
Quality Grind Podcast
Welcome to The Quality Grind Podcast, presented by Medvacon! Join hosts Joe Toscano, President of Medvacon, and Mike Kent, Director of Learning Platforms, as they (we) have some fun while tackling topics related to the “everyday grind” within Life Science industries.
Featuring conversations with key industry players, they’ll dive into their unique problem-solving strategies, career paths and personal interests. Most importantly, their (our) goal is to cultivate a community where information and experiences can be shared with and for the benefit of all, emphasizing the diversity of approaches to industry challenges and the importance of continuous engagement and learning.
Quality Grind Podcast
Navigating Cell & Gene Therapy: Cultivating Partnerships and Progress
Welcome to Part 3 of Medvacon’s 4-part series entitled “Navigating Cell & Gene Therapy”, where Joe and Mike continue their visit with industry leader Ray Kaczmarek. In this episode, the 3 dive deep into the significance of disciplined development, strong supply chains, and well-cultivated partnerships within the cell and gene therapy space.
The conversation emphasizes the importance of selecting the right partners and managing those relationships effectively to ensure business success and compliance. Key topics include understanding both scientific and financial investments, the implications of bad contracts, and the critical role that quality and supply agreements play in maintaining smooth operations.
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Ep 25 | Navigating Cell & Gene Therapy: Cultivating Partnerships and Progress
Jessica Taylor: [00:00:00] This is the Quality Grind Podcast presented by Medvacon. Conversations that go beyond compliance. Sharing insights geared toward helping you navigate the everyday grind of regulated life science industries. Here are your hosts, Joe Toscano and Mike Kent.
Mike Kent: We are at the halfway point of our visit with Ray Kaczmarek, having discussed the cell and gene therapy development process, and considerations for selecting and working with a partner organization.
Now, some key points from part two that stood out to me are having a solid understanding of what you're doing, why, and what enables you to be successful through your own development process is absolutely key. As Ray said, there's a template and guidance for this roadmap, but ultimately, we have to define it for our own program and [00:01:00] then be wise enough to recognize and leverage the parallel opportunities that exist to create a significant competitive advantage and accelerate our timelines.
We also discussed ways to determine if additional expertise or a full on partner is a good choice, and provided some points to consider for selecting and building a strong relationship with that partner.
In part three, we'll dive into the business case for disciplined development, strong supply chains, and well-defined quality agreements that don't have to be a drudgery. Bottom line? It's about setting your organization up for success on all fronts.
So let's pick up the discussion with Ray, Joe, and myself on the business side, with Part Three of Cell and Gene Therapy, here on The Grind.
Joe Toscano: And again, the reason, you know, a good partner, and make sure that you're managing it, right...
Ray Kaczmarek: That's right.
Joe Toscano: ...and you have ownership, is [00:02:00] a lot of these organizations will be making an investment in these types of products. Again, there it's an investment, right? So there's a financial component to it, but it's also for the greater good in terms of the impact that these products can have.
But we all know that a good product in this space will quickly be acquired by another company, right? Yeah. And at the end of the day, if these things are done well, that's a maximized investment. Where if they're falling short with either a bad manufacturer because you didn't pick the partner or manage the process right, that has huge financial implications in terms of what the worth of that is. Because if somebody has to come in behind you and fix it all, that's less money available for the acquisition.
Mike Kent: Oh, well if the acquisition happens, right?
Ray Kaczmarek: So they'll, be happy to come in and give you a minus number of what they... exactly... offer you because they don't like your contract. They don't like how your partner's doing when they do due diligence. They don't like, there's a variety of things as we start talking about the business aspects of what we do versus the compliance, the science [00:03:00] and everything else.
Bad contracts and bad partners are bad business. - Yeah. - A bad contract's a bad contract, period. Yeah. A bad partner is exactly that. Either you have to upgrade that partner, you have to have that piece in there, or it's gonna be bad for business, period, either from a compliance perspective or from an actual business management, M&A, whatever you're looking at. It could come back if it's not reputable and you're not getting supplies, now none of your suppliers are reputable suppliers. They're gonna look at that and they're not gonna offer you these large sums of money if they don't believe the supply chain is capable. I can't...
Mike Kent: Regardless of what the science may say...
Ray Kaczmarek: It doesn't matter. You're looking at the business aspects. Exactly. Your business aspects are just as important as your compliance aspects when we start talking about what we do. Which, it starts shifting you out as your roles get a little higher. You gotta deal more with business and less with compliance, but they're both hand in hand.
There's not much of a difference. It's just you have to have a [00:04:00] compliance mindset to your business, business transactions, because thou shall not do these things or you're gonna have a bad business relationship. And it is, and I always keep going back and using the word 'partnership' because early phase companies, if they do find a good partner, will work with them. They want that drug if they believe. Because they'll assess you just like you're assessing them. And if you go through that door and you think they're not going, "Well, how many lots per year? And what's probably, what's my maximum, what's the lifetime value of this company?" But yeah, that's actually driving a lot of how much they're going to work with.
Joe Toscano: Well, especially if they have reduced capacity, right, and they can pick and choose who they work with.
Ray Kaczmarek: Yeah. And, but even then, if they're saying, well, how much can I discount this? Well, what's the value of this product over time?
And if I think I'm going to have more opportunity and I'm trying to keep this client, I'm doing those things, there's a, there is a business aspect to the business.
And that's where you're back to, that's why [00:05:00] when I say you gotta know when you look at the partner, that's one of the key elements is do they have what they need? And then what, how are they business-wise, how savvy are they? Because that's, that is actually pretty good because they'll recognize things. You'll have partners out there that can even, or will even recognize or know you well enough to say, well, we'll do this and set this, and then we'll just finalize this and bill you in this quarter and we'll just carry that over. Is that, you know, that'll work for you. Well that's phenomenal for some of these guys, just based on what end of years are, what they're looking at, how they're trying to report cash, what they're doing. And then the terms that they give them, that allows them to do a little something different. But it gives them that next push they needed to make it for the next fundraise. But that's just being sensitive.
But that's also what I have to call, that's the CEO, the CEO conversation that's occurring. That's, they're having healthy relationships and that, and they're willing to have those relationships because if you go away, I have no [00:06:00] future revenue. So again, it's advantageous... ... to, if it's a product that might work, because it's early. It's advantageous to work with people to maintain your revenue lines because... You know, services are interesting because it moves right along, and all of a sudden the hockey stick's up. Why? Because I get all these products in my pipeline. And then all of a sudden, this one, this one and this one go commercial. That's where things take off.
Well, so early on, there's one of the companies I worked with at one point had pretty much 60% of the early phase, you know, pre and phase one market. They manufactured it. I mean, that's a pretty good understanding of what the market looks like, right? And it's a services organization. And then you're, then you're trying to draw and keep these people in. And the big part is because can you keep them in to where they don't take their hockey stick and go somewhere else, right? But that also is back to relationship...
Joe & Mike: Right...
Ray Kaczmarek: ...and how you set it up. So...
So for me, again, selecting the [00:07:00] partner becomes important. Understanding that you'll always have to go back to the other key elements of that, right? Is the team members and how they run the business and how they function and communicate.
Joe Toscano: Yep.
Ray Kaczmarek: And then you really have to have a look at compliance, which includes the ability to work with your type of product at the right level. Is it the right BSL level, whatever it's gonna be, and what they're interacting around that, but also around the compliance of their systems and their ability of their systems to cascade.
Mike Kent: Yeah.
Ray Kaczmarek: You know, if you can get to a phase three trial and you want to do a PPQ and they look at you and go, well, we're not gonna license this facility commercially. Are you gonna do the PPQ in that facility? Probably not. Why? Because you're gonna have to do it again somewhere else. And if that, that's what you decide to do, now you have to find a different partner or different facility.
So if they're not gonna grow with you some point somewhere along the line, your strategy should have already identified that. And that's where I'm back to the same thing. It could be Mr. Right Now, maybe [00:08:00] not Mr. Right. But the reality is you would like to be able to think you can select now and now, and you may not. But you have to at least know what it needs to look like. And if they can't grow with you, then what's your ability to transact and move.
The other thing from a business perspective, because we're talking about partnerships and what we're thinking about and how we could drive it, is any of these partnerships that you're working with, some of them have IP. And if you're driving that IP and you're thinking about this early is, okay, is there an opportunity if they can't keep up with your pathway that you can actually move that IP for relatively inexpensive and actually have it manufactured with your product somewhere else, right?
I don't want to get stuck paying $50 million in royalties and stuff because I got a commercial product that's just running crazy, right? And now I want to move it because you can't make it. That's expensive at that time. Yeah. There's value. Yeah. Up here, maybe there's not.
So thinking about your early phase contracting, you've gotta make sure there's enough of an [00:09:00] out to where if they're not capable, you just did all this work, you don't have the money to redo it again. And you can't say, well, if they're not capable and they're not gonna grow their facilities, capabilities and grow with you, you've gotta have that out for early business contracts. So again, business matters. That's where you're back to the relationships. A bad contract is a bad contract, which usually means it's eventually a bad relationship.
So both companies should benefit from certain things as you get it. But at the end of the day, you've gotta put outs in. You can say, oh, well I want a secondary manufacturer. Well, it's all fine and dandy unless they put a, a tightness on your IP.
So they can do things with that, you know, if what they have, it's just a matter of are you understanding those contracts or, early on and then having that strategy.
Joe Toscano: And the other part of it, too, is, it's a critical component. Again, where we're brought in at times is because some thought and process hasn't been put in place, but [00:10:00] supply chain, right?
Ray Kaczmarek: Yeah. Supply chain, which is...
Joe Toscano: Let's talk about the importance of that. You know, that is an area that you need to get locked down early. You need to have good agreements in place and a lot of people, it becomes more of an afterthought than being done at the appropriate moment, right? And the timing, well, we're laughing because we both have dealt with it, right?
Ray Kaczmarek: I like... I'd like to say... I like to say every early phase client that I've either worked with or company I've owned or run or whatever it's been, that we've had a supply chain expert. They're like, yeah, okay, usually it's me. Oh yeah, by the way, we need to do a supply chain now we got this filing coming up and then so, yeah, it's a party of one over here. Okay.
So it does get overlooked. I mean, in some ways where you get it is people look at it from a compliance aspect only, right? They look at it, did I qualify the vendor? Yeah. Do I got a C of A, do I have that piece? But they actually don't look at it from a full supply [00:11:00] and risk rate piece to it.
But where exactly does it come from and where do the materials leading into that come from? And how easy is it gonna be? Okay, now I just changed administrations. Am I gonna have import export issues? Because, I could easily, because you know what, somebody wants to secure something. And this gets your attention with that. Right. It's, it's not a knock one way or the other against the new administration.
Joe Toscano: Oh no.
Ray Kaczmarek: Just what... it's just, life happened in the current environment.
It's gonna happen. It's gonna happen in Europe, it'll happen in Asia, it'll happen. But when you have a change, the job of the supply chain professional is to assess risk. And there's worldly changes. I get a hurricane somewhere, I can be out of business. Do I have a secondary piece? I know early, early phase they're like, oh man, this is way too much. Well, it is way too much for a phase one product. It's very low volume that doesn't have it.
But as we start developing out the supply chain, it doesn't take a good consultant long to map your supply chain, show you where hotspots are, do those types of things, and you put a [00:12:00] little bit of money into that...
Joe Toscano: And get some backup, right?
Ray Kaczmarek: That's exactly right. And you have a path forward to all your future filings because you know your supply chain risk. And that's one of the things that people don't quite understand is really what is that risk and how do I know? Have I really mapped this out and have a good understanding of what it looks like? And then I have the compliance piece, because I can go and audit it and I can do the paper audit. Sure. I can do whatever I want. But the reality is that how does it actually work is not always what the paper says.
And then you've got, the other side of it is, would be distribution of your product when you get there. But that's a different, that's a whole other, that's an hour long conversation and other piece.
Mike Kent: Right. Yeah.
Joe Toscano: But to your point, there's so many factors that could influence that outcome. And if you haven't put some thought or have some contingencies in place, you could find yourself with the best product, the best partners, the best everything, and unable to make it right or... yeah.
Ray Kaczmarek: Yeah. Or, I can't get reagents.
Mike Kent: [00:13:00] Exactly. I, yeah, and these aren't off the shelf, Sigma Aldrich, send me a bottle of hexane. This versus this. These are specialized reagents. Specialized materials. Raw materials. Yeah.
Ray Kaczmarek: Most of them are for the products, yeah, animal free. you've got different types of things. It is evolving and there's a lot of specialized manufacturers, but the same thing when you look at what they're getting, where they're getting some of their materials. And you might have a competitor, you find out that they're getting their source materials from the same person. So if you, that person has an issue, those two are out. You really don't have redundancy.
And again, it just takes a little bit of this time and it's, most people will overlook that early on, to understand what the supply chain risk is.
But as we start, as I start looking into it, I like to start looking harder into that piece as I start getting into the phase two side of it. Is this really gonna, I'm now looking at efficacy. Is this really gonna become a drug? Is this really gonna be something I'm looking at? Could this [00:14:00] potentially go from phase two to commercial? I'm wanting to look at this a lot deeper now to vet my supply chain. Because right now I know what I can get and I know whether I can qualify the piece.
But what else do I have and where is the biggest risk? And I clearly identified them. And then more importantly, if I'm going to look at contracting for long term and I'm doing a commercial product, my key supplier is who I need to have the relationships and contracts with, or my partner needs to have a relationship or contract with, right?
So, if it's gonna be reactor bags and I have zero relationship with somebody and we have a run on things and I can't even make my product. Well, I'm hoping my partner, if they're manufacturing for me, has that relationship so they can get bioreactor bags.
But if I'm doing it myself, I have to have that relationship or I don't see anything come on a truck anytime soon.
Mike Kent: And that relationship, your oversight of the CDMO, you have to be asking that question of, okay, okay, what happens [00:15:00] if, do you have this in place?
Ray Kaczmarek: And a lot of times they've thought through that and and it's an easy discussion, right? And then sometimes it's, well, that's unique to your product, and you really didn't realize how unique that filter was to your product until you asked that question, right?
Mike Kent: Oh, yeah. And then it's a whole different, yeah, follow-up conversation.
Ray Kaczmarek: One that's got a 168 day lead time. A lot of people use it, but at this site, you're the only one.
Mike Kent: You're the only one. Right.
Ray Kaczmarek: That's why they don't have it on the shelf. Sure. Why would they, it's expensive. So, if I want to pay for it, yeah, they'll do it. But again, that's the partnership and relationship. As you start getting into those things and you start getting into more commercial, commercial things from development, some of the commercial stuff goes away because you're gonna put it in supply agreements and forecasting, and you're gonna make them accountable for certain things and stock inventory.
But they're still want to, they're still gonna have to buy things on your behalf and you're gonna have to pay for those things up front. And it's just gonna sit there until you're ready to manufacture because, but it's yours. Which [00:16:00] means you have different financial requirements and ties to get back to the business is different than compliance sometimes, but it all ties hand in hand. If it's expired and I'm gonna throw it away, well it hurts me financially and it also hurts me on a compliance piece, because now I'm not even using or forecasting stuff and I potentially got materials used in a process that no one's paying attention that it's expired.
If it's manual at your partner, it could be used. SAP? Probably less because it's scanned and it's those types of things. It's probably being caught until somebody doesn't do it. Probably. That's how it ends up in there, usually don't follow procedure. But again, those are things that you don't see a lot of as much. But you will see it because there's a failure mode and it has to be eliminated.
So, you know, again, I'm not saying there's everybody out there that's manufacturing, they make a lot of bad mistakes because they don't, right?
Joe Toscano: No. There's a lot of great people out there.
Ray Kaczmarek: But everybody, yeah, makes mistakes. And even the therapeutic company, I make a lot of mistakes. But [00:17:00] again, if you can't self reflect, look at it, understand what it is, and then go back and fix it, then that's where you're gonna struggle regardless of what side of the fence you work on.
Joe Toscano: So supply agreement's super important. But the other one that's equally if not more, is the quality agreements. So a lot of people will pick a partner with manufacturing, but maybe not pay attention there as much as they should or not review it in a manner that they're protected to the the degree that they should be.
So a lot of times when we're called in, it's to kind of help with those agreements, for a number of different reasons. But talk a little bit, Ray, about the importance of those quality agreements. What needs to be done, at what stage should it be done, and what should they contain at a minimum to protect both parties?
Ray Kaczmarek: Yeah, well, lot, a lot, lot there.
Yeah. I look at it this way is first is really sitting down when you're putting the quality agreement in, and in some ways it's almost mapping the relationship. What do I [00:18:00] really want you to be responsible for? I want you to hand me a C of A and a C of C, and you're gonna manage everything up to that, and you're responsible for making sure this is done and this, and this, and this and that whole... I mean, it's in the quality agreement. And that's exactly what you see a lot of times.
But then you see companies trying to jump in and help you with the investigation and help you with the batch review and help you with those things. But your quality agreement said they're responsible for doing those things. Okay? So are you doing that because you just can't let go or you're doing that because they can't do what they said they would do?
That's where the rub starts coming. What needs to be in there? First, I think as you look at each one of the sections of a quality agreement, and how we're gonna manufacture, who we're gonna manufacture, like key thing is knowing who they're using for subs and how they're qualifying, and who's doing that, and who's responsible for maintaining those things. That's the mapping I talked about. So if I'm gonna use a subcontractor for another large part of my process, [00:19:00] whether it's manufacturing or testing, it's gonna be in my quality agreement. But who's managing that, that contractor, right? Who's responsible for the audits? Who's ... And those things are important, right? And again, either I'm responsible because I directly put it in there, or you have that responsibility to manage the oversight, the audits, and that portion, and then I'm gonna provide the oversight to ensure that you're meeting the quality agreement, the QTA, So, if we start thinking about not having those conversations early on, and getting that agreement is usually where the, I see the first failure is, there's two different perspectives of how this is supposed to be written. And then you can start reading comments. But because we didn't take the time to really map out and talk about that and have that issue discussion and say, okay, this is what it is and this is how it translates, you, you're still gonna see it. And then all of a sudden I bring in a lawyer or a third party or this person and they have a different perspective. I bring in QP in?
A QP can change the whole reflection of what you're [00:20:00] looking at on a quality agreement because depending on where they're coming from and how their perspective is and what their ownership piece is, and how they're viewing this, they're, they may have some very, and I'll call them intense changes to where it would be, where there's gonna be a lot of discussion that comes through. But it also means there's gonna be a lot of different costs added to your program if you haven't worked through saying that's an essential area. Because if I want to market in Europe, I'm gonna have a QP somewhere and it's gonna be in my quality agreement, If I, and so, you're talking about certain things, can I market where I'm marketing? Am I manufacturing to that, those areas? Do I have this, these processes at least mapped out to know who's responsible and accountable? I can get a matrix, but again, if we didn't talk about it, how I fill this matrix out or interpret it is different. Okay. And then we get into the point where somebody's saying this is what it is, and they say, well, this is actually what it says, and it's not what you thought. [00:21:00] You know, so you get into that.
And again, to me it's making sure all the requirements are there for who you're using, what they are. Usually we have specs written in for the drug product as we get to the commercial side. There's a spec requirement to it. There's, different parts are pretty, like I say, in my mind, they're pretty standard. But the reality is, is if you are inexperienced in doing quality agreements, there are good people out there that are willing to look at these things and give you feedback.
Not every quality agreement that you get from a partner is gonna be mutual. Okay. Some of them will just give it to you as I will just make this, test it and hand it over to you, and that's it. I'm not responsible for making sure all the ancillaries are working and all that. That's, that they'll pretty much do it, almost hand it to you that way and make you come back and say, no, I need you to do this and this and this. So if you're not getting somebody that's giving you more of a mutual layout, I would say if you're not super experienced with it, [00:22:00] ask for help. Ask for help.
Joe Toscano: Ask for help. Yeah.
And I think that's where a lot of people get themselves in trouble with agreements, is they take it from the manufacturer. They believe that's what it needs to be because they don't have maybe the experience that they need to in order to evaluate it or correct it, and include things that would protect them. And then later it's very hard to change or get out of, unfortunately.
Ray Kaczmarek: Yeah. Yeah.
It's trying to understand what mutuality means. If that's your position. I'm a collaborator, so I'm gonna tell you mutuality is my position. There are some things I'm not gonna bend on that I don't want to give up. But I would expect the same thing on that side. Yeah. So how do we coexist? But a bad contract and a bad quality agreement for both parties is actually detrimental. Inspectable item. So we can ask, well, do you have quality agreement?
No.
So who's responsible? And the reality is back to, okay, hey you having that in place is important. It's important to have it in your Clinical program. Your Clinical may be different than your Commercial. But it's still important and it's [00:23:00] important to have the terms of your services agreements in your clinical programs, too, when you're working with these types of things.
So they sort of go hand in hand because you're gonna have, what's the requirements? What happens if this fails? Those types of things. And you're gonna have who's responsible for the quality pieces that come together. The reality is you do need those types of documents. They are business documents, as much as for a quality agreement, it's a compliance document as well. But it is a business document.
So that does mean if you're inexperienced, don't be afraid to ask for help. It's better to understand what you're getting into than to not, than to be playing catch up later.
Joe Toscano: There's so much risk, it goes it goes to that. Yeah. I mean, there really is not only dollars, but even a great product can fail because you don't have something in place that mandates the way it needs to be addressed.
Mike Kent: Well, if you're spending, spending a week trying to figure out what a section of a quality agreement means because there's been a distraction, it's not right, or discrepancy...
Ray Kaczmarek: ...it means it doesn't have anything in there...
Mike Kent: [00:24:00] ...exactly right. But that's a week that could have been, or all of, you know, it cascades in a lot of different directions is my point.
Ray Kaczmarek: But well, what I'll tell you is what I like more. When you talk more quality agreements, usually good questions lead to good discussion, which leads to a better agreement. And usually parties when they can sit down and question why something's this way or ask about these types of things or, well, we would like to have this put into it and then start talking about a European Marketing Authorization in the future and some of those other pieces. Well, does that stagger now? Or is that two years from now? So it goes in the update, right?
But being honest about those types of things for your business upfront and allowing those conversation actually helps you with a better mutual type structure. Because even if they, even if still was more one sided to begin with, there's certain things once I go to this region or I have this type of structure, like with a QP, that are only going to be internal to them. Period. Because it's [00:25:00] just the way it is. So they're gonna just go ahead and change a lot of that now because they're gonna own it anyway and they don't want to get caught switching programs midstream. It just makes sense to start it a certain way.
So, again, those conversations I think are usually very collaborative, because it's not, I've never seen a quality agreement about or one about how I want to get something over on you.
But I have tell you this, you supply agreements are usually about risk, risk reduction, and how can I reduce my business's risk? And I don't want to do it, but if this does, if this fails, I only want to pay you what the cost of the batch would be and nothing, nothing else or whatever it would be. Or, I don't even want to pay you for that unless it's gross negligence. It goes through and it doesn't work, and we had a few deviations, but they weren't gross negligence, I'd still expect you to pay me for it. Because it's not easy doing what we do. I mean, that's usually how the first agreements are written there. They come to you that way. And you negotiate from there. Yeah, again, there's a lot of ways to, to do it, but the quality agreement's super [00:26:00] essential. From a commercial aspect, it has to be detailed. You have to have the things in there that matter, you know, to the product itself and that they're verifying against, right?
So if you expect these specifications to be followed, you expect these facilities to be utilized. You expect this supply piece to be in there. They should have sections. Yep. Addendums, references, whatever it's gonna be. But that is pretty much a good summary of how the quality system will interact.
So, again that's the map. And you do a decent map with your partner, it's actually very easy to finish.
Mike Kent: I think Ray hit the nail on the head in Part Three. Having a solid relationship with all your partners, whether they be development partners, cogs in your supply chain, or anyone else who's helping you fulfill the needs of your organization, success really starts and ends with clearly understanding and agreeing on who's going to do what, how, why, and to what level [00:27:00] of expectation. Working through this process, we strengthen the business case for having all these ducks in a row maybe a little earlier than is typical.
We round out our series on Cell and Gene Therapy in Part Four, where we identify strategies for implementing quality systems and a compliance mindset across the development lifecycle. Now, Ray has a bit of a different approach to this, and I think you'll find it very pragmatic and even refreshing, and to me that's why it's effective and sustainable. We conclude the episode with a look forward to the exciting future of this dynamic genre of life sciences.
So join us, won't you, for Part Four of Cell and Gene Therapy
with Ray Kaczmarek, next time here on The Grind.
Joe Toscano: If Medvacon can help you and your organization, we're happy to do so. We specialize in the following areas: Quality and Compliance, [00:28:00] Validation and Qualification Services, Project Management, Tech Transfers, General and Specialized Training Programs, Engineering Services, and Talent Acquisition. If you have general questions as well, feel free to give us a call at any time.
We can easily be reached at 833 633 8226 or via our website at www.medvacon.com. Thanks so much, and we look forward to speaking with you.
Jessica Taylor: Thank you for listening to the Quality Grind Podcast presented by Medvacon. To learn more or to hear additional episodes, visit us at www.medvacon.com.