" Gene, Cell, and Vaccine Therapies Immunogenicity & Technologies - Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders"
Recent Advances in the Immunogenicity of Gene/Cell/Vaccine Therapies Based on Lesson Learned from Regulatory Submissions; Advice on Putting Together the Integrated Summary of Immunogenicity (ISI) and Challenges in Applying the Current Paradigm for Immunogenicity Testing for Gene & Cell Therapies; Immunogenicity Assessment & Clinical Relevance with Focus on Regulatory Feedback on TAb/NAb Assays; Progress in the Development and Characterization of Next Generation CAR-T; Latest Updates on the Wide Applications of Next-Generation Sequencing (NGS) and Nanostring in Bioanalysis and How Bioanalytical Labs are Handling the Method Development and Validation for NGS and Nanostring; Novel Case Studies and Challenges in the Expanded Application of qPCR, dPCR and ddPCR Assays for Genetic Multiplexing, Transgene and Target Gene Expression; Understanding & Misunderstanding in qPCR/ddPCR Cross-Validation & Data Comparability; AND LASTLY, WRIB Traditional KOL Industry/Regulators Focused and Highly Interactive Panel Discussions on Discovery/Regulated Gene, Cell, and Vaccine Therapies Immunogenicity & Technologies Applications and Recent Controversial Issues
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
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: 2024 White Paper in Bioanalysis
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2024 White Paper on Gene, Cell, and Vaccine Therapies Immunogenicity & Technologies - Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders
Consensus & Conclusions on Gene, Cell, and Vaccine Therapies Immunogenicity & Technologies - Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders for 2024 White Paper
Session Finale: ASK THE REGULATORS! Interactive Panel Discussion with All the Regulators
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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)
