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Garvey
Associates, Inc. (GAI) is a medical/scientific consulting
firm which, for the past 20 years, has worked with pharmaceutical,
medical device, and biologics firms worldwide. GAI designs
clinical trials and programs of clinical trials for drugs
and devices, analyzes, organizes, and presents data derived
from clinical trials and composes New Drug Applications (NDAs).
The firm has had a great deal of experience with a variety
of practical and theoretical problems related to clinical
trials, data analysis and interpretation and submissions to
and interactions with FDA.
GAI
has developed the data for and composed a complete NDA for
a major gastrointestinal drug, and has organized, written
and edited the clinical sections of NDAs for several major
drugs (including Zantac® for Glaxo, Vasotec® for Merck,
Kerlone® for Searle, Zebeta® for Lederle, Oxilan®
for Cook and Aciphex® for Eisai). The firm has also composed
and submitted many IND's 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 advisory committee
meetings. Dr. Garvey has provided expert opinion in a number
of legal cases involving drug and device labeling, failure-to-warn,
and Lanham Act actions. Although trained as a gastroenterologist
and currently practicing that specialty, Dr. Garvey has had
extensive experience with cardiovascular, metabolic, endocrine,
CNS, and dermatological drugs and with radiologic imaging
agents.
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