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Bethesda North Marriott Hotel and Conference Center

Oct 28, 2019 7:00 AM - Oct 30, 2019 12:30 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

DIA/FDA Oligonucleotide-Based Therapeutics Conference

Session 8 Track A & B: Hybridization-Dependent Off-Target Events

Session Chair(s)

Arthur A. Levin, PhD

Arthur A. Levin, PhD

Distinguished Scientist

Avidity Biosciences, United States

Imran  Khan, PhD

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)

Arthur A. Levin, PhD

Update from OSWG-Oligo Hybridization-Dependent Off-Target Events and Surveillance Across Platforms/Mechanism of Action

Arthur A. Levin, PhD

Avidity Biosciences, United States

Distinguished Scientist

Sagar  Damle, PhD

Large-scale Selectivity Assessment of Gapmer Antisense Oligonucleotides

Sagar Damle, PhD

Ionis Pharmaceuticals, Inc., United States

Associate Director, Functional Genomics

Mark K. Schlegel, PhD

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

Eric F. Donaldson, PhD

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

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