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
