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Sterling Chung
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May 13, 2026
Sterling Chung - Episode 4 - Regulatory Voices
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42:58Sterling ChungGUEST
But true mastery is to say, "Hey, we can generally be over an eighty to ninety percent, um, uh, you know, success rate in terms of manufacturer.
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43:06Sterling ChungGUEST
And then we understand it well enough that we know that these are gonna be truly the off-target effects that we sh-should see in, in clinic." And so I would say that, you know, that's just within, like, small molecule biologics and, uh, cell and gene therapy.
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43:23Sterling ChungGUEST
And then you take that, and then you say, "Hey, I'm gonna take a small molecule, and I'm gonna take a cell therapy, and I'm gonna combine it together and see what happens." And that in itself, like FDA has guidances around combination therapy and talking about contribution elements, but how a small molecule will help a cell is, uh, is truly that next frontier, right? Where we're taking our s- our mastery of, of small molecules to enhance the cell therapy that we truly don't understand fully, and we're learning to master, right? And, and that's-
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45:47Conner HarmanHOST
It-- is there a specific area or areas right now where guidance is particularly unclear, and then that means you guys have to, you know, do a lot of the guesswork?
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45:58Sterling ChungGUEST
Um, I would say, um, you know, there's more of this coming in from a CMC standpoint, and what I would say is, like the ecosystem for small molecules and biologics, I feel like is fully developed, right? Like stuff around, um, ADCs and, you know, those, those areas, it's like you know how to develop it from a non-clinical standpoint, uh, a CMC standpoint, and a clinical standpoint.
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46:23Sterling ChungGUEST
How do you take cells and do a non-clinical program around it? Or how do you do, uh, a targeted cell therapy that only hits human MH1s or MH2s and basically apply that in a monkey model or a rat model? And I think this is where FDA is struggling to say, "Hey, let's not use as many animal models." But at the same time, how do you ensure some amount of safety for humans when it's this novel of a concept? And then CMC, I mean, yes, there's basic framework that you work around, but like can they give us more specific around this particular type of cell type? They can't, because it, it's new for them too.