As President and Founder, Mark has twenty-five years of direct industry experience that covers all of the regulated industries the company is focused upon. Educational background includes a B.S. degree in Microbiology and a Masters in Business Administration. Employment assignments have included a supervisory role (2 years) in a food testing laboratory, Silliker Laboratories, where several analytical methods were applied to a great diversity of samples. Following this assignment, Mark began his career in the pharmaceutical industry with Allergan Pharmaceuticals (3 years) as a microbiologist responsible for the validation of all sterilization processes at several operating plants in the United States, Canada, and Puerto Rico. Additional experience was obtained by participating (7 years) in the start-up and commercial success of Hybritech, Inc. (the first commercial producer of monoclonal antibody products) as Quality Control Manager of injectable products, responsible for analytical laboratory control, facility and process validation, quality assurance functions, and liaison to the FDA relating to facility development and validation issues. Another start-up pharmaceutical company was the next project undertaken as Director of Quality for Telios Pharmaceuticals for four years, dedicated to the development and commercialization of synthetic peptide pharmaceuticals. Mark’s most recent employment was as VP of Quality and Regulatory for three years with River Medical, a start-up company that developed and launched, both in the United States and Internationally, the first pre-filled, disposable, controlled-rate infusion pump. At River Medical, Mark was responsible for obtaining a landmark FDA policy change that resulted in Rivers’ parenteral solutions packaged in plastic being regulated as 510(k) Medical Devices. Mark brings a great deal of experience to the company both from a technical and managerial perspective and has a major role in the day to day operations of the firm.
Wayne serves as the Sr. Vice President of Business Development and Co-Founder. Following twenty years in the aerospace industry, (Allison, AVCO, and Lockheed), he launched an independent professional practice, now fifteen years old specializing in: real-time radiographic system design, robotics and industrial control system design, R&D/Manufacturing facility design and new business development/technology assessment. Aerospace industry experience includes a wide range of assignments as project engineer and program manager for Department of Defense contracts, energy R&D programs, high-temperature composite materials development, and new technology applications. Wayne also has significant experience with scientific instrument selection and application gained while a member of the Directors’ staff a the Lockheed Palo Alto Research Laboratory. He holds a Bachelors degree in mechanical engineering, with distinction, from Cornell University, followed by graduate work in electrical engineering at Purdue University and is a California registered professional engineer (control systems).