Regulation Expert Witnesses

This expert has been working in regulatory affairs for nearly 25 years. As a Regulatory Affairs Associate with Bayer Healthcare Pharmaceuticals, he gained significant experience in all facets of drug life cycle, from coordinating, evaluating, and filing submissions for new and marketed products, to responding to Health Canada requests and negotiating with Health Canada scientific reviewers, to preparing and following clinical trial applications. He wrote and revised Product Monographs in consultation with medical and marketing departments, reviewed labeling and promotional material to ensure compliance, and conducted product label audits. He is a member and former Director of the Canadian Association of Professional Regulatory Affairs and also holds membership in the Regulatory Affairs Professional Society. Currently, this expert is the Principal of his own regulatory affairs consulting firm, providing regulatory expertise and services in the pharmaceutical, biotech, and medical device industries.

This expert is well versed in all areas of maritime safety and regulation. He spent 30 years in the United States Coast Guard serving as a Boatswains Mate and Chief Warrant Officer, among other positions in operations and safety. He has conducted a myriad of law enforcement boardings to ensure vessels were in compliance with federal law and safety requirements. He is Coast Guard trained in Jones Act, OSHA Regulations, ABYC standards, and SMS (Safety Management Systems) requirements. This expert is currently a marine safety consultant at his own private consulting practice, where he advises on liability and negligence of marine equipment and behavior aboard ships.

This highly qualified risk management and insurance expert earned her BA in Insurance at Howard University and PhD in Risk Management and Insurance at the University of Georgia. She is a member of several professional organizations including the American Risk and Insurance Association, Professional Liability Underwriting Society, Southern Risk and Insurance Association, Western Risk and Insurance Association, and Windstorm Insurance Network. She has received the RMIR Best Perspectives Article Award from the prestigious American Risk and Insurance Association. This expert sits of the editorial board for several peer reviewed journals and is the co-editor of the Journal of Insurance Regulation. She has published 30+ articles on the insurance industry and risk management and is a frequently invited guest speaker at major conferences. Formerly she was a senior claims representative at State Farm Insurance Company. Currently she is a professor in the department of risk management and insurance at a major university.

This expert has more than 15 years of continuous, progressively responsible experience in the trucking and warehouse industries, in addition to more than 10 years of operational experience with fortune 500 companies. He specializes in trucking regulation, including expertise in DOT standards, Title 49 CFR Transportation Regulations, National Highway Transportation Safety Administration, Federal Motor Carrier Safety Administration, Pipeline & Hazardous Material Safety Administration, Driver Qualification & Hiring Practice, Driver Training Practice, Driver's requirements & regulations, Safety performance, and Motor Carrier's Registration Requirements. He has presented at numerous technical conferences in the field of trucking and commercial vehicle safety.

This highly qualified expert has years of experience in assessing, developing and executing regulatory strategies. He is board certified in internal medicine and endocrinology and has been practicing for 34+ years. He received his PhD degree from Washington University and completed his residency training at Yale-New Haven Hospital. He is a fellow of the American College of Physicians and a member of multiple other professional societies, including the Endocrine Society and the American Diabetes Association, which honored him with its "Outstanding Service Award" in 1991. He has published 16+ peer-reviewed journal articles and lectures nationwide. He is the former executive director of global regulatory strategy, policy and safety at Merck Research Laboratories and the former chief of the diabetes program branch at the National Institute of Health. He is also a former consultant in the division of metabolism and endocrine drug products at the FDA. Currently, he is the owner of an individual pharmaceutical/regulatory consulting company in Pennsylvania.

This expert has 30+ years in the automobile rental industry and most recently held leadership positions in such renowned organizations as Hertz Rent-a-Car. Having working in numerous environments involving foreign jurisdictions and nationals, he is comfortable navigating the regulations and industry best practices relevant to automobile rental services.

This highly qualified expert has over 20 years of FDA experience encompassing virtually all of the FDA field positions. He also has 18 years of industry experience as a mid-level Manager and Senior Executive in clinical, regulatory, and quality in the medical device industry. He has personally designed quality systems, prepared regulatory submissions, and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, he was the Industry Representative on the FDA Circulatory Systems panel. Finally, he is a seasoned educator/speaker with over 250 public presentations to audiences ranging from senior executives, physicians, technical personnel, other medical personnel, major media, and the general public. Currently, he is an Industry Consultant with a leading FDA consulting corporation.

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 FDA regulation expert earned her B.S. in Environmental Chemistry from Purchase College and her M.S. in Environmental Science from the University of Colorado Denver. She began her career with the FDA in 1987 as a Chemist in the Denver Districts Laboratory and then became a Compliance Officer in 1992, specializing primarily in medical device and biologics cases. She later managed a group of eight investigators as a Supervisory Consumer Safety Officer and then became a Compliance Officer, tasked with evaluating reports and lab analysis to determine compliance with regulation. The expert finished her FDA career as a Senior Case Review Expert, a role she held from 2008 until the end of 2015. In this position, she was responsible for reviewing and evaluating proposed judicial actions to determine if they were compliant with the requirements of the the Federal Food, Drug, and Cosmetics Act and other regulations. Currently, the expert runs her own consulting business.

This industry veteran has held senior management positions in the global shredder industry for over 13 years. From 2003 until 2010, he was a Senior Vice President at Comet Group China, where he sold office products including shredders to mass market and big box retailers. He later served as the Vice President of Ofitech, a China-based paper shredder and laminator manufacturers. He then served as an Executive Vice President for OMiTECH and is now an EVP for a different shredder manufacturer.

This banking and regulatory expert is currently a Partner in the New York Office of a global law firm. He has over 45 years of industry experience, including 30 years at the Federal Reserve Bank of New York serving as General Counsel, Chief Operating Officer and First Vice President. In that capacity, he served as an alternate member of the Federal Open Market Committee and as a staff member of the President's Working Group on Financial Markets. The expert left the Fed in 1998 to become General Counsel at AIG, a position he held from 1998 until 2006. He has a B.A. in Economics from the University of Massachusetts and a J.D. from Cornell University Law School.

This experienced cosmetics ingredients expert joined Estee Lauder in 1981 as a QA Products Laboratory Supervisor. He remained with the company until 2006, most recently serving as the Director of Special Analytical Services and R&D. In this position, the expert was responsible for Estee Lauder's raw material program, which included oversight of analytical testing, evaluation of new raw materials, and troubleshooting formulation issues. The expert now works as a Product Steward for a personal care ingredients manufacturer, where he deals with R&D, regulatory evaluation, and technical services. He has a B.Sc. in Chemistry from the University of Vermont and an M.Sc. in Chemistry from Adelphi University.

This highly-qualified expert has extensive experience with DEA suspicious order monitoring, as well as opioid and other controlled substance regulations. He earned his BS from Great Lakes University and his MS from Everest University, where he graduated summa cum laude. He is a member of the National Association of Drug Diversion Investigators and the International Health Facility Diversion Association. He formerly served as a state trooper in the Alaska Department of Public Safety and a member of the narcotics detective federal task force at Rapides Parish Sheriff's Office. He later worked as a chief health and safety investigator at MAI LLC, a physical security contractor at the US Department of Homeland Security, and the director of regulatory compliance at Miami-Luken. He is currently a president and CEO at a private consulting company in OH.

This highly qualified transportation safety and compliance expert has been involved with trucking logistics for over 30 years. He earned a BS in history and political science from Vanderbilt University and an MS in personnel management from Troy State University. He is certified in homeland security and is a certified director of safety by the North American Transportation Management Institute. Formerly, this expert served as a logistics director and personnel manager for Wal-Mart, a corporate manager of DOT and fleet safety with Georgia Pacific Corporation, and the vice president of safety and compliance with Unisource Worldwide Inc. He went on to become a manager of safety and regulatory compliance at XATA Corporation before opening Haffenden Consulting where he was the owner and proprietor.Most recently, he served as the vice president of safety at CRST International before moving to his current role as a compliance strategy officer at a trucking logistics company in Iowa.

This expert has over 10 years of experience in risk management and regulatory compliance in the financial services industry, with a focus on identifying compliance issues and implementing solutions to mitigate risk. In his work with the CFPB, he identified millions of dollars in remediation for consumers. Formerly, he worked in consumer protection roles with the Consumer Financial Protection Bureau and the California Department of Financial Institutions, as well as in compliance and risk management roles at San Diego County Credit Union and Union Bank. Currently, he is a compliance advisor with a national financial services group and is based in California.