Articles by Sue E. Steven, PhD - BioPharm International

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Articles by Sue E. Steven, PhD

Sue E. Steven, PhD


Senior Director, process research and development, at Genentech, Inc.

Articles
Devising an International Clinical Trial Distribution Strategy: Genentech's Approach
April 2, 2008

A decision-criteria matrix and cost models helped pinpoint the best distribution approach for the short- and long-term.

Process Development: Think Like a Scientist—Behave Like a Business
August 1, 2007

Understanding the end-to-end management of chemistry, manufacturing, and controls (CMC) resources provides the opportunity to enhance long-term planning, leverage development options, manage resource trade offs, and track progress against plans. The goal is to improve the pharmaceutical development process to deliver the pipeline. This article provides an overview of the organizational structure of Process Research and Development (PR&D) and the CMC teams at Genentech; the alignment of resources based on CMC contracts, process development activity maps and project resource plans; and the business economic analysis for evaluating development options.

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