Workshop A – Developing an Analytical Genotoxicity Package: From Preclinical Development Through Drug Product Release & Beyond
Time: 9:00 am
day: Pre-Conference Day
A new generation of gene modified TIL therapy is on the horizon for patients, with genome editing approaches now being commonly employed as means to enhance TIL activity and persistence in the hostile microenvironment of solid tumors. Since genome editing may increase genotoxicity risk, and due to the importance of complying with an evolving regulatory landscape, the development of new assays and criteria to address such concerns becomes increasingly important.
Join this collaborative session to:
• Understand the requirements for a pre-clinical data package on genotoxicity
• Outline analytical methods to address genotoxicity concerns
• Discuss setting release criteria on genotoxicity parameters