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DIA/FDA Oligonucleotide-Based Therapeutics Conference

Breakfast Plenary Session: Global Regulatory

Session Chair(s)

Paul C. Brown, PhD

Paul C. Brown, PhD

  • ODE Associate Director for Pharmacology and Toxicology, OND, CDER
  • FDA, United States
Laurence  Whiteley, DVM, PhD

Laurence Whiteley, DVM, PhD

  • Senior Director, Global Pathology Team Leader
  • Pfizer Inc, United States
Representatives from the Pharmaceutical and Medical Devices Agency (PMDA) of Japan will present their proposal for a regulatory guidance for oligonucleotide therapeutics. Discussion will focus on the overall approach and whether aspects can be more widely applied. The information presented may also support discussion in other sessions of the meeting.


Yoko  Hirabayashi, MD

Draft Guideline for Non-Clinical Safety Evaluation of Oligonucleotide Therapeutics in Japan

Yoko Hirabayashi, MD

  • Director, Center for Biological Safety & Research
  • National Institute of Health Sciences (NIHS), Japan