Slides – EBF Autumn Focus Workshop 2023
Challenging the Current Paradigm for ADA testing
21-22 September 2023 – NH Malaga, Spain
PDF renditions of the powerpoint presentations given at the Focus Workshop can be viewed and downloaded from this page.
The agenda as executed can be viewed and downloaded by clicking here
Final Agenda
| Thursday 21-Sep-2023 | |||
| 09:00 | 09:10 | Welcome | |
| 09:10 | 11:00 | Session 1: Setting the Scene – the Current Landscape | |
| 09:10 | 09:35 | Jo Goodman, on behalf of the EBF | |
| Why this meeting? & Increasing the value of science in ADA testing | |||
| 09:35 | 10:00 | Lauren Stevenson, Immunologix Laboratories | |
| A 21st century paradigm: Immunogenicity assays are biomarker assays | |||
| 10:00 | 10:25 | Daniel Baltrukonis, Pfizer (not released for publication) | |
| All We Need Is Screen; When Confirmatory and Titer Tiers Are Not Necessary in Clinical ADA Assays | |||
| 10:25 | 10:45 | Q&A | |
| 10:45 | 11:00 | Prepare for Session 4: Introduction to the Round Tables | |
| A prepared mind: introduction to and intended deliverable of the themes the afternoon round table questions | |||
| 11:00 | 11:30 | Coffee break | |
| 11:30 | 12:30 | Session 2: Challenging the Current Paradigm – Case studies (20 min + 5 min discussion) | |
| 11:30 | 11:55 | Carsten Krantz, Novartis | |
| Considerations and opportunities on the lean approach of anti-drug antibodies based on the several cases. | |||
| 11:55 | 12:20 | Ching-Ha Lai (Vickie), Regeneron | |
| Clinical Case Studies of Different ADA Testing Strategies – What Do We Gain With 3 Tiers of Assessment? | |||
| 12:20 | 12:45 | Davide Guerrieri, Sandoz | |
| Signal-to-Noise for a more accurate determination of immunogenicity response | |||
| 12:45 | 13:45 | Lunch break | |
| 13:45 | 15:25 | Session 3: Rethinking Assay I – Case studies (20 min + 5 min discussion) |
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| 13:45 | 14:10 | John Cook, Charles River Laboratories | |
| Leaner Approaches to Clinical Analysis: Does the Confirmatory Assay Always Add Value? | |||
| 14:10 | 14:35 | Adriano Luis Soares de Souza, Fresenius Kabi Swiss | |
| Demonstrating the feasibility ADA titer determination by singlicate analysis: Case study based on a Tocilizumab biosimilar | |||
| 14:35 | 15:00 | Toralf Roch, CheckImmune | |
| Detection of anti-PEG antibodies in clinical studies | |||
| 15:00 | 15:25 | Gregor Jordan, Roche Diagnostics | |
| Model informed assay development (MIAD). How can we confirm with an orthogonal method the “Signal/Noise” immunogenicity reporting strategy? | |||
| 15:25 | 15:50 | Luis C. Perez Tosar, Novo Nordisk | |
| Re-thinking Radioimmunoassay for the detection of anti-drug antibodies against peptide drugs | |||
| 15:50 | 16:30 | Coffee break (reorganising the meeting room towards the round tables) | |
| 16:30 | 18:30 | Session 4: Round Table Discussion | |
| The delegates will be grouped into tables of maximum 10 (including moderator and note taker). The outcome of the discussion will serve as the basis for the recommendation for an alternative approach for clinically relevant ADA testing to be presented and discussed in plenary on day 2 | |||
| 18:30 | Day 1 Close Out | ||
| Friday 22-Sep-2023 | |||
| 09:00 | 10:40 | Session 5: Clinically Relevant Detection – Case studies (20 min + 5 min discussion) | |
| 09:00 | 09:25 | Hanna Widmaier, NuvisanEmmanuel Njumbe Ediage – Janssen R&D | |
| Cut-Point Limbo – low cut-points and their challenges | |||
| 09:25 | 09:50 | Karien Bloem, Sanquin | |
| Clinically relevant ADA testing for monoclonal antibody biologics | |||
| 09:50 | 10:15 | Foka Venema, Ardena | |
| Key publications for cut point calculations – CRO perspective: choosing between multiple implemented experimental and statistical approaches | |||
| 10:15 | 10:40 | Brendy Van Butsel, Sanofi | |
| Challenging the classical tiered approach in clinical ADA testing | |||
| 10:40 | 11:20 | Coffee break | |
| 11:20 | 12:45 | Session 6: Do metabolites quantification strategies need to change? | |
| 11:20 | 11:55 | Lysie Champion, Celerion | |
| Alternative approach to refine validation of immunogenicity assays with domain specificity characterization | |||
| 11:55 | 12:20 | Minh Dang, BioAgilytix | |
| Pros and Cons of Different Approaches to ADA Domain Specificity Characterization | |||
| 12:20 | 12:45 | Desislava Galeva, Labcorp Drug Development | |
| An alternative approach to the classic anti-drug antibody (ADA) titer assay used in a clinical trial | |||
| 12:45 | 13:45 | Lunch | |
| 13:45 | 14:45 | Online contribution | |
| 13:45 | 14:45 | Joao Pedras-Vasconcelos, CDER (online contribution) | |
| Regulatory feedback, incl. discussions on S/N as an alternative to titer assessment and the use of integrated PK/PD and titer as an alternative to formal NAb assay assessment, under what conditions that is possible? Includes Q&A “live – on line” |
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| 14:45 | 16:00 | Session 7: The Fruit of our Labour… | |
| 14:45 | 15:30 | Feedback from the Round Tables (incl. Q&A and refinement suggestions) |
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| 15:30 | 16:00 | Drafting the Workshop Recommendations | |
| 16:00 | Close out & Networking coffee break | ||
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Meeting Organisation: Jo Goodman (AstraZeneca), Michaele Golob (Nuvisan), Kyra Cowan (Merck KGaA), Robert Nelson (BioAgilytix) and Philip Timmerman (EBF), adding round table moderators: John Cook (CRL) and Salvatore Calogero (Swiss BioQuant) |
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| EBF Focus workshops are organised by the EBF vzw as non-sponsored non-profit events and are independent from EBF member companies. | |||
