(413a) Technology Roadmap: Context and Drivers for Roadmap Development

This presentation will discuss the current context within which the pharmaceutical industry must operate, including the regulatory environment and economic drivers. The critical role of product development and manufacturing as identified by the FDA will be summarized and the possible gains in reduction of development time and cost will presented. The societal drivers for new technologies and methodologies will be reviewed.These elements serve to define the big picture within which new technology development must be viewed.