His hands-on, practical FDA work experiences includes developing of product development strategies, organizing numerous pre-IND/IDE meetings, acting as an Agent for submissions to FDA, implementing pre-clinical and clinical programs, negotiating with FDA to resolve issues and with vendors for analytical, animal, clinical (CRO, investigators and institutions) and for product manufacturing during his 27 years of FDA legal practice and now as an Advisor; This work included developing the first bio-similar drug (505(b)(2) NDA application; and as an Arbitrator in conflicts regarding FDA matters, i.e., in disputes involving compliance with current Good Manufacturing (cGMPs) and Clinical (GCP) Practices regulations and meeting product specifications.