Transforming the Pharmaceutical Supply Chain

1. Auflage 2025
ISBN: 978-1-394-24412-6
Verlag: Wiley

Buch, Englisch, 336 Seiten

Effective and insightful solutions to the most pressing supply chain challenges facing pharmaceutical companies today

In Transforming the Pharmaceutical Supply Chain, veteran biotech supply chain strategist, Hedley Rees, delivers a reasoned and systematic solution to the most widespread and relevant challenges in the pharmaceutical supply chain. The book explains the deeply rooted issues within pharma supply chains and the modus operandi of the industry while also discussing effective solutions to the underlying causes that led to widespread system breakdown.

The author applies modern methods of product development and commercial supply successfully used by leaders in the field. He provides real-world examples of ways to make the delivery of medicines to patients efficient and effective.

Readers will also find: - A clear explanation of the development, manufacture, and delivery of drugs to patients
- Comprehensive explorations of the issues and challenges to the current supply chain system paired with effective solutions
- Expert witness accounts, anecdotes, case studies and examples of pharmaceutical supply chain difficulties and solutions
- Complete treatments of how to adapt supply chain techniques to a pharmaceutical era dominated by biologics and advanced therapies

Perfect for pharmaceutical and biopharmaceutical professionals working in drug development, Transforming the Pharmaceutical Supply Chain will also benefit industry professionals with a responsibility for the logistics, commercial supply, manufacturing, regulation, quality management, finance, and marketing of pharmaceuticals.

Autoren/Hrsg.

Rees, Hedley

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Public Health, Gesundheitsmanagement, Gesundheitsökonomie, Gesundheitspolitik
• Naturwissenschaften Chemie Chemie Allgemein Pharmazeutische Chemie, Medizinische Chemie
• Wirtschaftswissenschaften Betriebswirtschaft Bereichsspezifisches Management Produktionsmanagement, Qualitätskontrolle

Inhaltsverzeichnis

Contents

Transforming the Pharmaceutical Supply Chain. 1

Foreword. 5

Preface. 8

Introduction. 11

Setting a Transformative Agenda. 11

What should you expect to take away from this book?. 11

Book Format 12

Who should benefit from reading this book?. 14

Research Methodology. 15

A Positive View of the Future. 15

More than a generation of change will be required. 15

The Pharmaceutical Industry and its Supply Chain. 17

1 Industry Basics. 18

Pharmaceutical products. 18

Industry Business Models. 19

2 The Pharmaceutical Supply Chain. 24

3 Regulation of Pharmaceutical Products. 36

Regulatory Authorities. 36

Regulatory Modernization Initiatives. 47

4 Evidence of Serious Supply Chain Problems Emerge. 56

US GAO Sounds an Important Warning Bell 56

5 Investigating Worrying Supply Chain Symptoms. 67

Large Pharmaceutical Companies Outsource their Assets. 67

Symptoms Transition to Deep Concerns. 79

6 Impact of the Systems Dynamic on Supply Chain Performance. 86

7 The Outcome. 93

Basic assumptions in the Pharmaceutical Industry. 106

Section II: Managing the Supply Chain Strategically. 112

8 Introduction to Socio-technical Systems. 113

Closed and open systems. 113

The Socio-technical System. 114

Systems Complexity in the Supply Chain: Bullwhip Effect 119

9 Fundamentals of the Supply Chain. 122

What is a Supply Chain?. 122

The Supply Chain in Modern Times 122

Three States in the Supply Chain. 123

10 The Supply Chain and Competitive Edge. 125

Supply Chains, not Products, Compete. 125

11 Core Disciplines of Supply Chain Management 132

Planning & Inventory Management (PIM) 132

Strategic Procurement 146

Transport Logistics. 153

12 Support Disciplines of Supply Chain Management 163

Information systems (IS) and information technology (IT) 163

Industrial Improvement 170

Leadership and Culture in the Supply Chain. 186

Section III: Transforming the Pharmaceutical Supply Chain. 200

13 Shifting the Paradigm Gear 201

Why change?. 201

Facing reality. 201

14 Heuristic Methodology to Define the Transformation. 209

15 Introducing the Pharmaceutical Production System. 222

A new model for product development 223

16 Catalyst of Radical Change. 228

The First Step. 228

17 Delivering the Transformation with Stakeholders Onboard. 236

Returning to Purpose. 236

What can key stakeholders do to help?. 240

Governments. 240

Regulatory Authorities. 242

APPENDICES. 249

Über Autor(innen)

Hedley Rees, PhD, is Managing Consultant at PharmaFlow Ltd. He has 25 years' experience in the biotech industry, advising drug developers in the strategic management of their preclinical, clinical, and commercial supply chains. He is the author of Supply Chain Management in the Drug Industry: Delivering Patient Value for Pharmaceuticals and Biologics.