Early Process Development: The Wyeth Approach

Abstract

The paper describes our approach to early process development in the context of the new Wyeth productivity model to deliver two New molecular entities every year. As a consequence, the number of compounds in Predevelopment and Phase 0 increased fourfold, the cycle time from Discovery to the IND was shortened by 6 months, and the quantities for the Phase-0 batch increased to include Phase I supply. our new way of working to meet this paradigm without a major increase in headcount is delineated in this article.

Keywords

• Development
• Process
• Scale-up
• Strategy