Main Workshop DAY 2B - Wednesday June 21, 2023: 12pm to 5:30pm - Discussion Topic List

"Regulators' Advice on Immunogenicity, Gene Therapy, Cell Therapy, and Vaccines"

Session 1: Immunogenicity

  • US FDA:

    Tools to Assess Immunogenicity Risk and New Computational Methods
    Dr. Daniela Verthelyi, Chief, Lab of Immunology, US FDA

  • Japan MHLW:

    Using S/N ratio of screening assay as an alternative to titer
    Dr. Akiko Ishii-Watabe, Director, Japan MHLW

  • US FDA:

    Updates of the OCP Efforts on Evaluating Clinical Impact of Immunogenicity
    Dr. Mohsen Rajabi Abhari, Clinical Pharmacologist, Biologics lead , US FDA

  • US FDA:

    An update on Biosimilar Biological Product Authorization Performance Goals and Procedures
    Dr. Kimberly Maxfield, Lead for BsUFA III Reg Sci Program, US FDA

  • US FDA:

    An Update on FDA Immunogenicity Review Committee Activities
    Dr. Sophie Shubow, Senior Scientist, US FDA

  • US FDA:

    NAb Assays: Current Perspective from OBP
    Dr. Joao Pedras-Vasconcelos, Senior Staff Fellow, US FDA

Interactive Panel Discussion with the Regulators on Immunogenicity

  • Regulatory Panelists on Immunogenicity
    • Dr. Daniela Verthelyi (US FDA CDER)
    • Dr. Joćo Pedras-Vasconcelos (US FDA CDER)
    • Dr. Kimberly Maxfield (US FDA CDER)
    • Dr. Sophie Shubow (US FDA CDER)
    • Dr. Kara Scheibner (US FDA CDER)
    • Dr. Mohsen Rajabi Abhari, (US FDA CDER)
    • Dr. Meenu Wadhwa (UK MHRA)
    • Dr. Isabelle Cludts (UK MHRA)
    • Dr. Christian Mayer (Austria AGES/EU EMA)
    • Dr. Akiko Ishii (Japan MHLW)

Session 2: Gene Therapy, Cell Therapy, and Vaccines

  • US FDA:

    Recent Advances on Cell and Gene Therapies
    Dr. Nirjal Bhattarai, Chief, Tumor Vaccine and Biotechnology Branch, US FDA

  • Health Canada:

    Assessment of qualified laboratories for cell and gene therapies: Health Canada's approach
    Dr. Omar Tounekti, Manager, Health Canada

  • US FDA:

    Vaccine Assay Validation
    Ms. Leslie Wagner, Consumer Safety Officer, US FDA

  • EU EMA:

    Vaccine Assay Validation: Regulatory Perspective
    Dr. Alessandra Buoninfante, Scientific Officer, EU EMA

  • Austria AGES:

    Current Developments at the EMA
    Mr. Christian Mayer, Quality Assessor, Austria AGES

  • US FDA:

    Recent updates on Flow Cytometry and Cell Therapy
    Dr. Heba Degheidy, Biologist/ Senior product reviewer, US FDA


    International Reference Standards for Flow Cytometry
    Ms. Sandra Diebold, Principal Scientist, Head of Immunotherapy, UK MHRA-NIBSC

  • US FDA:

    Benchmarking and Improving Indel Calling from Oncopanel Sequencing Data
    Dr. Joshua Xu, Branch Chief, US FDA

  • Japan MHLW - NIHS :

    Bioanalysis of adenovirus vector by qPCR and digital PCR
    Dr. Yoichi Tanaka, Senior researcher, Japan MHLW - NIHS

Interactive Panel Discussion with the Regulators on Gene Therapy, Cell Therapy, and Vaccines

  • Regulatory Panelists on Gene Therapy, Cell Therapy, and Vaccines
    • Dr. Nirjal Bhattarai (US FDA CBER)
    • Dr. Heba Degheidy (US FDA CBER)
    • Dr. Leslie Wagner (US FDA CBER)
    • Dr. Joshua Xu (US FDA NCTR)
    • Dr. Alessandra Buoninfante (EU EMA)
    • Dr. Christian Mayer (Austria AGES/EU EMA)
    • Dr. Sandra Diebold (UK MHRA)
    • Dr. Omar Tounekti (Health Canada)
    • Dr. Yoichi Tanaka (Japan MHLW)

Agenda at a Glance Agenda at a Glance