Joseph Lee

Company: Independent Expert

Job title: Senior Director

Seminars:

Analytics Supporting CMC Potency Activities in Cell Therapies – Current Challenges 10:00 am

• Discussing the rapidly changing expectations in analytical development activities supporting cell therapies – emphasis on potency • Exploring viral vs non-viral delivery – potency for both drug substance (intermediate) and drug product • Outlining key considerations for the development of potency assays for cell therapiesRead more

day: Conference Day One AM

Panel Discussion: Potency Assay Development Over the Development Lifecycle 4:30 pm

• Should we start potency assay development early? Or should we wait until clearer signals emerge later in subsequent phases  that a therapy is likely to be safe and efficacious?  • How do we translate early phase potency assays into late phase assays?  • At what stage do you begin to qualify and validate? Read more

day: Conference Day One - PM