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> 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> |
| Arno Kromminga (on behalf of the EBF C> 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> |
| Johannes Stanta/Chris Cox (on behalf of the EBF) | |
| 17:50 – 18:30 | Q&A and closing remarks – Bioanalytical in support of C> in practiceBased on Question from survey, live-pols (?) during the sessions and open questions from the experts |
| 18:30 Adjourn |
