John Wiley & Sons Supply Chain Planning for Clinical Trials Cover Ensure your clinical trial supply chain is running smoothly with this practical guide Clinical tria.. Product #: 978-1-394-17955-8 Regular price: $139.25 $139.25 In Stock

Supply Chain Planning for Clinical Trials

A Practical Guide

Mills, Ryan

Cover

1. Edition June 2024
496 Pages, Softcover
Wiley & Sons Ltd

ISBN: 978-1-394-17955-8
John Wiley & Sons

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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.

Chapter 1: Introduction to Supply Chain Management

Chapter 2: Introduction to Clinical Trials

Chapter 3: Introduction to the Clinical Trial Supply Chain

Chapter 4: Quality Considerations

Chapter 5: Regulatory Considerations

Chapter 6: RTSM and Its Role in the Clinical Supply Chain

Chapter 7: Supply Chain Planning for Clinical Trials

Chapter 8: Finished Product Demand Planning: Basic Concepts

Chapter 9: Finished Product Supply Planning: The Production Plan

Chapter 10: Finished Product Expiry Planning

Chapter 11: Finished Product Supply Planning: The Distribution Plan

Chapter 12: Upstream Supply Planning: Primary Packaging, Drug Product, and Drug Substance

Chapter 13: Advanced Concepts in Demand and Supply Planning

Chapter 14: Clinical Supply Chain Reports, Budgets, and Metrics

Chapter 15: Clinical Supply Chain Planning Processes

Chapter 16: A Week in the Life of a Clinical Planner

Chapter 17: Comparator and Ancillary Planning

Chapter 18: Make-to-Order and Just-in-Time Supply Chains in Clinical Trials

Chapter 19: Direct-to-Patient Supply Chain Management

Chapter 20: Contract Organization Management and Oversight

Chapter 21: International Logistics for Clinical Biopharmaceutical Products

Chapter 22: Clinical Supply Chain Planning Tools and Technology

Chapter 23: Integrating the Clinical Supply Chain into a Commercial Launch

Appendix: Clinical Supply Chain Planning Data Elements and Formulas

Glossary

Index
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.

R. Mills, Denali Therapeutics, South San Francisco, CA