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10th Open Scientific EIP Symposium
Immunogenicity of Biopharmaceuticals



25 – 27 February 2019

Altis Hotel

Lisbon, Portugal

Monday, 25 February 2019

Training course:
Immunogenicity Risk Assessment
9:00 Practical guidance on Immunogenicity Risk Assessment and data presentation for regulatory dossiers – part I
Joao Pedras-Vasconcelos, USFDA/OBP, USA
Paul Chamberlain, NDA Advisory Board, France
10:30 Coffee/Tea Break
11:00 Practical guidance on Immunogenicity Risk Assessment and data presentation for regulatory dossiers – part II
Joao Pedras-Vasconcelos, USFDA/OBP, USA
Paul Chamberlain; NDA Advisory Board, France
12:30 Lunch
Assay validation and Immunogenicity Assessment
13:30 Practical advice on statistics on key validation parameters
Viswanath Devanarayan, Charles River Laboratories, USA
14:30 Major Challenges in the Assessment of Immunogenicity
EIP Team
Arno Kromminga, BioAgilytix, Germany
Daniel Kramer, Sanofi, Germany
Noel Smith, Lonza, UK
Sophie Tourdot, Pfizer, USA
Sofie Pattijn, ImmunXperts, Belgium
16:30 Close of the training course

Tuesday, 26 February 2019

09:00 Welcome and Introduction by the EIP chairman
Daniel Kramer, Sanofi, Germany
09:15 Keynote Lecture: AAV vectors and the host immune system, challenges and opportunities
Federico Mingozzi, Spark Therapeutic, USA
Session 1: Tolerance induction
Chair: Arno Kromminga
10:00 Modulation of immunogenicity by engineered antigen-specific regulatory T cells:
Fighting fire with fireman or police CARs
David W. Scott USUHS, USA
10:30 Coffee/Tea Break
Session 2: Aggregates and PTM impact on immunogenicity
Chair: John Smeraglia
11:00 Protein aggregates and immunogenicity. Does size matter ?
Wim Jiskoot, Leiden University, The Netherlands
11:30 PTM impact on immunogenicity
12:00 Lunch
Session 3: Immunogenicity Testing
Chair: Veerle Snoeck
13:30 EIP Assay Working Group update
Veerle Snoeck, UCB Pharma, Belgium
13:45 Biological variability of sample population and impact on ADA / NAb assay cut-point assessment
Boris Gorovits, Pfizer, USA
14:15 Immunogenicity testing of therapeutic antibodies in ocular fluids after intravitreal injection
Afasaneh Abdolzade-Bavil, Roche, Germany
14:45 AAPS ADA validation reporting initiative
Vibha Jawa, MSD, USA
15:15 Coffee/Tea Break
Session 4: Biosimilars
Chair: Martin Ullmann
16:00 EIP Biosimilars Working Group update
Martin Ullmann, Fresenius Kabi, Switzerland
16:15 Immunogenicity assessment for an adalimumab biosimilar
Anita Rudy, Sandoz, Germany
16:45 Clinical and regulatory issues in immunogenicity testing for insulins
Sandeep Anthalye, Biocon, India
Session 5: Social Event
Chair: Barbara Vercruyssen, Belgium
17:30 Get Together
22:00 Good Night

Wednesday, 27 February 2019

Session 6: Clinical relevance
Chair: Daniel Kramer
09:00 EIP Clinical Working Group update & Relevance of natural and induced antibodies
Arno Kromminga, BioAgilytix, Germany
09:30 Towards assessment of clinically relevant immunogenicity of monoclonal antibodies
Theo Rispens, Sanquin, The Netherlands
10:00 Evaluation of clinical impact in heterogeneous populations and additional monitoring of ADA and PK parameters using appropriately sensitive & specific bioanalytical methods
Anna Fogdell-Hahn, Karolinska Institute, Sweden
10:30 Coffee/Tea Break
Session 7: Prediction of Immunogenicity
Chair Tim Hickling
11:00 EIP NCIRA Working Group update
Sebastian Spindeldreher, Novartis, Switzerland
11:15 Construction of humanized mouse models for preclinical risk assessment
Nicolas Legrand, GenOway, France
11:45 The development of a quantitative systems pharmacology platform to predict and manage immunogenicity in clinical development

Piet van der Graaf, Certara, The Netherlands

12:15 Innovative methods for predicting clinical immunogenicity with high-dimensional data

Philippe Broët, Université Paris-Saclay, France

12:45 Lunch
Session 8: Regulatory – Risk assessment of novel modalities/CAR-T/gene therapy constructs
Chair: Paul Chamberlain
14:00 Immunogenicity risks of ATMPs and regulatory expectations for the risk mitigation
Paula Salmikangas, NDA Advisory Board, Finland
14:30 Panel Discussion:  ATMP
Paul Chamberlain, Paula Salmikangas, David W. Scott, Federico Mingozzi
15:15 Outlook
EIP Chairman – Daniel Kramer, Sanofi, Germany
15:30 Close of the conference