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