EIP Symposium

12th Open Scientific EIP Symposium
Immunogenicity of Biopharmaceuticals




March 1st - 4th 2021



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 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 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 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 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 & Outlook by the EIP Chairman
Daniel Kramer, Sanofi
16:45 Close of the conference