And so what does your center do?
The Center for Biologics is responsible for
regulating biological products.
That includes therapeutic products.
That includes vaccines, allergenic products,
blood, and tissue.
And your division on it?
And my office is responsible for vaccines
and related products.
Those related products are such products like
pro-biotics, allergenic extracts, products of that
nature.
And so, the FDA as a public health agency, how
does your work support that?
My work supports that in the sense that we're
responsible for facilitating the
availability of safe and effective vaccines, in my
case, or because my office and related products.
We're involved in evaluating those products
-- basically reviewing the dossiers from
manufacturers but we're also involved in testing
and doing research on a variety of different
products.
We have both research and laboratory component of
our office as well as desk reviewers.
Our office is composed of a variety of individuals
in different expertise such as clinical
reviewers, medical officers, nurses,
epidemiologists, statisticians,
microbiologists, virologists,
immunologists, the whole nine yards.
And you're a microbiologist?
And I'm a microbiologist.
And you've been a little busy with H1N1 I guess?
Yes, just a little bit.
H1N1.
But it's not -- this is nothing unique for us.
The pace might be unique but we deal with influenza
on a yearly basis so we pretty much know the
drill, and I'd say in the last four, five years,
preparing for a pandemic through various activities
with the seasonal influenza has prepared us
for, to deal with H1N1.
So it's a lot of work but we know the drill.
We were really ready for this weren't we?
We were ready for this.
But we didn't know what it was going to be.
As we never know what it's going to be, so I mean we
started out -- we had a test, we had a drill
because we started out with H5N1 as you would
commonly call the avian influenza.
And a number of people and scientists predicted that
that might be the next pandemic.
So we prepared not only at FDA but throughout the
various agencies within the Department of Health
and Human Services, so we were actually ready or
getting in the process of being ready to handle a
pandemic if it was H5N1 and we were somewhat
surprised that it turned out to be H1N1, but same
drill, so we were prepared to move into action on H1N1.
And when a vaccine is made, CBER scientists are
actually part of helping to develop a seed strain
and those kinds of things correct?
For the influenza, right.
Influenza is really unique because we are intimately
involved in the preparation of reagents,
seed strains and what have you for the preparation of
that vaccine, unlike other vaccines.
We may be doing research in preparation to master
cell banks and master seeds, but the
manufactures are not, in general, using those
particular reagents to make their products.
They may -- that helps us test the product and be
prepared to understand those products.
And what does the future look like?
There are just huge amounts of challenges
ahead.
Even if we think about how do we understand, most of
the vaccines, we have somewhat of an idea of
mechanisms of how they work, but we don't really
have a clear understanding of how all of these
products how they work.
We understand that they are effective;
we understand that they're safe,
but what is the mechanism,
what are the pathways that these products follow.
So I think the field of immunology is really
blossoming and is going to help us understand how
some of these products are effective in the future.
Why is that kind of knowledge important?
We know that many of these vaccines elicit some type
of cell mediate immunity, and having a better
understanding of that, we can target vaccines for
those areas and also, we can develop assays to
better understand the contributions of those
antigens to eliciting immune responses from the
cell mediated immunity.
So, it seems that you have a unique view of the
world.
You do a lot of -- at least some basic research
on all of this so you can understand the products
that come to you to be regulated.
Yes, that's correct.
And I think we also have a unique view because our
staff, most of our staff, started in a laboratory or
in a clinical setting, a hospital or some other
clinical setting, so we have -- our staff, they
have the ability and the knowledge base to evaluate
these products.
And even when new technologies come about,
we have the knowledge base to understand and to ask
the appropriate questions about how these products
might work, how these technologies might be
applied to these different products so it puts us in
a very unique position, unlike some other national
regulatory authorities across the world.
The expertise in FDA is in the FDA.
We grow our own, we hire the expert from the
outside, but we have them in house.
So we don't have to sort of contract out to -- for
that expertise, we have the expertise in house.
Because we have an awesome responsibility when
someone goes to the doctor or healthcare setting and
gets a shot to protect them from something;
they expect it to work and to be safe
and go home and be protected.
Absolutely, although we have to admit,
that products are not 100 percent safe
and effective,
but that's the goal.
Thank you, sir.
Sure.
Thank you.