Jun 18, 2026 · 1 hr 26 min · 9 segments
We love to hear from our listeners. Send us a message. For episode 131 of Cell & Gene: The Podcast, we’re sharing a recent "Better Biopharma"…
Jeff BuguliskisPanelistErin HarrisHost
Dan SchellPanelistRay DolgosPanelist
Katie AndersonPanelist
Rachel GravenhoferPanelistBen ComerPanelistAs you can see, we have a lot of diverse, uh, coverage here in terms of the life sciences industry and ecosystem.
So in the same order, I wanna go through and see, um, you know, as far as how this year's going, 2026, what have been the biggest developments in your space? Uh, whether these are things that you're excited about, you think are overall positive, whether they're kind of inviting some scrutiny, you're scared by it, uh, you don't know how it's gonna shake out.
Uh, I just wanna go around the horn and get everybody's thoughts on the biggest things happening in their industry so far into 2026.
So, um, I'm sure this will be reflective in, in everybody's thoughts for this year.
But for Pharmaceutical Online, we have, um, definitely seen AI continue, um, in its use in pharmaceutical discovery, development, manufacturing.
What I found really interesting this year is that, um, the, the joint effort of the FDA and the MEA to put out guidelines on AI use in pharma manufacturing- But also it was interesting that a manufacturer did, um, get a warning letter for their use of AI in, in manufacturing, and as it turned out, they didn't have enough human oversight.
And so all of these things combined present unique challenges, but also opportunities for the use of AI in, in pharmaceutical manufacturing moving forward that I think are particularly interesting.
Um, we're also seeing continued investment in pharmaceutical manufacturing, um, in the US and abroad.
Particularly, there's been quite a bit so far in twenty twenty-six in the Heartland, so more in Illinois, more in Indiana, uh, Pennsylvania, so less on, uh, the coast.
Um, I mean, there's still a good amount of, of investment in, in the-- in North Carolina, in the triangle there, but, uh, more in the Heartland.
Um, you know, I think, uh, Katie's right that, you know, no one's, no one's getting around AI, right? I mean, I think it's, it's probably affected all of our industries, all of our titles and, and so forth.
Um, for outsourcing, it's, it's still obviously a big part of that, but I think the things that, uh, that I'm seeing that are more, even more, a little bit more interesting that we've been talking about a lot, you know, we-we're getting a, uh, a lot of focus from sort of, you know, geopolitical friction, legislative pressures and so forth, and you're s- we're starting to see shifts in supply chain.
You know, sort of the, the old model of the global, uh, supply chain that, that had been in effect for, for quite a while, or the hyper-globalized supply chain, um, is po- potentially starting to fade away.
Um, some people have written about it and said that it's completely dead.
Others are saying, you know, maybe not so much, but it's somewhere probably in between.
Um, and you're seeing, you know, more of this onshoring or reshoring, uh, back to the US and, you know, for some drug sponsors moving away from the multifaceted, you know, uh, outsourcing, you know, for, say, something like an ADC where you have multiple points of where you might need, um, multiple CDMOs.
Some are moving to the one-stop shop and, you know, at least being the supply chain's kind of more localized, um, rather than being global.
Um, you know, I think also we're seeing more prepaying is coming, uh, along, you know, that's becoming a priority.
As you can see, we have a lot of diverse, uh, coverage here in terms of the life sciences industry and ecosystem.
So in the same order, I wanna go through and see, um, you know, as far as how this year's going, 2026, what have been the biggest developments in your space? Uh, whether these are things that you're excited about, you think are overall positive, whether they're kind of inviting some scrutiny, you're scared by it, uh, you don't know how it's gonna shake out.
Uh, I just wanna go around the horn and get everybody's thoughts on the biggest things happening in their industry so far into 2026.
So, um, I'm sure this will be reflective in, in everybody's thoughts for this year.
But for Pharmaceutical Online, we have, um, definitely seen AI continue, um, in its use in pharmaceutical discovery, development, manufacturing.
What I found really interesting this year is that, um, the, the joint effort of the FDA and the MEA to put out guidelines on AI use in pharma manufacturing- But also it was interesting that a manufacturer did, um, get a warning letter for their use of AI in, in manufacturing, and as it turned out, they didn't have enough human oversight.
And so all of these things combined present unique challenges, but also opportunities for the use of AI in, in pharmaceutical manufacturing moving forward that I think are particularly interesting.
Um, we're also seeing continued investment in pharmaceutical manufacturing, um, in the US and abroad.
Particularly, there's been quite a bit so far in twenty twenty-six in the Heartland, so more in Illinois, more in Indiana, uh, Pennsylvania, so less on, uh, the coast.
Um, I mean, there's still a good amount of, of investment in, in the-- in North Carolina, in the triangle there, but, uh, more in the Heartland.
Um, you know, I think, uh, Katie's right that, you know, no one's, no one's getting around AI, right? I mean, I think it's, it's probably affected all of our industries, all of our titles and, and so forth.
Um, for outsourcing, it's, it's still obviously a big part of that, but I think the things that, uh, that I'm seeing that are more, even more, a little bit more interesting that we've been talking about a lot, you know, we-we're getting a, uh, a lot of focus from sort of, you know, geopolitical friction, legislative pressures and so forth, and you're s- we're starting to see shifts in supply chain.
You know, sort of the, the old model of the global, uh, supply chain that, that had been in effect for, for quite a while, or the hyper-globalized supply chain, um, is po- potentially starting to fade away.
Um, some people have written about it and said that it's completely dead.
Others are saying, you know, maybe not so much, but it's somewhere probably in between.
Um, and you're seeing, you know, more of this onshoring or reshoring, uh, back to the US and, you know, for some drug sponsors moving away from the multifaceted, you know, uh, outsourcing, you know, for, say, something like an ADC where you have multiple points of where you might need, um, multiple CDMOs.
Some are moving to the one-stop shop and, you know, at least being the supply chain's kind of more localized, um, rather than being global.
Um, you know, I think also we're seeing more prepaying is coming, uh, along, you know, that's becoming a priority.
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