Collaboration targets improved understanding of ECG cardiac safety signatures and testing of new methodologies to enhance accuracy of safety assessment.
St. Paul, MN – VivaQuantTM has entered into a five-year collaboration with the FDA to research ways to improve the cardiac safety assessment of medications. In this research collaboration, VivaQuant’s advanced ECG processing tools will be used to derive continuous beat-to-beat measurements of cardiac electrical waves from preclinical and clinical ECG studies. As part of this research, the FDA and VivaQuant will study the differences in design, analysis, and reporting between preclinical and clinical ECG studies to identify synergies and opportunities to improve translation of results through the use of common practices.
In addition, continuous beat-to-beat measurements provided by VivaQuant Rhythm ExpressTM ECG software will be used to investigate the possible influence of autonomic tone on ECG-based information used to assess cardiac safety. Assessment of cardiac safety is required for nearly all of the medications being developed by the pharmaceutical industry. Changes in how cardiac safety is assessed were implemented by FDA and other global regulators in the early part of the last decade. Since then, not a single drug has been approved with an unexpected risk of torsade de pointes (life-threatening arrhythmias). Although the changes implemented by global regulators were effective at preventing proarrhythmic drugs from reaching the market, these changes may have resulted in lifesaving medications being falsely identified as unsafe. This has not only reduced the number of new lifesaving drugs available to patients but has also driven up the cost of drug development. As a result, the FDA is studying ways to reduce the number of drugs falsely identified as unsafe without compromising the accuracy of identifying drugs that truly are unsafe. VivaQuant is part of that effort.
“We are very excited about collaborating with the FDA on this initiative to improve drug safety screening,” said Dr. Marina Brockway, VivaQuant’s Chief Technology Officer. “We are hopeful that this research will lead to more safe and effective medications reaching patients.”
This work was supported in part by a grant from the National Institute on Drug Abuse of the National Institutes of Health under Award Number R44DA041815 and by the National Heart, Lung, And Blood Institute of the National Institutes of Health under Award Number R43HL110739.