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Cynthia Barajas - November 20 VIEW RECORDING - 21 mins (No highlights): https://fathom.video/share/QyY6jJZz-eofBqM53Cds4DnLhNSVVrdY --- 0:04 - Andrew Hartmann (UTAK Laboratories) If you're talking, I think you are on mute. Oh, I am on mute. 0:08 - Cynthia Barajas (Lab24) I'm sorry. How are you? I'm doing great. Yourself? 0:12 - Andrew Hartmann (UTAK Laboratories) Good. Thank you. I love that even like this many years after COVID, all of my meetings still start with some level of IT. I'm like, can you hear me now? Or my camera's off. I know. That's great. 0:23 - Cynthia Barajas (Lab24) So we are going to wait until we're waiting for our technical supervisor, Ken. I don't know if you've ever met with him in the past. He was basically the CLS for our department for many years, and now he's moved up and become the technical supervisor. And so I asked him to join us because he has a much better way of explaining what we're looking for, where I am still. So I was working more so in the molecular diagnostics department, and now I moved over to TOX. And so, but I've taken care of the... 0:58 - Andrew Hartmann (UTAK Laboratories) be... 0:58 - Cynthia Barajas (Lab24) So, Thank So the compliance basically for both departments. And so, but now I'm becoming more of the like scientist side of things. 1:08 - Andrew Hartmann (UTAK Laboratories) So I actually used do UTAKS compliance. I was our, like our regulatory manager, our ISO rep, like FDA, DEA, all of that was me. And now I just work in sales and I love it. Customers are so much more friendly than auditors. 1:22 - Cynthia Barajas (Lab24) Yes, but I rather, I don't know, I'll take an auditor over doing anything in sales any day. I, I don't have the personality for sales. Absolutely. You know, the only thing I preferred about the regulatory was like the turnaround time expectation. 1:38 - Andrew Hartmann (UTAK Laboratories) Like I remember interacting with the FDA and they sent me over like this whole list of things. And like six hours later, I had it back to them. And the lady was like, it takes most companies a few months to get all of this. And I was oh, I was already ready for it. Yeah. I was like, I came from the customer service world of like, hey, I just need to get everything done right away. Yeah. Otherwise they move on to someone else. 2:00 - Cynthia Barajas (Lab24) Yeah, we'll give him just a few more minutes, and if he doesn't, then we can just go ahead and start, which is fine. 2:09 - Andrew Hartmann (UTAK Laboratories) You guys are located in Redding, is that right? Yes, we're in Redding. California? No, not at all. 2:16 - Cynthia Barajas (Lab24) We're all the way in Northern California, almost Oregon. Oh, okay. Yeah, we're about maybe, I want to say, two and a half, three hours away from Oregon. We're up here. Gotcha. 2:28 - Andrew Hartmann (UTAK Laboratories) Hey, Ken. Welcome. Hi, Ken. 2:31 - Cynthia Barajas (Lab24) You're on mute, Ken. Oh, can you hear me now? 2:37 - Ken Yes. Yes. All right. Hello, hello. Hey, welcome. Appreciate you guys joining. Absolutely. 2:45 - Andrew Hartmann (UTAK Laboratories) Our home office is actually in Valencia, so we're like Southern California based. I moved out of California two years ago and now live in Missouri, where we just have terrible weather, and I sometimes regret it. BUD. 2:58 - Cynthia Barajas (Lab24) BUD, cost of living sounds… A lot nicer out there than it does here. You know, I get a whole house with like a basement and a garage for less than what my one-bedroom apartment was in Los Angeles. 3:09 - Andrew Hartmann (UTAK Laboratories) So yeah, it is significantly different. Exactly. 3:15 - Cynthia Barajas (Lab24) Well, up here, it's not as bad as Southern California. We're still like the more affordable part without having to live in the Central Valley. So we get, we have better views and decent cost of living. So I can't really complain. It's beautiful up here. Yeah, I love the redwoods and stuff. 3:32 - Andrew Hartmann (UTAK Laboratories) Those are gorgeous. absolutely. 3:34 - Cynthia Barajas (Lab24) But okay, we, so we reached out to you because we, as like I told you, I take care of the compliance for the laboratory. And we just, we have so many drugs that I can't get enough people to do correlation studies with. I, you know, we, we work with the CAP and API. We do some split samples with some other laboratories. Okay. And even then, we still have some drugs that are not covered, and we need them all covered. So we're kind of hoping that you have something, you know, that would work for us. I'm not sure what you guys have available, but Ken can explain it probably a little better than I can. Yeah, I think you pretty much covered, really, the gist of it, Cynthia. 4:21 - Ken That's pretty much what we need. When I asked you to reach out to UTAK, I had that in mind. But I also know that sometimes there's like, I think they're called calverification samples, or like, you know, samples with like known amounts of, you know, concentrations on, you know, in their formulation. And so that's kind of what I also had in mind. It doesn't necessarily have to be like a peer-reviewed or peer-compared sample. But, you know, as long as it's like a known sample. So formulation, then that's kind of the thing we are looking for. 5:06 - Cynthia Barajas (Lab24) That is true, because we might actually need that as well for the NDCOS. 5:12 - Andrew Hartmann (UTAK Laboratories) I can tell you guys, you're definitely not alone in this position of needing some material and not being able to find one of the big proficiency programs or something that's running in. Are we talking about urine controls? Is that correct? 5:27 - Ken Yes, so not necessarily controls, but yes. Yeah, the matrix is urine. Yes, we do urine and oral fluids. But I think that the bulk of the test analyzed that we don't have is going to be in urine. And just ballpark, around how many amylites are you looking to cover? 5:51 - Cynthia Barajas (Lab24) I know, we're looking for urine, we're down to one, two, three, four. 5:58 - Ken all a look. 5:58 - Cynthia Barajas (Lab24) So, Okay. All About four or five in urine. And for oral fluids, we're still about 12 different ones for the oral fluids. So about five for urine. 6:19 - Andrew Hartmann (UTAK Laboratories) Urine's about five of them. So the most common thing we see people doing in this position is we make for them what we call a blind sample, or we'll make a few different what we call these blind samples. So essentially how that process would work is you provide us with the list of the analytes that you're going to be looking for, and you tell us what your clinical range is. So lower end and upper end. We're going to put together a price quote, but we're not going to put the specific analytes or concentrations on the quote like we normally would if you were buying a product from us. So we see most of our customers split it up into like two products. don't even know like what drugs are going to be in which product, but we also see some do just like a single product. But essentially, you're going to buy a product from us. We're going to ship it to you completely blind. You're going to run it. You're going to get your values. And then once you've done that, you reach back out to us, and then we send you the IFU showing you what drugs we spiked into each one and the concentration we spiked it at. Perfect. That's kind of the most common thing. now, typically, our customers are not having us verify this with a third-party lab. So you're not getting like a reference value. You're just simply getting our gravimetrically spiked value. Okay. 7:40 - Cynthia Barajas (Lab24) So then it would be up to us to kind of set like our acceptable ranges and stuff. Exactly. Yeah. And I know a lot of the customers that we do this with, because our minimum order size is 50 ml to make these products. 7:52 - Andrew Hartmann (UTAK Laboratories) And, you know, for a proficiency test, that's usually far more material than you need. So from what other customers have told us is basically, you know, when they have. They that material around, they start talking to their other lab friends, and if, you know, another lab can test for that drug, they'll send them some of the product and, you know, compare to see, like, how you two are doing. Alternatively, you know, outside of that, we do work with some other partners, like Lighthouse Labs, who runs proficiency programs, and we make, like, the samples for them, but then they send them out, they do all the math, you know, that kind of stuff. So, you I can also try to put you in touch with, you know, another company. 8:31 - Cynthia Barajas (Lab24) Yeah, we work with Lighthouse already. Oh, okay. So they're covering some of your proficiency, just not all. 8:36 - Andrew Hartmann (UTAK Laboratories) Yeah. Gotcha. So, yeah, we could do the, I think the blind samples, then, if Lighthouse isn't covering it, is probably going to be the best path forward that we would be able to offer. 8:47 - Cynthia Barajas (Lab24) And you, would you be able to do both urine and the oral fluids, like this a lot? 8:52 - Ken Yeah, we sure can. 8:54 - Andrew Hartmann (UTAK Laboratories) Would you want them as, like, a single product, or would you want, like, at least two products so you don't know? What's in what? 9:02 - Cynthia Barajas (Lab24) Well, we run them on separate. Oh, no, we don't run them on separate. I don't know, Ken, I think that's a question for you. 9:08 - Ken Yeah, I typically, the proficiencies usually come in on the DMPM is usually three samples. Is that right, Sin, or is it five? It's five. DMPM comes five. Five, and then it's two events. Mm-hmm, I hear. 9:29 - Cynthia Barajas (Lab24) But I think the minimum, if it's not, like, if we're not reporting qualitative, then we can get away with three samples versus five. If it was a qualitative, then we can do, we can go down to two. But I believe we need at least three samples. Okay, yeah. 9:46 - Ken So I was going to suggest three samples in two events. So basically, you know, first half of the year, we get three samples, you know, could have all different samples. And then, you know, like twice a year. That would be my suggestion. Perfect. 10:09 - Andrew Hartmann (UTAK Laboratories) So just to kind of clarify, let's say we're talking the urine control. We'll say you have five analytes. Would you want those five analytes spread across three products so that each product only has like one or two of the analytes in it? 10:24 - Ken Correct. 10:24 - Andrew Hartmann (UTAK Laboratories) Almost all five. Okay. Yeah. 10:27 - Ken No, it doesn't. Yeah, they don't all have to. It's just kind of spread out randomly between the three. And you could even have one with like a complete negative. Yeah. 10:38 - Cynthia Barajas (Lab24) So each analyte just needs to be in there one time. 10:42 - Andrew Hartmann (UTAK Laboratories) Yes. 10:44 - Ken Correct. 10:50 - Andrew Hartmann (UTAK Laboratories) And would you have any preference on like fill size per vial? you know, we can do anything down to like 0.25 ml up to just like a 50 ml vial of each. But typically for something like this, I'd recommend like a 5ml vial and doing 10 vials to hit our minimum temperature times. 11:06 - Ken Yeah. Yeah. Yeah. There's no need to, you know, like have too much of it. Our spike volume is 100 microliters. So that's a very minute amount that we'll end up using. But it's better to have extra. Yeah, yeah, of course. 5ml would be 5 a perfect amount. Yeah. Okay, perfect. 11:31 - Andrew Hartmann (UTAK Laboratories) So yeah, kind of the only thing I would need from here to get you quoted is just the list of the analytes for the urine and the list of the analytes for the oral fluid, as well as what your ranges are. So we want to know kind of bottom end and top end. And then our team will randomly kind of choose which analyte to put into each of the three tiers, as well as, you know, a concentration at random from within your range. Okay, perfect. 11:57 - Cynthia Barajas (Lab24) I will go ahead and get you that. 11:59 - Ken that. Thank 12:00 - Cynthia Barajas (Lab24) Do you prefer it just straight on the body of the email, or do you prefer like an Excel or something a little bit more affordable? 12:06 - Andrew Hartmann (UTAK Laboratories) easiest for you to send over to us, really. We're pretty flexible, and it usually takes our team around two to three business days, once I have that information, to kind of get them all put together. And then once I have those quotes, I'll reach out to you with another meeting link like this, just so we can hop on and kind of go over them. These quotes are going to look different than most of ours, just because we leave so much information off, because we don't want you to know what drugs are going in each level. So it's more just like a price and some info on like lead time and that kind of stuff is what this quote will show. And then once you order that product, you're going to get it without any technical documents. So it'll just come in, you know, boxes. You're going to run it, and then whenever you're ready to know what we put in and the target value, you just let us know, and then we send you the IFU that has all of that information spelled out. 12:52 - Cynthia Barajas (Lab24) Okay, and then you also mentioned something differently, so the CAL verification stuff. That's separate, right? That's something you guys also offer, right? If needed. I'm not sure I understand what that means. 13:07 - Andrew Hartmann (UTAK Laboratories) Okay. 13:08 - Cynthia Barajas (Lab24) That's fine. 13:09 - Ken That's the end the conversation. I think I've seen it on the UTAK website. Yes. It might be referred to with a different terms. They've been called cal verification samples or calibration verification. Ah, that's the full one. This is a different term for it. There different words for people. Yeah. But basically, what they're used for is, and I think I've gotten from UTAK before and did it until I realized we were not actually required to do it. But basically, it's, I don't want to call them samples, but they're going to be formulations you get from UTAK with non-exact concentrations. And you You just use them to check your calibrations, and you run them at least in like triplicates, and then sometimes the vendor who sends you will have like a website, like a program, you can enter your results, and then you get your results. peer groups. Yeah. So a peer groups something we don't have, but what you're describing sounds kind of like our stock products, because when you buy our stock products, you get the list of the analytes. 14:30 - Andrew Hartmann (UTAK Laboratories) You get our target spike, but then you also get a third-party reference value where we pay a lab to run that test and share what their value is. So it just gives kind of further credibility to the results. I see. But we have labs that have us making their calibrators. We have labs that have us making their controls. We do linearity sets for labs. We do these like blind proficiency samples for labs. Really anything that you could think of making yourself in-house in like that talk space, we can take on that for you. We We set. set. That's So, you know, if you guys wanted to look at having UTAK make your calibrators for you, we can do high-level methanol stock solutions where you dilute down to make multi-level CALs or QCs. We can make individual levels for you. We have a ton of capability on our custom space. Fantastic. 15:16 - Ken So I really like what you're offering. I think it's going to fill up the gap that we had. I just had a little question. know you said you're going to have like an FIU, the information for use, which would, you know, like give us the information about what the concentrations are and what we should have expected. But I know that usually another thing inspectors will look for if you are doing a peer comparison is like a clear license of the lab you're doing the comparison with. Now, of course, you are not like a, I don't know if you have. Like a clear license, but is there anything else that would, can kind of supplement that, you know, that can stand in for that just to. Sure. 16:08 - Andrew Hartmann (UTAK Laboratories) So we're an ISO 13485 medical device manufacturer. So everything we manufacture is under that license. These products will get registered with the DE, or sorry, FDA. So you're going to get a UDI for them and kind of all of that. We can do a certificate of analysis that breaks down like the purity, the exact lot number of each drug, all of that kind of stuff. So, you know, we have a pretty robust documentation on the back end of, you know, that certificate of analysis literally has, you know, who our suppliers was, lot number, the purity, target concentration, like all of that. The IFU has instructions on how to like thaw, swirl, use, plus the target values. And then our ISO certificate is usually what most people need as far as like credibility that, you know, it's manufactured under controlled environments with quality management system, etc. that's we're do take It's So, Perfect. 17:00 - Ken Yeah, so I think we'll just need a copy of that ISO certificate, just, you know, probably the, like, a one-time thing, unless, of course, it gets renewed every so often, and so when it, you know, expires. Yeah, it's every couple of years, but I think we just went through recertification. 17:16 - Andrew Hartmann (UTAK Laboratories) So when we hop off here, I'll email over, Cynthia, I've got your email, so I'll just send you over the ISO certificate, and then if you could just reply back with the four to five analytes in urine and your target ranges. Yeah, course. the 12 analytes in oral fluid and the target ranges, I'll have those each quoted, broken up across three separate products, randomly choose which analytes go in each and the concentrations within your range, and then we can connect and review and, you know, see what you think and kind of tailor from there. Perfect. 17:46 - Ken I just wanted to mention, Cynthia, I think that, you know, there's that one, there's that one survey that we do with CAPT, the one that we just get one sample. So I want to say, since I feel. I like this is a better option. So I think that we will probably pull that out. And so therefore, what that means is you'll probably have a lot more analyzes. Yeah, actually, yes. So the list would be longer. Sure. Yeah. So, yeah, just expect more than what we mentioned there. That's right. I hadn't even considered that. But yeah, you're absolutely right. 18:25 - Andrew Hartmann (UTAK Laboratories) Yeah, it's going to be like… Oh, sorry. Go ahead. No, go ahead. Just so can understand our capabilities, we can do over 120 drugs within a single product sample. That's if you guys do look for like mass panels or anything like that, we have that capability. Okay. Last question. Do you guys have like a target budget or a price point for this? Anything I can give our team to try to help guide us? 18:54 - Cynthia Barajas (Lab24) Not. Not that I can think, but I don't really make that decision. 18:59 - Ken That's a little bit of a… 19:00 - Cynthia Barajas (Lab24) of our pay grade as far as finances go. We would run this by our director of operations, and she would kind of sign off on the pricing. Gotcha. 19:11 - Ken But we are growing lab, and so it's going to be quick, and it's not one of those things that has to go through that other platform. 19:23 - Cynthia Barajas (Lab24) Yeah, the turnaround on this email, like, yeah, this should be, honestly, this should all be finalized within, probably, definitely before Thanksgiving. I mean, because I just need to put together the email, send it to you, you give it back to us, we run it within the same building. It's, we're a small laboratory, so honestly, this should be done before Thanksgiving, ideally. Especially because I'm actually gone after Tuesday next week, so I want to finalize this before that. That's one thing I love about UTAC, is we're like a small business, so we're very quick and flexible to adapt. 19:56 - Andrew Hartmann (UTAK Laboratories) Decisions get made, you know, just like that set of something. The other companies I talk to where it's like months and months for approvals and government. No, it's not be like that. It's like years sometimes to get through a new product. No, not here. 20:11 - Cynthia Barajas (Lab24) Well, any other questions for me? 20:13 - Andrew Hartmann (UTAK Laboratories) Anything I can do while you guys have me? 20:16 - Cynthia Barajas (Lab24) I think this was great. Thank you so much for the call. Awesome. 20:19 - Andrew Hartmann (UTAK Laboratories) Yeah, I really appreciate the time and I look forward to connecting. Likewise. Anything else for you, Ken? 20:24 - Cynthia Barajas (Lab24) You're good? 20:25 - Ken I know. Happy Thanksgiving. Yeah, likewise. Thank you. Okay. Bye-bye. 20:32 - Andrew Hartmann (UTAK Laboratories) Bye-bye.