Key Consultants
Mr. Larry Pilot, RPh, J.D.
A former assistant to Commissioner and Director of the CDRH in the 1970s, and ,after his tenure at the FDA, he became a most respected lawyer for food and drug law at one of the largest firms in Washington D.C.
Mr. Frank Newby, B.S., M.S.
A former executive for major pharmaceutical companies such as GlaxoSmithKline, Aventis and Merck, and an executive at Scirex, one of largest CROs. Mr. Newby is currently the COO of CDISC, a well-known non-profit organization working with the U.S. FDA and the pharmaceutical/medical device industries for regulated developments on electronic data captures in compliance with 21 CFR Part 11 regulations.
Mr. Steve Jwanouskos
A former executive in regulatory affairs and quality assurance for Boston Scientific Inc., and a highly- regarded medical device consultant in the U.S. for many successful submissions and approvals for 510(k) and PMA types of products.
Ms. Irina Privin
A long time executive at Purdue Fredrick Company for clinical research, regulatory affairs, and quality assurance. Ms. Privin is a well-known expert in the regulated pharmaceutical world for product developments and GXP regulations (i.e. GLP, GCP, and cGMP).
James L. Rogers, Ph.D.
Dr. Rogers currently is the President of Summit Analytical, LLC providing full clinical statistics for pharmaceutical and medical device developments and regulatory filing processes. Dr. Rogers is highly regarded statistical expert with over 30 years experience working with the FDA and the US pharmaceutical and medical device industries for successful product developments and approvals. Prior to Summit Analytical, Dr. Rogers was an Executive in Scirex, and President in RDSI; and he was also a tenure professor on statistics and social sciences at Northwestern University and Whitten College. Dr. Rogers obtained his B.S. of mathematics from University of Colorado, and M.S. and Ph.D. in statistics from Northwestern University.
Stephen B. Montgomery, Ph.D.
Dr. Montgomery is a long time veteran of toxicologist in pharmaceutical industries with great track record of successes. He has been senior managements responsible for toxicology, safety and regulatory affairs for pharmaceutical and food products in many large pharmaceutical companies including Boehringer Ingelheim Pharmaceutical Company, Kimberly-Clark Corporation, Monsanto Life Science Company, and Daiichi Pharmaceutical Company. Prior to his long standing career in the pharmaceutical industry, Dr. Montgomery had a 4-year experience working as a Staff Regulatory Scientist (Toxicology/Pharmacology) at Bureau of Foods, Division of Toxicology in the US FDA. Dr. Montgomery earned his B.S. in Physics/Mathematics from Davis and Elkins College, West Virginia, and his Ph.D. in Medical Physiology from Georgetown University Medical Center, Washington, DC.
Mr. Arthur Wu
Educated in mathematics and computer sciences, Mr. Wu has over 20 years of experience in information technologies, network setup, administration, and security controls. He is also an expert on database administration. He has been working for different banks, computer, and network administration companies as a senior analyst, manager, and network specialist, successfully completing many difficult projects following client and federal requirements.
