EIP logo

Copyright © 2007-2022 European Immunogenicity Platform

Location photo

12th Open Scientific EIP Symposium on Immunogenicity of Biopharmaceuticals

March 1st — 4th 2021

Virtual

Programme

 

Monday, March 1st 2021

Training course
13:50 Coming together
Cut-Point Statistics
14:00 Hand on training cut-point statistics
Viswanath Devanarayan (GSK) & Ron Bowsher (B2S) & Amy Rosen (B2S)
14:00 Cut point evaluations and related considerations, including Q&A
15:00 Cut Point+ software demo/training, including Q&A
15:45 New data transformation strategy for normalization of signal responses, including Q&A
16:15 Closing remarks
16:30 coffee Break (with opportunity to visit the booths of our sponsors)
17:00 Tool for immunogenicity cut-point calculation and outlook for further statistical development
Els Pattyn (Ablynx, a Sanofi company) & Valerie Martin (Sanofi)
18:00 Close of the training course
 

Tuesday, March 2nd 2021

13:50 Coming together
14:00 Welcome and Introduction by the EIP chairman
Daniel Kramer (Sanofi)
Session 1: Immunogenicity Testing & Clinical Relevance
Chair: Arno Kromminga
14:15 EIP Assay Strategy Working Group update
Veerle Snoek (UCB)
14:40 Development/Validation of an extremely drug & target tolerant ADA assay
Karin Benstein (Sanofi)
15:05 Antibody-reagent complex formation as a critical factor for optimization of immunogenicity assays: A novel approach to justify comparability of ADA assays
Gregor Jordan (Roche)
15:30 coffee Break (with opportunity to visit the booths of our sponsors)
16:00 Cas9 Immunogenicity: Hindering introduction of CRISPR genome editing into clinics or crying wolf?
Zuben Sauna (CBER/FDA)
16:25 And the Children Shall Lead the Way: Benefits of therapeutic drug monitoring and immunogenicity testing for optimal patient outcomes
Amy Rosenberg (CDER/FDA)
17:00 Panel Discussion including Q&A
All speakers
17:20 End of Main Conference Day 1
 

Wednesday, March 3rd 2021

Session 2: Prediction of Immunogenicity
Chair: Sofie Pattijn
13:50 Coming together
14:00 EIP NCIRA Working Group update
Sebastian Spindeldreher (Integrated Biologix)
14:25 Enabling Routine MHC-II Associated Peptide Proteomics(MAPPs) for Risk Assessment of Drug-Induced Immunogenicity
Axel Ducret & Guido Steiner (Roche)
14:50 TCPro, a novel model describing the ex vivo immune response to therapeutic proteins and its use for assigning immunogenicity risk
Osman Yogurtcu (CBER/FDA)
15:15 coffee Break (with opportunity to visit the booths of our sponsors)
15:45 A high throughput dendritic cell internalization and processing assay for preclinical immunogenicity assessment: development, qualification, and extension
Yi Wen (Eli Lilly and Company)
16:10 EIP Assay Strategy Working Group update
Arno Kromminga (BioAgilytix)
16:35 Q&A
All speakers
16:50 EIP song
Chloé Ackaert (ImmunXperts)
17:00 End of Main Conference Day 2
 

Thursday, March 4th 2021

Session 3: Regulatory
Chair: Daniel Kramer
13:50 Coming together
14:00 Experience with the “Integrated Summary of Immunogenicity” in the US
João A. Pedras-Vasconcelos (CDER/FDA)
14:25 Experience with the “Integrated Summary of Immunogenicity” – The consultant’s perspective
Paul Chamberlain (Immunogenicity Integrated)
14:50 coffee Break (with opportunity to visit the booths of our sponsors)
15:20 Experience with the “Integrated Summary of Immunogenicity” in the EU
Günter Waxenecker (AGES)
15:45 Perspective and challenges in developing an “Integrated Summary of Immunogenicity”
Sue Richards (Sanofi-Genzyme)
16:10 Panel discussion “Integrated Summary of Immunogenicity” including Q&A
All speakers
16:30 Conference summary and Outlook by the EIP Chairman
Daniel Kramer (Sanofi)
16:45 Close of the conference
Back to top