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Thanhthao Tran - November 19 VIEW RECORDING - 20 mins (No highlights): https://fathom.video/share/DNrsq2n2VSapcMN3f9S7JEtBnTBEY4Fh --- 0:00 - Andrew Hartmann (UTAK Laboratories) Good morning, Andrew. 0:00 - Tran, ThanhThao (Mayo Clinic) How are you? I'm doing lovely. 0:04 - Andrew Hartmann (UTAK Laboratories) We're having one of our last few somewhat nice days of the year before it's about to get really cold here. Oh, yeah, yeah, yeah. Where are you located again? In Jacksonville, Florida. Oh, so you guys get the good weather. Yeah, well, it was a little bit cold last week. 0:20 - Tran, ThanhThao (Mayo Clinic) It's like in the 30s. But this week, it's okay. It's nice. That is cold for Florida. 0:26 - Andrew Hartmann (UTAK Laboratories) Oh, yeah. it is. We didn't know what to do, how to react to it. We have, we get like below zero a couple of times a year, and it's, oh, yeah, I just, I have a dog, and both her and I, like, we open the door, and we're just like, why are we doing this? Right. Well, I appreciate you hopping on a call here. So you had some interest in Bucilphan, is that right? Yes, yes, yes, yes. Are you looking for calibrators, controls, or both? Controls. Controls. Yeah, calibrators. We can talk about that. 1:02 - Tran, ThanhThao (Mayo Clinic) We can talk about that, but mainly we want the control. But we'll talk about celebrators, too. Perfect. 1:08 - Andrew Hartmann (UTAK Laboratories) So have you done any of our customs controls before, or is this going to be your first time walking through the process? This is my first time. 1:15 - Tran, ThanhThao (Mayo Clinic) But I mean, we have with you before, but personally with me, that's going to be your first time. So you might have to be patient with me. I'm learning as well. 1:24 - Andrew Hartmann (UTAK Laboratories) That's why I always feel like getting on a call is just a little bit better, because you can go through the ins and outs and answer any questions live time versus, like, back and forth emails. Yeah. So there's a couple of questions we're going to step through just to start working on the design. And you don't have to have final answers here. At the end of this call, if you'd like, I can, you know, email over the question so you can think about it and kind of come back and say, you know, here's the design. Gotcha. But our first question we're going to know is what matrix do you want these made in? 1:57 - Tran, ThanhThao (Mayo Clinic) Uh, I guess it should be the. The same, then it would be Sodium Heparin Plasma. Is that possible? Yep, it sure is. 2:12 - Andrew Hartmann (UTAK Laboratories) And then as far as like a fill size per file, typically with buculfan, we see about a 25-day thawed stability. We usually recommend you stick to like a, you know, either a daily or weekly usage vial, though. So do you have an idea of like what an ideal fill size per vial would be for you? 2:33 - Tran, ThanhThao (Mayo Clinic) So that test currently is really low. I don't know if we're going to start offering in-house. We're going to increase the volume, but as of right now, it looks like we only have like one patient a week. So which is we only run one time a week. So if you say the vial, good for 25 days, does that mean, I mean, we can... Make them up and thaw and aliquot them out in the freezer. Is that work or what do you? 3:07 - Andrew Hartmann (UTAK Laboratories) We don't want to see you doing that. So we don't, once we spike a control, we don't want to see you doing freeze-thaw cycles. So how much material do you use per run? 3:18 - Tran, ThanhThao (Mayo Clinic) It's only 100 microliter. That's going to be 0.1 ml. 3:27 - Andrew Hartmann (UTAK Laboratories) Is that right? Yes. And then you're just doing, so you're basically, you're using 0.1 ml per week. Yeah. Yeah, that's all we need. 3:46 - Tran, ThanhThao (Mayo Clinic) I'm trying to think of, yeah, because we normally, you know, we probably do 0.2 because I think in our process, we probably one set in front and one set at the end of the batch. So we're Thank So we probably 0.2 then per week. 4:07 - Andrew Hartmann (UTAK Laboratories) So I think what I would recommend then is let's do like a 0.4 ml fill size. Okay. Because we always want to add an extra 0.2 ml just to account for vial loss because, you know, if put in, you know, 0.2 into the vial, you're never going to get 0.2 out. Yeah, that's true. So we'll do a 0.4 ml fill size, and then that'll be like a one-week fill size. So you should be able to get two, you know, 0.1 ml aliquots out of that. So good. And then our minimum order size, it does seem like it's going to exceed your usage. So for us to make a custom product, we have to make at least 50 ml per level, which, you know, maybe we'll just make it 0.5 for ease of the sake, since we're going to be kind of tossing some probably at the end of the shelf life here. And then I'll quote you for 100 vials. Of each level, which would be, you know, our minimum order size. Okay. 5:04 - Tran, ThanhThao (Mayo Clinic) And another thing too, Andrew, because Rochester, Mayo and Rochester, they also use this product. So what if we factor in with them? 5:15 - Andrew Hartmann (UTAK Laboratories) You guys could totally do that. So we do that right now with one of your immunosuppressants controls. It just, it does require more coordination because essentially like you guys have to buy the same design at the same time. And then we manufacture it in like one batch. So would it be better? 5:33 - Tran, ThanhThao (Mayo Clinic) Would it be the pricing's better if we combine with them or you think it doesn't make, okay. 5:37 - Andrew Hartmann (UTAK Laboratories) No, I mean, the more material that we make in one manufacturing, the better of a per vial price we're going to get. And also with your volume being so low, like, you know, just to be transparent, you're likely going to be throwing out material at the end of this. So if you can tack on with another location that's also, you know, using it, but you're going to have to have like the same concentration. The same fill size, like, it's got to be the same product that you both are using, and then we coordinate your order together. So instead of making a batch just for you and a batch just for Rochester, we make one batch and ship you, you know, however many you ordered and ship Rochester, however many they ordered. Okay. Let me see. 6:19 - Tran, ThanhThao (Mayo Clinic) Yeah, if that's something we can work, we can work it out with them. Because soon we do, coordinate well with the immunos. I feel like we should be okay with doing that. But maybe we, if you don't mind, we can have, like, a prize quote for, like, us separate, and then if we go with them, what it's going to be. Yeah, totally. 6:40 - Andrew Hartmann (UTAK Laboratories) Give me just a minute here to see if I can find Rochester's last batch of this, just so I can kind of use that as a springboard for. Okay. 6:59 - Tran, ThanhThao (Mayo Clinic) Yeah. And then let's get can find I'm 7:20 - Andrew Hartmann (UTAK Laboratories) My computer always seems to know when I have somebody on a call and it slows down. It does look like their design is going to align pretty well with your needs. So they're doing a 0.3 ml fill size right now. They're getting that put into 81 pack packages and then they're getting three of those packs. So I can send you a copy of their last quote. It's no longer valid. So like that pricing, you know, is no longer valid, but it'll give you the contact info of who are working there. And then you'll also kind of see, you know, what the design is of what. They're doing. They also have sodium heparin plasma. So it looks like we're same on the matrix there. Okay. Let me just make myself a note here. Perfect. So yeah, after this call, I'll send you that quote as well. And then, you know, if you want to reach out and kind of start working with them as well and figure out like, hey, is it better for you to tack onto their order and find out when they're planning their next order and all that. you know, I've also seen some Mayo sites just like ship another Mayo site, some of the products. So, you know, instead of placing an order right now, maybe they've got some vials they can send you. And then we go on. Yeah. Okay. Yeah. That'd be good. 8:46 - Tran, ThanhThao (Mayo Clinic) I think we've done that before with the other sites in Arizona that we do that sometime. Because we like to go to the same lot together. if one running shorter and the other one I have extra, we shift it and then we go in the same lot together. Yeah, always think that's a great idea when they align. 9:03 - Andrew Hartmann (UTAK Laboratories) I think I've seen you guys do that with some vitamins controls as well. I know we're doing that with your immunosuppressants. So, you know, I do think that's a great path forward for you rather than buying a lot directly from us just for you because that will, you know, it would be a better price point for you. And with your low volume, you could get a limited amount of vials because they're ordering enough, you know, to get to that minimum order size. So you wouldn't have to order like 100 vials if you just wanted, you know, 52 vials for the year or something like that. I think that would be a better benefit for you. That's so good. 9:37 - Tran, ThanhThao (Mayo Clinic) And Andrew, do you have any of their stuff in stock or is it something that is when we talk now, if we need, we're going to go with it. You have to make some more. You don't have nothing left for that. don't keep anything on hand for these custom products. 9:50 - Andrew Hartmann (UTAK Laboratories) We make it just for the order. We ship it in full and then that's all we had. But, you know, they ordered this in November of 2024. So I imagine they still. We'll have some of this on hand if you wanted to, like, reach out to them and, you know, see if you could buy some vials from them. Okay. But if you wanted to go forward with a quote from us, kind of the next question we have is, like, how many levels would you be looking to have made? Three. Three levels? Yeah. Is that what they have up there? They have four levels. Oh, they have four? So doing a 50, a 300, a 2,500, and a 5,000. 10:29 - Tran, ThanhThao (Mayo Clinic) Oh, they have a wide variety of them, huh? Well, if they're going to have four, I guess we'll go with four, just in case we're going to go with them. Okay. And would you want to match those same concentrations, or is that not what's ideal for you? No, that sounds really good, like, because our range is going to be around there, too. So that sounds really good. That looks really good. Okay. 10:58 - Andrew Hartmann (UTAK Laboratories) Perfect. So... I think with them doing that 0.3 ml, let's go back to that for your fill size, because that will still give you, you know, I think enough for what you're doing. So I'll have you quoted now for 0.3 ml fill size. We'll do the minimum order size of 50 ml, so I'll work out the math on how many vials that ends up being. And we'll quote you for the same four levels that the other location is using. Okay. And then I'm also going to send you the copy of their last quote, just so you can see, like, you know, who's buying it, and you can reach out, you know, internally. But you'll also notice that they're buying a lot more material in the one go, so they're probably going to get a per vial price that's going to be better than what your quote is going to be at, since we're doing the minimum order. But just to be transparent with you, like, on our pricing and how all that works, so it'll take our team probably two or three. I'm days to generate this personalized quote for you, but right after this call, I'll go ahead and send over the existing quote from the other location so you can get started, you know, reaching out to them and seeing if they might be able to just ship you some now. Okay. So good. 12:15 - Tran, ThanhThao (Mayo Clinic) Thank you so much. Yeah. And then as far as calibrators go, we can do, you know, the same exact thing for calibration. 12:23 - Andrew Hartmann (UTAK Laboratories) Okay. So you would just let us know, you know, what matrix, what fill size, and how many of those vials you want, and then, you know, what concentrations you want for your calibrators. Okay. Now, when we're doing both calibrators and QCs for the same company, we usually see one of two things happen. So either companies don't care about having the manufacturing separated. So we use, you know, the same lot of matrix, the same manufacturing technician, and the same drugs. Then we also see other companies that prefer to have the separation. So we can use a different lot of matrix for your calibrators than we used for your controls. We can use a different manufacturing technician, and we can also use a different lot of drugs. The only one that adds to the cost of the product is if we do a different lot of drugs, because then we have to go out and buy, like, a separate lot of drugs just for, you know, just for your product. Gotcha, gotcha. Do you have an idea, you know, if you would want that completely separate? Would it be the same? 13:28 - Tran, ThanhThao (Mayo Clinic) I am feeling like we probably prefer separate. Okay. 13:38 - Andrew Hartmann (UTAK Laboratories) And, you know, that might be a great conversation for you to also have with the Rochester location. Find out what they're doing for calibrators. They make their own. They do? Yeah. Okay. You know, because we could make them for you, both you and Rochester. Again, that would be a better value for both of you, or if you'd just like to have us make them for you, we can also do a quote. Just making it for you. Yeah. 14:02 - Tran, ThanhThao (Mayo Clinic) Yeah, I'm trying to think, like, they make their own, but, like, they have the people, and I'm trying to think, what is worth for us is that we make it in-house, or is it worth for us to buy commercial? 14:15 - Andrew Hartmann (UTAK Laboratories) I'm always kind of curious why Mayo decides to do some things in-house and have us do other things. I assume it must be, like, the harder things, or somebody has messed something up, or... 14:25 - Tran, ThanhThao (Mayo Clinic) Yeah, I think my joy of time, because they have, like, up in Rochester, they have, like, a lot of people up there, and a lot of people with the experience and stuff like that with making stuff up. So they normally, what I see, they normally try to make stuff in-house, unless it's not worth it, like, it spends too much time, or, like you said, it might fail, it doesn't come out what they wanted it, then they will buy commercial. So, like, or, like I said, if it's not worth it to buy, like, it might take more time, more money, make one instead of buy one, then they will buy one. But the majority of time, they make their own, a lot of stuff. 15:00 - Andrew Hartmann (UTAK Laboratories) It I talked to at Rochester that said they had a product and it was like 3,000 aliquots and they were like, my thumb can't handle this. I I know, I know. Some of them, they have so, they have so much. 15:11 - Tran, ThanhThao (Mayo Clinic) I look at them and I say, oh my god, how long it takes them to do that. Yeah. Yeah, the Rochester one goes through some really high volume QCs with us, like just thousands and thousands of vials. 15:21 - Andrew Hartmann (UTAK Laboratories) I'm sure, I'm sure. But I think majority of them. They do it all, so. Yeah, yeah. 15:29 - Tran, ThanhThao (Mayo Clinic) But, you know what, let's do, let's do the different lot and see what you have. And the level we want, I think we're looking at 25. I don't have it on top of my head. Where is it, 25, 100, 200, hold on, give me one second. Let me call my developer really quick because she knows the concentration I had. I don't remember, give me one second. All right. Shea Breaks. So I think it's like $25,000, $1,000, $2,500, $5,000, and $10,000, I believe. $7,500 and $10,000, I believe that's the country, yeah. 17:20 - Andrew Hartmann (UTAK Laboratories) You know, that's enough to get us started and at least probably get us in the ballpark on pricing. And then if you find out, hey, it's something a little different, we can always make that update if we're in the same ballpark. Yeah. Awesome. Well, I think that is all I'm going to need to get started. So leaving here, I'm going to email you over the current quote that Rochester used for their last order. So you can kind of see their design and who we talked to. And, you I definitely think it's going to be in your best interest to reach out and, you know, see if you can get onto the order with them. As far as like price point wise, and then also you guys are using the same lot. So if there's any kind of issues, you can troubleshoot within yourself. But we'll go ahead and move forward quoting. Thank you. Basically mirroring their design just to the volume of what you're looking for. And then I'll get a quote worked up for calibrators, and we'll use a separate technician, a separate lot of matrix, and a separate lot of drugs. So those new quotes, give me about two or three business days to get them over to you, but the existing quote I'll have over to you a couple of minutes after we depart here. Okay. Okay. 18:25 - Tran, ThanhThao (Mayo Clinic) Awesome. Sounds good. Thank you. 18:26 - Andrew Hartmann (UTAK Laboratories) Any other questions? Anything I can do to help out? No, no, that's it. 18:31 - Tran, ThanhThao (Mayo Clinic) I mean, that's all I want to know, like, will that, how's with the price and what, and how long, once we decided we wanted, like, how long it took to make and get ready? 18:43 - Andrew Hartmann (UTAK Laboratories) You're probably looking in the ballpark of about 20 business days. 20 business days, okay. Are there any other, like, controls that you guys are looking at or calibrators you're looking at that you'd want to see a quote on? No, not currently, but soon, future, future. 19:00 - Tran, ThanhThao (Mayo Clinic) There will be a lot, but not at the moment. Yeah, definitely keep us in mind our flexibility. 19:05 - Andrew Hartmann (UTAK Laboratories) It's hard to market just how much we can do, but essentially we can make whatever your heart desires. All right. So good. 19:14 - Tran, ThanhThao (Mayo Clinic) Awesome. Well, I appreciate your time. 19:15 - Andrew Hartmann (UTAK Laboratories) Thank you so much. You're welcome. 19:18 - Tran, ThanhThao (Mayo Clinic) And thank you. Thank you for your time, too. Have a great one. 19:22 - Andrew Hartmann (UTAK Laboratories) Thank you. 19:22 - Tran, ThanhThao (Mayo Clinic) You too. Bye-bye. Bye. 19:30 - Andrew Hartmann (UTAK Laboratories) Bye.