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9th Open Scientific EIP Symposium on Immunogenicity of Biopharmaceuticals

13th - 16th November 2017

Lisbon, Portugal

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Monday, November 13th, 2017

Validation of ADA Assays – Recent experiences and issues
Arno Kromminga & Daniel Kramer
Advice on Putting Together an Integrated Summary of Immunogenicity
Paul Chamberlain (NDA)
Integrated Summaries of Immunogenicity: An FDA Reviewer’s Wish List
João A. Pedras-Vasconcelos (OPQ/CDER/FDA)

Tuesday, November 14th, 2017

From Assessment of Immune Responses to Therapeutic Proteins to Clinical Challenges: Addressing the Role of the Immune System in Complex Diseases
Amy S. Rosenberg (FDA)
FDA Regulatory Perspectives on Immunogenicity Risk Assessment from Phase 1 IND to BLA and Beyond
João A. Pedras-Vasconcelos (OPQ/CDER/FDA)
Novel Aspects of the latest EMA immunogenicity guideline
Pekka Kurki (University of Helsinki)
Pre-existing antibodies and the multi-tiered assay approach: Experience with the FDA
Madeleine Dahlbäck (Novo Nordisk)
Clinical Immunogenicity Testing: The Regulatory Challenge - Experience with the FDA
Szilard Kamondi (Roche)
Innovative approach for the quantitative analysis of therapeutic monoclonal antibody (mAb), and simultaneous characterization of Anti-Drug Antibodies (ADA)
Gilles Miscoria (Sanofi)
Assay Strategies to Analyse New Antibody Therapeutics in Preclinical and Clinical Studies
Kay Stubenrauch (Roche)
Determination of ADA in IFNβ treated MS patients
Anna Fogdell-Hahn (Karolinska Institutet)
Regulatory Panel

Wednesday, November 15th, 2017

“Immunotoxicity of Biologics”
Marc Pallardy (University Paris-Sud)
Preliminary data from the prospective ABIRISK IBD cohort: Clinical response and anti-drug antibodies
Matthieu Allez (ABIRISK)
Highly reproducible, sensitive and early detection and characterization of antidrug responses using RNA-seq
Niek de Vries (ABIRISK)

Thursday, November 16th, 2017

HLA class II peptide binding, T cell recognition and the deimmunization of proteins
Alessandro Sette
Role of T-cells in immunogenicity of biologics in Intesinal Bowel disease
Enrico Maggi (ABIRISK)
FVIII immunogenicity: Lessons from 5 years of ABIRISK… and beyond
Sébastien Lacroix-Desmazes (ABIRISK)
WP3: Evaluation of different T cell assay formats
Sebastian Spindeldreher (ABIRISK)
Response to T cell epitopes of therapeutic antibodies in healthy donors and in patients
Bernard-Maillere (Frederic Joliot Institute)
AAPS perspective on predictive assays
Vibha Jawa (Merck)
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