Regulatory Affairs Expert Witnesses

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 earned his BA in political science from Ohio State University. He then went on to serve as a mediator for consumer protection at the Office of the Indiana Attorney General. He also served as the Director of Medicaid contract management, the director of Provider Relations for Indiana Medicaid and as the Medicaid Program Integrity Director at Indiana Family and Social Services Administration. Currently, he is a senior advisor at a healthcare consultancy in Indiana.

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 human resources professional has over 14 years of experience in his field. He earned a BA in business management with an emphasis on human resources with the University of Phoenix and an MA in organizational development from Chapman University. This expert is active in his field as a member of several professional associations including both the National Human Resources Association and the National Restaurant Association. Formerly, he served as the director of employee relations, talent acquisition, and management development at Marie Callender's and Commissary. He went on to become the senior director of human resources and government affairs at PMC, LLC./Foxtail Foods Commissaries, Perkins Restaurants, and Marie Callender's Restaurants. Currently, this expert is a human resources and compliance consultant at an HR consultancy in California.

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 highly qualified expert is a certified director of safety with 8 years of experience in the upstream oil & gas industry in managing Department of Transportation compliance and HSE system as well as a comprehensive working knowledge of SH&E issues and governmental regulations. He received his BS in organizational leadership at Mountain State University before going on to complete his MA in business and organizational leadership at Webster University in St. Louis. He is a certified director of safety, advanced accident reconstructionist and aircraft crash investigator. He has previously served as a Texas state trooper for the Texas Department of Public Safety and currently serves in public safety as the director for the national investigative services division at an organization in Georgia specializing in homeland security. He has also previously served as safety director, manager and DOT compliance administrator for various organizations, including, Expedited Logistics and Freight Services, Hyperion Safety Services and Baker Hughes. Currently, he serves as manager for DOT and compliance at a transportation company in Texas.

This highly qualified expert has more than 25 years of experience in FDA regulation of medical devices, encompassing nearly all FDA field positions. He earned his BA in biological sciences at California State University and completed MBA courses with Golden Gate University. This expert is certified in regulatory affairs and is an active member of the Regulatory Affairs Professionals Society, the American Society for Quality, and the FDA Alumni Association. Further, he has several publications and has presented both nationally and internationally on topics in his field. In his early career, this expert served as a consumer safety officer, consumer affairs officer, and representative for small businesses at the FDA. He then held several industry leadership roles, including manager of regulatory affairs at Unitek Corporation and vice president of regulatory affairs in clinical research and quality assurance at both Retroperfusion Systems Inc. and Baxter Healthcare Corporation. Additionally, this expert was a medical device specialist, a compliance officer, and the director of import operations at the FDA Los Angeles District as well as a supervisory investigator at the FDA Saint Louis Office. Currently, he is a private consultant for FDA regulated businesses in Illinois.

This highly-qualified expert has over 25 years of experience in work zone safety, with demonstrated experience in health and safety management, regulatory compliance, safety auditing and reviews, and accident and incident investigations in areas of construction and mine safety. He earned his AS in electronics systems technology at Community College of the Air Force and his BS in occupational safety and health at Columbia Southern University. This expert holds several certifications in his field, including as a certified safety professional (CSP), a certified construction manager of environment safety and health (C-MESH), an OSHA and MSHA Part 48 metal/non-metal instructor, and a miner. He is also certified in fall protection and electrical safety, holding a NFPA 70E certification. He is active in his field as a member of the American Traffic Safety Services Association. He began his career as an antenna systems technician for the United States Air Force before transitioning to work as a loan officer for Freedom Mortgage Services and a senior financial officer for Carteret Mortgage Corporation. He also served as a lead instructor for the American Red Cross, a traffic control supervisor for Moore & Son, and a health and safety manager for Rogers Group Inc. Currently, this expert is the health and safety director of a safety industrial firm in North Carolina.

This expert earned his BS in health and exercise science and his MS in toxicology from Colorado State University and his MS in health services administration with a concentration in biopharmaceutical regulatory compliance and his PharmD from the University of Wyoming. He is active in his field as a member of the National Community Pharmacists Association and the American Pharmacist Association. He formerly served as a pharmacy intern and the flu clinic supervisor for the student health pharmacy at the University of Wyoming. Currently, this expert is a medical content writer for a medical consulting firm.

This highly-qualified securities expert has over 30 years of experience in equity securities and trading. He earned his BA from Saint Lawrence University and holds the Series 7, 9, 10, 24, 55, 63, & 99 licenses. He has held a number of distinguished roles, including the head of global equity sales at ABN AMRO, the CEO and COO of Harborside Securities, and the head of equities at Fidelity Capital Market Services. He has supervised and managed large and diverse sales and trading operations, and has a deep understanding of market structure, electronic trading, and alternative trading systems. Prior to his current position as the managing partner of a securities consulting firm, this expert served as both the chief operating officer and the chief compliance officer for Open Door Securities.

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.

This highly-qualified expert has extensive experience in automated external defibrillator (AED) program design and compliance. He earned his BS in public affairs from the University of Oregon and his JD from the Lewis & Clark Northwestern School of Law. He is a member of the Oregon State Bar and an advisory board member of the Sudden Cardiac Arrest Foundation and the National Center for Early Defibrillation. He has been the founder of several firms, including Lazar Jensen Geobel, Fios, Inc., and AED Risk Insights, Inc. Currently, this expert is the founder and president of an AED program compliance company that develops and publishes national AED program design guidelines that describe industry standards for AED programs and the AED Law Center.

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.

This licensed paramedic has over 37 years of EMS experience with 22 years in an administrative capacity. In addition, he has a plethora of certifications including EMS instructor, OSHA compliance instructor, and Emergency Vehicle Operator Instructor (EVOC). Finally, he has held several extremely prestigious EMS related positions including the Director of Emergency Management for Portland, CT before opening his own EMS training firm.

This expert has 40 years of experience as a wage and hour specialist. She worked for the US Department of Labor Wage and Hour Division for more than three decades, gaining extensive experience achieving compliance with the Fair Labor Standards Act, including white collar exemptions, regular rate in overtime computations, reconstructing hours of work, and child labor. She also has extensive experience in federal prevailing wage statutes, such as Davis Bacon, Service Contract Act and H-1B nonimmigrant employment standards. Currently, she is the Owner and Principal of her own wage and hour consulting firm, where she helps attorneys and their clients navigate the complex wage and hour laws in order to achieve compliance. She assists with conducting internal compliance audits, offers advice and support during federal and state wage investigations, and provides litigation support, including back wage estimates and expert testimony. She lectures for legal, human resource, and government agencies and holds membership in the Society for Human Resource Management, as well as the Northeast Human Resources Association.

This expert has been working in the petroleum industry for over 40 years. He has worked for numerous petroleum and energy firms in a variety of capacities, from production and drilling accountant and oil and gas accountant to senior internal auditor, control analyst, audit manager, and senior staff auditor. Awarded the honor of Fellow of the American College of Forensic Examiners, he holds a number of certifications for auditing, fraud examination, and consulting, while he has held membership in the Council of Petroleum Accountants Societies for over 40 years. Currently, this expert runs his own petroleum consulting firm, where he provides services in the areas of auditing, negotiation, reviews, due diligence, fraud, litigation support, and joint interest and contract compliance. His clients have included Amoco, Chevron, Exxon, and Texaco, among many others, and his audits have returned exceptions of up to $60 million. This expert is an author and widely published.

This expert has over 25 years of experience in the securities industry as an accounting and compliance specialist. Industry experience with broker-dealers, registered investment advisers, hedge funds,regulation, compliance, accounting, and information technology. He has been FINRA registered since 1984 and is also a licensed Financial and Operations Principal. He currently serves as Principal for a financial compliance services firm.

This highly qualified expert specializes in engineering and regulatory affairs for medical device commercialization. She earned a BS in mathematics from Oregon State University and a MS in Medical Device and Diagnostic Engineering from the University of Southern California. This expert currently owns and operates her own medical device company where she prepares and submits FDA regulatory services 510k applications.

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.