Immunogenicity and Bioassay Summit
  • Preliminary Agenda Now Available
  • Attend the Number 1 Immunogenecity Summit in the U.S. and Join 250+ of Your Peers  About the Summit
  • Sponsorship & Exhibit Opportunities are Available!
 
REASONS TO CHOOSE CHI’s IMMUNOGENICITY AND BIOASSAY SUMMIT 2015 
  • 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
  • 4 Short courses: Focussing on assay development, risk assessment and regulatory strategy, and on bioassay design and analysis

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

Dinner Short Courses
 
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.,

Biologist, Virology Interest Group, CBER-FDA, Director, Therapeutic Proteins, FDA/CDER

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

SUMMIT FEATURES 

  • 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 

 

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Register Now 


 2014 Brochure Cover 

Podcast 

IMN Podcast iconReducing and Monitoring Bioassay Variability 

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