EBF
EBF Focus

SPRING 2021: EBF Cyberconnect meetings

Due to anticipated continued COVID-19 travel restrictions,
the EBF will host 4 interactive training days / workshops in Spring 2021.
Click on below tabs to see the details of each meeting

 

INTRODUCTION & AIM OF THE WORKSHOP

On 27 and 28 April, the 2nd EBF Cyberconnect Event in 2021 will continue our journey on Biomarkers. After 2 consecutive Focus Workshop reconnecting the bioanalytical community with the EBF recommendations on Biomarker Assay validation and the principles of context of use (CoU), the EBF will increase its efforts on bringing CoU into practice by connecting the bioanalytical scientist with the end users of the data around case studies.

CALL FOR SPEAKERS

The call for speakers is closed

MEETING AGENDA

From the submitted abstracts, we built the agenda of the meeting. The current final agenda looks like below:

Day 1
12:30
12:45
Coming online
12:45
13:00
Getting started – Welcome
Philip Timmerman – EBF
13:00
14:00
Day 1 – 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
Day 1 – 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
16:20 16:45 Sabine Lennarz, Novartis
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
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
18:15 19:00 Zoom session remains open to allow 1/1 chat interactions
19:00 Zoom closes
Day 2
12:45
13:00
Coming online
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
2. Stakeholder management
3. Management/QA interactions
15:00
15:40
Break
15:40
17:30
Day 2 – Session 4: And what about regulations?
15:40 16:10 Michaela Golob, Robert Nelson, Jo Goodman, on behalf of the EBF
Feedback from the 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
17:30 18:00 Zoom session remains open to allow 1/1 chat interactions
18:00 Zoom closes

 

WHO SHOULD ATTEND?

Scientists and managers from Pharma R&D, CRO and Health Authorities involved in the challenges of Biomarker assay validation, stakeholder communication or, in general, bringing the principles of CoU into practice.

CALL FOR REGISTRATION

Registration is closed.

Meeting Organisation

Organising Committee: : Kyra Cowan (Merck KGaA), Ulrich Kunz (Boehringer Ingelheim), Robert Nelson (Covance), Michaela Golob (Nuvisan), Joanne Goodman (AstraZeneca), and Philip Timmerman (EBF)