Thursday, June 26, 2008: Short Courses
An additional fee is required to attend all short courses.
8:30 am - 5:00 pm
Short Course #3: Unwanted Immunogenicity of Protein Therapeutics
An additional fee is required to attend all short courses.
This short course is aimed to provide a comprehensive update of our current understanding of unwanted immunogenicity of protein therapeutics. Immunological backgrounds, including the possible role of B-cells and T-cells in the immunogenicity of self and non-self proteins, will be provided. Insight into product-related factors (in particular, protein structure and formulation), non-product-related factors, clinical implications, clinical evaluation and standardization of immunogenicity assessment, strategies to minimize or overcome immunogenicity, predictive models, immunogenicity of follow-on biologics including risk analysis, and regulatory aspects including FDA/EMEA guidelines will be addressed.
Moderators
Huub Schellekens, M.D., Ph.D.
Utrecht University
Wim Jiskoot, Ph.D.
Leiden University
Introduction to the subject and clinical implications
Huub Schellekens, M.D., Ph.D.
Utrecht University
Amy S. Rosenberg, M.D.
U.S. Food and Drug Administration
Immunological Background
Martin Bachmann, Ph.D.
Cytos Biotechnology Ag
Immunogenicity Assays - Development and Implementation Strategies
Meena Subramanyam, Ph.D.
Biogen Idec, Inc.
Prediction of Immunogenicity: Transgenic Animals
Wim Jiskoot, Ph.D.
Leiden University
Prediction of Immunogenicity: In Silico Screening Methods
Philippe Stas, Ph.D.
Algonomics NV
Risk Analysis and Management of Immunogenicity
Huub Schellekens, M.D., Ph.D.
Utrecht University
Regulatory Issues - FDA Perspectives
Amy S. Rosenberg, M.D.
U.S. Food and Drug Administration
Regulatory Issues- EMEA Perspectives
Manfred Haase, D.V.M.
ex-CHMP