Randall McCoy, Chief Executive Officer
Randall McCoy has more than 37 years of experience in the healthcare industry. His experience includes executive positions and scientific research and development. His previous employment includes George Washington University, Temple University Medical School and RCA/SRI International (Director of Life Sciences and Electronic Displays). Mr. McCoy has assisted both small and major pharmaceutical/device companies address FDA issues. He has also helped over 225 foreign and domestic companies introduce their FDA regulated drug and medical device products into the US and World market. Mr. McCoy currently has over 30 Patents US and International.
John Weber, Interim CFO
John Weber most recently served as Executive Vice President of Fujifilm Medical Systems USA, the highest ranked American corporate officer, from 2006 until his departure in 2009. His responsibilities included overseeing all corporate activity with the exception of R&D. During that time Fujifilm was ranked as the fastest growing medical imaging company, consistently ranking #1 or #2 in customer satisfaction. From 1998 through 2006 he served as Senior Vice President, Operations at Fujifilm USA where he spearheaded the transition of the company from a film distributor to a digital medical informatics company. From 1986 until 1998 he served as CFO where he helped to profitably manage Fujifilm's growth from an employee base of 75 to over 1,000. Prior to his distinguished career at Fujifilm Medical Systems USA, Mr. Weber served as the CFO for the confectionary and drinks division of Cadbury Schweppes Limited for three years and as Corporate Controller for an additional five years.
J. Roy Nelson, Ph.D., Chief Science Officer
Dr. J. Roy Nelson runs a FDA audited material testing laboratory with a Schedule I-V DEA drug license and with an electronic FDA submission portal. His laboratory provides material science supports for new medical devices for major pharmaceutical companies. In addition to numerous medical device and drug developmental projects, he has been on two FDA consent decrees remediations writing SOPs and other FDA compliance documents. He has eight years experience working with various collagen products, such as sponges. Prior to 1988 Dr. Nelson was a senior material scientist at RCA/SRI in Princeton, NJ. He has more than twenty US patents.
Lauri-Ann Hahn R.N., B.S.N., Director of Clinical Trials
Lauri Hahn has been involved with clinical trials/research since 1998. She has developed and trained Good Clinical Practices quality systems. Lauri is experienced in all areas of Clinical Research from planning and conducting studies to Clinical Report submissions to the FDA. Lauri served as Associate Director of Clinical Trials/Senior Project Manager for a Contract Manufacturing Company from 2006 to 2008 wherein she gained direct experience working with the Cultured Cell Technology. Prior to hat, Lauri worked at the National Institutes of Health (NIH). From 2001 to 2005, Ms. Hahn was the Head of Clinical Research at the University of Pittsburgh Department of Urology. Lauri has held positions as a Sponsor, a member of a Clinical Research Organization and Clinical Sub-Investigator. She graduated from the University of Pittsburgh in 1993 with a Bachelors of Science Degree in Nursing.