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)

Program Workshop

Status 28 May 2020 :

Covid-19 travel restrictions has forced the EBF C&GT Training Day to change the format of its original planned event (15 September 2020, Lisbon) into a live-streaming event (3 web-sessions from 15-17 September in the afternoon (EU time zone)/morning (NA-time zones)/Evening (Asia Time zones).

Agenda, version 28 May 2020 – all times are CET (Brussels time zone)

 

15 September 2020
     
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 A 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
19:00 – 19:20   Biomarker Assay Validation and Context of Use: A CRO’s Perspective From Discovery through Clinical Drug Development
    Kingsley Osuala, Charles River Laboratories
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
     
     
16 September 2020
     
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 A of the C&GT TD (16:00 – 18:00)
     
18:30 – 20:00   Session 5 – Translation of CoU into bioanalytical strategies
18:30 – 18:40   Comming online
     
18:40 – 19:00   Staging Biomarker Development
    Devangi Mehta – Immunologix
19:00– 19:20   Cytokines as Biomarkers of Immunotoxicity in Preclinical Safety Assessment: Navigating “Context of Use”
    Amy Reeves – Covance
19:20– 19:40   Understanding the Biomarker Strategy of Antisense Oligonucleotide (ASO) Drugs from Non-Clinical and Clinical Studies
    Nick White – AstraZeneca
19:40– 20:00   The chemokine MCP-1/CCL2 is a key biomarker for respiratory diseases and lung tissue harm
    Marita Zoma – Celerion
     
     
17 September 2020
     
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
    Kyra  Cowan/Jo Goodman, on behalf of the EBF
14:20 – 14:50   Closing Panel Discussion
    All
14:50 – 15:00   Adjourn
     
15:30 – 18:30   For C&GT TD delegates, go to session C of the C&GT TD (16:00 – 18:30)