Judy Gordon

Laguna Beach, CA

A clinical and regulatory consultant since 1998, Dr. Gordon brings over 20 years of experience in pharmaceuticals, biologics, and medical devices to her consulting practice, ClinReg Consulting Services, Inc. Dr. Gordon was with Chiron Vision, a division of Chiron Corporation, from the company?s founding in 1986 through its acquisition by Bausch & Lomb in 1997. At Chiron Vision, Dr. Gordon served as Sr. Vice President of R&D and as V.P. of Scientific Affairs, with responsibility for product development, clinical research, regulatory affairs, and regulatory compliance. In her consulting practice, Dr. Gordon has been involved in the development, clinical and regulatory activities for a broad range of products including injectable polymers for tissue bulking, novel refractive surgery devices, CAD systems for tumor detection, coils and polymers for aneurysm treatment, intracranial stents for stroke prevention, breast biopsy devices, intraocular drug delivery systems for treatment of macular degeneration and diabetic retinopathy, coronary atherectomy systems, and multiple other products representing novel technology. ClinReg?s Services include clinical protocol development, meetings with FDA, IDE and IND submissions, HUD and HDE submissions, premarket notifications, PMAs, and NDAs. Specialized services include preparation for Advisory Committee review of PMAs/NDAs, management of Data Safety and Monitoring Boards (DSMBs), review and reporting of adverse events, and preparation for FDA bioresearch monitoring. Dr. Gordon has taken multiple PMAs and NDAs through the FDA review process, and has directed large-scale clinical trials of both devices and pharmaceutical products. In total, Dr. Gordon has prepared all or part of 16 successful PMA applications for novel devices. She served as the industry representative to FDA?s Ophthalmic Devices Advisory Panel, and as the industry representative to the Mediation Dispute Panel of the Center for Devices and Radiolo