0:00
Hello.
My name is Martin Edelman.
I am the Chair of the Department
of Hematology / Oncology
and Deputy Director
for Clinical Research
at the Fox Chase Cancer Center
in Philadelphia, Pennsylvania.
I'm going to be discussing the
development of a cancer drug
with a focus on how the
process goes through
from the molecule
with the target
through to FDA approval,
with an emphasis on
the regulatory aspects
and trial design aspects.
0:32
These are my disclosures
and disclaimers,
and I'd like to emphasize
that the material
that I'm presenting
is an overview
of the drug development
process as perceived
by myself an oncology
drug investigator.
I do not work for companies
and I have not been part
of the corporate
world and this is
intended for
educational purposes.
It is not intended to be
encyclopedic, nor is guidance,
nor is legal advice and
has not been reviewed by
the US Food and
Drug Administration
or any other regulatory
organization.
1:01
This is my perspective.
It's distilled from my review of
various FDA presentation
statements,
papers regarding drug approval,
as well as some recent drug
approvals and rejections,
and my own personal
experience in
the design and execution
of various trials.
I am not associated with
the FDA in any way,
and I have never
personally submitted
a drug for FDA approval.
I have submitted for
INDs and exemptions.
1:26
This is the overview.
The overview is that I
am going to discuss the
regulatory aspects,
the evolution of US law laws
regards drug approvals,
a bit about the structure
of the FDA focusing
on oncology and
definitions of terms.
I'm going to talk a little
bit about preclinical studies
and target identification,
what the issues are with
cell lines, animal
studies, etc.,
and moving up to optimization of
the molecule target
assessment and validation.
But the major focus will be on
the clinical aspects of how
one goes from early phase,
phase II and III and
ultimately to approval.
