Specialized Workshop F2 - Friday April 11, 2025: 7am to 5:30pm
" AGENDA -
Gene, Cell, and Vaccine Therapies Immunogenicity & Technologies
- Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders "
| 07:00am-08:00am: |
Start your day at WRIB with Continental Breakfast |
Session 1: Current Thinking on Immunogenicity Risk Assessment & Mitigation for Gene, Cell and Vaccine Therapies
Session 2: Cell Therapy & Vaccine Immunogenicity Assays: Lesson Learned and Recent Regulatory Guidelines
Special Session: ASK THE REGULATORS! Interactive Panel Discussion with All 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 CBER)
- Dr. Vijaya Simhadri (US FDA CBER)
- Ms. Leslie Wagner (US FDA CBER)
- Dr. Joshua Xu (US FDA NCTR)
- Dr. Alessandra Buoninfante (EU EMA)
- Mr. Christian Mayer (Austria AGES / EU EMA)
- Dr. Shirley Hopper (UK MHRA)
- Dr. Meenu Wadhwa (UK MHRA)
- Dr. Sandra Diebold (UK MHRA)
- Dr. Sandra Prior (UK MHRA)
- Dr. Omar Tounekti (Health Canada)
- Dr. Sarah Wassmer (Health Canada)
- Dr. Chad Irwin (Health Canada)
- Dr. Julie Joseph (Health Canada)
- Dr. Adrian Wong (Health Canada)
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Session 3: NGS/Genomic Assays in a Regulated Environment: Cell Therapy, CRISPR Gene Editing and FFPE Sample Analysis
Session 4: PCR Sophisticated Applications for Diagnostic, Dengue Detection and mRNA Quantification
Session 5: 2025 White Paper in Bioanalysis
| 07:40pm-08:40pm: |
"Recommendations on Gene Therapy, Cell Therapy, and Vaccine and Panel Discussions for 2025 White Paper in Bioanalysis"
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