Project Management for Drug Developers (Drugs and the Pharmaceutical Sciences)

Dr. Joseph P. Stalder, Pharm.D., PMP, is the founder of Groundswell Pharma Consulting, based in San Diego, USA. Joe has worked in the biopharma industry for more than 20 years in both large and small companies, with 10 years of those years spent in project management. His experiences include PM department head, PMO head, and PM Lead on several late-stage development assets in oncology, infectious disease, cardiology, metabolism, and pulmonology. He received his Bachelor's degree in Pharmacology from the University of California, Santa Barbara, and his Doctor of Pharmacy program at the University of California, San Diego.

Project managers in drug development are the driving force behind the coordination of efforts. This book provides a practical reference for project managers in the pharmaceutical and biotech drug development industry, with the goal of assisting in creating an efficient and effective team structure and environment. The text details the role of project managers at each stage of drug development, the key interfaces that the PM will need to work closely with, and essential tools of the trade including frequently used techniques and methodologies. This book is useful for both entry-level and advanced-level PMs, as well as non-project managers from other functions.

Features

• Includes authors' recent experience with improved tactics and technologies/software at various stages of drug development.

• Provides the most up-to-date and best practices, techniques, and methodologies in project management.
  

• Details the role of the PM at each stage of drug development, including working with the key interfaces throughout the process.
  

• Diverse audience including nonproject managers in clinical development, clinical operations, regulatory affairs, medical affairs, clinical pharmacology, and biostatistics.
  
• Provides templates and timelines for critical paths from development to commercialization and has potential as a textbook on relevant courses.

In the face of relentless competition and evermore demanding expectations from regulators, patients, prescribers, and payers, the biopharmaceutical industry constantly strives for better, faster, and cheaper product development. But drug development is complex and risky, and the inevitable challenges that arise during the multi-year lab-to-launch process can only be overcome through careful coordination, collaboration, and communication. Hence the rise of the project management discipline in the industry over the last 30 years. Companies have realized the value that Project Management adds by converting complex strategies into actionable plans, and efficiently executing those plans across cross-functional boundaries. Project Management addresses several critical success factors for pharmaceutical product delivery (e.g., collaboration of multiple disciplines, coordination of business processes, communication across multiple stakeholders), and the unique combination of knowledge, skills, and behaviors that a Project Manager provides has become a crucial part of any drug development project.
There are several great books available about project management in the biopharmaceutical industry, but none focus specifically on the role of a Development Project Manager —- the ones who manage assets from first-in-human studies to submission of a market application. This book aims to address this audience, including both experienced drug developers who are looking to transition into project management and practicing PMs who are looking for best practices in managing clinical-stage assets.
We aimed for this book to be very practical, with modern tools, techniques, templates, and methodologies that are applicable to situations a Development PM is likely to encounter throughout the stages of drug development. In fact, when authoring the book, we set a standard of 20% theory and 80% practical. — just enough theory to make sense of the practice. We want the reader to be able to read a chapter and then apply what he/she learned the next day they go to the office.
We realize that no company is the same, and the expectations for each PM may differ slightly from company to company, and even from project to project. Nonetheless, drawing on experiences from over 30 biopharma companies — large and small, startup and mature, regional and international, small molecule, biologics, devices — we were able to agree on what we think are "best practices" that apply to most PMs. The output is a collection of examples and recommendations on how to address common challenges and capitalize on potential opportunities, regardless of the company or the project.
One caveat to the reader is that nomenclature is notoriously inconsistent between companies. What we may call a Core Team in this book may be called something else at your company. When we refer to the Safety department, it may be called Drug Safety Evaluation, Preclinical Operations, Toxicology, or some other variation. You may have to translate from our description to the term that is used in your company.
This book is organized into three parts. Part 1 sets a foundation of the drug development process and the role Project Managers play in drug development. Knowing that PMs work within the context of a project team and organizational management constructs, we highlight the interfaces that PMs have with team members, key business stakeholders, and governing bodies. A deep understanding of the drug development process and working ability to effectively manage these interfaces not only builds a PM's trust and credibility with the team, but also makes the PM's job easier because there will be fewer executional surprises to deal with.
Part 2 of this book dives deep into contemporary topics in drug development. These topics are being actively discussed within companies, at conferences, and in published articles, and there is no consensus on how they should be treated, nor will there ever be. What we present here is a synthesis of experiences into an aligned recommendation for how to address the issue in biopharma.
Part 3 of this book describes GRIDALL, a comprehensive framework for managing projects. After introducing the concept of GRIDALL and how it can be applied to biopharma, each chapter dives deep into the theory and practice of setting goals, managing risks, addressing issues, making decisions, taking action, and capturing lessons learned. This chapter has many tools and templates built in that can serve as a starting point for building a project management function in an organization or as an assessment tool to determine the completeness of an existing project management function.
If you've purchased this book, you already know the value that drug development companies bring to society in the form of improved health, longer lives, and happier living. What this book adds is that the consistent application of project management best practices will expedite the development of these important drugs so they can reach patients sooner. We hope that you will continue to carry the torch of progress in the field of project management so that our craft becomes more finely tuned and effective at delivering new medicines to the world.