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Informationen zum Autor 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. Klappentext "...[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. Zusammenfassung This book bridges the gap between practitioners of supply-chain management and pharmaceutical industry experts. It aims to help both these groups understand the different worlds they live in and how to jointly contribute to meaningful improvements in supply-chains within the globally important pharmaceutical sector. Scientific and technical staff must work closely with supply-chain practitioners and other relevant parties to help secure responsive, cost effective and risk mitigated supply chains to compete on a world stage. This should not wait until a drug has been registered, but should start as early as possible in the development process and before registration or clinical trials. The author suggests that CMC (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. Capable processes and suppliers, streamlined logistics, flexible plant and equipment, shorter cycle times, effective flow of information and reduced waste. All these factors can and should be addressed at the CMC development stage. Inhaltsverzeichnis 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 <...
