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Efficient Project Management of Biopharmaceutical Development: Insuring On-time and Compliant Development Programs

Presented at: BIO Process Zone Theater, San Diego, CA June 17, 2008

The efficient and cost effective development and commercialization of biopharmaceutical products requires close coordination of numerous activities, including cell line generation, upstream and downstream process development, development of analytical methods for product characterization and release, identification of suitable formulations to ensure product stability, and manufacture of clinical trial supplies. In many cases some or all of these activities are outsourced to external service providers to insure timely completion of all tasks. In order to provide the proper management of all internal and external CMC activities and to ensure seamless coordination of these technical activities with regulatory filings, effective project management tools must be used. Project management tools that can help identify critical path items, ensure proper allocation of resources, and orchestrate the interplay and dependencies of wide ranging CMC activities with pre-clinical and clinical activities to maximize the probability of successful product development are presented.