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4th Open Scientific EIP Symposium on Immunogenicity of Biopharmaceuticals

6th — 8th February 2012

Copenhagen, Denmark



Monday, February 6th, 2012

Introductory course on Immunogenicity
Course Leader: Christian Ross (Novo Nordisk)
The EIP course on immunogenicity includes a general introduction and update on immunogenicity. The presentations are given by experienced EIP members and selected specialists. The goal is to offer a broad coverage of the field of immunogenicity for people working in this field both in pharmaceutical companies and academic institutions.
10:00 Immunogenicity a growing field within basic research and drug development
Christian Ross, Novo Nordisk
10:30 The immunology and major mechanisms affecting immunogenicity
Huub Schellekens, University of Utrecht
11:30 Binding antibodies, Assay methodologies, Comparison of different methods, Screening Confirmation, Characterization of anti-drug-antibodies, etc.
Daniel Kramer, Merck-Serono
12:30 cutlery 77 Lunch
13:30 Neutralizing antibodies, Emerging trends in the development of NAb assays, Clinical implementation of an established NAb assay
Arno Kromminga, IPM Biotech
14:30 Predictive Immunogenicity tools, different methods, are they predictive, guideline status on predictive tools
Philippe Stas, Lonza
15:30 Critical review of previous immunogenicity issues: Interferons, EPO, Coagulation factors and mAbs. Learnings and future perspectives from research to clinical consequence.
Daniel Kramer, Christian Ross, Huub Schellekens
17:00 Registration and welcome reception

Tuesday, February 7th, 2012

Chair: Philippe Stas (Lonza)
09:00 Welcome and Introduction by the EIP president
09:15 Harmonization of clinical immunogenicity reporting
Gopi Shankar (Johnson & Johnson)
09:45 Aggregation, immune complexes and immunogenicity
Roy Jefferis (University of Birmingham)
10:15 Characterization and quantitation of aggregates and particles in interferon-beta drug products
John Carpenter (University of Colorado)
10:45 coffee Coffee/Tea Break
11:15 A fit-for-purpose strategy for the risk-based immunogenicity testing of biotherapeutics - a European industry perspective
Cathelijne Kloks (MSD)
11:45 A fit-for-purpose strategy: Panel discussion
Claudia Berger (Abbott), Hishani Kirby (UCB), Sebastian Spindeldreher (Novartis), Daniel Kramer (Merck Serono)
12:30 cutlery 77 Lunch break
14:00 Update on novel guideline drafts on immunogenicity of monoclonal antibodies and biosimilar drugs
Robin Thorpe (NIBSC)
14:30 Induction of antigen-specific immune tolerance with synthetic peptides
David Wraith (University of Bristol)
15:00 Tolerized animal models and immunogenicity
Vera Brinks (Utrecht University)
15:30 coffee Coffee/Tea break
16:00 Influence of Aggregates on In Vitro T Cell Responses
Christine Bryson (Antitope)
16:20 Technology Presentations
In vivo fate of protein aggregates upon injection – the use of fluorescence optical in vivo imaging
Grzegorz Kijanka (University of Utrecht)
Comparison of immunoassay technologies for the detection of antidrug antibodies against biotherapeutics: DELFIA, AlphaLISA and Gyros
Elli Oksanen (Syrinx Bioanalytics)
Better prediction of immunogenicity of biopharmaceuticals in humans: Is it possible?
Simon Folkertsma (TNO)
T cell epitope identification in Remicade® and Humira® using the REVEAL® Immunogenicity System
Matthew Frayne (ProImmune)
17:30 Close of the day
18:00 shuttle Departure of the busses to the social event
18:30 toast Social event at the Danish Center for Architecture
22:45 shuttle Return of the busses to the Tivoli Conference Center and Hotel


Wednesday, February 8th, 2012

TLRs and the germinal center antibody response
Anthony DeFranco (UCSF)
Immunogenicity of anti TNF biopharmaceuticals in rheumatic diseases: the causes and the consequences
Denis Mulleman (University of Tours, France)
The clinical relevance of immunogenicity to anti TNF agents in IBD
Gert Van Assche (IBD Leuven)
Inducing tolerance to Campath‐1H (alemtuzumab) in the treatment of multiple sclerosis
Alasdair Coles (Universities of Cambridge & Oxford)
Peptide‐MHC class I stability is a stronger predictor of CTL immunogenicity than peptide affinity
Mikkel Harndahl (University of Copenhagen)
Using Predictions of Peptide – MHC Class II Binding in Immunogenicity Ranking During Early Stage Biotherapeutics Development
Olga Obrezanova (Lonza)
Antibody response against adalimumab upon long term treatment appears to be IgG4 related
Pauline van Schouwenburg (Sanquin)
Establishment of a Cell-Based Assay Specific for a Growth Factor that Shares a Common Receptor Chain and Overlapping Biological Activities with Other Cytokines and Growth Factors
Michael G. Tovey (INSERM)
Aligning immunogenicity evaluation with the Regulator's needs for an integrated data analysis
Paul Chamberlain (NDA Advisory Board)
Optimising anti-TNF treatment on the basis of trough levels and anti-drug antibodies
Niels Vande Casteele (Katholieke Universiteit Leuven, Belgium)
Anti-Biopharmaceutical Immunization: Prediction and analysis of clinical relevance to minimize the risk
Marc Pallardy (INSERM)
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