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Erin Kirby - October 08 VIEW RECORDING - 21 mins (No highlights): https://fathom.video/share/Xnep88LvMJyZQdkusB7bJ6Md4B3TWsgN --- 0:00 - Erin Kirby (Orion Laboratories | Baton Rouge LA) I'm good. How are you doing? I am so hungry right now. 0:03 - Andrew Hartmann (UTAK Laboratories) All of my meetings have been with labs in Louisiana today, and I'm just thinking about how good that food is in New Orleans. I was like, maybe I should make some beignets tonight. It's like a New Orleans day or a Louisiana day for me. That sounds really good. 0:19 - Erin Kirby (Orion Laboratories | Baton Rouge LA) I love beignets. 0:21 - Andrew Hartmann (UTAK Laboratories) You know, I didn't think I would like them that much, and that Cafe Du Monde, man, those things were good. I thought it was just a tourist trap to lure people in, but I went back to that place like three or four times. Yeah, it's so good. 0:33 - Erin Kirby (Orion Laboratories | Baton Rouge LA) I actually have celiac, so I can't eat gluten, but they have gluten-free ones at a place that's nearby. But they also have some of the best beignets that are with wheat, I've heard. But I like it. So if you're ever in the area, I've got tons of recommendations. They also had a good kind of coffee. 0:59 - Andrew Hartmann (UTAK Laboratories) I think it was called like... It sounded like a lot, but it wasn't spelled like a lot. They have chicory coffee. 1:07 - Erin Kirby (Orion Laboratories | Baton Rouge LA) It's really good. Okay. Yeah. Yeah, it's interesting the different regional foods that are... 1:16 - Andrew Hartmann (UTAK Laboratories) St. Louis has something called gooey butter cake, and it's like as much sugar and butter as you can imagine putting into something, and just every bit delicious. The ooey gooey. Are you able to see the quote on my screen here? Um, no, I have you on my cell phone. 1:33 - Erin Kirby (Orion Laboratories | Baton Rouge LA) Let me pull you up on my computer real quick. 1:44 - Andrew Hartmann (UTAK Laboratories) Stop sharing for a minute so I can add you when you pop in on the computer. Here we are. 1:52 - Erin Kirby (Orion Laboratories | Baton Rouge LA) Okay, I'm here. It let me in automatically. I think it's because added the device. 2:01 - Andrew Hartmann (UTAK Laboratories) It's weird. Some of my meetings, it just lets people in without anything, and then other ones makes me, you know, click them to let them in. You can see okay now? 2:11 - Erin Kirby (Orion Laboratories | Baton Rouge LA) Yeah, I can see it. Perfect. 2:13 - Andrew Hartmann (UTAK Laboratories) So I had our team kind of follow your general naming conventions just to keep things a little easier on your end. So we'll call your CALs A through H, your QCs 1, 2, 3, and 4. The way our minimum order size works out, it's a hundred, sorry, a 50 ml minimum. So for packaging wise, it's just going to be a little bit over that. So we'll package it in a 36 pack. Each vial would be 0.5 ml, and then the minimum order quantity is going to be three vials, or sorry, three packs. So we've got our price per pack here, our extended pricing, and then kind of the whole kit and caboodle, including shipping. So at our minimum order size, if you wanted to get all of the CAL levels and all of the QCs, you're looking at about 87,000. All My We'll You Now, you're not tied to getting all of them. Should you just want to get, like, a single level of QC or a couple of the levels individually, you're more than welcome to, like, you know, pick and choose as you please. But you had also mentioned you were expecting kind of an increase in volume. So I had you quoted at kind of a three times order amount. And you can see there's, like, a significant drop in the per pack pricing just based on the volume that allows us to spread those, like, fixed costs further. So essentially, you know, kind of an estimated one year supply, you're looking at, like, 87. An estimated, once your volume picks up, you're looking at about 110, 110, 111. Okay. Is that kind of in the price range that you were expecting to see, or what are your initial thoughts there? 3:47 - Erin Kirby (Orion Laboratories | Baton Rouge LA) You know, I had no idea what I was expecting, frankly. Fair. I think that that looks about, like, the annual cost of those anyway for my purposes. So. That seems, it doesn't seem outrageous. Okay, great. 4:05 - Andrew Hartmann (UTAK Laboratories) Then the next thing to kind of go over is your analyte panels and your concentrations. So we've got all of your QCs listed out here together. This is going to be the list of the analytes going in, and then the target concentrations for each level. Now you'll notice most of them are going to have stability days, but some of these are going to be marked NA. What NA means is it means we don't have stability data in this matrix to make a claim. Now some of the analytes, like the seven aminos, do have known stability issues, but for the vast majority of them, our assumption is basically that they're likely to work. We just don't have the data to tell you for sure they're going to work. So if you're making these in-house, I would expect you to see kind of similar stability from whatever you're doing. Yeah. And then we've got your cow levels starting here. So again, just all of the same drugs and the different levels. So if you want to double check those concentrations or anything like that, all of that information is good. This breaks down the basic design aspects, so it's going to be a urine control, it's going to be a frozen form, so just thaw, swirl, and it's going to be ready to use. We're planning to put it in a 2ml silenized amber glass vial with a blue colored cap and using yellow labels right now. We do have five label color options available, so should you wish to color code, you have up to five colors that you can work with. Okay. When you place the order, lead time would be expected about 15 business days, so roughly three weeks. And then, if it's any custom order, if you order more than $25,000 worth of product, we do require a 20% deposit upfront prior to us starting manufacturing. Okay. And then, we kind of talked about using separate lots of drugs, separate lots of matrix, separate manufacturing technicians. So, right now, this quote and this price is all based on using the same everything. So same lot of drugs for the CALS as the QC, same matrix, same manufacturing technician. We can update that. The only one that would cost extra is the drugs, and that can kind of end up being significant with this many drugs and us having to go and source that many of them. But it is an option if you wanted to pursue it, look at it. But I want to just kind of, you know, see what questions you might have and what your initial thoughts are. 6:30 - Erin Kirby (Orion Laboratories | Baton Rouge LA) So my initial thoughts or questions would be, I've been asked to definitely move forward with oral fluid, so I would like to see what the pricing would be for oral fluid. And if an option is to use a methanol matrix instead of like urine or oral fluid, and us spike them ourselves. We could definitely do that. 7:00 - Andrew Hartmann (UTAK Laboratories) For the methanol matrix, with this many drugs, usually the problem we run into is hitting, like, high target values. So typically what our team is going to recommend is taking, like, your highest level of calibrator, doubling that concentration, and then making that as the calibrator or the methanol concentration. Does that make sense? Okay. 7:23 - Erin Kirby (Orion Laboratories | Baton Rouge LA) Oh, so you wouldn't do the serial dilution part. You would just prep the main master mix. If that's what you want. 7:32 - Andrew Hartmann (UTAK Laboratories) So essentially, like, the way we manufacture it in-house is we make a drug stock solution, and then we put that into the matrix. But if you just wanted to buy, like, the higher level drug stock solution in methanol with all of these drugs, like, combined in one vial, that's also an option. Okay. 7:51 - Erin Kirby (Orion Laboratories | Baton Rouge LA) Okay. Um. Is it... Okay. Hmm. I'm curious. I've had some changes to the menu since last we spoke. I have another, I have a final, final, final, finalization. I don't know how many times I can say that this week. So there were a few extra things that they asked me to add in and some things that they asked me to take out. So a handful of changes. Because there will be changes, I think it might be, I don't know, is it better to hold off on the quote until I have those changes for you? I know that it's subject to change, given some exchange there, but we're talking about probably less than 10 drugs. 8:48 - Andrew Hartmann (UTAK Laboratories) Yeah, I mean, a quote of this size takes quite a bit of time for our team. So I think we would prefer to kind of, you know, wait until we have the final design before pursuing, like, further options. Yeah. Yeah. But whenever you're I ready for that. I think you still have the questions in the email as far as what we needed to get you quoted. So if you could just kind of update those questions and say, hey, I want it in methanol, you know, here's the fill size for methanol, here's how many vials I want, and, you know, the concentration for methanol. again, do you think it'll work for you to do two times the level of your top cal, or do you think you'd need it to be higher than that? 9:29 - Erin Kirby (Orion Laboratories | Baton Rouge LA) I don't think that I understand what you meant when you said that. Sure. Yeah, let me go ahead and share screen again. 9:37 - Andrew Hartmann (UTAK Laboratories) So sometimes when people ask for these like high level mixtures, you know, they're looking at like 20,000, 30,000, you know, nanograms per mil for all the drugs. So usually what we would do instead is like take your high level. So right now in matrix, like, you know, six ma'am is at 400. So in methanol, you know, our suggestion would be Methanol at 800. So your high-level cal is like a 50-50 dilution between urine and methanol, and then it, you know, cuts down as you go. 10:09 - Erin Kirby (Orion Laboratories | Baton Rouge LA) I think I've been doing one to five is what I've been doing. So you want to go five times higher than this number? 10:18 - Andrew Hartmann (UTAK Laboratories) Oh, I don't know. But that's what I've been doing. 10:22 - Erin Kirby (Orion Laboratories | Baton Rouge LA) You can ask for it, and our team will, like, come back and tell me, like, hey, this is too much. 10:26 - Andrew Hartmann (UTAK Laboratories) So it's, like, something like that. You know, if you have a preference, please feel free to ask for it. I've just seen in these panels, like, they often come back and, like, hey, you need to connect with the customer. Like, this is just too high. You know, we can't hit that target for that many drugs. 10:42 - Erin Kirby (Orion Laboratories | Baton Rouge LA) Oh, right, right. I see what you're saying. Yeah, yeah. That's why we ended up with, like, a one to five, a 20% solution, because normally, in most labs, it's, at least that I've worked with, it's a 10%, like a one to 10. But because... Because the ampoules only come in like 100 micrograms instead of 1 milligram ampoules, it takes more volume, which is why we had to go to a 1 to 5 instead of a 1 to 10. So that, yes, all that was to say that makes sense. I'm following you. 11:19 - Andrew Hartmann (UTAK Laboratories) Yeah, it gets hard in these huge panels to, to hit, you know, high concentrations. So it is usually, you know, a little bit closer to like two times the top of the cow is like generally what I'm used to seeing. But again, feel free to request whatever you'd like to request. And then if there is any issues, we'll just connect with our team and kind of work out like how strong can we get it. 11:42 - Erin Kirby (Orion Laboratories | Baton Rouge LA) Okay, I just want to make a quick note here. And I'll send you a copy of this quote to right after this meeting. 11:51 - Andrew Hartmann (UTAK Laboratories) So you'll have it and can kind of pour over it in detail. 12:01 - Erin Kirby (Orion Laboratories | Baton Rouge LA) So, methanol stack suggested stock to be one to two, and again, there's an option for me to do the serial dilution, or for y'all to do the serial dilution, but it would still be top stock, like it would still be a one to two, even if I did it across all of the levels? 12:21 - Andrew Hartmann (UTAK Laboratories) No, so it's for you, like from your perspective, it's either buying it in methanol or buying it in matrix. Internally, the way that we manufacture it is, if your concentrations allow for serial dilution, we're going to make a high-level stock solution and then delete down. I didn't look at all of your concentrations to see if they all line up, but if they don't line up, then we make each level, like individually, if that makes sense. Okay. 12:51 - Erin Kirby (Orion Laboratories | Baton Rouge LA) The drugs have different levels, but usually when you make that top stock, you would do it for, like you'd spike at different volumes. At least that's what I would do in this laboratory setting. 13:02 - Andrew Hartmann (UTAK Laboratories) Yeah, so typically what I've seen our team do is like they'll make the highest level in like the urine and then they're going to then take some of that urine at the high level and then add more urine to bring it down to the next level and add more urine to bring it down and add more urine to bring it down. So they'll usually make like the finished product at the highest level and then just make it in way more quantity than we need and then pull from that to dilute down to then make those other levels. Okay, that makes sense to me. 13:33 - Erin Kirby (Orion Laboratories | Baton Rouge LA) Do you know, generally speaking, and I'm sure this is a hard question, but what is that offset price if we take it out of the matrix? Because I like generally I'm just high level thinking about it. I think that it would still be close to the same cost anyway because urine is cheap. 13:53 - Andrew Hartmann (UTAK Laboratories) My assumption is probably going to be a little less but not like groundbreaking less. It's less packaging for us. It's a little bit less work. But I think the higher concentrations of the drugs does offset, you know, kind of some of the other costs. It's so hard in this business to give estimates. So, you know, I can tell you in general, the methanol is cheaper depending on the drugs. I've seen it be anywhere from just five or 10% cheaper up to like 30 or 40%. So it can be a substantial amount. It just it all depends on like how the math works out, the total volume, all those other factors that come into play. Gotcha. Okay, cool. But more than happy to present the options, just we prefer to have like a finalized list before we keep working on it, because it took one of our team members, I think, right about a day and a half of work to go through all this one. I really thought that I was done with it. 14:47 - Erin Kirby (Orion Laboratories | Baton Rouge LA) And then they added in more stuff. And I was like, well, that's great. 14:51 - Andrew Hartmann (UTAK Laboratories) That's actually one of the great things about doing a custom, though, is because we know labs don't stay stagnant. So as your panel changes, your control changes. And so most people that are doing. doing. We're these kinds of QCs and CALs with us. Every time that we're re-quoting it, we're taking out some drugs, we're adding in some other drugs, we're adjusting some concentration, so every time you reorder, you've got that opportunity to make any changes, grow your panel, whatever you'd like. Okay, cool. 15:19 - Erin Kirby (Orion Laboratories | Baton Rouge LA) All right, I like it. Awesome. 15:21 - Andrew Hartmann (UTAK Laboratories) Well, I will send this over to you. Once you have your updated panel, if you could just send that over to me and kind of let me know which options you'd want to see, we'll run it by our team. We might need to connect if they have, like, some questions or some feasibility issues with concentrations just to make sure that we're working everything out. But yeah, I don't see any issues with oral fluid, urine, or methanol for this. Awesome. Cool. 15:45 - Erin Kirby (Orion Laboratories | Baton Rouge LA) Do you guys ever do serum? Yep, definitely. 15:49 - Andrew Hartmann (UTAK Laboratories) We have serum and plasma available. Gotcha. 15:53 - Erin Kirby (Orion Laboratories | Baton Rouge LA) Yeah, I'm thinking the only reason that I would get it in methanol is so that I could cross it across business lines. Yeah. And do like spiking myself in the oral fluid or in the methanol or in the urine. Sorry. So it's the same. Sorry to throw so many variables out there, but it's the same major prep when they put it in the methanol and then they spike it into the urine or whatever the matrix is. So my question is, can I do a bulk order that still amounts to that 500 mils if I split it across different matrices? Or would I have to do 500 per matrix? 16:35 - Andrew Hartmann (UTAK Laboratories) It's a 50 ml minimum per matrix. So even if we're doing methanol at a high level stock, it's going to be a 50 ml minimum. And from what I've seen in a lot of labs, that tends to be like more than they're going to use in that time. So like if that's the case, it would probably be a better value for you to get the methanol. And then you could make, you know, urine cows, you could make oral fluid cows, you could make serum cows like. all with that method all solution if it's the same drugs you're testing. Okay. 17:07 - Erin Kirby (Orion Laboratories | Baton Rouge LA) Yeah, that makes sense. And if I did a one to two, it wouldn't be that much more volume. Yes, that makes sense. 17:19 - Andrew Hartmann (UTAK Laboratories) Cool. Any other questions? Nope, I'm sure we've covered it all. As they come up, know, please feel free to reach out or, you know, book a call, and I'm happy to kind of walk through this with you. And, you know, maybe when you're ready to get quoted for the methanol and the oral fluid, might be good to just hop on another short chat and kind of walk through it and make sure we understand your design. I can bring in one of our technical members, too, that can speak a little bit more about how the actual product will be manufactured and all of that and then move forward and get you quoted. Okay. 17:50 - Erin Kirby (Orion Laboratories | Baton Rouge LA) So, oral fluid, I think, when we talked last week, was something I was hoping to do in the next six months. But since then, I've been... I'm with doing it immediately. 18:05 - Andrew Hartmann (UTAK Laboratories) You know that thing we said you'd be doing next year? Yeah, we actually did it yesterday. Yep. Yep, that's where I'm at. 18:12 - Erin Kirby (Orion Laboratories | Baton Rouge LA) So I'm going to try and validate two at the same time. Do you need a blank oral fluid matrix? 18:20 - Andrew Hartmann (UTAK Laboratories) Are you already getting that from us? 18:22 - Erin Kirby (Orion Laboratories | Baton Rouge LA) I have one, one vial or not, one tester. But that's it. Gotcha. 18:33 - Andrew Hartmann (UTAK Laboratories) Yeah, if you need a little bit more of the blank oral fluid to try out, I can send you another 10 mLs or so. So let me know what you need to test out. Yeah. That would be great. Do I owe you anything for that? No, I'll just go ahead and send that to you as a courtesy. Okay, thank you. 18:55 - Erin Kirby (Orion Laboratories | Baton Rouge LA) Perfect. 18:56 - Andrew Hartmann (UTAK Laboratories) So leaving here, my action items are to send you this formal quote, and then I'll also have our going to ask 20:00 - Erin Kirby (Orion Laboratories | Baton Rouge LA) Oh, we'll find a way to connect. 20:02 - Andrew Hartmann (UTAK Laboratories) Does that mean you have to work weekends, though? Every Saturday. 20:07 - Erin Kirby (Orion Laboratories | Baton Rouge LA) Most Sundays, also. 20:09 - Andrew Hartmann (UTAK Laboratories) But Mondays, I just check out. You know, I miss that on my old job. I would have, like, weekdays off. I used to work retail, and it was like, it was so nice to be able to go out on, like, a workday and, like, get oil change done or, like, deal with business stuff because it's like, I need an emissions test on my car and all the places around me are closed Saturday and Sunday. And it's like, when am I going to get there? Yep, exactly. You can do stuff, and everyone's at work. Pros and cons to everything. Yeah. Awesome. Well, thank you so much. 20:42 - Erin Kirby (Orion Laboratories | Baton Rouge LA) I can't thank you enough for the turnaround time. And if you could extend my thank you to your team that put together the quote, you're helping my business move forward. So I really appreciate it. And that's what we're here for. 20:56 - Andrew Hartmann (UTAK Laboratories) We're partners in this. Sounds good. Well, take care. Yeah, have a good one. Bye. Bye.