9th Open Scientific EIP Symposium on Immunogenicity of Biopharmaceuticals
13th — 16th November 2017
Lisbon, Portugal
Downloads
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)
