14th Open Scientific EIP Symposium on Immunogenicity of Biopharmaceuticals

26th — 28th April 2023

Lisbon, Portugal

Symposium sponsors

We would like to thank everyone who attended our 14th EIP conference.

For presentations for which we have received approval to publish on our website you will find a download icon in the programme below.

Hoping to meet you at future EIP conferences and always at your disposal for any further information,

Barbara Vercruyssen
Director Finance and Operations
European Immunogencity Platform

Program

Download the program as a PDF


Wednesday, April 26th 2023
Training Course
09:00		Coming together
In-Study Cut-Points
09:15		Practical Advice When and How to Perform in-Study Cut-points Daniel Kramer, Sanofi Viswanath Devanarayan, Eisai
10:30		Coffee Break
11:00		Immunogenicity - Always a Concern? EIP Experts
12:00		Lunch Break
Assay validation and immunogenicity assessment
13:30		Bring your own problems (break out sessions) Daniel Kramer, Sanofi Arno Kromminga, BioNTech Sebastian Spindeldreher, Integrated Biologix Sofie Pattijn, ImmunXperts Sophie Tourdot, Pfizer Veerle Snoeck, UCB Gregor Lotz, Roche Lydia Michaut, Novartis
15:00		Coffee Break
15:30		Continue “Bring your own problems (break out sessions)”
16:30		Close of the Training Course
17:00	18:30	Meeting of the EIP Working Groups Members of EIP working groups

Thursday, April 27th 2023
09:00		Welcome and introduction by the EIP chairman Daniel Kramer, Sanofi
09:15		Keynote: Immunogenicity characterization - Anti-brolucizumab immune response as one prerequisite for rare RV/RO adverse events Michael Gutknecht, Novartis
Session 1: Immunogenicity Assay Strategies Chair: Veerle Snoeck
10:00		EIP Immunogenicity Strategy Working Group Update Joanna Grudzinska-Goebel, Bayer on behalf of EIP
10:15		EIP Immunogenicity Assays Working Group Update Linlin Luo, Merck Sharp & Dome on behalf of EIP
10:30		Singlicate Analysis for Immunogenicity Johannes Stanta, Celerion
11:00		Coffee Break
11:30		S/N versus Titer to Quasi-Quantify Immunogenicity – Industry Perspective Daniel Baltrukonis, Pfizer
12:00		S/N versus Titer to Quasi-Quantify Immunogenicity – Statistical Perspective Viswanath Devanarayan, Eisai
12:30		S/N versus Titer to Quasi-Quantify Immunogenicity – Regulatory Perspective João Pedras-Vasconcelos, FDA
13:00		Lunch Break
Session 2: Prediction of Immunogenicity Chair: Sebastian Spindeldreher
14:00		EIP NCIRA Working Group update Sebastian Spindeldreher, Integrated Biologix on behalf of EIP
14:30		Number of Donors Needed to Adequately Assess in-vitro Assays Sofie Denies, SD Analytics
15:00		Coffee Break
15:30		Current FDA thinking on the use of non-clinical tools in Immunogenicity risk Assessments: Possibilities and Challenges Daniela Verthelyi, FDA
16:00		Opportunities and Challenges in Quantitative Systems Pharmacology: IG Simulator Evaluation Tim Hickling, Roche
16:30		Standardization of in-vitro Assays Laurent Malherbe, Eli Lilly Sofie Pattijn, ImmuneXperts
Session 3: Social Event Chair: Barbara Vercruyssen
17:30		Get Together
23:00		Good Night

Friday, April 28th 2023
Session 4: Immunogenicity of New Modalities Chair: Arno Kromminga
09:00		Role of the Innate and Adaptive Immune System to Immunogenicity in Gene Therapy Laura Salazar-Fontana, NDA
09:30		Aspects of the Immunogenicity Assessment Against mRNA Based Products Arno Kromminga, BioNTech
10:00		Understanding and Navigating Immune Responses to Cas Proteins Used in Gene Editing Zuben Sauna, FDA
10:30		Coffee Break
11:15		CAR-T Cell Therapy – Immunogenicity Lydia Michaut, Novartis
11:45		Lunch Break
Session 5: Clinical Relevance of Immunogenicity Chair: Gregor Lotz
13:00		Integrated PK/PD/ADA Approach Instead of NAb Assays Karin Nana Weldingh, NovoNordisk
13:30		Characterization of ADA Responses of T-cell engager drugs to Understand Impact on Exposure and Activity Gregor Lotz, Roche
Session 6: Regulatory Chair: Daniel Kramer
14:00		Nonclinical Immunogenicity Risk Assessment from Regulatory Perspective Tatjana Petkovic, Swissmedic
14:30		Feedback of Health Agencies to EIP member companies: a survey analysis Lydia Michaut, Novartis on behalf of the EIP assay working group
15:00		Conference Summary & Outlook by the EIP Chairman Daniel Kramer, Sanofi
15:15		Close of the conference

14th Open Scientific EIP Symposium on Immunogenicity of Biopharmaceuticals

26th — 28th April 2023

Lisbon, Portugal

Program

Wednesday, April 26th 2023

Thursday, April 27th 2023

Friday, April 28th 2023

Sponsors

BioAgilytix

QPS

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