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My name is Lewis Schrager,
I'm Vice President
of Scientific Affairs for Aeras.
I will be discussing
Regulatory Considerations
for Vaccine Development.
This is talk 2 of a series
of vaccine development talks.
Talk 1 was given
by Dr. Norman Baylor,
with a concentration
on chemical manufacturing
and control issues, as well as
pre-clinical regulatory issues.
My talk, talk 2, will focus
on clinical regulatory
considerations.
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I need to let you know
that the perspectives
that I'll provide in this
presentation are my own,
and are not intended
to represent
those of the US Food
and Drug Administration.
I do not work for the US
Food and Drug Administration,
but in years past I had,
I want to make
that perfectly clear.
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The outline of the talk,
in general, will be as follows.
We'll start off by talking about
investigational
new drug regulations
or IND regulations.
Then we'll talk about
the three pathways
that are available
to attain biological licenses,
they are called
biological license application
or BLA pathways:
the traditional pathway,
the accelerated approval
pathway, and the animal rule.
We'll talk about programs
that could accelerate
the clinical testing,
that is, the IND phase
and review the BLA phase
of these processes.
And these accelerated
clinical testing
and review processes
are fast track designation,
breakthrough designation,
and priority review.
We'll touch upon
the package insert,
just to familiarize
it with yourself,
given that it's the critical
regulatory work product
of vaccine development.
We'll focus on safety
and efficacy concepts
as vaccines are tested,
and give you the regulator's
perspective on these issues.
And then we'll touch on
a couple of other issues
that are important
when considering
vaccine regulation, one
being adaptive trial design,
another being
developing vaccines
for global infectious diseases,
and some of the regulatory
incentives that entail.
