Main Workshop DAY 2C & 2BWednesday September 28, 2022: 10am - 6:30pm - Discussion Topic List

"Regulators' Advice and Regulators Panel Discussions"

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

Immunogenicity:

  • US FDA

    The New US FDA Immunogenicity Labelling Draft Guidance

  • Health Canada

    Immunogenicity Labelling: Health Canada Regulatory Perspective

  • US FDA

    Assay Signal to Noise (S/N) as Potential Alternative to Titer for an ADA Response: A Regulatory Perspective from the Office of Clinical Pharmacology (OCP) & Office of Biotechnology Products (OBP)

  • US FDA

    Preclinical (in silico and in vitro) Assessment of Immunogenicity Risk for Biosimilarity and Interchangeability

  • UK MHRA

    Development of Reference Material as Positive Controls (PC) for ADA assays: An update from UK MHRA

  • US FDA

    Updates of the US FDA OCP Efforts on Evaluating Clinical Impact of Immunogenicity

Gene Therapy, Cell Therapy & Vaccines:

  • US FDA

    Unique Scientific Challenges in the Immunogenicity Assessment of Novel Modalities

  • UK MHRA

    Importance of immune-bridging data for Vaccine Approval: Recent experience with COVID-19 Vaccines

  • US FDA

    Understanding, Assessing and Managing Immune Responses to CAS-proteins

  • Japan MHLW

    Vaccine Serology Assays Validation from Japan

  • US FDA

    Perspective on Evolving Landscape of Gene and Cell Therapy Products

  • Health Canada

    Regulatory Considerations for Gene and Cell Therapy Products

  • US FDA

    Application of Flow Cytometry in Cell Therapy: Current Regulatory Perspective

  • Norway NoMA /EU EMA

    Vaccine Assays Validation as Clinical Endpoints

  • US FDA

    Vaccine Assays Validation: Perspective

  • Japan MHLW

    Gene Therapy in Japan

ASK THE REGULATORS!

  • Have an Open Dialogue with the Regulators including US FDA, EU EMA, UK MHRA, Health Canada, Japan MHLW
    Ask the Regulators any Questions you have on Immunogenicity, Gene Therapy, Cell Therapy, and Vaccine and Hear Their Feedbacks on submitted Studies and Inspections/Audits Outcomes

DAY 2B – Regulators' Inputs on Bioanalysis/BMV and Biomarkers & CDx/BAV

Regulated Bioanalysis/BMV:

  • US FDA

    Bioanalytical Considerations for Antibody-Drug Conjugates (ADC) & Recent Review Experience with Bioanalysis using LBA

  • UK MHRA

    International Reference Standard Materials (RSMs) for Biotherapeutics and Advanced Therapies

  • WHO

    Inspection & Review of CROs’ Computerized Systems Validation (CSV)

  • US FDA

    Bioanalytical Method Validation for Endogenous Analytes: US FDA Perspective

  • US FDA

    Regulatory Findings from Generic Drugs and Bioequivalence (BE) Submissions

  • US FDA

    Reflections on Remote Evaluation Activities Over the Past 2 Years

  • US FDA

    Regulatory Findings from Recent Inspections

  • UK MHRA

    Bioanalytical Observations, Findings and Data Integrity Issues

  • Health Canada

    Observations and Findings on Small Molecules

  • Brazil ANVISA

    Updated Regulations and Plans for ICH M10 Adoption in Brazil

Biomarker & CDx/BAV:

  • US FDA

    Biomarkers for Biosimilars: US FDA Perspective

  • US FDA

    CLIA Categorization Processes at CDRH

  • US FDA

    Updates from Biomarker Qualification Program (BQP) and Biomarker Assay Validation (BAV)

  • US FDA

    Updates from CDRH on In Vitro Diagnostics (IVD) Policies

  • Japan MHLW

    Recent Developments of Biomarker Assay Validation (BAV) in Japan for qPCR Assays

  • US FDA

    Next-Generation Sequencing (NGS) Panels for Precision Oncology Biomarkers

ASK THE REGULATORS!

  • Have an Open Dialogue with the Regulators including US FDA, EU EMA, UK MHRA, Health Canada, Japan MHLW, Brazil ANVISA, WHO
    Ask the Regulators any Questions you have on Regulated Bioanalysis/BMV and Biomarkers & CDx/BAV, and Hear Their Feedbacks on Submitted Studies and Inspections/Audits Outcomes




Agenda at a Glance Agenda at a Glance