Menu Back toSession 11: PMDA Highlight - Recent Publication of Japanese Guideline for Non-clinical and CMC Topics Related to Oligonucleotide Medicines

DIA/FDA Oligonucleotide-Based Therapeutics Conference

DIA Your Way! Join us live in-person or live from the comfort of your home/office. This event offers two learning avenues depending on your preference!

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

Scott Henry, PhD

  • 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

Points to Consider Document on CMC of Oligonucleotide Therapeutics in Japan

Kosuke Ito, PhD

  • Principal Reviewer
  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Kazushige Maki, DVM, PhD

Japanese Perspective on Non-clinical Safety Assessment for Oligonucleotide Therapeutics

Kazushige Maki, DVM, PhD

  • Senior Scientist, Toxicology
  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Kiyoshi Kinoshita, PhD

Non-clinical Safety

Kiyoshi Kinoshita, PhD

  • Manager, Regulatory Affairs, Area Japan Development
  • MSD K.K., Japan

Contact us

Registration Questions?

Send Email
1.888.257.6457

Additional Information

Live Meeting Policies

Discover DIA’s Live In-Person and Live Virtual Events