Clive Boulton has 20 years in high tech with extensive experience in software R&D. As a consultant, Mr. Boulton lead ERP implementation in over 100 customer engagements in small & mid-sized high tech enterprises globally including high tech, medical device and biosciences. He now heads up Exact Software’s Silicon Valley Innovation Center part of Exacts International Development team focused on innovation. Clive received his B.Eng. from Coventry University, UK and subsequently completed the commissioning course RMAS (Dettingen 1987). A certified resource professional (1991), Churchill Club Member (2003), and UCSC extension student taking certification classes in Biosciences.
Organization – Exact Software; Euronext Stock Exchange since June 1999. Revenue 2005: Euro 225M. Offices in over 40 countries; Over 2600 employees.
Richard Henry has over 22 years of experience improving manufacturing and financial business processes. Educated as a mechanical engineer at Brigham Young University and later receiving his MBA from Santa Clara University, Rich began working with FDA regulatory issues at Varian Associates’ Oncology division in 1986. He led the development of software resources for manufacturing and data collection related to Varian’s ClinacÒ cancer treatment radiology product. In 1995 he joined Johnson & Johnson’s LifeScan affiliate as their Chief Application Architect. In 1998, Rich moved into the manufacturing organization as a Principal Software Engineer and was instrumental in the design and implementation of LifeScan’s first application and database that are fully compliant to the FDA’s electronic records and signatures regulation (21 CFR Part 11). In 2000 Rich worked for Camstar Inc., a manufacturing execution system software development house to help them convert their product to work within an FDA regulated environment. In 2002, he started development on what is now QueBase’s flagship product, QueSuite™.
When a new company is formed to compete in the Bio-Pharm or Medical Device marketplace there are numerous software system procurement options. We will be exploring the systems that are at the heart of becoming a successful entrant. We will be suggesting the implementation timeline and setting expectations as to what these systems should be able to do in terms of helping the new company compress the time and reduce the funding required to get their product developed, tested, approved, marketed and sold.
