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Aug 2, 2010

Drug Discovery Collaborations between Academia and the Pharmaceutical Industry now available at ReportsandReports

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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?

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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