Breakout Discussions Part One, Wednesday October 10:
Table 1: Challenges in Developing Neutralizing Antibody Assays
Moderator: Deborah Finco, Ph.D., Senior Principal Scientist, Immunotoxicology COE, Pfizer, Inc.
Table 2: Dealing with Pre-existing Positive ADA Activity in Study Patients
Moderator: Jim McNally, Ph.D., Senior Principal Scientist, Pfizer, Inc.
Table 3: Practical Application of Immunogenicity Pre-Clinical Risk Assessment
Moderator: Paul Chamberlain, NDA Advisory Board
Table 4: Detection of Immune Complexes and Their Impact on Immunogenicity Assessment
Moderator: Steve J. Swanson, Ph.D., Executive Director, Medical Sciences, Clinical
Immunology, Amgen, Inc.
Table 5: Immunogenicity Testing During Clinical Trials
Moderator: Frank F. Weichold, M.D., Ph.D., Director, Clinical Pharmacology and DMPK, Translational Science, MedImmune, LLC
Table 6: IgE Anti-drug Assay Development and Validation
Jörgen Dahlström, Ph.D., MBA, Scientific Director, ImmunoDiagnostics, Thermo Fisher Scientific
Breakout Discussions Part Two, Friday October 12:
Table 1: Product-related Factors that Contribute to Immunogenicity
Moderator: Wim Jiskoot, Ph.D., Professor, Division of Drug Delivery Technology, Leiden University
Table 2: To what Extent can Immunogenicity Prediction affect the Clinical Strategy?
Moderator: Timothy Hickling, Ph.D., Associate Research Fellow, PDM Immunogenicity Sciences, Pfizer, Inc.
Table 3: Immune Tolerance Approaches
Moderator: Amy Rosenberg, M.D., Director, Therapeutic Proteins, CDER/FDA
Table 4: Relevance of Animal Models for Predicting the Immunogenicity of Therapeutic Proteins
Jack Ragheb, M.D., Ph.D., Principal Investigator, Immunology, Therapeutic Proteins, CDER/FDA
Delegates attending the Immunogenicity Summit 2012 may track-hop to the sessions at CHI’s concurrent event, PK/PD of Novel Constructs: Bispecific Antibodies, Antibody Fragments, and ADCs.
Complete event and registration details are online: http://www.ImmunogenicitySummit.com.
To inquire about sponsoring and/or exhibiting, contact Tim McLucas, 781-972-1342, email@example.com.
Writers and editors are encouraged to attend. To request a press pass, contact Lisa Scimemi at firstname.lastname@example.org.
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