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Session 7A and C (Nonclinical and Clinical Development Tracks): Translational Assessment of Oligonucleotide Effects in the Kidney
Session Chair(s)
Jan Kevin Losos, PhD
Director, Safety Assessment Projects
GlaxoSmithKline, United States
Imran Khan, PhD
Pharmacologist, OMPT, OND, ODEI, DPP, CDER
FDA, United States
In this joint session for the nonclinical and clinical tracks, the importance of renal toxicology for oligonucleotide therapeutics will be considered. Renal toxicity occurs in a dose-related fashion for some oligonucleotide products in nonclinical studies. Are nonclinical results predictive of what can be expected with therapeutic doses in clinical administration? This session will discuss two instances of renal toxicology in nonclinical studies as well as potential underlying mechanisms including exaggerated pharmacology. A final presentation will examine an instance of renal toxicity associated with the clinical administration of an oligonucleotide and its importance.
Speaker(s)
Glomerular Effects of Antisense Oligonucleotide Therapies and their Potential Mechanism
Kendall Frazier, DVM, PhD
GlaxoSmithKline, United States
Director, Cellular and Molecular Pathology
A Novel Antisense Oligo Targeting SGLT2 in the Kidney: Twists and Turns In Preclinical Development
Thomas Zanardi, PhD
Isis Pharmaceuticals, Inc., United States
Director, Toxicology
Renal Effects and Clinical Monitoring of Drisapersen
Kevin E. Meyers
Perelman School of Medicine at the Univ. of Pennsylvania, United States
Assistant Chief, Division of Nephrology
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