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0:00
Hello, I am Andrea Weir.
I'm a toxicologist by training,
and I've spent the majority
of my career in drug development.
I was a reviewer
of non-clinical pharmacology
and toxicology submissions
at the US Food and Drug Administration
from 1993 to 2005.
In 2005, I joined Charles River Laboratories
as part of a group
known as Navigator Services.
In that role, I provided scientific
and regulatory advice to clients
regarding their non-clinical
development programs.
In 2015, I joined ToxStrategies Incorporated
as a senior consultant
with the Biopharmaceutical/Pharmaceutical
Practice.
In this role, I assist clients
with managing the scientific
and regulatory challenges of their
non-clinical drug development programs.
0:53
During this presentation,
I will be providing an overview
of the Food and Drug Administration
and of drug development
from the non-clinical perspective.
I will be addressing potential
safety concerns
that could be identified
in non-clinical studies, as well as
considerations for using data
from non-clinical studies
to support safe drug development.
Finally, I'll be providing information
on the correlation between
non-clinical and clinical toxicities.
1:20
In the next several slides,
I will describe the different centers
within FDA and describe their function.
1:28
In the United States,
it is illegal to test new drugs in humans
or to market new drugs for human use
without having approval from the FDA.
FDA is responsible for ensuring
that clinical trials are safely conducted
and that safe and efficacious drugs
are approved for marketing.
