EBF
EBF Focus
Training Day: BA strategies for Cell & Gene Therapies 
Focus Workshop: Biomarkers in Pharma R&D
The meeting will be
organised in cyberspace


15-16-17 September 2020: C&GT Training Day (part of the day)
15-16-17 September 2020: Biomarker Focus Workshop (part of the day)

Slides – EBF Workshop 2020

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)