Specialized Workshop F2 - Friday April 16, 2027: 7am to 5pm - Discussion Topic List

"Gene, Cell, and Vaccine Therapies Immunogenicity & Technologies - Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders"


Session 1: Current Challenges in Assessing Preexisting Antibodies: Novel Capsid / AAV Serotypes, Route of Administration, NAb/TAb Correlation

Session 2: Continue Developments of Molecular Assays: NGS, PCR, Whole Genome Sequencing

Session 3: Advances in Monitoring RNA Therapies Immunogenicity

Session 4: Latest Insights on Bioanalytical Strategies for Oncology Therapies – Next-generation CAR-T & Personalized Cancer Vaccines

Session 5: 2027 White Paper in Bioanalysis

  • 2027 White Paper on Gene, Cell, and Vaccine Therapies Immunogenicity & Technologies

    Consensus & Conclusions on Gene, Cell, and Vaccine Therapies Immunogenicity & Technologies for 2027 White Paper

Session Finale: ASK THE REGULATORS! Interactive Panel Discussion with All the Regulators

  • Regulatory Feedbacks on Submitted Studies and Inspection/Audit Outcomes on Gene Therapy, Cell Therapy & Vaccines

    Regulatory Panelists: