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

By Hermann A.M. Mucke, PhD

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