Build and Manage Collaborative Research Across Corporate, Government and Academic Boundaries to Increase Productivity and Minimize Risk
Background
AdvanceTech Monitor (ATM) reports give you a unique advantage. Not only do you receive 26 chapters of expert opinion on the technology and business strategies behind Pharmaceutical/Biotech R&D Alliance, but you also receive over 150 tables and figures to illustrate points of discussion and over 150 weblinks to key internet sources of information.
Streamline your research and your ability to make timely, strategic decisions? Get the ATM advantage - one comprehensive resource that saves you both time and money and provides you with collective expert opinions that you will find nowhere else.
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Report Format
- 325+ pages of transcripts and commentaries
- 150+ tables and figures
- 150+ weblinks
- Available as searchable CD-ROM and printed hardcopy
Table of Contents
1. Executive Summary
1.1 Contracting and Licensing Agreements
1.2 Alliance Management
1.3 Consortium Approaches and Government Support
1.4 Collaborations with Academia
1.5 Landmark Alliances
1.6 Wall Street's Perspective
2. Introduction
2.1 Let's Make a Deal
2.2 Deal Me In
2.3 Big Deal
2.4 Deal Trends
2.5 What's the Big Deal?
2.6 References
CONTRACTING AND LICENSING AGREEMENTS
3. Key Terms and Provisions of Pharmaceutical/Biotechnology Alliance Agreements
3.1 Key Provisions for Successful R&D Contracts
3.2 Allocation of Intellectual Property Rights
3.3 Control of Joint Technology
3.4 Reach-Through Royalties
3.5 Partnering Paradigm Shift
3.6 Deal Structures
3.7 Decision-Making and Dispute Resolution
3.8 Term and Termination
3.9 Questions & Answers
4. New-Technology Valuation and Licensing Agreements
Part I: Valuating New Technologies
4.1 Introduction to Technology Development Alliances
4.2 Technology-Valuation Criteria
4.3 Valuation of Early-Stage Technologies
4.4 Valuation of Later-Stage Technologies
4.5 The Intellectual Property Valuation Process
4.6 New Product/Technology Development Assessment
4.7 New Product/Technology Success Assessment
Part II: The Licensing Process
4.8 Overview of the Licensing Process
4.9 Licensing from a Valuation Perspective
4.10 Up-Front License Fees
4.11 Royalty Rates
Part III: Negotiating the Deal
4.12 Factors to Consider in a Licensing Deal
4.13 Identifying 腺uyers-of a Technology
4.14 Positioning the Intellectual Property for a Potential Buyer
4.15 Negotiation Tactics for Technology Licensing
4.16 Types of Deals
4.17 The Technology-Transfer Process
4.18 Additional Resources
4.19 References
5. Web-Based Technology Licensing and Electronic Contracting
5.1 Technology Transfer in the Electronic Age
5.2 Finding Licensable Technologies Via the Web
5.3 Sources of Technology-Transfer Information
5.4 How to Search for Key Words in Specified Context
5.5 Marketing Licensable Technologies Via the Web
5.6 Overcoming Reluctance to Use Online Contracting
5.7 Online Contract Negotiation
5.8 Tracking Online Contract Negotiations
5.9 Legalization of Electronic Signatures
5.10 Other Benefits and Options in e-Negotiation
5.11 Questions & Answers
5.12 Cited Websites with Further Information
6. Aspects of Platform Technology Collaborations
6.1 Why Pursue a Platform Strategy?
6.2 Platform Technology Companies Face Challenges
6.3 Opportunities for Platform Technology Companies Provided by the SNP Consortium
6.4 Business Models -Analyze the Reward
6.5 Nonexclusive Deals Provide Access to the Platform
6.6 Exclusive R&D Collaborations Focus on a Specific Compound or Target
6.7 Exclusive Collaborations Between Platform Companies
6.8 Semiexclusive Deals and Consortia
6.9 The Beauty of Platform Deals
6.10 Questions & Answers
7. Equity-Based Partnerships
7.1 Alternate Sources of Funding for Biotechnology Companies
7.2 Sources of Equity Funding for Biotechnology Companies
7.3 Equity Investors as Popular Partners
7.4 Advantages/Disadvantages to Pharmaceutical Companies as Equity Investors
7.5 Advantages/Disadvantages to Biotechnology Companies as Recipients of Equity Investment
7.6 Structuring Equity Investments
7.7 Advanced Applications of Structuring Equity Investments Using Options
7.8 Adding Value Through Warrants and Puts -Two Case Studies
7.9 Questions & Answers
ALLIANCE MANAGEMENT
8. Pharmaceutical/Biotech Alliances: Lessons Learned from the Computer Industry
8.1 Hewlett-Packard's Alliances and Collaborations
8.2 Rationale for Collaborations
8.3 Relationship Structures
8.4 Pros and Cons of Alternative Business Relationships
8.5 Ten Key Questions in Developing a Business Case
8.6 Assess Core Competencies vs. Customer's Perceived Value
8.7 Strategic Relationship Development Process
8.8 Top Ten Deal Busters
8.9 Allying With Competitors
8.10 Needs/Offers Analysis
8.11 Alliance Structure Checklist
8.12 Negotiation
8.13 Questions & Answers
Appendix A Alliances: Objective -Structure Checklist
Appendix B Alliances: Structure -Key Consideration Checklist
9. Development and Management of Pharmaceutical/Biotech Alliances
9.1 The Need for R&D Alliances
9.2 Identifying Alliance Partners
9.3 Advantages and Disadvantages of R&D Alliances
9.4 Key Requirements for Successful Alliances
9.5 Types of Technology-Development Partnerships
9.6 Alliances to Support Corporate Goals
9.7 The Joint Venture Process
9.8 The Most Important Elements in Partnering
9.9 Questions & Answers
9.10 References
10. The Role of the Alliance Manager
10.1 Steps in Guiding an Alliance
10.2 Interpreting the Contract
10.3 Managing Expectations
10.4 Administering Alliance Operations
10.5 Assuring Alliance Performance and Productivity
10.6 Competencies of the Alliance Manager
10.7 Further Resources
11. Implementing Healthy Strategic Alliances
11.1 Building Healthy Alliances
11.2 Anatomy of an Alliance
11.3 Internal Resource Networks
11.4 Resource Mapping
11.5 Linking Decision-Making Structures
11.6 Institutionalizing Trust in an Alliance
11.7 Resolving Conflicts by Mapping Expectations
11.8 Metrics to Evaluate Ongoing Alliances
11.9 Key Elements of Healthy Alliances
12. Virtual Management of R&D Alliances
12.1 New Communication Technologies for Managing Alliances
12.2 Collaborative Workspace
12.3 Benefits of Collaborative Workspace
12.4 'Deal Space'
12.5 Outsourcing Space
12.6 Managing People and Relationships
12.7 Commercial Products
12.8 Virtual Alliance Management -A Cultural Change
12.9 Questions & Answers
13. Managing a Large Number of Alliances
13.1 Rationale for Business Alliances
13.2 Maximizing Alliances-Value and Output
13.3 Why Alliances Fail
13.4 Areas for Alliance Improvement
13.5 Processes: Creating a Standardized 腺est Practice-Approach
13.6 Technologies: Managing the Knowledge Capital
13.7 People: Developing Alliance Management Expertise
13.8 The Role of the Office for Alliance Management
13.9 Alliance Management Process Improvement
13.10 Standardization of Alliance Management
13.11 Questions & Answers
CONSORTIUM APPROACHES AND GOVERNMENT SUPPORT
14. The SNP Consortium
14.1 SNPs and The SNP Consortium
14.2 Consortium Members and Mission
14.3 Rationale Behind The SNP Consortium
14.4 Commitments of The SNP Consortium Members
14.5 Organization of The SNP Consortium
14.6 Overview of the Scientific Program
14.7 Timetable for SNP Identification and Mapping
14.8 Quality Management Program
14.9 Data Releases
14.10 Number and Types of SNPs to Create a Genome-Wide SNP Map
14.11 Intellectual Property Program
14.12 Future Directions
15. The Consortium as a Financial and Business Model
15.1 Why a Consortium?
15.2 A New Approach to Research Financing
15.3 Consortium Design and Characteristics
15.4 Management of Confidentiality
15.5 Management of the Shared Development Team
15.6 The Appeal of the Consortium Structure
15.7 Contractual Parameters
15.8 Success of the Exclusive Arrangement
15.9 Profit-Funded Technology
15.10 Questions & Answers
16. Managing Multiparty Alliances
16.1 What Happens After the Deal is Officially Struck?
16.2 Multiparty Alliances, Bilateral Partnerships: Adherence to the Same Rules
16.3 Unique Aspects of the Multiparty Alliance
16.4 A Good Beginning: The Best Chance for Success
16.5 Success and Failure in Multiparty Consortia in Other Industries
16.6 Multiparty Consortia in Biotechnology
16.7 The Whitehead Functional Genomics Consortium
16.8 The Millennium-Monsanto-Cereon Alliance
16.9 Key Structural Elements of Successful Consortia
16.10 The Creation of Operational Scientific Links
16.11 Multiparty Rights Allocation
16.12 Plan for Technology Transfer
16.13 Incentives that Pull the Consortium in the Wrong Direction
16.14 Multiparty Alliances Require Maintenance and Review
16.15 Maintain Flexibility in Adapting to Change
16.16 Create Alignment Through Incentives
16.17 Keep Interactions Informal and Free Flowing -But Monitor the Flow
16.18 Questions & Answers
17. Using FDA Databases and Computational Models in Regulatory and R&D Decision-Making
17.1 The FDA-CDER as a Unique Source of Scientific Information
17.2 Mission of the Regulatory Research and Analysis Staff (RRAS)
17.4 The Carcinogenicity Database
17.5 Collaborative R&D Agreement with Multicase
17.6 Interpretation of the Virtual Study
17.7 Validation of the Predictive Model
17.8 Computational Toxicology Applications
17.9 FDA-RRAS Long-Term Objectives
18. Enabling High-Risk R&D Alliances: The Advanced Technology Program
18.1 Purpose of the Advanced Technology Program
18.2 Intellectual Property Rights
18.3 Eligibility for ATP Awards
18.4 Benefits to Joint Ventures, Small Businesses
18.5 Application for ATP Awards
18.6 Evaluation of ATP Applications
18.7 Alliance-Specific Information from ATP
18.8 Choosing Partners and Managing ATP-Funded Alliances
18.9 ATP Funding of Biotechnology Programs
18.10 Industry Trends in ATP Biotechnology Projects
18.11 Future Funding Preferences
18.12 Questions & Answers
19. Successful Collaboration with Universities
19.1 A Bottom-Up Approach is Necessary
19.2 Individuals versus Groups
19.3 Knowledge versus Ignorance
19.4 Control versus Responsibility
19.5 Principles Before Profit
19.6 Why Develop University Inventions?
19.7 Compliance with Federal Law
19.8 Collaborations as a Source of Income
19.9 Collaborations as a Service to the Faculty
19.10 Managing Invention Disclosures and Patent Applications
19.11 Only 10% of Disclosures Earn Income
19.12 Not-For-Profit Means No Margin for Error
19.13 Winner-Takes-All is Losing Attitude
19.14 How to Expose Hidden Disagreements
19.15 Insights for Negotiating with Universities
19.16 Societal Benefit Is a Prime Motivator For Universities
19.17 Publication and Delay
19.18 Multiple Licenses with Key Inventions
19.19 Economic Development is Another Key Motivator
19.20 Questions & Answers
COLLABORATING WITH ACADEMIA
20. Millennium's Alliances: Focusing on Applications of Genomic-Type Technologies
20.1 Partnering to Create Value
20.2 徹ver-the-Top-Alliances
20.3 Millennium's Alliance with Monsanto
20.4 Millennium's Alliance with Bayer
20.5 Millennium's Alliance with Aventis
20.6 Ensuring Successful Partnerships
20.7 Questions & Answers
CASE STUDIES
21. The Triangle Pharmaceuticals/Abbott Laboratories Strategic Portfolio Alliance
21.1 Alliance Rationale for a Small Pharmaceutical Company
21.2 Triangle/Abbott Portfolio Deal
21.3 Lessons Learned Through Alliance Formation and Management
21.4 Questions & Answers
22. Vertex Pharmaceuticals-Alliances: Focusing on Drug Targets-Structural Similarity
22.1 Focused Alliance Strategy
22.2 Negotiating Terms that Meet Strategic Goals
22.3 The Vertex/Novartis Alliance
22.4 Increasing Future Productivity
22.5 Questions & Answers
23. Sequenom's Collaborations: Successful Licensing of a Platform Technology
23.1 The Race to Identify and Validate SNPs
23.2 SNP Typing Technology from Sequenom
23.3 Early Sequenom Collaborations
23.4 SNP Genotyping Market
23.5 The Evolution of Sequenom's Collaborations
23.6 Future Deal Structures
24. Value Creation in R&D Alliances: A Case Study of Lilly's Genomics Consortium with Academic Partners
24.1 The Need for Strategic Alliances as Necessary Business Functions
24.2 The Rationale for Proper Alliance Management
24.3 Pooling Complementary Assets to Form a Multiparty Alliance
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