Improve Effectiveness of Cardiac Assessments in Early Phase Trials with Early Precision QT and AI-powered Data Quality Checks
Early and accurate Phase I data is crucial to maintaining safety and determining the viability of new drug entities. Cardiac safety assessments, particularly those focused on the QT interval, play a key role in assessing potential toxicity and guiding portfolio decisions. Therefore, accurately evaluating cardiac safety earlier in the development process may save time, resources and costly future studies.
Register for this webinar to gain a clearer understanding of EPQT to ensure data quality, create efficiencies and potentially qualify for a TQT waiver.
Session information:
Time:
- 11:00 a.m. – 12:00 p.m. EDT (NA-East)
- 04:00 p.m. – 05:00 p.m. BST (UK)
- 05:00 p.m. – 06:00 p.m. CEST (EU-Central)
Early and accurate Phase I data is crucial to maintaining safety and determining the viability of new drug entities. Cardiac safety assessments, particularly those focused on the QT interval, play a key role in assessing potential toxicity and guiding portfolio decisions. Therefore, accurately evaluating cardiac safety earlier in the development process may save time, resources and costly future studies.
In this webinar, attendees will gain insight into:
- The advantages of leveraging EPQT and AI-powered data quality in early phase QT assessment
- Considerations for determining whether early phase QT data may support regulatory waiver of a stand-alone QT study
- How automatic, AI-enabled ECG quality assessments can provide timely feedback on the overall quality of the data and can help reduce the risk of missing or inaccurate data that is essential for obtaining a QT waiver
Speakers
Vic Patel, M.D., Ph.D.
Vice President & Chief Medical Officer, Cardiology at Clario
Dr. Vic Patel is board-certified in cardiology and holds a Ph.D. in Biophysics, having conducted extensive research on the mechanisms of cardiac arrhythmias. He was a Faculty Member at the University of Pennsylvania School of Medicine for 11 years, where he directed molecular arrhythmia research and practiced clinical electrophysiology. Dr. Patel then transitioned into drug development and cardiac safety as a clinical development leader and therapy area head, overseeing all phases of development.
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 their needs are met with robust, cost-effective solutions.
Borje Darpo, M.D., Ph.D.
Chief Scientific Officer, Cardiac Safety at Clario
Dr. Borje Darpo has held key roles on projects in all phases of clinical development. He has authored internal QT guidance documents for the design and conduct of clinical QT assessment. In collaboration with industry-leading cardiac safety experts and the US Food and Drug Administration, Dr. Darpo led the IQ-CSRC study, which validated the concept of applying exposure-response analysis on data from early-stage clinical trials to replace the TQT study. In addition to his role at Clario, he is an Associate Professor of Cardiology at the Karolinska Institute in Sweden.
Jean-Philippe Couderc, Ph.D., M.B.A.
Professor of Medicine and Computer/Electrical Engineering, University of Rochester
Dr. Jean-Philippe Couderc is a Scientist with experience in the development of groundbreaking technologies in Quantitative Electrocardiography and Cardiac Safety. He is internationally recognized as an authority in the development of computerized technologies related to cardiology. He is the 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. It is characterized by a creative mind leading to translational scientific discoveries, which have been highlighted by major media, including the Wall Street Journal.