Pharmaceutical and Biomedical Project Management in a Changing Global Environment (Wiley Series on Technologies for the Pharmaceutical Industry, Band 8) - Hardcover

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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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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.

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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.