Specialized Workshop F2 - Friday April 17, 2026: 7am to 5pm
"AGENDA - Gene, Cell, and Vaccine Therapies Immunogenicity & Technologies
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| 07:00am-08:00am: |
Start your day at WRIB with Continental Breakfast |
Session 1: Lipid Nanoparticle (LNP) Delivery System: in vitro Models, Redosing, Immunogenicity
Session 2: Next Generation Cell Therapy: Immunogenicity/Clinical Relevance & Bioanalytical Considerations
Special Session: ASK THE REGULATORS!
| -07:40pm: |
Regulatory Feedbacks on Submitted Studies and Inspection/Audit Outcomes on Gene Therapy, Cell Therapy & Vaccines
Regulatory Panelists:
- Dr. Zuben Sauna (US FDA)
- Ms. Leslie Wagner (US FDA)
- Dr. Wojciech Jankowski (US FDA)
- Dr. Binsheng Gong (US FDA )
- Dr. Wenming Xiao (US FDA)
- Dr. Alessandra Buoninfante (EU EMA)
- Mr. Christian Mayer (Austria AGES / EU EMA)
- Dr. Claire Kerridge (UK MHRA)
- Dr. Anna Nowocin (UK MHRA)
- Dr. Sandra Prior (UK MHRA)
- Dr. Omar Tounekti (Health Canada)
- Dr. Sarah Wassmer (Health Canada)
- Dr. Chad Irwin (Health Canada)
- Dr. Bradley Scott (Health Canada)
- Dr. Adrian Wong (Health Canada)
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Session 3: Recent Advances in Bioanalytical Molecular Assays: PCR & NGS
Session 4: Lesson Learned on Anti-Transgene Protein Immune Response & Preexisting Anti-AAV Threshold
Session 5: 2026 White Paper in Bioanalysis
| 07:40pm-08:20pm: |
"Recommendations on Gene Therapy, Cell Therapy, and Vaccine and Panel Discussions for 2026 White Paper in Bioanalysis"
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