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11th Open Scientific EIP Symposium on Immunogenicity of Biopharmaceuticals

17th — 19th February 2020

Lisbon, Portugal

Programme

 

Monday, February 17th, 2020

Training course
Immunogenicity Risk Assessment
09:00 Effective presentation of immunogenicity-related data in regulatory submissions: Practical guidance
Paul Chamberlain (NDA)
10:30 coffee Coffee break
11:00 Continuation Effective presentation of immunogenicity-related data in regulatory submissions: Practical guidance
Paul Chamberlain (NDA)
12:00 cutlery 77 Lunch
Assay validation and Immunogenicity Assessment
13:30 Major Challenges in the Assessment of Immunogenicity
Arno Kromminga (BioAgilytix) & Daniel Kramer (Sanofi)
15:00 coffee Coffee break
15:30 Continuation Major Challenges in the Assessment of Immunogenicity
Arno Kromminga (BioAgilytix) & Daniel Kramer (Sanofi)
16:30 Close of the training course
 

Tuesday, February 18th, 2020

09:00 Welcome and Introduction by the EIP chairman
Daniel Kramer (Sanofi)
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)

Downloads

ADA Testing in Repeated Dose Toxicity Studies - Strategies
Daniel Kramer (Sanofi)
Non-clinical Immunogenicity Risk Assessment
Sebastian Spindeldreher (NCIRA)
AAPS Therapeutic Product Immunogenicity Update
Vibha Jawa (Chair TPI Community)
T-B collaboration in the generation of anti-drug antibody response
Luca Piccoli (Institute for Research in Biomedicine, Università della Svizzera italiana,)
EIP Working Group on Immunogenicity Strategy Update
Veerle Snoeck (on behalf of EIP)
SMC™ : An alternative to other technologies for development of immunogenicity assay for cytokines ADA
Eric Guillemare (Sanofi)

Wednesday, February 19th, 2020

Immunogenicity Testing of Multi-Specific Nanobodies®
Samuel Pine (Ablynx)
From Assays to Benefit/Risk Assessment: A European Assessors Perspective on Unwanted Immunogenicity
Günter Waxenecker (BASG - Austrian Federal Office for Safety in Health Care)
Immunogenicity of engineered enzymes: Strategies for risk management with alpha-galactosidase A as a case example
Nikki Dellas (Codexis)
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