Strategies for Innovation in Pharmaceutical R&D: Enhancing R&D Through Biotech Alliances and CRO Outsourcing

Table of Contents

Chapter 1: Overview of the Global Industry

• 1.1 General Characteristics of the Pharmaceutical Industry
  • 1.1.1 Innovation
  • 1.1.2 Government Regulation and Pricing
  • 1.1.3 The Patent System
• 1.2 Economic Structure of the Pharmaceutical Industry
• 1.3 External Forces Impacting the Industry
  • 1.3.1 Rising Cost of Research & Development
  • 1.3.2 Changing Demographic Trends
  • 1.3.3 Biotechnology
  • 1.3.4 Consumerism
  • 1.3.5 Greater Generic Competition
  • 1.3.6 Information Technology
• 1.4 Technological Developments Affecting Innovation
  • 1.4.1 Co-specialized Research Methods
  • 1.4.2 Generic and Transversal Technologies
  • 1.4.3 Evaluating Technological Advances in Pharmaceutical Innovation

Chapter 2: The Environment of Pharmaceutical R&D

• 2.1 The Drug Development Process
• 2.1.1 Phase (1): Drug Discovery
• 2.1.2 The Pre-Clinical phase: Pharmacological Development
• 2.1.3 Phase (2): Clinical Development Phase I, II, III
• 2.1.4 Phase IV: Post Marketing Surveillance
• 2.1.5 Registration and Launch
• 2.2 R&D Decision-making Models
• 2.2.1 The 'Traditional' Model
• 2.2.2 The 'Modern' Model
• 2.2.3 Strategic Planning of R&D
• 2.3 Global Investment in Pharmaceutical R&D
• 2.3.1 Productivity of the Global Pharmaceutical Industry
• Case Study: The British Pharmaceutical Industry
• 2.3.2 The Cost of Drug Discovery and Development
• 2.3.3 Drug Development Times
• 2.3.4 Rates of Success in Pharmaceutical Innovation
• 2.3.4.1 Selection of Compounds
• 2.3.4.2 Cost Reduction
• 2.3.4.3 Competitive Pressures
• 2.3.5 Declining Productivity in Pharmaceutical Innovation
• 2.4 Key Therapeutic Area Definitions
• Case Study: Efforts to Improve the Productivity of Eli Lilly's Pharmaceutical Value Chain
• 2.5 Future Blockbuster Diseases
• 2.5.1 R&D Investment Priorities
• 2.5.2 Therapeutic Focus

Chapter 3: Strategies for Innovation in R&D

• 3.1 Sources of Stress in the Pharmaceutical Business Model
• 3.2 Generic Strategies for Pharmaceutical R&D
• 3.3 Traditional Approach of Mergers & Acquisitions
• 3.3.1 Reasons for Merging
• 3.3.2 The Advantages of an M&A Strategy
• Case Study: The Merger Between Pfizer Inc. and Pharmacia Corporation
• 3.3.3 The Disadvantages of an M&A Strategy
• 3.4 Alliances as an Alternative Strategy
• 3.4.1 Key Alliance Definitions
• 3.4.2 The Role of Strategic Alliances
• 3.4.3 Motives for Strategic Alliance Formation
• 3.4.4 Motives for Strategic Technology Alliances
• Case Study: Strategic Alliances Between Ligand Pharmaceuticals and Eli Lilly
• 3.5 Knowledge Sharing and Learning in Technology Alliances
• 3.5.1 Key Technology Definitions
• 3.5.2 Tacit Vs Explicit Knowledge
• 3.5.3 Knowledge Valuation
• 3.5.4 Learning Races
• 3.6 Different Types of R&D Partnering Models
• 3.6.1 The Research Phase
• 3.6.2 The Development Phase
• 3.6.3 Characteristics of the Different Types of R&D Partnering Models

Chapter 4: Enhancing R&D through External Collaboration - The Case of Biotechnology

• 4.1 The Importance of Establishing R&D Partnerships
• 4.1.1 Trends in Pharmaceutical Alliances
• 4.1.2 Trends in Licensing Agreements
• 4.2 The Significance of Biotechnology to the Pharmaceutical Industry
• 4.2.1 Biotechnology Products
• 4.2.2 Industry Structure
• 4.2.3 The Global Biotechnology Industry
• Case Study: Growth Strategies of the Japanese Biotechnology Industry
• 4.2.4 The Biotechnology Industry in the US
• 4.2.5 The Biotechnology Industry in Europe
• 4.2.6 Biotechnology R&D
• 4.2.7 Reasons for Entering into Licensing Agreements
• Case Study: Licensing Agreement Between Vertex Pharmaceuticals and Novartis Pharma
• 4.2.8 The Future of the Biotechnology Industry

Chapter 5: Enhancing R&D through External Collaboration - The Case of Outsourcing

• 5.1 The Importance of Outsourcing in Drug Development
• 5.1.1 Industry Structure
• 5.1.2 Perceptions of the Pharmaceutical Industry
• 5.1.3 The Role of the CRO
• Case Study: Outsourcing Strategies of Merck & Co.
• 5.1.4 The Market for Contract Research
• Case Study: The Acquisition of BioReliance Corporation by Invitrogen Corporation
• 5.1.5 Reasons for Entering into Contract Manufacturing Agreements
• 5.1.6 The Future of Outsourcing

Chapter 6: Strategies for Success, Reasons for Failures in R&D Alliances

• 6.1 The Advantages of External Partnerships
• Case Study: Licensing Collaboration Between Bristol-Myers Squibb and Lexicon Genetics
• 6.2 The Problems of External Partnerships

Chapter 7: Guidelines for Alliance Management

• 7.1 Managing External Partnerships
• 7.1.1 Effective Alliance Management Strategies
• Case Study: Alliance Management Strategies at Pfizer Inc.
• 7.1.2 Managing Intellectual Property Issues
• Case Study: Government IP Protection Strategies for Singapore's Biopharmaceutical Industry

Chapter 8: Key Company Profiles

• 8.1 Pharmaceutical Company Profiles
• 8.2 Biotechnology Company Profiles
• 8.3 Clinical Research Organization Company Profiles

Appendix: Summary of Key Trends in Partnering Activity

References

List of Figures

• Figure 1.1 External Forces Impacting the Pharmaceutical Industry
• Figure 2.1 Pharmaceutical Research and Development Process
• Figure 2.2 Composition of Global Pharmaceutical R&D
• Figure 2.3 Product Development Times for Pharmaceuticals
• Figure 2.4 Number of NMEs Launched Worldwide, 1994-2002
• Figure 2.5 R&D Investment by US Pharmaceutical Firms by Therapeutic Area
• Figure 3.1 Generic R&D Strategies
• Figure 4.1 Number of Major Alliances by Company, 1999-2003
• Figure 4.2 Growth in Pharmaceutical Alliances, 1993-2001
• Figure 4.3 Composition of Global Pharmaceutical Licensing Agreements
• Figure 4.4 Composition of Global Biotechnology R&D
• Figure 4.5 Composition of the EU Biotechnology Industry
• Figure 5.1 Composition of the Clinical Research Market, 2003
• Figure 5.2 Composition of Clinical Research Activities
• Figure 6.1 Most Commonly Occurring Problems in Alliances

List of Tables

• Table 1.1 Top 10 Companies by Pharmaceutical R&D Expenditure, 2003
• Table 1.2 Top 10 Companies by Pharmaceutical Operating Profit, 2003
• Table 1.3 Typology of Drugs Produced by the Pharmaceutical Industry
• Table 2.1 Contrasting Characteristics of R&D
• Table 3.1 Major Mergers in the Pharmaceutical Industry, 1987-2003
• Table 3.2 Motives for Strategic Alliances in Pharmaceuticals
• Table 3.3 Different R&D Partnering Models
• Table 4.1 Principal Technologies within Biotechnology
• Table 4.2 Top 10 Biopharmaceutical Companies by Sales Revenue, 2003
• Table 4.3 Biopharmaceutical Research Companies in Kansai, Japan
• Table 5.1 Companies with Clinical Development Expertise
• Table 5.2 ChemBridge Research Laboratories Alliance Partners
• Table 5.3 Top 10 Clinical Research Organizations by Sales Revenue, 2003
• Table 6.1 Benefits of Strategic Licensing Agreements