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10th Open Scientific EIP Symposium on Immunogenicity of Biopharmaceuticals

25th - 27th February 2019

Lisbon, Portugal

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Monday, February 25th, 2019

Deployment of the immunogenicity risk assessment assay-suite for protein design, risk assessment and de-immunization
Sophie Tourdot
FDA Recommendations on Integrated Summaries of Immunogenicity from Phase 1 IND to BLA and Beyond
João A. Pedras-Vasconcelos (OPQ/CDER/FDA)
In Silico & In Vitro Tools for Preclinical Immunogenicity Risk Assessment
Noel Smith
Immunology and causes of unwanted immunogenicity
Sofie Pattijn
Drug Tolerance and Target Interference
Arno Kromminga
Practical advice & insights on Immunogenicity cut points and some assay validation parameters
V. Devanarayan (Charles River Laboratories)
New FDA Immunogenicity Guideline
Daniel Kramer

Tuesday, February 26th, 2019

EIP Assay Working Group Update
Veerle Snoeck
Modulation of immunogenicity by engineered antigen-specific regulatory T cells: Fighting fire with fireman or police CARs
David W. Scott (Uniformed Services University of the Health Sciences)
The effect of neo-epitopes on the immunogenicity of antibody aggregates in a human IgG1 Tg mice
Juliana Bessa (Roche)
Immunogenicity of Insulins in Biosimilar Development
Sandeep N. Athalye (Biocon)
EIP Biosimilars Working Group update
Martin Ullmann
Immunogenicity Testing of Therapeutic Antibodies in Ocular Fluids After Intravitreal Injection
Afsaneh Abdolzade-Bavil (Roche)
Immunogenicity assessment of GP2017: A biosimilar to reference adalimumab
Anita Rudy (Sandoz)

Wednesday, February 27th, 2019

Evaluation of clinical impact in heterogeneous populations and additional monitoring of ADA and PK parameters using appropriately sensitive & specific bioanalytical methods
Anna Fogdell-Hahn (Karolinska University Hospital)
The development of a quantitative systems pharmacology platform to predict and manage immunogenicity in clinical development
Mario Giorgi, Piet van der Graaf & Andrzej Kierzek (Certara QSP)
“Human Immune System” mouse models for preclinical risk assessment
Nicolas Legrand (genOway)
Innovative methods for predicting clinical immunogenicity with high dimensional data
Philippe Broët (Université Paris-Saclay)
Clinical relevance of (unwanted drug-induced) immune responses
Arno Kromminga (presented by Lydia Michaut)
Towards assessment of clinically relevant immunogenicity of monoclonal antibodies
Theo Rispens (Sanquin)
Non-clinical Immunogenicity Risk Assessment (NCIRA)
Sebastian Spindeldreher
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