DILI is a leading cause of drug development failures and a frequent cause of drug label restrictions
BioIVT, a leading provider of research models and services for drug and diagnostic development, today announced that it is hosting a webinar that will present the latest in vitro research methods and International Transporter Consortium (ITC) guidance for assessing bile salt export pump (BSEP) inhibition to reduce and manage the risk of drug-induced liver injury (DILI) during drug development.
BSEP, a canalicular membrane transport protein, is responsible for bile acid efflux from hepatocytes in the liver and is of critical importance for normal bile flow and healthy liver function. BSEP inhibition can lead to cholestatic DILI in humans.
“DILI is responsible for drug development failures and label restrictions. Several approved drugs have even been removed from the market due to liver injury that was partially caused by BSEP inhibition,” said Kenneth R. Brouwer, PhD, RPh, vice president, ADME-TOX at BioIVT. “This is such an important area that ITC recently commissioned a review of all the in vitro BSEP inhibition research methods. It underscored the fact that to create an accurate DILI risk assessment, in vitro measures of BSEP inhibition need to be combined with in vivo drug exposure data and other mechanisms of action and inhibition.”
This one-hour webinar, entitled “How and When to Evaluate BSEP Inhibition to Help Reduce Human DILI Risk: International Transporter Consortium (ITC) Recommendations,” will be held on Thursday, July 18 at 11 a.m. EST.
Presenter J. Gerry Kenna, PhD, FBTS, pharmaceutical director at Safer Medicines Trust, a drug safety consultant, and vice president of the Board of Trustees of the Evidence Based Toxicology Collaboration, will review conventional and emerging in vitro models and provide practical advice on conducting BSEP inhibition studies. He will also discuss how to adapt in vitro liver models for high-throughput drug discovery, drug discovery limitations using hepatic models, and the use of high-content imaging in research. Dr. Kenna specializes in developing and implementing novel, human biology-based methods to improve drug safety evaluation.
A strong proponent of DILI research, BioIVT developed its C-DILI™ Assay to predict the potential of a compound to cause cholestatic DILI. It has a portfolio of products and services to study transporter effects and so can provide complete in vitro solutions. BioIVT is also the premier supplier of hepatic products, including hepatocytes and subcellular fractions, for research use.
Interested parties can register for this complimentary webinar here.
ITC is comprised of scientists from academia, industry and regulatory agencies around the world. It seeks to advance the understanding of transporter biology to develop drugs to improve human health.
BioIVT is a leading global provider of research models and value-added research services for drug discovery and development. We specialize in control and disease-state biospecimens including human and animal tissues, cell products, blood, and other biofluids. Our unmatched portfolio of clinical specimens directly supports precision medicine research and the effort to improve patient outcomes by coupling comprehensive clinical data with donor samples. Our PHASEZERO® Research Services team works collaboratively with clients to provide target and biomarker validation, phenotypic assays to characterize novel therapeutics, clinical assay development and in vitro hepatic modeling solutions. And as the premier supplier of hepatic products, including hepatocytes and subcellular fractions, BioIVT enables scientists to better understand the pharmacokinetics and drug metabolism of newly-discovered compounds and their effects on disease processes. By combining our technical expertise, exceptional customer service, and unparalleled access to biological specimens, BioIVT serves the research community as a trusted partner in elevating science. For more information, please visit www.bioivt.com or follow the company on Twitter @BioIVT.