0:04
Now we're going to move
from the vaccine's
safety aspects
or toxicology,
to the pharmacology aspects,
or proof-of-concept.
This is the flip side of safety.
So safety is the way
we try to identify risks
and assess risks,
and the proof-of-concept studies
or mode-of-action studies,
are how we try to assess
the potential for benefit.
So for drugs,
pharmacology encompasses
the concepts of pharmacokinetics
and pharmacodynamics.
But in fact for vaccines,
those concepts
don't really readily apply
and what we're really trying
to address is the immunological
mechanism for protection.
So we look at
immunogenicity in animals
and if there's a relevant
animal model,
then we try to do studies
of challenge-protection.
And I'll explain those
in more detail in a moment.
Often these types of studies
are research studies.
And in fact, they're rarely,
if ever, performed
in compliance with
good laboratory practices.
So even though they're
intended to support
regulatory decision making
about potential for benefit,
in fact, the fact
that they're not required
to meet these good
laboratory practice regulations
reflects the fact that,
in fact, in the US,
Phase 1 studies
can only be placed
on clinical hold for safety.
And so really the regulatory
decision making,
the precision
around that has to be
on the basis of risk
assessment or safety aspects.
