Backup Compound Strategies: Best Practices for Reducing Phase II Risk

Table of Contents

Chapter 1

• INTRODUCTION
• 1.1. Definitions
• 1.2. Scope and Organization of the Report

Chapter 2

• STRATEGIC CONSIDERATIONS
• 2.1. Importance of the Project
• 2.2. Type of Company
  • Big Pharma Companies
  • Smaller Biotechnology Companies
• 2.3. Risk of Attrition
  • Chemical Versus Biological Risk
  • Selection of Compounds
  • Market Risk
  • Interviewee Comments on Project Risk and Attrition
    • Big Pharma Companies
    • Smaller Biotechnology Companies
  • Timing
• 2.4. Backup Strategy: One-Size-Fits-All Versus Ad Hoc
• 2.5. Role of Modeling and Simulation in Devising Backup Strategies
  • Applying Statistical Methodology to Optimize a Backup Strategy
  • Valuing Backup Compounds and Projects
  • Backup Strategy Involving 2 or More Distinct Mechanisms for the Same
  • Indication
  • Structuring the Product Development Pipeline

Chapter 3

• TACTICAL ISSUES RELEVANT TO BACKUP COMPOUNDS AND PROGRAMS
• 3.1. Chemical Diversity of Backup Compounds
• 3.2. Level of Testing for Backup Compounds
• 3.3. Use of Target Product Profiles
• 3.4. Backups at Bristol-Myers Squibb

Chapter 4

• ORGANIZATIONAL CONSIDERATIONS
• 4.1. Designing a Backup Plan
• 4.2. Influence of Portfolio and Strategic Planning Managers
• 4.3. Availability of Resources
• 4.4. The In-licensing Alternative

Chapter 5

• BUSINESS CONSIDERATIONS
• 5.1. Applying Business Analysis to the Development of Backup Strategy
• 5.2. Organizational Learning from Failures
• 5.3. Fate of Redundant Backups
• 5.4. Role of Competitive Analysis

Chapter 6

• CHI INSIGHT PHARMA REPORTS BACKUP COMPOUNDS SURVEY-JUNE 2007

Chapter 7

• BEST PRACTICES
• 7.1. Three Industry Views on Backup Strategies
  • An Ideal Scenario
  • The Role of Backup Strategies in Pharma' s R&D Productivity Crisis
  • Efficiency in Backup Strategies
• 7.2. Considerations in Backup Strategies
  • Type of Backup Menu
  • Time Constraints
  • Strategic and Tactical Issues
  • Learning from Failure
  • Limiting the Number of Disease Areas Addressed

Appendix A

• EIDOGEN-SERTANTY' S APPROACH TO BACKUP STRATEGY
• Interview with Steven Muskal, PhD, CEO, Eidogen-Sertanty
• Eidogen-Sertanty Technology

Appendix B

• TARGET PRODUCT PROFILE TEMPLATE

Appendix C

• ABBREVIATED TARGET PRODUCT PROFILE

Appendix D

• INTERVIEWS WITH INDUSTRY EXPERTS
• Mark Ashwell, PhD, Vice President, Chemistry, ArQule
• Dario Doller, PhD, Group Leader Medicinal Chemistry, in a pharmaceutical research and development organization
• David Lester, PhD, Principal Consultant, ITHW, Inc.; Senior Vice President, Strategy and Corporate Development, Gene Express; former pharmaceutical R&D executive and FDA staffer
• Note: Interviews with other industry experts appear throughout the body of the report. These interview subjects, who requested anonymity, include strategic planning managers, project managers, discovery strategy managers, and discovery product managers in big pharma.

References