ショートコース
2023年3月13日(月) 8:00 - 10:00
SC1: Safety and Toxicity of Nucleic Acids
SC1:核酸の安全性と毒性
Presentation to be Announced
Nonclinical Considerations for the Development of Oligonucleotide Therapeutics
Sarah Lamore, PhD, Director, Toxicology, Pre-Clinical Development Sciences, WAVE Life Sciences
This presentation will review some of the common toxicities associated with oligonucleotide administration, discuss the regulatory expectations for the nonclinical safety evaluation of oligonucleotide therapeutics in the context of the applicable guidance documents, and present case studies based on recently approved products.
ADME and PK/PD Considerations for Preclinical Development of Antisense Oligonucleotides (ASOs)
Xiao Shelley Hu, PhD, Vice President, Head of DMPK and Clinical Pharmacology, Wave Life Sciences
ASOs are an emerging class of medicines for unmet medical needs. The ADME and PK/PD entail specific considerations to support effective preclinical development. This talk will focus on factors relevant to preclinical development of ASOs.
INSTRUCTOR BIOGRAPHIES:
Sarah Lamore, PhD, Director, Toxicology, Pre-Clinical Development Sciences, WAVE Life Sciences
Xiao Shelley Hu, PhD, Vice President, Head of DMPK and Clinical Pharmacology, Wave Life Sciences
* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。