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Welcome to the 'Toxicity
Testing of Oncology Drugs:
Unraveling the Last 15
Years of Progress'.
My name is Krishna Allamneni
and I'm a board
certified toxicologist,
currently working as a
chief development officer
for an oncology start-up.
Across more than two decades,
building and leading
pre-clinical
development departments in
the pharmaceutical
industry, I've gained
extensive experience in
strategically evaluating
benefit/risk profiles for
diverse therapeutic modalities,
including small and
large molecules
in a range of therapeutic
areas such as oncology,
hematology, CNS,
infectious diseases,
autoimmune conditions,
diabetes, and liver metabolism.
This presentation is an overview
of the last 15 years of
progress in the
nonclinical safety testing
of oncology drugs.
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In our previous talk in 2009,
we described the unique
considerations for
oncology drug
development and how
these considerations
shape the design,
scope, and timing of
the toxicology studies
that were conducted
for cancer drugs.
In addition, we focused on
pharmacodynamic markers
that were emerging as
game changers for oncology
drug development.
We went through the
similarities and
differences in safety
and toxicology testing,
comparing and contrasting
the programs that were
developed for small molecules
versus large molecules.
The ICH S9 guidance had just
come out and we introduced
that as a nonclinical
safety assessment guideline
on oncology therapeutic
development.
We also shared the
existing publications by
De George and the guidance
on the preclinical evaluation by
EMEA along with ICH M3 that
defined the timeline for
various nonclinical
safety studies.
Since that 2009 presentation,
there has been a
tremendous progress
in the field of oncology
drug development
in terms of modalities and
mechanisms of cancer drugs,
as well as guidances that
help sponsors developing
cancer drugs.
Consequently, although
not much has changed in
the standard parameters to
be tested in
nonclinical toxicology,
certain exemptions or
additional parameters are
added given the evolution
of our understanding.
In the 1980s, cancer
drug approvals
