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 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. Technology transfer, particularly of new biotechnologies that offer novel means to address unmet medical needs, offer a way to cost effectively address these challenges. They also provide technology developers with a mechanism to monetize their inventions.
However, while some drug makers and technology developers have optimized their biotech tech transfer methodologies and have developed sophisticated processes to select, monitor and manage a wide range of relationships, many other biotech tech transfer projects fail. A large proportion of these failures could be averted as many of the most common reasons for failure are preventable problems relating to due diligence failures, shortcomings in deal structure, management changes, cultural challenges, and inappropriate project organization and expectations. This report provides details on how to avoid these common pitfalls with case studies that illustrate best practices.


Key features of this report


• Discussion of the factors leading to current imperatives to increased biotech tech transfer.
• Detailed descriptions of both effective and ineffective biotech tech transfer approaches.
• In depth analysis of the types of different biotech tech transfer relationships, their advantages and disadvantages.
• More than 10 case studies that illustrate biotech tech transfer best practices.
• Comprehensive discussion of offshore biotech tech transfer, particularly focusing on India and China.


Scope of this report


• 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.
• Learn how biotech tech transfer will evolve over the next several years and why.
• Assess your competitive position vis-à-vis other technology sponsors or technology developers and learn about biotech tech transfer best practices via detailed case studies.
• Understand the reasons behind biotech tech transfer success and failure.
• Develop strategies to optimize your biotech tech transfer methodologies and protocols.


Key Market Issues


• The drug development industry is undergoing a significant change which 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 previously 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.
• Biotechnology offers a means to address unmet medical needs, particularly via personalized medicine, which small molecule approaches do not. With more than 3,500 biotech drug companies around the world, many have developed unique technologies and approaches to drug development.
• 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.

Key findings from this report


• After a decline in 2008 to 53 deals from 74 deals in 2007, biotech technology transfer volume for human medicines spiked in 2009 to 121 deals. Chapter 1
• More than half of biotech tech transfer deals fail. Chapter 2
• However, some firms experience very low failure rates of less than 10% while others report very high failure rates in excess of 70%. Chapter 2
• Many biotech tech transfer failures can be traced to an inability on the part of the sponsor to adequately perform initial due diligence. Chapter 3
• Over the next five years, the role of biotechnology in drug development is expected to expand strongly as biotech drug sales rise by 17.7% per year while small molecule drug sales grow by just 2.9% annually. Chapter 4

Key questions answered


• Why is biotech tech transfer rising so quickly? (Because biotechnologies offer a means to address unmet medical needs and many new technologies have been developed outside of Big Pharma)

• Which types of biotech tech transfer approaches are currently most common? (Licensing and acquisitions)

• Which trends will further boost biotech tech transfer in the future? (Economic recovery, healthcare reform, clarification of biosimilars regulation, rising biotech funding)

• What are the most common reasons for the failure of biotech tech transfers? Deficiencies in due diligence, inappropriate deal structure, differing cultures, inappropriate project organization and expectations and technology failure)


Report Highlights
Companies mentioned in the report: Eli Lilly , Ensemble Discovery , Gene Network Sciences , Genentech , GlaxoSmithKline , Horizon Discovery , Merck & Co. , Novartis , Novus Biologicals , Thiakis
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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
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 2010 - 2015 123
Where biotech fits into Big Pharma 125
Dedicated biotechnology companies 127
Biotech tech transfer deal trends 2010 - 2015 129
Volume and value 130
Ownership 132
Intellectual property issues 133
Success rates 134
Conclusion 135
Index 136

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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, 1997 - 2009 52
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, 2009 - 2015 124
Figure 4.8: Impact of industry and economic trends on conventional and biotech drug developers, 2009 - 2015 125
Figure 4.9: Relative importance of biotechnology for leading pharmaceutical companies, 2009 vs. 2015 127
Figure 4.10: Number and average size of global biotech companies, 2009 - 2015 130
Figure 4.11: Number and volume of biopartnering deals, 2009 - 2015 132
List of Tables
Table 1.1: Definition of biotechnology techniques 17
Table 1.2: Biotech tech transfer deals, 2009 36
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., 2010 95
Table 3.18: Technology transfer areas of interest for Merck & Co., 2010 (Contd.) 96
Table 3.19: Novartis private equity fund holdings, 2010 100
Table 3.20: Novartis private equity fund holdings, 2010 (Contd.) 101
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, 2009 - 2015 119
Table 4.24: Biosimilars approved in the US and EU, 2010 121

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