Challenging the Current Paradigm for ADA Testing
21-22 September 2023, NH Málaga, Spain
Slides – EBF Workshop 2020
Day 1 – 15 SEP 2020
timezone = CET (Brussels time zone)
| 13:00 – 13:10 | Coming online – Welcome – Meeting dynamics |
| 13:10 – 15:00 | Session 1 – Context of Use – the problem statement |
| 13:10 – 13:30 | Wrong Data – Wrong Decisions: the CoU Problem Statement |
| Jo Goodman, AstraZeneca | |
| 13:30 – 13:50 | Are we informed – have we informed ? The end user’s voice |
| Tova Landström, Ferring Pharmaceuticals | |
| 13:50 – 14:10 | Be Specific – Putting Biomarker Assay Validation in context |
| Lauren Stevenson – Immunologix | |
| 14:10 – 14:30 | Current understanding of COU and its impact – Results from the 2020 AAPS Survey |
| Yan Ni, Passagebio | |
| 14:30 – 14:50 | LC-MS/MS Biomarker Assay Validation Considerations from the New Guidance: Discussion of the Upcoming AAPS Whitepaper Recommendations |
| Carmen Fernandez-Metzler – PharmaCadence | |
| 14:50 – 15:00 | Q&A |
| 15:00 – 18:30 | Break – for C> TD delegates, go to session 1 of the C> TD (16:00 – 18:00) |
| 18:30 – 20:00 | Session 2 – Applications: Is there convergence or divergence with CoU principles? |
| 18:30 – 18:40 | Coming online |
| 18:40 – 19:00 | Biomarker assay development: Translation from research into clinical trials |
| Tobias Marquardt, Bayer (not released for publication) | |
| 19:00 – 19:20 | Biomarker Assay Validation and Context of Use: A CRO’s Perspective From Discovery through Clinical Drug Development |
| Sophie Cotton, Charles River Laboratories (not released for publication) | |
| 19:20 – 19:40 | Biomarker assays in a bioanalytical environment – a case study |
| Dorte Kornerup Ditlevsen – Lundbeck | |
| 19:40 – 20:00 | The Influence of Context of Use (CoU) on Biomarker Method Development and Validation |
| Krystal Alligood – BioAgilytix | |
| 20:00 | End of day 1 |
Day 2 – 16 SEP 2020
timezone = CET (Brussels time zone)
19:30– 19:50Cytokines as Biomarkers of Immunotoxicity in Preclinical Safety Assessment: Navigating “Context of Use”
| 13:00 – 14:30 | Session 3 – The Building Blocks of a Good BM Assay |
| 13:00 – 13:10 | Introduction to the session |
| John Allinson/Lauren Stevenson – Immunologix | |
| 13:10 – 13:30 | Considerations on matrix sources for biomarker assays |
| Radboud van Trigt, PRAHS | |
| 13:30 – 13:50 | EBF feedback for critical reagents in LBA biomarker assays |
| Susanne Pihl, on behalf of the EBF | |
| 13:50 – 14:10 | Parallelism Acceptance Criteria: Driven by Context of Use |
| Marc-Olivier Pepin, Charles River Laboratories | |
| 14:10 – 14:30 | Navigating through the composite source of BM assay variability |
| Sofia Stinchi, Merck KGaA | |
| 14:40 – 15:30 | Session 4 – Learnings and actions from the 2019 EBF FW |
| 14:40 – 14:50 | Introduction to the session – Interactive round table |
| Michaela Golob, on behalf of the EBF | |
| 14:50 – 14:55 | Logisitic break |
| Connecting to virtual breakout tables | |
| 14:55 – 15:30 | Round table: we will engage with the delegates around the key challenges related to understand CoU. |
| * hurdles in connecting outside of BA / inside BA | |
| * asking the rigth questions | |
| * understanding the questions asked | |
| * sense and nonsense of aligning CoU with development stage | |
| 15:30 – 18:30 | Break – for C> TD delegates, go to session 2 of the C> TD (16:00 – 18:00) |
| 18:30 – 18:50 | Session 4 (cntd) – Feedback from the round tables |
| Plenary feedback from the round table discussions | |
| 19:00 – 20:30 | Session 5 – Translation of CoU into bioanalytical strategies |
| 19:00 – 19:10 | Coming online |
| 19:10 – 19:30 | Staging Biomarker Development |
| Devangi Mehta – Immunologix | |
| 19:30– 19:50 | Cytokines as Biomarkers of Immunotoxicity in Preclinical Safety Assessment: Navigating “Context of Use” |
| Amy Reeves – Covance | |
| 19:50– 20:10 | Understanding the Biomarker Strategy of Antisense Oligonucleotide (ASO) Drugs from Non-Clinical and Clinical Studies |
| Nick White – AstraZeneca | |
| 20:10– 20:30 | The chemokine MCP-1/CCL2 is a key biomarker for respiratory diseases and lung tissue harm |
| Marita Zoma – Celerion | |
| 20:30 | End of day 2 |
Day 3 – 17 SEP 2020
timezone = CET (Brussels time zone)
| 13:00 – 14:30 | Session 6 – Closing Panel : Updated EBF Recommendation on CoU |
| 13:00 – 13:10 | Introduction to the Closing Panel Discussion: |
| 13:20 – 13:40 | Facilitate fast trial/project decisions and confirmation of context of use based on early PK and biomarker data – The VISTA Approach |
| Thomas Arnhold – Boehringer-Ingelheim | |
| 13:40 – 14:00 | EBF recommendation refining CoU requirements for the Biomarker assay community |
| Philip Timmerman, on behalf of the EBF | |
| 14:00 – 14:20 | Practical aspect of CoU – a deeper dive into the EBF recommendation |
| KyraCowan/Jo Goodman, on behalf of the EBF | |
| 14:20 – 14:50 | Closing Panel Discussion |
| All | |
| 14:50 – 15:00 | Adjourn |
| 16:00 | For C> TD delegates, go to session 3 of the C> TD (16:00 – 18:30) |
Copyright 2023 EBF
EBF vzw is the registered non-profit organisation of the European Bioanalysis Forum
Read more about EBF at our community site: www.e-b-f.eu