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

  • Publication Date:July 2010
  • Publisher:Business Insights
  • Product Type: Report
  • Pages:161

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?
  • 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
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