" 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.
Dr. Zuben Sauna, Division Director, US FDA - invited -
Health Canada:
Assessing the Clinical Impact of Immunogenicity in the Absence of a Neutralizing Antibody (NAb) Assay
Dr. Adrian Wong, Senior Clinical Evaluator, Health Canada -
US FDA:
Immunogenicity Risk Assessment in the AI Era: A Regulatory CMC Perspective
Dr. João Pedras-Vasconcelos, Senior Pharmaceutical Scientist, US FDA - invited -
Austria AGES/ EU EMA:
Reflection Paper on a Tailored Clinical Approach in Biosimilar Development
Mr. Christian Mayer, Quality Assessor, Austria AGES/ EU EMA -
US FDA:
Clinical Pharmacology Evaluations of Immunogenicity Impact
Dr. Yow-Ming Wang, Associate Director for Biosimilars & Therapeutic Biologics, US FDA - invited -
Health Canada:
Health Canada Review Process based on the use of Foreign Reviews
Dr. Omar Tounekti, Manger Cell and Gene Therapies, Health Canada -
US FDA:
Assessing Immunogenicity of Biological Drug Products using the Immune-Humanized Mouse Model
Dr. Kristina Howard, Research Veterinary Medical Officer, US FDA -
US FDA:
Immunogenicity Risk Assessment and Mitigation Strategies for Therapeutic Peptides
Dr. Mohanraj Manangeeswaran, Senior Research Scientist , US FDA - invited
ASK THE REGULATORS!
Interactive Panel Discussion with the Regulators on Immunogenicity of Biotherapeutics
- Regulatory Panelists on Immunogenicity of Biotherapeutics
- Dr. João Pedras-Vasconcelos (US FDA - invited)
- Dr. Mohanraj Manangeeswaran (US FDA - invited)
- Dr. Yow-Ming Wang (US FDA - invited)
- Dr. Kristina Howard (US FDA)
- Dr. Zuben Sauna (US FDA - invited)
- Dr. Vijaya Simhadri (US FDA - invited)
- Dr. Luke Lindsay-Hill (UK MHRA)
- Mr. Christian Mayer (Austria AGES/ EU EMA)
- Dr. Adrian Wong (Health Canada)
- Dr. Omar Tounekti (Health Canada)
- Dr. Sarah Cummings (Health Canada)
- Mr. Joao Tavares Neto (Brazil ANVISA)
Session 2: Gene Therapy, Cell Therapy, and Vaccines
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UK MHRA:
Individualized mRNA Cancer Immunotherapies
Dr. Shirley Hopper, Medical Assessor, UK MHRA -
US FDA:
Immunogenicity Risk Assessment of SaCas9, AsCas12a and CasΦ
Dr. Vijaya Simhadri, Biologist, US FDA - invited -
EU EMA:
Regulatory Science Changes in the EU Vaccine Approval Processes
Dr. Alessandra Buoninfante, Scientific Officer, Health Threats and Vaccines Strategy, EU EMA -
US FDA:
Immune Response to Ebola and Marburg
Dr. Surender Khurana, US FDA - invited -
Health Canada:
Secondary Malignancies related to CAR-T Cell Therapies
Dr. Sarah Cummings, Scientific Evaluator Cell and Gene Therapies, Health Canada -
UK MHRA:
Development of T cell Suppression Assay Controls for Cell Therapy Products
Dr. Anna Nowocin, Principal Scientist, UK MHRA -
US FDA:
NGS Bioinformatics Pipeline for Detecting Adventitious Viral Agents in Gene and Cell Therapy Products
Dr. Joshua Xu, SBRBPAS Expert and Branch Chief, US FDA -
Health Canada:
Use of Next-generation Sequencing (NGS) in Drug Development
Dr. Huixin Lu, Research Scientist, Health Canada -
UK MHRA:
Ensuring the Safety of Cell Therapies through Standards and Assay Development
Dr. Luke Lindsay-Hill , Senior Scientist, UK MHRA -
Health Canada:
Regulatory Perspective on Vaccine Clinical Assays & Current Regulations
Dr. Chad Irwin , Senior Scientific Evaluator, Health Canada
ASK THE REGULATORS!
Interactive Panel Discussion with the Regulators on Gene Therapy, Cell Therapy, and Vaccines
- Regulatory Panelists on Gene Therapy, Cell Therapy, and Vaccines
- Dr. Zuben Sauna (US FDA - invited)
- Dr. Vijaya Simhadri (US FDA - invited)
- Ms. Leslie Wagner (US FDA - invited)
- Dr. Surender Khurana (US FDA - invited)
- Dr. Joshua Xu (US FDA)
- Dr. João Pedras-Vasconcelos (US FDA - invited)
- Dr. Mohanraj Manangeeswaran (US FDA - invited)
- Dr. Shirley Hopper (UK MHRA)
- Dr. Luke Lindsay-Hill (UK MHRA)
- Dr. Anna Nowocin (UK MHRA)
- Dr. Alessandra Buoninfante (EU EMA)
- Mr. Christian Mayer (Austria AGES/ EU EMA)
- Dr. Omar Tounekti (Health Canada)
- Dr. Chad Irwin (Health Canada)
- Dr. Sarah Cummings (Health Canada)
- Dr. Huixin Lu (Health Canada)
- Dr. Adrian Wong (Health Canada)
