Rachel Kim
Economics and Management in the Biopharmaceutical Industry in the USA
Evolution and Strategic Change
Rachel Kim
Economics and Management in the Biopharmaceutical Industry in the USA
Evolution and Strategic Change
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This book presents an overview of the biopharmaceutical industry, putting it in a historical context. It provides readers with a detailed account of the achievements in drug discovery and development and current biopharmaceutical industry issues.
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This book presents an overview of the biopharmaceutical industry, putting it in a historical context. It provides readers with a detailed account of the achievements in drug discovery and development and current biopharmaceutical industry issues.
Hinweis: Dieser Artikel kann nur an eine deutsche Lieferadresse ausgeliefert werden.
Hinweis: Dieser Artikel kann nur an eine deutsche Lieferadresse ausgeliefert werden.
Produktdetails
- Produktdetails
- Verlag: Taylor & Francis
- Seitenzahl: 142
- Erscheinungstermin: 4. Dezember 2018
- Englisch
- Abmessung: 234mm x 156mm x 10mm
- Gewicht: 390g
- ISBN-13: 9781138500273
- ISBN-10: 1138500275
- Artikelnr.: 55045131
- Herstellerkennzeichnung
- Libri GmbH
- Europaallee 1
- 36244 Bad Hersfeld
- 06621 890
- Verlag: Taylor & Francis
- Seitenzahl: 142
- Erscheinungstermin: 4. Dezember 2018
- Englisch
- Abmessung: 234mm x 156mm x 10mm
- Gewicht: 390g
- ISBN-13: 9781138500273
- ISBN-10: 1138500275
- Artikelnr.: 55045131
- Herstellerkennzeichnung
- Libri GmbH
- Europaallee 1
- 36244 Bad Hersfeld
- 06621 890
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.
Author's Words: Overview of Strategic Management and Corporate Practice in the United States
Chapter 1. Introduction
Main Contributions of the Biopharmaceutical Industry
Current Public Health Issues in the United States
Chapter 2. In the Early Days of the Pharmaceutical Industry Worldwide
Aspirin in Germany and Penicillin from the United Kingdom to the United States
Aspirin Discovery in Bayer
Germany
Penicillin Discovery in the United Kingdom
Pfizer from 1849-1939: Fermentation Innovator
Pfizer in the 1940s: Large-Scale Penicillin Manufacturer
Pfizer in the 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 Breakthrough
Breakthroughs from the Two Collaborators
Fear of the Unknown
The First Patents in the Recombinant DNA Area
Genentech Was Born
Chapter 4. Emergence of Biotechnology Firms in the 1970s-1990s
Threats of Young Competitors with New Knowledge
New Biotechnology Firms' Emergence in a Social Context: Response of Science Communities
Science Department at UCSF
UC Berkeley
and Stanford
New Biotechnology Firms' Emergence in the 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 a Pharmaceutical Management Perspective
Case Study 3: Eli Lilly's Open Innovation
Early History of Eli Lilly
Case Study 4: Bristol-Myers Squibb (BMS)
Chapter 6. US Regulations on the 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 and 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 Renflexis®
The Future of Biosimilars
AbbVie: Best Strategist with Innovative Drugs
Generic Brands: Now Very Important Business Models
Chapter 8. Opportunistic Business Models in the Generic Drug Market
Mylan: The Path to Becoming a Giant Generic Drug Company
Unanticipatedly Strong Patents Defense of Bristol Myers Squibb
Turing Pharmaceutical: 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
and Promotions
Who Pays for Medicines in the United States
Direct-To-Consumer Advertising for Medicines
Food and Drug Administration
Case Study 5: The Path of Merck
The Unforgettable Mistake by Merck: Vioxx®
Chapter 11. Innovation Capabilities
Innovation from a Dynamic Capabilities Perspective
R&D Capabilities: Patents
Publications
and Alliances
Chapter 12. Immuno-cancer Therapy
Immuno-cancer Therapy: BMS versus Merck
Case Study 6: Gilead Sciences
Inc.
Case Study 7: Kite Pharma
Current Achievements in CAR-T Cell Therapy: Novartis versus. Gilead Sciences
New Business Models for CAR-T Cell Therapies
Chapter 13. The Biopharmaceutical Industry in the Future
High Expectations in Personalized Medicines
Emerging Markets
The Impact of Visionary and Strategic Leadership
New Business Models
Conclusion
Index
Chapter 1. Introduction
Main Contributions of the Biopharmaceutical Industry
Current Public Health Issues in the United States
Chapter 2. In the Early Days of the Pharmaceutical Industry Worldwide
Aspirin in Germany and Penicillin from the United Kingdom to the United States
Aspirin Discovery in Bayer
Germany
Penicillin Discovery in the United Kingdom
Pfizer from 1849-1939: Fermentation Innovator
Pfizer in the 1940s: Large-Scale Penicillin Manufacturer
Pfizer in the 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 Breakthrough
Breakthroughs from the Two Collaborators
Fear of the Unknown
The First Patents in the Recombinant DNA Area
Genentech Was Born
Chapter 4. Emergence of Biotechnology Firms in the 1970s-1990s
Threats of Young Competitors with New Knowledge
New Biotechnology Firms' Emergence in a Social Context: Response of Science Communities
Science Department at UCSF
UC Berkeley
and Stanford
New Biotechnology Firms' Emergence in the 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 a Pharmaceutical Management Perspective
Case Study 3: Eli Lilly's Open Innovation
Early History of Eli Lilly
Case Study 4: Bristol-Myers Squibb (BMS)
Chapter 6. US Regulations on the 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 and 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 Renflexis®
The Future of Biosimilars
AbbVie: Best Strategist with Innovative Drugs
Generic Brands: Now Very Important Business Models
Chapter 8. Opportunistic Business Models in the Generic Drug Market
Mylan: The Path to Becoming a Giant Generic Drug Company
Unanticipatedly Strong Patents Defense of Bristol Myers Squibb
Turing Pharmaceutical: 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
and Promotions
Who Pays for Medicines in the United States
Direct-To-Consumer Advertising for Medicines
Food and Drug Administration
Case Study 5: The Path of Merck
The Unforgettable Mistake by Merck: Vioxx®
Chapter 11. Innovation Capabilities
Innovation from a Dynamic Capabilities Perspective
R&D Capabilities: Patents
Publications
and Alliances
Chapter 12. Immuno-cancer Therapy
Immuno-cancer Therapy: BMS versus Merck
Case Study 6: Gilead Sciences
Inc.
Case Study 7: Kite Pharma
Current Achievements in CAR-T Cell Therapy: Novartis versus. Gilead Sciences
New Business Models for CAR-T Cell Therapies
Chapter 13. The Biopharmaceutical Industry in the Future
High Expectations in Personalized Medicines
Emerging Markets
The Impact of Visionary and Strategic Leadership
New Business Models
Conclusion
Index
Author's Words: Overview of Strategic Management and Corporate Practice in the United States
Chapter 1. Introduction
Main Contributions of the Biopharmaceutical Industry
Current Public Health Issues in the United States
Chapter 2. In the Early Days of the Pharmaceutical Industry Worldwide
Aspirin in Germany and Penicillin from the United Kingdom to the United States
Aspirin Discovery in Bayer
Germany
Penicillin Discovery in the United Kingdom
Pfizer from 1849-1939: Fermentation Innovator
Pfizer in the 1940s: Large-Scale Penicillin Manufacturer
Pfizer in the 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 Breakthrough
Breakthroughs from the Two Collaborators
Fear of the Unknown
The First Patents in the Recombinant DNA Area
Genentech Was Born
Chapter 4. Emergence of Biotechnology Firms in the 1970s-1990s
Threats of Young Competitors with New Knowledge
New Biotechnology Firms' Emergence in a Social Context: Response of Science Communities
Science Department at UCSF
UC Berkeley
and Stanford
New Biotechnology Firms' Emergence in the 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 a Pharmaceutical Management Perspective
Case Study 3: Eli Lilly's Open Innovation
Early History of Eli Lilly
Case Study 4: Bristol-Myers Squibb (BMS)
Chapter 6. US Regulations on the 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 and 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 Renflexis®
The Future of Biosimilars
AbbVie: Best Strategist with Innovative Drugs
Generic Brands: Now Very Important Business Models
Chapter 8. Opportunistic Business Models in the Generic Drug Market
Mylan: The Path to Becoming a Giant Generic Drug Company
Unanticipatedly Strong Patents Defense of Bristol Myers Squibb
Turing Pharmaceutical: 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
and Promotions
Who Pays for Medicines in the United States
Direct-To-Consumer Advertising for Medicines
Food and Drug Administration
Case Study 5: The Path of Merck
The Unforgettable Mistake by Merck: Vioxx®
Chapter 11. Innovation Capabilities
Innovation from a Dynamic Capabilities Perspective
R&D Capabilities: Patents
Publications
and Alliances
Chapter 12. Immuno-cancer Therapy
Immuno-cancer Therapy: BMS versus Merck
Case Study 6: Gilead Sciences
Inc.
Case Study 7: Kite Pharma
Current Achievements in CAR-T Cell Therapy: Novartis versus. Gilead Sciences
New Business Models for CAR-T Cell Therapies
Chapter 13. The Biopharmaceutical Industry in the Future
High Expectations in Personalized Medicines
Emerging Markets
The Impact of Visionary and Strategic Leadership
New Business Models
Conclusion
Index
Chapter 1. Introduction
Main Contributions of the Biopharmaceutical Industry
Current Public Health Issues in the United States
Chapter 2. In the Early Days of the Pharmaceutical Industry Worldwide
Aspirin in Germany and Penicillin from the United Kingdom to the United States
Aspirin Discovery in Bayer
Germany
Penicillin Discovery in the United Kingdom
Pfizer from 1849-1939: Fermentation Innovator
Pfizer in the 1940s: Large-Scale Penicillin Manufacturer
Pfizer in the 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 Breakthrough
Breakthroughs from the Two Collaborators
Fear of the Unknown
The First Patents in the Recombinant DNA Area
Genentech Was Born
Chapter 4. Emergence of Biotechnology Firms in the 1970s-1990s
Threats of Young Competitors with New Knowledge
New Biotechnology Firms' Emergence in a Social Context: Response of Science Communities
Science Department at UCSF
UC Berkeley
and Stanford
New Biotechnology Firms' Emergence in the 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 a Pharmaceutical Management Perspective
Case Study 3: Eli Lilly's Open Innovation
Early History of Eli Lilly
Case Study 4: Bristol-Myers Squibb (BMS)
Chapter 6. US Regulations on the 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 and 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 Renflexis®
The Future of Biosimilars
AbbVie: Best Strategist with Innovative Drugs
Generic Brands: Now Very Important Business Models
Chapter 8. Opportunistic Business Models in the Generic Drug Market
Mylan: The Path to Becoming a Giant Generic Drug Company
Unanticipatedly Strong Patents Defense of Bristol Myers Squibb
Turing Pharmaceutical: 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
and Promotions
Who Pays for Medicines in the United States
Direct-To-Consumer Advertising for Medicines
Food and Drug Administration
Case Study 5: The Path of Merck
The Unforgettable Mistake by Merck: Vioxx®
Chapter 11. Innovation Capabilities
Innovation from a Dynamic Capabilities Perspective
R&D Capabilities: Patents
Publications
and Alliances
Chapter 12. Immuno-cancer Therapy
Immuno-cancer Therapy: BMS versus Merck
Case Study 6: Gilead Sciences
Inc.
Case Study 7: Kite Pharma
Current Achievements in CAR-T Cell Therapy: Novartis versus. Gilead Sciences
New Business Models for CAR-T Cell Therapies
Chapter 13. The Biopharmaceutical Industry in the Future
High Expectations in Personalized Medicines
Emerging Markets
The Impact of Visionary and Strategic Leadership
New Business Models
Conclusion
Index