DIA/FDA Oligonucleotide-Based Therapeutics Conference

Convening industry and health authorities to inform, educate, and share advancements in oligonucleotide-based therapeutic product development.

戻る Agenda

Japanese Perspective on the Preclinical Safety Assessment of Oligonucleotide Therapeutics

Session Chair(s)

Arthur A. Levin, PhD

Senior Consultant

Levin BioScience, 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 :
Learn several initiatives towards Japanese guidelines for oligonucleotide therapeutics
Understand study design and species selection
Understand lessons from biopharmaceuticals

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