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0:00
Preclinical Safety Evaluation
of Biopharmaceuticals.
A Science-Based Approach to
Facilitating Clinical Trials.
Joy Cavagnaro,
President, Access BIO,
Boyce, Virginia.
0:14
This presentation will
outline the goals
of preclinical
safety evaluation,
highlight the differences
between pharmaceuticals
and biopharmaceuticals
based upon a consideration
of product attributes,
discuss what was
considered, at the time,
a new approach to preclinical
safety evaluation,
distinguishing principles
versus practices,
and establishing the
why for case by case.
I'll also outline the key
considerations of study design,
including species and
animal model selection
and the use of
surrogate molecules,
as well as establishing
dose response.
I will discuss the impact
of the immune response
and provide an overview of
the relevance of icities,
including general
toxicity, immunogenicity,
genetic toxicity,
reproductive and
developmental toxicity,
as well as carcinogenicity,
and highlight specific
considerations
based upon selected
product classes.
I'll also provide some insights
as to how best to select
the first-in-human dose,
as well as discussing
an opportunity
for realizing safer medicines.
1:20
The goals of preclinical
safety evaluation
include optimization of
lead candidate selection,
allowing for an early
introduction of new compounds
into clinical trials by
recommending initial starting dose
and dose escalation
scheme in humans,
identifying potential target
organ or organs of toxicity,
and identifying appropriate
parameters to monitor
in the clinic for
any delayed effects.
And to look for reversibility,
if there are effects,
and to identify
at-risk populations.
The goals also include ensuring
an uninterrupted
clinical development,
as well as providing data
in time for decision making
throughout the various
phases of clinical trials,
including Phase 1, 2,
and 3 clinical trials,
and ultimately, for
product labeling.
