The Editors’ Roundtable: A Midyear Look At The 2026 Life Sciences Industry

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Hello and welcome back to Better Biopharma, the official podcast of Bioprocess Online.
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I'm your host, Tyler Manichello, and on this very special edition of Better Biopharma, I'm joined by my colleagues from across the Life Science Connect publishing sphere for a mid-year check-in and editorial roundtable.
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Now there are a lot of people and publications present today, so I'll let them introduce themselves, starting with Katie, who is in our adjacent studio in the in the office right now.
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Katie?
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Thanks, Tyler.
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Hi, everybody.
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I'm Katie Anderson, Chief Editor of Pharmaceutical Online, and it's a pleasure to join you today.
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Hey everyone, I'm Jeff Pogoliskis.
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I'm the deputy editor at Outsource Pharma.
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It's great to be here amongst these uh fine folks here.
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So thanks, Tyler.
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Ben Comer here, uh Chief Editor at Life Science Leader.
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Uh happy as always to join this conversation.
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Hey everybody, Ray Dogum here, Chief Editor of Drug Discovery Online.
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Tyler, thanks for inviting me back.
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I'm really excited for this conversation.
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Hey guys, Rachel Grabenhofer here, the new face in the group.
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Um I'm the chief editor of Clinical Supply Leader, and I'm excited to join y'all today.
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Hi everyone, I'm Aaron Harris, chief editor of Cell and Gene and host of Cell in Gene the podcast.
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And thanks for having me back, Tyler.
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And I'm excited to work with my colleagues on this and to talk to the better biopharma audience.
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I'm Dan Schell, I'm the chief editor or clinical leader, and I like all of you.
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We like you too, Dan.
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Yes.
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Thank you, Jeff.
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I gotcha.
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Hi everyone.
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My name is Anna Rose Walsh, and I'm the chief editor of Advancing RNA.
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And I'm really happy to be back here.
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It's always a fun time when you get the Life Science Connect editors together in basically one digital room.
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So happy to be.
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Thank you guys.
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Great introductions.
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Um, and I'm very happy to have everybody together.
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This is always a fun time.
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Um, those in the audience may recall the last time we did this was uh I think that was our year-end 2025 retrospective.
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So we figured it would be time for a little mid-year check-in by the time this comes out.
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It'll be June, midway through the year.
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And so I wanted to use this time to both reflect on how our predictions are coming through and also just kind of reflect on everybody's year and projects they're working on they're excited by and uh just kind of happenings in their respective spaces.
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As you can see, we have a lot of diverse uh coverage here in terms of the life sciences industry and ecosystem.
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So in the same order, I want to go through and see um, you know, as far as how this year is going, 2026, what have been the biggest developments in your space?
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Uh, whether these are things that you're excited by, 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.
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Uh I just want to go around the horn and get everybody's thoughts on the biggest things happening in their industry so far into 2026.
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Katie, we'll start with you.
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Yeah, 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 uh pharmaceutical discovery, development, manufacturing.
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For 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.
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But also it was interesting that a manufacturer did um get a warning letter for their use of AI in in manufacturing.
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And as it turned out, they didn't have enough human oversight.
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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.
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Um, we're also seeing continued investment in pharmaceutical manufacturing um in the US and abroad.
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Particularly, there's been quite a bit so far in 2026 in the heartland, so more in Illinois, more in Indiana, uh Pennsylvania, so less on uh the coast.
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Um I mean, there's still a good amount of of investment in in the in North Carolina and the triangle there, but uh more in the heartland.
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So I think that's particularly interesting as well.
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Thank you, Katie.
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We'll move on to the other.
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So I'll I'll pick up from there.
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Um you know, I think uh Katie's right that you know no one's no one's getting around AI, right?
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I mean, I think it's it's probably affected all of our industries, all of our titles, and and so forth.
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Um for outsourcing, it's it's still obviously a big part of that.
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But I think the things that uh that I'm seeing that are more even more a little bit more interesting and that we've been talking about a lot, you know, we're we're getting a uh a lot of focus from sort of you know geopolitical friction, legislative pressures, and so forth.
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And you're we're starting to see shifts in supply chain, you know, sort of the the old model of the global uh supply chain that had been in effect for for quite a while, or the hyper-globalized supply chain, um, is potentially starting to fade away.
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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.
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Um, and you're seeing, you know, more of this onshoring or reshoring uh back to the US.
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And, you know, for some drug sponsors, moving away from the multi-faceted, you know, uh outsourcing, you know, for say something like an ADC where you have multiple points of where you might need um multiple C DMOs.
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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.
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Um you know, I think also we're seeing more prepaying is coming uh along.
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You know, that's becoming a priority.
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Um, you know, the capacity issues in in certain places, certain markets is still there, others not as much, but what that what people want instead is you know the uh let's say the you know the the reassurance that their you know uh their pipeline is not gonna falter.
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And so they're they're paying ahead of time, sometimes months, sometimes even years ahead of time to get that bioreactor, you know, and have that time that's needed to create their their products.
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So um yeah, it's been an interesting few months.
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Uh, I think you know, some of the you know the geopolitical events that have happened um have you know are really taking an effect when it comes to the outsourcing.
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Yeah, Tyler, I can um I can pick up there.
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I I think the the it's interesting that there's uh this uncertainty as Jeff said, Um, geopolitical uncertainty.
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We we have a war on uh regul some regulatory uncertainty.
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Um, but I remember um you know talking about in our last round table uh the positives, and I think JP Morgan was really positive this year uh in January.
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There were a lot of high expectations, and and surprisingly, uh the the leading biotech indices are are up about uh a little over double digits for the first five months of the year.
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I think there's been some pricing in, I guess, of some of the the geopolitical risks.
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Um, April was the most active uh IPO month in five years.
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Uh four companies raised over$1.5 billion in the biotech sector.
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So I think that's a really good sign.
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I think that uh the number of licensing deals that are happening, particularly in early stages with early stage companies, uh is also a positive thing uh to mention.
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Um so I think there are some good signs, despite uh in the macro environment, you know, despite some of the you know ongoing struggles uh that are happening all over the world and in certain regulatory agencies.
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Yeah, I want to echo every what everyone else said.
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I think AI is still a huge part of the drug discovery space.
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Um we are seeing some additional investments from major big pharma companies into AI drug discovery companies.
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So that's seems to be getting more of an important area for investment for these companies.
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Um the FDA is actually starting to announce major steps to implement more real-time clinical trials, especially early stages.
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I think that's important because for drug discovery, because a lot of the um feedback iterative loops that you need for good drug discovery requires you know human-level um analysis or data.
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So I think that it's good that the FDA is pushing this.
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Um again, an important topic that I'm still seeing continue to grow is NAMS new approach methodologies, different forms of early stage testing, you know, that includes organoids, organon chips.
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Um one thing that I keep hearing is the use of these tools with the in conjunction with AI to better computationally analyze what's happening with the data.
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So that seems to be a big trend.
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Um, here.
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Excuse me.
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Um, yeah, I think I can echo a lot of what everyone else has been saying in terms of AI.
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Um, I'll frame it more as adaptability though, because that's kind of the phrase I've seen thrown around a little bit, just in the little bit of uh exposure that I've had to the industry.
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But uh really how that's happening, of course, is sponsoring our sponsors are testing the limits of AI.
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Um obviously those forecasting abilities trying to make real-time changes to supply.
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They're still figuring that out.
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They don't necessarily trust it yet.
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Um, but I think that obviously is something we're seeing from the clinical supply standpoint.
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Also, um, an old one, but it it was mentioned.
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I'm sorry, I forgot who mentioned it before, but preparing like multiple plans B, C, D, Z, to pivot when it comes to like geopolitical issues that arise, um blocking supply routes, or when excursions occur, any number of things.
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So I think trying to be more adaptable using some of those AI-driven tools.
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Um, also, I think I've heard this just in a few discussions I've had, but viewing all aspects of the chain through a more proactive lens.
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So trying to think ahead and try to anticipate what you can't anticipate.
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Um, something that I've I've heard from a few um of our audience members too is getting clinical supply earlier to the table to help kind of proactively predict what some of those uncertainties are.
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So those are some things that I've been seeing.
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Yeah, so I think from a cell and gene therapy standpoint, um some of the things that I've seen throughout 2026 so far is that it seems to be a much more execution-driven process.
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You know, we're seeing a lot more focus on industrializing the field.
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So, of course, AI, which we've all talked about here, and AI-enabled process control automation, uh, you know, clear modular manufacturing.
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Um, I think to echo what Ben said earlier, more disciplined deal making.
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Um we're also seeing uh in vivo approaches and uh uh smarter delivery platforms, they're getting a lot more attention, which tells me that the field is expanding beyond traditional ex vivo.
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You know, there's Intelia therapeutics, in vivo CRISPO CRISPR, excuse me, therapy, um, Lanvo Z, there's Regenerons, um, Otarmony, which is really a defining moment for in vivo gene therapy and hearing loss.
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And so basically moving from ex vivo to in vivo, uh, really what that means for uh gene therapy is, or excuse me, celling gene therapy is simpler, faster, more accessible treatment for patients.
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Um, I think another interesting shift we're seeing is how much more effort is going into getting beyond the liver.
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So whether that means like the lungs, the lymph nodes, kidneys, pancreas, CNS, um, you know, other tissues that have just been traditionally much harder to reach, um, that's really where it's still a very big technical and clinical challenge, but we're making progress.
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Um, and then finally, what I'll say um on the regulatory front, um, so separate from this conversation, but still in conjunction with it, I think certainly I, for Cell and Jean, and I think a lot of us on this call are either working to build or perhaps restructure our editorial boards.
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And so I reached out to uh one of my go-to regulatory experts who's on our board, uh, Dr.
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Daniela Drago.
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She's a partner with NDA Partners, which is a pro-pharma group company.
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And I asked her, you know, really for her insight on what she truly sees as going on from a regulatory standpoint in celling gene therapy.
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And she really went long on exactly what we've seen so far.
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But to kind of put a fine point to it, she's saying that FDA, you know, signaled, signaled, excuse me, a more flexible case-by-case approach to cell gene therapy regulation, especially around CMC and um comparability and you know, trying to tailor safety assessment in especially genome editing therapies and um detailed recommendations about how sponsors should characterize the off-target effects.
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Um so that's coming right from her and uh so a good source of information for that.
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So that's that's what's been going on so far in terms of twenty so far in 2026 for TelenGene.
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Yeah, I'd say for me, uh it's what Ray had mentioned earlier about the real-time clinical trials initiative that the FDA just announced.
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Um I mean, it's probably the biggest thing that's going on now.
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And you know, essentially you're getting you're sending data earlier to the FDA for them to review, and there's a lot of AI involved, cloud infrastructure, things like that.
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Um, automatic extraction from EHRs.
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So this is exciting because my industry has always been very slow in our development timelines.
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In fact, the commissioner said 45% of the current timeline is essentially dead time, you know, it's spent on paperwork and data cleaning and stuff like that.
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So that's why they initiated this.
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Um so big advantages, you know, detect safety problems earlier, reduce delays, things like that.
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Um, for me, for clinical trials, some of the things that we're worried about are uh changes to monitoring models, site workflows, CRO responsibilities.
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You know, if you're sending data early directly to the FDA, you're bypassing some folks in that whole ecosystem.
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Um, so it's not being welcomed, you know, with open arms, but it's definitely um something that we need to improve uh for clinical trials.
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There's a lot of fears.
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I even had a conversation yesterday with um our coworker, John Ancia, who runs our clinical um tech site, and he was talking about the whole premature judgment fear, right?
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Like what happens if you know the FDA gets some of this data early on, and they immediately say, hey, we want to cancel this due to whatever um administrative uh issues that are going on.
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Um that all can be uh discussed later on.
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But I mean, there is definitely some skepticism um when you're talking about pushing for protocol changes midstream, um, but it could just discourage continuation of the whole program.
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So there are concerns.
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Um clinical trials have always been messy.
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Um, there's lots of different signals that change throughout, especially early on, and that's what we're talking about early on.
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Um and so I mean, just because there's some bad signals that are coming in early on doesn't mean that those are gonna not go away.
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I mean, that happens a lot.
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So this is a big deal for us.
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So I would say that's the biggest thing going on, the FDA's real-time clinical trials initiative.
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So I focus predominantly on the RNA space, which is split into what I call two different categories, right?
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So I'm gonna try to outline a little bit of what I've seen in both the mRNA or the coding RNA space, um, as well as the oligo or the or the non-coding coding space.
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But um I'd say on the mRNA side, everybody has kind of over the past couple of months, maybe past year or so, since the Trump um organization took took over the government.
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I would say there's been a lot of uh skepticism in the in the space as a whole.
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Obviously, um things have felt somewhat slow in terms of moving us beyond the world of vaccines into therapeutics.
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But I actually think that the mRNA space, I'm gonna take a hopeful, uh take a hopeful approach here, um, which is funny because most people call me the sunshine of the office for a reason.
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Um, and they do not mean it in a positive, happy, go-lucky way.
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Dan Shell is shaking his head.
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He is in theCUBE next to me, ladies and gentlemen.
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Um, but I actually think that the mRNA space, despite all of the political hangups it's experienced, has been going through a period of transformation.
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I think we're still very, very optimistic about what's ahead.
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Um, AMM, the Alliance for MRNA Medicines, has been doing a great job of advocating for the space, going to the hill as often as it can, putting together um different forums throughout on how we can sort of transform the manufacturing paradigm, make personalized medicines more of a possibility in the mRNA space, how we can continue to take this from a vaccine technology and understand it biologically.
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Um, you know, I was just at the USP AMM forum a couple of weeks ago talking about some of the biological nuances that we're still trying to understand as we are evaluating different methods for figuring out what our structure-function relationship is for a molecule.
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I see this element of transformation happening as well because there's still a lot of hope in what the modality can do.
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Um, and I think Aaron hit on this beautifully.
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In vivo has become in vivo car T has become a really hot thing.
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Um, I was gonna say some of the biggest evolutions I've seen, right, have been a couple of acquisitions that broke the bank towards the end of the year in terms of in vivo gene therapy or in vivo car T.
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But we just saw last week or a couple weeks ago that Lily acquired Orna, um, which is another In vivo Car T company working with circular RNA in particular.
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Uh, so there's a lot of hope as well in what mRNA can continue to do.
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Um, and I think there's still some effort to uh maybe get over some of the growing pains we've experienced from vaccines.
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I think there was some news in the past week about BioNTech uh closing some of its facilities, but I would take, again, a more hopeful look at that as we're learning, right, where the next gen of mRNA is going to be in terms of capacity, in terms of how much we're going to need.
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We're right sizing, right demand, um, which is a huge part, I think, of a maturity of a space.
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Um, on the oligo side of things, I'm still learning.
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Uh, this has been an area that I've overlooked um a little bit over the past couple of years, to my bad.
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Um, but I have started to attend conferences in that realm.
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And I will say that for a space that has been around for a while, we are still very much trying to figure out our CMC identity.
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Um, are we a small molecule?
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Are we a biologic?
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And how do regulators actually see us?
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There is some guidance.
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I would say one of the biggest pieces of news in that space over the past couple of months has been the release of the guidance from the NMPA or China's regulatory agency.
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Um and, you know, it is in line with an EMA guidance for the most part, but there are a couple of areas that suggest um differences in opinion between the regulators.
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And a lot of the time, I think this is something every space overcomes early on, especially as scientific differences between the different regulatory agencies.
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So I think that space is really still striving to carve out a path forward that's a little bit more streamlined from a CMC regulatory standpoint.
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So I'll stop there on the RNA front.
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Thank you all so much.
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I'd love getting a bird's eye view of the industry from hearing from everybody.
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It's not often that we get to just so candidly just kind of share everything that we're seeing in our space.
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Um, and as I as I kind of guessed, the common through line that talks As where we the common ground for all of us is in terms of coverage and our spaces uh is regulatory, and so the regulatory instability that we're seeing um kind of I think aligns with what we were saying back in December, like there was a lot of uncertainty there.
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And I like to think that the FDA is getting a bit better.
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I was reading some headlines this morning um from FDA press releases that they are there's two things that they're doing right now.
00:22:25.839 --> 00:22:33.279
The one is a one-day inspectional assessment uh as part of a broader initiative to make its inspectional resources more targeted and efficient.
00:22:33.599 --> 00:22:34.640
Good buzzwords.
00:22:34.720 --> 00:22:36.000
Hope that they can do that.
00:22:36.160 --> 00:22:42.720
Um, and the other the other FDA news I was reading this morning was about their kind of all in on AI, which we knew.
00:22:42.799 --> 00:22:53.119
We knew last year, but um I saw that they're releasing or launching ELSA 4.0, which is a significant upgrade to the agency's internal AI tool available to all FDA staff.
00:22:53.200 --> 00:22:56.559
This is a quote from significant reviewers to investigators.
00:22:56.799 --> 00:23:17.039
And it looks like they're also consolidating a bunch of this is the 40 disparate application and submission data resources, systems, and portals into Halo, harmonized AI and lifecycle operations for data, which is quote, expected to enable more penetrating deployment of AI capabilities within agency operations.
00:23:17.440 --> 00:23:23.680
And I think that kind of aligns with what we were talking about before with the uh FDA trying to just be more efficient.
00:23:23.759 --> 00:23:27.200
And Dan, like you were saying, uh, there's a lot of dead time there.
00:23:27.359 --> 00:23:30.559
Uh for those who don't know, I actually worked in clinical research for a couple of years.
00:23:30.640 --> 00:23:35.839
So I first hand was in the trenches with the paperwork, experiencing the inefficiencies.
00:23:36.000 --> 00:23:43.680
Um, so I think any any moves that the agency makes to digitalize and streamline in that way is a net positive.
00:23:43.920 --> 00:23:46.400
Um, go ahead.
00:23:46.480 --> 00:23:46.720
Go ahead.
00:23:46.880 --> 00:23:48.559
Yeah, no, I just you made a good point.
00:23:48.640 --> 00:23:55.680
Um, and so did Dan about how there's a lot of dead time waiting for results and feedback from the FDA.
00:23:55.839 --> 00:24:01.119
And for drug discovery, I just want to say that's really uh impactful because that's payroll time.
00:24:01.279 --> 00:24:07.519
That's time you may not um, you know, you might not have enough time to finish your studies.
00:24:07.599 --> 00:24:11.359
So actually, uh this is really a big deal for drug discovery.
00:24:11.519 --> 00:24:12.480
Just a quick point.
00:24:12.799 --> 00:24:13.039
Yeah.
00:24:13.200 --> 00:24:16.079
I mean, I can imagine, especially in a startup environment too, right?
00:24:16.160 --> 00:24:30.319
Like where I'm sure most of the people in your audience are, um, that's nothing to shake a stick at every day of paying without any any m progress or movement towards uh clinical clinical readout.
00:24:31.440 --> 00:24:41.680
And I'll add one more thing about the AI conversation is you know, we think about AI and the crux of it, the root of it, is that that data needs to be in some type of system, right?
00:24:42.079 --> 00:24:46.160
Well, the overwhelming majority of clinical trial sites are still using paper.
00:24:47.039 --> 00:24:49.920
I'm just gonna sort of theory that that sit in for a while.
00:24:50.079 --> 00:24:57.839
And people can debate with me on that, and there are different you know, percentages and everything, but a lot of them still use paper.
00:24:58.000 --> 00:25:05.599
So they don't have these integrated systems that all these AI tech folks are coming forward and saying this is gonna revolutionize things.
00:25:05.759 --> 00:25:10.480
You know, it's a cultural shift, it's a mind shift, and it's gonna take a while.
00:25:10.640 --> 00:25:12.880
So that's the only thing I'd add to all this.
00:25:13.359 --> 00:25:20.319
Well, I wonder, I know like many years ago we had some regulation to force hospitals to start using EHRs.
00:25:20.559 --> 00:25:25.680
Um, is that happening in like the clinical research space as much?
00:25:25.839 --> 00:25:32.640
And is there are there incentives like financial incentives for these clinical research organizations to actually deploy this kind of tech?
00:25:33.119 --> 00:25:43.519
Yeah, I would say that there are, you know, from an efficiency standpoint, and every AI company is going to tell you that if you don't do this, you're going to lose money or you can s you can save money by doing this.
00:25:43.680 --> 00:26:05.599
And I think that you see one of the repercussions of that is the rise of site networks and these bigger groups that are coming together and saying we can be more efficient if we streamline our back end operations, and much of that involves AI, whether it is involved with the patient data or just the business part of the the trial itself.
00:26:05.839 --> 00:26:09.839
You know, all that data or um all that paperwork that the commissioner was talking about.
00:26:11.119 --> 00:26:11.519
Yeah.
00:26:11.680 --> 00:26:18.880
I I was there as recently as 2023, and uh I I used to have to initial um adverse event things on paper.
00:26:18.960 --> 00:26:20.640
I mean, we and to answer your question, right?
00:26:20.799 --> 00:26:36.960
I mean, most hospitals do operate on an electronic medical record, but that has to be, you know, my job was taking that from the patient visits and putting that into the clinical databases, which are a bunch of different um what are they called?
00:26:38.400 --> 00:26:38.559
No.
00:26:38.799 --> 00:26:41.839
Um blank and Dan.
00:26:42.000 --> 00:26:47.119
What's the word for the uh the electric electronic databases that these studies use?
00:26:47.920 --> 00:26:48.480
CTMS?
00:26:49.200 --> 00:26:49.599
Yes.
00:26:50.000 --> 00:26:50.400
Yes.
00:26:50.960 --> 00:26:51.359
Those.
00:26:51.680 --> 00:26:52.960
There's they're all using different ones.
00:26:54.480 --> 00:26:55.200
Yes, exactly.
00:26:55.359 --> 00:27:14.319
And um so and plugging it in, but also keeping uh reduct you know, paper copies for I guess redundancy and just his legacy uh regulatory precedent was everything that is in both the electronical medical record and uh the clinical trial management systems also need to be on paper somewhere.
00:27:14.640 --> 00:27:19.759
Uh and it's just a slow-moving industry, it's highly regulated as we as we all are aware.
00:27:19.839 --> 00:27:29.839
So it's it's good to see progress on that front, but I'm sure it's it'll be a while before we're sitting here talking about there's no more paper and in clinical research in significant dead time.
00:27:30.240 --> 00:27:45.920
Um another thing that Jeff, you mentioned about um ADC supply chains and the complexity there, and especially in light of how supply chains across the world are being impacted by this war and this administration and and other factors.
00:27:46.079 --> 00:27:50.640
Um just shamelessly going to plug an event that we're doing a couple months in August.
00:27:50.720 --> 00:28:10.799
We're gonna be having a bioprocess online live event about ADC, the kind of manufacturing paradigm there, and especially the tech transfer of, you know, when you're working across different C DMOs and and partners, how how to how to manage ADC tech transfer in that in that ecosystem.
00:28:10.960 --> 00:28:13.039
So stay tuned for that out there in the audience.
00:28:13.680 --> 00:28:17.279
Tyler, I'll I'll see your shameless plugin and I'll do you one better.
00:28:17.440 --> 00:28:19.519
That's sooner coming Monday.
00:28:19.599 --> 00:28:30.640
Um, we'll be talking about ADCs and um, you know, sort of all things uh one stop shop versus multi, and I think will be a big part of that um event.
00:28:30.720 --> 00:28:32.640
We have some really great um folks.
00:28:32.720 --> 00:28:44.000
One of our editorial board members um is gonna be involved in it and and some other uh um consultants um you know who are well versed in the industry, been there for a number of years.
00:28:44.160 --> 00:28:46.720
Um so you know, again, tune into that as well.
00:28:46.799 --> 00:28:51.039
And I think it's it's certainly stuff that that is not going away, right?
00:28:51.200 --> 00:28:57.440
We could talk about this probably ad nauseum for you know many, many weeks um and still not scratch all the surface.
00:28:57.519 --> 00:29:10.480
But but you're right though, it it is something that comes up a lot, like all of these different areas, um, whether it's EDCs or any other type of you know of multi-part drug, you know, cell gene therapy obviously runs the same thing as Aaron knows very well.
00:29:10.559 --> 00:29:21.839
And you know, getting your APIs from one place to the old adage, like, well, the API is coming from China, you know, and and now we have to then onshore it and or bring it to Europe or something like that.
00:29:21.920 --> 00:29:32.799
And and so all of these, you know, companies are rethinking that with you know the administration's um uh new rules um you know for for onshoring.
00:29:32.960 --> 00:29:43.279
Um and while it hasn't been all bad, um the you know, the companies have many of the CDM owners have taken it in stride and said, like, yeah, we just we need to get stuff done and we're gonna do this.
00:29:43.519 --> 00:29:53.039
The one sort of slow moving issue that's come up when it comes to the onshoring is uh we're seeing a talent crisis um that's cropping up.
00:29:53.200 --> 00:30:07.119
Um so the letless number I saw for, I think, coming up for out of some of the major companies is like 22 new manufacturing sites across the US, which is expected to create close to like 45,000 jobs.
00:30:07.279 --> 00:30:27.920
Um but a lot of the talent uh within the US is either somewhere else, like in Europe and other parts of the world, um, because that was where it was needed, or it's clustered in, you know, obviously areas that that we all well know within like Boston or um, you know, San Diego, San Francisco, that sort of thing, you know, East Coast, West Coast um areas.
00:30:28.240 --> 00:30:37.759
So it's gonna be interesting the next you know uh couple of months to years to see how that all plays out and and you know what we're gonna do to try to fill that that talent crisis.
00:30:38.079 --> 00:30:39.279
Yeah, absolutely.
00:30:39.440 --> 00:30:51.519
I spoke with Herman Bosenhart um earlier earlier this year, actually, about the the talent quote unquote talent crisis and specifically as it as it relates to C DMOs and and their talent supply.
00:30:51.759 --> 00:30:54.960
Um and I'm happy that you were able to to plug that.
00:30:55.039 --> 00:31:02.559
Unfortunately, this will be in the past, but if uh if you head on over to Outsource Pharma, you'll be able to see the live event recording that Jeff is referencing.
00:31:02.720 --> 00:31:05.680
And that's actually a great segue into the next part of our conversation.
00:31:05.839 --> 00:31:18.720
I kind of wanted you to use this time to highlight some of the great things that you're all doing, we're all doing across our relevant spaces, respective spaces, um, from events coming up to podcasts to editorials.
00:31:19.039 --> 00:31:24.400
I want everyone to go around and kind of share what are your favorite projects of the year so far?
00:31:24.559 --> 00:31:26.319
What are you looking forward to?
00:31:26.640 --> 00:31:34.559
And um also as in terms of events, whether they're internal events that we're putting together or or industry conferences you're looking forward to, shows.
00:31:34.720 --> 00:31:40.720
Uh, I just want to go around the horn and and share the exciting things that we're all working on and looking forward to.
00:31:41.839 --> 00:31:43.359
Starting back with Katie.
00:31:45.279 --> 00:31:46.880
So many exciting things.
00:31:47.119 --> 00:31:57.279
Uh we did a uh live last month on proactive contamination control and aseptic fill finish.
00:31:57.599 --> 00:32:01.200
Um that was a really popular live, a fun discussion.
00:32:01.519 --> 00:32:15.359
Um, you know, at the end of the conversation, it uh went back to, you know, make sure you get into the facility and don't don't manage it um remotely.
00:32:16.559 --> 00:32:26.559
But um really the the proactive approach to different elements of manufacturing is something we're really focusing on this year.
00:32:26.720 --> 00:32:37.599
Um there's uh an upcoming live that I have on uh documentation and the the transformation.
00:32:37.680 --> 00:32:55.279
I we talked about this earlier, but the transformation to to a more digitized system um and and really being proactive with making sure that your your documentation is electronic and and digital so that you can um be ready for that inspection.
00:32:55.519 --> 00:33:08.559
And so, you know, proactivity is probably overused, but really can apply to a lot of different elements of pharmaceutical manufacturing and certainly something that we're gonna be focusing on um all year.
00:33:10.319 --> 00:33:11.599
That's great, Katie.
00:33:12.720 --> 00:33:13.119
Jeff?
00:33:13.359 --> 00:33:14.000
Yeah, yeah.
00:33:14.160 --> 00:33:17.599
So I got um three things uh I'll talk about real quickly.
00:33:17.759 --> 00:33:24.079
Um well, the all of the live events so far and coming up are are you know, they're they've been great and we always look forward to them.
00:33:24.160 --> 00:33:31.680
I think it's a you know fairly well established Medium Lewis has done that for years, and and it, you know, I'm trying to pick that up and and run with it.
00:33:31.839 --> 00:33:32.559
It's been great.
00:33:32.640 --> 00:33:35.599
But I have two new endeavors um that are coming out.
00:33:35.759 --> 00:34:01.599
One that uh you know has been going really well called the outsourcing advisor, and the idea of being just to you know talk to a lot of folks in the space, drug sponsors, um, and address really a lot of the pain points and and ways that we can, you know, help out our, you know, uh our folks within the biotech and pharmaceutic who are who are you know doing endeavors with outsourcing companies and um make it a sort of a resource, a quick resource.
00:34:01.680 --> 00:34:12.079
So a lot of the the videos that I'm recording are you know in different formats, different ways, but you know, the one overlying theme is you know to not only be helpful, but they're I'm trying to make them short and sweet.
00:34:12.159 --> 00:34:21.119
Um so some of them are only eight to ten minutes long, um, and you know, trying to make it so that people can, you know, watch them quickly, get the information they need and and and move on.
00:34:21.360 --> 00:34:23.840
So that's uh been a lot of fun and continuing.
00:34:23.920 --> 00:34:30.000
And you know, if anybody out there is listening to this and wants to be involved, you know, shoot me uh shoot me an email or something.
00:34:30.239 --> 00:34:33.199
Um I'm happy to uh take all those uh folks for recruiting.
00:34:33.360 --> 00:34:37.039
Um the other one that's been a little bit slower, but I'm I'm looking forward to it.
00:34:37.199 --> 00:34:43.039
I've had some bites here and there is you know, my my background is um is in infectious diseases.
00:34:43.119 --> 00:34:45.119
I'm trained molecular parasitologists, right?
00:34:45.199 --> 00:34:49.360
So did work in malaria, did work in toxoplasma and so for a number of years.
00:34:49.519 --> 00:35:00.000
And um, you know, with uh with that, and that's something I always keep an eye on, you know, how can we merge sort of you know outsourcing with you know infectious disease uh things?
00:35:00.079 --> 00:35:16.559
And there's some really interesting ways, you know, that when pandemics arise uh or when a new outbreak arises or something, you know, just even um, you know, uh an old disease just kind of crops back up again, you know, how do we get the drugs to the places you know, how do we ramp up that production?
00:35:16.719 --> 00:35:18.239
How do we, you know, do all of that?
00:35:18.400 --> 00:35:29.920
And um, there's lots of spaces, you know, the Gates Foundation, you know, the uh Chen Zuckerberg Initiative, all of these have really kind of you know invested a lot of time and money um to address sort of these things.
00:35:30.000 --> 00:35:32.480
Um, you know, WHO obviously as well.
00:35:32.639 --> 00:35:35.360
And so these are the folks that I I, you know, I want to try to talk to.
00:35:35.440 --> 00:35:39.280
Uh, I've been reaching out to some people and I have I've had some bites here and there.
00:35:39.360 --> 00:35:48.159
I'm hoping that someone from the uh uh the Gates Foundation uh, you know, we're trying to work that angle and then maybe uh in the next month or two uh will be able to talk to us.
00:35:48.239 --> 00:35:54.320
Uh not Bill, I wish it was, but you know, but uh but but someone from the organization high up.
00:35:54.400 --> 00:35:55.519
Um so that'll be a lot of fun.
00:35:55.599 --> 00:36:15.199
And then the third thing is, you know, obviously we just had uh last month um the uh CDMO awards uh every year, 15th annual, uh, which was a lot of fun, uh successful event, I think that that came off from I think all of our partners that were involved, you know, had a good time in you know in New York and it was uh it was a good time.
00:36:15.440 --> 00:36:16.239
First for me.
00:36:16.400 --> 00:36:17.280
So fun.
00:36:17.760 --> 00:36:18.159
Awesome.
00:36:18.320 --> 00:36:19.360
Thank you, Jeff.
00:36:19.599 --> 00:36:21.199
Ben, what do you got cooking?
00:36:21.519 --> 00:36:27.280
Uh well, since we're talking uh live events, I'll just mention one recent one that I thought was really interesting.
00:36:27.360 --> 00:36:33.920
Uh Life Science Leader live event on radio pharmaceuticals, uh new opportunities, overcoming operational challenges.
00:36:34.079 --> 00:36:39.599
We had uh three CEOs that are developing three different radioisotopes.
00:36:39.760 --> 00:36:46.320
And uh I thought, you know, it's um it's it's interesting because a lot of new isotopes are emerging.
00:36:46.480 --> 00:36:57.039
And to several Jeff and others' points about supply chain, it's especially acute in radio pharmaceuticals because of the half-lives of the isotopes.
00:36:57.119 --> 00:37:00.239
It's a just in time type of delivery.
00:37:00.320 --> 00:37:07.599
There are a number of redundancies needed because of the scarcity of availability of certain kinds of isotopes.
00:37:07.679 --> 00:37:34.800
Uh, and so uh hearing those three CEOs talk about three different isotopes and the kinds of challenges that that they've had to overcome, uh, I think is uh is is useful, particularly given the number of uh companies that are coming into the space and the you know number of billions of dollars that have been spent by large pharmaceutical companies buying up uh startup and and small to mid-stage radio pharmaceutical companies.
00:37:34.960 --> 00:37:41.760
Um, anyway, that's a life science leader live event that you can find on uh the Life Science Leader website.
00:37:41.920 --> 00:37:45.039
Uh as far as upcoming things that I'm excited about, Tyler.
00:37:45.199 --> 00:37:48.960
We'll be in uh bio together uh in a month or so.
00:37:49.039 --> 00:37:51.280
Uh so really looking forward to that.
00:37:51.360 --> 00:37:56.639
I'll be recording some podcasts and uh doing some uh reporting uh from bio.
00:37:57.119 --> 00:38:08.239
And um, maybe just the last thing I'll mention, uh kind of uh following on what Jeff was saying, I had had an opportunity to catch up with uh Life Science Cares uh a month or two ago.
00:38:08.400 --> 00:38:13.599
Um, and I was really pleased to see how much larger that organization has grown.
00:38:13.760 --> 00:38:33.840
It's now 10 years old and uh it's um uh a voluntary organization, but it's focused on education, educational needs and nutritional needs in the big biotech hubs uh that we've talked about, uh, addressing those communities directly and doing it on a voluntary basis.
00:38:33.920 --> 00:38:38.320
But uh hearing about the impact, the number of cities that that group has expanded to.
00:38:38.400 --> 00:38:44.880
They're now also in Switzerland, uh, is a real bright spot, I think, uh, for the industry.
00:38:47.199 --> 00:38:49.199
I have a few things uh cooking as well here.
00:38:49.360 --> 00:38:53.760
So one thing is we have a Drug Discover Online is a partnership with Nucleate Boston.
00:38:53.840 --> 00:39:05.679
So Nucleate is an accelerator program mainly focused on biotech startups and helping them develop their solutions and understanding their problem and markets, um, and also helping them find investors.
00:39:05.760 --> 00:39:08.880
So Drug Discovery Online will be doing some interviews with them.
00:39:09.039 --> 00:39:18.719
Um, they have sites and chapters all over the world, it's a global nonprofit organization and their Boston headquarters is their flagship site.
00:39:18.800 --> 00:39:20.480
So I'm pretty excited for that one.
00:39:20.639 --> 00:39:24.800
Um, Drug Discovery Online is developing its editorial advisory board.
00:39:24.880 --> 00:39:40.159
So if you are interested in actually in kind of um, you know, being a voice and trying to uh help our editorial team guide this space, uh, I'd love to talk to you and see what we can do together.
00:39:40.400 --> 00:39:44.639
There is a live drug discovery online live event on June 30th.
00:39:44.719 --> 00:39:46.960
I'd like to plug here uh on ProTax.
00:39:47.119 --> 00:39:56.639
What's interesting about ProTax is you know these these molecules have been around for quite some time, but only in like the research lab setting.
00:39:56.960 --> 00:40:09.599
Just recently, Arvanas, which is one of the companies developing these drugs, did get FDA approval uh with Vepanu, Vepanu, uh to treat advanced HER2 breast cancer.
00:40:09.679 --> 00:40:16.559
So I think it's starting this modality is starting to get some more attention and um you know ground in the space.
00:40:16.639 --> 00:40:25.199
So I'm really excited to have that panel with somebody from Cold Spring Harbor and uh and a startup using synthetic biology for Protex.
00:40:26.000 --> 00:40:36.480
And finally, a little personal sort of editorial I'm working on focused on a drug that was approved a long time ago in 1968 called Rogam.
00:40:36.719 --> 00:40:53.280
It's actually a blood product that helps pregnant women who have something called RH incompatibility or RH disease, meaning the fetus, their baby's feet, the fetus is blood type RH positive, while the mother is Rh negative.
00:40:53.360 --> 00:41:01.360
So essentially, the mother's immune system attacks would attack the baby after the after the first baby is born.
00:41:01.599 --> 00:41:06.079
Um, so the second baby would be affected almost like very consistently.
00:41:06.159 --> 00:41:11.920
So this was a big problem in history for a long time until this uh physician, Dr.
00:41:12.159 --> 00:41:16.320
John Gorman from um, you know, Australia.
00:41:16.480 --> 00:41:18.559
I am trying to get an interview with him.
00:41:18.800 --> 00:41:21.440
So um I got his email working on that.
00:41:21.519 --> 00:41:25.280
So I'm just excited to hopefully chat with John.
00:41:25.679 --> 00:41:27.760
But uh yeah, that's what I got.
00:41:27.840 --> 00:41:30.079
I got I'm sure I got more, but I'll leave it at that.
00:41:30.320 --> 00:41:31.119
Awesome, Ray.
00:41:31.199 --> 00:41:32.079
Thank you for sharing.
00:41:32.800 --> 00:41:35.039
Um, Rachel, what are you working on?
00:41:35.519 --> 00:41:46.960
Yeah, so I'm kind of in a unique position in that I'm forging a new path, I guess, if you will, um, with the help of our acquisitions editor, Elizabeth, because a clinical supply leader is sort of a fledgling.
00:41:47.039 --> 00:41:50.239
It's a spin-off from clinical leader in that community.
00:41:50.400 --> 00:42:01.039
Um, but for me, it's been a lot of fun so far, just researching the industry and understanding sort of the different niche functions, how it crosses over into maybe all the different areas that we've talked about here.
00:42:01.280 --> 00:42:03.440
Um, in addition to that, networking.
00:42:03.519 --> 00:42:04.880
So I've had some interviews.
00:42:04.960 --> 00:42:06.480
Um, those have been a lot of fun.
00:42:06.639 --> 00:42:14.159
And the more people I talk to, the more apparent it seems to become that um clinical supply has sort of a unique expertise.
00:42:14.239 --> 00:42:16.400
So it really kind of warrants its own community.
00:42:16.480 --> 00:42:17.760
So I'm advocating for that.
00:42:17.920 --> 00:42:19.599
I was really glad to hear that, of course.
00:42:19.760 --> 00:42:32.480
Um, but yeah, I think that going further into this, I look forward to doing more deep podcasts, more videos like you guys have been doing, kind of understanding what are those pain points and needs for clinical supply in particular.
00:42:32.719 --> 00:42:36.559
Um and also, same thing, we're we're building an advisory board.
00:42:36.639 --> 00:42:41.840
So we're looking for experts in that area if there's anyone who wants to raise their hand.
00:42:41.920 --> 00:42:44.000
Um, I'm open to suggestions.
00:42:44.239 --> 00:42:50.400
Um, one of the other things I'll say is I'm looking forward to hopefully in the fall, get out to some events to meet some people in person.
00:42:50.559 --> 00:42:52.559
So watch for me maybe this fall.
00:42:52.719 --> 00:42:59.840
Um, I'm looking at the GCSG, the Global Clinical Supplies Group, is doing its European Knowledge Forum in October.
00:43:00.079 --> 00:43:01.840
Also scope next February.
00:43:01.920 --> 00:43:03.920
I'm sure many of us are headed to that.
00:43:04.079 --> 00:43:07.840
Um, and there are some other clinical trial supply events too later this year.
00:43:07.920 --> 00:43:09.119
So we'll see what happens.
00:43:09.360 --> 00:43:14.960
But being out there networking more, getting to know who those influencers are in the industry is kind of where I'm at right now.
00:43:15.039 --> 00:43:16.159
So glad to be here.
00:43:17.519 --> 00:43:18.320
Awesome, Rachel.
00:43:18.400 --> 00:43:18.719
Thank you.
00:43:19.760 --> 00:43:22.639
Aaron, what's cooking on your site, Cellengine?
00:43:23.280 --> 00:43:33.519
Yeah, so I'm currently working on and recording a five-part special series for Cellengine the podcast um on in vivo technologies.
00:43:33.679 --> 00:43:35.920
You know, what I talked about at the top of our call.
00:43:36.079 --> 00:43:44.159
Um, the first episode I think airs on May 30th, and it'll air every Friday for five weeks until it concludes.
00:43:44.400 --> 00:43:49.760
Um, and I already recorded a conversation with uh Dr.
00:43:50.000 --> 00:43:53.280
Cassie Gorsuch of Precision Biosciences.
00:43:53.440 --> 00:43:59.119
Um, I'm talking to people from Beam, from Ray Therapeutics, uh Obsidian.
00:43:59.360 --> 00:44:01.039
Um And a few others.
00:44:01.119 --> 00:44:03.199
But anyway, um, I'm really excited for that to come out.
00:44:03.280 --> 00:44:06.480
Uh, it'll be selling the podcast airs every other Thursday.
00:44:06.559 --> 00:44:09.119
This will be every Friday, right in a row until it concludes.
00:44:09.199 --> 00:44:10.559
I think it's um I'm excited for it.
00:44:10.639 --> 00:44:13.280
I think it's gonna help our listeners quite a bit on the topic.
00:44:13.519 --> 00:44:15.280
Um, live events.
00:44:15.440 --> 00:44:16.719
There's a selling gene live.
00:44:16.800 --> 00:44:20.800
If there's a month in the year, there's a selling gene live uh that you can tune into.
00:44:21.039 --> 00:44:22.639
Um, no, I not really.
00:44:22.800 --> 00:44:24.960
I think we we do about 10, 11 a year.
00:44:25.119 --> 00:44:28.239
And the rest of the year we have some really excellent topics.
00:44:28.400 --> 00:44:31.519
Uh we cover, of course, manufacturing, supply chain.
00:44:31.599 --> 00:44:42.639
One that I'm really excited about and have been fighting for to get on the uh editorial calendar, if you will, for our live events is um how non-oncology indications.
00:44:42.800 --> 00:44:51.119
And so specifically, uh, I think it's in December, we're doing one on uh targeting cardiovascular disease with uh precision gene editing.
00:44:51.280 --> 00:44:57.519
Um so to the better biopharma audience, if you're interested in that, please do register it, register for it.
00:44:57.599 --> 00:45:02.239
It's a free uh event, um, about an hour of your time, and I promise it'll be worth it.
00:45:02.400 --> 00:45:08.159
And uh, in terms of travel, so my travel ends up being kind of toward the end of the year typically.
00:45:08.320 --> 00:45:14.559
Um, I'll of course be heading to meeting of the Mesa, ARMS event in October, meeting on the Mesa, excuse me.
00:45:14.719 --> 00:45:20.480
Um, and then I'm gonna be at Advanced Therapies in Boston uh in early November.
00:45:20.639 --> 00:45:27.440
I'm moderating a conversation, a panel discussion on uh AI's impact on cell therapy.
00:45:27.679 --> 00:45:28.800
So that should be good.
00:45:28.880 --> 00:45:33.760
Um, I'm gonna try to get to some local Philadelphia uh smaller events.
00:45:33.840 --> 00:45:34.880
In fact, I'm going to one tomorrow.
00:45:34.960 --> 00:45:43.599
By the time this airs, it will obviously already have been passed, but hopefully I will have some written editorial that people can uh check it out and see what the show is about.
00:45:43.679 --> 00:45:48.320
Tomorrow's it's called At Philly Um Cell and Gene Therapy Annual Conference.
00:45:48.639 --> 00:45:51.519
So uh yeah, that's what's that's what I'm working on.
00:45:51.679 --> 00:45:58.480
Um Aaron, I had a quick question about the uh the in vivo car T series you're putting together.
00:45:58.639 --> 00:46:00.159
That sounds very fascinating.
00:46:00.320 --> 00:46:04.880
Um and for reference, I I love the concept of In vivo car T.
00:46:05.039 --> 00:46:07.039
Like I when I first heard of it, I was like, what?
00:46:07.199 --> 00:46:08.400
They're doing what now?
00:46:08.559 --> 00:46:16.719
And I think actually to date, one of the most one of the top performing episodes of this show was featuring Interior Biotherapeutics uh about their in vivo car T.
00:46:16.880 --> 00:46:20.480
So I'm curious to hear, are you focusing more so on like what aspect of it?
00:46:20.559 --> 00:46:21.599
Is it the general development?
00:46:21.679 --> 00:46:22.480
Is it manufacturing?
00:46:22.559 --> 00:46:23.599
Is it clinical approach?
00:46:23.760 --> 00:46:26.000
Is it what can people expect from this series?
00:46:26.320 --> 00:46:28.239
It's it's actually soup to nuts.
00:46:28.320 --> 00:46:35.440
Uh so it's cell therapy, gene therapy, the manufacturing, the safety of it, and the skepticism of it.
00:46:35.519 --> 00:46:43.760
Um there aren't not everybody is on board with thinking that in vivo is going to be the answer that everybody thinks it uh thinks it's going to be.
00:46:44.000 --> 00:46:54.239
Um so what's nice about having the kind of broad range of companies uh is you know, they all they all target different aspects of In Vivo.
00:46:54.480 --> 00:46:58.320
So um, yeah, I highly recommend anybody who's interested in it to check it out.
00:46:58.480 --> 00:47:07.519
The the professionals and the leaders who we're having on the series are uh really dialed into what it is their company is doing.
00:47:07.599 --> 00:47:09.119
So um I'm looking forward to it.
00:47:09.199 --> 00:47:14.880
But I guess to a finer point is uh everything you just mentioned, uh soup to nuts of in viva.
00:47:15.440 --> 00:47:16.559
I'm looking forward to that as well.
00:47:16.639 --> 00:47:17.760
Thank you for sharing.
00:47:18.079 --> 00:47:20.800
Dan, what's going on in clinical leader?
00:47:21.360 --> 00:47:26.559
Uh for me, uh diversity in clinical trials has been something that I've been a big advocate for.
00:47:26.639 --> 00:47:29.199
It's been a big problem in the industry for a long time.
00:47:29.360 --> 00:47:30.639
Uh, it's nothing new.
00:47:30.800 --> 00:47:44.400
Um, the Trump administration brought in their minions and they cleared out everything on, you know, anything to do with diversity on the FDA website, and that pissed me off and pissed off a bunch of people and you know, put up a disclaimer, a bunch of stuff.
00:47:44.480 --> 00:47:48.159
And so I'm always for anything that's gonna move that forward.
00:47:48.320 --> 00:47:50.880
So that kind of leads me to this weird story.
00:47:51.039 --> 00:47:54.719
It was a rumor that I wrote about about Walgreens.
00:47:54.960 --> 00:47:57.760
So, why is Walgreens related to diversity in trials?
00:47:57.920 --> 00:48:07.280
Because about three, four years ago, companies like CBS, Walgreens, Walmart, Kroger, they all said, Hey, we're gonna get into the clinical trials business.
00:48:07.519 --> 00:48:18.239
Basically, that's gonna expand diversity or inclusion, the amount of people that can participate in clinical trials, because we have a ton of these pharmacies nationwide.
00:48:18.719 --> 00:48:21.679
Spoiler alert, that plan did not work.
00:48:21.840 --> 00:48:29.679
Um, and Walgreens, uh, I heard a rumor um about two weeks ago, is backing out of the whole thing.
00:48:29.920 --> 00:48:34.320
CVS backed out like a year later uh or a year earlier.
00:48:34.559 --> 00:48:40.239
Um, so I I I wrote this like newsy article about Walgreens backing out.
00:48:40.400 --> 00:48:45.039
They wouldn't give me any um comments on the record and everything.
00:48:45.119 --> 00:49:01.360
I I tapped into my editorial team and or editorial uh board and they gave me a lot of comments, but that whole concept of using a pharmacy as a clinical trial site is a good one for diversity, for exactly what I've just said.
00:49:01.599 --> 00:49:11.039
And as a result of that article, I got put in touch with some other folks that I didn't realize how many independent pharmacies there are across this nation.
00:49:11.199 --> 00:49:13.599
I mean, and there are a ton of these little ones.
00:49:13.760 --> 00:49:26.239
And you know, the the idea is oh, I know my pharmacist really good, and so if I'm gonna go in to see him or her, she's gonna say, you know, you're taking this particular drug, you might be good for a uh clinical trial.
00:49:26.480 --> 00:49:29.199
We can do that right here in this other room.
00:49:29.440 --> 00:49:33.679
So that operational part of it is not easy.
00:49:33.840 --> 00:49:48.800
Um, but my point is the model, the idea of running trials at pharmacies might still be alive, and it's gonna be alive, not in the big retailers, because all those folks are pretty much either scaling back or getting out of it.
00:49:49.119 --> 00:49:53.360
It might be alive at these smaller places, and that will help the diversity.
00:49:53.519 --> 00:49:58.079
Um, so that leads into my July clinical leader live is on diversity.
00:49:58.159 --> 00:50:01.679
I do one each year on that, um, always super popular.
00:50:02.000 --> 00:50:03.360
Um, so that's that.
00:50:03.519 --> 00:50:05.840
Um I've traveled a lot this year already.
00:50:05.920 --> 00:50:06.880
I traveled every month.
00:50:06.960 --> 00:50:12.559
I'm on my way to London um in two weeks to uh the clinical trial tech congress.
00:50:12.800 --> 00:50:20.639
Um and then in the fall, I I travel almost every I travel a lot in the fall to a lot of them.
00:50:20.880 --> 00:50:22.719
So um I'm out there.
00:50:23.039 --> 00:50:26.400
So in many ways I'm out there, right, Anna Rose?
00:50:28.559 --> 00:50:31.519
Dan's Dan's responsible for Hogg and the travel budget, I guess.
00:50:31.599 --> 00:50:38.960
That's all I'm getting out of the no, that's awesome about the um the independent pharmacies um contributing to the clean.
00:50:39.199 --> 00:50:44.880
I think that's a great, like you said, operationally, I think that makes sense as a as a paradigm.
00:50:44.960 --> 00:50:47.679
I hope that we see more more progress there.
00:50:47.920 --> 00:50:51.360
Hey, Tyler, if you don't mind, I also want to ask Dan uh one follow-up on that.
00:50:51.519 --> 00:50:58.320
Dan, what do you what do you think is the primary reason why CVS and and Walgreens couldn't make that model work?
00:50:59.360 --> 00:51:00.000
Money.
00:51:00.400 --> 00:51:01.360
Thanks.
00:51:03.760 --> 00:51:04.079
Okay.
00:51:04.239 --> 00:51:05.760
Yeah, I that was it.
00:51:05.920 --> 00:51:09.280
You know, I mean, uh that was obviously a big question.
00:51:09.440 --> 00:51:32.480
Um and when you're talking about large retail giants, and they're saying we're gonna start this new business entity that's gonna be within our existing entities, and then on paper it looks good, and then you start getting into the operations and the business part of it and the expenses, and it's like, oh shit, hold on a minute.
00:51:32.559 --> 00:51:36.000
This is gonna cost us a lot more, we're not gonna make as much money on this.
00:51:36.320 --> 00:51:40.239
That's why CBS realized it quickly, whether or not they say that or not.
00:51:40.559 --> 00:51:46.559
I'm pretty sure that's what happened with Walgreens because last year Walgreens got bought by a PE firm.
00:51:46.800 --> 00:51:58.159
And you know, so the PE firm is probably looking at everything and they're saying, hey, listen, we're not making much money as it is on the prescriptions and all the other stuff that we have in our stores.
00:51:58.480 --> 00:52:03.280
This clinical trial thing is gonna take a while to get off the you know, off the ground and everything.
00:52:03.440 --> 00:52:07.039
We're gonna have to invest in infrastructure and people and everything.
00:52:07.440 --> 00:52:11.119
You know, so I could be totally wrong, but I don't think I am.
00:52:11.440 --> 00:52:14.800
So like more complicated and more upfront than they expected.
00:52:15.119 --> 00:52:15.760
Absolutely, yeah.
00:52:16.079 --> 00:52:16.559
Absolutely.
00:52:16.800 --> 00:52:21.280
Everybody and and let's face it, that's the big argument for everything, right?
00:52:21.360 --> 00:52:29.519
In all of our industries, like all these AI companies are coming in going, hey, there's a there's a niche in there that we think we can fill, and it's gonna be really easy.
00:52:29.599 --> 00:52:32.320
And then they get in there and then they disappear.
00:52:32.559 --> 00:52:37.039
So hey, I'm gonna have to drop drop out here, guys.
00:52:37.280 --> 00:52:38.960
So all right, Dan.
00:52:39.039 --> 00:52:40.559
And well, thank you so much for joining us.
00:52:40.639 --> 00:52:43.440
Is there anything you want to tell the audience before dipping out of here?
00:52:44.079 --> 00:52:44.480
Or share?
00:52:44.719 --> 00:52:46.480
Yeah, I think I'm I I've covered everything.
00:52:46.559 --> 00:52:48.320
I'm gonna be around, you'll see me.
00:52:48.480 --> 00:53:02.880
Um and uh no, a lot a lot of stuff on the you know, the one thing I didn't mention is next year, 2027, there may be a clinical leader live event that we might be doing at very, very early stages right now.
00:53:03.119 --> 00:53:04.159
We're looking into that.
00:53:04.480 --> 00:53:05.280
Awesome.
00:53:05.519 --> 00:53:05.920
Awesome.
00:53:06.079 --> 00:53:08.079
Well, thank you so much, Dan, for joining us.
00:53:10.880 --> 00:53:13.360
In a rose, advancing RNA.
00:53:13.519 --> 00:53:15.360
What do you have in the chamber?
00:53:16.639 --> 00:53:28.800
Well, I'm gonna give a shout out to a project that I finished finally this spring that I was hinting at um in our last uh Butter Biopharma uh recording.
00:53:29.039 --> 00:53:34.800
So I had mentioned that I discovered I had somewhat of a superpower in terms of eating hot peppers.
00:53:34.960 --> 00:53:44.960
Well, that was because I've been doing a project called RNA Hot Takes, uh, which is the a new video series that I'm trying to get off the ground here.
00:53:45.519 --> 00:53:46.079
RNA.
00:53:46.400 --> 00:53:50.480
Um, season one is out and available on advancingRNA.com.
00:53:50.559 --> 00:53:58.559
Uh I sit down with the CEO of Radar Therapeutics, uh Sophia Lugo, and entree bios Michelle Lynn Hall.
00:53:58.880 --> 00:54:00.880
Um we sit down together.
00:54:01.119 --> 00:54:04.639
Each episode, it's a different pepper and a different question.
00:54:05.119 --> 00:54:07.199
So we started at jalapenos.
00:54:07.599 --> 00:54:16.000
We went all of the way to uh to Carolina Reapers, um, but also it had uh Trinidad Scorpion as well.
00:54:16.159 --> 00:54:25.280
Um we had to do, we had to, unfortunately, because I filmed this in January, February time frame, fresh peppers weren't available for the hottest, hottest ones.
00:54:25.519 --> 00:54:28.079
So we had to go to uh hot sauces.
00:54:28.639 --> 00:54:30.960
But it was still a great time as had by all.
00:54:31.119 --> 00:54:32.639
Only a few tears were shed.
00:54:32.800 --> 00:54:35.360
No one threw up, as far as I'm aware.
00:54:35.599 --> 00:54:39.920
Um, but I'm still I'm I'm planning to do a season two of this.
00:54:40.079 --> 00:55:00.000
So if anyone is listening that is in the RNA space, oligos or mrna, uh, that has a desire to uh put their tongues to the test, if you will, um, and talk to me about RNA while also eating something spicy, uh, please, please, please don't hesitate to reach out.
00:55:00.239 --> 00:55:02.639
I do have a uh a shameless ask.
00:55:02.719 --> 00:55:19.599
If anyone happens to have uh direct contact with Peter Marks or the police or the winners of the Nobel Prize, Caitlin Carico and Drew Weissman, I think it would be awesome to do uh some hot takes with with these people in particular.
00:55:19.840 --> 00:55:27.119
So if you're listening, any of you, uh, and you happen to have route to those people, please be in touch with Tyler.
00:55:27.360 --> 00:55:28.880
Tyler will let me know.
00:55:29.119 --> 00:55:38.000
Um, outside of eating hot peppers on the company uh on the company clock, um, I am working on a couple of different live events.
00:55:38.159 --> 00:55:41.599
My next one is coming up in a few weeks on analytical development.
00:55:41.840 --> 00:55:46.480
Um, and I will be doing one on plasma DNA coming forward.
00:55:46.800 --> 00:55:49.519
I am still building my editorial board.
00:55:49.679 --> 00:55:54.320
I just announced the official uh members of it just this week.
00:55:54.480 --> 00:56:08.480
Um, so I am always looking for more folks that are interested in being part of the editorial advisory board for advancing RNA, whether you're on the mRNA side or particularly, I do, I am looking specifically for folks on the oligo side as well.
00:56:08.719 --> 00:56:11.679
So uh please do not be shy.
00:56:11.760 --> 00:56:14.239
Uh come forward if you're listening.
00:56:14.639 --> 00:56:20.400
And then in terms of travel, I will be at Tides next week, uh mid-May in Boston.
00:56:20.559 --> 00:56:35.119
Um I'm really looking forward to that event, predominantly because I think as the oligo space is trying to uh build into larger indications, uh, there's a lot of movement happening on the manufacturing side with chemoenzymatic ligation um coming up.
00:56:35.280 --> 00:56:37.519
A lot of CDMOs are investing in this.
00:56:37.599 --> 00:56:43.920
Um, and a number of uh biotechs and pharma companies are starting to explore this as well.
00:56:44.159 --> 00:56:48.719
So I'm looking forward to learning more about that, learning more about the regulatory paradigm.
00:56:49.039 --> 00:56:55.119
And I am finally working on putting together a couple of panels for the fall.
00:56:55.360 --> 00:57:32.159
Um, I was invited to be part of a CPI um bioindustry association event in London uh to moderate a panel on uh personalized medicine and what the rest of the world can learn uh from the UK, because they're doing a what I would consider to be a groundbreaking um uh project in terms of linking up NHS and uh mRNA cancer vaccine or immunotherapy product um development, so that you know it's it's the I think the cancer um leap uh initiative.
00:57:32.559 --> 00:57:41.760
Um so I'm looking forward to talking to a couple of folks about how that pro how that program is going uh and what we can potentially take from it.
00:57:42.000 --> 00:57:45.280
So that will be hopefully sometime in September.
00:57:46.480 --> 00:57:47.280
Awesome, man.
00:57:47.519 --> 00:57:48.079
Thank you so much.
00:57:48.239 --> 00:57:51.360
That was uh yeah, everyone's plugging their editorial advisory boards.
00:57:51.440 --> 00:57:53.280
I think I I should also jump in on that.
00:57:53.360 --> 00:57:56.079
Uh if you're if you're listening out there, you're in the audience.
00:57:56.159 --> 00:58:01.360
I'm always recruiting for BioProcess Online's editorial advisory board, especially if you're a fan of the show.
00:58:01.599 --> 00:58:02.639
We'd love to have you.
00:58:02.719 --> 00:58:07.039
So, you know, slide in my LinkedIn DMs or find my email on the site.
00:58:07.280 --> 00:58:09.760
Um yeah, then thank you all for sharing.
00:58:09.840 --> 00:58:17.280
That's it's great to hear about what everybody's doing because I feel like we just get so siloed sometimes that there's a sometimes a lack of visibility there.
00:58:17.360 --> 00:58:20.480
So it's really cool to hear about all the cool things you guys are working on.
00:58:20.639 --> 00:58:23.199
Uh on my side of town, let's see.
00:58:23.360 --> 00:58:36.320
I think one of the most exciting things I got to do this year was host Oxford Global's Next Gen Biomed in London, which was uh career first for me, in both in terms of hosting and seeing an event, but also traveling internationally for work.
00:58:36.480 --> 00:58:38.320
That was awesome.
00:58:38.639 --> 00:58:48.480
But in terms of what the bioprocess and better bio from our audience can expect moving forward, uh, you've heard this term thrown around live events, this whole podcast.
00:58:48.559 --> 00:58:51.519
And if you're listening and you're like, what the heck are they talking about live events?
00:58:51.599 --> 00:58:58.320
These are virtual, essentially webinars, panel discussions with experts on a variety of topics across our spaces.
00:58:58.639 --> 00:59:07.039
For bioprocess online, we have one in May coming up that by the time you hear this, this will be passed, but it's on uh maximizing viral vector yields in manufacturing.
00:59:07.119 --> 00:59:09.360
So a lot of downstream conversation there.
00:59:09.519 --> 00:59:17.679
And our June event is going to be on more generally maximizing process productivity and the levers that you could pull to that effect.
00:59:17.920 --> 00:59:29.519
I alluded to our ADC one in August, and there's a couple down the down the pipeline that I'm not gonna hold off on on sharing for now, but we've we've got some exciting podcast episodes coming out.
00:59:29.599 --> 00:59:46.079
This one is the least of which um we have I've been doing this thing where I'm trying to tie together the live events in the podcast where uh we've done it twice now, where the conversation's so dang good and the time is so short, an hour's not nearly long enough to really dive into some of these these topics.
00:59:46.159 --> 00:59:49.760
So we've continued the conversation with panelists on the podcast.
00:59:49.920 --> 00:59:51.760
And like I said, we're too into that now.
00:59:51.840 --> 00:59:54.000
And I I'm really liking how that's going.
00:59:54.079 --> 00:59:54.880
I like that format.
00:59:55.039 --> 01:00:02.800
I think it kind of really does more justice to the topics that we dive into, and I'm hoping that the audience appreciates it as well.
01:00:02.960 --> 01:00:05.199
So I'm gonna try to keep that going.
01:00:05.440 --> 01:00:07.280
Uh let's see, we talked about conference.
01:00:07.440 --> 01:00:08.320
Oh, another thing.
01:00:08.480 --> 01:00:09.519
Yeah, Ben said of bio.
01:00:09.760 --> 01:00:10.400
I'm excited for bio.
01:00:10.639 --> 01:00:14.000
I'm excited for bioprocess international, bioprocessing summit.
01:00:14.239 --> 01:00:18.800
I think Katie and I might be venturing to New Orleans if I'm allowed to go to uh Katie.
01:00:18.960 --> 01:00:19.599
What show is that?
01:00:19.760 --> 01:00:20.639
Remind me.
01:00:21.679 --> 01:00:25.360
Farmside 360 in October, yes.
01:00:25.679 --> 01:00:28.159
Me and Katie are gonna try to go have beignets down there.
01:00:28.239 --> 01:00:29.519
Um we we are.
01:00:29.679 --> 01:00:36.480
We are going to have my brand with better biopharma, better bio beignets, um, patent pending.
01:00:36.639 --> 01:00:44.159
But another thing that I'm excited to hopefully do this year, and again, I don't want to put this out there in case it doesn't happen, but it seems like it's probably gonna happen.
01:00:44.320 --> 01:00:58.480
Uh, I'm in the works of trying to get some site visits scheduled where I could actually show up to local biotech companies that do their own manufacturing and development and just see how the sausage is made and hopefully turn that into content for you, our listeners.
01:00:58.639 --> 01:01:00.400
Um, super stoked on that.
01:01:00.559 --> 01:01:02.559
So yeah, thank you all for sharing all that.
01:01:02.639 --> 01:01:04.000
I'm so excited for everybody.
01:01:04.159 --> 01:01:21.360
Um and we've been going a bit long here, so I don't want to go too much longer, but I wanted to see if anybody's brave enough at this time to throw some predictions out there and put it on wax to be held up against you in the in the year end to see how they performed against real life.
01:01:21.679 --> 01:01:27.599
Anyone want to predict what's gonna happen in their space in the next six or so months?
01:01:28.239 --> 01:01:29.119
Good or bad.
01:01:29.360 --> 01:01:30.800
I'll make a quick one, Tyler.
01:01:31.039 --> 01:01:41.199
I think the a psychedelic is gonna get approved this year, and I think it's gonna be psilocybin, either an analog, well, probably uh like a synthetic analog, but that's that's my prediction.
01:01:41.599 --> 01:01:45.840
Seems like Compass is probably a a front runner in that space.
01:01:45.920 --> 01:01:46.800
Um, for sure.
01:01:46.880 --> 01:01:51.920
Now that now that they lock down the uh the commissioner's priority voucher.
01:01:52.400 --> 01:02:06.320
What what's interesting in there, Ben, and and maybe Jeff could weigh in here too, is um with psychedelics, it seems like the biotechs that are developing these psychedelics don't really have the capacity to manufacture it.
01:02:06.400 --> 01:02:17.280
So they're going to be outsourcing that manufacturing, but only a handful of CDMOs are are uh what is it, schedule one registered.
01:02:17.519 --> 01:02:21.039
So, you know, how is that capacity going to work?
01:02:21.440 --> 01:02:22.639
I'm just curious.
01:02:22.880 --> 01:02:54.400
I don't know if anyone knows the answer to it, but I think it'll be you know, much like I mean, not quite to the extent of GLPs that that we saw when the capacity crunch, but you're gonna see that that crunch because you know other Schedule One drugs, uh obviously painkillers and so forth that you know tie up the market or then are big sellers, they're you know, the companies that are making those are big and large and have a lot of buying power and they're gonna eat up a lot of that uh that time and buy a lot of that that you know time with these CDMOs.
01:02:54.559 --> 01:03:02.000
So I imagine it's gonna be it's gonna be a tough battle for some of these um you know smaller companies that are making psychedelic drugs.
01:03:02.159 --> 01:03:05.440
Um, but uh it'll be interesting to see how that that plays out.
01:03:05.519 --> 01:03:17.599
But I ultimately for the space, I think you know, Ben, you're making a great point that you know that the psychedelics is something that's been long overdue uh in terms of you know getting more research, getting drugs out there or whatever.
01:03:17.679 --> 01:03:21.039
And we we've seen you know the capacity they have to be able to help people.
01:03:21.119 --> 01:03:24.159
So I I'm I'll be fascinated to see what what happens here.
01:03:24.480 --> 01:03:27.280
You could possibly see some larger companies move into it.
01:03:27.440 --> 01:03:32.239
Atsuka already is probably the biggest company that's uh really gotten involved.
01:03:32.320 --> 01:03:44.079
They've made an acquis another acquisition in that space uh recently, but um, you know, you could there are some other companies that you could potentially see that have experimented with cannabis products like jazz pharmaceuticals.
01:03:44.320 --> 01:03:49.039
You could see uh companies like that potentially acquiring, you know, a compass.
01:03:50.079 --> 01:03:52.800
I hear uh if they Ben, that's a great prediction.
01:03:52.880 --> 01:03:53.760
We'll see how it holds up.
01:03:53.840 --> 01:04:00.559
I think that if they do, I heard that one of the concomit meds of those psychedelics will be Grateful Dead tickets.
01:04:02.079 --> 01:04:03.199
Uh all right.
01:04:03.440 --> 01:04:06.480
So Bobby, Bobby's not with us anymore, though.
01:04:07.039 --> 01:04:07.679
Yeah, that's right.
01:04:08.159 --> 01:04:08.880
Are they still touring though?
01:04:08.960 --> 01:04:10.239
I know John Mayer was their guitarist.
01:04:10.480 --> 01:04:10.960
I'm sure they are.
01:04:11.679 --> 01:04:14.239
So they're at the the sphere in Vegas and stuff.
01:04:14.400 --> 01:04:21.920
That'd be cool if your doctor prescribed you those psych psychedelic meds and you get to also go on a sick trip to the sphere.
01:04:22.480 --> 01:04:38.079
It's kind of a shame that Dan logged off already, but um from what I understand, one of the big hangups is in the clinical trial design and you know how to remove the bias if you're receiving it or not receiving the drug.
01:04:38.159 --> 01:04:42.480
Because obviously, if you're getting a psychedelic, you're probably gonna know.
01:04:42.719 --> 01:04:44.400
Um, or if you're not, you're probably gonna know.
01:04:44.559 --> 01:04:44.719
Right.
01:04:44.880 --> 01:04:47.039
So hard to do placebo.
01:04:47.599 --> 01:04:47.840
Right.
01:04:48.000 --> 01:04:57.199
So from what uh I understand, that was a big problem with Lycos's uh psychedelic drug that was really close to coming to the market.
01:04:57.360 --> 01:05:03.840
So it'd be it'd be interesting to see how they navigate around uh that particular challenge as well.
01:05:04.480 --> 01:05:06.559
Yeah, I'll just say one thing to that, Katie.
01:05:06.800 --> 01:05:17.760
I think uh a lot of the these companies are looking to spravato, which is the J and J inhaled ketamine product that was approved, um and kind of following following that pathway.
01:05:17.920 --> 01:05:26.159
I've talked to Compass folks at Compass who say the that the placebo issue um is one that that they can get past.
01:05:26.239 --> 01:05:29.519
But yeah, you're right, that is a still a remaining challenge.
01:05:30.480 --> 01:05:34.480
Yeah, it's certainly not the first drug to you know to have that that challenge.
01:05:34.639 --> 01:05:36.559
I think there's precedence for that.
01:05:36.719 --> 01:05:39.840
Um so you know, but but it will it will be creative.
01:05:40.000 --> 01:05:47.360
You'll have to come up with some pretty creatively designed uh scenarios for you know to test those things, depending on the the outcome, right?
01:05:47.440 --> 01:05:51.360
What you're testing for, you know, relief of whatever condition that may be.
01:05:51.440 --> 01:05:55.440
So the comparator drugs, too.
01:05:55.519 --> 01:05:56.480
I'll just throw that in there.
01:05:56.639 --> 01:05:59.679
That'll be interesting to see if they're extracting things from mushrooms.
01:06:00.079 --> 01:06:02.719
Or something like that to make comparisons.
01:06:02.880 --> 01:06:05.199
Um can I have a oh go ahead.
01:06:05.840 --> 01:06:07.519
I was gonna say how the drugs are made, right?
01:06:07.599 --> 01:06:09.360
Is that is gonna be interesting, right?
01:06:09.440 --> 01:06:14.559
Like I at scale, I think this has one have been one of the issues for psychedelics, right?
01:06:14.639 --> 01:06:19.440
At scale, you know, trying to do the extraction is is gonna be tough.
01:06:19.599 --> 01:06:38.880
Um there have been uh there are researchers and and I'm sure companies I I don't know, I don't particularly know how compass makes theirs uh or you know is looking to make theirs, but there are companies that you know using synthetic biology to create them within organisms like yeast or bacteria and then have them sort of be pumped out uh in that regard.
01:06:39.039 --> 01:06:50.239
So if if they can overcome you know that, then you're you're you know, maybe even some of the issues of outsourcing go away a bit too, because it might be a lot easier to to manufacture.
01:06:52.239 --> 01:06:57.280
I was just gonna throw a prediction out there from a clinical supply perspective, if I can.
01:06:57.440 --> 01:07:02.639
Um, and I'm glass half full person, an optimist, so I was hoping for chocolate milk.
01:07:02.719 --> 01:07:12.559
Um, but for clinical supply, I think that hopefully we'll see more and better reliable AI integration in uh all these different systems we've talked about.
01:07:12.719 --> 01:07:16.079
Um, improved DTP direct-to-patient logistics.
01:07:16.159 --> 01:07:19.360
Um, and also I'm I'm again glass half full.
01:07:19.440 --> 01:07:29.920
I'm hoping that we'll see a more holistic view from pharma product development standpoint when it comes to, again, I'm advocating for clinical supply, but it's sort of at the center of a lot of these different functions.
01:07:30.000 --> 01:07:32.639
So I'm hoping that we find ways to better leverage that.
01:07:32.800 --> 01:07:37.679
Um not as exciting as psychedelics, but those are my predictions.
01:07:39.519 --> 01:07:40.800
Still just as fun, I'm sure.
01:07:42.559 --> 01:07:44.719
Any any other industry predictions?
01:07:47.280 --> 01:08:05.840
I mean, it's it's not as exciting as psychedelics, um, but you know, I am excited to see how manufacturing moves the needle in in automation um and and reducing you know that human error component.
01:08:06.000 --> 01:08:18.720
Um we did see this year um the ISPE's FOIA awarded Solita one with like a fully automated uh start to finish uh facility.
01:08:19.039 --> 01:08:35.199
And so I imagine and I know there are other companies working on this, but as we move forward, there's going to be more facilities that mirror that uh approach where um they're fully automated from start to finish.
01:08:35.840 --> 01:08:42.960
I was just gonna say, I don't really have a prediction, but I have a wish for this space if that's possible to offer.
01:08:43.119 --> 01:08:48.960
Uh I don't dare predict this because it I'm pretty positive it's not gonna happen this year.
01:08:49.199 --> 01:09:03.039
Um but I think the entire RNA space, whether you're an oligomaker or an mRNA maker, you're probably sitting there wishing and hoping that somebody would make some sort of development uh in terms of the delivery of these products.
01:09:03.199 --> 01:09:05.119
I think right now the biggest.
01:09:05.439 --> 01:09:08.479
That is the industry's biggest Achilles heel.
01:09:08.560 --> 01:09:23.199
Um, if we can't get it outside of the liver, we aren't gonna have the therapeutic uh breadth that we hope for for these products, um, whether it be an in vivo car T or a protein replacement or a gene editing product, right?
01:09:23.439 --> 01:09:39.520
So um I think that my wish for this space is whether it's through passive or active targeting mechanisms or a completely non uh a new exciting non-viral delivery method.
01:09:39.680 --> 01:09:55.039
Um I would really like to see some sort of progress made uh within the the next year or two, uh, some big breakthrough uh that's going to get us beyond, get us beyond the hepatocytes.
01:09:55.199 --> 01:09:56.560
That would be really nice.
01:09:56.880 --> 01:09:57.920
That'd be great to see.
01:09:58.399 --> 01:09:58.720
Yeah.
01:09:58.960 --> 01:10:06.560
Yeah, I have a similar, not so not much of a prediction, but more of just uh something that I was speaking with, actually a fan of the show about recently.
01:10:06.640 --> 01:10:34.479
Um we're speaking on LinkedIn, and I'm curious if if Aaron and and Ray, if this is any if you've heard anything about this in your spaces, but it was about on the topic of organoid systems, and you know, she was specifically saying that she thinks that's a big, that's a growing segment of of bioforma where it's not necessarily obviously these things aren't therapeutic products, but they they will play in both the discovery and maybe in an assay type of role.
01:10:34.640 --> 01:10:39.439
And and and currently, I guess there's some scale-up challenges there with scaling organoid systems.
01:10:39.600 --> 01:10:42.239
Um, and if she's listening right now, then she'll know who she is.
01:10:42.399 --> 01:10:44.560
So thank you for for putting that in my mind.
01:10:44.640 --> 01:10:47.760
But it's something I've been thinking about, which like, how do you think that'll play out?
01:10:47.840 --> 01:10:49.680
Do you think are you hearing about that in your space?
01:10:49.840 --> 01:11:00.560
Like the the manufacturing of organoids and the scaling of that manufacturing, she seems to think is going to be a more and more prevalent area of of focus um in the future.
01:11:00.800 --> 01:11:01.760
Ray, do you agree with that?
01:11:02.000 --> 01:11:03.359
I I definitely do agree with that.
01:11:03.439 --> 01:11:13.439
I think organoids have been, you know, part of the research labs for a long time, but we are starting to see signs of a lot of standardization around organoids and how they're grown.
01:11:13.680 --> 01:11:17.199
Um, even you know, the FDA, NIH is supporting this.
01:11:17.439 --> 01:11:40.640
I'm actually having a drug discovery online live panel discussion in September on this specific topic, the standardization of organoids and how different organizations and institutions are ensuring the not just the quality, but the reliability of these systems and how they can be used for preclinical research and um just drug discovery in general.
01:11:40.800 --> 01:11:55.840
I think another cool point to talk about is regarding organoids is the fact that you can take individual human stem cells um and grow these organoids based on individual people, meaning personalized medicine.
01:11:55.920 --> 01:12:02.640
You can focus in on their specific genome and see how different drugs react to that person potentially.
01:12:02.880 --> 01:12:04.800
Um so I think that's pretty cool.
01:12:04.960 --> 01:12:11.520
Again, we're not doing that now because it's expensive and we don't have the infrastructure to make it work properly.
01:12:11.760 --> 01:12:24.399
So I think once we start to roll out more, you know, standards, more CROs start to do this, you know, reliably and again and again and again, learn from those mistakes, get better and better.
01:12:24.479 --> 01:12:27.680
This will be probably a very common thing.
01:12:27.920 --> 01:12:31.039
Um I'm definitely very excited about organoids.
01:12:31.520 --> 01:12:34.880
Kind of put a point on the end of especially what Ray said.
01:12:35.119 --> 01:12:45.600
Um for celling gene therapy, kind of what we're experiencing more, talking a little bit more on celling and celling the podcast, or IPSC-derived organoids, organoids, excuse me.
01:12:45.680 --> 01:12:48.239
Um, you know, kind of modeling neurological diseases.
01:12:48.319 --> 01:12:55.199
We talk a lot about Parkinson's, ALS, um, and that type of thing, uh, before clinical manufacturing.
01:12:55.439 --> 01:13:02.319
So uh definitely talking about it more, and I would say, especially from an induced player pollen stem cell perspective.
01:13:03.279 --> 01:13:03.760
That's great.
01:13:03.840 --> 01:13:06.479
Yeah, I'm excited to see where that where that all leads.
01:13:06.560 --> 01:13:14.720
And um, maybe there'll be areas to collaborate across our three sites in the future as it relates to organoids um and and their production.
01:13:15.039 --> 01:13:19.199
But you know, without further ado, we're we're at the end of our our podcast.
01:13:19.279 --> 01:13:22.560
So I want to ask you guys all the question that I ask all my guests.
01:13:22.880 --> 01:13:28.079
We'll make it a little bit unique because I know not everybody plays squarely in biopharma.
01:13:28.159 --> 01:13:29.840
The question is how can we better biopharma?
01:13:29.920 --> 01:13:34.800
But I'll rephrase that to be what would you like to see in your space?
01:13:34.960 --> 01:13:40.399
What would be maybe the biggest change that would have the net biggest positive impact?
01:13:40.640 --> 01:13:42.399
I can start off before you go, Katie.
01:13:42.560 --> 01:13:56.880
And that'll be, and I've I said this at Nextgen Biomed when I was there being interviewed, and I'll probably say it until I start seeing more of it, but I think it'd be great to see AI applications actually integrated into the manufacturing and development side of things.
01:13:56.960 --> 01:14:04.239
Like you hear mostly about AI and discovery, at least the past couple of years has pretty much been the buzzword, the the focus.
01:14:04.560 --> 01:14:17.199
But I think once investors and and tech companies understand the value add of streamlining development and optimizing manufacturing, I think we're gonna see a rush of tools to that effect.
01:14:17.359 --> 01:14:21.039
And I'm hoping that I'm hoping that we do.
01:14:21.279 --> 01:14:23.520
So that's my that's my answer to my own question.
01:14:23.680 --> 01:14:27.039
Katie, now let's hear how you think we could better pharma, maybe.
01:14:27.600 --> 01:14:28.720
Take the bio off it.
01:14:29.199 --> 01:14:35.439
So I'm gonna shift gears a little bit and talk about generics because I don't think we talk about them enough.
01:14:35.760 --> 01:15:09.279
Um how I think that we could better pharma um is to address you know the ongoing issue of of generics and their production, where they're produced, how they're produced, and make it bring the tech up to speed and the facilities up to speed so that we can make generics globally and facilities all over the world to bring uh these medicines to patient faster and more reliably.
01:15:09.520 --> 01:15:13.439
So that's really broad.
01:15:14.880 --> 01:15:15.359
That's okay.
01:15:15.439 --> 01:15:18.159
I'm I'm gonna go even broader uh to some extent.
01:15:18.479 --> 01:15:18.720
Let's go.
01:15:18.800 --> 01:15:24.479
Let's go, could well there's there's lots of technical issues when it comes to outsourcing that I think you know could better the the field or whatever.
01:15:24.560 --> 01:15:34.560
The the one thing that I've seen uh in my time here, you know, talking to people and and and different uh events I've been involved in, the overarching theme that I think is really communication.
01:15:34.640 --> 01:15:46.720
Uh it seems to be that you know, improving that communication between drug sponsors and you know their outsourcing partners is really the kind of key to getting a better partnership overall.
01:15:46.960 --> 01:15:49.039
So um it's something we do talk about.
01:15:49.119 --> 01:15:53.600
I bring it up a lot in you know in our events uh and so forth, and and different ways to do that.
01:15:53.680 --> 01:15:55.119
How can how can companies do that?
01:15:55.199 --> 01:15:56.560
How can drug sponsors do that?
01:15:56.640 --> 01:16:00.000
Um, but ultimately I think that's kind of the crux of a lot of it.
01:16:00.079 --> 01:16:02.319
Uh, and that's probably true for a lot of life too.
01:16:02.399 --> 01:16:03.680
So, you know, there you go.
01:16:04.000 --> 01:16:05.920
Ben, you wanna oh sorry, Tyler.
01:16:06.159 --> 01:16:07.600
Yeah, yeah, I I can hop in.
01:16:08.000 --> 01:16:17.279
Um I'm gonna keep with this theme of of being very broad, and this is uh you know a long-term um way, I think, to make bio better.
01:16:17.439 --> 01:16:44.880
But um just uh um the US investing, whether it's if it's not the government, then nonprofits, philanthropic groups, but but continuing to do basic science and continuing to focus on new discoveries, uh, which will not pan out or will not produce anything materially significant for maybe a a decade, but uh a decade, uh at least the last decade of my life has gone by pretty quickly.
01:16:44.960 --> 01:16:50.640
Uh, and so I I don't want to see those efforts stalled uh or halted in the U.S.
01:16:50.800 --> 01:16:55.840
Uh we have a long history of bringing fantastic science uh to the world.
01:16:55.920 --> 01:17:04.079
And I uh I just I really want to want to see that continue, whether it's through government resources or or or elsewhere.
01:17:04.800 --> 01:17:06.640
Amen to that as well, brother.
01:17:06.880 --> 01:17:08.720
Yeah, I would totally agree with Ben there.
01:17:08.880 --> 01:17:23.199
Uh I want to see more of that as well, but I also want to see more failures shared, the the failure, failed experiments, sharing that data, sharing that more transparently amongst the broader biopharma community.
01:17:23.279 --> 01:17:24.479
I think that'll be more helpful.
01:17:24.560 --> 01:17:35.920
I think there is this push towards open science, um, generally speaking, you know, sharing massive amounts of data, even large biopharma companies are getting involved with these initiatives.
01:17:36.079 --> 01:17:48.000
So I think that um will help sort of refocus other groups and making sure that we're not repeating um, you know, failed experiments.
01:17:48.079 --> 01:17:51.119
Although that's also useful sometimes, but uh yeah.
01:17:52.000 --> 01:17:52.720
Thank you, Ray.
01:17:53.199 --> 01:17:53.680
Rachel?
01:17:55.199 --> 01:17:57.520
So um I guess I'll go broad as well.
01:17:57.600 --> 01:18:12.880
Um I basically would say from a clinical supply for biopharma, we'll go that angle, um, is that it's it's really about um shifting from these static supply models, and this is already happening, but into like adaptive ones, but also patient-driven ones.
01:18:13.039 --> 01:18:25.760
I think that um, you know, I've seen discussions around like when it comes to forecasting, using real-time enrollment data and based on like site activation rather than just the protocol max enrollment.
01:18:25.920 --> 01:18:32.319
Also employing like smarter inventory buffers so that when you reach a certain percent, then it kicks on automatically.
01:18:32.399 --> 01:18:37.840
This is pulling in the AI aspect of that too, but kicks on like the production of the next lot automatically.
01:18:38.000 --> 01:18:41.359
Um, and then communication, I'll go back to that as well.
01:18:41.520 --> 01:18:43.520
Earlier integration of clinical supply.
01:18:43.600 --> 01:18:49.279
I'm a broken record, but that's what I, you know, bringing that back into an early discussion with CMC and clinical design.
01:18:49.359 --> 01:18:53.439
Um, I think those could all better the supply process for biopharma.
01:18:55.039 --> 01:19:00.079
Uh yeah, well, keep this super broad too, uh, for the cylinding companies.
01:19:00.319 --> 01:19:08.000
Um so it always used to be said, hey, you need to think about manufacturing long before, you know, pretty much at the discovery phase phase.
01:19:08.159 --> 01:19:13.039
Um to go out and say you need to also think commercialization um as well.
01:19:13.439 --> 01:19:19.199
And uh just make sure that if you're the companies that are doing that well, uh and think of all of that early.
01:19:19.359 --> 01:19:32.479
The term early and cylindry therapy is one of the terms I dislike the most because early is there's no timeline, you know, there's no exact timeline to it, but manufacturing, commercialization, think about that right at the outset.
01:19:32.560 --> 01:19:36.079
Um for the therapies that are being developed.
01:19:38.319 --> 01:19:39.119
Thank you, Aaron.
01:19:40.399 --> 01:19:41.199
And Dan's gone.
01:19:41.359 --> 01:19:42.560
Anna, we're going right to you.
01:19:43.279 --> 01:19:46.239
I know that kind of threw me for a loop there for a second.
01:19:46.800 --> 01:19:47.279
All right.
01:19:47.439 --> 01:19:49.439
Um, so I kind of have two.
01:19:49.760 --> 01:19:56.159
Um, and I'm gonna pick up on a thread of, you know, I think Jeff kicked us off with thinking about uh communication.
01:19:56.560 --> 01:20:14.079
Uh I think it's it's no surprise to anybody that since I cover the mRNA space, that I'm gonna keep harping on communication as being one of the most important pieces, but it's less um about the communication that happens inside the industry because I think we are in our own little echo chamber.
01:20:14.239 --> 01:20:19.039
Um, but it's really finding ways to communicate what our products do.
01:20:19.119 --> 01:20:28.239
And I would argue we need to get better focused on uh different stakeholders, not necessarily even the general population.
01:20:28.399 --> 01:20:34.720
I think, you know, we need to be looking for uh or looking to communicate much better with physicians.
01:20:34.880 --> 01:20:39.199
Um, they're the ones that patients are going to be trusting with their care, right?
01:20:39.439 --> 01:20:44.880
So making sure that the education is is focused on that, thinking about the payers.
01:20:45.119 --> 01:20:52.319
Um, you know, there was a really interesting discussion on LinkedIn that I that I was sort of being a fly on the wall for.
01:20:52.479 --> 01:21:11.840
Um, but if you think about some of the, you know, the big innovative work that's happening in the in vivo space, uh in vivo gene editing, specifically the Intelia news, um, you know, the their great phase three data uh in an indication that is pretty populated with other medicines, right?
01:21:12.000 --> 01:21:24.560
If you want patients to have access to that, um, there's some pretty big hurdles to getting a payer, right, that's going to be willing to cover uh a very big and expensive innovative therapy.
01:21:24.640 --> 01:21:28.960
Uh so whether the patients need it or not, you still have some walls you got to break through.
01:21:29.039 --> 01:21:40.960
So I think communication of your product, of its merits, um, of how it works to that payer, the physician population, um, is going to be really key here across the board.
01:21:41.199 --> 01:21:47.119
But I would also argue, too, you know, it's it's been a tough year for the mRNA space.
01:21:47.199 --> 01:21:51.199
And so I would probably just say to keep keep the faith.
01:21:51.439 --> 01:22:03.920
Um, you know, right now there are companies that are are downsizing that are, you know, the as I said, the the layoffs um are happening from say the different biontech uh sites just this past week or two.
01:22:04.159 --> 01:22:09.840
Um but I think that mRNA in particular has has not yet reached its heyday, right?
01:22:09.920 --> 01:22:26.800
I think we we um have seen some hurdles in the public responses to, you know, uh in terms of the vaccines, but um there's a different risk-benefit ratio in the therapeutic space.
01:22:26.960 --> 01:22:38.880
And I think that, you know, once patients are personally impacted um in a therapeutic way by an mRNA product, I think that's when the narrative will start shifting.
01:22:39.119 --> 01:22:40.560
So keep the faith.
01:22:40.640 --> 01:22:48.159
What you're doing is is important, um, even if it might feel like it's not uh recognized at this point.
01:22:48.560 --> 01:22:51.119
Um just keep keep going.
01:22:52.000 --> 01:22:54.000
Great message, and I couldn't agree more.
01:22:54.159 --> 01:22:54.720
Thank you.
01:22:54.880 --> 01:22:57.840
And uh thank you all so much for for joining me for this.
01:22:57.920 --> 01:22:58.880
This was really fun.
01:22:59.039 --> 01:23:07.760
I think it was I think it's really valuable to get insight into across the spaces and what everybody's working on and just what's happening in our respective markets.
01:23:07.840 --> 01:23:11.439
So thank you so much for being here to share with me, with each other, with our audience.
01:23:11.600 --> 01:23:17.279
Thank you out there for listening to this episode of Better Biopharma, the official podcast of Bioprocess Online.
01:23:17.439 --> 01:23:21.920
I'll link all my colleagues' websites in the description, and I hope to see you next time.
01:23:22.000 --> 01:23:22.319
Thank you.