• US FDA:

  Assays Supporting Immunogenicity Risk Assessments: The Road Ahead
  Dr. Daniela Verthelyi, Chief, Laboratory of Immunology, US FDA

• UK MHRA:

  Observations from Review of Immunogenicity of Biotherapeutics
  Dr. Meenu Wadhwa, Section Head, R&D Biotherapeutics & Advanced Therapies Division, UK MHRA

• Japan MHLW:

  Evaluating S/N Ratio of International Reference Standard of Anti-Infliximab Antibody by Collaborating with NIBSC
  Dr. Akiko Ishii-Watabe, Director, Division of Biological Chemistry and Biologicals, Japan MHLW

• US FDA:

  Assessing the Immunogenicity Risk of Generic Peptides: What Information Can Support Regulatory Decision?
  Dr. Mohanraj Manangeeswaran, Staff Fellow, Immunogenicity, US FDA

• Health Canada:

  Health Canada Considerations for Review and Labeling of Immunogenicity Data for Pre-market Biologic Drug Submissions
  Dr. Adrian Wong, Clinical Reviewer, Health Canada

• US FDA:

  Fit for Purpose Assays to Assess Innate Immune Response Modulating Impurities (IIRMI)
  Dr. Seth Thacker, Staff Fellow, Immunogenicity, US FDA

• US FDA:

  The use of MHC Associated Peptide Proteomics (MAPPs) Assays in the Immunogenicity Risk Assessment of Therapeutic Proteins and Novel Modalities
  Dr. Zuben Sauna, Director, Division of Hemostasis, US FDA

ASK THE REGULATORS!
Interactive Panel Discussion with the Regulators on Immunogenicity of Biotherapeutics

• Regulatory Panelists on Immunogenicity of Biotherapeutics
  • Dr. Daniela Verthelyi (US FDA CDER)
  • Dr. Zuben Sauna (US FDA CBER)
  • Dr. Mohanraj Manangeeswaran (US FDA CDER)
  • Dr. Seth Thacker (US FDA CDER)
  • Dr. Meenu Wadhwa (UK MHRA)
  • Dr. Sandra Diebold (UK MHRA)
  • Dr. Sandra Prior (UK MHRA)
  • Mr. Christian Mayer (Austria AGES / EU EMA)
  • Dr. Adrian Wong (Health Canada)
  • Dr. Akiko Ishii (Japan MHLW)

• Austria AGES / EU EMA:

  Development and Approval of Adeno-Associated Virus Vector Based Medicines: Challenges and Pitfalls
  Mr. Christian Mayer, Quality Assessor, Austria AGES / EU EMA

• Health Canada:

  Creating a Forward-Looking Review Framework for Cell and Gene Therapies in Canada
  Dr. Omar Tounekti, Manager, Health Canada

• US FDA:

  De-Immunization of the Full-Length SaCas9 Protein
  Dr. Vijaya Simhadri, Biologist, US FDA

• Health Canada:

  Regulatory Insights for Cell and Gene Therapy Products
  Dr. Sarah Wassmer, Senior Biologist/Reviewer, Health Canada

• Health Canada:

  Use of International Standards in the Development and Control of Vaccines
  Dr. Chad Irwin, Senior Scientific Evaluator, Health Canada

• UK MHRA:

  Reference Reagents & Standardization of Cell-Based Assay (CBA) for Mesenchymal Stromal Cells derived Extracellular Vesicles (EV) 
  Dr. Sandra Diebold, Head of Immunotherapy, UK MHRA

• US FDA:

  Benchmarking Fusion Detection by Targeted RNA Sequencing by NGS & PCR
  Dr. Joshua Xu, Branch Chief, US FDA

• UK MHRA:

  Immunomonitoring by ELISpot: SARS-CoV-2 T cell Response Evaluation in Vaccine Studies
  Dr. Sandra Prior, Principal Scientist, Cell-Based Assays, UK MHRA

• Health Canada:

  Regulatory Considerations for Accelerated Vaccine Development
  Dr. Julie Joseph, 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 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)