Main Workshop DAY 2C - Discussion Topic List

"Regulators' Advice and Regulators Panel Discussions on Immunogenicity, Gene Therapy, Vaccine, and Biomarkers"

Regulators' Inputs on Immunogenicity, Gene Therapy, Vaccine, and Biomarkers

Immunogenicity:

  • US FDA

    Current Status of Harmonized ADA Assay Validation Templates and Integrated Summaries of Immunogenicity at US FDA: Make your Regulator’s Day!
    -Dr. Joao Pedras-Vasconcelos, Sr. Staff Fellow Office of Biotechnology Products, US FDA

  • Health Canada

    Evaluation of Immunogenicity Data for Biotherapeutics during Clinical Review: Issues and Solutions from a Series of Case Studies
    -Dr. Elana Cherry, Division Manager Biologics and Genetic Therapies Directorate, Health Canada

  • US FDA

    Recent FDA Form 483 Observations of Immunogenicity Assays
    -Dr. Mohsen Rajabi Abhari, Pharmacologist Office of Study Integrity and Surveillance, US FDA

  • UK MHRA

    MHRA Regulatory perspective on Immunogenicity and Gene & Cell therapies
    -Dr. Andrew Exley, Medical Assessor Biologicals and Biotechnology Unit, Licensing Division, UK MHRA

Gene Therapy, Cell Therapy & Vaccines:

  • EU EMA

    Conservative Bioanalysis, Gene Therapy and Vaccines: Regulatory Perspective and Case Studies from Norway NoMA
    -Dr. Therese Solstad, Sr. Scientific Advisor, Head of Team for Quality Assessment of Biological Medicinal Products, Norway NoMA

  • US FDA

    FDA Perspective - Bioassays for the Assessment of Clinical Endpoints: Biomarkers and Assay Agreement
    -Dr. Sara Gagneten, Assoc. Director Division of Viral Products, CBER, US FDA

  • Health Canada

    Vaccine Bioanalytical & Immunogenicity Assays: Current Regulatory Perspective, Review Process and Scientific Principles
    -Dr. Richard Siggers, Sr. Scientific Evaluator Bacterial and Combination Vaccine Division, Health Canada

  • US FDA

    An Update on Regulatory Considerations for Gene & Cell Therapies at US FDA
    -Dr. Nirjal Bhattarai, Principal Investigator and Product Reviewer Division of Cellular and Gene Therapies, CBER, US FDA

  • US FDA

    Validation of Assays Performed by Flow Cytometry for Cell & Tissue Therapies: A Regulatory Perspective
    -Dr. Heba Degheidy, Staff Scientist Division of Cellular and Gene Therapies, CBER, US FDA

Biomarkers & Clinical Pharmacology:

  • US FDA CDRH

    Regulatory Updates on Review Criteria for Flow Cytometry
    -Dr. Kevin Maher, Regulatory Scientist Division of Immunology and Flow Cytometry, CDRH, US FDA

  • US FDA

    Key Performance Characteristics for Analytical Validation for Biomarker Qualification
    - Mr. Abbas Bandukwala, Science Policy Analyst Biomarker Qualification Program, US FDA

  • US FDA

    Opportunity for a Holistic Approach to Bioanalysis: A Clinical Pharmacology Perspective
    -Dr. Yow-Ming Wang, Associate Director for Biosimilars and Therapeutic Biologics, US FDA

Ask the Regulators!
Panel Discussion with the Regulators on Immunogenicity, Biomarkers, Gene Therapy & Vaccines

  • Regulatory Panelists on Immunogenicity
    • Dr. Joao Pedras-Vasconcelos (US FDA)
    • Dr. Haoheng Yan (US FDA)
    • Dr. Meiyu Shen (US FDA)
    • Dr. Mohsen Rajabi Abhari, (US FDA)
    • Dr. Isabelle Cludts (UK MHRA)
    • Dr. Elana Cherry (Health Canada)
    • Dr. Lucia Zhang (Health Canada)
    • Dr. Akiko Ishii (Japan MHLW)
  • Regulatory Panelists on Gene/Cell Therapy and Vaccine
    • Dr. Sara Gagneten (US FDA)
    • Dr. Nirjal Bhattarai (US FDA)
    • Dr. Heba Degheidy (US FDA)
    • Dr. Xiaofei Wang (US FDA)
    • Dr. Andrew Exley (UK MHRA)
    • Dr. Therese Solstad Saunders (Norway NoMA)
    • Dr. Richard Siggers (Health Canada)
  • Regulatory Panelists on Biomarkers & Clinical Pharmacology
    • Dr. Yow-Ming Wang (US FDA)
    • Mr. Abbas Bandukwala (US FDA)
    • Dr. Kevin Maher (US FDA)
    • Dr. Yoshiro Saito (Japan MHLW)