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Feeling the Beat

BACKGROUND: AN INDUSTRY SHIFT

In 2005, the US and European regulators introduced a new set of guidelines (E14 guidance) that require a robust characterisation of cardiac safety for noncardiac drugs. Specifically, drug developers are now required to demonstrate that their compounds do not have a significant effect on QT interval a surrogate marker for arrhythmia liability that is measured from the surface electrocardiogram (ECG). These new guidelines were developed in response to the post-market withdrawal of nine non-cardiac drugs for cardiac safety reasons, of which five were withdrawn specifically for contributing to druginduced arrhythmias. The studies performed to evaluate the effect of novel drugs on the QT interval have become known as thorough QT (TQT) studies.

Immediately after the introduction of the E14 guidelines, many drug developers elected to conduct the TQT studies early in the clinical development process, as had been envisioned by the regulators. However, having gained experience in these types of studies over the past three years, pharmaceutical sponsors have realised that this investment frequently leads to suboptimal returns. Specifically, the cost of a TQT study can range from $1.5 to $5 million, but the study only answers a single regulatory question (characterisation of the drug effect on the QT interval) and, for example, in drugs that have normal autonomic mediated QT changes, does not answer this question very well.


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Alexandra (Sasha) Latypova is co-founder and Executive Vice President of iCardiac Technologies, Inc. Prior to this position, Sasha headed sales and business development at VirtualScopics, Inc. She had previously worked as a Manager in healthcare practice at Analysis Group, Inc, where she advised pharmaceutical clients on a wide range of issues concerning product development, and provided economic analyses for pharmaceutical litigation cases. Sasha holds an MBA from the Amos Tuck School at Dartmouth College.

J Mikael Totterman is Chairman and CEO of iCardiac Technologies, a venture-backed company from the University of Rochester Medical Center. Prior to joining iCardiac Technologies, Mikael was Executive Vice President and Chief Operating Officer of VirtualScopics, Inc. Earlier in his career, he served as one of three principles responsible for overseeing a $250 million venture capital fund. He has also held positions at The Boston Consulting Group as well as Gemini Consulting. Mikael received his Bachelors Degree in Engineering from Stanford University, where he was a David Starr Jordan Scholar, and his MBA from the Amos Tuck School at Dartmouth College.

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Alexandra Latypova
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J Mikael Totterman
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