Aligning with the Right CMO

In this insightful podcast episode, industry experts Jason Martin and Ryan Doxey from Kymanox delve into the critical aspects of CMO (Contract Manufacturing Organization) selection for life science companies.

When organizations are considering a CMO, how do they find the right one for them? Listen to experts discuss the complexities in finding the right CMO partner and the value of getting experienced guidance. They covers key considerations from technical capabilities to cultural alignment to project planning and regulatory strategies.

This episode features:

Jason Martin, Sr. Director CGxP, Technical Services
with your host Rayn Doxey, Sr. Director, Technical Services

Key Points:

  • Evaluating CMO capabilities to ensure they can handle your specific technology/therapy area
  • Assessing cultural fit between the client company and CMO to enable a good partnership
  • Leveraging expert help to navigate the CMO selection process effectively
  • Structuring projects/agreements in phases to allow for recalibration points
  • Importance of communication and having client-side project management
  • Preparing for commercial scale-up and regulatory filings in advance
  • Conducting thorough audits and due diligence on CMOs
  • Advantages of having a secondary/backup CMO, especially for later stages
  • Challenges smaller companies face getting manufacturing slots with larger CMOs

Watch the Podcast Here

 

About The Factor: The Factor, your trusted podcast for the life sciences industry. Join us as we tackle the essential factors that drive successful commercial products. Our team interviews industry thought leaders to explore regulatory compliance, market trends, and innovation. Stay ahead in this dynamic industry.

Get in touch if you like to be a guest on the show: http://www.kymanox.com/get-in-touch

 

Read the Transcript: 

Announcer – 00:00:04: Welcome to The Factor, your trusted podcast for the life sciences industry powered by Kymanox. Today’s episode is all about contract manufacturing organization selection. When organizations are considering a CMO, how do they find the right one for them? We’re joined by two Kymanox executives, Ryan Doxey, Senior Director of Technical Services, and Jason Martin, Senior Director of CGXP Technical Services. To start, Jason gives us an overview of CMO selection as it relates to the life sciences industry.

Jason – 00:00:36: One of the things that we’re probably seeing more and more of in the life science industry is that we’re getting a tremendous amount of pipeline activity with these organizations that are coming up with novel therapies, whether it be through cell and gene, ophthalmics, injectables. And one of the struggles of these organizations is they don’t have their own manufacturing capability. It’s expensive. Real estate is expensive. The technology in which to manufacture is expensive. So what these folks are doing is they’re trying to find an organization that can help them on the manufacturing aspect and be a partner. And I think that’s where, when I think of CMO selection is, well, I need a partner to help me manufacture my product, but I don’t know what I don’t know. What does it take for me to find and partner with a CMO so that I can put my product in the best position to be successful.

Ryan – 00:01:36: Yeah, yeah. So that’s a great, great intro. And, you know, so one of the key things you talked about is the, you know, CMO selection and these considerations. Small company, large company. You know, new technology versus an established technology. You know, tell me a little bit about, as the small fish in a big pond with a new novel technology, what should you be looking for?

Jason – 00:01:57:  So I think one of the first things is capability. You see, not every CMO is capable of executing on every platform. So what you really want to do is you want to find, first find an organization that can actually execute your technology. Now, granted, some of the technologies are different, but at the same time too, is that the expertise that’s there, for example, you know, you, you wouldn’t bring your, your, your truck in to be repaired at a, at a bike shop. You wouldn’t do that. So what you do is same holds true with, if I have a gene therapy, I probably wouldn’t bring it to an ophthalmic CMO, to manufacture my product. So the other benefit to that is that a lot of times they have learned experiences that they’ve had with other products that they’ve worked on, where they have some best practices, where they find some efficiencies, where they may have insight that you do not on how to manufacture your product. And that really does pay itself back in dividends. That’s where I think it really helps to get an organization that understands and has, again, I use the word capabilities, has the capability to take on your product.

Ryan – 00:03:10: Understood. And so, you know, coming into this as a two-person company, two men and a molecule. You know, how should you go about, you know, the initial search for these CMOs, you know, and finding these capabilities that fit your niche? And still having them take you seriously?

Jason – 00:03:28: So, I think the first part of that question is, don’t do it by yourself. Again, you don’t know what you don’t know, and you don’t really may not know the right questions to ask. And, you know, I’ll have some shared experiences I’ll share that I’ll explain as we go along in the podcast, but I get, get yourself an organization, you know, much like a Kymanox, if you will, that can help you navigate that journey. We have a very broad network of folks that we worked with. We’ve worked with multitudes of CMOs and CDMOs. And because we have such a diverse network of ourselves that we’ve touched a lot of this. We have access to CMOs that, you know, people just don’t know they’re there. And we have been doing this long enough to know where there may be a good fit, or at least a consideration for a fit. So I think that’s where that’s really where a lot of that if you first want to start. The other aspect of that too, is that by getting somebody like a like a Kymanox, that has the understanding has the experience of CMOs. Selection, we know what questions to ask. We know what questions to ask the CMO because what makes a good relationship between a client and a CMO is the client needs to know what they’re asking a CMO to do. It may be as little as we just want you to make our product, or it may be as intensive. We want you to help us develop our product. The relationship just gets better the more that the client knows what they need. And so a lot of times they just need help with that. They need help with that. And that’s really kind of where they should start.

Ryan – 00:05:12: So you mentioned the technical capabilities and the use of a company like a Kymanox to help when a small company needs a little bit of firepower to get into the door. So also, can you talk to me about how a company like us could also help with some of the non-technical needs around building trust and the need to build a trust between the client and the CMO?

Jason – 00:05:36Yeah, that’s a great point. And I’d say, too, is that that’s probably one of the largest sticking points behind capability that can sometimes make for a rough relationship is that the trust and the cultural fit.

Ryan – 00:05:52: Yep.

Jason – 00:05:54: An organization like Kymanox is that we have founding relationships with a number of these commercial manufacturing organizations. We know how they work. We know how they operate. We understand their culture. One thing you don’t want to do is fit a client that with an organization has the capability to do it but doesn’t have the cultural fit with the client. That just makes for an abrasive relationship. And it makes for a lot of hardships along the way or it can make for a lot of hardships on the way. So one of the aspects is that it’s not just about the capability. It’s really also about the cultural fit. Does this organization fit with the client? Because we have that experience and because we, not only have we used CMOs in the selection process, we’ve also supported CMOs in the work that they do. So we see both sides of that fence. And myself, having been a CMO provider and also having been a CMO client. I have the opportunity to see both sides of the fence. And that CMO relationship really is important between the client and the CMO. It’s not transactional. It’s got to be a partnership.

Ryan – 00:07:13: And so, you know, barring off of that a little bit, so you’ve identified the CMO. You feel like there’s a good cultural fit. How do you get in the door? How do you get your company, your board, to sign off on sometimes a daunting statement of work proposal? Six figures plus, seven figures plus, depending on the stage? Do you just go all in or do you kind of… piecemeal it up front to get in the door, show the value, show the progression.

Jason – 00:07:44: Yeah.

Ryan – 00:07:44: Can you talk a little bit about that?

Jason – 00:07:45: That’s great. That’s a great question, is that I’ve seen it on both scales. I’ve seen it where it’s an all-in package, right? Smaller organizations, the two-minute-a-molecule picture is really stage it, stage it. And I think what you’ll find, too, is a lot of CMO organizations prefer it that way. And what that does is that that allows you to, gives you recalibration points where you can say, how is it looking? Does it look like this is going to be successful? If it’s not, we can recalibrate and we have to pivot. Whereas if you’re all in, you can lose sight and you can lose the oversight, if you will, of the project. This is where it’s really important, too, is to have someone who can liaise between the client and the CMO. The CMO is going to have a project manager. Many times the client won’t have a project manager, but maybe they may have a director of CMC who’s looking at data and things like that. But you really need somebody who has the experience of understanding what a CMO does. What a CMO is supposed to do, what a client does, and what a client is supposed to do. Because they really do keep the expectations realistic between the two. You’re going to have a master services agreement, a quality agreement, and things like that that holds you accountable. But at the same time, too, is you need somebody who knows what the big picture looks like, what that big project plan looks like, and keeps everybody moving in the same direction.

Ryan – 00:09:17: Great, great. Yeah, that’s really good insight. And so, again, building off of something you just mentioned, so the role of a project manager from the client perspective, how critical that is, right? So you mentioned the PM on the CMO side, but I would think they’re looking out for their own interest, right? And that really strong need for PM on the client side.

Jason – 00:09:40: Yeah. Yeah. Yeah. A hundred percent. You know, I haven’t found too many CMOs where they, yes, they, there’s a self-interest of course. Everybody has a, has a self bias, right? I haven’t seen too many times where, where it’s been the case where they haven’t, they haven’t taken their client’s best interests at heart too, right? Where there’s some, some sort of mutual understanding. But that’s where I think that the project manager on the client side or that liaising person between the client and the project manager on the CMO side, that’s where that relationship really buds. There’s discussions that happen there. Those discussions tend to be a bit more frank. And there’s a lot of candor that happens there as well. But you need that because your CMO wants to be successful. That’s right. You know, if you’re in a clinical stage product, maybe you’re phase one, phase two, and you have the CMO and a CMO is manufacturing your product, trust me, a CMO would love to take you to commercial. They’d absolutely love it. So if you don’t succeed, they don’t succeed. They want to be successful. They want to be a partner. Good, good.

Ryan – 00:10:50: Yeah. Thank you for that insight. And so to pivot a little bit from the cultural side, let’s talk a little bit about once you’re in the door and once you’re completing some work. So say you’re phase one, phase two, and you’re having success along the way, and it looks like you’re going to go into phase three. So at what point do you start talking about commercial supply and getting NDA, BLA ready? Can you talk a little bit about that transition from early stage to later stage within the CMO organization?

Jason – 00:11:20: Yeah. I think. As, as the process continues to move forward, many times the client is asking that question as well. When do I get ready for a BLA? When do I get ready for a regulatory filing? They may not know.

Ryan – 00:11:38: Right.

Jason – 00:11:38: And that’s where you really, again, you brought in somebody to help you find a CMO that fits your need. It’s a right fit. Do the same thing. Bring people in that have experience doing this to help guide you. You know, I would totally expect a client to tell me, hey, I’ve talked with my board. My board says, you know, we really want to go live, you know, Q2 2025. Great. We’re going to help you plan that.

Ryan – 00:12:03: Yep.

Jason – 00:12:04And we’ll let you know if you should have started a month ago or you can start in two months.

Ryan – 00:12:07Right.

Jason – 00:12:07: And then you work with that plan and you share it with the CMO. And the CMO helps you say this is a realistic plan or it’s not a realistic plan. And then you work together on how to remove those obstacles. But it’s got to be communication. It has to happen both ways. You will not be successful if you’re dropping uncommunicated plans and saying we’re going to be ready in three months to go GMP. The CMO is like, that’s probably not going to happen. And this is why. And that just can create a lot of conflict.

Ryan – 00:12:37: You know, and talking about capabilities and, you know, the need as you scale up. So, you know, again, you’re in phase one, phase two. They might not have the scale for the phase three. And how to approach equipment procurement, capital expenditures. You know, a lot of times smaller companies may see that as daunting and, you know, just a huge undertaking that, you know, financially they can’t support. You know, bringing that to the forefront of the conversations with the contract organization.

Jason – 00:13:04Yeah, that’s a great point. And that is a huge sticking point for a lot of organizations because you’re right. It’s expensive. If you’ve ever bought a mass spec or anything like that, they aren’t free. And so what you can do, what we’ve seen done and what we’ve done in the past is we’ve worked with CMOs where, hey, we’re going to go to phase, we’re going phase three. We’re looking at doing these larger production batches. Yes, we’re asking you to purchase this equipment. And it’s really trying to work with them on how do we get them to contribute to the capital expenditure. There’s got to be value in it for them. They aren’t going to buy a rare piece of machinery they’re only going to use for your product and then when it goes away. And the other aspect of it too is they may have capabilities. It may not even be at their current site, but it may be capabilities they can bring, either bring it from another site or to another site. You see that a lot with testing. They may not have the capability to do certain types of testing at their site, but their Richmond site has the capability of doing it. So again, it just brings leads upon leads. But you’ve got to have those conversations early. Hey, I’d rather have the conversation and say, and the answer would be, not just yet, than have the conversation be, oh, we should have done this a long time ago. Then you’re chasing your tail without being caught.

Ryan – 00:14:21: Yeah, good, good. Thank you, again, for that insight. So, again, you’re the senior director of CGXP Technical Services. So let’s touch a little bit on the quality regulatory aspects and how critical. The quality history and the regulatory history of a selected CMO is.

Jason – 00:14:38Yeah.

Ryan – 00:14:39: And, you know, can you borrow from one or scrimp on one? You know, if you have a really good cultural fit. But they’re a little bit shaky history. How do you kind of handle those situations?

Jason – 00:14:52: Boy. Again, having been part of an organization as a CMO, we experienced, this is my past life, experienced an organization that actually received a warning letter. And that really shook up the business, obviously. And it shakes up the clients. If I’m a client and there’s maybe a little bit of shakiness around that, around the regulatory aspect. It carries a ton of weight. It carries a ton of weight. They may be great people, good cultural fit. But if you end up with a warning letter, consent decree, it can be a game ender for you. So I would really, really focus on… On having the regulatory and the quality stuff be rock solid. Need not be perfect. And what I mean by that is, and I don’t mean cutting corners, but, for example, if you have a medical device and you need an ISO certification, they may be on their way to getting that certification. They’re telling you, hey, in four months, we’re going to have that certification. We’re currently… Executing on that. Okay. There, there, there’s some risks there, but that risk isn’t as great as we just had an inspection and we had six, four 83s and a pending warning letter. Yeah, you probably want to stay away from them. And you know, many clients put within, put in their agreements that if an organization gets a warning letter or actually within their quality manuals, they can’t do business with an organization under warning letter or consent decree. Now, what do you do now? You’re left scurrying to find another CMO and with all the effort and everything you just put in to find one. That happens, boy, that could just lead to a lot of heartache.

Ryan – 00:16:26: Understood. Understood. Yeah. Very good points. And so, you know, I think, from here, I’d like to talk a little bit about the landscape of contract manufacturing. And it’s only fair to bring up the recent Catalent acquisition by Novo, to increase their own capacity. And how do you see the landscape in the future with these smaller… These companies entering these blockbuster GLP-1s and needing capacity, capacity, capacity is the name of the game, right? Right. And not just contract capacity, but their own internal. So as we know, Novo Nordisk purchased Catalent, basically took all of their biologic sites and are going to be dedicating them to their GLP-1s. Do you see others kind of following suit?

Jason – 00:17:16: Boy, that’s a good question. I think the real challenge here is they have to navigate between Is it cost effective to expand what we currently have? Can we? Do we have the real estate to do that? And does it make financial sense to do that? Or does it make more financial sense to go out and buy the infrastructure, right? You know, if I have the ability to go out and buy the infrastructure, I’m buying the headcount and I’m buying the equipment. It’s already there, you know, and if it’s in good standing, a lot of your work is done. So, you know, if I need, if I need capacity, I need it quickly. That’s the route I’m going. If I need specialized capacity, obviously it’s probably something I’m going to have to invest some CapEx into and build it out. But this isn’t uncommon. What we’re seeing, I don’t think is uncommon in any industry. I mean, we saw it in the auto industry. We see it in this industry. We see it in digital chips and things like that. Where I think that I, boy, if I, if I could past the magic wand is I would love to see more CMOs that will take on these smaller organizations. You know, they’re, they’re the clinical stuff, the phase ones, the phase twos, you know, the, the, the CMOs really tend to stay away from it because it’s just, it’s not lucrative enough for them. It doesn’t fit in their business model. Um, but there are a lot of good drug candidates out there that are really starving to get into a commercial manufacturer just so they can get their project started. So they can, they can get first in human, they can get trial data, but it’s, they’re finding it really hard for these larger CMOs to allow them in and yeah, Hey, it, it, you know, it’s still a business. And, uh, when you’re taking up commercial line time and the changeovers, it gets really expensive, really fast.

Ryan – 00:19:08: Yeah. And so, you know, to that point, I think, you know, it’s important to touch on, you know, the fact that, you know, if you are early stage, small scale, pilot scale, you can’t fit into a commercial regime, you know, you don’t have the controls to fit in there. It’s okay. There are organizations out there where you can go and, and deliver on phase one, phase two clinical supplies. And then as you get successful, think about the future at a larger CMO or even build out the capabilities at the, at the smaller one.

Jason – 00:19:37: A hundred percent. You’re a hundred percent right. You know, it’s funny where I think where people struggle when it comes to those smaller, uh, girls, smaller batches is you just, they’re just not as well known. They’re not an accountant. They’re not an emergency. They’re not an Alonso, you know, um, they’re not those big, big names. And, um, so they, they’re a bit harder to find, but when you find them. That’s really kind of like, that’s the exciting part is, you know, you have an organization, again, like Kymanox, that has the network of these smaller CMOs that can help. And you get that started. And to your point, the next phase of that is you get a product. And I mean, it’s really giving you everything that you thought it would. Having that conversation with maybe, it’s time we think about going to a launch. Maybe now we do fit that business mold. And a smaller organization, it’s just, it’s too big for them. And there are plenty of smaller organizations that will come right out and tell you, we’re not doing commercial. We don’t want to do commercial. We only want to do phase one, phase two, small batch stuff. But we will help you transfer the process to a larger manufacturer when you decide to go that route.

Ryan – 00:20:41: And, you know, and so thinking about cost, you know, that whole paradigm. It’s natural. And companies have to understand that even though they feel like they might be pigeonholed and don’t see a commercial forecast, it’s out there. And it actually could be more costly of taking your small process into a large CMO versus using a smaller CMO that’s fit for purpose and then transferring out. Yeah, and so that’s done all the time.

Jason – 00:21:07: All the time. Yep.

Ryan – 00:21:08: Yep. So, you know, to kind of round this out, you know, we talked about the cultural fit. We talked about the technical capabilities. You know, trust is number one. You know, the landscape. So I’d like to talk a little bit about, you know, your experiences and kind of the pitfalls. And, you know, where we can… Help identify those pitfalls, eliminate them, and, you know, really streamline the process of getting into a CMO, get going, you know, and start delivering on clinical supply.

Jason – 00:21:39: Sure, sure. Yeah, you know, the first thing that comes to mind is, and I would tell this to the, you know, I’m working with a number of clients right now with CMO designation, and, you know, and I tell them, be very wary of an organization that does not have, that has not do your current platform. And what I mean by that, if you’re a gene therapy company and there’s a abominant company out there telling you, yeah, we can do your drug. We can do your drug. We’d love to get into the gene and therapy market. I would be very, very careful doing that. Extremely careful doing that. You are putting a tremendous amount of risk to your product because you’re dealing with folks that just don’t have this experience. They’re not set up to do it. So unless you are really ready to be on the floor all the time, which many folks are not, I would be very much really just be very careful there. I think the other thing too is around the cultural fit is having the ability to know what you’re getting into culturally. And this is very cliche to talk about cultural fit and things like that. But where it becomes very important is you’re not going to do well if you don’t get along and vice versa. You’re just not going to do well. It just creates delays upon delays upon delays upon delays upon delays. And this is where a strong contract really, really helps you. Contracts can’t be wishy-washy. The master service agreement can’t be wishy-washy. It’s got to be specific. It’s what you’re going to hold each other to, hold each other accountable to. So you got to make sure that you put the effort in. It’s like anything else. All the heavy lifting is done at the front end. So that’s where I would say those two parts right there to take a look at. We’re… Kymanox can really help is we’ve done all this. We’ve done all this before. We’ve seen it hundreds of times. We know where the tiger traps lay. And we’ve navigated this to the point that we can do it very efficiently. You can try this journey on your own. There’s no harm in that. It’s just going to take you more time. Where we have experience with very specific CMOs. I’ve touched everything you can imagine on a biotech spectrum. And we can get you into a CMO that is right-sized. It’s appropriate technology. They’ve got the capability. They’ve got the capacity. And they have the cultural fit. And everybody in the client, as long as, as well as ourselves, we’re all part of the partnership that gets that part done, it gets the CMO done.

Ryan – 00:24:25Yeah, exactly.

Jason – 00:24:26: Exactly.

Ryan – 00:24:26: So I’d like to touch a little bit on, you know, outside of the. The process and the manufacturing capabilities, but also we hit a little bit on the analytical and how important it is to, to get in early and to, to understand, you know, where the pitfalls are with your methodology.

Jason – 00:24:42: Yeah. Yeah. That’s a, that’s a, that’s another good point. You know, just because they can make that product, make your product, don’t mean they can test it.

Ryan – 00:24:49That’s right.

Jason – 00:24:49: You know, and not every CMO has an analytical component. But… They should know, right? They should know. And they should have the majority of it. This is where I think it becomes really important when I talk about, you know, the client really needs to know what they’re looking for is, do you need a CMO? Do you need a CDMO? Because they’re two totally different things. I mean, granted, we use them interchangeably, but do you need help on the development side? Would it be analytical development and things like that? Or, no, I don’t need it. All I need is somebody to manufacture it. Okay, that’s something different. But they should at least have the analytical expertise, if not to do it internally, to manage it if they have to do it externally, and understand what the testing means. Great that you send it out. What does the testing mean?

Ryan – 00:25:41Yeah, yeah.

Jason – 00:25:42: And that is a key part where that’s where the partnership comes into play.

Ryan – 00:25:48: Yeah.

Jason – 00:25:48: You know, between the CMO and the client. So to your point, goes back to the beginning, is they need to know what they need. And that’s where we help because many of these folks, they just don’t know what they need. They’ve been in academia for a long period of time, and they have a product or they have a molecule. Like, look, this could be really beneficial for therapy. But I just don’t know how to get it into the market.

Ryan – 00:26:11: Yeah, yeah.

Jason – 00:26:12: And this is how we start.

Ryan – 00:26:13: And so, you know, it seems like, you know, really getting in and pulling the curtain back and looking at the inner workings of the CMO, CDMO, understanding what you need, and then doing an audit of that CMO, going on site as best you can, you know, in this post-pandemic era. You know, is really critical. So can we talk a little bit about audits and what to look for, phase-appropriate audits, you know, for an early phase clinical supply versus a commercial-type audit?

Jason – 00:26:45: Yeah, yeah, that’s, you know, we just, like I said, we’re just doing this with a client that’s, they’re academic, and they’ve never put a product in market, and we’re sourcing a contract manufacturer for them, and, you know, that’s just, what do we do now? Do we just give them stuff and they make it? No, no, this is where we’re going to do some due diligence here. They’re going to tell us what they’re going to commit to doing. We’re going to tell them what we’re going to commit to doing. We’re going to put it on paper, and we’re also going to visit the site. Let’s go see what they’re doing. And it was interesting because the chief executive officer asked, he said, will they allow us to do that? If they want your business, they want you to do that, right? They want you to do that, and it shouldn’t be anything out of the norm. You go there for a couple days. You do an overall systems audit. Hey, do they have the minimum quality needs that’s supposed to have, do I feel comfortable with what they’re doing? How does the place look? Is it clean? Is it put together? How is it run? Anybody can make a beautiful website. Not everybody can make a beautiful plant. So, you know, getting out there and talking to the people that will be working on the project, that’s another critical part. Get in here and have conversations with them. Bring your team that’s going to be working on it. Hey, if we go with you, these are the people that are going to be part of this team. It really does start to meld the relationship. That’s important. That’s important. Again, talk about cultural fit. If you don’t get along with them, you don’t get along with your CMO, it’s going to be a long road.

Ryan – 00:28:18: I agree. I agree. Been there, done that, right?

Jason – 00:28:20Right.

Ryan – 00:28:21: And so, you know, to that point. You know, in an industry where, you know, having duplicates and triplicates of things is so important. You know, having a backup plan. You know, at what stage do you see that as being, you know, the critical, kind of a critical milestone in finding a backup?

Jason – 00:28:40: Right. Yeah. I would say, you know, there is nothing wrong with having a secondary CMO. And just as long as you’re honest with them, right, is, hey, we have a primary. We’re looking for a secondary. Many of the CMOs who are interested in the work, they’re fine with that. They’re a secondary to somebody. They’re a primary to somebody who has a secondary, right?

Ryan – 00:29:00: Yep.

Jason – 00:29:02: So I would say as you start to move into phase three, you really need to start thinking about that. Hey, because, you know. God forbid, you know, a good example is what just happened at Rocky Mount this year where tornado comes through, damages the facility. You can’t make product. And here you are, you’re trying to get, you know, product to market. But having a, but having that backup. It’s not that you don’t trust your primary. It’s just you, it’s a business contingency. And absolutely. NFL teams have backup quarterbacks for a reason.

Ryan – 00:29:33: That’s right.

Jason – 00:29:35: You know, there’s no different. There’s really no different. But I think that having that conversation with them, and again, just be transparent. I’ve never had anybody say, oh, why are you getting a backup CMO? They understand. And many times they have conversations with that CMO of this is what we’re doing. And again, it’s a partnership because they both know they have the same client.

Ryan – 00:29:57: Yep. And so you mentioned phase three, and I totally agree with you. And sometimes if you can work that in, the earlier the better, pre-registration.

Jason – 00:30:05: Yes.

Ryan – 00:30:05: And have that secondary source in your filing. That’s always a great thing to have.

Jason – 00:30:10: 100%. 100%. The more you can get ahead of that, the better off you are. I don’t think it’s a priority, like I said, when you’re talking clinical.

Ryan – 00:30:19: Yeah.

Jason – 00:30:19: But it’s going to be at some point.

Ryan – 00:30:21: Yep. Yeah. Great, great. So as we wrap up today, again, I want to thank you for flying down from Boston to join me here in this wonderful studio. I really appreciate the relationship we have and all the expertise you bring to this, to Kymanox, to our team. Any last thoughts? Last words of thought?

Jason – 00:30:39:  You know, first of all, thank you for having me. I apologize to those listening if I have a thick Boston accent, but, you know, my translator, unfortunately didn’t make the flight. But, no, it’s very near and dear to my heart to help these. The therapies that folks are working on, the new technologies and the stuff in the pipeline is so exciting. But many of it doesn’t get out there because they just don’t know how to get it there. Get help. Get an organization like a Kymanox that has been there, done that, can help ease you through the process and do it efficiently. Hey, this isn’t new for us. It’s not a learning experience for us to help you go through this. This is stuff we’ve already done, and we just really do enjoy watching the success of an organization who has a new drug product and getting it to market. I mean, that’s awesome. When you do that and you’re at that launch party and you’re like, we did it. We did it. I mean. We truly did it. And that’s what it’s all about for us.

Ryan – 00:31:38Yeah, because ultimately patients deserve better.

Jason – 00:31:40: That’s right. That’s 100%.

Ryan – 00:31:42Again. So thank you again. And yeah, look forward to the next one.

Jason – 00:31:46All right, brother.

Ryan – 00:31:47: Thank you.

Jason – 00:31:47: Thanks.

Announcer – 00:31:54That was Ryan Doxey and Jason Martin on CMO selection in the life sciences industry. If CMO selection is something your organization needs help with, be sure to visit kymanox.com. Thank you so much for listening to or watching this episode. Please subscribe or follow this podcast in whatever app you’re using right now, or follow Kymanox on LinkedIn for all updates. This episode was edited and produced by Earfluence. We’ll talk to you again soon on The Factor.