Building Biotech Technology Transfer Opportunities: Sponsor and Developer Strategies for Success

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1 Building Biotech Technology Transfer Opportunities: Sponsor and Developer Strategies for Success Drug developers have long been under pressure to introduce new products in an environment of escalating R&D costs, blockbuster patent expiration and the resulting generic competition. Current weak economic conditions have exacerbated these challenges with sweeping R&D staff and budget reductions. In order to remain competitive, drug-makers must now do more with less. Scope Detailed description of both effective and ineffective biotech transfer approaches. In-depth analysis of advantages and disadvantages of numerous biotech transfer relationships. Case studies illustrating best practices. Comprehensive discussion of offshore biotech transfers, particularly focusing on India and China. Forecasts of industry-wide biotech transfers through Research and analysis highlights The drug development industry is undergoing a significant change that may permanently re-shape product development activities. Many industry experts believe the industry is shrinking; at the very least, the focus is shifting from large in-house research teams to smart approaches, strategic outsourcing and technology transfer. Although cost-cutting has traditionally not been a concern for R&D departments, the current economic environment has brought expense-reduction programs into research labs. Most of the leading drug-makers have recently undertaken and/or are currently in the midst of broad R&D cost-cutting programs. Because drug-makers must continue to introduce new products, maintaining high productivity is key. Biotech tech transfer offers a means to achieve this by providing technology sponsors with access to new technologies.

2 Key reasons to purchase this research Understand the driving forces behind biotech tech transfer. Save time and money with the report's succinct compilation and analysis of current biotech tech transfer trends. Understand the reasons behind biotech tech transfer success and failure. Develop strategies to optimize biotech tech transfer methodologies and protocols. Learn how biotech tech transfer will evolve over the coming years and why.

3 Table of Contents Building Biotech Technology Transfer Opportunities Executive Summary 8 Overview of biotech tech transfer 8 Why biotech tech transfer deals fail 9 Strategies to ensure successful biotech tech transfer deals 10 The future of biotech tech transfer deals 11 Chapter 1 Overview of biotech tech transfer 14 Summary 14 The biotechnology industry today 15 Biotechnology technologies and techniques 15 Proliferation of investigational products 18 Funding issues 18 Need to partner to advance product development 19 The emergence of biotechnology brokers 20 Drug development challenges 21 More complicated disease targets 22 Escalating costs 22 Increased regulatory scrutiny 23 Diminished in-house R&D resources 24 Types of biotech tech transfer relationships 26 Academic R&D infusions 28 Biotech biotech deals 29 Pharma biotech alliances 30 Licensing 32 R&D collaborations 33 Sales, distribution and co-marketing agreements 33 Joint ventures 33 Acquisitions 34 Volume of recent deals 35 Relationship trends 51 Volume and value 51 Ownership 52 Conclusion 53 Chapter 2 Why biotech tech transfer deals fail 56 Summary 56 High failure rates 57 Symptoms of deal failure 57 Factors that do not affect deal failure 58 Implications of deal failure 59 Impact on technology developers 60 Impact on technology sponsors 61

4 Lost value of failed deals 61 Main causes of biotech tech transfer failure 62 Due diligence failures 64 Technology performance 66 Patent issues 67 Developer organization strength 67 Deal structure 69 Financial compensation 70 Management changes 71 Cultural differences 72 Project organization and expectations 74 Other preventable problems 76 Technology failure 77 Conclusion 77 Chapter 3 Strategies to ensure successful biotech tech transfer deals 80 Summary 80 Measures of success 81 Success for the technology developer 81 Success for the technology sponsor 82 Key biotech tech transfer strategies 82 Strategies for both technology developers and sponsors 82 Meeting technology challenges 82 Strategies for technology developers 85 Optimizing resources 85 Thinking like a customer 88 Working with professional tech transfer organizations 89 Prolific publishing 91 Strategies for technology sponsors 92 Thorough technology identification and due diligence 93 Structuring innovative deal terms 98 Addressing compensation issues 105 Fostering an entrepreneurial developer environment 105 Ensuring effective alliance management 106 Navigating cultural chasms 108 Addressing international intellectual property challenges 110 Conclusion 113 Chapter 4 The future of biotech tech transfer deals 116 Summary 116 Introduction 117 The future of drug development 117 Impact of the economy 119 US healthcare reform 120 Biosimilars 121 Biotechnology in

5 Where biotech fits into Big Pharma 125 Dedicated biotechnology companies 127 Biotech tech transfer deal trends Volume and value 130 Ownership 132 Intellectual property issues 133 Success rates 134 Conclusion 135 Index 136 List of Figures Figure 1.1: Frequency of biotech tech transfer deals by type of institution 27 Figure 1.2: Number and volume of biopartnering deals, Figure 1.3: Acquisitions as a proportion of biotech tech transfer deals, 53 Figure 2.4: Characteristics of biotech tech transfer failure causes 63 Figure 2.5: Relative importance to sponsor of technology developer 66 Figure 3.6: Strategies to optimize biotech tech transfer opportunities 83 Figure 4.7: Biopharmaceutical vs. other pharmaceutical sales, Figure 4.8: Impact of industry and economic trends on conventional and biotech drug developers, Figure 4.9: Relative importance of biotechnology for leading pharmaceutical companies, 2009 vs Figure 4.10: Number and average size of global biotech companies, Figure 4.11: Number and volume of biopartnering deals, List of Tables Table 1.1: Definition of biotechnology techniques 17 Table 1.2: Biotech tech transfer deals, Table 1.3: Biotech tech transfer deals, 2009 (Contd.) 37 Table 1.4: Biotech tech transfer deals, 2009 (Contd.) 38 Table 1.5: Biotech tech transfer deals, 2009 (Contd.) 39 Table 1.6: Biotech tech transfer deals, 2009 (Contd.) 40 Table 1.7: Biotech tech transfer deals, 2009 (Contd.) 41 Table 1.8: Biotech tech transfer deals, 2009 (Contd.) 42 Table 1.9: Biotech tech transfer deals, 2009 (Contd.) 43 Table 1.10: Biotech tech transfer deals, 2009 (Contd.) 44 Table 1.11: Biotech tech transfer deals, 2009 (Contd.) 45 Table 1.12: Biotech tech transfer deals, 2009 (Contd.) 46 Table 1.13: Biotech tech transfer deals, 2009 (Contd.) 47 Table 1.14: Biotech tech transfer deals, 2009 (Contd.) 48 Table 1.15: Biotech tech transfer deals, 2009 (Contd.) 49 Table 1.16: Biotech tech transfer deals, 2009 (Contd.) 50 Table 3.17: Technology transfer areas of interest for Merck & Co., Table 3.18: Technology transfer areas of interest for Merck & Co., 2010 (Contd.) 96 Table 3.19: Novartis private equity fund holdings, Table 3.20: Novartis private equity fund holdings, 2010 (Contd.) 101

6 Table 3.21: Novartis private equity fund holdings, 2010 (Contd.) 102 Table 3.22: Novartis private equity fund holdings, 2010 (Contd.) 103 Table 4.23: Millions of older and overweight persons in the US and EU, Table 4.24: Biosimilars approved in the US and EU,

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