I
am currently a toxicologist working for the Center for
Drug Evaluation and Research (CDER), US Food and Drug Administration,
where I serve in three official positions: Acting Associate
Director for Pharmacology and Toxicology, Office of Drug
Evaluation II (ODE II); Pharmacology/Toxicology Supervisor,
Division of Special Pathogen and Immunologic Drug Products
(DSPIDP) and Supervisory Co-Chair, CDER Immunotoxicology
Committee.
In my role as Acting Associate Director of ODE II, I serve
as the senior advisor to the office director on all issues
related to the toxicologic evaluation of drug products
regulated by the review divisions in that office. Products
regulated by ODE II include pulmonary, critical care, anesthetic,
metabolic, endocrine, and addiction drug products.
In my role as Supervisor in DSPIDP, I am responsible for
the nonclinical review of a variety of drug products, including
immunosuppressants used in transplant medicine, anti-parasitic,
anti-fungal, and tropical disease drug products, quinolone
antibiotics, and drugs used to treat Helicobacter-associated
ulcer disease and certain topical antimicrobial products.
As supervisory co-chair of the CDER Immunotoxicology Committee,
I am responsible for development and implementation of
guidance for industry on issues such as drug allergy, unintended
immunosuppression, and drug-induced autoimmune diseases.
I also serve on the CDER Pharmacology/Toxicology Senior
Policy Committee, where I am responsible for such issues
as nonclinical toxicology studies to support clinical drug
trials in pediatric patients and specific issues such as
drug-induced phospholipidosis.
I also serve as CDER/FDA representative to a variety of
expert committees and government activities outside of
FDA, such as the Interagency Coordinating Committee for
the Validation of Alternative Methods (ICCVAM) and the
Organization for Economic Cooperation and Development (OECD).
From 1988 to 1991, I held a post-doctoral position in
the Department of Anesthesiology Pharmacology/Toxicology
research laboratory at the University of Arizona.
I was very fortunate to have an outstanding mentor in
Dr. A. Jay Gandolfi, who was the director of the laboratory
and is now Associate Dean of the College of Pharmacy as
well as Professor of Pharmacology and Toxicology. I specifically
studied halothane immunotoxicity and animal models for
the disease, but I also had the opportunity to interact
with many people on a variety of toxicological issues.
The work was rigorous, rewarding, and and particularly
relevant to my current job in assessing drug toxicity.
The training I received at the University of Arizona was
absolutely pivotal in my professional development. The
teachers and staff of the University were, and still are,
top notch and I was indeed fortunate to have had the opportunity
to work in such an intellectually challenging and stimulating
environment.
It was at the University of Arizona that I learned how
to be a toxicologist and my success as a professional is
the result of my having been a member of the toxicology
community there. The U of A pharm/tox family remains a
strong network for all of us lucky enough to have trained
there.
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