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
In 2015, I joined ToxStrategies Incorporated
as a senior consultant
with the Biopharmaceutical/Pharmaceutical
In this role, I assist clients
with managing the scientific
and regulatory challenges of their
non-clinical drug development programs.
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
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.