Pazhani Sundaram, Ph.D
Dr. Sundram has strong experience in protein expression technologies, molecular biology, biochemistry, peptidomimetics and in drug delivery systems. Prior to starting Recombinant Technologies in 1998, he was trained at Yale School of Medicine for a decade. At Yale, Dr. Sundaram contributed in the research and development of a vaccine to treat human papilloma virus in a rabbit model. This work formed the basis for Merck in developing the vaccine for HPV 16, which is currently marketed as 'Gardasil'. Dr. Sundaram's research is acknowledged on the Merck's patent for the above vaccine.
Dr. Sundaram's research followed by a clinical trial on a herbal medicine for his doctoral thesis research translated to a marketable drug in India to treat coronary heart disease.
Natalie J. Kennel, RAC, ASQ CQE & CQMgr, FRAPS, founded NJK & Associates to bring her practical perspective to medical device quality and regulatory affairs. With more than 30 years in industry, most devoted to medical devices, Kennel has hands-on experience with development and manufacturing as well as Regulatory Affairs (RA)/Quality Assurance (QA) and clinical roles in both major and start up medical device companies. She applies her expertise to the regulatory, quality and clinical needs of medical device companies. Since forming her consulting business in 2005, she has submitted more than forty 510(k)'s, three de novo's, more than 44 Pre-submissions (including pre-IDE's), and most recently has been focused on Emergency Use Authorizations (EUA's). She holds a BS degree in Chemical Engineering from the University of Rochester.