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:
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) |