Position Yourself for Success by Perfecting Your Clinical Pharmacology Skillset-LIVE WEBINAR

Learners that complete this webinar will gain knowledge about a First-in-Class drug with a novel mechanism of action. SP-624 (generic name forvisirvat) is a small molecule activator of the sirtuin (SIRT) 6 enzyme. SIRT6 is a NAD+ dependent histone deacetylase and is believed to be the first activator of the enzyme tested in human clinical trials. It is currently being assessed in a Phase 2b/3 study for the treatment of major depressive disorder. The webinar presents data from single ascending dose and multiple ascending dose studies conducted in healthy male and female subjects. The safety, tolerability and pharmacokinetics after single multiple doses of forvisirvat will be reviewed.

The American College of Clinical Pharmacology® monthly journal article continuing education offerings from The Journal of Clinical Pharmacology.

Drug-induced nephrotoxicity (DIN) is a major clinical challenge for a variety of marketed drugs belonging to various therapeutic areas. Successful clinical prevention of DIN requires prior knowledge of drug’s mechanism of action coupled with pathogenic mechanisms of renal injury as well as patient- and drug-related risk factors. Recently, significant innovative advances in the identification of novel early biomarkers for DIN have been made. However, they are not beyond limitations. In such scenarios, mathematical modeling and simulation (M&S) may be used as a robust tool to understand and predict DIN in a clinical setting. This presentation highlights some of the recent advancements in mathematical M&S approaches for DIN. An example of the utility of multiscale and translational M&S for combinatorial effects of a DIN with a proposed preventive therapeutic will be showcased.