An FDA regulatory affairs expert witness with more than 30 years of experience in drug, biologic, and medical device development, this professional specializes in regulatory strategy, clinical trial compliance, data integrity, FDA submissions, inspection preparation, and interpretation of regulatory requirements. More than 10 years of expert witness experience includes consultations, deposition testimony, and courtroom testimony, with involvement in more than 50 matters, 20 depositions, and 5 instances of testimony. Litigation support has addressed drug, biologic, and medical device injuries, patent infringement, trade secrets, wrongful termination, insurance claims, mergers and acquisitions, stock fraud, software development, and data-integrity issues requiring analysis of FDA processes and compliance.

Educational attainment includes a Bachelor of Arts in Zoology, a Master of Science in Physiology, and a Ph.D. in Physiology. Earlier regulatory authority experience includes service as an FDA drug reviewer responsible for managing portions of the drug review process, reviewing protocols and statistical methodology, identifying unresolved deficiencies, communicating with sponsoring firms, and determining whether regulatory concerns had been adequately addressed.

Professional responsibilities include regulatory consulting for FDA-regulated organizations across product development, compliance, and submission strategy. Work encompasses INDs, NDAs, PMAs, 510(k)s, clinical study protocols, clinical study reports, standard operating procedures, electronic records, software validation, adverse-event reporting, Trial Master Files, Good Clinical Practice audits, and preparation for FDA inspections. He has also advised senior government leadership on regulatory pathways for drugs, vaccines, and medical devices and has trained more than 40,000 professionals on FDA technical, regulatory, and compliance topics.

Regulatory analysis further includes interpretation of FDA safety databases, review of scientific and medical literature, assessment of data quality and integrity, statistical analysis, and preparation of information for meetings with FDA reviewers. His combined experience as a former FDA reviewer, regulatory consultant, educator, and expert witness supports evaluation of how FDA reviewers assess evidence, how regulatory decisions are made, what companies knew or should have known, and what actions were required under applicable FDA compliance expectations.