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Session 11: PMDA Highlight - Recent Publication of Japanese Guideline for Non-clinical and CMC Topics Related to Oligonucleotide Medicines
Session Chair(s)
Scott Henry, PhD
Senior Vice President, Nonclinical Development, Ionis Pharmaceuticals, Inc., United States
This session will briefly review the Japanese Guideline regarding preclinical assessment of oligonucleotide medicines. This session will also introduce the outline of the points to consider document, and review issue related to CMC in Japan. Common questions will be addressed pertinent to this class of therapeutics.
Learning Objective : At the conclusion of this session, participants should be able to:
- Learn the basic concept of non-clinical safety evaluation required for the development of oligonucleotide therapeutics in Japan
- Explain the outline of points to consider document regarding CMC of oligonucleotide therapeutics in Japan
Speaker(s)
Kosuke Ito, PhD
Principal Reviewer, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Points to Consider Document on CMC of Oligonucleotide Therapeutics in Japan
Kazushige Maki, DVM, PhD
Senior Scientist, Toxicology, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Japanese Perspective on Non-clinical Safety Assessment for Oligonucleotide Therapeutics
Kiyoshi Kinoshita, PhD
Manager, Regulatory Affairs, Area Japan Development, MSD K.K., Japan
Non-clinical Safety
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