Immunogenicity Summit
Immunogenicity and Bioassay Summit

What’s NEW for 2014

Immunogenicity Assessment and Clinical Relevance

  • More on challenges in clinical development
    • Pfizer on challenges with pre-existing reactivity
    • GSK on target interference
    • Regeneron on interference from Fc-Fc interactions
    • Amgen and Novartis on drug interference in neutralizing antibody assays
    • BMS on impact of higher order complexes
    • Amgen on characterization of ADAs, specifically IgG4
    • MedImmune on
  • Three FDA participants in 2014:
    • Susan Kirshner, Ph.D., Associate Chief, Laboratory of Immunology, Therapeutic Proteins
    • Laurie Graham, Ph.D., Product Quality Reviewer, Monoclonal Antibodies
    • Laura Salazar-Fontana, Ph.D., Senior Staff Fellow and Immunogenicity Program Coordinator, Therapeutic Proteins
  • Focus on specific products:
    • NIBSC/MHRA on Interferon beta
    • GSK on enzyme replacement therapies
    • Genentech on their Knob-and-Hole therapeutic
    • Pfizer on ADCs
  • Focus on assay validation and cutpoints from Pfizer and MedImmune
  • Choice of 5 + interactive breakouts for in-depth discussion
  • Focus on risk assessment from Amgen
  • Comparing Biosimilars with the reference product from Parexel

Immunogenicity Prediction and Mitigation

  • Four FDA participants in 2014:
    • Amy Rosenberg, Ph.D., Director, Therapeutic Proteins
    • Jack Ragheb, Ph.D., Principal Investigator, Therapeutic Proteins
    • Daniela Verthelyi, Ph.D., Chief, Laboratory of Immunology, Therapeutic Proteins
    • Lydia Haile, Ph.D., Postdoctoral Fellow, Laboratory of Immunology,Therapeutic Proteins
  • More focus on the impact of sub-visible particles , aggregates and impurities from FDA, Roche and MedImmune
  • Focus on specific products: Adnectins from Adnexus; Hemophilia products from Novo Nordisk; Factor VIII from Apitope/University of Bristol and Selecta Biosciences; and Immunotoxins for cancer from NIH
  • Academic talks on Impact of route of administration from Universities of Colorado and SUNY at Buffalo
  • Choice of 5 + interactive breakouts for in-depth discussion
  • We will continue to focus on mouse models, predictive tools, and suppression and tolerance mechanisms
Optimizing Bioassays for Biologics 
  • Increased coverage and case studies on feedback from health authorities
  • Presentations on working with molecules with multiple mechanisms such as ADCs, bispecifics, and fragments
  • Comparability and characterization case studies with cell based and non-cell-based assays
  • Showcase of new assay technologies and formats
  • Choice of 3 interactive breakout discussions:
    • Strategies for Bioassays with Multiple Mechanisms
      Moderator: Gillian Payne, Senior Director, Bioanalytical Science, ImmunoGen, Inc.
    • Selecting the Right Bioassay
      Moderator: Natko Nuber, Ph.D., Biologics R&D, Novartis
    • Maintaining Assay Consistency
      Moderator: LaKenya Williams, Ph.D., Senior Research Investigator I, Bioanalytical Sciences - Biologics, Bristol-Myers Squibb
  • Speakers from the FDA and USP

 

 

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2016 Immunogenicity and Bioassay Summit Brochure


2016 Immunogenicity and Bioassay Summit Brochure  

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