Regulation Expert Witnesses in Pennsylvania

This expert has almost a decade of experience in the field of hospital compliance and nursing. He earned his BS and MS from East Stroudsburg University, his MS in nursing from Saint Josephs College, and his DBA in healthcare management & leadership from California Intercontinental University. He is a licensed registered nurse and a certified professional in healthcare quality. He is a member of the American Association of Critical Care Nurses and the American Hospital Association. He previously served as the nursing director of emergency services at Cape Regional Medical Center, as the administrative director of nursing for emergency & critical care services at Nazareth Hospital, and as the chief compliance officer & nurse executive at Weisman Children's. This expert is currently a contributing professor at a university in New Hampshire and an independent nurse consultant in New Jersey.

This highly-qualified environmental engineer is a recognized expert in air quality analysis, human health exposure, and risk assessment. He earned a BS in biochemistry from The College of Saint Rose followed by an MS in chemistry and a PhD in environmental science and engineering from Clarkson University. He is an elected member of several national committees, including serving as treasurer of the International Society for Exposure Science, on the board of directors for the Air & Waste Management Association, and as an expert panelist for the US EPA Air Quality Monitoring in Communities committee. He has formerly served as a staff scientist and principal investigator at the Health Effects Institute (HEI) and as a senior environmental toxicologist and environmental compliance manager for the Massachusetts Department of Public Health. He is currently the founder, chairman, and CEO for an air quality and human health exposure consultancy.

This highly-qualified expert has 25 years of experience in the field of finance and securities. He received his BA in economics and philosophy from Elon College before earning his MA in economics from the New School for Social Research, where he also completed PhD-level coursework. This expert is a FINRA/Wharton certified regulatory and compliance professional and FINRA arbitrator, and holds a Series 65 securities license. He is active in his field as a member of the Securities Industry and Financial Markets Association. He has formerly as an administrative assistant, financial consultant, and vice president of Merrill Lynch & Co., as well as the managing member of both Duval Asset Management and Heterodox Capital Partners. Currently, this expert is the CEO and CIO of an investment advisory firm in New York, as well as the managing partner of a securities litigation consultancy.

This highly-qualified expert has extensive experience in the field of academic medical center construction management and design development. His work has involved determining space analytics, programming space for optimal occupant outcomes in research and academics, program development, and commissioning of laboratory space. He received his BA from Queens College before earning his MA in environmental policy and engineering and MBA in marketing from the State University of New York at Stony Brook. This expert holds multiple certifications, including OSHA 10 construction and chemical safety training, CDC biohazard safety training, hazardous waste management, and regulated medical waste management. He is active in research in his field, having authored several papers and presented at various conferences throughout his career. He has formerly served as an emergency medical technician with the NYC Emergency Medical Services, a field compliance investigator with the New York State Division of Criminal Justice Services, the interim vice dean for research at the State University of New York at Stony Brook's School of Medicine, and the interim departmental administrator for the neurology department at the Stony Brook University Medical Center. Currently, this expert serves as the associate dean for research, facilities, and operations at a medical school in New York.

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 expert has over 30 years of experience as an insurance regulator and consultant. He earned his BS in commerce from Rider College. He is an accredited insurance examiner and is a member of the Statutory Accounting Working Group and NAIC Financial Analysis Working Group. He was formerly an assistant chief insurance examiner for the financial analysis unit, at the New Jersey Department of Banking and Insurance. Additionally, he was an assistant commissioner and the chief insurance examiner for the office of solvency regulation at the New Jersey Department of Banking and Insurance. He is currently a managing member of an insurance regulation and compliance service company.

This qualified expert has been involved in the field of medical technologies for over forty years and is experienced with matters concerning FDA compliance on which he has authored several articles and papers and given talks on FDA compliance worldwide. He is also the vice president of a private medical technologies firm, making him intimately qualified to comment on the case at hand.

Since graduating from Northwestern Law School, this expert has worked as a corporate attorney for over 12 years. He has extensive experience advising as to SEC-registered and exempt transactions, including initial public offerings, common and preferred equity offerings and debt offerings. Additionally, he has worked in large, prestigious law firms such as Sidley Austin and also worked at the U.S. Treasury Department on the Troubled Asset Relief Program. He currently is the founder of a law firm in New York City that specializes in offering corporate and securities law assistance to middle-market businesses and venture capital/private equity funds, frequently advising as to registration, disclosure, compliance and operational issues. The firm also prepares and negotiates a variety of contracts for its clients, from asset purchase agreements to non-disclosure agreements to real estate contracts of sale. He is an adjunct professor at a NJ Law School, where he teaches various corporate law-related courses, has had articles published in the ABA Business Law Today journal, and regularly teaches continuing legal education classes (CLE).

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 has been working with commercial vehicles for over 40 years. He has directed multiple freight trucking companies, and currently he runs his own transportation service company, offering consulting services as well as training for maintenance, operation, performance, safety, and regulations related to commercial vehicles. This expert has published numerous articles on commercial truck safety as well as training manuals. He is a frequently invited guest speaker at major automotive conferences and has presented on commercial truck safety, crashes and warning devices, and general brake tolerances and procedures. This expert is certified as an ASE Certified Medium/Heavy Truck Technician and as a defensive driving instructor by the National Safety Council. He has testified nationwide in State and Federal court.

This extremely qualified expert is a certified pharmacist with years of experience in community pharmacy management and regulatory affairs. He received both his BS degree in pharmacy and his MBA degree from the University at Buffalo. He is a member of multiple professional associations, including the American Association of Colleges of Pharmacy, the American Pharmacists Association and the American Society for Pharmacy Law. He has given 100+ lectures statewide in NYS. His outstanding work has earned him several honors, including the Pharmacists Society of the State of New York's "Faculty Excellence Award" the Pharmacists Association of Western New York's "Pharmacist of the Year" award and the national Bowl of Hygeia award. He is the former coordinator of pharmacy services at the Community Health Center of Buffalo. He is also the former director of pharmaceutical care services at the University of Buffalo. Currently, he is a clinical associate professor of pharmacy practice and administration at a major university, where he also serves as the senior associate dean of the pharmacy school's student, professional and community affairs.