EBF
EBF Focus
Biomarker Assay Validation – Bringing Context of Use into practice
NH Málaga Centro
Málaga, Spain
18-19 September 2019

 

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
 
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)
 
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
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.
 
14:30 – 15:00 Summary, conclusion and next steps
15:00 – 16:00 Closing Tea break and adjourn