Encompassing the full spectrum of project management’s role and responsibility encountered in the pharmaceutical industry, Pharmaceutical Project Management outlines the key objectives, risks, and challenges of each stage of the pharmaceutical lifecycle, from discovery and preclinical phases through clinical development, manufacturing, registration, and launch.
New updated material includes:
- expert recommendations and informative articles on decision-making
- planning principles and planning systems
- management of subcontracted development
- manufacturing project management
- team leadership and skill sets
- drug development strategies
It covers primary project management objectives, functions, and descriptions of the nature and execution of work activities in a clear and reader-friendly format to illustrate key characteristics and objectives, assist managers in projecting the risks and challenges of each development option, and supply concise recommendations for successful project planning.
Table of Contents
Strategic Project Management. Strategic Portfolio Management. Project Management, Planning and Tracking-From Basic Concepts to Application. Discovery Project Management. Preclinical Project Management. Project Management of Chemistry, Manufacturing and Control. Clinical Project Management. Project Management of Registration and Product Launch. Life Cycle Project Management. Project Managing People and Teams. Project Management of Contracted Development. Training in Project Management
Tony Kenedy is Vice President of Development at Trigen, Ltd in London, U.K. Dr. Kennedy, a Medical Research Council Postdoctoral Research Fellow at The School of Pharmacy, London University, U.K., was awarded his Ph.D. by London University, U.K. and was previously the Global Head of Project Management at Roche, Switzerland. He was the editor of the first edition of Pharmaceutical Project Management which was published by Marcel Dekker in 1998, and his career has been devoted to the discovery and development of novel drugs while working in large pharmaceutical and small biotech companies. Dr. Kennedy has directed global drug development teams in several therapeutic areas including cardiovascular, gastrointestinal, infectious disease, rheumatology and oncology, and led the Roche-Gilead joint development team that took the flu antiviral Tamiflu to registration three years after the discovery of the molecule.
”This book is easy to read, contains a wealth of information of the ‘how-to’ variety and highlights many of the stumbling-blocks to efficient project management. It will help ‘novices’ prepare to manage their project meeting, and allow a ‘Well, at least I’m not the only one with that problem,’ companionship for the experienced project manager.”
---European Journal of Parenteral Sciences (for previous edition)
“. . .A major aspect of the book is of value for those either new to the pharmaceutical industry or newly assuming broader project responsibilities is the comprehensive discussion of the drug development process.”
---Journal of Controlled Release (for previous edition)