
Early Process Development: The Wyeth Approach
Author(s) -
Michael O’Brien,
Michael Kolb,
Karen Sutherland,
Kevin M. McCoy,
Anthony S. Pilcher
Publication year - 2006
Publication title -
chimia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.387
H-Index - 55
eISSN - 2673-2424
pISSN - 0009-4293
DOI - 10.2533/chimia.2006.518
Subject(s) - context (archaeology) , productivity , process (computing) , phase (matter) , process management , computer science , operations management , biochemical engineering , process engineering , business , chemistry , engineering , history , economics , archaeology , economic growth , organic chemistry , operating system
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.