Considerations for Immunogenicity Risk Assessment and Mitigation and Bioanalytical Strategies for the Next Generation of Biologics Vibha Jawa, Ph.D. – Merck / Predictive and Clinical Immunogenicity / QP2, PPDM
9:30 AM - 10:00 AM
Applications of Computation Tools in Cell Therapy Cindy Xia, PhD – Takeda Pharmaceuticals International Co.
10:00 AM - 10:30 AM
Analysis of T-cell Vector Integration Sites for a Murine Gamma-Retroviral Vector encoding the Anti-CD19 Chimeric Antigen Receptor used in the Production of Axicabtagene Ciloleucel Joe Benoun
10:30 AM - 11:00 AM
Making Sense of Deep Sequencing: FDA Perspective Joshua Xu, PhD – U.S. Food and Drug Administration