Backup Compound Strategies: Best Practices for Reducing Phase II Risk

By Ken Rubenstein, PhD

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