European Bioanalysis Forum

Slides – EBF Focus Workshop 2022

Program of EBF Focus Workshop  “Points to Consider on Cut Points” April 28-29, 2022

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: 28 April 2022 (all times are in CET = Brussels Time zone)
12:45 13:00 Getting started – Welcome
Philip Timmerman – EBF
13:00 14:00 Session 1: Introduction to the meeting and problem statement
Jo Goodman – on behalf of the EBF
Robert Nelson – on behalf of the EBF
Introduction presentation to introduce the items discussed at the meeting, includes but not limited to: Cut Points  (CPs) – what and why; Difference from PK assays (CoU); In study vs. validation CP; Clinical relevance of CPs; regulatory challenges; the changing landscape on ADA and new modalities
14:00 15:40 Session 2: (Strategic) Thoughts to consider
14:00 14:20 Kyra Cowan, on behalf of the EBF
Increasing challenges: feedback from discussions in the EBF
14:20 14:40 Nicoline Videbæk, on behalf of the EBF NAb team
Cut point considerations for Nab assays from the EBF
14:40 15:00 Devangi Mehta, Immunologix Laboratories
Beyond the Confirmatory Cut point – Reconsidering the value of the confirmatory tier
15:00 15:20 Heather Revell, Labcorp Drug Development
Assessing specificity of ADA to multi-domain protein therapeutics
15:20 15:40 Panel discussion/ Q&A
15:40 16:00 Break
16:00 18:30 Session 3 – Case studies (including a short logistic break)
16:00 16:20 Sebastien Boridy, Charles River Laboratories
Overcoming challenges in experimental design for in-study cut-point determination
16:20 16:40 Jenny Valentine, Regeneron
Population Specific Cut Points in Oncology: Do We Really Need a Different Cut Point for Every Tumor Type?
16:40 17:00 Matt Horsham, LGC
Where do we draw the line? – Investigating low analytical cutpoints and the impact on in study cut points
17:10 17:30 Brendy Van Butsel, Sanofi
Applying in-study cut-points in a rare-disease setting
17:30 17:50 Harley Williams (replacing Marleen Lutz), Celerion Switzerland AG
Challenges in the detection of anti-Filgrastim antibodies facing a low false positive rate
17:50 18:10 Hisanori Hara, Novartis Pharma AG
A case study of cut point evaluations at early stages of clinical studies and how to provide reliable interim ADA results
18:10 18:30 Mafalda dos Santos Marques Resende, Novo Nordisk
In-study CP setting in NAb assays – a case study
18:30 19:00 Close out Q&A
19:00 Day 1 adjourn
Day 2: 29 April 2022
13:00 14:40 Session 4: Cross validation, general considerations and case studies
13:00 13:20 Michaela Golob, on behalf of the EBF
introduction to the session and feedback from discussions in the EBF ADA team
13:20 13:40 Alok Rathi, EMD Serono
Cross-Validation of a Neutralizing Antibody Assay Across Global Sites For A Multi Domain Protein
13:40 14:00 Yang Xu, Merck Sharp & Dohme
Experiences and Challenges in Evaluation of ADA Assay Performance with the Same ADA Method Across Multiple Laboratories
14:00 14:20 Amy Lavelle, on behalf of the AAPS NABH (Neutralizing Antibody Harmonization) sub team
Harmonized Approach to Cross Validations of ADA and Nab Immunoassays
14:20 14:40 Panel discussion
14:40 15:00 Break
15:00 16:00 Session 5 – Thinking outside the box-plot
15:00 15:20 Gregor Jordan, Roche Diagnostics GmbH
Screening assay data transformation – can a Weibull transformation help to achieve the theoretical FPR?
15:20 15:40 George Walters, LGC
Advantages and Challenges of Automation in Immunogenicity
15:40 16:00 Atiya Taqui, Gilead Sciences
Random and Fixed Effects Model for Cut Point Determination
16:00 16:20 Daniel Baltrukonis, Pfizer, Inc.
Simplifying and Automating Anti-Drug Antibody Cut Point Determination
16:20 16:40 Panel discussion
16:40 17:00 Break
17:00 18:00 Session 6: Regulatory expectations and challenges, including ISI and closing panel discussion
17:00 17:20 Johannes Stanta, on behalf of the EBF
Overview of regulatory expectations for cut points for pre-existing Ab
17:20 17:40 Paul Chamberlain, Immunogenicity Integrated Platform
How to use the Integrated Summary of Immunogenicity (ISI) for effective communication of ADA assay cut point strategy and method life-cycle history to regulators
17:40 18:00 Close out panel discussion – summarising questions and discussions from the workshop and from  questions submitted prior to the workshop
18:00 Adjourn
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