EIP Symposium

11th Open Scientific EIP Symposium
Immunogenicity of Biopharmaceuticals




17 – 19 February 2020

Altis Hotel

Lisbon, Portugal



Monday, 17 February 2020

Training course:
Immunogenicity Risk Assessment
9:00 Effective presentation of immunogenicity-related data in regulatory submissions
Paul Chamberlain, NDA
12:00 Lunch
Assay validation and Immunogenicity Assessment
13:30 Major Challenges in the Assessment of Immunogenicity
João A. Pedras-Vasconcelos, CDER/FDA, invited
Arno Kromminga, BioAgilytix, Germany
Daniel Kramer, Sanofi, Germany
16:30 Close of the training course

Tuesday, 18 February 2020

09:00 Welcome and Introduction by the EIP chairman
Daniel Kramer, Sanofi, Germany
Session 1: Novel Gene Therapies
Chair: Arno Kromminga
09:15 Keynote Lecture: AAV vectors and the host immune system, challenges and opportunities
Federico Mingozzi, Spark Therapeutic, USA
10:00 Genomic therapies
Jim McNally, CRISPR Therapeutics, invited
10:30 Coffee/Tea Break
Session 2: Immunogenicity Testing
Chair: Veerle Snoek
11:00 EIP Assay Working Group update
Veerle Snoeck, UCB, Belgium
11:30 Drug and target tolerance with high sensitivity
Arno Kromminga, BioAgilytix, Germany
12:00 ADA testing in preclinical trials- strategies
Daniel Kramer, Sanofi, Germany
12:30 Lunch
Session 3: Prediction
Chair: Sofie Pattijn
14:00 EIP NCIRA Working Group update
Sebastian Spindeldreher, Integrated Biologix, Switzerland
14:30 The Two-Faced T cell Epitope and Janus Matrix; Relevance to Biologics and Immunogenicity
Annie DeGroot, EpiVax, USA
15:00 Neutralizing anti-drug antibody response to natalizumab
Luca Piccoli, University Bellinzona, Italy
15:30 Artificial neural network algorithm trained on mass spectrometry-based peptidomcs enhances drug immunogenicity prediction
Carolina Barra Quaglia, Technical University of Denmark
Session 4: Social Event
Chair: Barbara Vercruyssen
17:00 Get Together
23:00 Good Night

Wednesday, 19 February 2020

Session 5: Clinical relevance
Chair: Sophie Tourdot
09:00 Immunogenicity of engineered enzymes: strategies for risk management with engineered alpha-galactosidase A as a case example
Nikki Dellas, Codexis, USA
09:30 Characterization of ADA responses against bispecific cancer immune therapeutics
Gregor Lotz, Roche, Germany
10:00 Patient factors and immunogenicity: case studies with replacement enzymes
Susan Richards, Sanofi-Genzyme, USA
10:30 Coffee/Tea Break
Session 6: Novel modalities / Multi Domain Constructs
Chair: Gregor Lotz
11:00 Review – Multi Domain Constructs
Boris Gorovits, Pfizer
11:30 Immunogenicity Assays for Multi-Specific Nanobodies
Samuel Pine, Sanofi-Ablynx
12:00 Lunch
Session 7: Regulatory
Chair: Daniel Kramer
14:00 Specific Aspects of regulated Immunogenicity Assessment
João A. Pedras-Vasconcelos, CDER/FDA, invited
14:30 A European assessors perspective on unwanted immunogenicity
Günther Waxenecker, Ages, Austria
15:00 Panel discussion on ATPM risk assessment, novel modalities, assay performance
Günther Waxenecker, Ages, Austria
João A. Pedras-Vasconcelos, CDER/FDA
Paul Chamberlain, NDA
15:30 Outlook
15:45 Close of the conference