11th Open Scientific EIP Symposium on Immunogenicity of Biopharmaceuticals
17th — 19th February 2020
Lisbon, Portugal
Program
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 break
11:00
ContinuationEffective presentation of immunogenicity-related data in regulatory submissions: Practical guidance Paul Chamberlain (NDA)
12:00
Lunch
Assay validation and Immunogenicity Assessment
13:30
Major Challenges in the Assessment of Immunogenicity Arno Kromminga (BioAgilytix) & Daniel Kramer (Sanofi)
15:00
Coffee break
15:30
ContinuationMajor 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)
