A penny today or a dollar tomorrow – early stage development for future success
January 15-19, 2017
Too often left until deep in clinical trial territory, planning for commercial manufacture of cell and gene therapies ideally starts on the day that the product is conceptualized. Making the right decisions early can not only smooth the path through clinical development to market, but result in substantial time and money savings even in the early stages. Conversely, waiting too long can have dramatic down-side consequences, particularly if major process changes are required, or supply chain/logistics challenges are encountered. This presentation will examine some of the early questions to ask and decisions to be made in order establish a solid platform for future success, discussing how industrial manufacturing principles and quality-by-design concepts can guide the transition from method to manufacturing for cell and gene therapies.
Nick Timmins, "A penny today or a dollar tomorrow – early stage development for future success" in "Scale-up and Manufacturing of Cell-based Therapies V", Tom Brieva, Celgene Cellular Therapeutics William Miller, Northwestern University Chris Mason, University College London Eds, ECI Symposium Series, (2017). http://dc.engconfintl.org/cellbasedtherapies_v/76