EBF
EBF
EBF
European
Bioanalysis
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Focus Workshop Slides 2018 September

Program of EBF Focus Workshop  “Today’s challenges and solutions in assessing immunogenicity in patients
September 19-20, 2018

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 

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
 
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 (slides are not available)
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)
 
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
 
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 (slides are not available)
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 (slides are not available)
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.
 
14:30 – 15:00 Summary, conclusion and next steps
15:00 – 16:00 Closing Tea break and adjourn