Challenging the Current Paradigm for ADA Testing
21-22 September 2023, NH Málaga, Spain
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> 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 |
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