Bioanalytics
Jim McNally, PhD
Chief Scientific Officer
BioAgilytix
Durham, North Carolina
Description: Technology platforms not typically used for regulated bioanalysis are being used more frequently to support cell and gene therapy programs. Flow cytometry, ELISpot, and quantitative PCR are all tools being leveraged to assess exposure, durability, immunogenicity and function of these novel modalities. In this talk, we'll discuss their utilization and current thoughts around expectations for performance characteristics in the regulated space.