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Hello. My name is
Yael Mandelblat-Cerf.
I received my PhD from
the Hebrew University
of Jerusalem.
I had my postdoctoral
research training
at MIT and Harvard
Medical School.
Following that, I
transitioned to
the pharma industry and gained
experience in early
drug development.
Currently I work for
the National Institute
of Mental Health.
Today I will be discussing
the topic of interpreting
non-clinical toxicity studies
in psychiatric drug development,
human relevance, and safety.
0:32
Let's start by
unpacking this title.
What are we going
to cover today?
I would start by going over
the specific challenges of
drug development for
psychiatric diseases.
I will then discuss
the basic concepts
and goals of non-clinical
toxicity studies.
I'll specifically address
the challenges of
tox studies for such
psychiatric therapeutics
and finally discuss
the relevance of
these preclinical studies to
predict safety in humans.
What I will not cover is
the specific details and
processes of non-clinical
toxicity studies in general.
If interested, I invite you to
review multiple talks
in HSTalks that
cover these topics.
What is our mission?
1:14
Our mission is to provide
some relief for patients
suffering from mental health
diseases including depression,
schizophrenia, PTSD, anxiety
and bipolar disorder,
as well as ADHD and autism.
As illustrated in the slide,
there is a great unmet need.
Mental health disease are
chronically diseases that
impact millions of people
in the US from children to
elderly and patients may
suffer from them
throughout their lifespan.
It can be very debilitating
impacting the ability of
people to be
functional in society,
join the workforce, raise
families or interact
with their community.
Mental health diseases
impact to different extent
the individual cognitive and
social processes as well
as emotional processes with
either positive or
negative valence.
Accordingly in
schizophrenia, for example,
impacts over 3 million
in the US is typically
associated with
hallucinations and
delusions as you
see in the slide.
But it can also cause deficits
in cognitive function.
Therapeutic candidates may not
be able to address
all the deficits.
In our example, it may target
the cognitive impairment
in schizophrenia or
the increased
hallucinations but may not
improve both of them which
brings us to the challenges.
The previous slide already
