Preface

Welcome to the exciting, dynamic, and complex world of clinical trial supply chain management! If you’re reading this book, there is a good chance you’re responsible for managing some aspect of the clinical trial supply chain or are interested in learning how to do so. Congratulations, you’ve made an excellent career choice. This work is deeply impactful as the decisions made by clinical supply chain planners directly impact millions of clinical trial participants around the world who need access to cutting‐edge therapies. Your work contributes to extending and saving lives on a grand scale.

The top priority of this job is to ensure that every person who enters a clinical trial receives the drug they’re expecting when they expect to receive it. Theoretically, producing the right amount of drug for a clinical trial should be easy. The total amount of drug required to service a clinical trial is known because the clinical protocol prescribes the number of subjects who will enroll and how much drug each subject will take over the duration of the trial. Multiply these two variables and we have our supply requirement for the trial. In a world of unlimited resources, we could simply make double or triple that amount of drug, and we’d have more than enough to supply the trial. I’ve seen that strategy employed in my past!

But we don’t live in a world of unlimited resources. This is particularly true for the burgeoning class of pre‐commercial biopharmaceutical and cell therapy companies for whom every dollar is precious. Supply chain management gives us the tools to develop an optimal supply plan that adequately supplies the trial while also minimizing the amount of money it takes to do so. Across the industry, there has been increasing recognition that effective supply chain management is a potential gold mine of savings for a company. One large‐molecule drug substance batch costs anywhere between $2 and 5M, enough to fund a Phase I study (or two) on its own! Meanwhile, a 2016 study showed that drug companies waste almost half of the clinical trial supply they produce.1 More recent data suggests that the number may be as high as a staggering 75%.2

Combatting this waste epidemic starts with better supply chain planning. The word planning has a specific definition in the supply chain lexicon. It is the process of optimizing the manufacture and delivery of goods by balancing supply and demand. When supply is balanced with demand, the consumer gets what they expect, when they expect it, and waste and costs are minimized throughout the supply chain. Simply put, better planning leads to better outcomes.

That’s why I decided to write this book. I’ve worked in clinical supply chain management for over 15 years, partnering with hundreds of dedicated, talented colleagues who are committed to eradicating disease and improving lives. Many people who work in the biopharmaceutical sector have received extensive training in their area of expertise. Doctors, chemists, biologists, and pharmacologists all have degrees that underpin their day‐to‐day work. However, when you look at the backgrounds of people who work in biopharmaceutical supply chain management, you’ll often find a hodgepodge of degrees and backgrounds. While some people do have formal business training via business school or have past experience in logistics or a related discipline, many don’t. And even amongst those with a specialized degree, their exposure to the nuances of clinical trials is often limited. This means that most people walking into a clinical supply chain role have never been trained or had exposure to a clinical trial supply chain. Even for those of us who do have formal training in business and supply chain management, we’ve had to relearn much of what we were taught in the classroom because the practical application differs so much from the theoretical concept in the world of clinical trials.

This is because supply chain planning for clinical trials is fundamentally different from managing a commercially available good that can be purchased at your local grocery store. The demand forecast is built on a completely unique set of assumptions. Supply planning requires an understanding of not only the manufacturing steps in the process but also the quality standards and regulatory requirements of the biopharmaceutical space. Throw in relatively short expiry periods, a heaping dose of stakeholder complexity, and enormous costs, and you’ve developed a recipe where newcomers to clinical trial supply chain management are often lost and must learn their job the hard way – through trial and error.

This book aims to put a stake in the ground for clinical trial supply chain planning. You’ve probably heard the phrase “proper planning prevents poor performance,” and nowhere is that truer than for clinical trials. There are so many variables in play that can impact supply availability; it takes a trained professional to understand what to do, when to do it, how to do it, and who to work with to make sure it’s all done properly.

Unfortunately, there isn’t one “right” way to do this. Every biopharmaceutical company, every product, and every clinical trial is unique and has its own set of considerations and challenges. But there are a set of guiding principles and concepts that every clinical planner needs to be aware of and understand. This book attempts to lay those out in a way that’s approachable for someone who is entirely new to supply chain management or to clinical trials. Please understand that the content here isn’t designed to cover every possible approach, strategy, or scenario. The space is too complex and moves too fast for that, and even an encyclopedia wouldn’t have enough room to contain it all. The broad strokes are here though, and a good bit of detail, too.

While this book spends a majority of its time on supply chain planning in the traditional context, there is much more to discuss than just demand and supply planning. To reach the broadest audience possible, the book is laid out in three sections:

• Clinical Supply Chain Foundations: Chapters 1–6 are intended for the audience who has never been formally trained in supply chain management or worked on a clinical trial before. These chapters introduce the reader to general supply chain management, clinical trial design, the pharmaceutical supply chain, how quality impacts the clinical trial supply chain, regulatory considerations, and the randomization and trial supply management technology. The intent of these chapters is not to cover every potential topic in detail but rather to provide a broad introduction of the concepts that are most relevant and important for supply chain planning.
• Supply Chain Planning for Clinical Trials: Chapters 7–19 comprise the majority of the text and offer a deep dive into the world of supply chain planning for clinical trials. Beginning with an overview of the objectives and elements of demand and supply planning, this section walks the reader through the supply chain planning process in a step‐by‐step fashion. Demand forecasting, finished product supply planning, finished product distribution planning, expiry planning, and upstream drug substance and drug product planning are all covered in extensive detail. More advanced concepts like aggregate forecasting, attrition, SKU‐switching, and low case‐high case planning are also given attention. Supply chain planning in this space is about much more than just the mechanics of creating and maintaining a plan though. It’s also about effectively using data to monitor and communicate supply chain performance. And effective business process design and implementation are necessary to get information to the clinical planner and to supply outputs to the stakeholders who need to act on the plan. We’ll cover all of these points in this section as well. Special note should be made of Chapter 16, which takes the reader through a day in the life of a clinical planner and provides insight into what makes the job both tremendously exciting and equally challenging. Chapters 17–19 introduce nontraditional clinical trial supply chains including comparators, just‐in‐time supply chains, and direct‐to‐patient supply chains and talk about supply chain considerations holistically from both a planning perspective and an operational perspective.
• Additional Clinical Supply Chain Considerations: Chapters 20–23 conclude our journey by touching on other aspects of clinical trial supply chain management that influence supply chain planning specifically. Contract manufacturing and logistics are two fundamental areas of the clinical trial supply chain, and planners who are familiar with the intricacies of these spaces tend to produce better plans. It’s also impossible to conclude a review of supply chain planning without touching on the tools and technology that clinical planners use to create and maintain their plans. We conclude with a review of the final step of the clinical development process, commercialization, and how to integrate the clinical and commercial supply chains within an organization.

There is also an appendix that catalogues the data elements and equations used in the supply chain planning process, and a glossary that catalogues the definition of key terms, of which there are many. Every chapter concludes with a summary of key takeaways for the reader to consider. More...