Immunogenicity Summit
Immunogenicity and Bioassay Summit


Following year-on-year success, CHI presents the Eighth Annual Immunogenicity and Bioassay Summit 2016: 3 conferences, FDA presenters plus 40+ additional presentations, 15+ interactive breakout round table and panel discussions, short courses, exhibit/poster hall, and networking opportunities with 250+ delegates. Immunogenicity Prediction & Control 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 immunogenicity assessment and bioassays, and develop programs that ensure their products are safe and efficacious, and satisfy regulatory requirements.


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


  • FDA on meeting regulatory expectations, documentation, and aggregates
  • Immunogenicity case studies for TNF inhibitors, endogenous products, ADCs, enzymes, Factor VIIa, gene therapy products, etc.
  • Focus on drug tolerance and target interference
  • Significance of neutralizing antibodies and pre-existing antibodies
  • Immunogenicity assessment of biosimilars
  • Factors that contribute to immunogenicity
  • Relationship between predictive immunogenicity and clinical outcome
  • Overcoming immunogenicity, deimmunization and tolerance
  • Bioassay bridging, transfer and validation
  • Bioassays for multi-specific antibodies: ADCs, bispecifics, and beyond
  • Emerging bioassay formats and technologies
  • Statistical tools for bioassays


“Program and participants first class.”
- Associate Director, Novo Nordisk

“Breakout interaction with FDA experts was very valuable.”
- Associate Director, Alexion Pharmaceuticals Inc.

“Interesting new data and very relevant to the field.”
- Senior Scientist, Process Development, Amgen, Inc.

“Provided good overview of current problems and progress in the field.”
- Scientist, Bioanalytical Sciences, Immunogen

“Congratulations on a very well put together conference.”
- Assistant Vice President, Pfizer

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• Keynote & Featured Speakers •

Bori Gorovits

Boris Gorovits, Ph.D., Senior Director, PDM, Pfizer, Inc.

Joao Pedras-Vasconcelos

Joao Pedras-Vasconcelos, Ph.D., Biotech Quality and Immunogenicity Reviewer, Office of Biotechnology Products, CDER-FDA

Valerie Quarmby

Valerie Quarmby, Ph.D., Staff Scientist, BioAnalytical Sciences, Genentech, Inc.

Susan Richards

Susan Richards, Ph.D., Presidential Scientific Fellow, Translational Medicine Early Development, Sanofi R&D

Melody Sauerborn

Melody Sauerborn, Ph.D., Head, Research and Development, Mymetics BV

Perceval Sondag

Perceval Sondag, Senior Statistician, Non-Clinical Statistics, Arlenda

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2016 Immunogenicity and Bioassay Summit Brochure

2016 Immunogenicity and Bioassay Summit Brochure  

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