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.
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 engage directly with the experts.
Join this webinar to gain insights into the evolving landscape of cardiac safety assessments and strategies for optimizing drug development outcomes.
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.
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.
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.
Who Should Attend?
This webinar will appeal to professionals in the following areas:
- Clinical Pharmacologists
- Clinical operations (early phase)
- Medical Monitor/Head of Development for Program
- Clinical operations, clinical development, clinical research
- Regulatory affairs
- Clinical monitoring
- Clinical Scientists
- Protocol Managers
- Clinical Data Managers
- PK Experts
What You Will Learn
Attendees will gain insights into:
- Review the importance of the first-in-human trial and the opportunities it affords
- Understand the advantage of leveraging EPQT and AI-powered data quality in early-phase QT assessment
Clario is a leading healthcare research and technology company that generates the richest clinical evidence in the industry. Across decentralized, hybrid and site-based clinical trials, Clario’s deep scientific expertise, global scale and the broadest endpoint technology platform allows our partners to transform lives.