EBF
EBF
EBF
European
Bioanalysis
Forum


EBF vzw is the registered non-profit organisation of the European Bioanalysis Forum

 

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
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
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
12:45
13:00
Coming online
13:00
15:30
Day 2 – Session 3
Session chair: Robert Nelson, Covance
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&GT Team
CGT immunogenicity overview
Immunogenicity assessments against the transgene product
14:00 14:30 Manuela Braun – on behalf of the EBF C&GT 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
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
18:00 19:00 Zoom session stays open for post meeting interactions
19:00 Zoom session closes