United States of America
Tracey Zoetis, M.S. advises sponsors on regulatory and pharmacology/toxicology issues for FDA-regulated products, including pharmaceuticals, biologics, medical devices, and combination products. Her more than 25 years of experience in toxicology has afforded her a broad perspective on varied and interesting product safety issues. She has been employed by two major CROs, the FDA, and both large and small consulting firms.
As a Study Director, she designed and conducted all types of toxicity studies, in a variety of laboratory species, using most recognized routes of administration. As a Pharmacology and Toxicology Reviewer in the FDA Center of Drug Evaluation and Research, she authored reviews of nonclinical data to support the safety of products intended for clinical trials and marketing. She served as CoChair of the FDA working group responsible for drafting the guidance on nonclinical testing in support of pediatric indications. She was an author on a series of articles comparing postnatal developmental milestones across species. She has published over 10 scientific articles and abstracts, is co-editor of a scientific book on dosing animals during infancy, and her work is published in a developmental and reproductive toxicology text book. She is known for her practical approaches to drug development and for opening effective lines of communication between sponsors and regulatory authorities. She helps sponsors work to keep nonclinical issues from becoming rate-limiting steps in an overall drug development program.