European Bioanalysis Forum

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)
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”
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)
15:30 16:00 Drafting the Workshop Recommendations
16:00 Close out & Networking coffee break
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)
EBF Focus workshops are organised by the EBF vzw as non-sponsored non-profit events and are independent from EBF member companies.
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