EBF Focus

EBF Alpha to Omega Events

Due to anticipated continued COVID-19 travel restrictions,
the EBF will continue to host interactive training days / workshops 2022.
Click on below tabs to see the details of the first meeting:
Points to Consider on Cut Points – 28-29 April 2022

Agenda Details

Day 1: 28 April 2022
(all times are in CET = Brussels Time zone)
12:15 Zoom opens – Coming online
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/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
Session includes Q&A for items that are not covered later in the workshop
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
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
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
17:00 17:10 Short (logistic) break
17:10 17:30 Brendy Van Butsel, Sanofi
Applying in-study cutpoints to multiple characterization assays in a rare-disease indication, a case study
17:30 17:50 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
(all times are in CET = Brussels Time zone)
12:30 Zoom opens – Coming online
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, 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 16:40 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 16:50 Short logisitic Break
16:50 18:30 Session 6: Regulatory expectations and challenges, including ISI and closing panel discussion
16:50 17:10 Johannes Stanta, on behalf of the EBF
Overview of regulatory expectations for cut points for pre-existing Ab
17:10 17:30 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
17:30 17:50 Open slot
Sharing industry Experiences with Health Authorities on Cut Point  discussions
17:50 18:30 Close out panel discussion – summarising questions and discussions from the workshop and from  questions submitted prior to the workshop
18:30 Adjourn
18:30 19:00 Zoom session remains open to allow 1/1 chat interactions
Organising Committee: Kyra Cowan (Merck KGaA), Michaela Golob (Nuvisan), Joanne Goodman (AstraZeneca), Hisanori Hara (Novartis), Johannes Stanta (Freeline Therapeutics), Robert Nelson (Labcorp Drug Development) and Philip Timmerman (EBF)