E-Cigarette Expert Witnesses

This expert's research career has been focused in the area of drug safety. As a clinical epidemiologist and pharmacologist, he uses large administrative databases in Canada and the United States as the main data source for his research. In the last ten years he has made significant contributions to this area quantifying rare drug adverse events with popular prescription drugs. His research has been used by the FDA, Health Canada and European Medicines Agency

A 17-year veteran of the U.S. Food and Drug Administration (FDA), this expert served as the Regulatory Counsel to the Associate Commissioner for Regulatory Affairs, and previously, in scientific, inspectional, compliance and criminal and civil enforcement capacities as an FDA Consumer Safety Officer (CSO), Compliance Officer (CO), a Senior Special Agent (SA) with the Office of Criminal Investigations (OCI) and as an analytical regulatory microbiologist. During his last three years at FDA he spearheaded the agency's integration efforts with Customs and USDA on crosscutting interagency enforcement and operational issues; served as the FDA's point-person in managing the intersection of imports and FDA's new bioterrorism regulations; established joint agency and industry working groups to evaluate counterfeiting and tampering risks to food and drug distribution supply chains; was the agency lead in its strategic planning efforts to reinvent the FDA's import programs; wrote the initial statement of work and acted as program manager over the FDA's new PREDICT, risk-based electronic entry screening system; and directed the development of the FDA's agency-wide Risk-based Import Strategic Plan designed to improve compliance of foods, dietary supplements, drugs, medical devices, cosmetics, and biological products imported into the U.S. As CEO of a FDA consulting firm and Founder of an affiliated law firm, he currently represents domestic and foreign companies of all sizes, assisting them in identifying USDA, FDA, Federal Trade Commission (FTC), Environmental Protection Agency (EPA), and state requirements. He focuses his practice on FDA matters, including but not limited to: matters relating to FDA inspections, FDA criminal, regulatory and administrative enforcement actions for medical devices, drugs, cosmetics, alcohol, tobacco, dietary supplements, and foods.

This expert is an established specialist on marketing and global supply chain practices within global impact areas, including the fast moving consumer goods and IT industry. He has held a number of executive and senior management roles, including appointments at Proctor & Gamble and TELUS Communications, Inc. He earned his BS in computer science from the University of Windsor, his MBA from Wayne State University, and a PhD in supply chain management from the University of Capetown. He currently serves as an adjunct professor of supply chain management at an Ivy League University and a prominent California university. In addition to his faculty commitments, he has spoken at a TEDx event, OPAL and UN, and consults on a number of supply chain projects globally.