Details

<p>Chapter 1: Introduction to Supply Chain Management</p> <p>Chapter 2: Introduction to Clinical Trials</p> <p>Chapter 3: Introduction to the Clinical Trial Supply Chain</p> <p>Chapter 4: Quality Considerations</p> <p>Chapter 5: Regulatory Considerations</p> <p>Chapter 6: RTSM and Its Role in the Clinical Supply Chain</p> <p>Chapter 7: Supply Chain Planning for Clinical Trials</p> <p>Chapter 8: Finished Product Demand Planning: Basic Concepts</p> <p>Chapter 9: Finished Product Supply Planning: The Production Plan</p> <p>Chapter 10: Finished Product Expiry Planning</p> <p>Chapter 11: Finished Product Supply Planning: The Distribution Plan</p> <p>Chapter 12: Upstream Supply Planning: Primary Packaging, Drug Product, and Drug Substance</p> <p>Chapter 13: Advanced Concepts in Demand and Supply Planning</p> <p>Chapter 14: Clinical Supply Chain Reports, Budgets, and Metrics</p> <p>Chapter 15: Clinical Supply Chain Planning Processes</p> <p>Chapter 16: A Week in the Life of a Clinical Planner</p> <p>Chapter 17: Comparator and Ancillary Planning</p> <p>Chapter 18: Make-to-Order and Just-in-Time Supply Chains in Clinical Trials</p> <p>Chapter 19: Direct-to-Patient Supply Chain Management</p> <p>Chapter 20: Contract Organization Management and Oversight</p> <p>Chapter 21: International Logistics for Clinical Biopharmaceutical Products</p> <p>Chapter 22: Clinical Supply Chain Planning Tools and Technology</p> <p>Chapter 23: Integrating the Clinical Supply Chain into a Commercial Launch</p> <p>Appendix: Clinical Supply Chain Planning Data Elements and Formulas</p> <p>Glossary</p> <p>Index</p>

<p><b>Ryan Mills, MBA,</b> 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.

<p><b>Ensure your clinical trial supply chain is running smoothly with this practical guide</b> <p>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. <p><i>Supply Chain Planning for Clinical Trials </i>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. <p><i>Supply Chain Planning for Clinical Trials </i>readers will also find: <ul><li>Tools for minimizing risk and expense by optimizing the relationship between supply and demand </li><li>Detailed discussion of topics including quality and regulatory considerations and the business processes that support clinical trial supply chain management </li><li>Spreadsheet-based models to illustrate key concepts, adaptable to the readers’ specific scenarios</li></ul> <p><i>Supply Chain Planning for Clinical Trails </i>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.

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