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EBF
EBF
European
Bioanalysis
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Slides – EBF Training Day 2020

Program of EBF Focus Workshop  “Cell & Gene Therapy Training Day” 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)

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