New options for avoiding a dedicated TQT study – the impact of the new ICH E14/S7B revisions
In this webinar, we will discuss the impact of the new ICH E14 and S7B revisions on the cardiac safety assessment of new compounds. Dr. Darpo will discuss the new E14 material and the practical implications for taking advantage of the new pathways potentially available for drug developers. Dr. Kleiman will discuss the changes to S7B from the view of a clinician, with an emphasis on how drug developers on the clinical side will need to review in vitro and in vivo CV safety data. They will then share their impressions on the new opportunities that these revisions provide for drug development, as well as some thoughts on the as yet unresolved issues that will only become clarified over the next few years as regulators become more familiar with nonclinical data.
Session Information:
Title: New options for avoiding a dedicated TQT study – the impact of the new ICH E14/S7B revisions
Date: Friday, September 30th, 2022
Time: 11:00 a.m. EST
In this webinar, we will discuss the impact of the new ICH E14 and S7B revisions on the cardiac safety assessment of new compounds. Dr. Darpo will discuss the new E14 material and the practical implications for taking advantage of the new pathways potentially available for drug developers. Dr. Kleiman will discuss the changes to S7B from the view of a clinician, with an emphasis on how drug developers on the clinical side will need to review in vitro and in vivo CV safety data. They will then share their impressions on the new opportunities that these revisions provide for drug development, as well as some thoughts on the as yet unresolved issues that will only become clarified over the next few years as regulators become more familiar with nonclinical data.
Speakers
Robert Kleiman, MD
Vice President, Cardiology & Chief Medical Officer at Clario
Dr. Robert Kleiman is the Chief Medical Officer at Clario, with board certifications in cardiology and cardiac electrophysiology. He has performed research in both basic cellular electrophysiology as well as clinical electrophysiology. Dr. Kleiman trained at the University of Pennsylvania and practiced clinical cardiology for 12 years before joining Clario in 2003.
In his current role, he currently oversees all of Clario’s cardiology services, supports business development and provides cardiac safety consultative services advising sponsors on optimal cardiac safety strategy for their development program (e.g. clinical protocol development, expert cardiac report development and regulatory support).
Borje Darpo, MD, PhD
Chief Scientific Advisor, Cardiac Safety at Clario
Dr. Borje Darpo is Chief Scientific Officer, Cardiac Safety at Clario, with board certifications in cardiology and internal medicine. He completed his cardiology training at Sahlgrenska University Hospital, Göteborg and was appointed Associated Professor at Karolinska Hospital, Stockholm in 2000. Borje held various positions within CROs and pharmaceutical industry covering a wide variety of therapeutic areas.
Borje represented European pharmaceutical industry on the ICH E14 Expert- and Implementation Working group between 2000 and 2008. In collaboration with industry and the FDA, he led the IQ-CSRC study, which validated the concept of applying exposure-response analysis on data from early stage clinical trials to replace the Thorough QT study. This contributed to the revision of the ICH E14 guideline, which since December 2015 allows this approach to replace the TQT study.
In his current role, he supports business development and provides cardiac safety consultative services advising sponsors on optimal cardiac safety strategy for their development program (e.g. clinical protocol development, expert cardiac report development and regulatory support).