EBF Cyberconnect Events:
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 | |||
