Drug Discovery Collaborations between Academia and the Pharmaceutical Industry: Cultural factors, intellectual property considerations, case studies, and future trends

The pharmaceutical and biopharmaceutical industries are engaged in a business environment which is witnessing a dramatic escalation of R&D costs, key patent expiries, and sustained high attrition rates for new molecules in development.

In response, pharmaceutical companies have recognized the need to expand the range of creative stimuli for their research processes in order to reinvigorate their drug discovery pipelines. Consequently the industry has sought to develop external collaborations not only with other companies but also more frequently with academia, to obtain access to new technologies to enhance their drug discovery capabilities and to in-license candidates for further development. Indeed, collaboration is becoming an essential component of today’s drug discovery efforts and it is commonly undertaken with multiple partners through an often iterative, continuous, and long lasting process, which adds to the complexity of efficiently managing both the collaboration itself and the data generated.

This report explores the opportunities and challenges that are presented by collaboration with university researchers as well as identifying the key inputs from both the industrial and academic partners. The different organizational cultures and structures are examined along with consideration of the goals for each institution and the issues these create. The report discusses the various types of agreement which can be used, highlights legislation of importance to the appropriate protection of intellectual property, and presents case studies of notable collaborations In addition the report offers thoughts on the future for collaborative agreements and the benefits they will bring to both parties.

Key features of the report

• Describes the different types of collaboration between academia and the pharmaceutical/biopharmaceutical industries, the cultural issues and organizational conflicts presented by these forms of collaborations, and the management processes required to overcome these challenges.

• Reviews the international and national legislation governing the intellectual property rights for owners of the technology (the university) and the technology transfer partner that will exploit the technology (the pharmaceutical industry)..

• Identifies a variety of different collaborative agreements and groups these into two main categories

• Provides a number of case studies illustrating the important features of these collaborations, the practical implications and complexity of the agreements reached, and the pitfalls encountered in some cases.

• Focuses on the evolving nature of collaborations between the pharmaceutical industry and academic institutions, developing the emerging themes and exploring the opportunities for drug discovery using novel collaborative models and approaches.


Key benefits of the report

• Provides the executive with an insight into the complex nature of the issues and challenges facing both academia and the industry when establishing the terms and conditions of any collaborative agreement together with the problems associated with the differences in management styles and cultures of individual parties in the collaboration.

• Describes the methods used to identify a suitable collaboration candidate and helps the reader to understand the factors that affect partner selection and the dynamics of the resulting network.

• Highlights the problems associated with knowledge and technology transfer between collaborating partners as well as the common challenges to be overcome before companies are able to exploit the new technologies.

• Identifies and describes the various emerging quasi institutions, such as research clusters, that take advantage of developments in communication technologies.

• Provides an insight into the future of academic–industry collaborations and the importance that information and communication technologies is having on the development of the next generation of collaborative partnerships.

Key highlights

While academic institutions have attempted to remain true to the principles of open inquiry and intellectual freedom, political-economic forces such as globalization, an increasingly conservative political agenda, a tightening of public financial support for higher education and their changing role in society have resulted in the emergence of the corporate and entrepreneurial universities.

The traditional view that there should be separation between the “ivory tower” academic based sciences and the more commercial and applied developmental research conducted in industry is now obsolete. Instead there is considerable synergy between basic research carried out in academia and applied research that is undertaken in the pharmaceutical industry.

Major collaborations have a broad range of stakeholders, and failure to take all viewpoints into account can lead to significant opposition which ultimately may undermine the value of the partnership to both parties. Both the exact terms of the agreement and the presentation of those terms to the wider community are of crucial importance to a successful collaboration.

Key questions answered by this report

• What are the key drivers influencing change to a more collaborative approach to R&D in the pharmaceutical industry?
• What are the latest developments in the collaborative approach to R&D and which models represent the best opportunities for the pharmaceutical industry.
• What are the issues and concerns over the evolving collaborative R&D paradigms?
• What are the intellectual property management issues that should be considered by each party?
• Which changes in patent legislation are of greatest relevance to the formation of collaborations in different countries?
• What are the different types of academia–industry collaborations?
• What are the pros and cons for each party in academia–industry collaborations?
• What are the critical success factors for academia–industry collaborations?
• What are the main factors to take into account when negotiating academia–industry collaborations?
• What are the cultural, change management and goal alignment challenges?
• What are the future directions for academia–industry collaborations?
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Table of Contents
Drug Discovery Collaborations between Academia and the Pharmaceutical Industry: Cultural factors, intellectual property considerations, case studies, and future trends
Executive summary 10
Background to collaborative research agreements 10
Critical issues for effective collaborations 11
Management of intellectual property rights 11
Case studies 12
The future of collaborations, licensing, and alliances 14
Chapter 1 Background to collaborative research agreements 16
Summary 16
Innovation and innovation models 17
The closed innovation model 17
The open innovation model 18
Consequences of the open innovation model 20
Intellectual property (IP) protection and open innovation 22
Types of collaborations 24
Sponsored research projects (SPR) contract research 24
Industry mentors for postdoctoral fellows 25
Gifts from companies for unrestricted research support 26
Research centers, industry affiliated programs, or consortia 26
Use of university laboratories, facilities, and centers by company researchers 27
Technological licensing and start-up venture creation 28
Advantages of collaborations between academia and industry 29
Advantages for academia 29
Advantages for the pharmaceutical industry 30
Disadvantages of collaborations between academia and industry 31
Disadvantages for academia 31
Practical difficulties in negotiating and managing a collaboration 31
Deleterious effects on faculty and students 32
Affect on the university reputation and financial challenges 32
Disadvantages for the pharmaceutical industry 33
Commercial interests are a low priority amongst academics 33
Discord regarding intellectual property rights 33
Types of collaboration agreements 34
One-to-one research collaborative agreements 36
Model consortium agreements 37
Identification of suitable collaborators and research partners 38
Strategic fit 39
Impact on internal strengths and weaknesses 39
Impact on strategic direction 40
Critical factors for successful collaboration resource planning 40
Clear support from senior management 40
Dedicated project management for each collaboration team 41
Complimentary strategy for both entities involved in the collaboration 41
Commitment to time and financial resources 41
Commitment to a supportive environment that fosters innovation 41
Assimilation of new knowledge by the sponsoring pharmaceutical company 42
Formulation of a well-defined collaboration agreement 42
Understanding the drafting of contractual terms and conditions 42
Definitions of the agreement 42
Collaboration agreement outline 43
Negotiating the terms and conditions of an agreement 48
Academic institution considerations 48
Pharmaceutical and biopharmaceutical industry considerations 48
License agreements 48
Upfront payments or signing fees 51
Annual or other periodic fees 51
Milestone payments 52
Duration and termination 53
Chapter 2 Critical issues for effective collaborations 56
Summary 56
Introduction 57
Cultural, change management, and goal alignment challenges 57
Organizational culture 57
The culture of academia 59
Pharmaceutical industry corporate culture 60
Corporate management and research collaborations 62
Management of open innovation and open science disclosure procedures 64
Lack of transparency between collaborating partners 65
Mismatch in time scales between academic study and commercial drive for results 65
Managing conflict and bridging cultural gaps between collaborating partners 65
Difference in research questions addressed by academia and industry 66
Effectiveness and efficiency of knowledge management and knowledge transfer 66
Institutional incentives and integration of research and educational missions 66
University reward and incentive structures 66
Potential misuse of student time and conflicts of interest 67
Payment of indirect costs incurred by the university 68
Goal alignment challenges in research collaborations 69
Challenges associated with technology and knowledge transfer 70
Challenges associated with the knowledge transfer process 70
Challenges associated with the technology transfer process 73
Chapter 3 Management of intellectual property rights 78
Summary 78
Introduction 79
Intellectual property rights and national policy considerations 80
WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) 80
The Bayh-Dole Act in the US 82
The Cooperative Research and Technology Enhancement (CREATE) Act 83
European position on patents and intellectual property protection 84
Intellectual property protection issues in Brazil 85
Russian legislation to strengthen regulation of pharmaceutical IP 86
Latest regulatory and legislative changes in India 87
Patent laws and WTO TRIPS in China 88
R&D collaborations and the uncertainty of intellectual property rights 91
The duration of patent examinations 91
Economic and strategic uncertainty for the industry 94
Uncertainties over publication of proprietary knowledge by academics 96
Uncertainties over disclosure of unprotected information 96
Conducting R&D in countries with weak IPR protection 97
Negotiating and bargaining associated with IPR 98
Protection of trade secrets 98
Protection of patentable IP 101
Chapter 4 Case studies 106
Summary 106
AstraZeneca and the University of Virginia 107
Review of the collaboration by AstraZeneca 109
Management of IP and entrepreneurial activities at UVa 109
AstraZeneca optimizes collaboration through interoperable technologies 110
Roche and the Translational Medicine Research Hub in Singapore 110
Management of IP and entrepreneurial activities at A*STAR 112
Industry collaboration with the University of Dundee and the Medical
Research Council (MRC) 113
Management of IP and entrepreneurial activities at DSTT 114
Partnership of Sanofi-Aventis with the French Life Sciences and
Healthcare Alliance (AVIESAN) 115
Collaborative alliance between GlaxoSmithKline and the Harvard Stem
Cell Institute (HSCI) 115
Other GSK collaborations 116
Problematic collaborations 118
The Scripps Research Institute and Novartis 118
The Scripps Research Institute (TSRI) 118
Novartis AG 119
Collaboration Agreement between TSRI and Novartis 119
The Scripps Research Institute and Pfizer 121
The University of California Berkeley (UCB) and Novartis Agricultural
Discovery Institute, Inc (NADII) 121
Controversial aspects 122
Conclusion 124
Chapter 5 The future of collaborations, licensing, and alliances 128
Summary 128
Introduction 129
Changing paradigms in traditional universities 130
The evolution of the corporate university 130
The emergence and evolution of the entrepreneurial university 132
Synergy between ivory tower academics and entrepreneurial scientists 135
The emergence and growth of research clusters and incubator hubs 138
Institutional changes to European university practices 140
Science parks 142
Incubator or enterprise hub models 144
Virtual incubators 145
The Triple Helix model of university–industry–government 147
Appendix 149
Methodology statement 149
Primary data and information gathering 149
Secondary data and information gathering 150
Glossary of abbreviations and acronyms 151
Index 160
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List of Figures
Figure 1.1: The current paradigm: a closed innovation system 18
Figure 1.2: An open innovation system 19
Figure 1.3: Schematic model illustrating knowledge spillover 21
Figure 2.4: The traditional management process 63
Figure 2.5: The university/company knowledge transfer process 73
Figure 2.6: The technology transfer process 74
Figure 3.7: Average duration of US patent applications pendency 93
Figure 3.8: The European patent applications grant procedure 94
Figure 3.9: Patent option value 95
Figure 5.10: Typology of faculty views of academia-industry relationships 137
Figure 5.11: Queen’s University Belfast pharmaceutical research cluster 139
Figure 5.12: Effect of legislative changes on university governance in Europe 142
Figure 5.13: Evolution of the technology business incubator model 145
Figure 5.14: Schematic of the Triple Helix model 148

List of Tables
Table 1.1: The project checklist 44
Table 1.2: Financial contribution (from the sponsor) and external funding 45
Table 1.3: Checklist for participants’ background information 45
Table 1.4: IPR of project results 46
Table 1.5: Confidentiality and academic publication 46
Table 1.6: Liability 47
Table 2.7: Academic versus industry management approach 64
Table 3.8: US legislation governing patenting and transfer of federally funded R&D 83
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