SUPPLY CHAIN MANAGEMENT IN THE DRUG INDUSTRY -- CONTENTS -- CONTRIBUTORS -- PREFACE -- I SURVEYING AND MAPPING THE TERRITORY -- 1 Setting a Transformational Agenda -- 1.1 Aims and Aspirations of the Book -- 1.2 Book Format -- 1.3 Intended Readership -- 1.4 A Book About Two Worlds in Contrast -- 1.5 The Pharmaceutical Lottery -- 1.6 Supply Chain Management in Context -- 1.7 The History of Supply and Value Generation -- 1.8 The Development of Processes to Manage the Supply Chain -- 1.9 Life in SCM -- 1.10 Moving Forward -- 2 Plotting a Course to Patient Value -- 2.1 Why Focus on Patient Value? -- 2.2 Where Does the Patient Currently Fit? -- 2.3 Why Is It Necessary to Plot a Course? -- 2.4 Understanding How the Course Is Presently Set -- 2.5 Capturing Value for Patients -- 3 Pharmaceutical Drug Development -- 3.1 Drug Development's Role in the Supply Chain -- 3.2 Introduction to Drug Development -- 3.3 The Medicinal Product -- 3.4 Clinical Trials -- 3.5 Related Development Programs -- 3.6 Managing Clinical Programs -- 3.7 Regulatory Affairs and Authorities -- 3.8 Supply Chain Management in Development Programs -- 3.9 Manufacture and Supply of Commercial Products -- 3.10 Supply Chain Management for Commercial Products -- 4 End-to-End Pharmaceutical Supply Chains -- 4.1 Introduction -- 4.2 Where Does Responsibility for the Supply Chain Lay? -- 4.3 Sponsoring Companies, License Holders, and Their Supply Chains -- 4.4 Supply Chains for Small-Molecule Products -- 4.5 Starting at the Final Destination -- 4.6 How Drugs Enter the Body -- 4.7 Design of Drug Delivery Systems -- 4.8 What This Means for the Supply Chain -- 4.9 Key Aspects of GMP and GDP in Relation to SCM -- 4.10 Overview of the Stages on Route to Patient Delivery -- 4.11 Manufacture and Supply of Biological Entities -- 5 Why Pharma Supply Chains Don't Perform.

5.1 Supply Chain Underperformance -- 5.2 Is There a Case to Answer? -- 5.3 Birth to Infancy: The Supply Chain Critical Stage -- 5.4 Commercial Supply Under the Patent Protection Umbrella -- 5.5 What This Means for the Pharmaceutical Supply Chain -- II BUILDING A KNOWLEDGE FOUNDATION IN SCM -- 6 Supply Chain Management as a Competitive Weapon -- 6.1 Competition and Business Strategy -- 6.2 The Marketing Mix -- 6.3 Porter's Five Forces -- 6.4 Porter's Generic Competitive Strategies -- 6.5 Porter's Value Chain -- 6.6 Competitive Strategy and Customers -- 6.7 The Japanese Experience -- 6.8 Total Quality Management -- 6.9 Lean Thinking -- 6.10 Focusing on Value for Money -- 6.11 SCM Processes in Competitive Strategy -- 6.12 SCM in Biotech and Virtual Companies -- 6.13 Competition in Pharmaceuticals -- 7 Supply Chain Management Holistic -- 7.1 The Relevance of SCM to Pharmaceuticals -- 7.2 Production Systems and the SCM Holistic -- 7.3 The Core of SCM -- 7.4 First Principle of SCM -- 7.5 Supply Chains as a Series of Interconnected Systems -- 7.6 Processes to Manage the Supply Chain -- 7.7 A Word About Processes -- 7.8 How the SCM Processes Should Mesh Together -- 7.9 Production and Inventory Control -- 7.10 Strategic Procurement -- 7.11 Transportation, Storage, and Distribution -- 7.12 Information Systems and Technology -- 7.13 Improvement -- 8 Production and Inventory Control -- 8.1 Core Mission -- 8.2 First Principles of Production and Inventory Control -- 8.3 The Wholesome Trinity in P&IC -- 8.4 The Wholesome Trinity and Customer Expectations -- 8.5 Leveraging the Wholesome Trinity -- 8.6 The Impact of Variety on Supply Chains -- 8.7 Designing Appropriate Production Systems -- 9 Strategic Procurement -- 9.1 Core Mission -- 9.2 The Purchasing Portfolio -- 9.3 The Process of Procurement -- 9.4 Strategic Sourcing and Planning -- 9.5 Outsourcing.

9.6 Basic Principles in Contracting for Supply -- 9.7 Finally, Typical Organizational Tension over Procurement -- 10 Transportation, Storage, and Distribution -- 10.1 Defining the Core Mission -- 10.2 International Trade and Commerce -- 10.3 The World Trade Organization -- 10.4 Intermediary Arrangements -- 10.5 Terms of Trade: Incoterms -- 10.6 Ownership of Goods: Title -- 10.7 Third-Party Logistics Providers -- 10.8 Customs -- 10.9 Shipping Regulations Relating to Materials -- 10.10 A Finishing Note -- 11 Information Systems and Information Technology -- 11.1 Overview -- 11.2 Brief Lay History of Computer Systems Development -- 11.3 Important Perspectives on Information Systems -- 12 Improvement -- 12.1 Why Improve? -- 12.2 Improvement and Production Systems -- 12.3 The Improvement Journey -- 13 Bringing the Holistic Together -- 13.1 Setting the Scene -- 13.2 The Process Explained -- 13.3 Developing an Action Agenda -- 13.4 Case Study -- III PLANNING AND EXECUTING SUPPLY CHAIN CHANGE -- 14 Improvement in Pharmaceuticals -- 14.1 Where Are We Now? -- 14.2 Subsequent Developments Since Inception -- 14.3 A Blueprint for Quality by Design -- 15 Exemplar Thinking in Organizational Improvement -- 15.1 Where Are We Now? -- 15.2 What Is Meant by "Exemplar"? -- 15.3 A Dialogue on Exemplar Improvement -- 15.4 An Approach to SCM Based on Systems Thinking -- 16 Building a Foundation for Sustainable Change -- 16.1 Focus on the Individual -- 16.2 Individuals as Leaders -- 16.3 Individuals as Motivators and the Motivated -- 16.4 Individuals as Group Members -- 16.5 Individuals as Participants in Cultural Change -- 16.6 Case Study: Miles Ltd., Bridgend, Glamorgan -- 17 A Cure for the Pharmaceutical Supply Chain -- 17.1 What Is the Disease State? -- 17.2 What Is the Label Claim for the Medicine? -- 17.3 What Will Life Hold Without the Medicine?.

17.4 What Is This Better Way to Develop Drugs? -- 17.5 Full-Scale Production of Drugs -- 17.6 What Are the Barriers to Change? -- 17.7 What Are the Potential Benefits of Change? -- 17.8 Defining the Art of the Possible -- 17.9 Ending with the Beginning -- END NOTES -- INDEX.