Michael Sadick

Company: Precision Biosciences

Job title: Senior Director, CMC Analytical Development

Seminars:

Resetting Expectations for CAR-T Potency Assessment… “Baby, You Can Drive My CAR” 2:30 pm

• ‘Full serial dilution curve’ bioassays have been difficult to establish for cell therapy modalities, but they provide critical assessment of potency/relative potency • Target cell cytotoxicity assays may well be more MOA reflective than cytokine release bioassays • This presentation will describe successful utilization of a luciferase-complementation-based cytotoxic assay (Promega HiBiT assay) • Application…Read more

day: Day Two

Panel Discussion: Assess Novel Technologies for Analytical Development 9:00 am

• Stress the need for higher throughput technologies, with less variability and greater user ease • Regulatory agency guidelines on the use of new technologies • Compare thoughts on ddPCR Vs qPCR … Elisa Vs Ella testingRead more

day: Day Two