Main Workshop DAY 2B & 2C - Discussion Topic List
June 22, 2020, 11am to 4pm ET: 2B & 2C Part 1
June 23, 2020, 11am to 4pm ET: 2B & 2C Part 2

"Regulators' Advice and Regulators Panel Discussions - Day 2B & 2C"

View Main Workshop DAY 2B & 2C Agenda

DAY 2C – Regulators' Inputs on Immunogenicity, Gene Therapy, Vaccine, and Biomarkers


  • 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


    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:


    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


    CDRH CLIA Categorization Processes
    -Dr. Peter Tobin, Chemist Division of Program Operations and Management, CDRH, US FDA

Ask the Regulators!
Interactive 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. Peter Tobin (US FDA)
    • Dr. Yoshiro Saito (Japan MHLW)

DAY 2B – Regulators' Inputs on Regulated Bioanalysis & BMV

Chair: Dr. Fabio Garofolo, Chief Scientific Officer, BRI Biopharmaceutical Research Inc
  • EU EMA

    Updates on the Status of the ICH M10 BMV Guideline
    - Drs. Jan Welink, Sr. Clinical Assessor, EU EMA

  • Brazil ANVISA

    Brazil ANVISA ICH Initiatives and Updates Regulation (Revision of Bioequivalence Guideline, BE of Orally Inhaled Drug Products and Dermatological Products)
    - Mr. Gustavo Santos, General Manager of Medicines and Biological Products, Briazil ANVISA

  • US FDA

    Observations from US FDA Inspections and Evaluation of Case Studies
    - Dr. Arindam Dasgupta, Deputy Director of the Division of New Drug Study Integrity, US FDA

  • Health Canada

    Biosimilar Requirements at Health Canada
    - Dr. Catherine Soo, Sr. Clinical Evaluator Clinical Evaluation Division, Health Canada

  • US FDA

    US FDA Regulatory Perspectives on Stability of Biotherapeutics
    - Dr. Sam Haidar, Senior Science Advisor Office of Study Integrity and Surveillance, US FDA

  • Health Canada

    Recent Small Molecules Regulatory Findings from Health Canada: Impact on delays in the reviewing process and negative decisions
    - Dr. Anna Edmison, Senior Clinical Assessment Officer Division of Biopharmaceutics Evaluation, Health Canada

  • US FDA

    Novel and Advanced Instrumentation Capabilities at FDA in support of Bioanalysis Studies that impact Regulatory Science, Policy and Surveillance
    - Dr. Patrick Faustino, Lab Chief in the Division of Product Quality Research, US FDA

  • US FDA and UK MHRA

    Data Integrity in Bioanalysis – Current Regulatory Perspective

    • From Generic Drug Products at US FDA
      - Dr. Nilufer Tampal, Acting Deputy Director Office of Bioequivalence, US FDA
    • New Regulatory Findings from UK MHRA
      - Mr. Stephen Vinter, Operations Manager GLP Monitoring Authority and Laboratories Group, UK MHRA

Ask the Regulators!
Interactive Panel Discussion with the Regulators on Bioanalysis & BMV Guidance

  • Regulatory Panelists on Bioanalysis / BMV:
    • Dr. Tahseen Mirza (US FDA)
    • Dr. Arindam Dasgupta (US FDA)
    • Dr. Sam Haidar (US FDA)
    • Dr. Mohsen Rajabiabhari (US FDA)
    • Dr. Nilufer Tampal (US FDA)
    • Dr. Suman Dandamudi (US FDA)
    • Dr. Patrick Faustino (US FDA)
    • Dr. Diaa Shakleya (US FDA)
    • Dr. Jinhui Zhang (US FDA)
    • Drs. Jan Welink (EU EMA)
    • Mr. Stephen Vinter (UK MHRA)
    • Mr. Michael McGuiness (UK MHRA)
    • Dr. Anna Edmison (Health Canada)
    • Dr. Catherine Soo (Health Canada)
    • Dr. Susan Stojdl (Health Canada)
    • Mr. Gustavo Santos (Brazil ANVISA)

Final Agenda Agenda at a Glance