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<v ->CMC has been an ongoing challenge,</v>

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particularly around the consistency

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and scaling of these processes.

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I'd be interested to hear, in addition

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to any general observations you have

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about how companies address these issues,

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is there anything that you'd like to see them do differently

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about how they engage with FDA in this area?

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<v ->Yeah, I'm not sure whether it's how they engage.</v>

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It's how we as a field might engage,

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which is that if we could leverage

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a given vector and reuse it

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so that we weren't reinventing the manufacturing process

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every time a new therapy came along,

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we might be a lot better off.

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Because right now,

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I can say

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from the cheap seats,

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it looks like there's a lot of time spent

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and a lot of effort on the secret sauce of manufacturing.

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Whereas to me, it seems like

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the real brainpower, the innovation here, should be

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in the actual constructs of what we're actually doing

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to address the disease on the business end:

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so what's addressing the disease,

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rather than how you're going to make it.

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Something is more valuable if the probability

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of success is higher.

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And if you stay within these four walls

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of how you do your development program

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for your academic gene therapy,

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you will allow us to know that we have a higher probability

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of success in transferring your process into ours.

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And therefore, the asset inherently has more value.

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So I think if industry came together and thought about that,

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it could really help this move forward.

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Because

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I think then a lot of the academic investigators

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would have the incentive that they need to come

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into using a certain set of processes.

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Whereas right now, it's kind of like "Hey, I'm going

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to do it the way I want to, and tough luck, industry.

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You want a gene therapy for this enzyme deficiency.

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You're just going to have to adapt the way I've come to it."

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No, maybe the way to come at this is,

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"Look, if you want to have an asset

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as an academic investigator that's really valuable to us,

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you do it in a certain way so that when we pick it up,

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we can actually run with it."

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And we'll compensate you for that,

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the tech transfer piece of it, which I'm not the expert in.

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There's got to be some way to incentivize it on that end.

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That comes, by the way,

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from experience. When I was in cross-academic medicine,

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and when I was in industry,

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as much as we would get really excited

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about clinical results,

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the things that usually were

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some of the biggest speed bumps were not clinical results.

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They were that you couldn't make the thing.

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If you had it, you couldn't make it.

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And that's a big problem.