The Gil Roth Show | How CDMOs, CMOs, & PBOA Are Navigating Through the Uncertainty

How are CDMOs, CMOs, and the PBOA adapting to industry uncertainty? Join Gil Roth on The SCORRCAST as he discusses the challenges, opportunities, and strategies shaping the future of contract development and manufacturing. Gain insights into market trends, risk management, and how key players are navigating change in the pharmaceutical and biotech sectors.

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Music. Hello everyone, and welcome back to another episode of The SCORR cast where we dive deep into the most pressing topics in life, science, marketing, business development and beyond. Today I am really excited to be joined by who I consider just a true expert in this space, Gil Roth. And I'm going to have Gil introduce himself in a moment, but we are going to talk a little bit about everything Gil I've often heard in just different recordings of you. You refer to it as The Gil Show. I'm very excited to make the SCORR cast today the gil show, and we are just going to riff. We're going to talk about uncertainty in the market. We're going to talk about the administration. I'm going to force a couple of marketing questions on you about branding and storytelling, and I'm sure we will, like I said before, dance around from one topic to the next. But before we do that, I think everybody that's listening to this is probably familiar with you, Gil, but if not, would you? Would you be so kind to give us kind of an introduction, maybe a little bit of your your background, and then what I always ask for right out of the gate is just, what are you passionate about as part of this introduction, and then we'll jump in, sure. Thanks so much, and I appreciate the opportunity to be on the show. So my name's Gil Roth. I run the Pharma and Biopharma Outsourcing Association, which is a nonprofit trade group that advocates for the CMO and cdmo sector. I founded that in 2014 after about 15 years as the founding editor of contract pharma magazine, which was the first real trade publication for the CMO, I'll say cdmo sector. But we existed before cdmo became an actual term. And I was around when it was it was founded and popularized. Anyway. I've been around this space since 1999 which isn't possible because that's 26 years, but somehow they've added up. What I do is help represent the cdmo sector. Initially, my thought when launching pboa was to work with Congress and make sure that they understood the cdmo perspective. At the time, we wanted to help negotiate the second iteration, second five year period of the generic drug user fee amendments, and those user fees will come up, I'm sure, as part of our conversation today, because there's a lot going on in that space. In the process of doing this, we really got FDA to better understand the perspective of cdmos. They really didn't get who we were. They understood we had the same quality requirements and specs as in house pharma sites did, but they didn't understand the business. Didn't understand what it meant to work as a cdmo with so many different clients, and to potentially be advancing manufacturing technologies and platforms that maybe individual drug companies wouldn't invest in on their own, but from a cdmo perspective, could be leveraged across a number of drug applications. So we worked with the FDA. In the process, I learned we also had to work with Congress to help shape legislation before it ever gets to FDA. And in the process of that, I discovered I had to register as a lobbyist with the federal government, which I really did not expect when I launched this association. We also use a lobbying firm in Washington. I'm based in northern New Jersey. That firm keeps us up to date on what's happening in on Capitol Hill and in the environs, how that impacts our sector. They help me set up meetings and get down to the Hill to talk to specific congressional staffers and help socialize certain ideas and try to advance and advocate the cdmo perspective. And then beyond that, we've also got a number of working groups we built where cdmos get to talk to each other, and that's really proved to be really valuable for the industry. It's something I didn't expect going in because I schmooze as part of my my my nature, and I thought everybody else kind of schmoozed and connected with everybody else. And then I've realized, no, you guys all have real jobs where you're in your own silos, working at your companies. And if I can help facilitate things and bring people together from different cdmos, you can say competitors, but they're also peers, getting them to talk to each other in an anti trust compliant way, of course, has really proved valuable for the sector. So it's really that regulatory, legislative and then the business advocacy that we provide through pboa. And it's something that if you ask what I'm I'm passionate about, I'll tell you the origin of this association. The original idea was I would launch it and hand it off to some firm down in Washington to keep it going, and I would keep working on contract pharma until whenever. And I kind of realized a few months into the idea for this association, after I'd brought it up with a lot of companies, but. No one cares about these guys the way I do. I've been to individual cdmo people's, their weddings, their kids, high school graduations. I understood the red headed stepchild nature of this industry that for so long, companies would never reveal that they use cdmos. They would always say, we make what we sell. We sell what we make. Over time, that has opened up. But yeah, it occurred to me that, you know, if we hand it off to some Hired Gun, they're not really going to care the same way. They'll get a paycheck and they'll they'll do an effective job, maybe, but you know, it might not fit into their long term goals, and to me, helping this industry grow and really highlighting the importance that it has in the healthcare system. On a professional level, that's the thing that I'm passionate about. We can go into all the wacky personal stuff that I do too, but that's, you know, the sort of stuff that just adds color and character. So anyway, that's my over long introduction. Alec, thanks. I love it. And maybe the second half of this episode, we're going to go into the wacky personal passions, but i There are a couple of things right out of the gate. I love this aspect of community within the industry, and I think that at times within just the life sciences as a whole, SCORR obviously having an emphasis within the, you know, the cdmo side, but also on the clinical research. See our CRO side, you know, e Clinical Technology, there is a lot of hesitancy around that word community. And yet the collaboration is so important. When you created this and you started to see kind of that interest bubble up for hey, I want that community. I want to have an event to talk to my peers. Was there any pushback right out of the gate, or was that something that people were really receptive to? What was kind of that initial response to building interesting the the actual, you know, forming working groups thing happened while I was at an FDA public meeting on quality metrics. So like 2016 or so and several of our member companies quality leads were sitting around me, we're all waiting. And then the generic industry spokesman got up and talked about how their quality technical group had worked on X, Y and Z, related to quality metrics. And I turned to those quality leads and say, if I go up there and talk about our quality technical group, will you guys pretend that you were part of this? Because we didn't actually have one until that moment? And they said, Yeah, we should launch one of those. And I said, yes, you're you're right. That's a good idea. So getting those people to interact with each other, just the quality leads from so many of our member companies, that's really been the big success of the working groups that we have, and they have so much to share with each other in non, you know, again, non anti trust, violating ways, non proprietary knowledge ways. Sometimes they'll ask questions of the group during a call. Other times they'll ask me to ask on their behalf, if it's sensitive, maybe they don't want companies knowing that they're the ones asking a certain thing, and I'll send back the responses anonymized too, but it's still a sign that there's so much for these companies to learn from each other, that that's really important. And like I was saying, they are competitors, but also peers. Now, the other thing we do, and it's something SCORR Is participated in. We do an annual meeting every fall, and that is only for our members and and our affiliate members companies like SCORR that provide services and goods to the the cdmo sector. And when I pitched it to my board of trustees, there was a little hesitation, because they're used to conferences and trade shows being about business development. And I told them, that's part of it, but this is also about networking with each other. And FDA is going to come in and speak, and they're going to ask questions from you guys. And it's it is different. You guys speak differently when your customers are not in the room and giving you, you know, a safe space to talk to each other, to talk to the agency, to talk to the other subject matter experts that we bring in. It's important. Cdmos deserve a place where they're the guest, where they're not the ones paying for the exhibits and being locked out of the conference sessions. And I, through my 26 years in the space, I've been to those shows where, no, no, we're all going into the conference room. Now you guys have to stay out here in an empty exhibit hall. You're just paying the bills for us. It's not right. And I make sure that affiliate members, who sometimes help sponsor the event, everybody is invited into the conference sessions. So giving cdmos Again, that sense of community has been really important, and they've gotten to know each other, which is good, and it's an industry where people move around and the contacts that they make through through me and through the meetings, it helps you know somebody you've looked at or met face to face over the big dinner that we have, and the networking receptions, those things build a lot of camaraderie and familiarity within the space that maybe in our silos we don't necessarily have. Of, yeah, I love that. The just building community, breaking down the silos is is of paramount importance. And I kind of jumped in here. I said I wanted to start at the high level before, and now we've gotten a little granular, but I do want to take a step back. You mentioned. So we're going on 11 years now, or so of pboas. You know, in 2014 pretty hectic 11 years, different administrations. We have the COVID 19 pandemic, and now here we are in 2025 new administration takes office in January, and a hectic three months, to say the least, for lack of a good question here, what's the state of what's the state of Gill? What's the state of the industry? Where is your head at? How are you looking at all of these things that are happening on an ongoing basis, kind of at a minute by minute basis, where one update comes in, and maybe it's not going to be the factual thing, two, three days later. Where are you at right now or one day later. Frankly, Sunday night, there was a Wall Street Journal piece about how this is Sunday March 23 there was an update on the shape that tariff policy was going to take beginning April 2, and by the next day when my flight back from my niece's wedding landed that had already changed, or at least been moderated, with potential for a significant change in another couple of days. So staying on top of that sort of shifting degree of policy, trying not to, trying to keep our members informed without saying things in a definitive way, sometimes, which I did early on, when first tariff policies were being announced with Canada, Mexico and China, and then discovered 15 minutes after I hit send, that the Mexico policy had changed, and six hours later, Canada's was changed. I recognized early on, okay, this is the current state of where things are. Let's, you know, retain flexibility and try to understand the potential for change and what some of the drivers of that might be. So, you know, trying to stay on top of the uncertainty aspect of this, what the goals of this administration are when it comes to something like tariffs, it's been important, and it's something that was certainly discussed a lot during DCad. Nobody has a definitive answer to these things, but it's a question of, what are they doing to either retain flexibility or figure out if X, Y and Z is the case where the current state of the situation is, what markets will we be serving Well, and what could X percent added to our customers top line through tariffs impact how they work with cdmos, or what regions they choose to either manufacture or market in. So that's created a lot of a lot of uncertainty and a lot of just trying to understand through larger industry players as well as other industries responses where things could go. You know, the automotive industry pushed back very quickly about the Canada tariffs because of the amount of back and forth of parts and different things that were shipped back and forth across the US and Canada borders, and what that would mean in terms of tariffs ultimately hitting us vehicles, there was a postponement of that, of tariffs on those parts being done. We'll see what the final result of this stuff all is, if April 2 turns out to be the big tariff date this might air after all that, and everything I'm saying will be invalidated by then, which is part of my point. From a cdmo perspective, we need to know what their customers are looking at, and understand what some of the drivers are, what some of the potential responses are. One thing I heard from DCad a few times was that x cdmo, cdmos outside the US, seem to be looking at acquisitions of assets in the US, whether that's other cdmos or facilities that might be available ways of establishing a US operating beachhead, basically, which I assume is meant to at least try to mitigate some of the impact of tariffs with the ideas of either moving customers to their to those us sites, or at least showing the administration that you're investing in the US. So it does create a great deal of uncertainty, but it's Well, the thing that I told FDA back when we were negotiating gdufa Two, this is 2015 2016 the big thing about those user fee negotiations were we are not the guys filing the generic drug. Applications, we were being hit with very large facility fees as part of the gdufa one setup, which we were not involved in negotiating, and the line I settled on, and it's held up when we talk to a lot of other parties, is we don't drive the bus, but the bus doesn't go anywhere without us. And as cdmos, that's where we are. We don't control the drug applications. When people ask us about supply chains, and can't you make more of drug X, Y or Z for the US market, we can't do anything without the license holder, but the license holder can't make the drug without the cdmo. So that's our understanding of where we are, I guess in the in the policy chain. Also because, you know, we do have a role to play, but we understand that pharma and bio and other parties have a much bigger role to play when it comes to helping shape what that policy looks like. I love the we don't drive the bus analogy here, but I also know, you know, none of these things can happen in a quick manner, right? So we talk about taking a customer from Europe or Asia Pacific and then trying to bring them into a facility in the United States. This isn't something that happens overnight, right? And transfer regulatory processes, etc, could take years, right? The the the big knock, and this, this something that goes back to the Biden administration, and I've talked about it, and there have been public comments, so I'm not giving away anything proprietary. Under the previous administration, there was a a multi country, in this case, five country slash region, attempt to figure out alternate supply chains for drugs that are currently solely sourced from China. This was, again, publicly stated goal, so not giving anything away. We're not supposed to talk about who was in the room, or even admit that we ourselves were in the room. I was in the room. I got invited. It was during bio. I was invited one week before. It was the first time an email showed up in my box with nsc.gov as the address, and I thought, boy, I didn't think the National Security Council knew who I was, and I'm not super happy that they do, but, but I was invited along to this, this meeting, which was again, five regions trying to figure out, what if you took, like the any of the essential medicines lists that are out there, the US or the European Commissions or the who's and maybe identify 20 really critical ones and figure out how to source those completely outside of China. What would it take? And the thing we've been talking about with supply chains throughout you know, even before COVID In 2019, we were involved in some national security conversations with the Senate and the House about this, the commodity generic APIs are really the things they're concerned about, and those are not things you can move quickly and easily to other regions. And again, we're more on the dosage form side than the API side with pboa, but we have enough companies that are also API makers, even the small molecule space, that they recognize what the value chains look like, why they evolved the way they did, why certain things are made solely in China, and it's a major challenge to build An entire chemical infrastructure and all the environmental issues, health standards, just wages, etc, that make it much more likely to be made solely in China. So trying to move all that stuff to the US or another region becomes a major challenge, and it would involve years and years of infrastructure building to get there. So when there's discussion about onshoring and trying to bring everything back here, it's really a question of what you're trying to bring back and what the timelines would be like, what the economics would be like. A lot of the key starting materials would still come from other regions. Excipients, largely are going to come from China and other countries, while, and this is something that that's come up in recent years, while excipients are incredibly important to the pharma industry for all of our solid dosage drugs, the pharma industry is not super important to the guys who actually make those ingredients for excipients, which are largely food grade products, and it's a much bigger market for them than Pharma. So telling them, oh, hey, can you move all your operations somewhere here for this thing that only accounts for a small percentage of your your market isn't really a starter, but without excipients, same thing, they don't drive the bus. Bus doesn't go anywhere without them. So you still need a supply chain that's able to accommodate those nodes that simply cannot be moved to another site. There does need to be a lot more understanding of how many drugs are sole sourced, not just within a single country, but for a single facility. And this is something that's really come up, especially on the generic side. Yeah, and again, it's more API side, but FDA has started to put together their map somewhat from the reporting amounts bill that came out during the Cares Act back in 2020 but also through existing data they've had for years and years, through generic drug applications and drug master files that companies might think that they are sourcing from different API facilities, and turns out, they're all coming from one API facility, and that's not safe. Ultimately, you know, five different generics are all getting the API from the same site. That means, if that site goes down, all of those different providers are out of the market, and that's when we think that having five different generic companies for a single drug is robust. It can turn out to be just as fragile as having only one. So anyway, that's part of the globalization and supply chain rejiggering that is at least part of the goal of the current tariff policy and some of what we're looking at, again, from a dosage form perspective, we really do try to highlight that the US has a lot of capacity for the important types of meds, and that we're making the pills, tablets, files, syringes, pre filled syringes. In the case of the GLP one class. There's an awful lot that's going on in America. We don't need a gigantic incentive structure to cause more competitors to come into this space when there are certain aspects that are very well served in the US already. Yeah, that was a it was a five minute answer. And there was actually substance in there, though, right? Oh, there was so much substance. But just to, just to bring it back, even into the conversations that we're having on a day to day basis, it makes sense why commercial leaders, marketers, business development teams. There's this sense of analysis, paralysis of Who do I talk to? What do we do? Because of all of this uncertainty and being able to prepare for six months from now, 12 months from now, let alone 1824, that five year picture kind of feels like you're just closing your eyes and throwing darts, and there's really not a way to be able, like you said you could make a decision today that is irrelevant in the world that we're living in in tomorrow or, let alone a couple of years from now. And that's that's stressful. It's stressful. See the the innovator side, if your customers as a cdmo are primarily innovators, there's some more more flexibility built in because there's more money built in, right? When your customers are commodity generics firms, or at least you're accommodating part of that market, they cannot take a risk. Yeah, let's make a second source for this product that we only sell for a penny a tablet. That's right. It becomes very, very difficult for them. So yeah, they have a lot at stake, and there's a lot of patients who rely on these things, which is, it's paramount we always kind of elite or lied over that when we're talking inside the industry, because we all understand the patient is absolutely right, tops. But I've discovered in recent years that people actually listen to these podcasts outside of industry, so sort of important to make sure patients, 90% of prescriptions in the US by volume, are generics. So making sure that that market is served, even while the margins on it are tiny, and there's going to be a great deal of pressure if you start putting tariffs on their inputs or on the countries that they're being exported from, that's something that could potentially have significant impact on patients going forward. And we talk impact, we've kind of gone down the tariff and some of those regulatory pieces you mentioned, and you kind of teased out the user fees aspect of this, and I've heard you talk about this before in different conversations, you know, maybe even in the newsletter, if I'm if I'm remembering correctly, just in terms of what that impact is going to have from the FDA perspective. Not a good question here, but give us the rundown of where we're at there. Well, I'll tell you what's at stake now, as I mentioned earlier, all the major user fee programs, it's prescription drug, generic drug, medical device and biosimilars, those four majors, all the user fee packages come up for reauthorization every five years. The over the counter monograph one was that that was enacted as also part of that cares Reporting Act. And that's of a slightly different timing because of the year it got instituted, but they're looking to sync it with the other four. So the user fee packages consist of industry and FDA sitting down to to negotiate commitments on FDA part, usually centering around review timelines for drugs, but also for issuing. Guidance on certain types of drugs, or in some cases, on the FDA side, getting supplemental fees to improve its it capacity and to hold some programs and to increase some of the meetings that they hold with drug applicants, as well as being able to hire inspection staff. But the upshot of all that is these commitments yield what FDA is, what the expected timelines for a drug review are not an approval, but a review. Now, in the PDUFA case, for the innovators, they were at a point a few years ago where 96% of NDAs and BLAS did receive approval in their first cycle. I don't know where that number is right now, with generics, it's a much lower first cycle approval, but they have improved the median time to get a generic approved. But the thing is, all of those commitments on FDA side, the things they agree to, they come back to industry and say, Okay, this is how many full time equivalents or FTEs will need to hire to meet those goals. And industry comes back with that's that's more FTEs, because every FTE equals a certain fully loaded dollar amount, and that carries through year upon year, and the user fees and inflation comes in every year and increases the cost per FTE, and that's when industry figures out, okay, we're not this one wasn't as big a priority. We don't need that those FTEs added, but we do need this other category, and that's going to equal 10 more people in the program, or this many more reviewers at CBER, blah, blah, blah, and that means that all the user fees are based on FDA ability to hire and retain personnel, and with some of the recent issues that have occurred through government streamlining of the workforce, industry has To make sure they have faith that FDA will be allowed to hire and retain personnel under the user fee acts going forward, these staffers, these FTEs, are hired with user fee money, so it's not taxpayer funds that are paying for them, but we need to make sure that we trust that FDA can Do this as we head into the user fee negotiations, in our case, pboa will be at the table for gdufa, but the other majors there again, PDUFA, Basu and medufa, I'm sure their industry groups are also making sure, or trying to talk through with FDA and potentially Congress, that if we negotiate these fees, We know that FDA will be able to hire and retain people, for example, with the training aspect of things we know. We've been told that for the inspectorate at FDA, it's about a year and a half after being hired that they're able to act their new inspectors are able to inspect a site on their own. They need significant training to be onboarded. And with that initial wave of firings that took place, or workforce cuts of everybody who'd been zero to two years at various agencies, right, a lot of tumultuousness and a lot of lack of productivity is you can't get these people up to speed. So we want to make sure we have assurances that user fee staff will be, will be kept, that they'll be, you know, not subject to any sort of streamlining. As part of this, 40% of FDA is budget does come from the medical side, user fees. I believe another 6% comes from the tobacco industry user fees, but that's a separate settlement. So it's we're ready for negotiations. This fall, we've already been working with our counterparts at AAM and talking with FDA and developing our data call questions in advance, as we do every five years. But yeah, it's the uncertainty that was created at the beginning of the administration regarding the federal workforce that can ultimately impact the entire sector, not just enrollments as cdmos, because, as I mentioned, all those user fees are tied to drug review timelines. And if you're a small R and D company with your one product with an NDA or bla and all of your investor money is hinged on, okay, your PDUFA goal date for that review is date X. That gives you some business certainty and some structure. And if this model falls apart and industry can't rely on fixed goal dates going forward, that could create a lot of issues when it comes to R and D, productivity, willingness of investors to put money into this space, etc. So it's something we're certainly keeping an eye on. It's not something we directly impact from the cdmo perspective, but something that will directly impact us if that predictability of reviews is affected and that. Way, yeah. Side note question here, how do you, before we even get into I've got a couple of questions about cell and gene therapy and marketing, how do you on a day to day basis, skill maintain all of this, you know, we talk about, I asked the question about passion and interest, and you know, I can tell that this is something that you could talk about for another four hours, way too long. On this far longer, right? I'm also trying to be diplomatic in my language, so my number one keys, as I tell people, and as I was just saying, with a one of my trustees right before this call, because he's in the same boat as me. I don't have children. I have no social life really, and I don't drink. So those are really three things that that, you know, have helped me be much more productive, or at least be able to retain all this stuff, because I'm not worried about sending somebody to college at this point. Yeah, it's it is challenging trying to figure out not just what is happening, but what is under what is happening? And it's not just talking about this administration, but my experience of the last 11 years, figuring out what somebody actually is saying as a subtext, or what the tensions and dynamics and drivers are for some of their decisions that, again, from a cdmo side, we might have limited perspective into, but learning how to to better read other people and then retain all that and sort of build a mosaic. That's that's what I do. The other big thing is tooting my own horn, the my ability to do all this stuff, not just the retaining it all, but the fact that people will fill me in on important things that are going on that aren't necessarily public information. There's a good deal of trust they have in me and my the good will that I have in this sector, really, people will share things with me, knowing that it'll help me put together a composite idea of what's going on without violating their trust. You know, I can start to build a idea that I can share with others without saying Company X told me this happened, and it helps they my role in that way kind of helps them have somebody they can validate some of these theories and observations with and see if customers are hitting other cdmos with the same sorts of questions or demands without asking things that could be potentially anti trusty. So it helps them, you know, better understand where things are coming and going without having to find out exactly which company is doing X, Y or Z. So yeah, it's a lot of work, but, you know, it's better than putting out a magazine. I figure I love it. It's, it's all a testament to to the work and the relationships over the the last 26 years. So I it's, it's fantastic. You know, even just seeing it firsthand, I do. I want to pivot a little bit so I consider myself an outsider in in the industry. I've been at SCORR for four years. Came in account strategist, working with our clients on a day to day basis, have moved over to business development because I wouldn't stop talking. And Leo was was tired of it when I started couple of clients right out of the gate that I'm working on are selling gene therapy, and I couldn't read a newsletter or an article in 2021 that was not cell and gene therapy, cell and gene therapy, and it felt like there was a lot of momentum. And now what we're hearing from our strategic advisory board, from our clients, and just the industry as a whole, from our side, is, hey, maybe we're taking a step back on on cell and gene therapy. Maybe we we're going to divest that portion of the business. So we're going to move away from that. Can you give me a little bit of an insider's update on on what that cell and gene therapy landscape is and maybe what's causing some of that slowdown? Yeah, so first, and this is something I've talked about. Let's see 2023 was the first time I brought this idea up in the press conference during cphi Back in Barcelona, which I'll get to in a moment. The this not our industry as cdmos, but the larger pharma and biopharma industry. There have been buzzword sort of investor crazes over my time in here, and something that had come up for me in relation to cell and gene therapies was antibody drug conjugates, which similarly went through a period of intense Investment and Development and buzzword craze had some clinical I don't want to say failures exactly, so much as slowdowns. Things took longer than they expected. That led to investor lack of faith, people pulling out, et cetera. Then the science and the clinical data started to bear through. And as I put it back, in fall of 2023 you couldn't go five minutes without. An ADC agreement being made, and the market finally caught up with the successes that occurred on the clinical and scientific side of things, as well as the manufacturing end. I think we see something similar with and cell and gene therapy are two very different things, and there are ways of breaking those down that are very, very different within them, but as a catch all, whatever. So within the cell and Gene space, I think one of the the the clinical side still has to catch up. I think investor expectations were too high for how quickly return could happen, and the COVID era warped a lot of things, as far as what the the timelines could look like that changed the way clinical trials were done for a bit, etc, with cell and Gene You also have the issue of reimbursement, which in the US, drives everything. And if your drug costs two and a half million dollars per dose, this is going to change how things are handled on the insurance side, what patient uptake is like. And we've seen companies that have, like bluebird bio, for example, had two or three approvals in this space for effective drugs, and I've gone out of business. Basically, bluebird sold for about $30 million recently to some private equity firms. Was valued at one point at, you know, 10 billion reimbursements been a huge factor in this stuff. I think you know that stuff will get worked out as the medic as the the therapies themselves produce a great deal of long term savings. One of the issues is simply Insurance Company X is on the hook for two and a half million dollars for this drug, but the patient is probably going to be at Insurance Company y5 years from now. So why should we at x pay for this when all the bills that would have been covered if he wasn't doing this are going to be paid by insurance company. Why it's heartless and, you know, very mathematical way of looking at this stuff, but that seems to drive some of the reimbursement issues within this space. You know, reliability, understanding the durability of some of these drugs, is also open ended and ensure insurers don't want to put up huge amounts now and then discover three years from now that, oh, the effect actually waned, and they're going to need another dose, or they're no longer eligible for a dose because of a, you know, the viral vector delivery system for some of these things. And as such, you know the those old medical bills that you thought were never going to occur. Now we're going to occur the model that I always go back to, and this is pre cell and gene therapy is still so valid from Gilead, which cured hepatitis C, had you literally got rid of the disease. It wasn't a you'll need to take this for the rest of your life. It was, I think 12 weeks of treatment, and insurers and Medicare etc balked because it was $80,000 for a course of treatment. On the flip side, these people were not going to need liver transplants, which would cost you a lot more than$80,000 but that short term financial hit governed some of the uptake with this stuff, especially on a governmental side, and especially within the prison population, where hepatitis C was rampant, and again, somewhat heartlessly, there was a do we need to give these guys this drug? It's very expensive, which wasn't cool. Over time, there were more entrants into the market, the cost fell for that reason. But still, it's, you know, that the dynamics of reimbursement and the economics in the US drive a lot of this stuff. And I believe, like I said, that cell and gene will advance. There will be much more financially sustainable models going forward. It's going to take a few years to catch up, and by then, we'll be talking about how AI never worked out and became a buzzword that everybody threw money into with no ROI, but that's just me editorializing. So I, as everybody asks, I love the I love the editorializing. Um, you mentioned the buzzwords. It's something that I from a marketing, branding, positioning standpoint, have picked a bone with, and I think we have a mutual connection that also refers to this as the the sea of sameness, and that if you throw buzzwords out there, and we try to be everything to everyone, all at once, and hey, if you, if you name it, we can do it type of approach. You know, you think that that's a positive, but as more and more competitors are in the market, it's not going to be a positive. You're not going to stand out. I'm curious the AI is, is one on the clinical research side. We were just at a trade show in February where. Yeah, the amount of times I saw data driven insights had me ready to lose my mind, because we've been doing data driven insights for a lot longer than you think. It's not just because we have an AI tool to utilize it so, so I'm just curious, what are your thoughts on this topic of conversation, pre AI, it was all big data. If you remember that it was the giant data sets are going to yield all of these, these great insights, especially for drug development and clinical trial results. So they put a new buzzword on it, with AI. We know it's actually machine learning and not AI. That's right, driving this stuff, but that's a that's not a sexy buzzword. So we need to use AI now from a strictly from a cdmo perspective, there are, I believe, benefits within that machine learning landscape or predictive analytics for manufacturing processes that seems to be the application that could actually be beneficial the more data you have on manufacturing of certain modalities or particular products, whatever, the the more the machine learning algorithms, whatever can look through that data and start to see, oh, when this starts to go out of spec, that's when you know, six weeks after that, you start to get a failed batch. Let's start fixing that stuff early. Now, a chunk of this stuff is still dependent on the data being collected in in structured formats, having enough sensors to pick up on these things, which is much more the province of the continuous manufacturing guys like Fernando Muzio out of Rutgers with a lot of the I've heard them say up meetings, there should be sensors in every single tablet press, because the more data you bring in, you will be able to start getting some of those benefits and returns from the problem is a lot of those things are those low, low value commodity generics that I brought up earlier. And increasing cost through more technology is not something they can really viably invest in. But still, that seems to be an area of application for this whole AI and machine learning landscape, when it comes to the cdmo side, that said, it's all dependent on significantly huge amounts of data, as well as, again, the reliability of that data, if everything's collected on paper, going to be tough trying to get all that stuff into spreadsheets that this the systems can read. And if you're talking about very small run, small volumes of products or super specific, personalized medicines like the cell and Gene space, you're probably not going to generate the sorts of data, the amount of data you need to reliably use machine learning, where the human eye is basically going to pick up on these signals too. So, you know, there's a lot of promise to me. It's not just in pharma. The whole AI thing has felt like a giant bubble from the beginning, and I'm waiting to be proven right on this one, but I don't have any money in it one way or the other. So, you know, I can put it out. I'm with you on the marketing side. I think that there for me, I don't go as far as to say that I am anti AI in marketing, because there's somebody listening to this that thinks that I should be really deep in AI, and they could be a potential client. But it's, it's, I think it is very similar to that, that bubble that you are referring to, okay, before, before we wrap up, I do want to ask kind of a I was just getting started. I know you are, I know you are, but I only have an hour on your calendar, and I know how busy you are. I go along after this. I have to write a 25 minute presentation for tomorrow, but this will help. So I love that well. And this is, this is going to air next week, so people who are listening to this, this was April 3, maybe, hopefully I'm a dad by then. I don't know if I can wait two more weeks. Yeah, we'll see. But I am curious, you know, we talk about the sea of sameness, one of the things that I talked about on a podcast a couple of months ago, going to CP h i North America. CP h i worldwide. You're going to see a lot of the the same language being said by different companies right now, whether that is on the hey, we're a full service end to end, one stop shop, or, you know, if you think about, you know, a specific niche within, like, sterile, fill, finish, there's a lot of this same messaging that's being utilized. From your from my perspective, this is, like my enemy number one, and what I'm trying to solve. But from your perspective, how important is it for these companies to have a story that actually helps them stand out in in 2025 is that something, for lack of a better question that should be a focus for these organizations right now, with where we're at today, what are your thoughts around marketing and messaging as it pertains to just the market as a whole? Sure, it's you. The it's a relationship driven business. Still. You know, when I started out, it was like this, before I knew what any of the relationships were like, I came in with no knowledge of the sector whatsoever. But it turned out, person at cdmo X used to work at in house Company Y, and there was trust at in house Company Y, Oh, this guy wouldn't be selling us bad cdmo operations, you know, let's work with them. The we'll talk particularly about like the sterile fill finish space. You know, we fill vials, we fill cartridges, we fill syringes, we have pre filled syringes, etc. How do you differentiate? You know, it can be track record. If you're a company like Grand River aseptic manufacturing. Johnson and Johnson came to you during COVID and operation warp speed. You manufactured for them without a fail. They also handled the Bavarian Nordic monkey pox vaccine. They've done a lot of other projects outside of those two pandemic responses or epidemic responses, but that showed a track record, certainly, and the technology they have in their site, they can show off and really win customers through that sort of thing. And there's a story in that respect another let's see cdmo, who joined as a startup, but has continued, and they're bringing in their customers now in cog biopharma. I think of them, a bunch of the guys who were the founders of that were veterans of Cook, pharmaca. They had a track record within the sector from their time at Cook. I think that helped when it came to work. We brought the team back together. We're launching a new cdmo in the sterile, fill, finish space you worked with us before. We're going to build something that is, you know, purpose built from the ground up, you know, for this marketplace. And that, I think, was very, very strong messaging for them, beyond the technology, quality levels and everything else. I think there was a personal connection that people could make in the sector and understand, you know, who these guys were, if you had longevity in the space for some procurement guy who's cycled in, cycled back out, things are going to be different. You're going to be looking at a bunch of pricing metrics, quality and compliance, and then you somewhat fall into that sea of sameness thing. It might just be geography and available capacity that dictates your buying decision. But really, I think having messaging, having the ability to show that, you know, we're not just filling files. We're guys you've worked with before, or people who are investing in X level of technology, or have, you know, these relationships with certain potential client companies or governments as the case may be that that helps when it comes to some of the messaging, but, yeah, it's very difficult. I remember in the magazine days that one magazine, one cdmo, started advertising with a photo of one of their their people, and a little quote and testimonial from them, and within six months, like 10 other cdmos had the same style of AD, and it was like, yeah, it's not helping. You know that you just picked up on one guy's thing that worked, and now you're all replicating it. That's not, you know, gonna help anyone make a buying decision one way or the other. So, yeah, it's still a significant challenge. But I think the the relationship aspect of this thing, and it's part of why DC cat is the success it is, right? It's companies that do the legwork, that sit down and have those meetings. You're not standing in a booth, you know you're you're talking about, and you are walking through hotel lobbies and bumping into people that you know, you've known for years, but needed to connect with and have a little conversation and a follow up with, yeah, that's, that's the which are breaking into the space. That's the big challenge is, you know, where do you get to the point where you you have those relationships and you're comfortable with everybody, and you can make those calls and get people into the room. Yeah, it's the meaningful conversations. And that's where for us, a lot of times, we'll look at what's the story that we can tell that fosters those meaningful conversations. And if you are just checking the box, and everybody else is just checking the box, it's going to come down to, well, I actually know somebody at this company, or this is a little bit easier, and now you start to become, for lack of better terms, a little bit of that commodity of just, okay, we're just going to go with who checks the most boxes for us, versus having you know that that actual interest in working with the company that has it has a different story. Okay, that's why, during our last conference, or in person conference in October. We actually, yeah, we had SCORR and two of its peers, not competitors, peers, sit down for a panel to just talk about marketing and what we've learned. We did one of these virtually end of 2020, I think before the vaccines had rolled out, we had a SCORR and one of its peers and two of our members sit down for a panel just to talk about, how do you market when no one can go anywhere, there's no trade shows, you cannot bring someone to your facility. And as we said at the time, it's not like catalent or thermo had an advantage, like they couldn't secretly. Fly people to their site when no one else, no one could do this. How did you change? And this was sort of a follow up, just getting guys to those guys and the customers in the room to talk through. You know, what did you learn? How things change? How do you decide what shows are important to go to? And how do you again, get that messaging across at a time that there's a great deal of need, the R and D mix is changing in certain ways. You have something like GLP ones that's totally bending the capacity that's out there and utilization of certain types of modalities and delivery systems. And what do you show that you're you know, you're in that space, you're active, you're available. It's something we mentioned geography earlier, but it's funny that two of my startup companies in cog in Fishers, Indiana, and Selkirk in Spokane, Washington, neither of those are on the beaten path exactly. But if you build a good facility, and you have a good story, and you can, you know, show that we can make this stuff, we're here for you, will support you beyond just the units that are being turned out, it's meaningful, but you do have to get in the door and be able to prove that. And again, the INCOG guys had a group track record that really helped them as part of the process. Yeah, and that's been their whole story, too. We're very familiar with the INCOG team, and that's been the story that they tell on a consistent basis, is that team that they've brought together, and they've done a really nice job of that as well. Okay, Gil, this has been, I feel, I feel four times smarter. Anybody that's listening to this is going to feel four times smarter. I really appreciate you being able to take such a complex and evolving landscape and be able to talk about it in bite sized pieces. Listen, I'm just happy. This is the first podcast I've had to do for industry in about a year where nobody's brought up bio secure. So I'm just happy. Basically, I had it. I had it on an asterisk to the side. I had it on an asterisk. That'll be a follow up. Yes, we'll do that. We'll do that on the next episode, last minute or so here, obviously I'm going to link to all the things. But where can people consume your content? You know, is it LinkedIn? Is it the website? Where can people find you over the next couple we do have a website, which is I really need to update, and it's pharma, bio.org, but if you go to LinkedIn and look up the pharma and bio the pboa, basically the pharma, biopharma outsourcing Association. You'll find the group there. I'm on as Gil Roth. You can always look me up and connect and I post. I do a newsletter every Friday, which you can sign up for through the website, and that I put in our member news, other outsourcing news, key articles, guidances, other things that are coming out that impact our sector. And then a wacky part near the end, where I write about what I've been reading lately, which everybody seems to dig. So the newsletter is really a good thing to get that recurring. This is what pboa is up to. This is what's going on in the the industry and and to be able to get a little more intelligence as to, again, what's going on outside your silo. Yeah, I love it. What have you been reading lately? Give us a sneak peek. What have you oh, gosh, let's see. I just finished still pictures on photography and memory by Janet Malcolm, a posthumous collection of essays on her part, the big, great one I finished a couple of weeks ago is the twilight of Bohemia. This book about this place in Manhattan called West Beth that was converted Bell Labs, buildings on the far west West Village, like down right by the West Side Highway or 12th Avenue, 1969, or 70, it came online as affordable artists housing in these like five or six buildings that are combined together. And it's survived 55 years. Unfortunately, when the city and the foundation putting it together started the application process for this stuff, they didn't put a time limit and how long anyone could stay there. So they created affordable housing for artists in New York, and didn't quite realize some of them would stay there the entire 55 years since it was founded. But it's a neat history of that and some of the personalities and the artists who live there. This is all part of Gill secret identity stuff, which if you ever Google my name, you will find before pboa, and then your mind will be blown. But yeah, this book is really fascinating in terms of what New York was like in the 70s and 80s as this, this housing was taking off, how the art world changed, what it means to raise kids in a world a couple of buildings surrounded by writers, painters, all different types of artists. It's a really fascinating book. And actually went to the book launch during DCAT down at West Beth. My friend Peter was the author, and Tuesday night was the launch party. I'm like, you know, I've, I've just finished nine hours of meetings. Why don't I take the subway downtown and pick a one guy in a suit who shows up to this, this, this book launch, and we had a really nice. This evening there, before I headed back to my hotel and dive back into DC cat the next morning. I love it, the wacky world of Gil Roth's all the GIL show. Like we say, it might just be the episode title for this episode of The SCORR cast Gil I can't thank you enough for taking the time, shared all of your insights with us. That'll do it for another episode of The SCORR cast. I know if you listen to this, you found this one valuable. Make sure that you subscribe. Leave it a five star review on Spotify. You can now leave comments, and so you can leave a comment for Gil. Certainly reach out to him if you have any questions, connect with them and really, really, really pay attention to the newsletter and the consistent updates that him and the team are putting out until next time. Gil, thank you so much. Thank you. It's been great. As always, thank you for tuning in to this episode of The SCORR cast, brought to you by SCORR Marketing. We appreciate your time and hope you found this discussion insightful. Don't forget to subscribe and join us for our next episode. Until then, remember, marketing is supposed to be fun.