Benefits of Utilizing Early Precision QT and Artificial Intelligence-Powered Data Quality Assessments in Early Phase Trials

The probability of success (POS) for developing a new drug is 10% to 15% but is as low as 3% in oncology and up to 33% in ophthalmology. Most new drug entities, ~70% 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. Plasma concentrations are often, therefore, achieved which will not be exceeded in patients. While some SAD or MAD studies include more rigorous assessments for changes from baseline in QT and other electrocardiogram (ECG) intervals, more common is a safety assessment based on the Principal Investigator’s read of 12-lead ECG printouts. 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. 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.

Join this webinar to gain insights into the evolving landscape of cardiac safety assessments and strategies for optimizing drug development outcomes.

Speakers

Vic Patel, MD, Vice President & Chief Medical Officer, Cardiology, Clario

Dr. Vic Patel, MD, PhD, is board-certified in cardiology with a PhD in Biophysics and has done extensive research on mechanisms of cardiac arrhythmias. He was on faculty at U. Penn. School of Medicine for 11 years where he directed molecular arrhythmia research and practiced clinical electrophysiology. Dr. Patel then moved into drug development and cardiac safety as a clinical development leader and therapy area head across all phases. At Clario, Dr. Patel oversees cardiology consulting and ECG/Holter core lab services, while leading the biostatistics and medical writing groups. He works with our global customers to ensure they are satisfied and provided with robust, cost-effective solutions.

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Alain Gay, MD, Senior Cardiologist, Cardiology, Clario

Dr. Alain Gay, MD, is board-certified in cardiology. After completing his training as a cardiologist at the Hopital Cardiologique in Lille, France. Dr. Gay practiced for 10 years in a community hospital, completing his training in cardiac electrophysiology and cardiac pacing. Dr. Gay then moved into drug development and medical affairs studies for 15 years at Bayer. He contributed to establishing studies standards in heart failure and contributed to the prelaunch and launch of both Xarelto® and Kerendia®. At Clario, Dr. Gay is a contributor to the ECG core lab, also reading Holters and other recording devices. He works with our global customers to ensure their needs are met with robust, cost-effective solutions.

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Jean-Phillippe Couderc, PhD, MBA, Professor of Medicine & Electrical and Computer Engineering, University of Rochester

Jean-Philippe Couderc is a Scientist with experience in the development of groundbreaking technologies in the field of quantitative electrocardiography and cardiac safety. Internationally recognized authority in the development of computerized technologies related to cardiology. Scientific Founder and Chief Technology Officer of iCardiac Technologies Inc, Dr Couderc is also the Founder and Director of the Telemetric and Holter ECG warehouse, an initiative developed with the US FDA under a private-public partnership and funded by the National Institute of Health. Characterized by a creative mind leading to translational scientific discoveries which have been highlighted by major media including the Wall Street Journal.

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