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 The missing presentations will not be published.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
Program
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 Break
11:00
Practical Advice for the Integrated Summary of Immunogenicity Daniel Kramer (Sanofi)
12:00
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 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 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)
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 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
Get Together
23:00
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 Break
11:15
Impact of chemical modifications on T cell response to biopharmaceuticals Bernard Maillère (CEA)
12:00
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)
