Hello and welcome back to Better Biopharma, the official podcast of BioProcess Online. I'm your host Tyler Manuel, 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 midyear check-in and editorial roundtable. Now, there are a lot of people in publications present today, so I'll let them introduce themselves, starting with Katie, who is in our adjacent studio in the office right now. Katie.
Thanks, Tyler. Hi, everybody. I'm Katie Anderson, chief editor of Pharmaceutical Online, and it's a pleasure to join you today.
Hey everyone, I'm Jeff Buguliskis. I'm the deputy editor at Outsourcing Pharma. It's great to be here amongst these fine folks here. So, thanks, Tyler.
Ben Comer here, chief editor at Life Science Leader. Happy as always to join this conversation.
Hey everybody, Ray Dogum here, chief editor of Drug Discovery Online. Tyler, thanks for inviting me back. Really excited for this conversation.
Hey guys, Rachel Grabenhofer here, the new face in the group. I'm the chief editor of Clinical Supply Leader, and I'm excited to join you all today.
Hi everyone, I'm Erin Harris, chief editor of Cell & Gene and host of Cellene the podcast. And thanks for having me back, Tyler. And I'm excited to work with my colleagues on this and to talk to the Better Biopharma audience.
I'm Dan Schell. I'm the chief editor for Clinical Leader, and I like all of you.
Hi everyone. My name is Anna Rose Welch, and I'm the chief editor of Advancing RNA. And I'm really happy to be back here. It's always a fun time when you get the Life Science Connect editors together in basically one digital room. So happy to be here.
Thank you, guys. Great introductions. And I'm very happy to have everybody together. This is always a fun time. Those in the audience may recall the last time we did this was, I think, that was our year-end 2025 retrospective. So we figured it would be time for a little midyear check-in. By the time this comes out, it'll be June, midway through the year. 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 just kind of happenings in their respective spaces. As you can see, we have a lot of diverse coverage here in terms of the life sciences industry and ecosystem. So in the same order, I want to go through and see, you know, as far as how this year is going, 2026, what have been the biggest developments in your space? Whether these are things that you're excited about, you think are overall positive, whether they're kind of inviting some scrutiny, you're scared by it, you don't know how it's going to shake out. 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.
Yeah. So I'm sure this will be reflective in everybody's thoughts for this year, but for Pharmaceutical Online, we have definitely seen AI continue in its use in pharmaceutical discovery, development, manufacturing. What I found really interesting this year is that the joint effort of the FDA and the EMA to put out guidelines on AI use in pharma manufacturing, but also it was interesting that a manufacturer did get a warning letter for their use of AI in manufacturing, and as it turned out, they didn't have enough human oversight. And so all of these things combined present unique challenges but also opportunities for the use of AI in pharmaceutical manufacturing moving forward that I think are particularly interesting. We're also seeing continued investment in pharmaceutical manufacturing in the US and abroad. Particularly, there's been quite a bit so far in 2026 in the heartland. So more in Illinois, more in Indiana, Pennsylvania. So less on the coast. I mean, there's still a good amount of investment in North Carolina and the triangle there, but more in the heartland. So I think that's particularly interesting as well.
Thank you, Katie. We'll move on.
So I'll pick up from there. You know, I think Katie's right that, you know, no one's getting around AI, right? I mean, I think it's probably affected all of our industries, all of our titles and so forth. For outsourcing, it's still obviously a big part of that. But I think the things that I'm seeing that are even more a little bit more interesting that we've been talking about a lot, you know, we're getting a lot of focus from sort of, you know, geopolitical friction, legislative pressures and so forth. And we're starting to see shifts in supply chain. You know, sort of the old model of the global supply chain that's been in effect for quite a while, or the hyper-globalized supply chain, is potentially starting to fade away. 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. And you're seeing, you know, more of this onshoring or reshoring back to the US. And, you know, for some drug sponsors, moving away from the multi-faceted, you know, outsourcing, you know, for say something like an ADC where you have multiple points of where you might need multiple CDMOs, some are moving to the one-stop shop and, you know, at least being the supply chain's kind of more localized rather than being global. You know, I think also we're seeing more prepaying is coming along. You know, that's becoming a priority. You know, the capacity issues in certain places, certain markets is still there, others not as much. But what people want instead is, you know, the reassurance that their pipeline is not going to falter. And so 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 products. So yeah, it's been an interesting few months. I think, you know, some of the geopolitical events that have happened, you know, are really taking an effect when it comes to the outsourcing.
Yeah, Tyler, I can pick up there. I think it's interesting that there's this uncertainty, as Jeff said, geopolitical uncertainty. We have a war on, some regulatory uncertainty. But I remember talking about in our last roundtable the positives, and I think JP Morgan was really positive this year. In January, there were a lot of high expectations, and surprisingly, the leading biotech indices are up about a little over double digits for the first five months of the year. I think there's been some pricing in, I guess, of some of the geopolitical risks. April was the most active IPO month in five years. Four companies raised over $1.5 billion in the biotech sector. So I think that's a really good sign. I think that the number of licensing deals that are happening, particularly in early stages with early-stage companies, is also a positive thing to mention. So I think there are some good signs despite, in the macro environment, you know, despite some of the ongoing struggles that are happening all over the world and in certain regulatory agencies.
Yeah, I want to echo what everyone else said. I think AI is still a huge part of the drug discovery space. We are seeing some additional investments from major big pharma companies into AI drug discovery companies. So that seems to be, you know, getting more of an important area for investment for these companies. One thing I think that wasn't mentioned was how the FDA is actually starting to, they announced major steps to implement more real-time clinical trials, especially early stages. I think that's important because for drug discovery, because a lot of the feedback iterative loops that you need for good drug discovery requires, you know, human-level analysis or data. So I think that it's good that the FDA is pushing this. 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, organ-on-chips. One thing that I keep hearing is the use of these tools in conjunction with AI to better computationally analyze what's happening with the data. So that seems to be a big trend. Um, yeah.
Ling Ray here, excuse me. Yeah, I think I can echo a lot of what everyone else has been saying in terms of AI. I'll frame it more as adaptability, though, because that's the kind of the phrase I've seen thrown around a little bit just in the little bit of exposure that I've had to the industry. But really how that's happening, of course, is our sponsors are testing the limits of AI. Obviously, those forecasting abilities, trying to make real-time changes to supply. They're still figuring that out. They don't necessarily trust it yet. But I think that obviously is something we're seeing from the clinical supply standpoint. Also, an old one, but it was mentioned, 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, blocking supply routes or when excursions occur, any number of things. So I think trying to be more adaptable using some of those AI-driven tools. 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. So trying to think ahead and try to anticipate what you can't anticipate. Something that I've heard from a few 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. So those are some of the things that I've been seeing.
Yeah. So I think from a cell and gene therapy standpoint, some of the things that I've seen throughout 2026 so far is that it seems to be a much more execution-driven process. You know, we're seeing a lot more focus on industrializing the field. So of course, AI, which we've all talked about here, and AI-enabled process control automation, you know, clear modular manufacturing. I think to echo what Ben said earlier, more disciplined deal-making. We're also seeing in vivo approaches and smarter delivery platforms. They're getting a lot more attention, which tells me that the field is expanding beyond traditional ex vivo. You know, there's Intellia Therapeutics' in vivo CRISPR, excuse me, therapy, Livo Z. There's Regeneron's Otarmony, which is really a defining moment for in vivo gene therapy and hearing loss. And so basically moving from ex vivo to in vivo, really what that means for gene therapy is, or excuse me, therapy is simpler, faster, more accessible treatment for patients. I think another interesting shift we're seeing is how much more effort is going into getting beyond the liver. So whether that means like the lungs, the lymph nodes, kidneys, pancreas, CNS, you know, other tissues that have just been traditionally much harder to reach. That's really where it's still a very big technical and clinical challenge, but we're making progress. And then finally, what I'll say on the regulatory front, so separate from this conversation but still in conjunction with it, I think certainly I for Cell & Gene, and I think a lot of us on this call are either working to build or perhaps restructure our editorial boards. And so I reached out to one of my go-to regulatory experts who's on our board, Dr. Danielle Adrago. She's a partner with NDA Partners, which is a ProPharma Group company. And I asked her, you know, really for her insight on what she truly sees as going on from a regulatory standpoint in cell and gene therapy. She really went long on exactly what we've seen so far, but to kind of put a fine point to it, she's saying that FDA, you know, signaled, excuse me, a more flexible case-by-case approach to cell gene therapy regulation, especially around CMC and comparability, and, you know, trying to tailor safety assessment in especially genome editing therapies and detailed recommendations about how sponsors should characterize the off-target effects. So that's coming right from her, and so a good source of information for that. So that's what's been going on so far in terms of 2026 for Cell & Gene.
Yeah, I say for me, it's what Ray had mentioned earlier about the real-time clinical trials initiative that the FDA just announced. To me, it's probably the biggest thing that's going on now. 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. Automatic extraction from EHRs. So this is exciting because my industry has always been very slow in our development timelines. 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. So that's why they initiated this. So big advantages, you know, detect safety problems earlier, reduce delays, things like that. For me, for clinical trials, some of the things that we're worried about are changes to monitoring models, site workflows, CRO responsibilities. You know, if you're sending data early directly to the FDA, you're bypassing some folks in that whole ecosystem. So it's not being welcomed, you know, with open arms, but it's definitely something that we need to improve for clinical trials. There's a lot of fears. I even had a conversation yesterday with our coworker John Ania, who runs our clinical tech site, and he was talking about the whole premature judgment here, right? 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 administrative issues that are going on.' That all can be discussed later on, but I mean, there is definitely some skepticism when you're talking about pushing for protocol changes midstream. But it could discourage continuation of the whole program. So there are concerns. Clinical trials have always been messy. There's lots of different signals that change throughout, especially early on, and that's what we're talking about, early on. And so, I mean, just because there's some bad signals that are coming in early on doesn't mean that those are going to not go away. I mean, that happens a lot. So this is a big deal for us. So I would say that's the biggest thing going on, the FDA's real-time clinical trials initiative.
So I focus predominantly on the RNA space, which is split into what I call two different categories, right? So I'm going to try to outline a little bit of what I've seen in both the mRNA or the coding RNA space as well as the oligo or the non-coding space. But 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 organization took over the government, I would say there's been a lot of skepticism in the space as a whole. Obviously, things have felt somewhat slow in terms of moving us beyond the world of vaccines into therapeutics. But I actually think that the mRNA space, I'm going to take a hopeful approach here, which is funny because most people call me the sunshine of the office for a reason. And they do not mean it in a positive, happy-go-lucky way. Dan Schell is shaking his head. He is in the cube next to me, ladies and gentlemen. But I actually think that the mRNA space, despite all of the political hang-ups it's experienced, has been going through a period of transformation. I think we're still very, very optimistic about what's ahead. 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 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. You know, I was just at the USPAMM 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. I see this element of transformation happening as well because there's still a lot of hope in what the modality can do. And I think Erin hit on this beautifully. In vivo, in vivo CAR-T has become a really hot thing. I was going to 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. But we just saw last week or a couple weeks ago that Lilly acquired, which is another in vivo CAR-T company working with circular RNA in particular. So there's a lot of hope as well in what mRNA can continue to do. And I think there's still some effort to maybe get over some of the growing pains we've experienced from vaccines. I think there was some news in the past week about BioNTech 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. We're right-sizing demand, which is a huge part, I think, of a maturity of a space. On the oligo side of things, I'm still learning. This has been an area that I've overlooked a little bit over the past couple of years, to my bad. But I have started to attend conferences in that realm, 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. Are we a small molecule? Are we a biologic? And how do regulators actually see us? There is some guidance. 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. And, you know, it is in line with an EMA guidance for the most part, but there are a couple of areas that suggest differences in opinion between the regulators. And a lot of the time, I think this is something every space overcomes early on, especially is scientific differences between the different regulatory agencies. 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. So I'll stop there on the RNA front.
Thank you all so much. I love getting a bird's eye view of the industry from hearing from everybody. It's not often that we get to so candidly just kind of share everything that we're seeing in our space. And as I kind of guessed, the common through line that touches where we, the common ground for all of us is in terms of coverage in our spaces is regulatory. And so the regulatory instability that we're seeing kind of, I think, aligns with what we were saying back in December, like there was a lot of uncertainty there. And I like to think that the FDA is getting a bit better. I was reading some headlines this morning from FDA press releases that they are, there's two things that they're doing right now. The one is a one-day inspectional assessment as part of a broader initiative to make its inspectional resources more targeted and efficient. Good buzzwords. Hope that they can do that. And the other FDA news I was reading this morning was about their kind of all-in on AI, which we knew last year, but 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. This is a quote from significant reviewers to investigators. And it looks like they're also consolidating a bunch of, it says the 40 disparate application and submission data resources, systems and portals into HALO, Harmonized AI and Life Cycle Operations for Data, which is, quote, expected to enable more penetrating deployment of AI capabilities within agency operations. And I think that kind of aligns with what we were talking about before with the FDA trying to just be more efficient. And Dan, like you were saying, there's a lot of dead time there. For those who don't know, I actually worked in clinical research for a couple years. So I firsthand was in the trenches with the paperwork, experiencing the inefficiencies. So I think any moves that the agency makes to digitalize and streamline in that way is a net positive. And another thing...
Oh, go ahead. Go ahead.
Yeah. No, I just, you made a good point. And so did Dan about how there's a lot of dead time waiting for results and feedback from the FDA. And for drug discovery, I just want to say that's really impactful because that's payroll time. That's time you may not, you know, you might not have enough time to finish your studies. So actually, this is really a big deal for drug discovery. Just a quick point.
Yeah. I mean, I can imagine especially in a startup environment too, right? Like where I'm sure most of the people in your audience are. That's nothing to shake a stick at. Every day of paying without any progress or movement towards clinical readout. 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 data needs to be in some type of system, right? Well, the overwhelming majority of clinical trial sites are still using paper. I mean, I'm just going to put a theory to that and let that sit in for a while. And people can debate with me on that and there are different, you know, percentages and everything, but a lot of them still using paper. So they don't have these integrated systems that all these AI tech folks are coming forward and saying this is going to revolutionize things. You know, it's a cultural shift. It's a mind shift and it's going to take a while. So that's the only thing I'd add to all this.
Well, I wonder, I know like many years ago we had some regulation to force hospitals to start using EHRs. Is that happening in like the clinical research space as much? And are there incentives, like financial incentives for these clinical research organizations to actually deploy this kind of tech?
Yeah, I would say there are, you know, from an efficiency standpoint, every AI company is going to tell you that if you don't do this, you're going to lose money or you can save money by doing this. 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 trial itself, you know, all that data or all that paperwork that the commissioner was talking about.
Yeah, I was there as recently as 2023 and I used to have to initial adverse event things on paper. I mean, we, and to answer your question right, I mean, most hospitals do operate on electronic medical record, but that has to be, you know, my job was taking that from patient visits and putting that into the clinical databases which are a bunch of different, um, what are they called? CO. No. Um, I'm blanking. Dan, what's the word for the electronic databases that these studies use?
CTMS.
Yes. Yes. Those, they're all using different ones.
Trial management system.
Yes. Exactly. And so, and plugging it in, but also keeping a red, you know, paper copies for, I guess, redundancy and just his legacy regulatory precedent was everything that is in both the electronic medical record and the clinical trial management systems also need to be on paper somewhere. And it's just a slow-moving industry. It's highly regulated as we all are aware. So it's good to see progress on that front, but I'm sure it'll be a while before we're, that you're talking about there's no more paper in clinical research and significant dead time. Another thing that Jeff, you mentioned about 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 other factors. Just shamelessly going to plug an event that we're doing a couple months in August. We're going to 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 CDMOs and partners, how to manage ADC tech transfer in that ecosystem. So stay tuned for that out there in the audience.
Tyler, I'll see your shameless plug and I'll do you one better that's sooner coming Monday. We'll be talking about ADCs and, you know, sort of all things one-stop shop versus multi. And I think will be a big part of that event. We have some really great folks. One of our editorial board members is going to be involved in it and some other consultants, you know, who are well-versed in the industry, been there for a number of years. So, you know, again, tune into that as well. I think it's certainly stuff that is not going away, right? We could talk about this probably at nauseam for, you know, many, many weeks and still not scratch all the surface. But you're right, though, it is something that comes up a lot, like all of these different areas, whether it's ADCs or any other type of, you know, multi-art drug, you know, cell gene therapy obviously runs in the same thing as Erin knows very well. And, you know, getting your APIs from one place, the old adage like, well, the API is coming from China, you know, and now we have to then onshore it and or bring it to Europe or something like that. And so all of these, you know, companies are rethinking that with, you know, the administration's new rules, you know, for onshoring. And while it hasn't been all bad, the, you know, the companies have, many of the CDMOs have taken it in stride and said like, yeah, we just, we need to get stuff done and we're going to do this. The one sort of slow-moving issue that's come up when it comes to the onshoring is we're seeing a talent crisis that's cropping up. So the number I saw for coming up 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, you know, jobs. But a lot of the talent within the US is either somewhere else, like in Europe and other parts of the world, because that was where it was needed, or it's clustered in, you know, obviously areas that we all well know within like Boston or, you know, San Diego, San Francisco, that sort of thing. You know, East Coast, West Coast areas. So it's going to be interesting the next, you know, couple of months to years to see how that all plays out and, you know, what we're going to do to try to fill that talent crisis.
Yeah, absolutely. I spoke with Herman Boozhart earlier this year actually about the talent, quote-unquote, talent crisis and specifically as it relates to CDMOs and their talent supply. And I'm happy that you were able to plug that. And unfortunately, this will be in the past, but if you head on over to Outsourcing Pharma, you'll be able to see the live event recording that Jeff is referencing. And that's actually a great segue into the next part of our conversation. 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 respective spaces. From events coming up to podcasts to editorials. I want everyone to go around and kind of share what are your favorite projects of the year so far. What are you looking forward to? And also in terms of events, whether they're internal events that we're putting together or industry conferences you're looking forward to, shows, I just want to go around the horn and share the exciting things that we're all working on and looking forward to. Starting back with Katie.
So many exciting things. We did a live last month on proactive contamination control and aseptic fill finish. That was a really popular live, a fun discussion. You know, at the end of the conversation, it went back to, you know, make sure you get into the facility and don't manage it remotely. But really the proactive approach to different elements of manufacturing is something we're really focusing on this year. There's an upcoming live that I have on documentation and the transformation. We talked about this earlier, but the transformation to a more digitized system and really being proactive with making sure that your documentation is electronic and digital so that you can be ready for that inspection. 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 going to be focusing on all year.
That's great, Katie. Jeff.
Yeah. So I got three things I'll talk about real quickly. Well, all of the live events so far and coming up are, you know, they've been great and we always look forward to them. I think it's a, you know, fairly well-established medium. Lewis has done that for years and, you know, I'm trying to pick that up and run with it and it's been great. But I have two new endeavors that are coming out. One that, you know, has been going really well called the Outsourcing Advisor and the idea being just to, you know, talk to a lot of folks in the space, drug sponsors, and address really a lot of the pain points and ways that we can, you know, help out our, you know, folks within the biotech and pharma space who are, you know, doing endeavors with outsourcing companies and make it a sort of a resource, a quick resource. So a lot of the videos that I'm recording are, you know, in different formats, different ways, days, but, you know, the one overlying theme is, you know, to not only be helpful, but I'm trying to make them short and sweet. So some of them are only eight to ten minutes long. And, you know, trying to make it so that people can, you know, watch them quickly, get the information they need and move on. So that's been a lot of fun and continuing. And, you know, if anybody out there's listening to this and wants to be involved, you know, shoot me an email or something. I'm happy to take all those folks for recruiting. The other one that's been a little bit slower, but I'm looking forward to it. I've had some bites here and there is, you know, my background is in infectious diseases. Trained molecular parasitologists, right? Did work in malaria, did work in toxoplasma and so for a number of years. And, you know, we thought with that and something I always keep an eye on, you know, how can we merge sort of, you know, outsourcing with, you know, infectious disease things. And there's some really interesting ways, you know, when pandemics arise or when a new outbreak arises or something, you know, just even, you know, an old disease just kind of crops back up again, you know, how do we get the drugs to the, I mean, how do we ramp up that production? How do we, you know, do all of that? And there's lots of spaces, you know, the Gates Foundation, you know, the Chan Zuckerberg Initiative, all of these have really kind of, you know, invested a lot of time and money to address sort of these things. You know, WHO obviously as well. And so these are the folks that I, you know, I want to try to talk to. I've been reaching out to some people and I've had some bites here and there. I'm hoping that someone from the Gates Foundation, you know, we're trying to work that angle and maybe in the next month or two we'll be able to talk to us. Not Bill, I wish it was, but, you know, but someone from the organization high up. So that'll be a lot of fun. And then the third thing is, you know, obviously we just had last month the CDMO Awards, every year, 15th annual, which was a lot of fun, successful event. I think that came off and I think all of our partners that were involved, you know, had a good time and, you know, in New York and it was a good time first for me. So.
Awesome. Thank you, Jeff. Ben, what do you got cooking?
Well, since we're talking live events, I'll just mention one recent one that I thought was really interesting. Life Science Leader live event on radiopharmaceuticals, new opportunities, overcoming operational challenges. We had three CEOs that are developing three different radioisotopes. And I thought, you know, it's interesting because a lot of new isotopes are emerging. And to several Jeff and others' points about supply chain, it's especially acute in radiopharmaceuticals because of the half-lives of the isotopes. It's a just-in-time type of delivery. There are a number of redundancies needed because of the scarcity of availability of certain kinds of isotopes. And so hearing those three CEOs talk about three different isotopes and the kinds of challenges that they've had to overcome, I think is useful, particularly given the number of companies that are coming into the space and the number of billions of dollars that have been spent by large pharmaceutical companies buying up startup and small to mid-stage radiopharmaceutical companies. Anyway, that's a Life Science Leader live event that you can find on the Life Science Leader website. As far as upcoming things that I'm excited about, Tyler will be in BIO together in a month or so. So really looking forward to that. Be recording some podcasts and doing some reporting from BIO. And maybe just the last thing I'll mention, kind of following on what Jeff was saying, I had an opportunity to catch up with Life Science Cares a month or two ago. And I was really pleased to see how much larger that organization has grown. It's now 10 years old and it's a voluntary organization, but is focused on educational needs and nutritional needs in the big biotech hubs that we've talked about, addressing those communities directly and doing it on a voluntary basis. But hearing about the impact, the number of cities that that group has expanded to, they're now also in Switzerland, is a real bright spot, I think, for the industry.
I have a few things cooking as well here. So one thing is we have a Drug Discovery Online partnership with Nucleate Boston. So Nucleate is an accelerator program mainly focused on biotech startups and helping them develop their solutions and understanding their problem and markets and also helping them find investors. So Drug Discovery Online will be doing some interviews with them. They have sites and chapters all over the world. It's a global nonprofit organization and their Boston headquarters is their flagship site. So I'm pretty excited for that one. Drug Discovery Online is developing its editorial advisory board. So if you are interested actually in kind of, you know, being a voice and trying to help our editorial team guide this space, I'd love to talk to you and see, you know, what we can do together. There is a Drug Discovery Online live event on June 30th. I'd like to plug here on PROTACs. What's interesting about PROTACs is, you know, these molecules have been around for quite some time, but only in like the research lab setting. Just recently, Arvin, which is one of the companies developing these drugs, did get FDA approval with Vepu, Vepenu, to treat advanced HER2 breast cancer. So I think it's starting, this modality is starting to get some more attention and, you know, ground in the space. So I'm really excited to have that panel with somebody from Cold Spring Harbor and a startup using synthetic biology for PROTACs. 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 RhoGAM. 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 fetus is blood type Rh positive while the mother is Rh negative. So essentially the mother's immune system would attack the baby after the first baby is born. So the second baby would be affected almost like very consistently. So this was a big problem in history for a long time until this physician, Dr. John Gorman from, you know, Australia. I am trying to get an interview with him. So I got his email, working on that. So I'm just excited to hopefully chat with John. But yeah, that's what I got. I'm sure I got more, but I'll leave it at that.
Awesome. Ray, thank you for sharing. Rachel, what are you working on?
Yeah. So I'm kind of in a unique position in that I'm forging a new path, I guess, if you will, with the help of our acquisitions editor, Elizabeth, because Clinical Supply Leader is sort of a fledgling. It's a spin-off from Clinical Leader in that community. 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. In addition to that, networking. So I've had some interviews. Those have been a lot of fun and the more people I talk to, the more apparent it seems to become that clinical supply has sort of a unique expertise. So it really kind of warrants its own community. So I'm advocating for that. I was really glad to hear that, of course. But yeah, I...
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. And also, same thing, we're building an advisory board, so we're looking for experts in that area if there's anyone who wants to raise their hand. I'm open to suggestions. One of the other things I'll say is I'm looking forward to hopefully in the fall getting out to some events to meet some people in person. So, watch for me maybe this fall. I'm looking at the GCSG, the Global Clinical Supplies Group is doing its European knowledge forum in October, and also SCOPE next February. I'm sure many of us are headed to that. And there are some other clinical trial supply events too later this year. So, we'll see what happens. 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. So, glad to be here.
Awesome. Awesome. Rachel, thank you. Erin, what's cooking on your site, Cell & Gene?
Yeah. So, I am currently working on and recording a five-part special series for Cell & Gene, the podcast, on in vivo CAR-T. You know what I talked about at the top of our call. The first episode I think airs on May 30th and it'll air every Friday for five weeks until it concludes. And I already recorded a conversation with Dr. Cassie Gorsuch of Precision Biosciences. I'm talking to people from Beam, from Ray Therapeutics, Obsidian, and a few others. But anyway, I'm really excited for that to come out. The podcast airs every other Thursday. This will be every Friday right in a row until it concludes. I think it's... I'm excited for it. I think it's going to help our listeners quite a bit on the topic. Live events, there's a Cell & Gene Live. There's a month in the year there's a Cell & Gene Live that you can tune into. No, not really. I think we do about 10, 11 a year and the rest of the year we have some really excellent topics. We cover, of course, manufacturing, supply chain. One that I'm really excited about and have been fighting for to get on the editorial calendar, if you will, for our live events is how non-oncology indications. And so specifically, I think it's in December, we're doing one on targeting cardiovascular disease with precision gene editing. So to the Better Biopharma audience, if you're interested in that, please do register for it. It's a free event, about an hour of your time, and I promise it'll be worth it. And in terms of travel, so my travel ends up being kind of toward the end of the year typically. I'll of course be heading to the Meeting on the Mesa event in October, Meeting on the Mesa, excuse me. And then I'm going to be at Advanced Therapies in Boston in early November. I'm moderating a conversation, a panel discussion on AI's impact on cell therapy. So that should be good. I'm going to try to get to some local Philadelphia smaller events. In fact, I'm going to one tomorrow. By the time this airs, it will obviously already have passed, but hopefully I will have some written editorial that people can check out and see what the show is about. Tomorrow's, it's called the Philly Gene Therapy Annual Conference. So, yeah, that's what's... that's what I'm working on.
Awesome. Erin, I had a quick question about the in vivo CAR-T series you're putting together. That sounds very fascinating. And for reference, I love the concept of in vivo CAR-T. Like, when I first heard of it, I was like, 'What? They're doing what now?' And I think actually to date, one of the top performing episodes of this show was featuring Interius Biotherapeutics about their in vivo CAR-T. So I'm curious to hear, are you focusing more so on like what aspect of it? Is it the general development? Is it manufacturing? Is it clinical approach? Is it... what can people expect from this series?
It's actually soup to nuts. So it's cell therapy, gene therapy, the manufacturing, the safety of it, and the skepticism of it. Not everybody is on board with thinking that in vivo is going to be the answer that everybody thinks it's going to be. So what's nice about having the kind of broad range of companies is, you know, they all target different aspects of in vivo. So, yeah, I highly recommend anybody who's interested in it to check it out. The professionals and the leaders who we're having on the series are really dialed into what it is their company is doing. So, I'm looking forward to it. But I guess to a finer point, it's everything you just mentioned, soup to nuts of in vivo.
I'm looking forward to that as well. Thank you for sharing. Dan, what's going on in Clinical Leader?
For me, diversity in clinical trials has been something that I've been a big advocate for. It's been a big problem in the industry for a long time. It's nothing new. 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. And so, I'm always for anything that's going to move that forward. So, that kind of leads me to this weird story. It was a rumor that I wrote about about Walgreens. So, why is Walgreens related to diversity in trials? Because about three, four years ago, companies like CVS, Walgreens, Walmart, Kroger, they all said, 'Hey, we're going to get into the clinical trials business.' Basically, that's going to expand diversity for inclusion, the amount of people that can participate in clinical trials because we have a ton of these pharmacies nationwide. Spoiler alert, that plan did not work. And Walgreens, I heard a rumor about two weeks ago is backing out of the whole thing. CVS backed out like a year later, or a year earlier. So I wrote this like newsy article about Walgreens backing out. They wouldn't give me any comments on the record and everything. I tapped into my editorial team and or editorial 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. 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. I mean, and there are a ton of these little ones. And you know, the idea is, oh, I know my pharmacist really good, and so if I'm going to go in to see him or her, she's going to say, you know, you're taking this particular drug, you might be good for a clinical trial. We can do that right here in this other room. So that operational part of it is not easy. But my point is, the model, the idea of running trials at pharmacies might still be alive, and it's going to be alive not in the big retailers because all those folks are pretty much either scaling back or getting out of it. It might be alive at these smaller places, and that will help diversity. So that leads into my July Clinical Leader Live is on diversity. I do one each year on that. Always super popular. So that's that. I've traveled a lot this year already. I traveled every month. I'm on my way to London in two weeks to the Clinical Trial Tech Congress. And then in the fall, I travel almost every... I travel a lot in the fall to a lot of them. So, I'm out there. So, in many ways I'm out there, right, Anna Rose?
Dan's responsible for hogging the travel budget. I guess that's all I'm getting out of that. No, that's awesome about the independent pharmacies contributing to the CL. I think that's a great, like you said, operationally. I think that makes sense as a paradigm. I hope that we see more progress there.
Hey Tyler, if you don't mind, I just want to ask Dan one follow-up on that. Dan, what do you think is the primary reason why CVS and Walgreens couldn't make that model work?
Yeah, that was it. You know, I mean, that was obviously a big question. And when you're talking about large retail giants and they're saying, 'We're going to start this new business entity that's going to 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, hold on a minute. This is going to cost us a lot more. We're not going to make as much money on this.' That's why CVS realized it quickly, whether or not they say that or not. I'm pretty sure that's what happened with Walgreens because last year Walgreens got bought by a PE firm, 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. This clinical trial thing is going to take a while to get off the ground and everything. We're going to have to invest in infrastructure and people and everything.' You know, so I could be totally wrong, but I don't think I am.
So, like more complicated and more upfront than they expected.
Absolutely. Yeah. Absolutely. Everybody, and let's face it, that's the big argument for everything, right, in all of our industries. Like all these AI companies are coming in going, 'Hey, there's a niche in there that we think we can fill and it's going to be really easy.' And then they get in there and then they disappear. So, hey, I'm going to have to drop out here, guys.
All right, Dan. Well, thank you so much for joining us. Is there anything you want to tell the audience before dipping out of here or share?
No, I think I've covered everything. I'm going to be around. You'll see me. And 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. Very, very early stages right now. We're looking into that.
