Recordered Friday, October 2, 2020
Co-Chairs: Michael K. Pugsley, MS, FBPhS, PhD, Cytokinetics; and Steve Tichenor, PhD, Charles River Laboratories
This continuing education course will include lectures that describe fundamental areas of safety pharmacology studies (CNS, Respiratory, Cardiovascular systems) for both new chemical entities (NCE) as well as biotechnology-derived products. It will also include some discussion of clinical issues (and methods) as well as novel non-clinical methods and approaches that may be added to the core ‘battery’ of tests used to explore the safety of novel therapeutic agents. Attendees will be introduced to discussion regarding the role safety pharmacology has as an integral component within the safety program for drug development. We will also introduce the Comprehensive In Vitro Proarrhythmia Assay (CIPA) cardiovascular paradigm being developed for hazard identification, elimination and risk assessment that would help to obviate conduct of the clinical “Through QT” (TQT) study. Furthermore, this course will provide attendees with a crucial resource that explains the important role safety pharmacology has in the overall pharmaceutical drug development process.