EBF Alpha to Omega Events

Due to anticipated continued COVID-19 travel restrictions,
the EBF will continue to host interactive training days / workshops 2022.
Click on below tabs to see the details of the first meeting:

Points to Consider on Cut Points – 28-29 April 2022

Agenda Details

Day 1: 28 April 2022
(all times are in CET = Brussels Time zone)

	12:15		Zoom opens – Coming online
	12:45	13:00	Getting started – Welcome
			Philip Timmerman – EBF

	13:00	14:00	Session 1: Introduction to the meeting and problem statement
			Jo Goodman/Robert Nelson – on behalf of the EBF
			Introduction presentation to introduce the items discussed at the meeting, includes but not limited to: Cut Points (CPs) – what and why; Difference from PK assays (CoU); In study vs. validation CP; Clinical relevance of CPs; regulatory challenges; the changing landscape on ADA and new modalities
			Session includes Q&A for items that are not covered later in the workshop

	14:00	15:40	Session 2: (Strategic) Thoughts to consider
	14:00	14:20	Kyra Cowan, on behalf of the EBF
			Increasing challenges: feedback from discussions in the EBF
	14:20	14:40	Nicoline Videbæk, on behalf of the EBF NAb team
			Cut point considerations for Nab assays
	14:40	15:00	Devangi Mehta, Immunologix Laboratories
			Beyond the Confirmatory Cut point – Reconsidering the value of the confirmatory tier
	15:00	15:20	Heather Revell, Labcorp Drug Development
			Assessing specificity of ADA to multi-domain protein therapeutics
	15:20	15:40	Panel discussion/ Q&A

	15:40	16:00	Break

	16:00	18:30	Session 3 – Case studies
	16:00	16:20	Sebastien Boridy, Charles River Laboratories
			Overcoming challenges in experimental design for in-study cut-point determination
	16:20	16:40	Jenny Valentine, Regeneron
			Population Specific Cut Points in Oncology: Do We Really Need a Different Cut Point for Every Tumor Type?
	16:40	17:00	Matt Horsham, LGC
			Where do we draw the line? – Investigating low analytical cutpoints and the impact on in study cut points

	17:00	17:10	Short (logistic) break

	17:10	17:30	Brendy Van Butsel, Sanofi
			Applying in-study cutpoints to multiple characterization assays in a rare-disease indication, a case study
	17:30	17:50	Marleen Lutz, Celerion Switzerland AG
			Challenges in the detection of anti-Filgrastim antibodies facing a low false positive rate
	17:50	18:10	Hisanori Hara, Novartis Pharma AG
			A case study of cut point evaluations at early stages of clinical studies and how to provide reliable interim ADA results
	18:10	18:30	Mafalda dos Santos Marques Resende, Novo Nordisk
			In-study CP setting in NAb assays – a case study

	18:30	19:00	Close out Q&A
	19:00		Day 1 adjourn


Day 2: 29 April 2022
(all times are in CET = Brussels Time zone)

	12:30		Zoom opens – Coming online

	13:00	14:40	Session 4: Cross validation, general considerations and case studies
	13:00	13:20	Michaela Golob, on behalf of the EBF
			introduction to the session and feedback from discussions in the EBF ADA team
	13:20	13:40	Alok Rathi, EMD Serono
			Cross-Validation of a Neutralizing Antibody Assay Across Global Sites For A Multi Domain Protein
	13:40	14:00	Yang Xu, Merck Sharp & Dohme
			Experiences and Challenges in Evaluation of ADA Assay Performance with the Same ADA Method Across Multiple Laboratories
	14:00	14:20	Amy Lavelle, AAPS NABH (Neutralizing Antibody Harmonization) sub team
			Harmonized Approach to Cross Validations of ADA and Nab Immunoassays
	14:20	14:40	Panel discussion

	14:40	15:00	Break

	15:00	16:40	Session 5 – Thinking outside the box-plot
	15:00	15:20	Gregor Jordan, Roche Diagnostics GmbH
			Screening assay data transformation – can a Weibull transformation help to achieve the theoretical FPR?
	15:20	15:40	George Walters, LGC
			Advantages and Challenges of Automation in Immunogenicity
	15:40	16:00	Atiya Taqui, Gilead Sciences
			Random and Fixed Effects Model for Cut Point Determination
	16:00	16:20	Daniel Baltrukonis, Pfizer, Inc.
			Simplifying and Automating Anti-Drug Antibody Cut Point Determination
	16:20	16:40	Panel discussion

	16:40	16:50	Short logisitic Break

	16:50	18:30	Session 6: Regulatory expectations and challenges, including ISI and closing panel discussion
	16:50	17:10	Johannes Stanta, on behalf of the EBF
			Overview of regulatory expectations for cut points for pre-existing Ab
	17:10	17:30	Paul Chamberlain, Immunogenicity Integrated Platform
			How to use the Integrated Summary of Immunogenicity (ISI) for effective communication of ADA assay cut point strategy and method life-cycle history to regulators
	17:30	17:50	Open slot
			Sharing industry Experiences with Health Authorities on Cut Point discussions
	17:50	18:30	Close out panel discussion – summarising questions and discussions from the workshop and from questions submitted prior to the workshop

	18:30		Adjourn

	18:30	19:00	Zoom session remains open to allow 1/1 chat interactions

Organising Committee: Kyra Cowan (Merck KGaA), Michaela Golob (Nuvisan), Joanne Goodman (AstraZeneca), Hisanori Hara (Novartis), Johannes Stanta (Freeline Therapeutics), Robert Nelson (Labcorp Drug Development) and Philip Timmerman (EBF)