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13th Open Scientific EIP Symposium on Immunogenicity of Biopharmaceuticals

25th — 27th April 2022

Lisbon, Portugal

We would like to thank everyone who attended our 13th 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. The missing presentations will not be published.

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



Monday, April 25th 2022

Training Course
09:00 Coming together
Immunogenicity Risk Assessment
09:15 Practical advice to perform immunogenicity risk assessments for INDs/IMPDs, BLAs/MAAs
Daniel Kramer (Sanofi)
Introduction to in vitro Immunogenicity
Sofie Pattijn (ImmunXperts)
10:30 coffee Coffee Break
11:00 Practical Advice for the Integrated Summary of Immunogenicity
Daniel Kramer (Sanofi)
12:00 cutlery 77 Lunch
Assay validation and immunogenicity assessment
13:30 Bring your own problems (breakout sessions)
Daniel Kramer (Sanofi)
Arno Kromminga (Kromminga Consulting)
Sebastian Spindeldreher (Integrated Biologix)
Sofie Pattijn (ImmunXperts)
Sophie Tourdot (Pfizer)
15:00 coffee Coffee Break
15:30 Continue Bring your own problems (breakout sessions)
16:30 Close of the training course

Tuesday, April 26th 2022

09:00 Welcome and introduction by the EIP chairman
Daniel Kramer (Sanofi)
09:15 Keynote: Understanding immune responses to SARS CoV2 infection and vaccination
Alessandro Sette (LaJolla Institute for Immunology)
Session 1: Prediction of Immunogenicity
Chair: Sebastian Spindeldreher
10:00 Introduction and EIP NCIRA Working Group update
Sebastian Spindeldreher (Integrated Biologix)
10:15 COVID influence on in vitro assays
Chloé Ackaert (ImmunXperts)
10:45 coffee Coffee Break
11:15 Computational directed improvements in developability and its impact on dendritic cell uptake
Bruno Gonzalez-Nolasco (Generate Biomedicines Inc)
11:45 HLA-DQA1*05 Carriage Associated With Development of Anti-Drug Antibodies to Infliximab and Adalimumab in Patients With Crohn’s Disease
Aleksejs Sazonovs (The Sanger Institute)
12:15 cutlery 77 Lunch Break
Session 2: Immunogenicity Assay Strategies
Chair: Veerle Snoeck (UCB)
13:30 Considerations for immunogenicity risk assessment — Status update
Veerle Snoeck (UCB)
14:00 Strategies for Selecting Positive Controls for ADA Assays
Linlin Luo (Merck & Co)
14:30 coffee Coffee Break
15:00 Immunogenicity Mechanisms of Immunocytokines and T cell Bispecifics
Jerome Egli (Roche)
15:30 Cross-Validation of ADA Assays
Daniel Kramer (Sanofi)
16:00 Immunogenicity Risk Assessments for Cell and Gene Therapies
Vibha Jawa (BMS)
16:30 Immunogenicity Titer Analysis — What are the options?
Martin Ullmann (Fresenius Kabi)
Session 3: Social Event
Chair: Barbara Vercruyssen
17:30 toast Get Together
23:00 moon stars Good Night

Wednesday, April 27th 2022

09:00 Memorial Wim Jiskoot
Huub Schellekens (Utrecht University)
Session 4: The influence of critical quality attributes (CQAs) on Immunogenicity
Chair: Patrick Garidel
09:45 Role of Small Aggregates on Immunization
Marc Pallardy (INSERM)
10:15 Particle analysis in biopharmaceuticals: An overview from protein particles to living cells and relevance for immunogenicity
Dr. Andrea Hawe (Coriolis Pharma)
10:45 coffee Coffee Break
11:15 Impact of chemical modifications on T cell response to biopharmaceuticals
Bernard Maillère (CEA)
12:00 cutlery 77 Lunch Break
Session 5: Clinical Relevance of Immunogenicity
Chair: Gregor Lotz
13:00 Immunogenicity Assessment of Emicizumab (Hemlibra®)
Thomas Emrich (Roche)
13:30 Quantification of Bevacizumab Activity Following Treatment of Patients With Ovarian Cancer or Glioblastoma
Florian Deisenhammer (University of Innsbruck)
Session 6: Regulatory
Chair: Daniel Kramer
14:00 Immunogenicity Information in Labeling: Highlights from the new FDA draft guidance
João Pedras-Vasconcelos (CDER, FDA)
14:30 The role of clinical pharmacology in assessing clinical relevance of immunogenicity — a regulatory perspective
Yow-Ming Wang (CDER, FDA)
15:00 Conference Summary & Outlook by the EIP Chairman
Daniel Kramer (Sanofi)
15:15 Close of the conference
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