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Expertise Description

I have more than 35 years of experience in Immunology, Virology, and Biochemistry, with over 25 years of regulatory affairs and drug development experience (drugs, biologics, devices). This experience includes CMC, clinical, promotion and advertising, cGMP, cGCP, and success interacting and negotiating with FDA and international health authorities. I am a monoclonal antibody expert. I have founded a pharmaceutical and medical device consulting company to assist companies in strategic planning, FDA liaison and negotiation, FDA meetings, regulatory submissions and formation and execution of plans, and to help meet unanticipated needs and challenges. I have over 5 years of expert witness experience with consultations and deposition.

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Consulting Experience

My consulting experience includes acting as a regulatory consultant for several pharmaceutical companies.


Professional Experiences

My professional experience includes regulatory affairs and product development for drugs, biologics and medical devices (Rx, Rx to OTC, OTC, ANDA, 510(k)). I have experience with both small and large companies. I have worked with extensive negotiations with all divisons at FDA, including DDMAC. I have assisted clients in CMC, clinical, strategy, FDA meetings, inspections, line extensions, and due diligence.


Education

Degree Subject Institution
Ph.D. Immunology/Virology/Biochemistry Cornell University
M.S. Transplantation and Tumor Immunology New York University
B.S. Biomedical Sciences Tufts University

Awards & Affiliation

American Association of Pharmaceutical Scientists
Food and Drug Law institute
Drug Information Association
Regulatory Affairs Professionals Society
Association of Food and Drug Officials

Primary Affiliation

American Association of Pharmaceutical Scientists