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Informationen zum Autor Ryan Mills, MBA, is Senior Director and Head of Supply Chain for Denali Therapeutics, South San Francisco, CA. He has over 15 years of experience in pharmaceutical and biotechnology production, and his background in supply chain planning has involved some of the highest-performing companies in the world. Klappentext Ensure your clinical trial supply chain is running smoothly with this practical guide Clinical trials are a critical part of the pharmaceutical development process. These trials cannot proceed without timely and regular receipt of the drugs being tested, which can prove a challenge for drug manufacturers who have not yet established the structures required to produce quality-controlled specimens of the drug at scale. Managing supply chains of pre-production drugs for clinical trials is therefore an essential component of drug development. Supply Chain Planning for Clinical Trials offers a practical introduction to this process for researchers and industry professionals. Beginning with the basics of clinical trial supply chain management, it proceeds step by step through all aspects of demand and supply planning for clinical trials. The result is a thorough overview that also offers practical examples of how to plan supply for clinical trials. Supply Chain Planning for Clinical Trials readers will also find: Tools for minimizing risk and expense by optimizing the relationship between supply and demand Detailed discussion of topics including quality and regulatory considerations and the business processes that support clinical trial supply chain management Spreadsheet-based models to illustrate key concepts, adaptable to the readers' specific scenarios Supply Chain Planning for Clinical Trails is ideal for pharmaceutical industry professionals involved in clinical trial supply planning, as well as academics and researchers interested in the pharmaceutical industry and its logistics. Inhaltsverzeichnis Preface xiii Acknowledgments xvii 1 Supply Chain Management 1 1.1 Supply Chain Management 1 1.2 Plan 3 1.3 Source 6 1.4 Make 8 1.5 Deliver/Return 11 1.6 Data, Analytics, and Metrics 12 1.7 The People-Process-Technology Framework 16 1.8 Key Takeaways 16 Notes 17 2 Introduction to Clinical Trials 19 2.1 Introduction to Clinical Trials 19 2.2 A Conversation About Clinical Trials 19 2.3 Intrinsic Elements of a Clinical Trial 23 2.4 Extrinsic Elements of a Clinical Trial 26 2.5 Preclinical Drug Development 27 2.6 The Clinical Development Plan 28 2.7 Phase I Clinical Trials 29 2.8 Clinical Pharmacology Trials 30 2.9 Phase II and III Clinical Trials 31 2.10 Adaptive Trials 32 2.11 Master Protocol Designs - Platform, Basket, and Umbrella Trials 32 2.12 Decentralized Clinical Trials 33 2.13 Post-marketing Clinical Trials 34 2.14 Clinical Trial Stakeholder Summary 34 2.15 Trends in Clinical Trial Design and Conduct 36 2.16 Key Takeaways 37 Notes 38 3 Introduction to the Clinical Trial Supply Chain 39 3.1 Introduction to the Clinical Trial Supply Chain 39 3.2 Drug Modalities 40 3.3 Starting Materials and Drug Substance 43 3.4 Drug Product 44 3.5 Analytical Development and Characterization 45 3.6 Manufacturing Process Development 48 3.7 Packaging 49 3.8 Labeling 51 3.9 Distribution 53 3.10 Clinical Trial Supply Chain Summary 54 3.11 CMC Development and Manufacturing Strategy 55 3.12 CMC Stakeholder Summary 57 3.13 Trends in Clinical Manufacturing and Supply Chain Management 61 3.14 Key Takeaways 62 Notes 63 4 Quality Considerations 65 4.1 What Is Quality? 65 4.2 Goo...
