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0:00
My name is Rebecca Sheets
and this lecture
has to do with the context
of the preclinical studies
that are intended
to support moving
from the research arena
into clinical trials
of vaccines.
0:16
Although other
speakers in this series
may be coming
from a more academic
or industry background,
in fact my background
is more from
a regulatory perspective.
And so this lecture will be
presented in that context.
However I also have
to give the disclaimer
that I am reflecting
solely my own opinions
and I am not speaking
on behalf of
the U.S. government.
I will apologize though that
although I know this is intended
for an international audience
I will be giving a bit
of a U.S. centric lecture,
so I apologize for that.
0:52
The outline of
the presentation is to give you
a little bit of
introduction in context.
And then to talk about
the two types of studies
that regulators need
in order to make their
risk benefit decisions
about what should
proceed into clinical trials.
And those are safety studies
and proof-of-concept studies.
1:15
It's important to understand
that vaccines are a diverse
class of product types
and unlike small
molecule drugs,
they're complex macromolecules.
They may be as
simple as a peptide
but mostly they are
as complex as whole organisms.
They can be multivalent,
which means that they
can contain immunogens
from more than
one strain or serotype
or even from more
than one organism,
for example,
the diphtheria tetanus
and acellular pertussis vaccine.
Regulators expect to receive
two types of information
about preclinical development
of medicinal products,
regardless of
whether their drugs
are biological products.
And there are studies that
support the safety of the product,
upon which they can
make assessments of risk.
These are generally referred
to as toxicology studies.
And the other are
studies that support
the proof of concept
or mode of action
of the product.
And this is what they
base their decisions
about the potential
for benefit would be.
And these are generally
referred to as
pharmacology studies
which reflects
the original intent
of toxicology and
pharmacology studies
to the application
of chemical drugs.
It's also important for
an international audience
to be aware that there
is a trilateral agreement
between the U.S. ,
the European Union, and Japan.
And many other
countries follow this
international conference
on harmonization.
And the preclinical studies
or non-clinical studies,
which I'll explain in a moment,
are covered by the ICH
topics of safety or 'S' topics.
Vaccines unfortunately
are not well covered by the ICH.
However if you have
a biotechnological vaccine
then there is the S6
document that could apply.
However there are other
national and international
guidances or guidelines
on preclinical aspects
that are relevant to vaccines
and I'll describe those.
It's also important
to understand
preclinical versus non-clinical.
In fact historically,
these types of studies were
expected to be performed
prior to moving into the clinic.
But now many studies
are actually undertaken
simultaneously
with clinical studies.
And therefore it was decided
along the time
of the ICH process
to use the term
non-clinical instead.
However that's somewhat
of an undescriptive title.
And so in fact these terms
really are synonymous.
And what it all means
is really
the laboratory analyses
and the animal studies
that are intended to support
regulatory decision-making
about clinical development,
and ultimately
about registration
or as we call it in the U.S. ,
licensure of vaccines.
