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6th Open Scientific EIP Symposium on Immunogenicity of Biopharmaceuticals

24th - 26th February 2014

Lisbon, Portugal

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Monday, February 24th, 2014

Cutpoint estimation assuming a mixing distribution within the mixed model - using R
Ludwig A. Hothorn (Leibniz University Hannover, Germany)
Challenges for the determination of cutpoints
Sabine Bader, Nicole Justies, Thomas Emrich, Kay-Gunnar Stubenrauch, Julia Heinrich (Roche)
Controlling the rate of false positives in future tests. A Bayesian perspective.
Bruno Boulanger (Arlenda, Belgium)
The Role of Biostatistics in Immunogenicity Testing
Gopi Shankar (Janssen)
Simplified strategy for Immunogenicity cutpoint evaluations & some practical considerations
V. Devanarayan (AbbVie)

Tuesday, February 25th, 2014

Neutralizing Antibody Assays CLB vs. Bioassays
Deborah Finco
Immunogenicity and response to biologics
Christian Jorgensen (INSERM)
The effect of DMARDs on immunogenicity of anti­‐TNFs
Meghna Jani (MRC - Medical Research Council)
The Clinical Impact of Drug Immunogenicity
Sandra Garcês (Gulbenkian Institute of Science)
Revised EMA immunogenicity guideline, other guidelines and reflections on unwanted immunogenicity
Robin Thorpe
Alternative Approaches for Assessment of Drug Neutralizing Activity of ADA Responses
Arjen Companjen (on behalf of European Bioanalysis Forum topic team 19)

Wednesday, February 26th, 2014

Detection of Immune Complex Formation in Non-Clinical Studies and Implications for Clinical Risk Assessment
Steven Swanson (AMGEN)
Sources of Immunogenic Nano- and Microparticles in Therapeutic Protein Products: Bioprocessing, Shipping, and Mishandling by Clinics and Patients
John F. Carpenter (University of Colorado)
The new mouse model tolerant to hIFNß
Mohadeseh Haji Abdolvahab (Universiteit Utrecht)
Antibody Immunogenicity
Herman Waldmann
Anti-Biopharmaceutical Immunization: Prediction and analysis of clinical relevance to minimize the risk “Achievements 2013 and plan for 2014”
Marc Pallardy (INSERM)
WP3: Evaluation and development of technologies for predicting immunogenicity
Bernard Maillere (CEA)
Aggregation of therapeutic proteins after mixing with human plasma: implications for drug development
Tudor Arvinte (Therapeomic)
Tregitopes: Their role in the prediction and mitigation of immunogenity
Anne S. De Groot (EpiVax)
Can we use cellular markers to predict immunogenicity?
Elizabeth Jury (University College London)
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