-BASE BIOTECH COMPANY’S ALZHEIMER’S DISEASE VACCINE 82 7.1 UBIA, A Local Company with Global Products 82 7.2 UBIA’s Project Management 84 7.3 Evaluation of the Alzheimer’s Disease Product Pipelines 86 7.4 Valuation of the Alzheimer’s Disease Product Pipelines 89 7.5 Match Making Strategy 99 7.6 Summary & Recommendations for the Company 101 CHAPTER 8 CONCLUSIONS 104 8.1 Summary of Findings and Contribution of the Study 104 8.2 Limitations of the study 106 8.3 Recommendations for Future Research 1074472528 bytesapplication/pdfen-US健康照護生物科技製藥生命週期管理產品組合管理專案管理鑑價HealthcareBiotechnologyPharmaceuticalProduct PipelineLifecycle ManagementPortfolio ManagementProject ManagementValuationotherhttp://ntur.lib.ntu.edu.tw/bitstream/246246/63829/1/ntu-96-P93743025-1.pdf