An Integrated Approach to Assess Drug-Induced Cardiovascular Liabilities 

Can we improve translation of preclinical data to clinical outcomes?

Early in the drug development lifecycle, the process of evaluating compounds for hemodynamic and electrophysiological cardiovascular risk does not follow a regulated guideline, but more of an investigational method. Determining in-vitro assessments that translate to the whole animal and, more importantly, to the clinical outcome is paramount. One approach would be to assess the test article on cardiac electrophysiology and mechanics in assays with increased complexity.  With overlapping functional outputs it may then be possible to assess biomarkers from multiple assays that translate across the complexity of scales from: 1) individual cardiac targets (ion channels, transporters, contractile proteins, and organelles), 2) single cell systems (stem-cell derived human cardiomyocytes (SC-hCMs), cellular integration), 3) isolated hearts (organ integration) to 4) the whole animal (whole body integration).   

Please join us for this complimentary luncheon seminar where our scientists will discuss an integrated approach to de-risking compounds for cardiovascular liabilities.

Date: October 25, 2017

Time: 11:00 AM – 2:00 PM

Location: Green Acre Campus Pointe

10300 Campus Point Drive

San Diego, CA 92121

Salon A


Brian Roche, PhD, DSP, DABT

Executive Director, Global Safety Pharmacology, Charles River

Brian Roche, a dual-boarded toxicologist (DABT) and safety pharmacologist (DSP), has recently been appointed to the new role of executive director of global safety pharmacology at Charles River. In this role, Dr. Roche manages the company’s global safety pharmacology portfolio, which includes aligning best practices across sites and providing the highest level of scientific support to our partners. Dr. Roche completed his PhD and postdoctoral work in cardiovascular physiology at The Ohio State University. He worked in safety pharmacology at Quintiles QTest Labs and Battelle Memorial Institute before accepting the director of safety pharmacology position at WIL Research in 2014. Following the 2016 acquisition of WIL Research by Charles River, Dr. Roche has contributed to the scientific collaboration and establishment of best practices across our safety pharmacology sites.

Jim Kramer, PhD

Principal Scientist, Charles River

Jim Kramer received his doctorate in Biomedical Science from Wright State University. He completed his postdoctoral work at Case Western Reserve University School of Medicine. Starting as a study director for ChanTest, Dr. Kramer has devoted his 17-year career to determining the effects of drugs on various cardiac safety models, but primarily on the conductance of cardiac ion channels, the proteins that underlie the electrical activity of the heart.  He’s played a key role in the development of the Comprehensive in vitro Proarrhythmia Assay (CiPA) and currently co-leads the Drug Selection and High Throughput Ion Channel Platform Validation committees.