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  The New US FDA Immunogenicity Labelling Draft Guidance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

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