Advanced
Emerging
Xihui Xu, PharmD, PhD
Director
Toxicology
QurAlis Corporation
Cambridge, Massachusetts, United States
Jennifer Sisler, PhD
Senior Advisor
Toxicology
Eli Lilly and Company, Inc.
Indianapolis, Indiana, United States
Belete Teferedegne, DVM, PhD, DABT
Director
Clinical Pharmacology and Safety Sciences
AstraZeneca
Gaithersburg, Maryland, United States
Tom Zanardi, PhD, DABT
Executive Director
Toxicology
Ionis Pharmaceuticals
Carlsbad, California, United States
Chun-Ting (David) Lee, PhD, MSPH
Toxicologist
Division of Pharmacology and Toxicology, Neurology, Office of Neuroscience, CDER
US FDA
Educational Support Provided by: QurAlis Corporation
Oligonucleotides and mRNA therapeutics have advanced over the past 20 years, as well as the number of drugs approved. With the advancement of this field, there has been an increase in novel targets and delivery mechanisms. While the field has advanced in targeted knockdown, the challenges have also increased such as local tolerability and off-target toxicity. This symposium will focus on these advancements and strategies for different modalities, including GalNAc siRNAs, ASOs, mRNA vaccines. Each talk will focus on the development strategy including type of studies performed, dose selection and the use of surrogate molecules if appropriate for an IND-enabling package and beyond.
Symposium Chair: Xihui Xu, PharmD, PhD – QurAlis Corporation
Symposium Speaker: Jennifer Sisler, PhD – Eli Lilly and Company, Inc.
Symposium Speaker: Belete Teferedegne, DVM, PhD, DABT – AstraZeneca
Symposium Speaker: Tom Zanardi, PhD, DABT – Ionis Pharmaceuticals
Symposium Speaker: Chun-Ting (David) Lee, PhD, MSPH – US FDA