European Bioanalysis Forum

Slides – EBF Autumn Focus Workshop 2022 – 2

Biomarkers/CoU – 
Sharing Experience through Examples

29-30 september 2022 – NH Malaga, Spain

PDF renditions of the powerpoint presentations given at the Focus Workshop can be viewed and downloaded from this page.
The agenda as executed can be viewed and downloaded by clicking here

Final Agenda

Thursday 29-Sep-2022
09:15 09:30 Introduction to the Focus Workshop (FW)
09:30 10:30 Session 1: Updates from the EBF BM team
09:30 10:00 Kyra Cowan, on behalf of the EBF
FB from BM team discussions on organisational design driving CoU principles
10:00 10:15 Peter Groenen, on behalf of the EBF
Context of Use ….it depends on who you ask.
10:15 10:30 Richard Hughes, on behalf of the EBF
The BM toolbox…did you know there is more in life than LBA & LC/MS?
Sessions 2 – 7: Case studies
Each case study presentation (20-25 min) is followed by a 15-20 min round table discussion on how the case study uses (or doesn’t use) CoU principles.
11:00 13:00 Session 2:
Getting an appetite to discuss case studies 1, 2 and 3
11:00 11:40 Ulrich Kunz – Boehringer Ingelheim
Case Study 1: An explorative physiological response pd biomarker – from CoU to measurement using a commercial ELISA kit
11:40 12:20 Case Study 2: Lien Dejager – UCB Biopharma (not released for publication)
Importance of cross-functional interactions to define, align and understand CoU
12:20 13:00 Case Study 3: James Lawrence – F-Star Therapeutics
Context of Use? It’s Just Exploratory!
14:40 16:20 Session 3:
Understand the principles of CoU – do we understand the same?
& Case studies 4, 5 and 6
14:40 15:00 Peter Groenen – Idorsia
Case Study 4: CoU, from Babylonic confusion to patient benefit: how to be accurate and precise.
15:00 15:40 Philip De Decker (not released for publication)
Case study 5: CoU as guide for the bioanalytical assay objectives for a phase I dose escalation study
15:40 16:20 Daniel Thwaites – Labcorp drug development
Case study 6: An Evolving CoU Culture on Biomarker Assay Validation – Applications from LBA to ELISpot in Supporting Immunotoxicology Safety Assessments
16:20 17:00 Coffee break
17:00 19:00 Session 4:
A stakeholders perspective & Case studies 7 and 8
17:00 17:40 Luise Gram Schleiss – NovoNordisk
A Translational Medicine stakeholder perspective on cross-functional communication for biomarkers
17:40 18:20 James Beecroft – F. Hoffmann La Roche
Case Study 7: Implementing COU statements for the first time – the importance of stakeholder discussions
18:20 19:00 Anna Laurén – NovoNordisk
Case Study 8: Cross-functional collaboration to form the assay strategy for Target engagement and potential CDx biomarkers
19:00 Anticipated End of day 1
Friday 30-Sep-2022
09:00 09:05 Introduction to day 2
09:05 10:40 Session 5:
Different technologies – Different challenges? & Case studies 9 and 10
09:05 09:20 Philip Timmerman, EBF (not released for publication)
Themed presentation – BMs amenable to Chromatographic assays: are the challenges different?
09:20 10:00 Mathias Gebauer – Merck KGaA
Case Study 9: Identification of pathways represented in liquid biopsy samples from osteoarthritis and autoimmune disease patients by microRNA biomarker profiling which could be used for patient stratification in clinical trials
10:00 10:40 Axel Meyer – Abbvie
Case study 10: Validation of a ddPCR Assay According to its Context-of-Use
11:20 13:00 Session 6:
BM and regulatory expectations & Case studies 11 and 12
11:20 11:40 Anna Laurén, on behalf of the EBF
Themed presentation: Spotlight on CLIA and recent IVDR – when is it relevant for biomarkers and COU?
11:40 12:20 Laetitia Sordé​ – Sobi
Case study 11: IVD, fit for purpose…somewhere in between
12:20 13:00 Ulrich Kunz – Boehringer Ingelheim
Case Study 12: A total soluble target ELISA – translating CoU into an analytical strategy and a validation plan
14:00 15:20 Session 7:
The challenges for CROs on CoU and Case studies 13 and 14
14:00 14:20 Michaela Golob/Robert Nelson, on behalf of the EBF
Themed presentation: The challenges for CROs on CoU
14:20 14:50 Richard Hughes – Drug Development Solutions, part of Alliance Pharma Inc
Case Study 13: Off-the-shelf “validated” biomarker assays – fitting a square peg into a round hole
14:50 15:20 Manuel Daldin – IRBM (not released for publication)
Case Study 14: Novel and ultrasensitive SMC assay for the measurements of polyglutamine length- independent huntingtin protein, a pharmacodynamic biomarker in human CSF
16:00 17:00 Close out session: Summary session on all case studies
Learnings, take home messages and conclusions from the presented case studies
(3-5 min recap/case study).
Agreeing on recommendations from the FW
17:00 Adjourn
Meeting Organisation: Kyra Cowan (Merck KGaA), Anna Laurén (NovoNordisk), Joanne Goodman (AstraZeneca), Ulrich Kunz (Boehringer-Ingelheim), Michaela Golob (Nuvisan) and Philip Timmerman (EBF)
EBF Focus workshops are organised by the EBF vzw as non-sponsored non-profit events and are independent from EBF member companies.
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