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Program of EBF Focus Workshop  “Focus Workshop:  Biomarkers/CoU – Case Studies Dissected” 27-28 April 2021

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 2: 27 April 2021
13:00 14:00 Session 1: Setting the stage
13:00 13:15 Philip Timmerman,  EBF
Is there appetite for CoU?  – Feedback from a recent survey on CoU
13:10 13:30 Kyra Cowan, on behalf of the EBF
Context of Use, removing the appetite for PK-criteria and practice for BM  – the basic revisited
13:30 13:40 Jo Goodman, on behalf of the EBF
The current (assumed) regulatory landscape on Biomarker Assays
13:40 14:00 Lauren Stevenson, Immunologix labs
The blind leading the clear-sighted – undermining the science of COU
14:00 14:30 Break
14:30 18:00 Session 2: case studies
14:30 14:35 Robert Nelson, on behalf of the EBF
Introduction in the case studies sessions
14:35 15:00 Wietske Lambert, PRA-HS
Enzymatic activity by LCMS – to assess enzyme inhibition
15:00 15:25 Snezhana Kirmaz – Comac Medical
Strategizing and overcoming milestones during a phase II clinical trial for two renal biomarkers by direct scientific team-to-Sponsor line of communication
15:25 15:50 Jean-Christophe Genin, F. Hoffmann-La Roche
Case study : The importance of collaboration with stakeholders in order to define the appropriate BA strategy
15:50 16:00 Remaining questions from the session
16:00 16:20 Short Break
Session 2: case studies, cntd
16:20 16:45 Sabine Lennarz, Novartis (not released)
The brave new world of biomarker development in early clinical trials – defining a fit-for-purpose assay validation strategy on an emerging platform
16:45 17:10 Claire Seal, F-Star
A case study on successful development and validation of a serum biomarker assay – the important of good communication
17:10 17:35 Léa Costes, Sanquin (not released)
Biomarker assays and context of use: two stories, one success
17:35 18:00 John Allinson, Immunologix labs
Scientific and financial risks when COU is MIA
18:00 18:15 Remaining questions from the session
Day 2: 28 April 2021
13:00 15:30 Day 2 – Session 3: Organisational design influencing CoU practices
13:00 13:10 Ulrich Kunz, on behalf of the EBF
Introduction to the session
13:10 13:30 Anna Laurén, NovoNordisk
Learnings from past projects to form new strategies for Biomarker validation and sample analysis
13:30 13:55 Mark Ma, Alexion
Improve reliability and efficiency in biomarker research
13:55 14:00 Logistic break – going into smaller groups
14:00 15:00 Breakout discussions – round tables – 3 themes around optimising organisational design – identifying hurdles and suggestion of optimisation for:
1. The BioA lab (Q1)
2. Stakeholder management (Q2)
3. Management/QA interactions (Q3)
15:00 15:40 Break
15:40 17:30 Day 2 – Session 4: And what about regulations?
15:40 16:10 Feedback from the round tables / breakouts
16:10 17:00 Panel discussion: value and risk of a regulatory guideline for Biomarker Assays
Based on Pre-meeting survey question to delegates
Including polling on who had issues and wants to share them?
17:00 17:30 Final Q&A, next steps and adjourn
17:30 Adjourn