I have been with the DuPont Pharmaceuticals Company (now
Bristol Myers Squibb Company) as a Senior Research Scientist
for the past two years, in the Safety Assessment group.
As a Study Director/Monitor I am responsible for the in-life
conduct of Toxicology studies (acute, subchronic and chronic,
and exploratory mechanistic studies) performed on drug development
candidates within the company as well as for the monitoring
of external contract studies.
My responsibilities include design, review and implementation
of all Toxicology study protocols and writing of study reports
assuring that the scientific objectives of the study are
met and that worldwide regulatory and GLP guidelines are
satisified. Drugs currently in development that I have been
involved with in this capacity include HIV therapeutics,
CNS active drugs, oncology agents, anti-obesity agents, and
drugs for the treatment of inflammation and thrombosis.
I also serve as the Toxicology Project Team Leader for a
cohort of non-nucleoside reverse transcriptase inhibitors
(NNRTI) being developed by DuPont Pharmaceuticals for the
treatment of HIV.
This
requires my interaction with Safety Assessment management
and Drug
Discovery personnel as well as a multidisciplinary
team outside of the Safety Assessment Group (the "Project
Team" which includes Chemistry, Analytical Chemistry
and Pharmacy personnel, Clinical Research personnel, and
folks involved with the business end of drug development,
including those in Regulatory Affairs, Manufacturing, and
Business) to support the development of these drugs.
Membership on the Project Team also involves the writing
of regulatory documents to support the entry of the development
candidate into Phase I and II clinical trials and beyond
(ERC, IND, etc.). Acting as a Project Team Leader requires
a sound multi-disciplinary working knowledge of Pharmaceutical
Toxicology (i.e., genetic toxicity testing, acute/subchronic/chronic
testing, reproductive/developmental testing, immunotoxicology,
toxicokinetic analyses and mechanistic approaches).
The multidisciplinary approach of the Pharmacology and Toxicology
department at The University of Arizona was invaluable in
my preparation for a successful career in industry.
As a
Toxicologist in industry, the ability to "wear
many hats" is very important, as well as the ability
to synthesize study data into a clear assessment of the toxicity
of a drug in animal models, and to determine the potential
relevance of those toxicities to humans.
I had many things to learn when I first arrived at DuPont
Pharmaceuticals about how the Pharmaceuticals industry works,
but luckily the foundation of knowledge and work ethic that
I established while at The U of A allowed me to learn quickly
and succeed.
|
