Back to Agenda
Japanese Perspective on the Preclinical Safety Assessment of Oligonucleotide Therapeutics
Session Chair(s)
Arthur A. Levin, PHD
Distinguished Scientist, Avidity Biosciences, United States
Representatives from Japanese regulatory and industrial joint working teams, including EWG members for ICH S6(R1), have discussed over the past two years the preclinical safety assessment of oligonucleotide therapeutics in comparison with biopharmaceuticals and low molecular new chemical entities. Unique perspectives will be shared with time for Q&A.
Learning Objective :
Speaker(s)
Yoko Hirabayashi, MD
Division Head, National Institute of Health Sciences, Japan
Japanese Initiative to Develop a White Paper for Oligonucleotide Therapeutics
Kazushige Maki, DVM, PHD
Senior Scientist, Toxicology, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Study Design and Species Selection to Detect On-Target and Off-Target Effects
Takahiro Nakazawa
CSO, AnGes, Inc., Japan
Lessons Learned from Biopharmaceuticals
Have an account?