Biomedical Expert Witnesses in Kentucky

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 expert received a Ph.D. in Biomedical Physics and is board certified in Radiology. She is a certified Radiation Safety Officer and a member of the American College of Medical Physics and American Nuclear Society.

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 decorated expert has a quarter century of electrical engineering experience, earning graduate qualifications at MIT, where his work had important biomedical applications. He is a member of several professional societies such as the Institute for Electrical and Electronic Engineers and Virginia Academy of Science. Active in research, he has won numerous grants and has been published widely. He has consulted on IP issues in the past and holds several patents for his inventions.

This highly qualified expert earned his B.S. and M.S. in Mechanical Engineering and a Ph.D. in Biomedical Engineering from Marquette University. From 1977 until 2010, he held increasingly senior roles within Baxter Healthcare Corporation, most recently serving as the Technical Director of Applied Science & Technology. He was an Adjunct Professor at Northwestern University and spent four years at Exponent before becoming an independent consultant. The expert is a registered Professional Engineer in Illinois and has received 17 U.S. patents.

This highly qualified expert has over a decade's experience in orthopedic trauma medical device sales in both a field capacity as well as executive, following a career in law enforcement in special operations. Extensive experience, has been in thousands of surgical procedures; and has previously conducted hundreds of criminal investigations. At DePuy Synthes, Companies of Johnson & Johnson, he managed a large territory in Orthopedic Trauma devices, providing clinical expertise and training to surgeons and hospitals regarding the proper use of the company's trauma line. He is currently the Vice President at another orthopedics device company specializing in carbon fiber trauma and oncology products. In summary, this expert has sales, compliance and sales training experience, with a Law Enforcement, Collegiate Athletics, and a military academy background.

This highly qualified expert has extensive experience in the fields of cancer, biomedical research, pre-clinical animal research and ethics, and drug development, among others. After earning his BS from East Carolina University and his MS from The University of North Carolina at Greensboro, this expert completed his PhD in genetics and molecular biology at The University of North Carolina, Chapel Hill. He also went on to complete his MBA in biosciences management at North Carolina State University. This expert is an active member of the American Association of Immunologists, the Society for Leukocyte Biology, and the American Association for Cancer Research. In addition to being extensively published, he is the current associate editor of Frontiers in Immunology and Frontiers in Microbiology. Further, this expert has been engaged in a variety of university program development and research operations leadership roles throughout his career. Among his former roles, he has served as a research analyst with the Center for Human Genetics at Duke University Medical Center, a research associate for microbiology and immunology at The University of North Carolina Chapel Hill, and as an assistant professor of inflammatory diseases at Virginia-Maryland College of Veterinary Medicine. This expert currently maintains two assistant professorships at a public medical school in Virginia, in addition to his primary role as an associate professor of inflammatory diseases at a veterinary medicine education school.