FDA Regulations Expert Witnesses in Iowa

This expert is the president of a healthcare government relations and regulatory policy consultancy firm that she founded after an extensive career in healthcare and government. She was the Vice President for Government Relations and Public Policy at Celgene and was the Vice President for Regulatory Policy at GE Healthcare. She served in the administration of President George H.W. Bush as Special Assistant for Legislative and Public Affairs in the Office of the Commissioner, US Food and Drug Administration. She is a certified Regulatory Affairs specialist and is the author of numerous reports and is currently on the Board of Directors of the FDA Alumni Association. Her formal education includes a BA in Government from Georgetown University and an MS in Science and Technology Commercialization from The University of Texas at Austin.

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 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.