[ 5/11 (Fri) ]
Non-clinical and Clinical strategy in Europe for Advanced therapy (Cell therapy)



Representative Info. Youn-Seung Kim, GinaPath Co., Ltd., +82-70-5001-3831, yskim@ginapath.com
Time Session Title
10 : 00 ~ 10 : 40 Advanced Therapy Medicinal Products in Oncology and beyond
Enrico Pesenti, CEO, Accelera
10 : 40 ~ 11 : 20 Strategies for preclinical pathology evaluation of cell and gene therapy products and related effects
Klaus Weber, CEO, Anapath
11 : 20 ~ 12 : 00 LC-MS/MS quantitation for peptides, therapeutic proteins and antibodies
Christoph Siethoff, CEO, SBQ
12 : 00 ~ 12 : 40 Break
12 : 40 ~ 13 : 20 MSD and Gyrolab, different platforms for large molecule quantitation
Salvatore Calogero, Principal investigator, SBQ
13 : 20 ~ 14 : 00 Preclinical evaluation of cell and gene therapy products: some in vivo practical examples
Anne-Laure Leoni, Managing Director, Eurofins BioPharma Product Testing
14 : 00 ~ 14 : 40 Design of regulatory strategic non-clinical safety study for FIH clinical trials
Akihito Shimoi, Operation Director, INA Research
14 : 40 ~ 15 : 00 Break
15 : 00 ~ 15 : 40 Cutting edge technique of eye-examination, helping R&D of eye drops
Yasue Sakaguchi, Toxicologist, INA Research
15 : 40 ~ 16 : 00 Global e-submission: SEND helpes Korean Pharma's new drug development
Anzai Takayuki, Vice President, PDS Lifescience