New York City-based AMC Health, a provider of end-to-end telehealth solutions, has named Michael J. O’Brien president of its Clinical Trials Division, signaling the company’s commitment to expand telemonitoring into broader areas of healthcare. O’Brien will leverage his 30 years of broad-based C-suite experience in the life sciences and information technology industries to meet the surging demand for innovative telemonitoring offerings in clinical drug development.
Previously, O’Brien was president and CEO of Beardsworth, a full-service CRO.
“I am very excited to join AMC Health, and to lead the effort in becoming the premier provider of telemonitoring services in the clinical trials marketplace,” O’Brien said. “AMC Health’s ability to customize integrated patient monitoring solutions offers sponsors and CROs more efficient and comprehensive measurements of the health of patients participating in a trial.“
The FDA recently approved a phase II trial in which most of the biometric and patient-reported outcomes will be collected by AMC Health’s telemonitoring platform, an industry first. This trial will study the effects of lisinopril, a widely used blood pressure medication, to treat multiple sclerosis. Partnering with Transparency Life Sciences (TLS), AMC Health will provide telemonitoring technologies to collect data on blood pressure and heart rate, mobility, physical and mental function, symptoms, side effects, quality of life and medication adherence directly from patients’ homes. According to TLS CEO Tomasz Sablinski, “Telemonitoring will reduce the cost of this study by more than 50%.”
“Pharmaceutical companies have faced real challenges enrolling and retaining participants for clinical trials, collecting accurate data and analyzing and reporting the results,” said Nesim Bildirici, president and CEO of AMC Health. “Innovative telemonitoring technology in clinical trials will transform drug development in an industry that is poised to take advantage of its many benefits.”
O’Brien added, “The convergence of technology advancements in telemonitoring, the need for more efficient means of conducting trials, and the ongoing pursuit of better data to support new drug applications will continue to drive demand for innovative solutions such as telemonitoring.”
Pharmaceutical companies are being squeezed from many directions, creating powerful incentives to reduce the time and costs associated with developing new drugs. Additionally, the FDA has recently signaled its receptivity to this new way to conduct drug approval trials. Telemonitoring can aid in many facets of the clinical trial process, including recruitment, data capture and data analysis. It can alert patients and researchers when medications are not taken as directed, which can significantly improve the rate of adherence. And it can provide objective, accurate and timely data by uploading data directly from the in-home biometric monitors, so there is less need to audit and monitor the data collection process.