Healthcare Industry News: Roche
News Release - February 28, 2011
LipoScience Appoints Thomas Clement Vice President of Regulatory and Quality AffairsRALEIGH, N.C.--(Healthcare Sales & Marketing Network)-- LipoScience, Inc., a diagnostic company that is advancing patient care through high value proprietary tests based on nuclear magnetic resonance (NMR) technology, today announced it has appointed Thomas Clement as Vice President, Regulatory and Quality Affairs. In this role, Mr. Clement will develop and implement regulatory strategies needed to support the approvals and clearances of the products coming through the development pipeline and support the continual activities required within the organization to maintain an effective and complaint quality system.
“Tom has successfully registered a variety of diagnostic and biological products and brings with him a breadth of knowledge of the regulated industry,” said Richard O. Brajer, chief executive officer of LipoScience. “Today’s regulatory environment is becoming increasingly more complex with the development of new technologies and applications and Tom possesses the skills and experience needed to lead LipoScience and our products in the right direction.”
Mr. Clement has extensive experience working with the FDA as well as European and other international regulatory agencies. Most recently he served as Vice President of Global Regulatory and Clinical Affairs at QIAGEN, a leading provider of sample and assay technologies. In this position, he was responsible for managing all regulatory and clinical activities in support of the diagnostic, infectious disease and women’s health programs. He previously held management positions at Roche Molecular Systems, Organon Teknika Corporation, Amersham and Biotech Research Laboratories.
“LipoScience’s exciting technology has the potential to reshape the way patients and their physicians understand and manage their risk of cardiovascular and other metabolic diseases,” said Mr. Clement. “I look forward to helping the company bring new innovations to market in pursuit of this goal.”
About LipoScience, Inc.
LipoScience, Inc. is a highly innovative diagnostic company that is advancing patient care by developing high value proprietary tests based on nuclear magnetic resonance (NMR) technology. The NMR LipoProfile® test, the company’s flagship product, measures the number of lipoprotein particles in a simple blood sample and provides physicians and their patients with actionable information to manage the risk of heart disease. To date, more than 5 million NMR LipoProfile tests have been ordered by physicians. LipoScience is preparing to decentralize the technology to increase access and distribution to support new clinical standards of care in the areas of cardiovascular disease, diabetes and other metabolic disorders. For further information on the Company, please visit www.liposcience.com.
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