12th Open Scientific EIP Symposium on Immunogenicity of Biopharmaceuticals
1st — 4th March 2021
Virtual
Program
Monday, March 1st 2021 |
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| 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) |
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| 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) |
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| 18:00 | Close of the training course | |||
Tuesday, March 2nd 2021 |
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| 13:50 | Coming together | |||
| 14:00 |
Welcome and Introduction by the EIP chairman Daniel Kramer (Sanofi) |
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Session 1: Immunogenicity Testing & Clinical Relevance Chair: Arno Kromminga |
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| 14:15 |
EIP Assay Strategy Working Group update Veerle Snoek (UCB) |
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| 14:40 |
Development/Validation of an extremely drug & target tolerant ADA assay Karin Benstein (Sanofi) |
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| 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) |
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| 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) |
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| 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) |
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| 17:00 |
Panel Discussion including Q&A All speakers |
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| 17:20 | End of Main Conference Day 1 | |||
Wednesday, March 3rd 2021 |
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Session 2: Prediction of Immunogenicity Chair: Sofie Pattijn |
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| 13:50 | Coming together | |||
| 14:00 |
EIP NCIRA Working Group update Sebastian Spindeldreher (Integrated Biologix) |
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| 14:25 |
Enabling Routine MHC-II Associated Peptide Proteomics(MAPPs) for Risk Assessment of Drug-Induced Immunogenicity Axel Ducret & Guido Steiner (Roche) |
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| 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) |
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| 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) |
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| 16:10 |
EIP Assay Strategy Working Group update Arno Kromminga (BioAgilytix) |
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| 16:35 |
Q&A All speakers |
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| 16:50 |
EIP song Chloé Ackaert (ImmunXperts) |
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| 17:00 | End of Main Conference Day 2 | |||
Thursday, March 4th 2021 |
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Session 3: Regulatory Chair: Daniel Kramer |
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| 13:50 | Coming together | |||
| 14:00 |
Experience with the “Integrated Summary of Immunogenicity” in the US João A. Pedras-Vasconcelos (CDER/FDA) |
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| 14:25 |
Experience with the “Integrated Summary of Immunogenicity” – The consultant’s perspective Paul Chamberlain (Immunogenicity Integrated) |
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| 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) |
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| 15:45 |
Perspective and challenges in developing an “Integrated Summary of Immunogenicity” Sue Richards (Sanofi-Genzyme) |
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| 16:10 |
Panel discussion “Integrated Summary of Immunogenicity” including Q&A All speakers |
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| 16:30 |
Conference summary and Outlook by the EIP Chairman Daniel Kramer (Sanofi) |
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| 16:45 | Close of the conference | |||