In this free webinar, gain insights into the evolving landscape of cardiac safety assessments and strategies for optimizing drug development outcomes. The attendees will review the importance of the first-in-human trial and the opportunities it affords. The featured speakers will discuss the advantage of leveraging Expert Precision QT (EPQT) and AI-powered data quality in early-phase QT assessment.
TORONTO, Feb. 29, 2024 /PRNewswire-PRWeb/ -- The probability of success (POS) for developing a new drug is 10–15 percent but is as low as 3 percent in oncology and up to 33 percent in ophthalmology. Most new drug entities, ~70 percent fail in Phase I or the first-in-human (FIH) trial predominantly due to unmanageable toxicity or poor pharmacokinetics. These findings highlight the importance of the FIH trial in drug development where the main causes for failure are assessed and dictate if an asset progresses to late-phase development or the whole program fails.
Increased efficiency could be realized if cardiac safety data are generated from studies performed earlier in the clinical development program. In single ascending dose (SAD) or multiple ascending dose (MAD) FIH studies, escalating doses of the new drug entity are given to small cohorts of subjects often up to the maximum tolerated dose. Therefore, plasma concentrations that will not be exceeded in patients will often be achieved. While some SAD or MAD studies include more rigorous assessments for changes from baseline in QT and other electrocardiogram (ECG) intervals, a safety assessment based on the Principal Investigator's read of 12-lead ECG printouts is more common. This approach cannot confidently detect changes in the QT interval at the precision level of a TQT trial.
In response, iCardiac Technologies, acquired by Clario in late 2017, introduced a transformative cardiac safety testing method, i.e., Expert Precision QT (EPQT), to improve the overall productivity of pharmaceutical development and, in collaboration with The Food and Drug Administration (FDA), has been tested successfully in a comprehensive clinical trial.
Presented by Clario's cardiac safety experts, Dr. Vic Patel and Dr. Jean Philippe Couderc, the webinar will review the opportunities provided by FIH trials to detect and manage the safety signals of a new drug entity. The advantage of using EPQT to leverage data from small FIH trials, along with specific results of how EPQT can assess the risk of QT interval prolongation will be discussed. Finally, an overview of how the AI-powered data quality tool was developed and its ability to assess data quality will be presented. The session will conclude with a live Q&A, providing participants with an opportunity to directly engage with the experts.
Join Vic Patel, MD, Vice President & Chief Medical Officer, Cardiology, Clario; Alain Gay, MD, Senior Cardiologist, Cardiology, Clario; and Jean-Phillippe Couderc, PhD, MBA, Professor of Medicine & Electrical and Computer Engineering, University of Rochester, for the live webinar on Thursday, March 21, 2024, at 10am EDT (3pm CET/EU-Central).
For more information, or to register for this event, visit Benefits of Utilizing Early Precision QT and Artificial Intelligence-Powered Data Quality Assessments in Early Phase Trials.
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