Slides – EBF Training Day 2021
Program of EBF Focus Workshop “Biomarker Assay Validation – Bringing Context of Use into practice” March 23-24, 2021
PDF renditions of the powerpoint presentations given at the Focus Workshop can be viewed and downloaded from this page. The program itself can be viewed and downloaded by clicking here
| Day 1: 23 March 2021 | ||||
| Times are in CET-zone (Brussels) | ||||
| 12:30 | 12:45 | Coming online | ||
| 12:45 | 13:00 | Getting started – Welcome | ||
| Philip Timmerman – EBF | ||||
| 13:00 | 15:30 | Day 1 – Session 1 | ||
Session chair: Jo Goodman, AstraZeneca |
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| 13:00 | 13:30 | Jo Goodman, on behalf of the EBF | ||
| Immunogenicity – an introduction | ||||
| 13:30 | 13:50 | Rob Nelson, on behalf of the EBF | ||
| Immunogenicity and regulations | ||||
| 13:50 | 14:10 | Anna Laurén, on behalf of the EBF | ||
| EBF recommendation on preclinical ADA | ||||
| 14:10 | 14:40 | Roland Staack, on behalf of the EBF | ||
| Drug Tolerance target interference | ||||
| 14:40 | 15:00 | Viswanath Devanarayan, GlaxoSmithKline | ||
| Cutpoint settings | ||||
| 15:30 | 18:00 | Day 1 – Session 2 | ||
Session chair: Michaela Golob, Nuvisan |
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| 15:30 | 16:00 | Viswanath Devanarayan, GlaxoSmithKline | ||
| Outlier exclusion, including Q&A on CP/Outlier exclusion | ||||
| 16:00 | 16:30 | Mantas Malisauskas – Merck KGaA | ||
| Pre-existing ADA: why should we care? | ||||
| 16:30 | 16:50 | James Lawrence – F-Star | ||
| Characterisation | ||||
| 16:50 | 17:10 | Meina Liang – AstraZeneca | ||
| Case study on domain specificity | ||||
| 17:10 | 17:30 | Ingeborg Dreher, on behalf of the EBF | ||
| Towards an EBF recommendation on nAb | ||||
| 17:30 | 18:00 | Nicoline Videbaek – NovoNordisk | ||
| nAb assay case study – Much ado about nothing? | ||||
| including session Q&A | ||||
| 18:00 | 19:00 | Zoom session stays open for post meeting interactions | ||
| 19:00 | Zoom session closes | |||
Day 2: 24 March 2021 |
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12:45 |
13:00 |
Coming online |
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13:00 |
15:30 |
Day 2 – Session 3 | ||
Session chair: Robert Nelson, Covance |
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| 13:00 | 13:30 | Arno Kromminga – BioAgilytix | ||
| New Modalities – New Challenges or more of the same? | ||||
| 13:30 | 14:00 | James Munday – on behalf of the EBF C> Team | ||
| CGT immunogenicity overview | ||||
| Immunogenicity assessments against the transgene product | ||||
| 14:00 | 14:30 | Manuela Braun – on behalf of the EBF C> team | ||
| Immunogenicity pre-screening in CGT development | ||||
| 14:30 | 15:00 | Christian Joffroy – Novartis | ||
| Flow cytometry based IG assays for CART | ||||
| 15:00 | 15:30 | Q&A | ||
| 16:00 | 18:00 | Day 2 – Session 4 | ||
Session chair: Kyra Cowan, Merck KGaA |
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| 16:00 | 16:30 | Kyra Cowan – Merck KGaA | ||
| Clinical Immunogenicity: Case Studies in the Life Cycle of ADA Assays | ||||
| 16:30 | 16:50 | Daniel Kramer – Sanofi | ||
| Risk Based Approach | ||||
| 16:50 | 17:10 | Jonas Blaes – AbbVie | ||
| Regulatory requirements translated into day-to-day practice | ||||
| 17:10 | 17:30 | Michael Partridge – Regeneron | ||
| Are we over reporting ADA? | ||||
| 17:30 | 18:00 | Close out discussion and Q&A | ||
18:00 |
Adjourn |
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| 18:00 | 19:00 | Zoom session stays open for post meeting interactions | ||
| 19:00 | Zoom session closes | |||
