Management
Michael P. Murphy, President and CEO
M.Sc. Cell Physiology, San Diego State University
Michael Murphy is the President and CEO of ParagonDx, a molecular diagnostic products company based in Research Triangle Park, N.C. Michael is considered an industry pioneer and thought leader with more than 24 years of scientific and business experience in the field of pharmacogenomics. Michael is a serial entrepreneur in the pharmacogenomics space, starting both Gentris Corporation and Intek Labs. He has also held senior management positions with PPGx and Clingenix. Michael is a member of the Pharmacogenomics Advisory Group a working committee of the American Association of Clinical Chemistry. He is a frequent lecturer and author on pharmacogenomic topics and currently sits on the editorial review board of the journal, Pharmacogenomics. Michael received his B.S. and M.S. degrees from San Diego State University and was trained in molecular biology at the Salk Institute.
Karen Nield, Vice President, Finance and Human Resources
Karen is a CPA with more than 13 years of broad range public and private industry accounting experience. Formerly with PriceWaterhouse Coopers, she worked internationally in the Transaction Services Mergers and Acquisitions division based out of their Washington, D.C. office. She specializes in financial forecasts, maintaining compliance of state laws and standardizing human resources policies, attracting top talent and strengthening employee benefits. Karen has dual BS degrees in Accounting and Marketing from University of North Carolina.
Lee Richardson, Vice President of Business Development
Lee, who has over 20 years of business experience in a variety of industries, brings knowledge of international and domestic sales, marketing and business development to ParagonDx. Lee has held management positions in the pharmacuetical, telecommunications and software industries. He had a 17-year stint at SAS Institute, where he was Vice President, Asia/Pacific and Latin America and led SAS' expansion into international markets. Lee received his BA from Duke University and an MA from the University of North Carolina at Chapel Hill.
Dean Watson, Executive Director, Product Operations
Dean Watson is Executive Director of Product Operations at ParagonDx. He is an experienced leader in the management of the aseptic production of live, attenuated biologics in the pharmaceutical and animal health industries. Dean is a seasoned director of projects and programs aimed at increasing efficiencies, throughput and compliance. He has thorough experience in cGMP, FDA/CBER, and ISO compliance. In his prior role, Dean served as the Production liaison for FDA inspections and follow-up. Dean will be responsible for the development and implementation of production, quality control, warehousing and distribution processes for ParagonDx products including, but not limited to, diagnostic kits and analyte specific reagents.
Deborah Kloos, Director, Quality Systems
Deborah has 11 years' experience in medical device product development preceded by 5 years in basic microbiology research at North Carolina State University. First as a staff scientist at Trinity Laboratories, then at MedTek, she assumed various roles in manufacturing, laboratory management, R&D and quality assurance/regulatory affairs. At MedTek, she managed development of latex agglutination test kits and colorectal cancer screening tests, including FDA clearance and launch of an innovative OTC fecal occult blood test kit. At ParagonDx, her responsibilities include management of quality control, regulatory affairs, cGMP (Current Good Manufacturing Practices) and QSR compliance. She has led ParagonDx’s 510(k) submissions, receiving FDA clearance for two products, the CYP2D6 Human Genomic Reference Controls and The Rapid Genotyping Assay – CYP2C9 & VKORC1. Deborah received her B.A. from Texas Christian University.
Pamela Nakhle, Ph.D., Director, Clinical Affairs
Pamela has over 14 years experience in biochemical and molecular biology research, including eight years experience in product development of molecular diagnostic products. Formerly with Xanthon, Inc., Pamela was one of the leading scientists responsible for the development of a novel electrochemical sensor for the direct detection of DNA and RNA. In her current role at ParagonDx, her responsibilities include management of all medical device clinical trials and preparation of 510(k) data submissions. She has played a lead role in obtaining FDA clearance of two ParagonDx products, the CYP2D6 Human Genomic DNA Reference Controls and The Rapid Genotyping Assay – CYP2C9 & VKORC1. Pamela holds a Ph.D. degree in Biological Chemistry from the University of North Carolina at Chapel Hill.
