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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)
Japanese Initiative to Develop a White Paper for Oligonucleotide Therapeutics
Yoko Hirabayashi, MD
National Institute of Health Sciences, Japan
Division Head
Study Design and Species Selection to Detect On-Target and Off-Target Effects
Kazushige Maki, DVM, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Senior Scientist, Toxicology
Lessons Learned from Biopharmaceuticals
Takahiro Nakazawa
AnGes, Inc., Japan
CSO
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