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.
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A best practices guide to bringing new pharmaceutical or biomedical innovations to market
With stringent requirements for quality and patient safety, developing biomedical products is one of the toughest commercial endeavors a company can undertake. Companies continually strive to accelerate new product introductions by reducing development time. However, the best technologies and product concepts cannot reach patients without effective resource management planning for delivering results.
With contributions from experts in the pharmaceutical, medical device, and biotechnology industries, this multidisciplinary guide to project management offers solutions to the problems faced when bringing a highly technical and regulated product to the marketplace. Chapter-by-chapter, the book addresses the following topics:
Project leadership in the biomedical industry
The role of project management throughout the product lifecycle
Clinical trials and project management
Project management in drug and device development
Managing product risk
Building alliances
Technology transfer
Challenges in an international environment
For any life sciences professional facing these daily realities, this indispensable reference is the key to maximizing resources, keeping costs and schedules in check, and transforming an idea into a safe, effective, and successful product.
SCOTT D. BABLER is a Senior Project Manager at Integrated Project Management Company, Inc. (IPM). He has worked with organizations of all sizes to successfully apply core project management practices to the dynamic life sciences and medical device environment. He has led multi-functional project teams in technology, design, development, quality, regulatory and manufacturing.
Integrated Project Management Company, Inc. (IPM) is a leading provider of onsite project management services for the life sciences industry. Since 1988, IPM has pioneered the application of excellence in project management best practices to consistently drive measurable results for their clients. Areas of expertise include product development, alliance management, business process improvement, technology transfer, and regulatory/quality compliance. IPM has offices in Boston, Chicago, St. Louis, and San Francisco.
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