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 | |||
