Human In Vitro Assays for Cardiac Contractility and Electrophysiology Measurements

TOPICAL COLLECTIONS

Guest Editors

Ksenia Blinova

US Food and Drug Administration, Center for Devices and Radiological Health (CDRH), Office of Science and Engineering Laboratories, Division of Biomedical Physics

Dr. Ksenia Blinova is an Assistant Director for neurological and cardiovascular devices, electrophysiology, and computer modeling at the Division of Biomedical Physics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health (CDRH), US Food and Drug Administration (FDA). She also leads an Induced Pluripotent Stem Cell and Electrophysiology Laboratory that conducts collaborative regulatory research supporting the review and development of FDA-regulated products, including medical electrophysiological devices and in-vitro diagnostics. Dr. Blinova received her PhD in physics and mathematics in 2001 from Moscow State University. She completed cardiac metabolism and physiology, a postdoctoral fellowship at the National Heart, Lung, and Blood Institute at NIH in 2008, and FDA Commissioner’s Fellowship in 2010.

Jennifer Beck Pierson

Health and Environmental Sciences Institute

Jennifer Pierson received her BS in Biology in 2005 from Villanova University and her Master of Public Health in 2007 from Drexel University. She has worked in research laboratories and at a local health department, focusing on epidemiological investigations. Jennifer is currently a Senior Scientific Program Manager at Health and Environmental Sciences Institute (HESI), where she provides scientific support to technical committees. Jennifer has extensive experience in project development and grant and budget management. In her role at HESI, Jennifer manages the Cardiac Safety Committee, which focuses on improving the understanding of cardiovascular risk from drugs or chemicals. The Translational Biomarkers of Neurotoxicity Committee focuses on improving the prediction of neurotoxicity. Through these committees, she has understood in vivo models, in vitro, in silico and 3D technologies used to predict risk. Jennifer has also co-authored numerous papers over the last ten years.

Collection Overview

The effect of medical treatments on heart contractility and electrophysiology can be beneficial (on-target) or adverse and is often a significant factor to be considered for both cardiac and non-cardiac therapies. The decision to advance a drug or medical device to clinical trials involves extensive preclinical testing. The development of novel preclinical testing approaches is valuable in early medical product development and ultimately in regulatory safety and effectiveness assessment of drugs or medical devices seeking regulatory approval. New therapies are traditionally first evaluated in animal models, but this approach has multiple limitations, including limited translatability, lack of appropriate disease models, cost, and ethical considerations. Recent biotechnological advances leading to the discovery of induced pluripotent stem cells (iPSC) enable the development of in vitro systems utilizing human or even patient-specific cardiac cells, or cardiomyocytes (CM). iPSC-CM technology combined with new and improved methods of measuring cellular health and function using reproducible and moderately high throughput in vitro assays opens a new era in the preclinical medical therapy development and assessment space.

This Methods Collection aims to garner and share cutting-edge experimental protocols, data acquisition, and analysis methods, and results interpretation approaches in translational iPSC-CM assays for cardiac contractility and electrophysiology for the convenience of drugs and medical devices developers, regulatory scientists, academic researchers, physicians, and other stakeholders. The invited contributors may come from the US or other countries and represent academia, industry, regulatory agencies, or any other scientific organization and will benefit from the high-quality video production provided by the JoVE team when sharing their methods.