Specialized Workshop F2 - Friday April 16, 2027: 7am to 5pm - Discussion Topic List
"Gene, Cell, Vaccine Therapies Discovery, Development & Regulatory Approval - 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, Vaccine Therapies Discovery, Development & Regulatory Approval
Consensus & Conclusions on Gene, Cell, Vaccine Therapies Discovery, Development & Regulatory Approval for 2027 White Paper
Finale: ASK THE REGULATORS!
-
Panel Discussion with All the Regulators:
Have an Open Dialogue with the Regulators including US FDA, EU EMA, UK MHRA, Austria AGES/ EU EMA, Health Canada
Ask the Regulators any Questions You Have on Gene Therapy, Cell Therapy, and Vaccine and Hear Their Feedbacks on Submitted Studies and Inspections/Audits Outcomes