Hedley Rees

Supply Chain Management in the Drug Industry

Delivering Patient Value for Pharmaceuticals and Biologics

• Gebundenes Buch

Produktbeschreibung

Bridging the gap between practitioners of supply-chain management and pharmaceutical industry experts, this book helps these groups understand their different worlds and how to jointly contribute to improvements in supply-chains within the globally important pharmaceutical sector. The author suggests that chemistry manufacturing controls drug development must reset the line of sight-from supply of drug to the clinic and gaining a registration, to the building of a patient value stream. The book examples factors including: capable processes and suppliers, streamlined logistics, flexible plant and equipment, shorter cycle times, effective flow of information and reduced waste.

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"...[This] interesting exploration of SCM issues includes business, control, regulatory and technical aspects. . . .a must-read for those entering into the SCM fields as well as all those who intersect with SCM." -Bob Coleman, former FDA Investigator and current Senior Compliance Expert, IHL Consulting Group, Inc. A timely guide for improving productivity, driving out cost, aising quality In response to the global pressure to contain healthcare budgets while improving compliance, the pharmaceutical industry is moving supply chain center stage, in an attempt to build supply chains comparable with the aerospace, semi-conductor, electronics, and automotive industries. This book bridges the gap between practitioners of supply chain management and pharmaceutical industry experts. It shows them how to jointly contribute to meaningful improvements in supply chains within the pharmaceutical sector. Supply Chain Management in the Drug Industry suggests that CMC (chemistry, manufacturing, and controls) drug development must reset the line of sight-from supply of drug to the clinic and gaining a registration, to the building of a patient value stream. In addition, the book: * Provides a practical guide to the application of supply chain management (SCM) processes and practices in the pharmaceutical setting * Stresses the importance of integrated SCM throughout a pharmaceutical organization * Encourages the critical need for cultural shift and fosters collaborations between SCM practitioners and pharmaceutical scientists With a thorough exploration of SCM from beginning to end of the pharmaceutical process, this book helps secure responsive, cost effective, and risk mitigated supply chains to compete on a world stage.

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Produktdetails

• Verlag: John Wiley & Sons / Wiley
• Seitenzahl: 458
• Erscheinungstermin: 22. Februar 2011
• Englisch
• Abmessung: 240mm x 161mm x 29mm
• Gewicht: 850g
• ISBN-13: 9780470555170
• ISBN-10: 0470555173
• Artikelnr.: 30977031

Autorenporträt

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.

Inhaltsangabe

CONTRIBUTORS xiii
PREFACE xxi
I SURVEYING AND MAPPING THE TERRITORY 1
1 Setting a Transformational Agenda 3
1.1 Aims and Aspirations of the Book 3
1.2 Book Format 5
1.3 Intended Readership 6
1.4 A Book About Two Worlds in Contrast 8
1.5 The Pharmaceutical Lottery 8
1.6 Supply Chain Management in Context 17
1.7 The History of Supply and Value Generation 22
1.8 The Development of Processes to Manage the Supply Chain 24
1.9 Life in SCM 25
1.10 Moving Forward 26
2 Plotting a Course to Patient Value 29
2.1 Why Focus on Patient Value? 29
2.2 Where Does the Patient Currently Fit? 29
2.3 Why Is It Necessary to Plot a Course? 33
2.4 Understanding How the Course Is Presently Set 39
2.5 Capturing Value for Patients 42
3 Pharmaceutical Drug Development 45
3.1 Drug Development's Role in the Supply Chain 45
3.2 Introduction to Drug Development 47
3.3 The Medicinal Product 48
3.4 Clinical Trials 49
3.5 Related Development Programs 52
3.6 Managing Clinical Programs 57
3.7 Regulatory Affairs and Authorities 58
3.8 Supply Chain Management in Development Programs 65
3.9 Manufacture and Supply of Commercial Products 68
3.10 Supply Chain Management for Commercial Products 69
4 End-to-End Pharmaceutical Supply Chains 73
4.1 Introduction 73
4.2 Where Does Responsibility for the Supply Chain Lay? 74
4.3 Sponsoring Companies, License Holders, and Their Supply Chains 75
4.4 Supply Chains for Small-Molecule Products 76
4.5 Starting at the Final Destination 78
4.6 How Drugs Enter the Body 78
4.7 Design of Drug Delivery Systems 79
4.8 What This Means for the Supply Chain 82
4.9 Key Aspects of GMP and GDP in Relation to SCM 82
4.10 Overview of the Stages on Route to Patient Delivery 86
4.11 Manufacture and Supply of Biological Entities 90
5 Why Pharma Supply Chains Don't Perform 103
5.1 Supply Chain Underperformance 103
5.2 Is There a Case to Answer? 103
5.3 Birth to Infancy: The Supply Chain Critical Stage 104
5.4 Commercial Supply Under the Patent Protection Umbrella 111
5.5 What This Means for the Pharmaceutical Supply Chain 116
II BUILDING A KNOWLEDGE FOUNDATION IN SCM 125
6 Supply Chain Management as a Competitive Weapon 127
6.1 Competition and Business Strategy 127
6.2 The Marketing Mix 128
6.3 Porter's Five Forces 128
6.4 Porter's Generic Competitive Strategies 129
6.5 Porter's Value Chain 129
6.6 Competitive Strategy and Customers 133
6.7 The Japanese Experience 142
6.8 Total Quality Management 142
6.9 Lean Thinking 143
6.10 Focusing on Value for Money 146
6.11 SCM Processes in Competitive Strategy 148
6.12 SCM in Biotech and Virtual Companies 150
6.13 Competition in Pharmaceuticals 152
7 Supply Chain Management Holistic 155
7.1 The Relevance of SCM to Pharmaceuticals 155
7.2 Production Systems and the SCM Holistic 155
7.3 The Core of SCM 156
7.4 First Principle of SCM 156
7.5 Supply Chains as a Series of Interconnected Systems 158
7.6 Processes to Manage the Supply Chain 160
7.7 A Word About Processes 161
7.8 How the SCM Processes Should Mesh Together 163
7.9 Production and Inventory Control 163
7.10 Strategic Procurement 163
7.11 Transportation, Storage, and Distribution 164
7.12 Information Systems and Technology 164
7.13 Improvement 165
8 Production and Inventory Control 167
8.1 Core Mission 167
8.2 First Principles of Production and Inventory Control 167
8.3 The Wholesome Trinity in P&IC 174
8.4 The Wholesome Trinity and Customer Expectations 177
8.5 Leveraging the Wholesome Trinity 179
8.6 The Impact of Variety on Supply Chains 180
8.7 Designing Appropriate Production Systems 183
9 Strategic Procurement 187
9.1 Core Mission 187
9.2 The Purchasing Portfolio 188
9.3 The Process of Procurement 195
9.4 Strategic Sourcing and Planning 198
9.5 Outsourcing 201
9.6 Basic Principles in Contracting for Supply 206
9.7 Finally, Typical Organizational Tension over Procurement 213
10 Transportation, Storage, and Distribution 215
10.1 Defining the Core Mission 215
10.2 International Trade and Commerce 217
10.3 The World Trade Organization 217
10.4 Intermediary Arrangements 220
10.5 Terms of Trade: Incoterms 223
10.6 Ownership of Goods: Title 225
10.7 Third-Party Logistics Providers 226
10.8 Customs 227
10.9 Shipping Regulations Relating to Materials 229
10.10 A Finishing Note 230
11 Information Systems and Information Technology 233
11.1 Overview 233
11.2 Brief Lay History of Computer Systems Development 234
11.3 Important Perspectives on Information Systems 236
12 Improvement 255
12.1 Why Improve? 255
12.2 Improvement and Production Systems 257
12.3 The Improvement Journey 258
13 Bringing the Holistic Together 277
13.1 Setting the Scene 277
13.2 The Process Explained 278
13.3 Developing an Action Agenda 285
13.4 Case Study 289
III PLANNING AND EXECUTING SUPPLY CHAIN CHANGE 293
14 Improvement in Pharmaceuticals 295
14.1 Where Are We Now? 295
14.2 Subsequent Developments Since Inception 310
14.3 A Blueprint for Quality by Design 311
15 Exemplar Thinking in Organizational Improvement 335
15.1 Where Are We Now? 335
15.2 What Is Meant by "Exemplar"? 338
15.3 A Dialogue on Exemplar Improvement 338
15.4 An Approach to SCM Based on Systems Thinking 357
16 Building a Foundation for Sustainable Change 363
16.1 Focus on the Individual 363
16.2 Individuals as Leaders 368
16.3 Individuals as Motivators and the Motivated 370
16.4 Individuals as Group Members 372
16.5 Individuals as Participants in Cultural Change 376
16.6 Case Study: Miles Ltd., Bridgend, Glamorgan 378
17 A Cure for the Pharmaceutical Supply Chain 395
17.1 What Is the Disease State? 395
17.2 What Is the Label Claim for the Medicine? 396
17.3 What Will Life Hold Without the Medicine? 397
17.4 What Is This Better Way to Develop Drugs? 397
17.5 Full-Scale Production of Drugs 407
17.6 What Are the Barriers to Change? 410
17.7 What Are the Potential Benefits of Change? 413
17.8 Defining the Art of the Possible 414
17.9 Ending with the Beginning 417
END NOTES 419
INDEX 429

Rezensionen

"A recommended read for all wishing to shift performance to greater levels." (Supply Management, 1 February 2012)

"This book is ideal reading for those entering or currently working in the field of supply chain management, such as clinical supply managers, or those in operations or production and planning ... This book would be an excellent resource for small pharmaceutical companies that may have limited experience of supply chain implementation or outsourcing, giving a thorough overview of the process and plenty of food for thought." (The Pharmaceutical Journal, 16 November 2011)

"This is a solid text that is equally suitable for the newcomer or experienced profesional in the pharmaceutical/biologics industries . . . Overall, I recommend the book for its educational perspective on the industry and the significance of effective SCM for its future success." (Quality World, 1 July 2011)

"Hedley's interesting exploration of SCM issues includes business, control, regulatory and technical aspects. The book is salted with many personal experiences which keep the reader entertained as well as informed. This book is a must read for those entering into the SCM fields as well as all those who intersect with SCM." (Samedan Ltd, 4 February 2011)