QIAGEN Appoints New Head of Global Regulatory Affairs
Tom Clement to direct and execute enhanced strategy for expanding scope of regulatory approvals for molecular diagnostic products
Venlo, The Netherlands / Germantown, Md., January 19, 2009 - QIAGEN today announced that Tom Clement has joined the Company as Vice President Regulatory and Clinical Affairs on January 12, 2009. In his new position, he will direct and coordinate QIAGEN's Regulatory Affairs Department and all global activities related to regulatory submissions.
Tom Clement joins the company from Roche Molecular Systems, where he was Vice President of Quality and Regulatory. Prior to Roche, he worked at other diagnostic and medical device companies including Organon Teknika (bioMérieux), Amersham, Biotech Research Laboratories and others. He holds a Bachelor of Science from the University of Maryland.
"Tom brings more than thirty years of industry experience to QIAGEN", said Douglas Liu, Vice President Operations. "He has a proven track record of obtaining U.S. FDA and EU IVD Directive approvals, of which many were first of their kind. Throughout his career, he has demonstrated excellent skills in leadership and in identifying, developing and implementing strategic regulatory and clinical initiatives. As a global leader in molecular diagnostics, QIAGEN has a substantial portfolio of regulated products and is continually widening its scope of submission for approval of its sample and assay technologies in the U.S., Europe and Asia. Tom's expertise will allow us to further refine and execute our regulatory and clinical affairs strategy which is key to our company's overall growth."
QIAGEN's offers one of the world's broadest panels of molecular diagnostic tests, which includes the only FDA-approved test for human papillomavirus (HPV), the primary cause of cervical cancer.
QIAGEN N.V., a Netherlands holding company, is the leading global provider of sample and assay technologies. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are used to make such isolated biomolecules visible. QIAGEN has developed and markets more than 500 consumable products as well as automated solutions for such consumables. The company provides its products to molecular diagnostics laboratories, academic researchers, pharmaceutical and biotechnology companies, and applied testing customers for purposes such as forensics, animal or food testing and pharmaceutical process control. QIAGEN's assay technologies include one of the broadest panels of molecular diagnostic tests available worldwide. This panel includes the only FDA-approved test for human papillomavirus (HPV), the primary cause of cervical cancer. QIAGEN employs more than 3,000 people in over 30 locations worldwide. Further information about QIAGEN can be found at http://www.qiagen.com/.