Reviewer: Rahmat M. Talukder, PhD, RPh (The University of Texas at Tyler)
Description: This book discusses the challenges and risks associated with pharmaceutical project management at various phases of drug development. This second edition adds information on outsourcing and drug development and teams and team leadership, among other topics.
Purpose: Successful completion of a project requires basic understanding of the planning, operation, and decision making process. The current trend in the pharmaceutical industry is to outsource at different stages of development, which sometimes poses greater challenges in terms of managing the project. Project management is a broad area; nevertheless, the authors have tried to cover the basics in this book. In that sense, it is a successful effort.
Audience: It is implicit that the book is aimed at pharmaceutical scientists and managers. There is no doubt that anyone involved with pharmaceutical product development will benefit. In addition, it will be a good reference for graduate students who want to work in the pharmaceutical industry. Both the editor and some of the authors are well known in the field of pharmaceutical product development. All have solid experience in project management, and they share their experience in this book, making this a good reference.
Features: The authors have tried to provide the basics on objectives, risks, and challenges in various phases of pharmaceutical product development and product lifecycle management. The book also offers discussions on strategic planning and tools, operational strategies, financial modeling, team responsibility, and leadership skills. Planning systems, optimizing plans, and establishing Gantt charts are also discussed. One of the key elements in any product development is cost containment and the current trend in pharmaceutical product development is to outsource at different stages. This environment has made it even more challenging to effectively manage projects and this book touches on the basics of addressing these challenges. Most notably, the authors share their experiences. One author details a "true story" of a project that failed essentially because of the project manager's lack of understanding of pharmaceutical product development and project management. There is some overlap of the topics in chapters. The book covers the basics of project management, but a more in-depth discussion would be more appropriate. For example, the constraints of planning and execution, estimation and allocation of human and material resources, quality management, and other issues could be briefly discussed. Because of the size of the book, some figures appeared crowded.
Assessment: This is a good reference for anyone interested in pharmaceutical product development and product lifecycle management. The authors provide informative discussions on various issues and challenges related to project management. Moreover, the authors share their experience in the book, which may provide a learning opportunity for readers. There are some shortcomings, e.g., figure quality is not great, the basics of project management could be discussed a greater detail, etc. Nevertheless, the book is relevant, as the current trend in pharmaceutical product development involves outsourcing, and the authors have tried to address issues associated with this kind of project management. This second edition comes out 10 years after the first edition and has some new material, e.g., management of projects that involved outsourcing, drug development strategies, manufacturing project management, etc., that are all relevant to current pharmaceutical project management.
