Foreword xi
Preface xv
Acknowledgments xvii
Introduction 1
Setting a Transformative Agenda 1
What Should You Expect to Take Away from This Book? 2
Book Format 3
Who Should Benefit from Reading This Book? 5
Research Methodology 6
A Positive View of the Future 6
More Than a Generation of Change Will Be Required 7
References 7
Section I The Pharmaceutical Industry and Its Supply Chain 9
1 Industry Basics 11
Pharmaceutical Products 11
Industry Business Models and the Supply Chain 12
References 20
2 The Pharmaceutical Supply Chain 21
The End-to-end (E2E) Supply Chain in Perspective 21
Production Supply Chain: Small Molecule Products (Originator and Generic) 21
Production Supply Chain: Biologic Products (Originator and Biosimilar) 24
Production Supply Chain: Advanced Therapies—Autologous 30
References 36
3 Regulation of Pharmaceutical Products 39
Regulatory Authorities 39
Licensing Medicinal Products for Sale 40
Electronic Common Technical Document 41
Drug Development Programs 42
Regulatory Good Practices (GxP) 43
Expert Witness Statement: Alan Kennedy 48
Regulatory Modernization Initiatives 52
References 62
4 Evidence of Serious Supply Chain Problems Emerge 65
U.S. Government Accountability Office Sounds an Important Warning Bell 65
The Heparin Tragedy 67
FDA/Xavier University Co-sponsored Global Outsourcing Conference (GOC) 68
Governments and Regulatory Authorities Respond 71
References 78
5 Investigating Worrying Supply Chain Symptoms 81
Large Pharmaceutical Companies Outsource Their Assets 81
The Valley of Death Creates the Patent Cliff 85
Merger and Acquisition Becomes the Next Strategic Realignment 85
The Emergence of Biologics (eg Monoclonal Antibodies) 87
Commercial Potential of Recombinant DNA 88
What Is the Purpose of the Orphan Drug Act? 91
Value-based Pricing and HEOR Groups Emerge 92
Symptoms Transition to Deep Concerns 98
References 104
6 Impact of the Systems Dynamic on Supply Chain Performance 107
Circling Back to Professor Andrew Cox's Assessment 107
Supply Chain Underperformance Through the Development Process 108
Differences Between the Commercial and Clinical Supply Chain Challenges 112
Commercial Launch and Supply (and Phase IV—Clinical Trials After Launch) 115
7 The Outcome 119
Politicians Have Been Calling Out the Spiraling Price of Drugs 119
Wildly Varying Estimates of Drug Development Costs and Clinical Trial Failures 119
Generic Drugs Are Not Always the Same as the Originator’s 120
Animal Testing Is Still the Only Way 121
Me-too Drugs 122
Patient-centricity Is About Brands Not Cures 122
Counterfeit Drugs 123
Price Gouging 123
Is Big Pharma Becoming More Focused on the Patient These Days? 124
Does the Industry Overlook Side Effects? 124
Expert Witness Statement: Dr Ray Perkins 125
Do Genes Define Our Biological and Medical Destiny? 129
Of Missing Methods, Moldy Models, Mutated Mindsets, and Muddled Medications 131
To Ship or Not to Ship? That Is the Question 133
Basic Assumptions in the Pharmaceutical Industry 135
Impact of Basic Assumptions 138
An Expert Witness Statement: Professor Daniel Steenstra 138
What Is a Paradigm Shift? 139
References 141
Section II Managing the Supply Chain Strategically 143
8 Introduction to Socio-technical Systems 145
What is a System? 145
Closed and Open Systems 145
The Socio-technical System 147
Systems Complexity in the Supply Chain: Bullwhip Effect 153
Example of a High-performing Socio-technical (Production) System 154
References 155
9 Fundamentals of the Supply Chain 157
What Is a Supply Chain? 157
The Supply Chain in Modern Times 158
Three States in the Supply Chain 159
Reference 160
10 The Supply Chain and Competitive Edge 161
Supply Chains, Not Products, Compete 161
Linking Porter’s Value Chain Model to the Supply Chain System 164
Expert Witness Statement: Nick Rich, PhD, Professor in Operations Management, Business, at Swansea University 167
References 169
11 Core Disciplines of Supply Chain Management 171
Planning and Inventory Management 171
Strategic Procurement 189
Transport Logistics 197
References 209
12 Support Disciplines of Supply Chain Management 211
Information Systems (IS) and Information Technology (IT) 211
Industrial Improvement 219
Expert Witness—Javid Cheema 226
Leadership and Culture in the Supply Chain 239
References 255
Section III Transforming the Pharmaceutical Supply Chain 257
13 Shifting the Paradigm Gear 259
Why Change? 259
Underpinning Principles of the New Paradigm 261
Time to Switch on Your Imagination 263
Aviation as a Comparator with Pharmaceuticals 265
Redefining Basic Assumptions for the New Paradigm 266
References 268
14 Heuristic Methodology to Define the Transformation 269
Primary Analysis 270
Supporting Evidence 270
Small Molecule Product Supply Chain 270
Primary Analysis 270
Supporting Evidence 271
Confirmatory Supporting Evidence 273
Cimetidine—More Confirmatory Supporting Evidence 275
Biologic Product Supply Chain (Including Allogeneic Products) 279
Overview 283
Manufacturing Capability 283
References 284
15 Introducing the Pharmaceutical Production System 285
Drugs Are Physical Products 285
A New Model for Product Development 287
Adopting Production Systems Principles in Hospitals 291
References 293
16 Catalyst of Radical Change 295
The First Step 295
Criteria for Patentability: New and Useful Process 296
The Patent Came After the Process 296
What Is Compound Claims Patent Law? [2] 297
What Is the Purpose of Patent? 298
Compound Claims for New Molecules 299
Patent Law Moves Center Stage 300
Previous and Ongoing Patent Change Initiatives 300
References 304
17 Delivering the Transformation with Stakeholders Onboard 305
Returning to Purpose 305
What Can Key Stakeholders Do to Help? 310
Governments 310
Regulatory Authorities 313
Clinicians in the Healthcare System 314
Investors in Drug Development 315
Universities and Colleges 315
Patients 317
Key Stakeholder Groups Inside the Pharmaceutical Supply Chain 317
Engaging Pharmaceuticals in Supply Chain Management (SCM) 320
More than a Generation of Change Is Required 320
References 321
Appendices 323
Index 341
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