Early Process Development: The Wyeth Approach

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.