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Length 236 pages
Date published October 2005
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Pharmaceutical R&D Productivity:
The Path to Innovation
Bryan G. Reuben, M.A.,
M.Sc., D.Phil. and Michael L. Burstall, M.A., M.Sc., D.Phil
New Page 1
Executive
Summary
Chapter 1. Is There a Discovery Deficit?
1.1. Numbers of New Drugs
1.2. All the Easy Problems Have Been Solved
1.3. The Decline of Europe’s Competitiveness
1.4. The High Cost of Drug Development
Methodology and Assumptions of DiMasi and Colleagues
Methodology and Assumptions Behind the Bain Drug Economics Model
1.5. Clinical Trials—Discovery and Preclinical Trials
1.6. Revenue
Where Has All the Money Gone?
Manufacturing Costs
1.7. Blockbuster Drugs
1.8. Pipelines
1.9. Conclusions
Chapter 2. Management of Research
2.1. The Mechanism of Creativity
Relationship Between Academic Research and Applied Science/Technology
The Organizational Problem
2.2. Organization of R&D
Hierarchical and Divisional Management
Matrix Management
The Problem of Setting Priorities
Other Problems
Problems of Identity
Restructuring
Where the Companies Stood
Specialists versus Generalists
2.3. Total Quality Management, Business Process
Reengineering, and Business Process Management
-Reengineering Bristol-Myers Squibb
-Process Reengineering at Wyeth
-Reorganizing Pharmacia-Upjohn and Schering-Plough
Are Metrics the Answer?
2.4. Typology of Scientists and University Relationships
Three Types of Scientists
Deprofessionalization of the Professions
The View from Industry
Employee Dissatisfaction: Private Scientists and Organizational Scientists
2.5. The Centralize/Decentralize Cycle
2.6. Decision Points in the Development of a New Drug
Lead Compounds Sidebar: Process Trends in Pre-IND Drug Development: Tox Testing
Investigational New Drug Application
Clinical Trials
The Challenges of Marketing
2.7. Conclusions—The CEO Shortage
Chapter 3. Mergers and Acquisitions
3.1. Categories of Mergers and Acquisitions
3.2. Economies of Scale
Discovery-Phase Economies
Diseconomies of Scale
Redundancies, Downsizing, etc.
3.3. Conclusions
Chapter 4. Platform Technologies and Biotechnology
4.1. Three Salient Enabling Technologies
4.2. Combinatorial Chemistry and Lead Generation
4.3. Biomarkers
Targeted Drugs
Toxicogenomics
4.4. Biotechnology
The Biotechnology Industry
How Biotechnology Companies Differ from Big Pharma
The Contrast Between the United States and Europe
The Target Validation Bottleneck
Disease Targets for Biopharmaceuticals
Gene Therapy and Gene Editing
Antibiotics
4.5. A Philosophical Conclusion
Chapter 5. Regulatory, Social, Political, and Economic Factors
5.1. Development of the FDA
Thalidomide’s Impact on the Drug Development Process and NME Rates
The Pharmaceutical Industry’s Image Problem
The Impact of Tightening NDA Requirements: PDUFA
The FDA’s Changing Role
Problems of 2003 and 2004
Vioxx and the COX-2 Inhibitors
The Fallout from Vioxx: Consumers, Industry, and Government
FDA Reform
Company Disclosure
5.2. Regulatory Problems in Europe: Hostility toward “Chemicals”
The Experience with Genetically Modified Crops
Onerous Regulation and Monitoring of Chemicals: Precautionary Principle
Regulatory Problems in Europe: Animal Rights Terrorism
5.3. Patents
TRIPS-Uneven Compliance
Deciding What Can Be Patented
Global Health Crises and the Limits on Patent Protection
5.4. The Downward Pressure on Prices
Reference Pricing in the EU and Other Controls
Free Pricing Comes Under Threat in the United States
The U.S. Government As Dominant Purchaser: Implications for Drug
Pricing and R&D
5.5. Conclusions
Chapter 6. GlaxoSmithKline Case Study
6.1. Early Glaxo Discoveries
6.2. The Beecham Bid
6.3. Ranitidine—Zantac Profits Fund Glaxo’s R&D Expansion
6.4. The Wellcome Takeover
A Merger of Disparate Cultures
Wellcome’s Transition from a Hierarchical to a Matrix Organization
6.5. The SmithKline Beecham Merger
SmithKline Beecham’s Matrix Culture Imported into Glaxo-Wellcome
6.6. Centers of Excellence for Drug Discovery
A Bridge Between Late Discovery and Clinical Development
An Attempt to Capture the Flexibility and Culture of the Biotechs
6.7. Patent Expirations and Future Outlook
6.8. Conclusions
Chapter 7. Sanofi-Aventis Case Study
7.1. Historical R&D Performance
7.2. Relationships With the United States
7.3. The Aventis Merger
Employment Changes
Multinational or Francocentric?
Are the Differences Surmountable?
More Compounds Into the Clinic
A Gentle Takeover or a “Sorting Out”?
7.4. Patent Expirations and Future Prospects
7.5. Conclusions
Chapter 8. Conclusions
8.1. Anatomy of the Discovery Deficit
The Cost of Drug Development
Managing the Organization
The Impact of Mergers and Acquisitions
Investment in Technology
Socioeconomic Trends
Serendipity
8.2. Future Scenarios
The Doomsday Scenario
Better the Devil One Knows
Approaching Utopia
A Braver New World
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