Part I: The Global Health Care Crisis.
1. The world's health care crisis : the United States' leadership
The US Health Care Crisis
The US Health Care System
2. The health care crisis in other parts of the world
The French Health Care System
The UK Health Care System
Private insurance use in Europe
Other industrialized nations
The developing world: in search of hope
The pharmaceutical industry
Part II: Understanding the biopharmaceutical business.
3. A brief commercial history of the biopharmaceutical industry up to the year 2000
The pharmaceutical industry begins
The Swiss pharmaceutical industry
The English pharmaceutical players
The United State enters the scene
Impact of World War I (1914-18)
Impact of World War II (1939-45)
Regulatory pathways for biotechnology
4. The biopharmaceutical industry in the twenty-first century : titanic challenges ahead
The biotechnology business crisis
The biopharmaceutical industry's short-term solutions to the crisis
5. Understanding research and development and marketing in a biopharmaceutical company
Conducting clinical trials
6. The pharmaceutical regulators
Causes of the drug approval lag
FDA and EMEA initiatives to optimize drug approval
FDA Critical Path Initiative
The FDA Amendment Act of 2007
Part III: The complexity of innovation.
7. The academia : industry relationship
8. Translating academic innovation into health care products
Translating basic discoveries into commercial products venture capitalists
Challenges in translating innovation into commercial products
Intellectual Property Rights
Taxpayers' money for innovation and commercial applications
Important implications for the developing world
9. The biotechnology world and its challenges
10. Causes of the pharmaceutical crisis
Drug discovery and development before biotechnology
Impact of biotechnology in drug discovery and development
Part IV: Morality and duty on a lonely planet.
11. Wealth versus poverty
Medicines for the developing world: yes, this is our problem
12. Social responsibility, governmental role, and nongovernmental organizations
Part V: Reinventing research and development.
13. Time for reorganization
Reorganization of research and development at the industrial level
Suggestions for improving the system
Conclusion: Future trends.
