Please wait while the transcript is being prepared...
0:00
In this talk, the focus
is pre clinical to
clinical translation,
supported by coverage of the
critical process of moving
biomedical discoveries
from pre clinical studies
to early clinical trials,
emphasizing the importance and
complexity of this
translational journey.
We will discuss the challenges
and using animal models,
the role and validation
of biomarkers,
and strategies for integrating
pharmacokinetic and
pharmacodynamic data.
Additionally, we will examine
early phase clinical
trial design
and common pitfalls
in translation.
Finally, we will highlight the
importance of
continual learning,
scientific rigor,
and collaboration
to successfully
develop new therapies.
We explore the essential
journey of translating
biomedical discoveries from
the preclinical stage
to clinical trials.
Preclinical to
clinical translation
is the backbone of
therapeutic development,
but is fraught with
both scientific promise
and complexity.
Success requires more than
robust laboratory data.
It demands navigating
regulations,
using biomarkers strategically
and designing careful studies.
Understanding key
concepts, limitations,
and solutions in this process is
critical for drug or
biologic development.
One of the main challenges
in pre clinical to
clinical translation is
the use of animal models.
Although animal studies reveal
mechanisms and
potential toxicities,
important species differences
in genetics, physiology,
and disease progression can
limit their ability to
predict human outcomes.
For instance, a therapy
may work well in mice but
