Pharmaceutical and Biomedical Project Management in a Changing Global Environment (Wiley Series on Technologies for the Pharmaceutical Industry)


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Pharmaceutical and Biomedical Portfolio Management in a Changing Global Environment explores some of the critical forces at work today in the complex endeavour of pharmaceutical and medical product development. Written by experienced professionals, and including real-world approaches and best practice examples, this new title addresses three key areas � small molecules, large molecules, and medical devices - and provides hard-to-find, consolidated information relevant to and needed by pharmaceutical, biotech, and medical device company managers.Pharmaceutical and Biomedical Project Management in a Changing Global Environment (Wiley Series on Technologies for the Pharmaceutical Industry) Review
Project management in Pharma and Biotech has its own unique challenges. There is a host of regulatory, fda, iso, etc style issues that are unique to these types of projects. As a disclosure, I am not a project manager, but I am a stakeholder in biotechnology product development projects. I work on the product management/marketing and operations side of these types of products so I am very familiar with the unique challenges of bringing these types of products to market. This book would serve as an overview for someone in project management but would be a very good guide to a project manager who was moving from one aspect of biomedical project management to another (for example, from drug development to in vitro diagnostics). This would also be a very good guide to someone who is a stakeholder in these types of projects because it would provide a good overview of whats at stake on a systems level (because it is very easy to get lost in the weeds).The authors put a lot of emphasis on the importance of viewing the project on a systems level instead of as a collection of individual contributions (or silos). This is a critical point to keep in mind, one problem with these types of projects is that one groups metrics may not always be in line with what is best for the system as a whole (a reliance on cost cutting measures for procurement may be disastrous for quality management downstream) or people fail to see the forest for the trees. The role of stakeholders is discussed as is the importance of product concept design (distinguishing the must haves from the nice-to-have features of a new product) and risk assessment. There are chapters devoted to specific types of projects:
in vitro diagnostics
drug development (both for profit and non for profit)
strategic alliances
outsourcing and managing contract manufacturers (and a very good case study)
technology transfers
international team management
clinical trial management
setting a plan for managing through the product lifecycle
regulatory strategies for international projects
The book finishes with a section devoted to portfolio management which includes managing R&D pipelines, stage gating, and resource management. This book does a good job of providing an overview of all the basics. It was written by professionals from within the various industries covered. This book will not "teach" you project management in these industries, it provides a useful set of guidelines and examples. I would definitely recommend this book to anyone who is seeking a more in-depth understanding of bringing pharma or biomedical products to market.
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