Immunogenicity Summit
Archived Content

Mark Your Calendar for Immunogenicity Summit 2013! November 11-13, 2013
Hyatt Regency on Capitol Hill, Washington, DC
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The Leading Summit Connecting Industry, Academia and Regulators on Immunogenicity Testing, Immunogenicity Avoidance and Regulatory Guidance

 

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A 2-part event covering developments in assay technologies, risk assessment, regulatory guidance and means of predicting and avoiding immunogenicity
 

Following year-on-year success, CHI presents their fourth Immunogenicity Summit. We will continue to provide strong interaction and discussion with the regulatory authorities (40 FDA representatives in 2011), updates on immunogenicity testing strategies and means of controlling immunogenicity. New this year will be a focus on characterization and impact of immune complexes, in vivo assessment with immune tolerant mice, and anti-idiotype assays for hypersensitivity.  Last year's attendance was up by 20% with over 250 attendees representing over 50 global organizations.

PART ONE:

Immunogenicity Assessment and Clinical Relevance
October 10-11 

COMBINED SESSION:

Regulatory Guidance
October 11 

PART TWO:

Immunogenicity Prediction and Mitigation
October 11-12 


Pre-Conference Short Courses

October 9 

SC1: Assays for Measuring Binding Antibodies

SC2: Neutralizing Antibody Assays

SC3: Navigating the Regulatory Hierarchy of Concerns to Minimize the Impact of Immunogenicity-Related Risks on Product Registration (Dinner Short Course) 

 


Keynote & Featured Speakers

Steve SwansonSteve J. Swanson, Ph.D.
Director, Medical Sciences, Clinical Immunology, Amgen 

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

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

Daniela VerthelyiDaniela Verthelyi, M.D., Ph.D.
Chief, Immunology, Therapeutics Proteins, CDER/FDA 

Jack RaghebJack Ragheb, M.D., Ph.D.
Principal Investigator, Immunology, Therapeutic Proteins, CDER/FDA 

Paul ChamberlainPaul Chamberlain
NDA Advisory Board 

Roy JefferisRoy Jefferis, Ph.D.,
C.Chem, FRSC, MRCP, FRCPath, D.S., Professor Emeritus, School of Immunity & Infection, University of Birmingham UK 

Valerie Quarmby, Ph.D.
Director and Principal Scientist, BioAnalytical Sciences, Genentech, Inc. 



Quotes 

 

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Podcast 

IMN Podcast iconReducing and Monitoring Bioassay Variability 

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