Slides – EBF Workshop 2020
Program of EBF Focus Workshop “Biomarkers in Pharma R&D – A roadmap from Context of Use to Using the data” September 15-17, 2020
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 – 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) |
