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Session 8 Track A & B: Hybridization-Dependent Off-Target Events
Session Chair(s)
Arthur A. Levin, PhD
Senior Consultant
Levin BioScience, United States
Imran Khan, PhD
Pharmacologist, OMPT, OND, ODEI, DPP, CDER
FDA, United States
In 2012, the Oligonucleotide Safety Working Group published guidelines that outline approaches for assessing hybridization-dependent off-target events. Significant progress has been made in the intervening years in our understanding of this phenomena and new technologies have been more widely accepted that allow us to assess off-target events more thoroughly. Also, in the intervening years, there have been increasing reports of hybridization dependent toxicities being identified in non-clinical studies. It is now time to re-interrogate how to best study off-target events and define new guidelines. The attendees at this session should come away with a greater understanding of the nature and mechanisms of off-target effects and how bioinformatics approaches can minimize them and how to assess them.
Speaker(s)
Update from OSWG-Oligo Hybridization-Dependent Off-Target Events and Surveillance Across Platforms/Mechanism of Action
Arthur A. Levin, PhD
Levin BioScience, United States
Senior Consultant
Large-scale Selectivity Assessment of Gapmer Antisense Oligonucleotides
Sagar Damle, PhD
Ionis Pharmaceuticals, Inc., United States
Associate Director, Functional Genomics
Preclinical and Clinical PK of GalNAc SSOs at Doses Below and Above ASGPR Saturation Approaches to siRNA “Off-Target” Assessment
Mark K. Schlegel, PhD
Alnylam Pharmaceuticals, Inc. , United States
Principal Scientist, RNAi Discovery
Concerns with Antisense and siRNA Antiviral Drugs from a Clinical Virology Perspective
Eric F. Donaldson, PhD
FDA, United States
Virology Reviewer, CDER/OND/OAP/Division of Antiviral Products