Immunogenicity Summit
  • Final Agenda Now Available
  • Slide 2
  • Slide 1
About the Summit 

Following year-on-year success, CHI presents the Sixth Annual Immunogenicity and Bioassay Summit 2014: 3 conferences, 8 FDA presenters plus 40+ additional presentations, 15+ interactive breakout round table and panel discussions, 4 short courses, exhibit/poster hall, and networking opportunities. Immunogenicity Prediction & Mitigation is designed to help investigators design and select non-immunogenic products for early-stage decision making, while Immunogenicity Assessment & Clinical Relevance and Optimizing Bioassays for Biologics will enable investigators to overcome the complexities of bioassays and immunoassays and develop programs that ensure their products are safe and efficacious, and satisfy regulatory requirements. Browse through this website to view the final agenda. Register today to attend the Number 1 Immunogenicity and Bioassay Event bringing together industry, academia and regulatory authorities.

What’s NEW for 2014? 
  • More on immunogenicity challenges in clinical development;
    pre-existing reactivity, target interference, Fc-Fc interactions,
    drug interference, impact of higher order complexes, characterization of ADAs, assay validation and cut points
  • Focus on specific products: interferon beta, enzyme replacement therapy, Knob-and-Hole therapeutics, ADCs, Factor VIII, immunotoxins, hemophilia products, Adnectins
  • Choice of 14+ new interactive breakouts for in-depth discussion
  • More focus on the impact of sub-visible particles, aggregates and impurities
  • New angle on impact of route of administration
  • Increased coverage and case studies and feedback from health authorities
  • Presentations on working with molecules with multiple mechanisms such as ADCs, bispecifics, and fragments
  • and much more! 
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

Amy RosenbergAmy Rosenberg, Ph.D.
Director, Therapeutic Proteins FDA/CDER


Steven SwansonSteven J. Swanson, Ph.D.
Executive Director, Medicinal Sciences, Clinical Immunology Amgen, Inc.


Baolin ZhangBaolin Zhang, Ph.D.
Senior Investigator, Therapeutic Proteins, Biotechnology Products, FDA


Jaya GoyalJaya Goyal, Ph.D.
Director, Translational Sciences, Biogen Idec


Susan KirshnerSusan Kirshner, Ph.D.
Associate Chief, Laboratory of Immunology, Therapeutic Proteins, Biotechnology, CDER/FDA


Tim HicklingTim Hickling, Ph.D.
Associate Research Fellow, Pharmacokinetics, Dynamics and Metabolism, Pfizer, Inc.

  • 8 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 

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2014 Brochure Cover

Download Brochure 

Premier Sponsor : 

 Charles River(1) 


IMN Podcast iconReducing and Monitoring Bioassay Variability 

2013 Speaker: Janet L. Lathey, Ph.D., Director, Immunology and Assay Development, BioDefenseDivision, Emergent BioSolutions