Immunogenicity Risk Assessment: Are Preclinical Methods Informative? (S03)

Symposium Chair(s)

• Laurent Malherbe, PhD

  Executive Director
  Toxicology
  Eli Lilly and Company, Inc.
  Indianapolis, Indiana, United States

• Kristina Howard, DVM, PhD

  Research Veterinary Medical Officer
  Division of Applied Regulatory Science, OCP, OTS, CDER
  US FDA
  Silver Spring, Maryland, United States

Symposium Speaker(s)

• Julie TerWee, MS

  Director, Global R&D Bioassay and Microbiology
  Medicinal Sciences
  Pfizer
  Lake Forest, Illinois, United States

• Sofie Pattyn, PhD

  CTO
  ImmunXperts, a Q2 Solutions Company
  Gosselies, Hainaut, Belgium

• Mohanraj Manangeeswaran, PhD

  Senior Research Scientist
  CDER/OPQ/OPQR
  US FDA
  Silver Spring, Maryland, United States

Immunogenicity risk remains a concern for all therapeutic protein products, regardless of regulatory pathway. There is increased interest in in vitro assay methodologies for all aspects of drug development, and particular interest with respect to immunogenicity due to the inability of most non-clinical models to inform human immunogenicity risk. This symposium will present results from a collaboration between industry, CRO & regulatory laboratories to evaluate potential positive and negative controls for in vitro immunogenicity assays completed with a range of assay formats. Speakers from each sector will present in vitro assay methods ranging from innate to adaptive immune function that could be used for immunogenicity risk assessment. In vitro assay methodologies will be followed by a presentation of humanized mouse study data asking if it could also be informative for immunogenicity risk assessment. The session concludes with a Q&A/panel discussion.

Presentations:

• 9:00 AM – 9:20 AM CT

  HESI/AAPS Reference Panel for Preclinical Immunogenicity Risk Assessment
  

  Symposium Speaker: Laurent Malherbe, PhD – Eli Lilly and Company, Inc.
• 9:20 AM – 9:50 AM CT

  In Vitro Assay Methods for Pre-clinical Biosimilar and Generic Drug Product Evaluation
  

  Symposium Speaker: Julie TerWee, MS – Pfizer
• 9:50 AM – 10:15 AM CT

  In Vitro Immunogenicity Assessment: Perspective from a CRO
  

  Symposium Speaker: Sofie Pattyn, PhD – ImmunXperts, a Q2 Solutions Company
• 10:15 AM – 10:45 AM CT

  Break
• 10:45 AM – 11:15 AM CT

  Can the Humanized Mouse Model Inform Immunogenicity Risk Assessment?
  

  Symposium Speaker: Kristina Howard, DVM, PhD – US FDA
• 11:15 AM – 11:45 AM CT

  Testing Process and Product Related Impurities to Inform Immunogenicity Risk
  

  Symposium Speaker: Mohanraj Manangeeswaran, PhD – US FDA
• 11:45 AM – 12:00 PM CT

  Panel Discussion