Biology Expert Witnesses in Delaware

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 highly-qualified laryngology expert has experience with voice and airway disorders, laryngeal and airway trauma, difficult airways, and vocal fold paralysis. She received her BSE in mechanical engineering from the Pratt School of Engineering at Duke University and her MSE in mechanical engineering from the University of Michigan before earning her MD from Wayne State University. She subsequently completed her residency in otolaryngology with a focus in head and neck surgery at Henry Ford Health System and her fellowship in voice and airway surgery at the Cleveland Clinic Foundation. This expert is board-certified in otolaryngology and is active in her field as a member of the American Academy of Otolaryngology-Head and Neck Surgery, the International Association of Phonosurgeons, and the Triological Society. Formerly, she served as a global product development engineer at General Motors Corporation, an assistant professor of immunology & microbiology at Wayne State University School of Medicine, an assistant professor of otolaryngology at Oakland School of Medicine, and a locum tenens otolaryngologist at ProMedica Memorial Hospital. Currently, this expert serves as a staff laryngologist at a health network, as well as an assistant professor of surgery in otolaryngology at a university, both in Pennsylvania.