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 Training Day 2020

Day 1 – 15 SEP 2020

timezone = CET (Brussels time zone)

16:00 – 18:00 Session 1 – General Overview of C&GT and the Bioanalytical Challenges
16:00 – 16:10 Coming online – Welcome and introduction
Philip Timmerman, on behalf of th e EBF
16:10 – 16:30 An overview of Cell and Gene Therapies and how they differ from traditional biologics
Fraser McBlane (Novartis) (not released for publication)
16:30 – 16:50 Regulatory overview
Manuela Braun (Bayer)
16:50 – 17:10 Understand how to measure and demonstrate exposure during the development of cell therapies
James Munday (Covance)
17:10 – 17:30 Am I Biomarker or am I PK?
Thomas Emrich (Roche) (not released for publication)
17:30 – 17:50 How to approach the development and validation to measure the expression of the transgene product.
Chris Cox (PsiOxus)
17:50 – 18:00 Q&A and closing remarks for Session 1
End of Day 1 – for Biomarker FW delegates, go to session 2 of the FW (18:30 – 20:00)

Day 2 – 16 SEP 2020

timezone = CET (Brussels time zone)

16:00 – 18:00 Session 2 – Therapy Immunity and Immunogenicity
16:00 – 16:10 Introduction to the session
Chris Cox (on behalf of the EBF)
16:10 – 16:30 Bioanalytical approaches to assess the immunogenicity in C&GT
Arno Kromminga (on behalf of the EBF C&GT team)
16:30 – 16:50 Assessing cellular Immunogenicity for CGT
James Munday (Covance)
16:50 – 17:10 Pre-clinical challenges and translational solutions
Philippe Ancian ( Ch arles River L aboratories)
17:10 – 17:30 Pre-Existing Antibodies: Considerations for Cell & Gene Therapy Products
Kelli Phillips (PPD)
17:30 – 17:50 Integrated summary of immunogenicity
Jo Goodman (on behalf of the EBF)
17:50 – 18:00 Q&A and closing remarks
End of Day 2 – for Biomarker FW delegates, go to session 5 of the FW (18:30 – 20:30)

Day 3 – 17 SEP 2020

timezone = CET (Brussels time zone)

16:00 – 18:30 Session 3 – Addressing the bioanalytical Challenges
16:00 – 16:10 Introduction to the afternoon sessions
Johannes Stanta (on behalf of the EBF)
16:10 – 16:30 qPCR applications and how to approach the method development and validation
Milena Blaga (on behalf of the EBF qPCR Team)
16:30 – 16:50 Case Study: Measuring transgene product activity as a demonstration of therapeutic efficacy
Paula Miranda ( Un iCu re)
16:50 – 17:10 Case Studies: The use of ELISpot in CGT
Julia Ober-Blöbaum (BioAgilytix)
17:10 – 17:30 Current industry standards and expectations for reliable Flow Cytometry Assays to support celland gene therapies
Daisy Yuill (UCB Biopharma) (not released for publication)
17:30 – 17:50 Feedback and comments from a recent EBF survey on regulatory challenges for BA in C&GT
Johannes Stanta/Chris Cox (on behalf of the EBF)
17:50 – 18:30 Q&A and closing remarks – Bioanalytical in support of C&GT in practiceBased on Question from survey, live-pols (?) during the sessions and open questions from the experts
18:30 Adjourn