Economics and Management in the Biopharmaceutical Industry in the USA Evolution and Strategic Change

Author’s Words. Overview of Strategic Management and Corporate Practice in the U.S., Chapter 1. Introduction, Main Contributions of the Biopharmaceutical Industry, Current Public Health Issues in the U.S., Chapter 2. In Early Days of Pharmaceutical Industry Worldwide , Aspirin in Germany & Penicillin from the UK to the US, Aspirin Discovery in Bayer, Germany, Penicillin Discovery in the United Kingdom , Pfizer in 1849-1939: Fermentation Innovator, Pfizer in 1940s: Large-Scale Penicillin Manufacturer, Pfizer in 1950s: New Pharmaceutical Company with Terramycin®, Streptomycin Discovery by Waksman and Patented by Merck, Shift from Germany to the United Kingdom and United States: 1950 –1960s, Chapter 3. The Birth of Biotechnology , Slow Progress Despite Gene Splicing Technology , Breakthroughs from the Two Collaborators, Fear of the Unknown, The Fist Patents in Recombinant DNA Area, Genentech was Born, Chapter 4. Emergence of Biotechnology Firms in 1970s – 1990s , Threats of Young Competitors with New Knowledge, New Biotechnology Firms Emergence in Social Context: Response of Science , New Biotechnology Firms Emergence in Legal Environment, Case Study 1: Genentech, The First Biotechnology Firm , Case Study 2: Amgen, The Second Biotechnology Company, Chapter 5. New Biotechnology Firms Emergence from Pharmaceutical Management Perspective , Case Study 3: Eli Lilly Open Innovation, Early History of Eli Lilly , Case Study 4: Bristol-Myers Squibb (BMS) , Chapter 6. U.S. Regulations on Biopharmaceutical Industry and Their Impact, Drug Act Amendments of 1962: Scientific Evidence of Safety and Efficacy, Drug Price Competition and Patent Restoration Act of 1984 for Generic Drugs, The Orphan Drug Act of 1983 for Rare Diseases, Off-Label Prescribing Practice, The Prescription Drug User Fee Act (PDUFA) in 1992, Chapter 7. Law & Strategies: How Biopharma’s Strategies Adapted in Response to U.S. Law Changes, Healthcare Spending in the United States: The Economics of BioSimilars, Law Changes Since 2009, Implications of the Biologics Price Competition and Innovation Act (BPCIA) , Biologics: New Business Models, Dogfight 1: AbbVie’s Humira® versus Amgen’s Amjevita®, Dogfight 2: AbbVie’s Humira® versus Samsung Bioepis?Co.’s Imraldi®, Dogfight 3: Johnson & Johnson’s Remicade® versus Samsung’s biologic: Renflexis, The Future of Biosimilars, AbbVie: Best Strategist with Innovative Drugs, Generic Brands: Now Very Important Business Models, Chapter 8. Opportunistic Business Models is the Generic Drug Market, Mylan: The Path to Becoming a Giant Generic Drug Company, Unanticipatedly Strong Patents Defense of Bristol Myers Squibb, Turing Pharmaceutical Company: Too Opportunistic, Yet Legal Business Model, Chapter 9. Low Productivity of Drug Companies, Steep Rising Cost of Drugs as Strict Regulations Occurred, Low Productivity in Terms of New Drugs Approval, Chapter 10. Payers, Purchasers, & Promotions, Who Pays for Medicines in the U.S., Direct-To-Consumer Advertising for Medicines, Federal Drug Administration (FDA), Case 5: Path of Merck, The Unforgettable Mistake by Merck: Vioxx^®, Chapter 11. Innovation Capabilities, Innovation from Dynamic Capabilities Perspective, R&D Capabilities: Patents, Publications, and Alliances, Chapter 12. Immuno-cancer Therapy, Immuno-Cancer Therapy: BMS vs Merck, Case Study 6: Gilead Science Inc. , Case Study 7: Kite Pharma, Current Achievements in CAR-T Cell Therapy: Novartis vs. Gilead Science , New Business Models for CAR-T Cell Therapies, Chapter 13. Biopharmaceutical Industry in the Future, High Expectations in Personalized Medicines, Emerging Markets, Impact of Visionary and Strategic Leadership, New Business Models, Conclusion, Index

Biography

Rachel Kim has obtained academic degrees that include a Doctorate in Business Administration and a Master's in Business Administration with a focus on strategic management from Alliant International University, San Diego, and a Bachelor of Science degree in Industrial Pharmaceutics from Ewha Womans University, South Korea. Dr Kim is currently a Researcher and Consultant on U.S. healthcare and has consulted for major pharmaceutical companies.