SPI Infoamtion

Table of Contents

Executive summary

Background to collaborative research agreements
Critical issues for effective collaborations
Management of intellectual property rights
Case studies
The future of collaborations, licensing, and alliances

Chapter 1 Background to collaborative research agreements

Summary
Innovation and innovation models

The closed innovation model

The open innovation model

Consequences of the open innovation model

Intellectual property (IP) protection and open innovation

Types of collaborations

Sponsored research projects (SPR) contract research

Industry mentors for postdoctoral fellows

Gifts from companies for unrestricted research support

Research centers, industry affiliated programs, or consortia

Use of university laboratories, facilities, and centers by company researchers

Technological licensing and start-up venture creation

Advantages of collaborations between academia and industry

Advantages for academia

Advantages for the pharmaceutical industry

Disadvantages of collaborations between academia and industry

Disadvantages for academia

Practical difficulties in negotiating and managing a collaboration

Deleterious effects on faculty and students

Affect on the university reputation and financial challenges

Disadvantages for the pharmaceutical industry

Commercial interests are a low priority amongst academics

Discord regarding intellectual property rights

Types of collaboration agreements

One-to-one research collaborative agreements

Model consortium agreements

Identification of suitable collaborators and research partners

Strategic fit

Impact on internal strengths and weaknesses

Impact on strategic direction

Critical factors for successful collaboration resource planning

Clear support from senior management

Dedicated project management for each collaboration team

Complimentary strategy for both entities involved in the collaboration

Commitment to time and financial resources

Commitment to a supportive environment that fosters innovation

Assimilation of new knowledge by the sponsoring pharmaceutical company

Formulation of a well-defined collaboration agreement

Understanding the drafting of contractual terms and conditions

Definitions of the agreement

Collaboration agreement outline

Negotiating the terms and conditions of an agreement

Academic institution considerations

Pharmaceutical and biopharmaceutical industry considerations

License agreements

Upfront payments or signing fees

Annual or other periodic fees

Milestone payments

Duration and termination

Chapter 2 Critical issues for effective collaborations

Summary
Introduction
Cultural, change management, and goal alignment challenges

Organizational culture

The culture of academia

Pharmaceutical industry corporate culture

Corporate management and research collaborations

Management of open innovation and open science disclosure procedures

Lack of transparency between collaborating partners

Mismatch in time scales between academic study and commercial drive for results

Managing conflict and bridging cultural gaps between collaborating partners

Difference in research questions addressed by academia and industry

Effectiveness and efficiency of knowledge management and knowledge transfer

Institutional incentives and integration of research and educational missions

University reward and incentive structures

Potential misuse of student time and conflicts of interest

Payment of indirect costs incurred by the university

Goal alignment challenges in research collaborations

Challenges associated with technology and knowledge transfer

Challenges associated with the knowledge transfer process

Challenges associated with the technology transfer process

Chapter 3 Management of intellectual property rights

Summary
Introduction
Intellectual property rights and national policy considerations

WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS)

The Bayh-Dole Act in the US

The Cooperative Research and Technology Enhancement (CREATE) Act

European position on patents and intellectual property protection

Intellectual property protection issues in Brazil

Russian legislation to strengthen regulation of pharmaceutical IP

Latest regulatory and legislative changes in India

Patent laws and WTO TRIPS in China

R&D collaborations and the uncertainty of intellectual property rights

The duration of patent examinations

Economic and strategic uncertainty for the industry

Uncertainties over publication of proprietary knowledge by academics

Uncertainties over disclosure of unprotected information

Conducting R&D in countries with weak IPR protection

Negotiating and bargaining associated with IPR

Protection of trade secrets

Protection of patentable IP

Chapter 4 Case studies

Summary

AstraZeneca and the University of Virginia

Review of the collaboration by AstraZeneca

Management of IP and entrepreneurial activities at UVa

AstraZeneca optimizes collaboration through interoperable technologies

Roche and the Translational Medicine Research Hub in Singapore

Management of IP and entrepreneurial activities at A*STAR

Industry collaboration with the University of Dundee and the Medical
Research Council (MRC)
Management of IP and entrepreneurial activities at DSTT
Partnership of Sanofi-Aventis with the French Life Sciences and Healthcare Alliance (AVIESAN)
Collaborative alliance between GlaxoSmithKline and the Harvard Stem Cell Institute (HSCI)

Other GSK collaborations

Problematic collaborations

The Scripps Research Institute and Novartis

The Scripps Research Institute (TSRI)

Novartis AG

Collaboration Agreement between TSRI and Novartis

The Scripps Research Institute and Pfizer

The University of California Berkeley (UCB) and Novartis Agricultural Discovery Institute, Inc (NADII)

Controversial aspects

Conclusion

Chapter 5 The future of collaborations, licensing, and alliances

Summary
Introduction
Changing paradigms in traditional universities

The evolution of the corporate university

The emergence and evolution of the entrepreneurial university

Synergy between ivory tower academics and entrepreneurial scientists

The emergence and growth of research clusters and incubator hubs

Institutional changes to European university practices

Science parks

Incubator or enterprise hub models

Virtual incubators

The Triple Helix model of university-industry-government

Appendix

Methodology statement

Primary data and information gathering

Secondary data and information gathering
Glossary of abbreviations and acronyms
Index

List of Figures
Figure 1.1: The current paradigm: a closed innovation system
Figure 1.2: An open innovation system
Figure 1.3: Schematic model illustrating knowledge spillover
Figure 2.4: The traditional management process
Figure 2.5: The university/company knowledge transfer process
Figure 2.6: The technology transfer process
Figure 3.7: Average duration of US patent applications pendency
Figure 3.8: The European patent applications grant procedure
Figure 3.9: Patent option value
Figure 5.10: Typology of faculty views of academia-industry relationships
Figure 5.11: Queen's University Belfast pharmaceutical research cluster
Figure 5.12: Effect of legislative changes on university governance in Europe
Figure 5.13: Evolution of the technology business incubator model
Figure 5.14: Schematic of the Triple Helix model

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