Garvey Associates, Inc.

Medical, Scientific and Regulatory Consulting

Brief Description of Experience Relative to the FDA Approval Process

Garvey Associates, Inc. (GAI) is a medical/scientific consulting firm that has worked with pharmaceutical, medical device and biologics firms worldwide for more than 30 years. GAI designs clinical trials and programs of clinical trials for drugs and devices; analyzes, organizes, and presents data derived from clinical trials; and composes and edits clinical sections of (b)(1), (b)(2) and (j) New Drug Applications (NDAs). The firm has had a great deal of experience with a variety of requests for Investigational New Drug (IND) exemptions, and practical and theoretical problems involving clinical trials, data analysis and interpretation of clinical trials, submissions to and interactions with FDA, and pre- and post-approval drug labeling.

Under the leadership of Dr. Thomas Q. Garvey III, MD, GAI has developed the data for and composed a complete and successful 505 (b)(1) NDA, sections of several other 505(b)(1) NDAs, and other major (b)(1), (b)(2) and (j) NDAs. The firm has also composed and submitted many INDs and has been involved in design, analysis, and presentation of clinical studies for NDA supplements; preparation and prosecution of submissions for OTC switches of major prescription drugs; due diligence (assessment of compounds for licensing or acquisition); and preparation of sponsors for various FDA interactions including pre-IND (PIND) , End of Phase 2 (EDP2), pre-NDA, and Advisory Committee Meetings.

Dr. Garvey has provided expert opinion in a number of legal cases involving drug and device labeling, failure-to-warn, patent issues affecting drug approval and labeling, and Lanham Act actions. Although trained as a gastroenterologist Dr. Garvey has had extensive experience assisting in development of and scientific and regulatory problem solving for cardiovascular, metabolic/endocrine, CNS, ophthalmologic, oncologic pulmonary and dermatologic drugs and imaging agents. He has participated as an expert panelist in numerous "mock Advisory Committee meetings" for a wide variety of drug products.