" Regulators' Advice on Immunogenicity/Technologies of Biotherapeutic, & Gene, Cell & Vaccine Therapies "
Session 1: Immunogenicity of Biotherapeutics
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US FDA:
Immunogenicity Risk Assessment of Novel Modalities using in silico, in vitro and ex vivo tools.
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Health Canada:
Assessing the Clinical Impact of Immunogenicity in the Absence of a Neutralizing Antibody (NAb) Assay
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US FDA:
Immunogenicity Risk Assessment in the AI Era: A Regulatory CMC Perspective
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Austria AGES/ EU EMA:
Reflection Paper on a Tailored Clinical Approach in Biosimilar Development
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US FDA:
Clinical Pharmacology Evaluations of Immunogenicity Impact
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Health Canada:
Health Canada Review Process based on the use of Foreign Reviews
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US FDA:
Assessing Immunogenicity of Biological Drug Products using the Immune-Humanized Mouse Model
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US FDA:
Immunogenicity Risk Assessment and Mitigation Strategies for Therapeutic Peptides
ASK THE REGULATORS!
- Have an Open Dialogue with the Regulators including US FDA, Austria AGES/ EU EMA, 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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US FDA:
Regulatory Updates on Gene Therapy Products
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UK MHRA:
Individualized mRNA Cancer Immunotherapies
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US FDA:
Immunogenicity Risk Assessment of SaCas9, AsCas12a and CasĪ¦
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EU EMA:
Regulatory Science Changes in the EU Vaccine Approval Processes
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US FDA:
Immune Response to Ebola and Marburg
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Health Canada:
Secondary Malignancies related to CAR-T Cell Therapies
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UK MHRA:
Development of T cell Suppression Assay Controls for Cell Therapy Products
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US FDA:
NGS Bioinformatics Pipeline for Detecting Adventitious Viral Agents in Gene and Cell Therapy Products
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Health Canada:
Use of Next-generation Sequencing (NGS) in Drug Development
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UK MHRA:
Ensuring the Safety of Cell Therapies through Standards and Assay Development
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Health Canada:
Regulatory Perspective on Vaccine Clinical Assays & Current Regulations
ASK THE REGULATORS!
- Have an Open Dialogue with the Regulators including US FDA, EU EMA, UK MHRA, 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
