EBF
EBF
EBF
European
Bioanalysis
Forum


EBF vzw is the registered non-profit organisation of the European Bioanalysis Forum

 

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&GT TD delegates, go to session 1 of the C&GT 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&GT TD delegates, go to session 2 of the C&GT 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&GT TD delegates, go to session 3 of the C&GT TD (16:00 – 18:30)