FDA Regulations Expert Witnesses in Kentucky

This highly qualified expert has provided valuation and corporate finance consulting services since 1987. He is a Chartered Financial Analyst (CFA) and he is a member of several prestigious associations including the Healthcare Financial Management Association and the American Society of Appraisers. He previously worked as the Senior Managing Director of American Appraisal Associates Inc where he was the Chair of Healthcare Industry Practice. Currently, this expert works as Managing Director in a global consulting firm in Illinois. He specializes in the valuation of a wide variety of businesses and business interests, fairness and solvency opinions, consulting with corporations with respect to corporate finance issues, and estimating economic damages. He has provided opinions of value, fairness, and solvency for many purposes such as acquisitions, divestitures, business and strategic plan reviews, business unit performance measurement, SEC filings, US GAAP and other financial reporting requirements, US federal, state, and non-US tax reporting requirements, regulatory compliance, various dispute resolution and litigation procedures and general advisory purposes. This expert has worked with clients across a wide variety of industries such as business and consumer services, construction, engineering and real estate development, construction materials, banking, financial institutions and insurance, healthcare services and managed care.

This extremely qualified clinical expert is an internationally recognized clinical pharmacist, author, patient advocate, and expert in patient adherence with medications and the development of multi-component patient education programs that increase patient adherence from worldwide clinical trials through product launch through post-marketing stages and increase patient safety. She has expertise in the translation of complicated medical terminology into language the average consumer will understand, integration of behavior modification and design, working with medical teams to provide documentation required for FDA approval process, and developing health professional’s tools for patient counseling to ensure that the patient education materials are used correctly. She also has expertise in working with medical device companies and packaging companies to ensure that it will be easy for patients to understand the “how to use” instructions and use the products correctly. She received her BSP degree and completed her residency training in hospital pharmacy at the University of Saskatchewan before receiving her Pharm.D. degree from the University of Cincinnati. She is a founding member of the American College of Clinical Pharmacy, a former member of the Board of Directors and Chairperson of the Business Council at the National Council on Patient Information and Education, and is active in many professional and consumer organizations, including the American Association of Colleges of Pharmacy and the Alliance for Safe Online Pharmacies. She has published 150+ peer-reviewed journal articles on patient education and adherence and serves as a reviewer for the American Pharmacists Association. She is the author of 23 books on how to use medications safety for health professionals and consumers. She has appeared on many radio and television shows to help consumers learn how to take their medications correctly. She is also the former director of clinical affairs at the American Pharmacists Association, which honored her with its Foundation Pinnacle Award for her outstanding leadership. Additionally, she is the former coordinator of the ambulatory patient pharmacy at Sunnybrook Medical Center and a former associate professor of clinical pharmacy at the University of Toronto. Currently, she is the CEO of a major patient education company that develops information to help patients understand how to manage their medications, medical devices and therapies correctly, consults with pharmaceutical companies on how to promote patient understanding and patient safety, develops multi-component patient education programs requiring FDA approval, and develops patient education programs for world-wide clinical trials to increase patient adherence so that the approved FDA dosage is more accurate and thus safer.

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 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 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.

This seasoned expert specializes in auto finance and lease regulatory compliance, with over 30 years of experience in the consumer vehicle leasing and financing areas. He regularly consults as an expert witness on auto leasing and finance-related matters, including dealer finance practices, insurance sale practices, and Regulation Z & M issues. In addition, he has consulted for the Federal Reserve Board and National Credit Union Administration on leasing and lending regulatory issues. The expert is the Managing Director of a trade association for major retail automobile lessors, and he also runs a private consulting business. He has been cited in numerous publications and occasionally appears on television as a representative of the industry. The expert earned his B.S. from Yale University and has a J.D. from the University of California, Berkeley School of Law.