Challenging the Current Paradigm for ADA Testing
21-22 September 2023, NH Málaga, Spain
Final Program Focus Workshop
Version 27 July 2018
19-20 September 2018, Lisbon
Today’s challenges and solutions in assessing immunogenicity in patients
19/sep/2018 | |
08.45 – 09.00 | Welcome and aim of the meeting |
09:00 – 12.30 | Harmonized approaches for immunogenicity method validation |
09:00 – 09:25 | Introduction to the session – Overview of current global regulations |
Jo Goodman, on behalf of the EBF | |
09:25 – 09:50 | Harmonisation of immunogenicity testing : The EU perspective |
Meenu Wadhwa (National Institute for Biological Standards and Control) | |
09:50 – 10:10 | Case Study: Request for a full tiered approach assay validation for a well-known drug used for a new indication – when clinical experience was not sufficient |
Anna Laurén, Wieslab/Eurodiagnostics |
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10:10 – 10:50 | Coffee break & networking |
10:50 – 11:10 | Analytical scientists and the statisticians collaborate to make the right decision for cut-points |
Alexandra Hawes, LGC | |
11:10 – 11:30 | Practical solutions to outlier decisions, pre-existing and treatment-boosted ADA and low biological variability |
Viswanath Devanarayan, Charles River | |
11:30 – 11:50 | Experiences with different cut-point approaches in clinical immunogenicity testing |
Szilard Kamondi, Roche | |
11:50 – 12:30 | Panel discussion |
Moderator: Robert Nelson. Panelists: Viswanath Devanarayan, Jo Goodman, Meenu Wadha, FDA representative (approval pending) |
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12:30 – 13:40 | Lunch |
13:40 – 15:00 | Harmonized approaches for immunogenicity method validation – cntd |
13:40 – 14:00 | Effect of different approaches on perceived assay sensitivity and drug tolerance – sense and nonsense of positive controls |
David Egging, Synthon Biopharmaceuticals BV | |
14:00 – 14:20 | Feedback on EBF immunogenicity harmonisation activities |
Jo Goodman, on behalf of EBF | |
14:20 – 14:40 | AAPS-sponsored ADA Validation Testing and Reporting Harmonization |
Meina Liang, on behalf of the AAPS community | |
14:40 – 15:00 | Panel discussion |
Moderator: Michaela Golob. Panel: Meina Liang, Shobha Purushothama, Jo Goodman, Robert Nelson |
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15:00 – 15:40 | Tea break & Networking |
15:40 – 17:30 | Progress in Clinical nAb assays |
15:40 – 15:50 | Introduction to the session |
James Munday, on behalf of the EBF | |
15:50 – 16:10 | Integration of PK-PD-ADA data for assessment of immunogenicity impact |
Robert Nelson, Novimmune | |
16:10 – 16:30 | Developing neutralising assays – challenging molecules and challenging requirements |
Carina de Lemos Rieper, Novo Nordisk | |
16:30 – 16:50 | Inferring Neutralising Antibodies – When data integration is appropriate? |
Shobha Purushothama, Biogen | |
16:50 – 17:30 | Q&A |
17:30 – 17:30 | End of Day 1 |
20/sep/2018 | |
08:45 – 09:00 | Introduction to day 2 |
09:00 – 12:00 | Clinical immunogenicity and the value for the patient and physician |
09:00 – 09:20 | Introduction to the session |
Michaela Golob, on behalf of the EBF | |
09:20 – 09:40 | Clinical relevance of unwanted drug-induced immune responses |
Arno Kromminga, BioAgylitix | |
09:40 – 10:00 | Considerations of immunogenicity assessment at different clinical phases |
Kate Peng, Genentech | |
10:00 – 10:20 | Evaluation of clinical impact of immunogenicity and its challenges |
Veerle Snoeck, UCB | |
10:20 – 11:00 | Coffee Break & networking |
11:00 – 11:30 | After 20 Years of immunogenicity testing, where do we stand today |
Daniel Kramer, Sanofi | |
11:30 – 12:00 | Taking the “false” out of ADA testing results: towards better interpretation of clinical relevance |
Lorin Roskos, MedImmune | |
12:00 – 13:15 | Lunch |
13:15 – 14:30 | Panel discussion – Clinical immunogenicity and the value for the patient and physician |
13:15 – 13:30 | Introduction to the closing panel discussion |
Jo Goodman, on behalf of the EBF | |
13:30 – 14:30 | Panel discussion |
Moderator: Jo Goodman. Panel: Lorin Roskos, Venke Skibeli (Norwegian Medicines Agency, member of the Biosimilar Medicinal product Working Party (BMWP), Robert Nelson and Daniel Kramer. |
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14:30 – 15:00 | Summary, conclusion and next steps |
15:00 – 16:00 | Closing Tea break and adjourn |