Julian Wilkins

Vice President, PharmaConsult US Inc

Julian Wilkins was educated as an Architect in the United Kingdom.. He practiced as an architect and project team manager for IDC now AMEC from 1972 to 1988. From 1978 onwards all the projects he handled where for the pharmaceutical industry.

In 1990 he co-founded an isolator company in the United Kingdom, which became part of what is now Bioquell. The company undertook many ground breaking projects in pharmaceutical containment for Merck, Glaxo, Cyanamid, Wyeth, etc.

In 1999 with Stephanie Wilkins, he founded PharmaConsult US, Inc, a specialist consulting company involved in the containment of pharmaceutical processes. PharmaConsult US provide concept, design, ergonomic evaluation, bid documentation, vendor management, FAT, SAT, IQ, OQ, Surrogate and Functional Test protocols and execution as well as star- up assistance and training. Our main areas are:

Product and patient exposure. Regulators are extremely sensitive to the risks of cross contamination and in the US they now require a risk assessment. We are uniquely placed because were intimately involved in ISPE’s Risk-MaPP Guidance published in 2010. Since Publication the ADE has become the standard for limit setting. E have complete a very large number of assessments the most notable being for some 30+ sites worldwide to successfully answer a warning letter from the FDA.

Occupational Exposure. The only way to get containment right is to concentrate on the detail. We design the systems to be well engineered and cost effective. Because the key vendors realize that they are competing on a level field our bids achieve very competitive pricing. For some vendors we are one of their biggest customers. We not only design the systems but we manage the whole procurement, integration and qualification process.