Strategic Management of Resources and Portfolios: Structuring Risk to Maximize Opportunity in Pharmaceutical R&D

Table of Contents

Chapter 1

ACCEPTING STRUCTURED RISK TO REALIZE OPPORTUNITY: THE ESSENCE OF ENTREPRENEURSHIP

• 1.1. Nature and Dictates of the Risk/Resource Relation
• 1.2. Business Complexity: “Home-Grown” Risk or Business Perspective
• 1.3. Projects, Portfolios, and Strategy
• Development Strategies of Life Science Companies
• Portfolios: High-Level Implementation of Strategy
• Projects: Tactical Materialization of Strategy Within the Portfolio

Chapter 2

DRUG R&D AS AN ENVIRONMENT TASKED TO DELIVER EFFICACY

• 2.1. From Return on Resources to Return on Investment
• 2.2. Proactive R&D Inventory Management and Optimization
• 2.3. Outsourcing Equipment Asset Management
• 2.4. User-Based Management of Consumables and “Soft” Assets
• 2.5. Process Engineering and the Six Sigma Concept
• Six Sigma in Pharmaceutical Marketing and Sales
• Six Sigma and Clinical Development
• 2.6. Reporting and Reviewing in R&D

Chapter 3

UNDERSTANDING AND ASSESSING DRUG DEVELOPMENT RISK/BENEFIT BALANCE

• 3.1. Real Options Analysis: Financial Metrics for R&D Valuation
• Valuation in Development Projects
• Real Options Analysis as a Solution to the Valuation Dilemma
• Implementing Real Options Analysis
• 3.2. Valuation of Intellectual Property
• Patents
• Patent Valuation
• 3.3. Predictive Safety from Discovery to the Phase I Clinical Stage
• 3.4. Phase II Study Designs and Relevance of Data
• 3.5. Phase III Programs and Prediction of “Field Performance”

Chapter 4

RISK AND RESOURCE REQUIREMENT THROUGHOUT THE DRUG LIFE CYCLE

• 4.1. Scientific and Clinical Development Risk
• Risk and Resources from Discovery to IND
• Phase I Risks and the Consequences of the TGN-1412 Affair
• Phase II
• Phase III
• 4.2. Regulatory Risk
• 4.3. Legal Risk
• Legal Challenges During Development
• Lawsuits Concerning Approved Drugs
• 4.4. Risk Management for Launched Drugs
• Formal Postmarketing Surveillance Systems
• Handling Unexpected Adverse Events
• 4.5. Commercial and Competitor Risk
• Market Risk from New Scientific Data
• Market Risk from a Changing Competitive Situation
• 4.6. Intellectual Property Risk
• Evolving Patent Regulations
• Patent Reform Act of 2007
• Circumvention of Patents and Challenge by Claiming Different Use
• Circumvention Risk Case Study #1: Amlodipine
• Circumvention Risk Case Study #2: Viagra and Levitra
• Circumvention Risk Case Study #3: Gabapentin
• 4.7. Operational Risk: Failure of Execution

Chapter 5

PORTFOLIO MANAGEMENT: ACTING ON PORTFOLIO RISK/RETURN-ON-INVESTMENT BALANCE

• 5.1. Prioritization as the Key Issue
• 5.2. The Human Factor in Portfolio Management
• 5.3. Portfolios and the Planning Process: Building the Models
• Benchmarking in a Dynamic R&D Environment
• Managing Portfolio Resource Bottlenecks
• Classical Decision Analysis
• Monte Carlo Simulation of Outcomes
• Robustness Against Multiple Outcome Scenarios
• Adaptive Clinical Trials: An Emerging Challenge to Resource Management
• 5.4. Enhancing the Portfolio Through M&A and Inlicensing
• 5.5. Decision Support Software from Contact Management to Business Intelligence
• CRM, PLM, SCM: Operating with Basic Resources
• Enterprise Resource Planning Software: The Great Operative Integrator
• Portfolio Management Software for the Life Sciences
• DecisionIris (Visual i/o)
• Enrich Portfolio System
• PDWare Portfolio
• ProModel Portfolio Simulator and Pharma R&D Solutions
• Data Warehouses and Business Intelligence Software for Strategy Support
• Explicit Risk Analysis Software Tools
• Product Life Cycle Management
• 5.6. Managing Data Security in the Digital Business

Chapter 6

CASE STUDIES IN PORTFOLIO RESOURCE ALLOCATION

• 6.1. Pfizer
• 6.2. Wyeth Pharmaceuticals
• 6.3. Bayer Schering Pharma
• 6.4. Genzyme Corporation
• 6.5. Three Examples from the Strategic Decisions Group

Chapter 7

SYNOPSIS AND RECOMMENDATIONS

• 7.1. Evaluation of a Project
• 7.2. Portfolio Management

• References
• Company Index with Web Addresses