Muutke küpsiste eelistusi

E-raamat: Biopharmaceutical Supply Chains: Distribution, Regulatory, Systems and Structural Changes Ahead [Taylor & Francis e-raamat]

(North Carolina State University, Raleigh, USA)
  • Formaat: 272 pages, 3 Tables, black and white; 25 Illustrations, black and white
  • Ilmumisaeg: 06-Jun-2012
  • Kirjastus: CRC Press Inc
  • ISBN-13: 9780429252594
  • Taylor & Francis e-raamat
  • Hind: 110,79 €*
  • * hind, mis tagab piiramatu üheaegsete kasutajate arvuga ligipääsu piiramatuks ajaks
  • Tavahind: 158,27 €
  • Säästad 30%
  • Formaat: 272 pages, 3 Tables, black and white; 25 Illustrations, black and white
  • Ilmumisaeg: 06-Jun-2012
  • Kirjastus: CRC Press Inc
  • ISBN-13: 9780429252594
A comprehensive exploration of the massive changes in the biopharmaceutical supply chain that have occurred during the past 10 years, and predicted future trends, Biopharmaceutical Supply Chains: Distribution, Regulatory, Systems and Structural Changes Ahead documents the specific impacts of these changes for key players in the supply chain.

Based on interviews with industry professionals, the book presents an overview of the key challenges and discusses how leading biopharmaceutical companies handle these challenges. It exposes the underlying structures that support the biopharmaceutical supply chain, focusing specifically on distributionthe point at which manufacturers release a finished product to the time that it is administered, and the complicated set of channels that exist between these two points. This overarching view of the supply chain provides an important piece of intelligence that can inform business strategy for life sciences manufacturers and distributors and help them achieve success in this industry.
Preface ix
Chapter 1 Biopharmaceutical Distribution: Early Structural Developments and the Changes Ahead
1(22)
Introduction
1(3)
Structural Evolution of Biopharmaceutical Distribution
4(3)
The Move Away from Distribution
5(2)
The Biopharmaceutical Supply Chain (BPS)
7(14)
Branded and Generic Manufacturers
7(4)
Wholesalers
11(2)
Drug Chain Pharmacies
13(3)
Hospitals and Group Purchasing Organizations
16(2)
Health Maintenance Organizations and Pharmacy Benefits Managers
18(3)
Bringing the Supply Chain Together
21(2)
Chapter 2 Key Forces and Myths of Distribution in the BPS Supply Chain
23(32)
Key Forces Overview
23(1)
Myths of Biopharmaceutical Distribution
24(24)
Compensation Forces
24(4)
Structure of Fee-for-Service Inventory Impacts
28(3)
Perception of Manufacturers to FFS
31(1)
Manufacturers---Stable Group
31(1)
Manufacturers---Explorer Group
32(1)
Manufacturers---Malcontent Group
33(1)
Manufacturers---Oblivious Group
33(1)
Channel Forces
34(5)
Group Purchasing Organizations
39(2)
Product Forces
41(7)
Conclusion
48(7)
Compensation
48(1)
Regulation
49(1)
Channel Forces
50(1)
Product Proliferation and Customer Segmentation
51(4)
Chapter 3 Regulatory Trends
55(38)
Introduction
55(1)
A Complex Regulatory Distribution Environment
56(2)
Regulatory Environment for Wholesalers
58(11)
Prescription Drug Marketing Act (PDMA) of 1988
58(2)
Hatch-Waxman Act: The Entry of Biosimilars and Generics
60(1)
Medicare Modernization Act of 2003
60(1)
Medicare
61(2)
Reimportation
63(1)
Medicare B: Impact on Oncology
64(1)
Medicare D: Free Samples
65(1)
Possible Robinson--Patman Liability for Price Discrimination
66(2)
Other Important Drug Distribution Laws
68(1)
Legislation That Ended the Forward-Selling Model for Wholesalers and Manufacturers
69(3)
The Obama Healthcare Reform Act
72(4)
State Licensing Codes
74(1)
Direct Mail
75(1)
Challenges to Enforcement---Counterfeit Drugs
76(2)
Subsequent Legislation in Anticounterfeiting and Pedigree: A Case Study
78(3)
Rebate, Pricing, and Payment Structures for Medicaid: A Significant Threat on the Horizon for Wholesalers
81(4)
Impact of Material Handling Legislation on Pharmaceutical and Biotech Distribution
85(5)
Cold Chain
85(2)
The Rise of Biologics versus Pharmaceuticals
87(3)
Pay-for-Performance Mandates
90(1)
Conclusion
91(2)
Chapter 4 The Last Mile: Changes in the Hospital Environment That Impact the Life Sciences
93(34)
The Healthcare Imperative
93(2)
Patient Safety and Total Cost of Patient Care
95(1)
The Root Cause: Multiple Handoffs
96(5)
Life before Automated Pharmaceutical Dispensing
98(1)
Automated Dispensing Market Penetration
98(2)
Limitations to Automated Dispensing
100(1)
The Race to the Bedside
101(2)
The Genesis of an Idea
101(1)
Automated Replenishment
102(1)
The Journey toward Automated Pharmaceutical Distribution
103(8)
Phase 0 Preautomation
103(2)
Phase 1 Implementation of Auto-replenishment
105(2)
Phase 2 Early Integration
107(2)
Phase 3 Auto-replenishment Integration
109(2)
Total Patient Cost
111(5)
Challenges on the Horizon for Biologics and Pharmaceuticals in the Hospital Provider Environment
116(8)
Personalized Medicine and Pay-for-Performance
118(1)
Reimbursement Models
118(1)
Pay-for-Performance (PFP)
118(1)
Step Edit Therapy
119(1)
Price Capping
120(1)
Outcome-Based Pricing
120(1)
Accountable Care Organizations
120(2)
New Developments in Comparative Effectiveness
122(2)
Conclusions
124(3)
Chapter 5 The Blurring of Boundaries in Biopharmaceutical Supply Chains: The Case of Oncology Medicine
127(32)
Introduction
127(4)
The Oncology Market
128(2)
Growth of Cancer Treatments
130(1)
The Oncology Supply Chain
131(2)
The GPO--Distributor--Physician Relationship in Oncology
133(3)
Services Provided by Specialty Wholesalers and Distributors
135(1)
Differentiated Services
135(1)
Profitability in the Oncology Market
136(1)
Class-of-Trade (COT) Pricing
137(2)
Emerging Relationships in the Oncology Supply Chain
139(2)
Competitive Acquisition Program (CAP)
141(1)
J-Codes
142(3)
J-Code Specificity Challenge
143(1)
Dosing Challenges
143(1)
Cost Challenge
144(1)
Payer and Reimbursement Systems
145(3)
Managed Care Synopsis
147(1)
Misaligned Incentives in the Oncology Supply Chain
148(7)
Payers
148(1)
Oncologists
149(2)
Specialty Pharmacies
151(1)
Home Infusion Companies
152(1)
Hospitals
152(1)
Manufacturers
153(2)
Patients
155(1)
Conclusion
155(2)
Endnotes
157(2)
Chapter 6 The Changing Landscape of the Life Sciences Supply Chain: Recommendations for Players in the Industry
159(84)
Introduction: An Industry in Flux
159(1)
A Multi-agent Simulation View
160(3)
Massive Disruptions in Biopharma Value Chains
163(6)
Growing Adoption of Price Restrictions by Regulators and Governments
163(1)
Declining R&D Productivity
164(1)
Emphasis on Pay-for-Performance
165(1)
Increasing Emphasis on Personalized Medicine
165(1)
Fragmentation of Mass Markets
166(1)
Emergence of Biotech and Biologics
167(1)
More Restrictive Regulations
167(1)
Increasing Use of Pervasive Monitoring
168(1)
Changing Roles of Primary and Secondary Care
168(1)
Opportunities
169(2)
Global Market Channel Development and Alternative Reimbursement Models
171(12)
Growth of Global Markets
172(1)
Opportunity: Emerging Markets
173(1)
Patent Protection Issues
174(4)
The AIDS Epidemic
178(2)
"Acting Locally"
180(1)
The United States
180(1)
Europe
181(1)
Asia
181(1)
The Rest of the World
181(1)
Partnering with Governments as Part of the Solution
182(1)
Opportunity: Personalized Medicine and Customized Therapeutic Distribution
183(10)
Personalized Medicine
184(6)
Opportunity: Compliance
190(2)
Aligning Capabilities to Drive Solutions
192(1)
E-Pedigree and Serialization: The War on Counterfeit Drugs and Black Market Sales
193(1)
Counterfeit Drug Challenges
193(30)
The Rise of E-Pedigree Regulation
195(3)
The Early Promise of RFID Technology
198(4)
Counterfeiting and Pedigree Technology Solutions
202(2)
GS1 and the Serialization Alphabet Soup
204(5)
Distinguishing Attributes
209(2)
Key Issues Surrounding Traceability
211(1)
The Global Serialization Landscape
211(5)
Pfizer: Setting Priorities and Learning from Experience
216(1)
Merck: Learning to Manage the Process
217(2)
What Does It Take to Be Able to Implement Serialization?
219(2)
Critical Requirements for Successful Collaboration
221(1)
Rx-360: Industry Collaboration Initiative for Global Track-and-Trace
221(2)
Opportunity: Specialized Distribution Channels
223(14)
Direct-to-Consumer Customized Distribution for Oncology and Injected Biotherapies
225(1)
Temperature-Controlled Specialized Distribution
226(1)
Why Is Cold Chain a Current Issue?
227(1)
Industry Changes
227(1)
New Technologies
228(1)
Data Logger Technology
228(1)
Cooling Technology
229(3)
Looking Forward: What's Next?
232(5)
References
237(6)
Additional Reading
240(3)
Index 243
Rob Handfield is the Bank of America University Distinguished Professor of Supply Chain Management at North Carolina State University, and Director of the Supply Chain Resource Cooperative (http://scm.ncsu.edu). He also serves as an Adjunct Professor with the Supply Chain Management Research Group at the Manchester Business School. He received his PhD in Operations Management from the University of North Carolina at Chapel Hill, and a BSc in Applied Math from the University of British Columbia.

The SCRC is the first major industry-university partnership to integrate student projects into the MBA classroom in an integrative fashion, and has had 15 major Fortune 500 companies participating as industry partners since 1999. Prior to this role, Handfield was an Associate Professor and Research Associate with the Global Procurement and Supply Chain Benchmarking Initiative at Michigan State University from 1992-1999, working closely with Professor Robert Monczka.

Handfield is the Consulting Editor of the Journal of Operations Management, one of the leading supply chain management journals in the field, and is the author of several books on supply chain management, the most recent being Supply Market Intelligence, Supply Chain Re-Design and Introduction to Supply Chain Management (Prentice Hall, 1999, 25,000 copies sold, and translated into Chinese, Japanese, and Korean). He has co-authored textbooks for MBA and undergraduate classes including Purchasing and Supply Chain Management 5th revision (with Robert Monczka) and Operations and Supply Chain Management 2nd revision (with Cecil Bozarth).

Handfield is considered a thought leader in the field of supply chain management, and is an industry expert in the field of strategic sourcing, supply market intelligence, and supplier development. He has spoken on these subjects across the globe, including China, Azerbaijan, Turkey, Latin America, Europe, Korea, Japan, Canada, and other venues.