Supply Chain Management in the Drug Industry Delivering Patient Value for Pharmaceuticals and Biologics

by Rees, Hedley

• ISBN13: 9780470555170
• ISBN10: 0470555173
• Edition: 1st
• Format: Hardcover
• Copyright: 2011-02-22
• Publisher: Wiley

Summary

A timely guide for improving productivity, driving out cost, aising quality

Author Biography

Hedley Rees runs the independent consulting company Biotech PharmaFlow, which specializes in pharmaceutical supply chain management. He has been actively building, managing, and continuously improving supply chains in biotech for the last fifteen years.

Table of Contents

Contributors	p. xiii
Preface	p. xxi
Surveying and Mapping the Territory	p. 1
Setting a Transformational Agenda	p. 3
Aims and Aspirations of the Book	p. 3
Book Format	p. 5
Intended Readership	p. 6
A Book About Two Worlds in Contrast	p. 8
The Pharmaceutical Lottery	p. 8
Supply Chain Management in Context	p. 17
The History of Supply and Value Generation	p. 22
The Development of Processes to Manage the Supply Chain	p. 24
Life in SCM	p. 25
Moving Forward	p. 26
Plotting a Course to Patient Value	p. 29
Why Focus on Patient Value?	p. 29
Where Does the Patient Currently Fit?	p. 29
Why Is It Necessary to Plot a Course?	p. 33
Understanding How the Course Is Presently Set	p. 39
Capturing Value for Patients	p. 42
Pharmaceutical Drug Development	p. 45
Drug Development's Role in the Supply Chain	p. 45
Introduction to Drug Development	p. 47
The Medicinal Product	p. 48
Clinical Trials	p. 49
Related Development Programs	p. 52
Managing Clinical Programs	p. 57
Regulatory Affairs and Authorities	p. 58
Supply Chain Management in Development Programs	p. 65
Manufacture and Supply of Commercial Products	p. 68
Supply Chain Management for Commercial Products	p. 69
End-to-End Pharmaceutical Supply Chains	p. 73
Introduction	p. 73
Where Does Responsibility for the Supply Chain Lay?	p. 74
Sponsoring Companies, License Holders, and Their Supply Chains	p. 75
Supply Chains for Small-Molecule Products	p. 76
Starting at the Final Destination	p. 78
How Drugs Enter the Body	p. 78
Design of Drug Delivery Systems	p. 79
What This Means for the Supply Chain	p. 82
Key Aspects of GMP and GDP in Relation to SCM	p. 82
Overview of the Stages on Route to Patient Delivery	p. 86
Manufacture and Supply of Biological Entities	p. 90
Why Pharma Supply Chains Don't Perform	p. 103
Supply Chain Underperformance	p. 103
Is There a Case to Answer?	p. 103
Birth to Infancy: The Supply Chain Critical Stage	p. 104
Commercial Supply Under the Patent Protection Umbrella	p. 111
What This Means for the Pharmaceutical Supply Chain	p. 116
Building a Knowledge Foundation in SCM	p. 125
Supply Chain Management as a Competitive Weapon	p. 127
Competition and Business Strategy	p. 127
The Marketing Mix	p. 128
Porter's Five Forces	p. 128
Porter's Generic Competitive Strategies	p. 129
Porter's Value Chain	p. 129
Competitive Strategy and Customers	p. 133
The Japanese Experience	p. 142
Total Quality Management	p. 142
Lean Thinking	p. 143
Focusing on Value for Money	p. 146
SCM Processes in Competitive Strategy	p. 148
SCM in Biotech and Virtual Companies	p. 150
Competition in Pharmaceuticals	p. 152
Supply Chain Management Holistic	p. 155
The Relevance of SCM to Pharmaceuticals	p. 155
Production Systems and the SCM Holistic	p. 155
The Core of SCM	p. 156
First Principle of SCM	p. 156
Supply Chains as a Series of Interconnected Systems	p. 158
Processes to Manage the Supply Chain	p. 160
A Word About Processes	p. 161
How the SCM Processes Should Mesh Together	p. 163
Production and Inventory Control	p. 163
Strategic Procurement	p. 163
Transportation, Storage, and Distribution	p. 164
Information Systems and Technology	p. 164
Improvement	p. 165
Production and Inventory Control	p. 167
Core Mission	p. 167
First Principles of Production and Inventory Control	p. 167
The Wholesome Trinity in P&IC	p. 174
The Wholesome Trinity and Customer Expectations	p. 177
Leveraging the Wholesome Trinity	p. 179
The Impact of Variety on Supply Chains	p. 180
Designing Appropriate Production Systems	p. 183
Strategic Procurement	p. 187
Core Mission	p. 187
The Purchasing Portfolio	p. 188
The Process of Procurement	p. 195
Strategic Sourcing and Planning	p. 198
Outsourcing	p. 201
Basic Principles in Contracting for Supply	p. 206
Finally, Typical Organizational Tension over Procurement	p. 213
Transportation, Storage, and Distribution	p. 215
Defining the Core Mission	p. 215
International Trade and Commerce	p. 217
The World Trade Organization	p. 217
Intermediary Arrangements	p. 220
Terms of Trade: Incoterms	p. 223
Ownership of Goods: Title	p. 225
Third-Party Logistics Providers	p. 226
Customs	p. 227
Shipping Regulations Relating to Materials	p. 229
A Finishing Note	p. 230
Information Systems and Information Technology	p. 233
Overview	p. 233
Brief Lay History of Computer Systems Development	p. 234
Important Perspectives on Information Systems	p. 236
Improvement	p. 255
Why Improve?	p. 255
Improvement and Production Systems	p. 257
The Improvement Journey	p. 258
Bringing the Holistic Together	p. 277
Setting the Scene	p. 277
The Process Explained	p. 278
Developing an Action Agenda	p. 285
Case Study	p. 289
Planning and Executing Supply Chain Change	p. 293
Improvement in Pharmaceuticals	p. 295
Where Are We Now?	p. 295
Subsequent Developments Since Inception	p. 310
A Blueprint for Quality by Design	p. 311
Exemplar Thinking in Organizational Improvement	p. 335
Where Are We Now?	p. 335
What Is Meant by ôExemplarö?	p. 338
A Dialogue on Exemplar Improvement	p. 338
An Approach to SCM Based on Systems Thinking	p. 357
Building a Foundation for Sustainable Change	p. 363
Focus on the Individual	p. 363
Individuals as Leaders	p. 368
Individuals as Motivators and the Motivated	p. 370
Individuals as Group Members	p. 372
Individuals as Participants in Cultural Change	p. 376
Case Study: Miles Ltd., Bridgend, Glamorgan	p. 378
A Cure for the Pharmaceutical Supply Chain	p. 395
What Is the Disease State?	p. 395
What Is the Label Claim for the Medicine?	p. 396
What Will Life Hold Without the Medicine?	p. 397
What Is This Better Way to Develop Drugs?	p. 397
Full-Scale Production of Drugs	p. 407
What Are the Barriers to Change?	p. 410
What Are the Potential Benefits of Change?	p. 413
Defining the Art of the Possible	p. 414
Ending with the Beginning	p. 417
End Notes	p. 419
Index	p. 429
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