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Methods for Pre-screening Protein Therapeutics for Potential Clinical Immunogenicity
Sunday, November 11
8:30 am – 4:00 pm
Short Course
ACPE #073-999-07-505-L04
The screening of biological compounds for T cell immunogenicity plays an important role in the safety and efficacy of protein therapeutics. There is a considerable amount of interest in this area of research and it is important to provide developers with the necessary information about the tools and options that are available to reliably assess their compound. Which tools are the most effective and appropriate for preclinical screening of protein therapeutics? This lively debate will help to frame the question and speed the development of safer protein therapeutics. The goal of this meeting is to begin to develop a consensus on the role of cellular immunity (T helper cells and T regulatory cells) in the development of anti-drug antibodies and immune-related adverse events such as aplastic anemia following the administration of erythropoietin. In addition, methods for predicting and confirming T cell immunogenicity (in silico, in vitro and in vivo) will be compared and contrasted. New theories about immunogenicity and standards for the determination of immunogenicity will be discussed. An attempt will be made to clarify what is known about the contribution of cellular immune response to protein therapeutics (drawing from what is known about protein immunogens such as vaccines) and what is not known including such topics as the role of T regulatory cells and cytotoxic T cells.
Moderators
Steve Swanson, Ph.D.
Amgen, Inc.
Amy N. Rosenberg, M.D.
U.S. Food and Drug Administration
Preclinical Screening for Immunogenicity
Gene Koren, Ph.D.
Scios, Inc.
What Makes Proteins Immunogenic? How to Predict, Measure and Fix?
Annie S. De Groot, Ph.D.
EpiVax and Brown University
Tolerance vs. Immunogenicity, the Role of T Reg Cells
David W. Scott, Ph.D.
University of Maryland, School of Medicine
Confirming Predictions: HLA Binding Assays
Bill Kwok, Ph.D.
Benaroya Research Institute at Virgina Mason
Monoclonal Antibody Immunogenicity
Geoff Hale, Ph.D.
BioAnaLab Limited
Transgenic Mice as a Model for Immunogenicity Screening
Huub Schellekens, Ph.D.
Utrecht University