Healthcare Industry News:  Rochester Medical 

Devices Cardiology

 News Release - November 6, 2007

Network Formed to Tackle Cardiac Safety Challenge

Providers to Offer Drug Developers an Integrated Solution for Advanced Cardiac Safety Testing

ISSAQUAH, Wash. & ROCHESTER, N.Y.--(HSMN NewsFeed)--A group of companies that specialize in cardiac safety testing have joined forces to create the drug development industry’s most comprehensive and technologically advanced solution for determining how drugs affect the heart.

The Cardiac Safety Network integrates preclinical and clinical cardiac safety analysis services from Spacelabs Healthcare, of Issaquah WA, iCardiac Technologies of Rochester NY, and Charles River Laboratories, of Wilmington MA. The Cardiac Safety Network will offer drug developers a complete solution with services that span from recruitment and monitoring of clinical trial subjects to the submission of cardiac safety data to the FDA.

“Cardiac safety represents a critical concern for drug developers today but the science has been hampered by uncertainty regarding the optimal biomarkers,” said Dr. Wojciech Zareba, an internationally known expert in cardiac safety evaluation and professor of Medicine at the University of Rochester Medical Center. “A world-class resource, with state-of-the-art facilities, equipment and advanced ECG-based biomarker analysis, addresses the need for more definitive cardiac safety data,” Dr. Zareba also serves as chief medical officer at iCardiac Technologies.

The FDA currently mandates a cardiac safety study, known as Thorough QT (TQT), for all new drugs in development. The purpose of the TQT study is to determine if a drug has the potential to cause dangerous arrhythmias. TQT analysis requires proper subject selection and preparation, state-of-the-art ECG equipment, and an expert ECG core laboratory. Drug development companies often must contract with multiple organizations to complete the studies, an expense that adds to the already staggering cost of drug development.

The FDA and the industry at large recognize the TQT studies have shortcomings. For drugs that affect heart rate, for instance, prevailing methods of ECG analysis produce a relatively high rate of false positive results. Consequently, drugs with therapeutic potential that do not pose significant cardiac risk may never reach the market.

The Cardiac Safety Network addresses the clinical and cost challenges associated with TQT studies. The network offers advanced ECG biomarkers and analytical software tools that greatly improve the precision of TQT studies. Greater precision improves the quality of the data in the study and allows clinical researchers to reduce – in some cases by as much as 40 percent -- the number of subjects required to reach statistical significance. At the same time, the network’s integrated approach enables drug developers to conduct an entire study, from protocol development and subject recruitment to FDA submission, with one point of contact, eliminating the cost of engaging multiple organizations while shortening the timeline.

“The Cardiac Safety Network combines the industry’s most precise Thorough QT analysis services with insight derived from advanced ECG-based biomarkers,” said Jim Roop, president of clinical services at Spacelabs Healthcare. “Without spending any more than they would for a traditional Thorough QT study, drug developers now will be able to meet FDA requirements while significantly improving the quality and depth of their cardiac safety data.”

About the Cardiac Safety Network

The Cardiac Safety Network provides preclinical and clinical cardiovascular safety analysis services and data management. One point of contact integrates services from Spacelabs Healthcare, iCardiac Technologies and Charles River Clinical Services, the pharmacology unit of Charles River Laboratories. The Cardiac Safety Network boasts state-of-the-art facilities and equipment for centralized ECG and Holter monitoring. It offers both the traditional QT analysis required by ICH E14 regulatory guidelines, plus Beyond QT, a comprehensive repolarization analysis using advanced ECG-based biomarkers. The network’s clinical pharmacology units conduct patient recruitment and monitoring and supply dedicated wards for cardiac safety testing.

About Spacelabs Healthcare

Spacelabs Healthcare, Inc. (www.spacelabshealthcare.com) is an international developer, manufacturer and distributor of medical equipment and services including patient monitoring solutions, anesthesia delivery and ventilation systems, diagnostic cardiology solutions and supplies and accessories selling to hospitals, clinics and physicians offices. Additionally, the Company provides ECG laboratory services to pharmaceutical and biotech companies undertaking clinical trials, whereby patient ECG data is recorded, analyzed, tabulated and interpreted.

About iCardiac Technologies

iCardiac Technologies (www.icardiac.com) provides development and analysis of advanced ECG-based cardiac safety biomarkers. Based on more than 30 years of research at the University of Rochester, a leading institution for ventricular arrhythmias and repolarization, iCardiac developed an advanced ECG-based cardiac safety analysis service that gives drug developers more precise and cost-effective methods for QT interval measurement, as well as a suite of advanced ECG-based cardiac safety markers.


Source: The Cardiac Safety Network

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