Main Workshop DAY 2B - Wednesday April 11, 2018

"Regulators' Advice - Latest Regulatory Inputs
from Major/Influential Regulatory Agencies on New Guidances and Findings"

Day 2B Discussion Topic List

  • Participating Regulatory Agencies around the globe:
    • Regulated Bioanalysis / BMV
      • Dr. Sean Kassim, Office Director, US FDA
      • Dr. Sam Haidar, Senior Advisor for Science, US FDA
      • Dr. Seongeun (Julia) Cho, Division Director, US FDA
      • Dr. Brian booth, Division Deputy Director, US FDA - TBC
      • Dr. Jan Welink, Senior Pharmacokinetic Assessor, EU EMA
      • Dr. Olivier Le Blaye, Inspector, France ANSM - TBC
      • Mr. Stephen Vinter, Operations Manager, GLPMA & Laboratories Group Inspections, UK MHRA
      • Ms. Emma Whales, Inspector, UK MHRA
      • Mr. Gustavo Mendes Lima Santos, Head of Bioequivalence, Brazil ANVISA
      • Dr. Anna Edmison, Senior Clinical Assessment Officer, Health Canada
    • Biomarkers
      • Dr. Christopher Leptak, Director OND Regulatory Science Program / Director Biomarker Qualification Program, US FDA
      • Dr. Shashi Amur, Scientific Lead, Biomarker Qualification, US FDA
      • Dr. Shirley Hopper, Medical Assessor, UK MHRA
      • Dr. Yoshiro Saito, Director Div. Medicinal Safety Science, Japan MHLW-NIHS
    • Immunogenicity
      • Dr. Daniela Verthelyi, Chief Immunology Lab, US FDA
      • Dr. Susan Kirshner, Associate Chief Immunology Lab, US FDA
      • Dr. Yow-Ming Wang, Associate Director of Therapeutic Biologics Program, US FDA
      • Dr. João Pedras-Vasconcelos, Biotech Product Quality & Immunogenicity Reviewer, US FDA
      • Dr. Meenu Wadhwa, Section Leader, UK MHRA-NIBSC
      • Dr. Isabelle Cludts, Biotherapeutics, UK MHRA-NIBSC
      • Dr. Pekka Kurki, Research professor, Finland Fimea
      • Dr. Elana Cherry, Division Chief, Biologics and Genetic Therapies Directorate, Health Canada
      • Dr. Akiko Ishii, Director, Div. Biological Chemistry and Biologicals, Japan MHLW-NIHS
  •  

  • Regulated Bioanalysis:
    • Recent Regulatory Findings/Deficiencies/483s from Audits & Inspections for both LBA & LCMS submissions
    • Updates on BMV Guidance/Guideline
    • Regulatory Perspectives on submitted Studies using LCMS and Hybrid LBA/LCMS for Biotherapeutics Bioanalysis
    • Regulatory Perspectives on Use of ADA Assays by Hybrid LBA/LCMS
    • Regulators' review of ISR most important values in the last decade and the future opportunities
    • US FDA Regulatory Stability Research: Supporting Data from Stable and Unstable Compounds
    • Regulatory Perspectives on current Industry Standards for Internal Standards (IS) Response Troubleshooting & Interpretation
  •  

  • Immunogenicity
    • Updates US FDA Draft Guidance for Industry, Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products
    • Application of the latest EU EMA Immunogenicity Guideline
    • Regulatory Perspectives on:
      • ADA Incidence & Clinical Relevance
      • Integrated Summaries of Immunogenicity
      • How to present immunogenicity data during drug development & post-approval and feedback on recent submissionses
      • Quality of ADA Assays, Sensitivity & Drug Tolerance
      • Standardization of ADA Assays
      • Current industry standards on Cut-Points and Pre-Existing Antibodies Evaluation
      • Triggers for Audits/Inspections on ADA Assays
      • Impact of innate immune modulating impurities on product immunogenicity
    • Japan MHLW perspective on status of the Japanese document “Points to Consider for ADA Assays by AMED (Japan Agency for Medical Research and Development)
    • Health Canada updates on Biologics and Genetic Therapies
  • Biomarkers
    • US-FDA Perspective on Biomarker Qualification and the Importance of Assay Performance
    • Updates on the Duke-Margolis/C-Path/US FDA White Paper: “Scientific and Regulatory Considerations for the Analytical Validation of Assays Used in the Qualification of Biomarkers in Biological Matrices”
    • EU-EMA perspective on Biomarkers Assay Development & Validation in Europe: “Concept Paper on Predictive Biomarker-Based Assay Development in the context of drug development and lifecycle”
    • Japan MHLW perspective on Biomarker Assay Validation in Japan: Items for “Biomarker Measurements for Drug Development by AMED (Japan Agency for Medical Research and Development)
  •  

  • Ask the Regulators! - Traditional Interactive Panel Discussion with the Regulators
    • You will have the opportunity to ask your questions directly to any regulators on the panel in this engaging Panel Discussion with the Regulators.
    • You can also send your questions beforehand. Please click on this link to submit questions for regulators (you can be anonymously if you choose to).

 

 

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