BioCentury This Week

Ep. 349 - Start-up Spotlight, Compounding Wegovy & Neuropysch

• BioCentury • Season 7 • Episode 349

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2025 marked the end of a four-year slide in series A financings for biotechs, with 144 biotechs raising an aggregate of $8 billion, up $1 billion from the prior two years. On the latest BioCentury This Week podcast, BioCentury’s Danielle Golovin assesses which companies VCs backed last year and what their investments say about where technology is headed.
Washington Editor Steve Usdin offers a perspective on why compounded Wegovy is an assault on the biopharma industry and also explains how the spending bill signed into law last week is a rebuke to proposed White House biomedical cuts.
And Executive Editor Selina Koch unpacks her interview on The BioCentury Show podcast with neuroscientist and Seaport Chair Steven Paul, noting that while serendipity drives drug discovery in psychiatry, it’s engineering that gets it across the finish line.

View full story: https://www.biocentury.com/article/658367

#BiotechFinancing #SeriesAFunding #VentureCapital #DrugDiscovery #BiopharmaPolicy

00:00 - Introduction
02:15 - Start-up Spotlight
11:03 - Compounded Wegovy
18:10 - Congress Rebuffs Trump Cuts
23:50 - Steve Paul on Neuropsychiatry

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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[AI-generated transcript.]

Jeff Cranmer:

After four years of declining series A activity in biotech last year brought a bit of stability in the number of biotechs able to raise startup capital. On today's BioCentury, this week podcast, we assess biotech's series A class of 2025. Plus compounded Wegovy is more than a scam, it threatens innovation, Steve Usdin is here to tell you why. And more from Steve in Washington, last week's spending law represents a rebuke proposed White House, biomedical cuts and serendipity. It drives discovery in psychiatry drug development, but it's engineering that gets it across the line. We have takeaways from Selina Koch's conversation with Steve Paul, formerly of Karuna, currently of Seaport. He joined our sister podcast, The BioCentury Show. I'm Jeff Cranmer, host of the BioCentury This Week podcast, and joining me today are my colleagues.

Simone Fishburn:

Simone Fishburn, Editor in Chief.

Danielle Golovin:

Danielle Golovin, Senior Biopharma Analyst.

Steve Usdin:

Steve Usdin, Washington Editor.

Selina Koch:

And Selina Koch, executive editor.

Jeff Cranmer:

All right, we will turn to Danielle and her brilliant, uh, deep dive into series A companies and their technologies. But first, we're excited to introduce a new exclusive opportunity for BioCentury subscribers launching at the BioCentury BayHelix East-West Summit, that will be in March, March 9th through the 11th. Step inside the BioCentury Lounge, a dedicated space designed to connect, recharge, and inspire conversation among industry leaders. Experience unique networking moments, insider insights, and a place to unwind between sessions at our fifth East-West Summit don't wait, check out more at BioCenturylounge.com. Danielle, this is, uh, this has become a thing your, your series A analysis. We, uh, don't know if we're in year three or four, but, uh, it's always something I really look forward to reading each year because, you remind us of who some of the hottest, newest companies are, and who the investors are backing them. Uh, what was the main takeaway from your analysis, and I should say your analysis with our colleague Lindsay Martin, who, uh, did a lot of the data, for this deck.

Danielle Golovin:

Yeah, exactly. So I'm speaking on behalf of myself and Lindsay who helped me big time this year. And the big good news is that 2025 stopped the downward slide in series A activity. So after four years of going down, down, down this year, we have 146 series A rounds, and last year we had 149, so basically stabilizing. And even though the total number of raises were the same, the total amount raised was 8.1 billion, and this is up from 7 billion the prior two years. And while the number of 100 million plus mega rounds was similar in 2025 to 2024, there were seven mega rounds at over 200 million. That's the most in five years. We also saw the largest raise in five years. This is Verdiva Bio's, $411 million raise. Uh, Verdiva is developing an oral GLP-1 peptide as well as oral and subq amylin and agonist for obesity and other cardiometabolic diseases.

Selina Koch:

Danielle, let's talk a little bit about, um, who's in these rounds. I think you also looked at, you know, the most active investors. And interestingly, kind of the sizes of syndicates was also something you saw a change in.

Danielle Golovin:

Yeah, exactly. So Eli, Lilly and Nova Holdings were the most active investors participating in 11 rounds each. And if we looked at, you know, broke it down by the number of investors for series A rounds, only 6% of investors go it alone. That's the smallest percentage for solo investment when compared with the past, four years prior. And I guess accordingly, the, the bigger syndicates, so syndicates with five plus investors rose to 56%, and that's up from 42% last year.

Simone Fishburn:

Okay, well it's kind of interesting that Lilly. Novo were the most active. Of course, both of them have lots of money now. and both of them obviously the leaders in the GLP-1. So we're gonna be keeping an eye on those investments and seeing strategically as we kind of go a little deeper into this in the future. How much those companies are branching out and using their, their, their deep pockets to be, stimulating company formation in, in different areas. maybe you can talk a little bit about whether there were modality or technology themes among the Series A companies. Anything that, you know, what specifically caught your eye?

Danielle Golovin:

Yeah, sure. So as far as modality as usual, the biggest category was small molecules, 37 companies. Next was antibodies at 27, within antibodies, we broke it down a bit to bispecifics, t-cell engagers, B-cell depletion strategies. And then despite, you know, safety setbacks, and commercial challenges, cell and gene therapies came in third and fourth. Um, among cell therapies, ex vivo autologous CAR Ts are still the most popular choice. But we did find one purely in vivo CAR T Company called Stylus and then a second T-CURX, which mentions potential for in vivo. We also identified two companies each making CAR Ms, car macrophages and CAR NK cells. Within technology. Yeah, I mentioned B-cell depletion strategies. So we highlighted four companies there making biologics for autoimmune disorders. That's Hinge, LTZ, Oral, and Timberline. So check out my BioRender, laying out those technologies.

Selina Koch:

One thing I thought was really interesting when I looked at these data was the, strong showing by cell and gene therapy, but especially gene therapy. was above RNA modalities in terms of number of companies getting series A funding last year, which is just backwards. From the clinical picture, right? We see all kinds of pharma saying, look, RNA is scalable. RNA is the future. RNA interference in particular is, you know, really taking off and we're making these big investments. And then at the most innovative end, you know, these really early stage companies, you see this like maybe a little budding of a comeback of gene gene therapy.

Danielle Golovin:

Yeah, I think, I think that has to do with vehicle delivery. A chunk of these companies are focused on targeted delivery, and that's essential when you're, you know, delivering a gene therapy or a gene editing program, which we also saw a small cluster in gene editing and gene writing.

Simone Fishburn:

So a question I actually wanna bring in Selina and Jeff maybe respond to this as well. I thought it was interesting the number of companies or the proportion of companies that at their series A financing have a pharma deal, right. And that seemed to be quite substantial. And I sort of wonder whether you are thinking that, you know, coming out of this bear market and this sort of environment where it's been hard to raise funds. Whether that's just put an over-indexing or over-emphasis on the value of a validating deal from a pharma company. Sort of how do you, do you think it's just the same as ever, or do you think that like in this environment that's just gonna be an even bigger, say, draw for investors if you walk in with a pharma farmer in your pocket from a deal?

Jeff Cranmer:

Yeah, I mean, that's an interesting point, Simone. I, I guess I was thinking about it in, in the other way, um, more from the pharma perspective of, you know, all the patent cliffs coming, the need to go earlier and earlier to tap into some of the innovation that these companies are bringing forth.

Simone Fishburn:

Yeah. I mean, both can be true, Jeff. we don't know. Um, and you know, the numbers have been so low in recent years. We don't know if this is an increase over other years or something, but I do think that, it's always a thing for small companies just to be able to create that pharma deal. And so there's the pharma point of view, which you pointed out, and then there's the sort of validating thing from, from the small company's point of view.

Jeff Cranmer:

Yeah. Huge, hugely validating. That's, that's for sure.

Selina Koch:

And before you get that series A, I mean, series A have been hard to come by, right? So if you can get some funding somewhere else, then,

Jeff Cranmer:

yeah.

Selina Koch:

then why wouldn't you? Why wouldn't you? Yeah. Yeah. They can help you. You know, they can synergize or whatever.

Jeff Cranmer:

how about indications, Danielle, uh, were there any leading indications around which these companies were being formed?

Danielle Golovin:

Yeah, so as usual, most series A's went to cancer companies with 51, next was 31 in INI, 24 in neuro, and 25% of those in neuro were in neuropsych. I thought that was interesting. we identified rare disease and pulmonary as growing areas and women's health finally made the chart, yay. Um, in rare disease, we identified 13 companies with, you know, their lead product is in a rare disease and it spans neurology, metabolic, muscle, renal, ophthalmic, and derm. In pulmonary, we identified five companies, four of which have a lead program in COPD, so again, thought that was interesting. And two of the four in COPD, Novo invested in, just to mention that they are branching out, outside of obesity. And as far as women's health, we have ReproNovo, Granata, Volastra, and NK CellTech. So ReproNovo is advancing an oxytocin receptor antagonist for embryo implantation and adenomyosis. Granata has a pipeline to improve reproductive health, and Volastra and NK CellTech have lead programs in ovarian cancer.

Jeff Cranmer:

You had mentioned, Lily being pretty busy. They, uh, participated in two of the rare neuro plays, uh, Alchemab and Augustine. I guess to Simone's earlier point 6 of the companies, in rare disease, have a deal with another biotech or pharma, Lily being one of them. Alchemab, that's an ALS.

Selina Koch:

I thought it was striking that there were more psychiatry companies in that series A list than neurodegeneration focused companies, we'll get into this probably later, but you know, the human genetics revolution that's come through has generated this long list of targets that people think are high value for neurodegeneration, and, and that's not really been the case in psych. So it's a different, playbook there. Um.

Danielle Golovin:

Exactly, and to come is my next story on atlases, a roundup of, the sort of molecular profiling that academics have done and we identified some in these neuropsychiatric diseases. Look out for that as one of my next stories.

Jeff Cranmer:

Awesome. And, uh, we'll get to neuropsych later in the show when we talk about Selina's conversation with Steve Paul. But we're gonna take a quick break and we're gonna turn to wegovy and find out what's happening there. It's been, uh, rapid fire bit of news across the bow over the past few days, and we'll hear about it from Steve after this.

Alanna Farro:

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Jeff Cranmer:

Alright, we are back. Steve, you wrote a perspective on Friday. I bet you never thought you'd be writing about Hims & Hers, but, uh, here you are.

Steve Usdin:

Here I am with Hims & Hers. Yeah, what I wrote about, you know, I think everybody knows the, the broad outlines of, of what's happened. Uh, Hims & Hers uh, put out an advertisement saying that they're gonna be selling a compounded version of Wegovy's oral anti obesity drug. There was a, a big outcry about that. FDA Commissioner Marty Makary went on X and said that FdA was gonna take swift action against companies mass marketing illegal copycat drugs. Then the HHS Chief Counsel, put out a, a more specific statement saying that they're, they've referred Hims & Hers to the Department of Justice for prosecution. What he called, he wrote F-D-C-N-A and possible title 18 provisions, and that last bit means federal criminal offenses like What I wrote and what I think is important is that what Hims is doing with Oral Wegovy and, and I think possibly with it, its other products, is an assault not just on Novo or other companies that sell similar products, but on the whole, uh, biopharma industry and what FDA and what HHS need to do is demonstrate that its actions are not limited to Hims or to a particular product that has received widespread media attention. It has to enforce the boundary between pharma compounding and the approval system that underlies all biopharmaceutical innovation. And I say that because I think that integrity of the whole drug approval system and the whole drug development system depends on a social contract. Companies invest in proving the safety and effectiveness of a product. They receive a defined period of market exclusivity. and if mass marketed, compounded copies are allowed to compete before that period ends. There's not gonna be much incentive to develop new medicines in the first place.

Simone Fishburn:

Steve, I think maybe you could outline for people what the role is for compounding. Like what is kosher compounding, where, what is the place that it has in the ecosystem? Why, why, you know, why is it allowed? And where

Steve Usdin:

Well, I'm not sure that any compounding is kosher. Okay. But, um, you need to go to a bigger authority than me to talk about that,

Simone Fishburn:

I, I'll ask the rabbi. We, well, we, we have rabbis for this. Yes.

Steve Usdin:

Okay, so, so here's the, here's the deal. It's complicated, okay. But there's two kinds of, compounding, maybe more than that, that people usually think of. The traditional form of compounding is when, a compounding pharmacy makes a product at the demand or request of a physician, for a particular patient because there's nothing that's FDA approved that would be applicable for that patient. Um, a classic example might be that there's a pediatric formulation that's needed, it's a patient who's too young to swallow a pill and there's no, um, liquid version of it on the market. So a compounder would create, that liquid version for a particular patient, for a particular product. There's also, large scale, this provisions in the US law, and this is more controversial, that allow large scale compounding in cases where there's a shortage. That was the case with Semaglutide and some of the other GLP-1s. When they first came on the market, they were in shortage of the companies were manufacturing them, couldn't meet U.S. demand, so compounders were allowed to make large quantities of 'em and they made large quantities of 'em. There were millions of doses of compounded, Semaglutide products that were, um, sold in, in the United States. And I, and I should say that, um, the current FDA Commissioner, Martin Makary, he was the Chief Science Officer for a company called Sesame Health, that one of their principle lines of business was connecting patients with compounded versions of, um, of semaglutide during this period when it was legal to do so, because there was a shortage of those products.

Jeff Cranmer:

Steve, curious, is there a, uh, temptation or maybe a history of the government using compounding to relieve pricing pressure.

Steve Usdin:

Yeah, there is, you know, it's, it's happened before. I've written about it. I called it kind of one of the darkest moments really for FDA prior to the current administration, which has had its share of dark moments, um, which was when FDA under pressure from Congress and from the White House said that it would look the other way and allow mass compounding of a drug that Makena Pharmaceutical was making. At that time it was called 17P. It was a drug that's used to, uh, prevent premature births and, it was being marketed at a high price. There was a lot of, public outcry about it. And, um, FDA said, okay, well it's gonna look the other way and allow compounded versions of it on the market. They ultimately, backed down in the face of, political pressure, but there's been, um, you know, suggestions before Robert F. Kennedy Jr was confirmed that he was sympathetic to the use of compounding as a way to, reduce prices and to improve access. Former Deputy FDA Commissioner Josh Sharfstein, had written in, uh, medical journals also proposing the use of enforcement discretion for compounding as a way to reduce, pricing and to improve access for, American patients. And all of this is highly problematic. One, because of the issues that I raised about the erosion of the incentives for drug development, for innovation, if it can just be, um, wiped away by companies compounding. And two, because there's a history of tragic manufacturing problems with compounded, drugs of, people dying, of people having serious illnesses because of, subtherapeutic doses, super therapeutic doses and contaminated products that come out of compounding pharmacies.

Jeff Cranmer:

Alright, let's turn to the spending law real quick before we jump over to Selina and a little taste of neuropsychiatry. Uh, Steve, uh, spending bill passed. I recall a lot of talk from the White House about slashing NIH funding, reorganizing NIH like moving ARPA out of NIH, but haven't seen much of that. What, what's going on here?

Steve Usdin:

Actually, I'm surprised that this hasn't gotten more attention than it has basically, the Trump administration made a bunch of requests to Congress. They wanted, to cut the NIH budget by 40%. They wanted to codify some of the controversial steps that Doge tried to impose in the first weeks of the Trump administration in terms of overhead reimbursement for academic institutions. They wanted to move ARPA-H out of, NIH and into a newly created entity that would be charged with implementing the, uh, make America Healthy Again. Ideology. Congress looked at all this and kind of shrugged its shoulders and said, no, we're not doing it right. They, um, appropriated$48.7 billion for NIH. That's an increase of about$415 million compared to 2025. That's a big difference, from cutting 40%, which the Trump administration wanted them to do. That would've put NIHs budget at 27.9 billion. As for this new entity that the Trump administration wanted Congress to create, Congress kinda looked at it and said, nope, we're not, we're not doing that. Same thing for the, uh, overhead, formula that they, uh, they wanted to create for NIH Congress, didn't do it. And in fact, it puts some language in the law, that makes it impossible or difficult, for the Trump administration to do what it had tried to do, in, the early days of administration in terms of overhead policies for academic institutions. And then I should say very quickly, the other thing that was really important in the spending bill, was the reauthorization of the Rare Pediatric Disease Priority Review Voucher program. That's gonna be really important in stimulating development of gene and cell therapies, for very rare diseases, mostly diseases that affect children. in the story that I wrote about it, I listed, uh, about 30, uh. Products that have received designation, rare pediatric designation since the expiration of the voucher program. Now, those products will all be eligible for vouchers If past performance, is any measure of what's gonna happen going forward, probably about 10% of those will end up actually, being approved as drugs and will get the vouchers. And I think that's important because none of them would've gone forward in the absence of a voucher.

Jeff Cranmer:

All right, and, and then there's quite a few other things in there that, uh. Help, kids with rare diseases, get access to drugs, which is, uh, you can read about in Steve's story. Steve, is this like a failure of RFK Junior? Who, like, is it, or is it just sort of like a, you said it was like kind of a shrug, like what happened here? Why didn't, Trump administration is pretty good at getting its way in a lot of, uh, areas, what happened here?

Steve Usdin:

I think it's more of a reversion to the mean, and I think that it's something that we're probably gonna see a little bit more of, um, in the coming year or two. there's very few things that are more popular in Congress than funding biomedical research, and I think that's for a couple of reasons. One reason, of course, is that it affects everyone. there's nobody who hasn't been touched by disease and there's nobody who doesn't hope that American science will come up with therapies that are gonna help them and they're gonna help their loved ones, to live, better lives. There also probably isn't a single member of Congress who doesn't have an institution in their district that receives NIH funding. That's not by accident. Um, NIH has deliberately over the years, spread the money out, in ways. And I think that you could say that that's a good thing. It's, it's very unlikely that all of the good ideas in biomedicine are concentrated in the two or three places where, the leading academic institutions are. But it's also been a deliberate policy in order to gain, support in the Congress. And I think that as, as for some of the other, the other measures, I think, again, the thing isn't surprising to me, for example, that they reauthorized Pediatric, PRVs, the real surprise is that it was such a heavy lift and that it was so difficult for them to do it because it's a no-brainer and because there's nobody, who really opposes it. And even though it's something that has such clear and obvious benefits, it was a tremendous lift, in order to get it across the, um, the finish line.

Simone Fishburn:

Well, I think Steve, you're right. I mean, it's a question of how much more will we see this? This is bipartisan in a way. It's low hanging fruit for something that should be able to get across. and I think people are increasingly concerned about the threat from China and the devaluation, or decimation, or whichever word you want of a US biomedical science. So let's see how this plays out in the, in the rest of the year and then going forward.

Steve Usdin:

I think what really quickly, I think one other place where we're gonna see it, President Trump, came out and said that he wants Congress to codify MFN most favorite nation, pricing for prescription drugs. And I think this is another area where we're gonna see Congress, um, take a look at it, including Republicans take a look at it and say, um, no, no, we're really not gonna do that.

Jeff Cranmer:

Well, well we'll see. Selina, you had a great conversation, on our sister podcast, The BioCentury Show last week. With Steve Paul, Steve Paul, of course, led Karuna Therapeutics, which BMS bought, uh, in 2023 for $14 billion. He's now board chair at Seaport, which he co-founded in 2024, with former leaders of PureTech Health. Selina, what did you learn talking to, uh, Dr. Paul?

Selina Koch:

Yeah, he was also behind Sage Therapeutics, which brought the first, uh, treatment for postpartum depression to the market. And he, before that, spent 17 years at Eli Lilly working in R&D and in neurosciences. So he's seen a lot. He's a veteran of this, this industry. Um. One of the things, when he tells his stories of, of these, how he identified certain kinds of biology and decided to take it forward there is a lot of serendipity in those stories. You're developing something for one indication and you realize if you keep your eyes open, maybe it didn't work for that, but there's a subset where it worked, you know, in a way you didn't expect. And that becomes the germ for the thing that's ultimately successful. And there, there is maybe, more of that in psychiatry than in other areas of drug development, even though it's, of course it's a theme throughout drug development. But something that I think that to me really stood out. You know, you can't build a systematic, rational approach to finding biology based on serendipity, right? You can keep your eyes open for it. But several of his examples follow another kind of theme. And when I was gathering up the, the catalyst, we did this big catalyst project, like what are the milestones coming this year? And I was doing the neuro ones. So I was poking around on lots of companies websites, including across the psychiatry field. So his examples are not unique. Lots of companies in the psychiatry space are taking the approach of looking for molecules that have been in humans before. So when we talk about trying to like trying to find causal biology and base everything on, on human data as much as possible, often what that means for people is human genetics, while psychiatric diseases are very polygenetic, and they have environmental triggers and they're just super heterogeneous more so even than other things that we consider heterogeneous, right? So what does human biology look like? And it seems to me kind of the main theme, the main workhorse right now is clinical data. So there's a long track record of failures, failed clinical trials in psychiatry, but many of those compounds produced interesting signals, but they had some kind of liability that held them back. That was the case in the Karuna story. That's the case with some, some of what Seaport is working on. If you go into Danielle's, series A analysis and you look at what were the three biggest fundraisers neuroscience series a last year, one of those companies was Draig Therapeutics, same thing. These are companies, veterans of Merck, GSK, who worked on AMPA receptor modulators in the past that had safety issues, and they now are coming back and figuring out how to solve those. That really stood out to me as kind of a unifying theme.

Simone Fishburn:

So Selina, lemme come back to what you said before because that sort of worries me. If the unifying, if, you know, if the unifying theme. or one of the major marks of progress depends on serendipity, and you sort of indicated that that might be more the case in psychiatry than other diseases. But if so that would actually actually worry me because as you said yourself, it's not a strategy. So, you know,

Selina Koch:

While, while there is a lot of serendipity, the point I was trying to make is the way you move away from serendipity and do something a bit more systematic using this approach, right, is you, you use the human biology that's available to you, and often that's the form of clinical data, human data from clinical trials. And you mine this large history of failures, for things that actually showed some promise but had some liability associated with them. That was the reason that blocked their progress. And now you do that with fresh eyes using all the modern tools we have today. So the chemistry we can do today that we couldn't do, then the delivery we can do today that we couldn't do then. Seaport is a good example of this it's a delivery play.

Simone Fishburn:

What I think I'm hearing you say that's very interesting is that in psychiatry at least. Given the new tools, there's a lot of reason to go back and look at the things that we couldn't move forward. Weaving the field, couldn't move forward in the past. That, that it isn't really serendipity. It's actually new tools and information that might allow us to build strategies towards making those products where we couldn't before, 'cause we didn't have a precision approach kind of thing.

Selina Koch:

That's right. I mean, that conversation started about, it's still all about serendipity, but which is frightening. I agree with you. But where it ended, or at least for me as I was thinking about it, is it's not really all about serendipity. it's about engineering solutions. So. People always say, okay, we don't understand the biology of psychiatric conditions. We just don't know how they happen. And, and to an extent that's true, but at the end of the day, it's all about synaptic activity in the brain. There's some set of synapses in a circuit or a couple of circuits that aren't behaving the way they're supposed to. So the fact that people are still tinkering with neurotransmitter receptors and ion channels and things is not necessarily a sign of lack of progress, right. Because those are how you manipulate synaptic transmission and normalize neural circuit activity. The point is to figure out why they failed in the past and is there something in today's toolkit that can help do, make you do a more precise, you know, job that that separates the efficacy from those, the safety issues.

Steve Usdin:

So, it's precision, but it's precision with persistence, right? And the persistence is, not just giving up when, when something doesn't seem to work or when something doesn't work because it's too dangerous. But saying, keeping on hammering at it and saying, well, is there a way to, to go around, the problem that's causing the, the adverse effects that make something unacceptable from a safety standpoint.

Selina Koch:

Totally true. And what I think the thing that was so exciting about Karuna is that, because it was successfully, it did that successfully. It was this example that you can do that, and it led to a $14 billion acquisition. So while a lot of pharmas got outta psychiatry right, and it was kind of dead for a while, when you can do that, it shows that there is appetite from on the buy side.

Steve Usdin:

And I wonder, you know, if you look, if you go back in history also a lot of the psychiatric drugs that are being used now have adverse effect profiles that I think if somebody were to come into FDA with them now, they, they might not even get approved in the first place. You know, tardive dyskinesia is not a trivial thing. The other adverse effects that are associated with some of these very commonly prescribed psychiatric medicines are not things that maybe that, FDA or other regulators would accept today.

Selina Koch:

Totally.

Simone Fishburn:

I have one more question on this front, at least from me is you know, the Karuna a very elegant solution. was really a, a solution that is still based on very well established targets and just sort of cleverly dialing out, again, using known modalities, known targets, dialing out the, uh, adverse side effects, which, you know, I, I think there's probably more space for that in neuro than one might realize, but it's still gonna be finite to some degree as a strategy. My question really is to what degree, do you think that new targets and new modalities are going to be a play if you're able to say that in psych, are you seeing, are you seeing that because with genetics we quite often think about going off to genetic target with genetic medicines, right? but a lot of these are not that.

Selina Koch:

That's exactly right. Yeah. So dialing out safety issues, like there's various ways to do that. In the case of Karuna, there's a combination therapy, but sometimes it's making it using different chemistry solution, like making a better positive allo steric modulator. That's one whole side of things, and I do think there's a lot of territory there. Another way to revisit something from the past and do it better is with better delivery. Seaport has one solution to that which bypasses first pass metabolism, you know, and kind of absorbs these things as if they're liquids, but they're not, they're small molecules. Then there's this whole arena of blood-brain barrier shuttles, which is taking off across all of neuroscience, neurology. I expect that will be useful in psych at some point too, or the order not, that's not the first place that's being applied. And there are other kind of overarching strategies with which you can revisit something from the past and do it differently now. Oh one the big ones, which is really nascent, but it's gonna take off eventually, is finding biomarkers so that you can actually match a drug to the responders. Precision medicine, it's happening in cancer. It's been successful there for a while now. We have a few biotechs like Alto Neuroscience trying to do this in psychiatry, in some cases with older compounds because now they think they know, which of this very heterogeneous population is going to respond. We'll see how that plays out. Eventually, it'll work or there's, in the short term or the long term, we don't know.

Steve Usdin:

I imagine the first place you're gonna see it is in clinical trial recruitment and trying to enrich trials for patients who are likely to be responders.

Selina Koch:

Yeah, that's exactly right.

Jeff Cranmer:

All right, well, Selina's, wonderful conversation with, Dr. Steve Paul available, wherever you get your podcasts and like and subscribe and follow our podcast, The BioCentury Show and BioCentury This Week, and we will be back next Tuesday, the day after the US President's holiday, with a fresh episode of BioCentury This Week. And a thank you to Kendall Square Orchestra for creating the music for, all of our podcasts. And a shout out to our production guru Cole Travis, who, uh, keeps things running, at BioCentury with all of our multimedia needs.

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