Specialties & Experience of this Expert Witness

Additional Information

25 years of experience in infectious disease including food microbiology, chemical/ biological defense and regulatory science. Initial employment in the Federal Government was with the Agricultural Research Service (ARS) performing genetic engineering of dairy bacteria. From there, he went to the Department of Defense, specifically Naval Surface Warfare Center (NSWC), working in chemical and biological warfare defense. Spent 12 years as a Clinical Microbiology reviewer in the Center of Drug Evaluation and Review (CDER) at FDA. He has extensive experience with FDA submissions including: pre-IND, IND, NDA, labeling supplements, and post-marketing for antibiotics, topical antiseptics, biologics and generic drugs. As an independent consultant, provided guidance on microbiology and regulatory affairs for clients developing antimicrobials, medical devices and biologics allowing clients to navigate through the FDA regulatory process. This guidance included providing advice for developing protocols and strategies; review and advice on IND, NDA, BLA and ANDA submissions and meeting minutes; advice on regulations, guidelines and guidance documents; assistance in dispute resolution; advice on labeling; support of clients in strategic meetings; accompanying clients in face-to-face FDA meetings; and preparation of clients for Advisory Committee meetings. Served as an expert witness in litigation and provided assessment of scientific and data integrity of biotech companies and assessment of causation in food poisoning.