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-: In the interim,
do you have any advice for CTG companies on how to best
engage with FDA? And do you see any opportunities
that they have that they're not taking advantage of?
-: No, I think they're generally doing a
pretty good job taking advantage of things.
You know, I think we have had the interact meetings,
which is like a pre-pre-IND meeting.
People come in for their pre-IND meetings and people
contact us. I would say if anything, you know, we
as an agency want to try to do better in the timeliness of
communication around gene therapies in particular,
because with the pandemic we've been so underwater that
we're behind on meetings, especially for gene therapies.
My dream is to have Type A-like meeting timelines for
most routine interactions
because if we could get to meetings within 30 days for
simple questions, it would allow people to move a lot more
quickly. And I think it would put the agency's
actions more in line with the
small biotech ecosystem. Because, you know,
we kind of move at this pace,
when it takes us, you know, 90 days to get back to someone,
that is at the pace of large pharma.
-: And so what does that mean then for you and CBER in your
priorities? I mean, how are you thinking then about
developing the resources and capabilities
to help work with industry in the way that you describe?
-: Yeah, so right now we're working to look at
what we can do on our Office of Tissues and Advanced
Therapies to essentially think about whether we can put
together a group or a hub of people where,
for gene therapies-particularly for small indications-
we could essentially be somewhat transformative in what
we're doing and kind of forward-leaning.