" Regulators' Advice on Immunogenicity/Technologies of Biotherapeutics, and Gene, Cell & Vaccine Therapies "
Session 1: Immunogenicity of Biotherapeutics
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US FDA:
Comparative Assessment of Immunogenicity Risk for Products in Complex Formulations
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US FDA:
The use of Artificial Intelligence/Machine Learning (AI/ML) tools in Predictive Immunogenicity
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UK MHRA:
Development of WHO Reference Reagent Panel for Fc-domain Interactions
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US FDA:
Immunogenicity of Peptides: Risk Assessment & Mitigation
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Health Canada:
Labeling the Immunogenicity of Biotherapeutics in the Canadian Product Monograph
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US FDA:
Scientific and Regulatory Perspectives on Drug Hypersensitivity Reactions
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US FDA:
HRMS-based Precision Analytics for Synthetic Oligonucleotides: Characterization and Impurity Profiling
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US FDA:
The Slings and Arrows of Outrageous (Mis)fortune- Product Quality Commiserations in CDER's Immunogenicity Risk Assessment of Biologics
ASK THE REGULATORS!
- Have an Open Dialogue with the Regulators including US FDA (CDER, CBER), UK MHRA, Health Canada,
Ask the Regulators any questions you have on Immunogenicity of Biotherapeutics, and Hear Their Feedbacks on Submitted Studies and Inspections/Audits Outcomes
Session 2: Gene Therapy, Cell Therapy, and Vaccines
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Austria AGES/ EU EMA:
New EMA Guideline on Quality Aspects of mRNA Vaccines
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US FDA:
Use of the MHC Associated Proteomics Assay to Evaluate the Potential Immunogenicity of CAS Proteins used in Gene Editing
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Health Canada:
Use of Platform Data to Support Development of Cell and Gene Therapy Products
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UK MHRA:
Considerations for Potency Testing of Extracellular Vesicles (EV)-based Therapies
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US FDA:
Rational Immunosilencing of a Promiscuous T-cell Epitope in the Capsid of an Adeno-associated Virus
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UK MHRA:
Ongoing Research into Cell and Gene Therapy Standards
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Health Canada:
Current Perspectives on Establishing Vaccine Specifications
ASK THE REGULATORS!
- Have an Open Dialogue with the Regulators including US FDA (CBER), Austria AGES/ EU EMA, UK MHRA and Health Canada
Ask the Regulators any questions you have on Gene Therapy, Cell Therapy, and Vaccines, and Hear Their Feedbacks on Submitted Studies and Inspections/Audits Outcomes
