A pharmacology and FDA regulatory science expert witness with over 20 years of experience provides analysis in matters involving drug and device safety, regulatory compliance, and clinical development standards. This expert has 15 years of expert witness and consulting experience, including depositions, with work focused on evaluating safety, efficacy, and adherence to federal regulatory frameworks governing pharmaceuticals and medical devices.

Professional training includes a Doctor of Pharmacy (Pharm.D.), supported by postdoctoral residency and fellowship experience in clinical pharmacology and cardiovascular research. These qualifications provide a foundation in drug development, pharmacotherapy, and clinical trial methodology, including the application of biostatistics and regulatory science to therapeutic evaluation.

Within regulatory and advisory roles, this expert has contributed to high-level policy and safety evaluations involving drug approval processes, labeling determinations, and post-market safety analysis, including prior service in a senior advisory capacity within federal regulatory agencies. Responsibilities have included reviewing clinical trial protocols, analyzing safety and efficacy data, and assessing regulatory submissions in accordance with established federal guidelines. Experience also includes interpretation of large-scale adverse event databases and development of data-driven recommendations related to drug safety and public health policy.

Additional expertise includes clinical trial design, investigational drug evaluation, and independent scientific analysis in litigation contexts. This work involves reviewing medical and scientific literature, assessing regulatory compliance, and forming opinions related to pharmaceutical safety, medical device safety, and clinical outcomes. Professional recognition includes fellowship status with organizations such as the American College of Chest Physicians and the American Society of Clinical Pharmacology and Therapeutics, reflecting ongoing engagement with pharmacology standards and clinical research practices.