1st Edition

Biopharmaceutical Supply Chains
Distribution, Regulatory, Systems and Structural Changes Ahead

ISBN 9781439899700
Published June 6, 2012 by CRC Press
272 Pages 25 B/W Illustrations

USD $105.00

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Book Description

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 distribution—the 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.

Table of Contents

Key Forces Driving the Biopharma Supply Chain
Key Forces
Compensation Forces
Channel Forces
Product Forces
Overview of Pharma Value Chain
Pharma Distribution
randed vs. Generic Manufacturers
Challenges in Pharma Distribution

Challenges in the Clinical Supply Chain
Plan Challenges

Regulatory Trends
Regulatory Environment
Impact of Recent Legislation on Pharmaceutical and Biotech

The Race to the Bed Side, Specific to Hospitals
The Healthcare Imperative
Using New Technologies
The Journey Towards Automated Pharmaceutical Distribution
Future Applications of Cardinal ASSIST
Getting started with Cardinal ASSIST
Single unit bar code technology

Industry Reactions to Evolving Distribution Models
Intro, Background on Research Methods
Industry's Perception of Fee for Service Model
Alternative Channels on the Horizon
Impact on Reimbursement of Impending Legislation in Medicare and Medicaid
Next Steps
Compliance Issues

The Path Forward for the Industry
Emerging Forces and Trends
Opportunity: Customized Therapeutic Distribution
Opportunity: Compliance
Opportunity: Direct to Consumer Shipping for Oncology and Injected Biotherapeutics
Opportunity: New Warehouse Automation Technology
Opportunity: Data Integration
Opportunity: RFID Expansion
Opportunity: Cold Chain Technology and Pedigree Requirements


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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.


"Handfield provides insights into the need for patient-centric value chain collaboration, and is a must-read for manufacturers, wholesalers, and payor/providers in the biopharmaceutical industry"
—Robert Lechich, Director of Operational Excellence, Pfizer Corporation

"Handfield challenges our current and arguably provincial notions of supply chain commonly held in the biopharmaceutical industry and forces us to really see it for what it isa process that ultimately connects the initial product manufacturing process directly to the patient and all points in between. His systemic approach dismantles various paradigm silos to reveal a complex series of interconnected activities and players, demonstrating a dynamic whole and clearer view to making the current healthcare debate more meaningful."
—Bill Welsh, PhD, Associate Director, Strategic Programs, Golden LEAF Biomanufacturing Training & Education Center, North Carolina State University, Raleigh, USA