Early chemical development at Legacy Wyeth Research.

This article describes an approach to early process development in the context of the productivity model in legacy Wyeth (i.e. to deliver two New Drug Applications per year for New Molecular Entities). As a result of the model, the cycle time from lead selection to phase I decreased and the number of compounds in early development increased. In response, Wyeth Chemical Development devised a resource-neutral approach to early process development, which is described here. This model harvested synergies from integrating advanced technologies and aggressive sourcing with a matrix research organization and efficient ways of working. It provided a model that met the business needs of our former organization while ensuring the timely delivery of high-quality active pharmaceutical ingredients and safe, scalable processes.