2015 Archived Content

  • 7 FDA experts on a range of topics: Presentations, breakout discussions and a short course
  • Addresses the real challenges in immunogenicity assessment
  • Risk assessment strategies
  • Immunogenicity for biosimilars: from the FDA, from Europe and an industry case study
  • Models for immunogenicity prediction
  • Impact of impurities, aggregates and SVPs
  • Deimmunization and tolerance mechanisms: including a clinical case study
  • Advances in bioassay technologies and potency testing
  • Bioassays assays for multiple modes of action and challenging therapeutic areas
  • Bridging studies and assay transfer
  • Choice of 12+ interactive breakout discussions: to help you iron out your immunogenicity and bioassay challenges

Pre-Conference Short Courses - View Details
November 16
  • SC1: Basics of Immunogenicity Testing
  • SC2: Challenges of Immunogenicity Assessment
    (Dinner Course)

Dinner Short Courses - 
View Details
November 18  
  • SC3: Immunogenicity Risk Assessment & Regulatory Strategy
  • SC4: Strategic Assay Design and Analysis

Keynote Speakers:  

Hickling TimTim Hickling, Ph.D.,  

Associate Research Fellow, Pharmacokinetics, Dynamics and Metabolism, Pfizer, Inc.


Kibbey MauraMaura C. Kibbey, Ph.D.,  

Senior Scientific Liaison, Biologics & Biotechnology, United States Pharmacopeia


Lu Xiaobin VictorXiaobin (Victor) Lu, Ph.D.,  

CMC Reviewer, Division of Cellular & Gene Therapies, OCTGT, CBER, FDA


QuarmbyValerie Quarmby, Ph.D.,  

Staff Scientist, BioAnalytical Sciences, Genentech, Inc.


Rispens TheoTheo Rispens, Ph.D.,  

Senior Scientist, Immunopathology, Sanquin


Rosenberg AmyAmy Rosenberg, Ph.D.,  

Director, Therapeutic Proteins, FDA/CDER



  • 7 FDA Presenters
  • Access All 3 Conferences for One Price
  • Network with 250+ Global Attendees
  • Hear 45+ Scientific Presentations
  • Learn from FDA, Industry, and Leading Academic Research Centers
  • Dedicated Exhibit/Poster Viewing
  • Choose from 4 Short Courses
  • Interactive Roundtable Breakouts & Panel Discussions
  • Dedicated Networking Opportunities