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Program

11th Open Scientific EIP Symposium
on
Immunogenicity of Biopharmaceuticals

 

Program

 

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
 
10:30 Coffee break
 
11:00 “Continue” 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
Arno Kromminga, BioAgilytix, Germany
Daniel Kramer, Sanofi, Germany
 
15:00 Coffee break
 
15:30 “Continue” Major Challenges in the Assessment of Immunogenicity
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 AAV immunogenicity : novel vectors and new questions
David Favre, AskBio, USA
 
10:45 Coffee break
 
Session 2: Immunogenicity Testing
Chair: Veerle Snoek
11:15 EIP Assay Working Group update
Veerle Snoeck, UCB, Belgium
 
11:45 SMCXpro : An alternative for the development of immunogenicity assays
Eric Guillemare, Sanofi, France
 
12:15 ADA testing in repeated dose toxicity studies – strategies
Daniel Kramer, Sanofi, Germany
 
12:45 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 Coffee break
 
15:15 T-B collaboration in the generation of anti-drug antibody response
Luca Piccoli, Institute for Research in Biomedicine, Università della Svizzera italiana,
Bellinzona, Switzerland.
 
15:45 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
16:30 Get Together
 
23:00 Good Night
 

Wednesday, 19 February 2020

Session 5: Clinical relevance
Chair: Claudio Calonder
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
Arno Kromminga, Bioagilytix
 
11:30 Immunogenicity Assays for Multi-Specific Nanobodies
Samuel Pine, Sanofi-Ablynx
 
12:00 Lunch
 
Session 7: Regulatory
Chair: Daniel Kramer
14:00 A European assessors perspective on unwanted immunogenicity
Günther Waxenecker, Ages, Austria
 
14:30 Panel discussion on ATPM risk assessment, novel modalities, assay performance
Günther Waxenecker, Ages, Austria
Paul Chamberlain, NDA
 
15:00 Outlook
 
15:15 Close of the conference


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