Life Science Connect Editors' Roundtable: Wrapping Up 2025 And Looking Ahead

This week's special holiday episode of the Business of Biotech brings seven chief editors from the Life Science Connect family together to talk about the life sciences industry topics, trips, and reporting that mattered most in 2025, and what each editor has planned for 2026. From the RNA, cell, and gene therapy space to small molecule manufacturing, bioprocessing, drug discovery, and outsourcing, the editors weigh in on key industry trends, new developments, and policy surprises from their respective coverage areas. Topics include biotech funding dynamics, FDA leadership, China's growing role, favorite holiday movies, and much, much more. Special thanks to Tyler Menichiello and the Better Biopharma podcast for hosting this roundtable discussion. Happy New Year!     

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Transcript

Two Shows, One Special Roundtable

Ben Comer 0:03

Welcome back to the business of biotech. I'm your host, Ben Comer, Chief Editor at Life Science Leader, and today's episode is a departure from our normal programming, chatting with biotech and pharmaceutical builders, movers, and shakers. Today we're turning the microphones around on a selection of Life Science Connects family of editors, myself included, to find out what's happening in their unique coverage areas, what motivated and surprised them last year, and what's on deck in 2026. I hope you enjoy the episode. And remember, if you'd like to watch a video cast of any Business of Biotech episode, you can find them under the Business of Biotech tab at life scienceleader.com. We'll be back with insights from industry leaders next week. And as always, thank you for listening.

Tyler Menichiello 0:54

Hello and welcome back to Better Biopharma, the official podcast of Bioprocess Online. On this very special episode, I am joined by my fellow chief editors from the Life Science Connect ecosystem to film an editorial roundtable where we're going to discuss our favorite projects throughout the year and our outlooks for 2026. Joining me is our chief editor for Pharmaceutical Online, Katie Anderson, here in the studio.

Katie Anderson 1:17

Hi, everybody.

Tyler Menichiello 1:18

We're also joined by Dr. Jeff Bugaliskis, Deputy Chief Editor at Outsource Pharma.

Jeff Buguliskis 1:23

Hey, Tyler, thanks for having me.

Tyler Menichiello 1:25

Thank you, Jeff. Joining us also is Ben Comer, Chief Editor at Life Science Leader.

Ben Comer 1:30

Glad to be here, Tyler.

Tyler Menichiello 1:32

Ray Dogum, Chief Editor at Drug Discovery Online.

Ray Dogum 1:36

Hey, Tyler. Appreciate being here.

Tyler Menichiello 1:38

Erin Harris, Chief Editor at Cell & Gene.

Erin Harris 1:42

Hey, Tyler, thanks for the invitation. Happy to be here.

Tyler Menichiello 1:44

Of course. And last but certainly not least, Anna Rose Welch, Chief Editor at Advancing RNA.

Anna Rose Welch 1:50

Hi, Tyler. Thanks so much for having me. I'm thrilled to be here.

Tyler Menichiello 1:54

I am so happy to have you all here. I've been looking forward to this for weeks. And since this episode is dropping on New Year's Eve, I found it fitting to go through what we've done through the year and really, you know, reflect on our spaces and our markets and industry and just share what we are proud of that we've worked on and what we're excited by. So thinking back on this time last year, how do you think 2025 compared to your predictions and expectations that you set forth in 2024? What ended up happening or not happening that you thought would? Ben, you're in my top left. Let's start with you.

Ben Comer 2:27

Yeah, I think uh from uh like a macroeconomic perspective, I expected at the end of last year for the funding situation to have improved more than it did. I mean, I I think it's gotten a little bit better. There's maybe been a slight thaw in biotech IPOs after like a total freeze uh earlier in the year. Um, but uh, you know, it it's it's still fairly sluggish uh in the public markets right now.

2025 vs. Expectations: Funding Reality

Ray Dogum 2:56

Yeah, actually on that note, Ben, I just wanted to add, I think like the second half of the year it's uh it's improving a little bit. Uh we've seen it improve a little bit, but for drug discovery, like the early stage science and research stuff, I feel like the funding environment is still pretty hostile for those groups. So at least that's what I'm seeing.

Ben Comer 3:16

And there's probably some knock-on effects, you know, from the NIH cuts uh and that kind of thing.

Ray Dogum 3:23

Yeah, no, absolutely. During the shutdown, there was actually uh 75% of the NIH employees were fuller furloughed, so definitely slowed things down a bit.

Erin Harris 3:33

Yeah, I'll jump in here from a selling gene perspective. Uh echo completely what Ben and Ray have both said. You know, 2024, uh, the start of 2024 was a period of clinical technological validation, if you will. There was a lot going on with um a strong financial climate, but cut to early 2025 and it really moved into a more risk-averse funding climate. Um and now same thing I think. Yeah. And now um for cell and gene therapy, um the focus is in 2025 has been on commercial viability and scalability for advanced therapies, um, even among what is clearly a more, like I said, risk-averse uh investment climate. So um with industrializing, it's not the best word to use, but um, you know, I get yeah, optimizing industrializing manufacturing being the goal.

Tyler Menichiello 4:39

Yeah, I definitely picked up on that risk aversion you're talking about. It kind of felt like it was a noticeable shift, I thought. And Anna, you're also speaking from the advanced therapy space. Do you agree?

RNA’s Crosswinds: Politics, Deals, Uncertainty

Anna Rose Welch 4:51

Well, so in looking back on, you know, just some of the outlook based off of what I talked to folks, you know, at the end of 2024, going into 2025, what I think was interesting in that nobody somehow i in the RNA space really seemed to put together the impact that Trump taking office would have on the mRNA space in general, which in turn leads to a lot of sort of regulatory uncertainty, um, a lot of uh just general, I think, risk aversion um around the technology for mRNA in particular. So you have, I think this year, you've seen this weird sort of, I don't know if I want to call it a double-edged sword of effects where on the one hand, you've seen sort of a lag in funding for and a lag in faith, right, in mRNA technology overall. Um but then at the same time, you've seen these really inflated deals come through from big pharma for certain mRNA in vivo products, right? Which I think is kind of a really interesting reflection of some of the work that's being done in the advanced therapy space overall and some of the challenges that we face with the autologous, the ex vivo, right uh spaces to try and industrialize that. There's been, you know, you had um BMS and orbital um deals, you had AB and Capstan and the In Vivo Carti spaces. Uh, you had Verve and Eli Lilly strike a deal around there or be Verve be acquired by Eli Lilly for their in vivo gene therapy. So we've seen some really huge platform deals, which is somewhat unusual in the mRNA space. Um, as well as, you know, in the in the oligo space too, Novartis and Avidity for their antibody oligonucleotide conjugates, right? So there's been some interesting platform deals, but all in all, I think there's still somewhat of a slog, and a lot of that has to do with some of the regulatory and political uncertainty impacting that that RNA space in general.

Jeff Buguliskis 7:02

Yeah. So I'm gonna I'm gonna chime in and be a little counter to everybody else, but I haven't been here for the full year, obviously. But I have the luxury of being able to speak with uh our chief editor, Louis Garguilo, about the space, you know, and where we've been pretty aligned on stuff. But obviously, you know, for outsourcing, we're not dealing with funding issues as much, right? Where, you know, you guys mostly can write about you know pre-clinical type stuff, which does require a lot of funding. We're seeing a little bit different stuff. You know, there is, you know, outsourcing seems to be, you know, still riding uh a lot of waves. Uh, there's been a lot of uh production work. Um, and the thing that would affect it the most in theory would be, you know, the tariffs. Um, and I think everybody was very, you know, antsy in the beginning of the year, going, like, you know, what are these? How are these tariffs going to affect everything? You know, what is it gonna impact is it gonna have? And, you know, Louis and I talked about it, and basically what we came down with, and and he's written a uh a bunch of articles about this, is really the resiliency of this outsourcing space um and how they were able to shift, still making products and and sort of in some cases sidestep tariffs. Um, so for example, there were certain companies, uh, European-based companies that basically decided, hey, we have enough money, we're gonna build plants in the US and we're gonna sidestep the tariff. Um and they were able to do that, and production still went on. And, you know, um the GLP one wave is still there, and I think people were worried about capacity for a really long time, but that seems to have subsided. And you know, I think uh everybody kind of got on the same page and and things have been running pretty smoothly so far from my perspective.

Katie Anderson 8:44

Well, I think, you know, no one really could have predicted how big the investments in pharma pharma manufacturing facilities was really going to be for 2025. Um, you know, we knew after the the announcements earlier in the year that companies were planning on investing heavily in manufacturing. I mean, but just look at some of the billions of dollars that they're putting towards these new facilities um all over the US and abroad. Um it it's I'm excited to see uh what's gonna happen there in the future. So and I mean, we know some of it was already pre-planned, but um more than I think any of us could have anticipated.

Outsourcing Resilience And Tariff Workarounds

Tyler Menichiello 9:31

Yeah. Yeah, and that raises a good question I wanted to ask you guys too. Is like, what were you maybe most surprised by? I mean, me, I I can go first and say maybe this is just my naivety talking, but I did not see the severity of turnover at the FDA, you know, at the beginning of the year. Like I didn't foresee that. Um I I don't I forget what when the cutting the funding cuts hit to NIH, but I also, you know, I didn't see that coming. Maybe I should have, but I I didn't see it coming or at least having the effect that it did. So maybe let's go around the horn and see if there's any other kind of surprises that you were like, whoa, I always have wrote about this.

Erin Harris 10:08

I'll just say I didn't I didn't necessarily see the uh high profile brief resignation reinstatement of uh Dr. Vinay Prasad. Um I know that was around the regulatory uncertainty, um, kind of that forced sector-wide re-evaluation of AV vector safety um and trial design, uh kind of what was going on at Serepta. But um he was uh you know removed from his position, reinstated. But I I I don't quote me on the timeline, but it was pretty quickly a pretty quick turnaround.

Katie Anderson 10:48

With two weeks or something. Yeah, yeah.

Tyler Menichiello 10:52

We're quoting with laugh.

Katie Anderson 10:53

With laugh is very nice.

Erin Harris 10:55

It was very quick. Um, but I think that you know, there's you know, just the with Peter Marks and Nicole Verdun and the the various people who have since gone on left the FDA have gone on to other things at other roles. Um I I'm hoping for a more steady 2026.

Manufacturing Surge And Facility Investments

Speaker 6 11:20

Yeah. And Erin, you have you know a lot of connections to kind of the older FDA, at least. I mean, I know you've talked personally with Peter Marks and uh Nicole Verdun. Like, do you have any connections at the new FDA or is it completely or is anybody actually if you have if anybody in the in the group has connections to the FDA, let us know.

Erin Harris 11:39

I I personally uh do not um at least, you know, as I I don't, I'll leave it at that. Yeah.

Katie Anderson 11:48

I always think that you know all the all the new legislation um from the FDA, all the new um actions are are great to see, right? They're exciting. But now we're on our fifth director of of CDER, and frankly, there's not a lot of long-term leadership left in the FDA. So the execution of some of this new um these new um policies, like how's it going to happen? Who's going to do it? Who's gonna lead it? Yeah. That has like a good working knowledge in the industry.

Biggest Surprises: FDA Turnover And Morale

Anna Rose Welch 12:27

I think I would I was gonna add on a little bit to what Aaron said. I I perhaps should have anticipated the resignation of of Peter Marks. I feel like hindsight though is still 2020. I just I would say of this year, nothing quite hit me, both practically and also emotionally, like finding out about the resignation. I remember it was like a Friday night at 10 30 p.m., right? Which is what else does a single woman in her 30s do but scroll LinkedIn on the couch at 10 30 at night on a Friday? Um, I mean, really. And I remember feeling sort of like I was hit by a truck, you know. And I think I I vaguely think I remember texting Aaron to just be like, Aaron, yeah, what what WTF, you know, like what just happened? It's a big deal. Yeah.

Katie Anderson 13:18

It was huge.

Tyler Menichiello 13:19

Our editorial group chat was in a frenzy that you know from the follow of that. I remember.

Anna Rose Welch 13:24

I mean, I I can think of, I'm sure there are developments, you know, that that certainly happened throughout 2025 in the mRNA space, you know, again, some of those acquisitions being a big deal, the big pharma attention being a big deal that that I think struck me as a as a really interesting positive, um, positive in the space that I wasn't anticipating coming into 2025. But at the same time, nothing quite resonates still to this day, I think, with with what I felt and what I still think of, you know, the the resignation of Peter Marx of the entire advanced therapy space.

Jeff Buguliskis 14:01

It's a big loss for them. I mean, I I'm sort of 50-50 on it in terms of like I kind of expected it, but then also didn't. Maybe I just was disillusioning myself. You know, I've I've spoken with Peter over the years, and you know, he was this guy that always wanted to help the industry, like so I kind of thought maybe he would, you know, tough it out. But then seeing how far they were, you know, they were pushing him, and i I guess I'm not surprised, but I think the surprising part was really how many other people went afterwards. Um, you know, the sheer number of people that that left in sort of key positions, I think was was not on my uh you know, bingo card at all. I I, you know, at that, and that's that's a big loss. I mean, the FDA had you know it had its issues to begin with, right? And you know, like you said, I think like Aaron said, you know, like it's it's it's leaderless now to some extent. So you know who is gonna step up to that role? Uh it's gonna be interesting to see for the next year and and beyond.

Tyler Menichiello 14:57

Yeah. Yeah, I agree. Hindsight being 2020, like you said, you know, it could the the writing might have been on the walls, but I agree with you, Jeff. I did not see I did not see the the fallout, like the sheer amount of of people that would lead the senior leadership and but I also just think how emotional it was too.

Anna Rose Welch 15:18

I mean, I I think it just surprises me, you know. I mean, we're in these, we're in these roles, which I think is, you know, we're kind of periphery to the industry to some extent as as editors, right? We we have this bird's eye view, but we don't work for pharma. We don't in technically, I mean, Aaron, some of us have engaged with members of the FTA, of course, but we're not necessarily in the trenches, right, doing this work. And so I mean for yourself.

Tyler Menichiello 15:45

I Moonlight is an operator on the side. I go clock in its side.

Anna Rose Welch 15:50

Tyler, you're full of secrets. We're gonna hate it to be cool. So just with you. Um, but like I I don't think I anticipated just just again, the sheer sort of emotional reaction I would have to some of the to some of the um events of of 2025 from a regulatory standpoint.

Guidance Shifts And N-of-One Milestones

Ray Dogum 16:10

For sure. I will say though, um, on a positive note, on a regulatory positive note, so the NIH uh announced this is kind of a little off topic in terms of leadership, but some of the policies, uh they announced that they will no longer award funding to new grant proposals uh that relied exclusively on animal models. So basically making NAMS or new approach methodologies more prominent. And that's been, you know, an important trend throughout the year, like starting in like April with the monoclonal antibodies roadmap for NAMS, and it's continuing. I feel like this is sort of like building up. I think, you know, not to jump ahead, but I think in 2026, NAMS are gonna be even more uh of an important topic. And I I mean, I don't want to say they're doing a good or a bad job, but the NIH and FDA are supporting this new sort of policy. So I think that's positive. Um, in terms of the leadership, yeah, there are there are concerns. I mean, I think the morale of these employees who work there, the actual people who are going every day um to the labs or offices, you know, they gotta wonder every week, like, you know, am I gonna have a job in a couple weeks? Um January's coming, potential another shutdown could happen too. So they're concerning things. Um real solutions.

Ben Comer 17:38

Tyler, uh, I have just a kind of niche surprise uh that's sort of is related to the FDA, but um is a little different. I'm really surprised that the rare pediatric disease priority review voucher program uh hasn't been reauthorized. It expired at the end of last year. Uh the House has recently passed uh the Give Kids a Chance Act, which would reauthorize the program, I think through 2029. Um, but the Senate has not passed it yet. Um, so you know, as a result, the those priority review vouchers, the price has gone up, you know, to like $150 million. But uh that was just seemed like kind of a you know an easy yes for for Congress. But um that that program uh is still currently expired. Wow.

Tyler Menichiello 18:29

I did not hear about that. That's certain that it wasn't an immediate yes, like you're saying.

Defining 2025: AI, NAMS, And In Vivo

Anna Rose Welch 18:35

So I had a couple of additional, I would say, high-level surprises from the RNA space in general. Um and I would say one of which was the publication of a guidance in the uh personalized immunotherapy space or mRNA-based immunotherapy space. So for those of you listening who aren't necessarily quite as familiar with the mRNA world right now, the the industry is kind of in a really um is making a big push towards the therapeutic realm. Um and one of the biggest areas that is kind of the farthest along in development is the personalized immunotherapy space. And so the mHRA just released guidance this year on personalized mRNA immunotherapies. And one of the sections of the guidance was specifically geared towards caretakers and physicians, which I thought was a really kind of beautiful um demonstration of patient centricity that we don't necessarily always see from a regulatory guidance, right? So that was one really pleasant surprise. Um the other was on a really high note, right? We the mRNA space did have a really big win outside of the vaccine world. Um, you know, we had the celebrations of COVID, but in 2025, early on, I think in May, we heard about the dosing of baby KJ. And so that was a N of one mRNA-based CRISPR therapy. And that was sort of the industry moved mountains, right? To bring together a lot of suppliers, manufacturers, sites of care to help make this a reality. And just based off of the research I've done as of late, it sounds like he is still stable. Everything is going really well with that therapy. So that was a really beautiful win. And then finally, on the oligonucleotide side, uh, we're starting to see a lot more commercial maturity in that space. And so this is an area that for 2026 I'm going to be trying to dig a lot more into and learn more about. But in recent weeks, we just saw the approval of Arrowheads Redemplo, which is an SIRNA uh an SIRNA product. And it's an indication that is actually also being treated by another RNA product called by Ionis called Tringolza. Um, but what's really interesting about these approvals is that you have two different oligo constructs. You have the siRNA versus the ASO. And so I think in the upcoming year, two years, right, we're gonna start seeing more competition between these RNA modalities heating up. And it's, I think that's a real sign of market maturity when you're starting to try to figure out what molecule is best at targeting certain things or editing certain things, or um, you're just you're learning more, I think, about these molecules in relation to each other, which is a really um, I think an interesting uh indication of of market maturity.

Tyler Menichiello 21:47

Yeah. Thanks, Anna.

Anna Rose Welch 21:50

Maybe a lot there, Tyler.

Tyler Menichiello 21:52

That was a huge one. You did. It was all great. It was all great. I agree that was a huge win for the um RNA space. I'm glad to hear that that baby's doing well. Um, I don't want to spend all our time looking backwards, I want to look forwards, but just to put a bow in our reflections on 2025, if we could all just go around the uh metaphorical room and if we've boiled it down to if you know what what you think defined what trends or topics you think defined your space, or what you saw as the most significant developments in your space in 2025, I think that'll be a good place to, you know, kind of tie the knot and and move forward in our outlook. Or at least industry speaking, I do want to get some personal highs and lows from everybody as well.

China’s Rising Biotech Influence

Katie Anderson 22:40

But I mean, I think in in the pharma space, definitely one of the biggest themes was modernization. Uh the addition of new technology, be it AI, um, upgrading upgrading processes, um, things of that nature. Everybody is talking about how they can do the processes better, faster. And especially now that all these company, many of these companies have new facilities, larger facilities, and they're tasked with upping their production. Continuous processing and AI and automation all really come to the forefront of of the major discussions.

Tyler Menichiello 23:26

So I can double. Oh, sorry, yeah.

Erin Harris 23:31

Oh, you got it.

Personal Highs: Travel, Panels, New Shows

Ray Dogum 23:33

Yeah, I was just uh saying, um, you know, piggybacking off of the AI conversation, I think that AI was huge for drug discovery as well. Um, we saw Lily actually build a new space at Toon Lab, they called it. It's basically like an AI factory where they're sharing um some of the models with other pharma companies in like a privacy-preserving way, I think, through federated learning. So I think that's pretty interesting. Um, many open source models are being used now by drug discoverers like OpenFold 3, Bolts 2. I think there's a lot of promise with these tools, basically, these like protein folding, understanding how the activity of a certain chemical or structure um can potentially impact you know different cells and um proteins in the body. So that's that's definitely a growing space. And I think as there's more data, as people generate, collect more, not just you know, synthetic you know, AI data, but they're doing work in the wet labs as well and you know, incorporating that all together. I'm expecting a lot of interesting insights to come out of that um for next year as well. And again, as I mentioned earlier, NAMS, NAMS are huge, like organoids, organon chips, uh the use of AI um for testing, you know, toxicology preclinical is definitely a big deal. Um, and yeah, leave it at that.

Erin Harris 25:04

Um, I'll jump in here. I'll talk about uh just to continue on with the AI conversation. It's obviously not going anywhere. And for sound gene therapy, advanced therapies, we're talking about AI and automation and manufacturing. Um, I think one of the a couple of the very big things that came out of uh especially 2025 out of our space is um the transition from not only treating niche rare diseases diseases, excuse me, to targeting widespread common conditions um using uh novel delivery systems like in vivo gene editing. Um you know, we're expanding into autoimmune disorders like lupus and MS. Um they're gaining much more momentum. Um you know, opening up new large therapeutic areas beyond oncology. Um, and finally, I'll end on I mean there's there's there are quite a few things, but I think we'll see more into 2026. Certainly um in vivo therapies. I think we'll see more excitement about in vivo, we'll see more data and we'll get more fine-tuning um around the business model and and how it's used.

Tyler Menichiello 26:21

Yeah, I agree, Erin. I'm really excited about the in vivo um cell therapy approach. I mean, I think our best performing episode of Better Biopharma this year was the interior episode on in vivo CART and process development. Um yeah, everyone else, if you want to.

Jeff Buguliskis 26:39

Thanks, Tyler. I think um I'll, you know, not to beat a dead horse with the AI perspective, but you know, obviously we just can't get away from it this year. I think for you know, for outsourcing, it's gonna play out a little bit differently. I think AI is gonna be a big factor. But, you know, as much as AI for drug discovery is really kind of sexy and like that, you know, for for cell and gene therapy or whatever and the way they're using it, I think how that plays out in sort of an outsourcing perspective on the plant floor is a different scenario. It's probably something that's already been done before it, you know, comes to some of these companies. But I think from uh you know a drug sponsor perspective to the you know, the C DMOs, I think AI is going to be used in in a lot more, but maybe in a less sort of you know sexy way. It's gonna be used, I think, more for, you know, to to to better communication, to better like processes, like, you know, paperwork and kind of just expedite a lot of the sort of mundane things that may have, you know, taken up some time and that can be done much, much quicker. Um, and maybe help, you know, with the communicated communication processes between these uh two groups. So I think it'll be used a lot. I just, you know, I think it's just gonna be used differently than than a lot of the other uh folks spoke about.

What We’re Building In 2026

Katie Anderson 27:55

And I think similar to my market, Jeff. I think it's going, it's it's one of its most useful applications is in data, right? Data aggregation. Ultimately to produce better quality drugs and um reduce deficiencies, reduce imperfections. So yeah.

Tyler Menichiello 28:16

Yeah, completely agree. I figured I figured AI would be around the horn kind of unanimous. And I think it probably will be that way for the next, the foreseeable future at least. Um Ben, did you have anything to share before we Yeah?

Ben Comer 28:29

I mean, uh I would just say uh China's emergence as a biotech powerhouse uh has seemingly been a part of almost every conversation I've had with leaders at at biotech and pharma companies.

Tyler Menichiello 28:43

Yeah.

Ray Dogum 28:44

Yeah, on that, Ben, uh I'm just reading now, five of the top 10 RD licensing deals involve China, a company based in China. So pretty significant.

Jeff Buguliskis 28:55

Yeah, and I just, you know, to tap on that too, I just put a a new list out, which is, you know, like the top 10, you know, nations that are, you know, uh sort of redrawing the outsourcing map. And China was definitely at the top of that list. You know, it's they're they don't really, at least currently they don't have the the governmental issues that that we're having, and their government's actually putting tons of money behind their people and and and you know the the biotech and bioeconomy and so forth. So um, yeah, I think they're gonna they're gonna be eating our lunch uh if not already, pretty, pretty soon.

Tyler Menichiello 29:30

So it's wild what can happen when a government uh invests in. Yeah, it's wild. Uh so moving on here, I wanted to touch on a personal, professional, personal uh note here and just hear from everybody what your favorite moments from the year were. You know, whether it's favorite, whether it was some professional achievements or some projects you worked on, uh, what are you most proud of in 2025 and what were some of your high points of the year? With whoever wants to start first. Anna, you're smirking. Let's go with you.

Anna Rose Welch 30:04

And if we're ready, ready. Um, so I would I'd say I have two, and I can only really divulge one. But I can give half. I can give half on the second one. So the first one, um, yeah. So the first one was earlier this year, I was um, I did the keynote for the CAS uh the very first inaugural CAS mRNA symposium. And so that was essentially supposed to sort of give an overview of the mRNA space, uh, which I did, but I did it through the realms of the artist Picasso. Um, I decided to create, for those of you who are familiar with with potentially with my work, you'll you should know I am a poet uh first and foremost. And so metaphors tend to come pretty readily. Uh so I had gone to see a sketch exhibit early on in the year that was of Picasso's body of work. And throughout the generations of his work, I started to think and pick up on trends that I felt the mRNA industry was also kind of going through, right? We were sort of, we're currently in the state of trying to find our voice, right? Figure out um our different scientific technique, right? What our molecules can do, similar to what an artist does, right? To to learn, learn the basics and and find their own, find their own artistic style. So I was really proud of how that turned out. Um, I think it it went over really well. Um, and I have a few pieces of content that I based off of that presentation. Secondly, I will say just last week I single-handedly ate four Thai chilies in a row for another uh creative project that I'm working on that is going to be dropping on advancing RNA uh in January when things are really, really cold. We're heating it up. Um, and I'm really wine. I am really, really proud to report that I did not get sick, I did not have indigestion, and it did not come back to bite me in any way, shape, or form. So I think, I think, ladies and gentlemen, I may have discovered a secret superpower that I can actually handle spicy things.

Tyler Menichiello 32:26

Love that.

Anna Rose Welch 32:27

Culturally and figuratively.

unknown 32:29

Yeah.

What To Watch: Policy, Jobs, Data Sharing

Jeff Buguliskis 32:29

Anna Rose, can I ask a quick question? Like, will you will you let us know when you think that the RNA space is gonna enter its, you know, sort of blue period, like Picasso had? Is that the is that upcoming? Okay.

Anna Rose Welch 32:42

I think I think we kind of are on the cusp of that. 2025 was definitely um, I think an introduction to that in in many ways. And I think as we start to get more data readouts in 2026, there's there's probably gonna be uh some sedation.

Tyler Menichiello 32:57

Right. Fair enough, fair enough. Anna, was that was that exhibit the immersive one that you know projects on the floor and the wall and everything?

Anna Rose Welch 33:07

Because I think I went to that same No, this was this was at the Cleveland Art Museum, and it was just his sketches. And I did not realize that Picasso was A, so prolific, and B, just how stylistically diverse he was. I mean, he was all over the board in terms of his style. And frankly, the mRNA, RNA world, right, with all of its different modalities and therapeutic approaches, is arguably just as diverse, right? So it was it was a really to me when the metaphor hit it was like divine inspiration.

Tyler Menichiello 33:43

I heard you keep a notebook by the side of your bed to wake up and jot down metaphors in a cold sweat when you wake up. Is that true?

Anna Rose Welch 33:51

Yeah, it's it's not a notebook, it's the notes app on my phone. Uh we keep it millennial style over here.

Tyler Menichiello 33:58

Oh yeah. That's great. Who who else eat chilies on on camera with

Erin Harris 34:07

anything would pale in comparison to the creativity?

Ray Dogum 34:10

Right.

Erin Harris 34:11

It's exceptional.

Ray Dogum 34:13

Yeah, um, that was a good starting point, Anna. I guess you know, something I could say, I joined halfway through the year, so I didn't have as as much time. Um actually joined on the same day as Katie, so shout out Katie. But um meeting you guys and even just seeing you guys in conferences like was a real highlight for me, actually. It definitely was. You know, hanging out with Ben and Tyler in Boston was a really good time, especially Anna too. Um yeah, those are highlights of my year. I will say though, second highlight, let's call it, interviewing Bob Langer, um, the most cited engineer in the world. And I got to go to his lab and office and talk to him about everything from the federal shutdown to um organoids to you know drug delivery. Um we talked a lot about mRNA actually, which probably would be no you know surprise to anybody because he's co-founder of Moderna. Um, but yeah, that would be the second highlight, I would say.

Tyler Menichiello 35:18

Yeah, that's a great highlight. And I share the your first highlight, which was us gallivanting through Boston, getting up to no good after after bio. That was that was really fun.

Jeff Buguliskis 35:29

Yeah, I'm gonna add to Ray's too, because obviously I came in after even Ray and Katie, and um, and so really getting to to know everybody on the team and getting to talk and doing stuff like this, obviously. You know, this uh this is a lot of fun. I'm glad you know we're doing this. I hope our audience all like it too, get to know us a little bit better. Um, but obviously, you know, this is it's a great team, great group of people. So getting to know all you guys uh throughout the year has been has been fun. And I look forward to hopefully meeting up, uh, got to meet up with Aaron at a show in Philly and then hopefully the rest of the team at a at other shows.

Tyler Menichiello 36:00

So Ditto Jeff. I hope our audience is still with us as well.

Commercial Currents: GLP-1 And Coverage

Katie Anderson 36:06

I mean, for for me, being new to, you know, uniquely new to the pharma space, unlike some of my colleagues, just being able to jump in feet first and or head first, depending on how you look at it and and learn about this space. I'm gonna be learning about it for quite some time, but it it's been an exciting journey and I'm surrounded by very supportive, uh, amazing colleagues that have helped me along the way. Um I haven't done a ton of traveling this year, but I did get to go to the um the ISPE annual um meeting and expo in Charlotte this year. And that was, I would say, one of the highlights of my year. I went to the FOIA, the Facility of the Year Award banquet, where they awarded innovation and sustainability. And it was just amazing to see all of the unique things that are happening out in these facilities. For example, JJ in Italy, they had a unique challenge where they had to change their flexible bottle packaging line from extra large batches to small to medium batches to fit the demand. And so they brought in 17 robots that can handle something like I think it's like 500 SKUs and 170 different packaging options. Well, just really cool innovation and manufacturing happening out there in facilities all over the world, and it was really neat to see those get awarded on stage. I also went to the Women in Pharma event at ISPE, and that was a lot of fun. Um, not only to go to a jazz club and get to meet some of the amazing ladies in pharma, but it had a theme of walking in their shoes, the women who've paved the way in pharma. We had a trivia that happened where we got quizzed on the different um women who have made changes in in the pharma industry and and it was a lot of fun.

Tyler Menichiello 38:16

That's awesome.

Katie Anderson 38:17

Yeah.

Tyler Menichiello 38:21

Who's next?

RNA Trials: Limits, Promise, And Competition

Erin Harris 38:23

Um, I'll go quickly, I think. Well, I saved all of my travel for one period of the year. I did everything in November. You moved out your literally you did everything in November. It was probably two weeks of uh uh heavy, heavy uh, you know, high think, high preparedness. But uh I went to London for Cell 2025. I was the Oxford Global asked me to be the host of that event. And I think we all do a really good job of moderating panels and being invited to moderate panels on stage, certainly via our live events. Um, this was for me um a whole other level because it was uh soup to nuts, you know, opening the event, closing the event, doing networking, you know, opening networking drinks, moderating panels, um, you know, introducing keynote speakers. So it was a high level of preparedness. And uh I I kind of got to see what it looks like to put on an in-person event. And I know we're gonna be going down that road across all of our products um in the next year or two years here. And so um I got to see what that looks like done well. Uh, and so I think I have some, I was able to accumulate some really important notes of how when we take that on as a uh broadly as a company, what we can be doing right. Um, because like I said, working with Oxford Global, they just did a really fantastic job putting on that show. It is not easy. I don't I've I've attended shows as, you know, as an attendee, as uh a panelist, as a session moderator. And all of that work, at least for me, I think is is very hard and very time consuming, and you have to be dialed in. And then there's putting on an event. So um I learned a lot and I was super grateful for the opportunity. And I got to go to London, so that was pretty cool. Um that's awesome. Yeah.

Tyler Menichiello 40:18

With everything everything going on with the uh airlines, I'm happy that you made it back in one piece and are here with us today because that's a lot of travel in a short period of time.

Erin Harris 40:27

Yeah, and if that if that I mean, thankfully it it didn't impact international travel. Um it they said out of the gate, I mean that could have changed, obviously. But if if you know me and my background, that absolutely the timing of that was very Aaron Harris-like. That that's exactly what would have happened that the day I was supposed to leave or two days before they, you know, there was a ton of air travel hiccups.

Tyler Menichiello 40:53

So I worked out. Thank God.

Ben Comer 41:01

Tyler, um, as professional achievements uh or high points this year, uh travel-wise, I'll say it was fantastic hanging out with you and Ray, getting to meet Ray in person in Boston at bio uh was was a lot of fun. Um as far as a professional highlight, I think for me, uh taking over hosting duties of the business of biotech has been a really incredible experience and a learning experience, you know, a chance for me to try my hand at uh a new format and a new medium. Um, but I I have to give a shout out to Matt Pillar for doing the the truly hard work of launching the podcast and building the audience over five years, you know, prior to my tenure, uh, and for trusting me not to mess it all up.

Tyler Menichiello 41:50

Yeah, I feel you on the on the the fear front there. So it's definitely um intimidating to delve into that space. And I feel you on that. I mean, starting this podcast was fun, scary, exciting, all the emotions, you know, really. But yeah, I think you've been doing great since uh since taking over. Yeah. Thanks, Eyler.

Ben Comer 42:13

Right back at you. I think Better Biopharma is awesome. Oh.

Bioeconomy And Outsourcing’s Stress Test

Tyler Menichiello 42:16

Man, you're gonna make me blush on camera, dude. Thank you. Um, no, yeah, I mean, just to to chime in, I also obviously had a lot of fun at my first bio in Boston, uh, which coincided with all of us getting to meet up. But yeah, starting this podcast was a huge professional step for me. Becoming chief editor of Bioprocess Online. I mean, talk about filling in Matt's shoes. We both kind of did a different flavor of that this year, and it's uh yeah, definitely big shoes to fill, intimidating. But again, it feels I I'm honored to be trusted with it, and I I know you feel the same way. Um yeah, networking at Bio's museum party was a blast. Um that was super duper fun. I I had some good some good editorial experiences with a handful of guests this year. Like a couple of my favorite projects were uh I think the Siren episode with Dr. Nicole Polk, the the CEO and founder of Siren. Like she's always a fun, a fun hang and person to talk to about the industry, and she keeps it real, and that was a really fun episode. So was uh Bonum Therapeutics episode when we talked about conditionally active biologics. Even discovering those this year, I might be you know late to this show here, but I didn't really know much about conditionally active biologics before 2025, and now it's kind of my favorite modality of sorts. So that was really an exciting one, too. And of course, uh working with Herman Bosenhart, friend of the show, and I know many of you have have talked to or worked with him before, he's always a blast as well. So those are a couple of my favorite uh editorial moments this year.

Anna Rose Welch 43:54

I love that you have a favorite modality. That's so delightfully nerdy.

Tyler Menichiello 43:59

Listen, they are super duper sick. I don't know what you know about the mean. I could send you some pieces.

Katie Anderson 44:04

Such as some they're gonna be your new favorite. Yeah.

Tyler Menichiello 44:08

And if they're not yet, you out there in the audience, if they're not your favorite yet, buckle up because I'm forcing.

Anna Rose Welch 44:14

MRNA is a renaissance lady. All right. So she's she's pretty uh she's the apple of my eye at the moment. But could swim me. You can swim me.

Tyler Menichiello 44:25

Fair enough. And you have every right to be biased. Wow. So, you know, per personally, professionally speaking, before we get into, you know, our spaces, our markets, and industry in 2026, what is everybody looking forward to personally and professionally in 2026? What projects do you have on the horizon? What do you want to do more of uh for our audience? What kind of initiatives do you have? I mean, don't share too much. We want to keep them on their toes, but what's everyone excited for in 2026 personally?

Katie Anderson 44:55

Well, personally, it's none of your best. Fair enough. I think professionally, um, I have two main things that I want to accomplish next year, uh, amongst everything else. I would like to build a an expert advisory board. That's a big, a big task for me next year of uh leaders in small mall pharma manufacturing. And I would like to visit facilities. Uh haven't gotten out there and done that yet. And that's something that I really need to see and and would like to get the opportunity to do next year.

Tyler Menichiello 45:32

So yeah, same, especially in Pittsburgh. I mean, they're a rack.

Katie Anderson 45:35

I wanna I wanna put on uh I wanna put on some PPE and and get out there.

Tyler Menichiello 45:39

If you're listening in Pittsburgh, hit us up, we'll come, free a chart, we'll bring cameras, it's no big deal.

How To Better Biopharma: Our Playbook

Erin Harris 45:46

Or not. Or not. Right. Yeah. ADM with you on two of the three, or the actually I do I we are also gonna be, I shouldn't say building from scratch, but rebuilding our editorial board um for various reasons. But uh we're gonna be adding to the board that exists. Um I'm really excited for that to work with new leaders in the space uh to help us really guide and shape what Cell Engine is gonna be doing going forward. Um, also traveling a little more locally, uh definitely uh, you know, pounding the pavement in Philadelphia, uh at the various biotech's uh rich CDMO community too. So seeing what's out there. Um and the only other thing I'm super jazzed about is that in 2025 for Challenging the Podcast, we did a special series. Um we air every other Thursday, but we did a four week four consecutive week series called FDA Fridays. Uh, I want to continue that into 2025, but um do one on prep supply chain and one on manufacturing. So um that's those are things I'm really looking forward to for challenge and for next year.

Ray Dogum 47:00

That's awesome, Erin. I could jump in here.

Katie Anderson 47:03

Um I was gonna say Anna just wants to eat more Thai chilies.

Anna Rose Welch 47:07

So it's gonna get hotter and hotter, Katie. It's gonna get hotter and hotter.

Tyler Menichiello 47:13

Anna wants to come up with more metaphors and eat more chilies. And we love it.

Anna Rose Welch 47:16

That's a pretty good goal. That's a pretty good goal.

Katie Anderson 47:19

But I'll let I'll let Ray talk first and then I'll end up.

Ray Dogum 47:22

No, it's okay. Go go right ahead. Go for it.

Katie Anderson 47:24

I'm not I mean Ray also wants to eat more chilies.

Ray Dogum 47:28

I love spicy food.

Anna Rose Welch 47:29

So we have we have a few. Ray and I have been cooking up some behind the scenes uh magic here that involve another type of food. So, you know, we'll who knows what's gonna happen in 2026. Oh my gosh. I would say, you know, I'm I'm looking forward to traveling as much as I possibly can uh in 2026. One of the things that's one of my favorite parts of the job is actually being out there and hearing what people are talking about live, being able to meet people that I've only ever seen over Zoom or reconnect with the people um that I, you know, know and connect with pretty regularly throughout throughout my time in a space. So I'm really looking forward to that. I'd ideally like to take this pepper eating uh challenge, which again, we will take it on I'm not. I can't, I can't reveal yet what it is, but once it drops, you'll understand. Um, in January, I'd really like to start taking it on the road live. Uh and it it perhaps um how do I say expose other folks to this, uh to the magic of eating peppers and and uh learning more about the mRNA space. Um I would say too, one of the big priorities for me in in 2026 is to expand my knowledge continually. I mean, we're all we're always doing that, but I have not done justice to the fact that the RNA space is not just mRNA or self-amplifying or circular RNA, it's also your oligonucleotides. Um so I am really looking to build my network in that space, starting with building an editorial board, right, that covers both both sides of the RNA industry. Um, I'm gonna be expanding some of my live events to focus more on that manufacturing paradigm, that set of raw materials, right? Those types of uh molecules. Um, and just in general, trying to write more uh and and draw more of that audience to the site. So, and there's, you know, uh, I'm selfish in this that I I do really love to learn. And I've spent a couple of years delving into the the intricacies of mRNA. And so now uh there's a pretty rich amount to dig into, I think, and a really great amount of room to sort of start to um bring metaphor to the to the oligonucleotide sector. So those are some of my goals.

Tyler Menichiello 49:59

Love it. That's great, Anna. Thank you.

Ray Dogum 50:01

Yeah, and I'm looking forward to seeing you on Hot Ones at some point, maybe next year. Who knows? On a personal level, I probably won't be traveling a lot, at least not long distance, uh, because the Dogum household will be welcoming a baby girl in early 2026. So that's uh probably the biggest thing for for me next year. On the professional side, I'm also looking forward to building out our editorial advisory board for drug discovery online and also doing the virtual live panels. I think they're actually a lot of fun. I only did one this year, focused on NAMS, but next year we'll have a lot more. So I'm looking forward to that. Um yeah, pass it off. Awesome, Mary.

Tyler Menichiello 50:47

Congratulations again. That's just so exciting for you and the missus. Thank you. Thank you very much. Sorry for you. New editor in training.

Jeff Buguliskis 50:58

Um, yeah, so I think for me, for professionally, it's you know, the single sing well, single compound word would be multimedia, doing a lot of multimedia for next year. Um, you know, I I've I've been pretty lucky. Obviously, you know, uh chief editor Louis Garguilo's put together a pretty big uh editorial panel. I think we have about 33 uh folks that he's he's utilized uh pretty frequently over the years in various aspects. Um, but you know, we came up with this idea of trying to engage them editorially in or sorry, uh in multimedia in a different way. Um, some you know different uh video context, some interviews, some you know, different styles that I just got finished recording some that that they're being worked on right now. So hopefully they'll be out uh pretty soon. Um and then I'm also looking to start uh a podcast myself, but you know, trying to do you know a little bit different style. Um not that there's anything wrong with the the classic style, but you know, just trying to uh mix it up a little bit, try something different, short, sweet, kind of, you know, a little bit more editorial story behind it, and with weaved in with, you know, uh some quotes and and you know, video stuff from various guests that I have uh to tell a story in as sort of brief time as possible, is as well as to help the audience. I think the end of the day, you know, Lewis and I talk all the time, and then you know, our main goal is to really try to help drug sponsors with their questions that they have when trying to engage with you know outsourcing partners. And that's really our our main goal. And so a lot of this multimedia stuff is gonna be really geared towards that. And uh and then hopefully uh the you know the audience likes it. Uh we're gonna try to make it fun and interesting.

Tyler Menichiello 52:41

So that's awesome, Jeff.

Holiday Sign-Off And Favorite Movies

Ben Comer 52:44

Yeah, Jeff, I look forward to uh to that podcast. Um, I'm uh excited about for next year, and this is in part just due to my current outlook, outlook inbox, but uh JP Morgan is coming up uh in in January. That conference uh really helps set the agenda for the for the coming year, in my experience. I'll be recording some uh in-person business of biotech episodes out there and uh doing some interviews and and catching up with folks that a lot of times I I only see in San Francisco for JP Morgan. Um, so that's always a good time. And then uh Life Science Leader 2 is gonna be launching some new um live webcast, digital events next year. Um, and so uh I'm excited about some of the topics we've been discussing for those live events. Um and uh and then lastly, I guess I you know just want to try to bring new voices uh into Life Science Leader, whether it's through the podcast, business of biotech through written articles or or through the new live events.

Tyler Menichiello 53:50

Yeah, that's exciting, Ben. Everybody has quite a year plan. I'm excited to see it all play out. Um, like you know, like Jeff said and a couple of you mentioned, I definitely I too want to get into more multimedia. Um got my got my feet wet a bit this year, but I want to lean more into that. Um get the podcast sponsored. That's my big goal. If you're out there and you got some advertising dollars to spend, hit up your boy. I'll be waiting. Um and yeah, so enough about enough about us as as personalities. Let's talk about the industries we serve here or the markets we serve. Uh looking out into 2026, what's everybody excited for to see in the industry? Um, you know, what do you hope to see? What do you think could happen that people should pay attention to, good or bad, and what trends do you think will continue? What have you heard from your advisory board? Just really just give us a full plate and we could start with whoever wants to go. If you want me to start up, I uh I just saw some recent news about the National Biopharmaceutical Manufacturing Center of Excellence that is is currently uh it was proposed. I don't know if it's in the House or Senate. I'm not good, I'm not politically minded to be honest with you, but I know it's it's a it's it's a proposal right now that you know all in an effort to onshore domestic manufacturing. And um it seems I saw something that kind of resembles a reincarnation of the BioSecure Act. And so that's something that I want to pay attention to. Um and hopefully, hopefully the the former leads to more domestic bioprocessing jobs. I mean, I see the lamentations on the our biotech subreddit every day about the the job market. I really hope that that turns around. But um yeah, and again, to raise earlier point about the Eli Lilly Toon Lab collaboration, like I hope to see more of that. I hope to see more sharing of data insights and use use cases with with AI and things like that. But just a couple of things I'm looking forward to.

Erin Harris 56:03

Yeah, I think um, Tyler, I could that's all really excellent important information, but it'll apply across the board. I think I could piggyback on what you're saying and a couple of things that um if we can I think what excites me most for cell gene therapy is that people seem to be getting better about um you know uh operating like uh like a long-term ecosystem and not a collection of isolated programs. Um that was a big theme across the events that I went to uh at the end of the year here. Um and sharing not only the wins uh but also the missteps, the losses. Um, you know, we can all learn from each other. We're all trying to, yes, build businesses, but also ultimately impact patient outcomes. And so that's how one of the ways we do it. Um I would say the other thing that I'm really excited for is this platformization of manufacturing. Um, I think today's a lot of today's celling therapy companies, they operate with a real uncomfortable level of digital fragility, I guess you could call it. Um, we're talking about uh workflows and supply chain tools, and they're they all exist kind of on these isolated islands. And and how are we going to work to platformize uh these systems so that we can bring, you know, kind of these bespoke therapies into a broader uh patient population. Uh we seem to be getting better at that, uh, especially toward the end of the year here, but I'm really excited to see how that plays out into 2026 and beyond. It's not gonna happen overnight, but um, there seems to be a collective mindset about why all that is important.

Tyler Menichiello 57:50

Great, Erin. Thank you.

Ben Comer 57:55

I think um I'll just say something about the the commercial side of of biotech and pharma. I think that's gonna be an interesting space to watch drug pricing. Uh we have you know most favored nations, uh Trump RX. Uh I mean, I think it's hard to understate the impact of the the growth of the GLP1 market, uh, for example. I mean, we've talked about Eli Lilly's manufacturing, they're the first company to ever have a over a trillion dollar valuation, uh, which is um pretty wild. So I, you know, I and now, you know, in starting in 2026, I think through a pilot program, Medicare and Medicaid will start covering GLP ones for weight loss uh for the first time ever, at least for Novo and Eli Lilly, who have agreed to participate uh in that program. So I expect that to be an additional windfall for both companies. Um, but uh that I think the commercial side is one that I'm gonna be definitely um looking at and uh and paying attention to next year.

Katie Anderson 59:00

Well, and speaking to GLP ones specifically, Ben, next year we're gonna see the first oral GLP one come out for weight loss. And I think that's going to change the market significantly. I mean, as you said, Eli and and Novar are the front runners in getting theirs out to market first, but um, there's a handful right behind them.

Anna Rose Welch 59:21

So there was just some preclinical RNA data on the oligo side that suggests that there could be RNA competition to to some of these GLP ones. So I know.

Tyler Menichiello 59:34

Watch out, everybody.

Anna Rose Welch 59:36

I think it's it's pretty early stage data. I'd have to look up more facts about it, but that's been kind of blowing up my LinkedIn feed the past the past day or two. So interesting. Um, kind of on those, on that note, I would say one of the things that I'm most excited about in 2026, and a little bit trepidatious as well. As I think 2026 is gonna be the year that we do start to learn really. Really, really learn some of the limitations and some of the benefits, right, of RNA in a therapeutic capacity. I think we're moving forward into the clinic. We've had some really great readouts this year preclinically. We've had a couple of really nice readouts in the from the clinic as well with RNA candidates in the therapeutics realm outside of the prophylactic vaccine space. But at the same time, we also have seen some less than than positive news, right? In the in the mRNA space as well. So I think, you know, one of the bigger clinical trials, one of the leading in vivo gene editing companies, IntelliA, got some some problematic news, right? There was a patient death in their trial. So that's kind of paused that uh that trial for the moment while they try to figure out what happened. And so I think that, you know, we're sort of, we've been saying this for a few years, but I think 2026 is going to be the year where we start to finally see what mRNA is at an early stage capable of therapeutically. I have a wish that um, you know, we do as a space continue to make progress politically. Um I know AMM or the Alliance for MRNA Medicines has been working over time, right, to try and educate Congress, the Senate, um, just the executive um members, right? What exactly is happening um with mRNA in this world, why some of the policies that they are uh instituting are very harmful for both the US as a leader in biosafety, in terms of the US as a leader in biology, right? Innovation, um, but also how it can be harmful to mRNA itself as a as a therapeutic agent. So I'd love to see more positive progress, more I would say public-facing education around what mRNA is and how it works in a way that is, you know, helpful for the layperson to better understand, especially as we do start to move into more therapeutic indications. And then finally, I think, you know, I'd I talked a little bit about this as well, but starting to see more competition amongst some of the modalities in the RNA space and and really helping us carve out what a competitive commercial product looks like, both on the mRNA side, but also right on the oligo side. Um, I think that that's gonna be those are some of the things that I'm most looking forward to in 2026.

Jeff Buguliskis 1:02:46

I think a lot of the stuff that we've been talking about plays into, you know, what we call the bioeconomy, and you know, um and it's just something we've that I've been focused on for a few years, you know, learning about and and you know, learning what's been going on. And, you know, it touches sort of all aspects, right? Everything from government to the you know, basic science research to actual, you know, pharma, uh sort of drug production, drug development, and and even outsourcing to some degree. So it'll be interesting to see how you know uh a lot of that plays out. You know, the US was dumping a lot of money into the into the bioeconomy, and you know, the Biden administration had put uh you know, executive order together that uh unfortunately was just uh this year, I think was just deleted, um, but was also you know doing for a lot of you know um bioproduction, bioeconomy work as well. So it was kind of setting us out there to be a leader. Um hopefully that continues into you know into 2026 in in some other form and however that may be, because like we we talked about earlier, there's you know other other countries that are are surpassing us in in many, many ways. And and you know, that's never going to be a good thing for the future of when it comes to uh you know uh sort of scientific uh research as well. But um from you know from a title perspective from from outsourcing, you know, I I mentioned in the beginning, I think the thing uh I to to look forward to for next year is is what we're starting to see at the end of this year and and to continued, which is the the resiliency of the space, you know, being able to adapt um to pretty you know tumultuous times um and just uncertainty, right? Like it's every other week it was something different, you know, a different tone that came out from you know from the administration of like what you know what's gonna be tariffed, what's not, and and what area is gonna be, you know, uh hit and which which one's not and so forth. And um, you know, these organizations just really kind of said, okay, you know, here's what we're gonna do and we're gonna move forward because, you know, uh one, it's business, we need to get this stuff done, and you know, we need to get paid. But it at the end of the day, it's also making products for patients. Um, and so, you know, I think they've done a pretty good job of of meeting a lot of those demands. You know, the GLP one, like I mentioned earlier, you know, as we all have, um, that was gonna be a big crush. And I think everybody was was thinking, oh my God, we're gonna we're gonna run out of space, we're gonna run out of capacity. And it turned out not to be the case, thankfully. Um, now with maybe with what you know, Katie was talking about earlier with the new drug, the new, you know, oral uh GLP one medication, you could start all over again. Cause the the the last data that I saw from a clinical trial for that, it was even that the data looked even better than you know, um, some of the current uh drugs on the market. So so who knows? It'll be interesting to see for the future.

Katie Anderson 1:05:28

But but small mall is faster. So we're gonna work at the lens. Um I I think from my perspective, now that we have increased capacity for manufacturing and the you know, the request for lower prices, we're really going to see advanced manufacturing techniques take technologies take off in ways that they haven't before. I mean, we've been talking about continuous manufacturing for a long time, but it's it's really only been applied largely in in big pharma where they have the funds readily readily available to make that initial investment. But now you're going to see, you know, mid-sized small pharma investing in in more advanced manufacturing technologies so that they can keep their prices competitive and increase their, you know, their manufacturing capacity. So that's what I'm looking forward to in in 2026.

Ray Dogum 1:06:29

Um one thing that's really big on my list is just this NAMS new approach methodologies. This is a market that's growing. You're you're seeing a lot of different companies trying to develop specific protocols or tools, whether it's like a heart on a chip sort of thing, or brain on a chip, or brain organoids. Um, you know, we're already seeing some regulatory push for uh standard standardization of these tools so that multiple sponsors, other companies can, you know, let use them in their preclinical models. And I think when I say pre-clinical models, you know, this could be toxicology, metabolism, uh, pharmacokinetics. There's a lot of different ways to use MAMS. Um, so I'm looking forward to more innovations around that space. And something that actually Tyler said earlier regarding data sharing, I do think, or at least I hope, that more companies start to find you know creative ways of sharing pre-competitive data with each other so that it can, you know, share some of these insights so that we don't have like redundant lab work being done by multiple groups multiple times. Um again, I know that's hard because especially in in the early stages, your data is basically what values your company, you know. So um that'll be tricky, but I think there are ways to do it potentially. So looking forward to learning more about that.

Tyler Menichiello 1:07:58

Thank you, Ray. Um well, guys, we've been on for quite a while, and I want to hold you up. I know you're all very busy. So without further ado, we're gonna get to the main question of the show, which is in your opinion, how can we better biopharma? Meaning, whether it's the way we design, manufacture, distribute, otherwise make and develop these drugs, how can we improve the way we do that? And so I'll make an exception for our small molecule friends in the crowd here, not everybody. So I guess broader, more broadly, how can we better pharma and better biopharma? Katie, we'll go with you.

Katie Anderson 1:08:37

Since you're making fun of small mall, I'll go first. Um I I mean sort of circling back to the beginning of this conversation, where we're gonna see big improvement is the adoption of new technology, AI, automation, robotics. Um, and I think that can be intimidating for some leadership. And so jumping into that technology is important, but defining the value before you jump into it, I think is more important. And I actually sat in a ISPE Pharma 4.0 uh conference earlier today, and they said exactly that. Um, don't let technology intimidate you, but before you jump in and say we have to add AI now or whatever the case may be, define the value and identify um the business benefit and then jump in.

Tyler Menichiello 1:09:31

So that's great.

Katie Anderson 1:09:32

Yeah. And that's kind of infringing on your territory, Ben, and I'm sorry about that.

Ben Comer 1:09:38

No, no, not at all. I'm gonna go broad on this question to uh Tyler. Uh I think, you know, to better biopharma, keep taking big risks uh, you know, to address patient needs and underserved indications. You know, don't necessarily add a Me2 GLP1 to your pipeline, you know, to boost your valuation temporarily. And then lastly, stop building packet uh patent thickets.

Erin Harris 1:10:06

I'm gonna go abroad to um, but I'm gonna say build for scalability much earlier than perhaps you are or think you need to, um, meaning you know, designing man or sorry, designing therapies uh with manufacturability in mind, um investing in those analytical strategies, AI automation, um creating more transparent payer engagements, which is a whole other um and anyway, but thinking about access long before the BLA filing. Um and share those share those missteps and anything, anything you can with the entire ecosystem. Everyone benefits from it.

Tyler Menichiello 1:10:52

So I agree with all the ones.

Anna Rose Welch 1:10:56

Yeah, I would jump in there and say this is entirely somewhat self-serving. So maybe we can avoid the fact this is gonna sound selfish, but also is a really good um way of bettering biopharma. It's really important to communicate. I think we've learned in the mRNA space the challenges that come from not communicating clearly, what your technology can do. But I would also argue the importance of talking to people like us, right? And sharing your best practices and your learnings. Um, you know, I hope AI doesn't come for our jobs, right? At the end of the day. Um, you know, we're all we're all people and and we can tell a good story, and so can you, right? Those of you who are listening, you can tell an important story. Um, and the work that you do may not seem sexy, uh, but I can tell you that it absolutely is. So, you know, be don't be afraid to to share what you've learned uh with with folks like us and and with your with your peers in the industry. I think that's really important. Can't be said.

Tyler Menichiello 1:12:03

I don't think it's selfish at all.

Katie Anderson 1:12:04

No, we're really nice.

Tyler Menichiello 1:12:05

We're really nice.

Speaker 2 1:12:06

We are look we smile.

Jeff Buguliskis 1:12:10

I'm gonna I'm gonna build off on this podcast.

Tyler Menichiello 1:12:13

Yeah.

Jeff Buguliskis 1:12:14

I'm gonna build off of what Anna Rose said and you know, um go a little older school too, in the sense that uh customer service, you know, it's something we're hearing from you know some of the smaller biotechs um, you know, in the in the outsourcing space is that they're just you know, they've they've they've had some bad service from some of the these organizations, and it's it's leaving a bit of a bad taste in their mouth. So I think that's something that, you know, uh we're gonna try to address uh next year. Um, you know, how do we improve that? And I think communication obviously is part of that uh process, but uh just in general, some you know, better customer service. I mean, there's so many outsourcing companies now. And Lewis had read an article and he used a really good analogy about like supermarkets and how you can choose supermarket, and I and I thought that was really good. And I I actually thought of like, you know, car dealerships. You can buy a car anywhere, right? You can buy there's seven car dealerships to get the same car, but what makes you choose the one is technically, you know, probably something like service. You know, assuming you're getting the same price, you probably go there because, like, hey, I like them. They they gave me good service and they service my car well or whatever. And it's the same principle here for outsourcing, you know, um, there's lots of companies that will do the same job. It's it's a matter of, you know, finding the right partner, and and I think good customer service is going to be the key there.

Tyler Menichiello 1:13:25

Yeah, that's a great point, Jeff. It I actually those one of my highlights of the year that I meant to mention before was hosting a panel at at Bio that dove into that exact subject about CDMOs and the kind of uh the experience that small biotech companies feel versus larger biotech companies and that you know perceived disparity. So I agree that it's shout out Set of Ants for having me um moderate that panel. That was awesome. But no, I agree. I hope to see more um improvement there in that realm.

Ray Dogum 1:13:56

Ray? Yeah, so how to make bio or biopharma better. I think making sure that the new innovations, like the new modalities, the new discoveries are still funded. I feel like, especially this year, funding has shifted away from risky assets, um, kind of like what Ben was saying, to more, you know, conservative clinical stage companies. We need to find maybe alternative methods for funding these projects, these like you know, few people research projects. Um one idea is something called decentralized science, which like the there's a whole community out there focusing on ways to do that. So I encourage people to just maybe check it out, see if it fits with your programs. Um still a relatively new idea, but I think it's it could be it could better biopharma, is what I'm saying. Yeah, that's great, Ray. Thank you.

Tyler Menichiello 1:14:50

Thank you, man. Um I I had two written down, and since I'm the host, I'll give you both of them because I'm allowed. But I think the one is something that you know we touched on throughout the discussion, which is just this whole idea of collaborating and sharing um pre-competitive data. Like I think that's, or at least the insights that we derive from them, especially as all these companies are using very similar tools, digital tools, which we just had a live event about. That's another story. But just we're everyone's trying to do the same thing and using these tools for the first time and really just trying to make carve away, make a path, like sharing across the industry in a way that doesn't that would honestly help competition. I think is important to uh, you know, what the saying with the rising tide raising all the boats, like exactly that. Just share best practices around AI implementation and and data insight sharing. And I think more importantly, and and diving deeper into this whole AI paradigm that we're witnessing in real time is just don't undervalue human potential or like overlook the value of humans in in all of it. I mean, I think the best way we could improve this industry is to invest in the next generation of the workers and the people that are gonna be bringing these things ahead. Like, we need to not let AI, we can't outsource every single part of the professional world to AI. Um, don't outsource your thinking to AI. We need students in school to learn still and enter the workforce. We need to be investing in the next generation of workers. So yeah, my my answer would be to not undervalue humans in the whole grand scheme of things. And now we'll end on one fun question in the holiday spirit. We'll go around and I'll ask all the editors to either A, give me your favorite holiday movie, or B, uh, if it's appropriate, your favorite holiday tradition that you guys do in your house or your family.

Katie Anderson 1:16:52

Uh my favorite holiday movie is National Lampoon's Christmas Vacation, hands down. Yeah.

Tyler Menichiello 1:16:57

That's a great one. I'd say my say is my man. Yeah. Either that or elf were my uh bread and honey growing up for sure.

Erin Harris 1:17:06

I would say it's a tie for Christmas vacation for sure. But my long-standing favorite movie is It's a Wonderful Life. But the reason is is because it's a great movie. And if anybody hasn't watched it, it still holds up today. It's excellent. But when I was in like fifth or sixth grade and I was thoroughly convinced I was gonna marry Joe McIntyre of New Kids on the Block, that was his favorite movie. And so I felt that if he was gonna marry me someday, I would have to make that my favorite movie too. Uh turns out it's just a great movie. He and I didn't end up together, but it's still one of my favorite movies.

Ray Dogum 1:17:39

That's awesome. It's awesome. Um, I can go next. So hard to pick a favorite movie, but I do love Home Alone 2. And the reason I like number two is there's a funny scene where they're in the basement and Marv gets electrocuted and then he turns into like a skeleton. I just in my mind as a child watching that was just hilarious. So it still sticks with me.

Anna Rose Welch 1:18:01

Right though. Right. I think Home Alone 2, I like it better than I like it better than one. I think I was because I always love the scene where they're hiding up at the in the attic of Carnegie Hall. You know, you always thought that was really neat as a kid. Um, okay, my answer is gonna be completely off the wall.

Tyler Menichiello 1:18:19

Uh, but I can tell by the way you were squirming when on mute when I asked the question.

Anna Rose Welch 1:18:25

My favorite Christmas movie um is not life-affirming or positive, but it is called Violent Night. So it's what that's advertising. I thought you were gonna go diehard, and I'm like, How's the Christmas movie? I mean I am of the mind that diehard is a Christmas movie. Oh, right, 100%. But um, I would say Violet Night because Santa is a Viking and he comes to avenge and save a young a young girl from from some goons that are that are ransacking their uh Christmas Christmas.

Ray Dogum 1:18:57

Wow, I've watched that movie. It is hilarious. They're coming out with a sequel next Descender, by the way, December 2026. Violet night.

Anna Rose Welch 1:19:05

I don't know how I feel about sequels, but the first one, hands down, solid choice. Wow, solid choice for it.

Jeff Buguliskis 1:19:14

Okay, I I agree. Die Hard is definitely a Christmas movie, and apparently so is uh Lord of the Rings. I just found out that uh Tolkien actually was a huge Christmas fan and and rode that to be, you know, to be told around Christmas time, which I thought was pretty fascinating. Um, for me, you know, I agree, Christmas Vacation is great or whatever, but I've always been a sucker for you know A Christmas Carol, uh, just in all its various forms. Like I kind of end up watching, you know, all the different ones from the oldest ones, you know, to like some of the newer ones, you know. Um, just you know, it's a it's a great story. And it's interesting that Scrooge is really not, although he's been maligned as being, you know, this worst character, he turns out to be the great character in the end, you know, that we everybody always Forgets about that part. It was like, Oh, you're a Scrooge. I'm like, Well, Scrooge was a great character, really. He turned into a great character. Everybody just forgets the ending part, but yeah, that's that's mine. Jeff, you get called Scrooge a lot. I do.

Tyler Menichiello 1:20:11

So no, sounded like uh that sounded like a personal story there.

Katie Anderson 1:20:16

He's so misunderstood.

Tyler Menichiello 1:20:18

Scrooge is actually a really cool guy. A lot of people don't give him enough credit for the change. He's the best dynamic. Very dynamic. Ben?

Ben Comer 1:20:26

Uh I'd I'd probably have to go with uh Christmas vacation, but I'll just quickly give an honorable mention to a movie called Prancer that um my mother for many years made us watch every Christmas Eve.

Anna Rose Welch 1:20:38

It's so good. So good. Yes, 100%.

Ben Comer 1:20:42

Very sweet.

Tyler Menichiello 1:20:45

Well, Katie, Jeff, Ben, Ray, Aaron, Anna, thank you all so much for joining me on this episode of Better Biopharma, the official podcast of Bioprocess Online. Thank you all for tuning in. We'll see you next year.