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(soft introduction music)

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<v ->In the interim,</v>

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do you have any advice for CTG companies on how to best

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engage with FDA? And do you see any opportunities

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that they have that they're not taking advantage of?

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<v ->No, I think they're generally doing a</v>

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pretty good job taking advantage of things.

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You know, I think we have had the interact meetings,

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which is like a pre-pre-IND meeting.

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People come in for their pre-IND meetings and people

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contact us. I would say if anything, you know, we

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as an agency want to try to do better in the timeliness of

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communication around gene therapies in particular,

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because with the pandemic we've been so underwater that

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we're behind on meetings, especially for gene therapies.

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My dream is to have Type A-like meeting timelines for

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most routine interactions

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because if we could get to meetings within 30 days for

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simple questions, it would allow people to move a lot more

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quickly. And I think it would put the agency's

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actions more in line with the

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small biotech ecosystem. Because, you know,

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we kind of move at this pace,

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when it takes us, you know, 90 days to get back to someone,

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that is at the pace of large pharma.

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<v ->And so what does that mean then for you and CBER in your</v>

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priorities? I mean, how are you thinking then about

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developing the resources and capabilities

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to help work with industry in the way that you describe?

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<v ->Yeah, so right now we're working to look at</v>

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what we can do on our Office of Tissues and Advanced

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Therapies to essentially think about whether we can put

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together a group or a hub of people where,

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for gene therapies-particularly for small indications-

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we could essentially be somewhat transformative in what

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we're doing and kind of forward-leaning.