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Kristin Dragomir-Daescu - October 16 VIEW RECORDING: https://fathom.video/share/BMJiM6ERk6b1Jk-Nzu-nz1xaizAgdS4i Introductions and meeting context @ 0:00 The participants introduced themselves, including Andrew Hartmann, Nicole Miller, and Raleigh Gallina from UTAK Laboratories, and Kristin Dragomir-Daescu, Courtney, and Hannah from the Mayo Clinic. They discussed the purpose of the meeting, which was to review a quote for a new product order. Product details and specifications @ 3:46 Raleigh Gallina walked through the details of the quote, including the product SKUs, pack sizes, pricing, and stability information. The group discussed the need to increase the fill volume to accommodate the dead space in the Mayo Clinic's Hamilton instruments. They also agreed to switch to amber vials to address light sensitivity concerns. Calibrators and controls @ 8:00 Andrew Hartmann inquired about the Mayo Clinic's use of calibrators and external controls for their benzodiazepine assay. Kristin Dragomir-Daescu explained that they currently use only UTAK controls, but are looking to incorporate a mix of internal and external controls as they continue to develop the new assay. Next steps and timeline @ 8:50 The group discussed the expected timeline for manufacturing and delivering the new product, with Nicole Miller estimating a 15-business day lead time but noting they may be able to deliver sooner. Kristin Dragomir-Daescu indicated she would work with her supply chain team to get a purchase order placed once the updated quote is received. Kristin Dragomir-Daescu - October 16 VIEW RECORDING - 10 mins (No highlights): https://fathom.video/share/BMJiM6ERk6b1Jk-Nzu-nz1xaizAgdS4i --- 1:35 - Dragomir-Daescu, Kristin E. Let us know, kind of, what you find. Hey, Kristin. Hello. How are you doing? Kristin and company. 1:43 - Andrew Hartmann Good. Yeah, good. 1:43 - Dragomir-Daescu, Kristin E. How are you? Doing well. 1:46 - Nicole Miller How about yourselves? 1:47 - Raleigh Gallina (UTAK Laboratories) Good, we're good. 1:48 - Dragomir-Daescu, Kristin E. I've got Courtney here with me. She is one of our technical specialists who is kind of the keeper of this assay. Okay, so she's going to be my expertise here. Awesome. Beautiful. 2:00 - Raleigh Gallina (UTAK Laboratories) Well, you can tell Kristin I've also brought our heavyweights here, so I'll do just a quick round of introductions. And selfishly, I'm excited to meet you in person, too. I'm a bit new in seat, so I'll go ahead and begin. My name is Raleigh, even though I've been with UTAK for five years. I'm new to customer care, so thanks for letting me connect and put a face to my name. And I believe you know Andrew, but I'll have you go next, Andrew. Hey, I'm Andrew. 2:27 - Andrew Hartmann I've been with UTAK for almost 11 years now. I think I've helped you on several orders, so I'm looking forward to supporting you. 2:34 - Dragomir-Daescu, Kristin E. And then, hi, I'm Nicole Miller. 2:35 - Nicole Miller I'm the Director of Engineering here, so I've been here for about 10 years. I think we've communicated via email, too, but I don't think you've ever met face to face here, too. But I oversee product design and also quality assurance. Wonderful. 2:47 - Dragomir-Daescu, Kristin E. Yeah, so for those that haven't met officially, I'm Kristen. I'm one of the assistant supervisors for the Clinical and Forensic Toxicology Lab. I help with a lot of the logistics of the day-to-day stuff in the lab. Like ordering, verifications, project management, you name it, you're kind of a jack of all trades. And say, Courtney, if you want to do a little intro, then we'll go to Hannah. I'm Courtney. I have been at Mayo for eight years, but I'm new to this lab, so I'm kind of new to mass spec in general. But learning a lot as I go. I'm Hannah. I've been CFTL, it'll be nine years in January. And I'm a technical specialist. Beautiful. Nice to meet you all. 3:32 - Raleigh Gallina (UTAK Laboratories) I thought maybe because we had three people on the call, you snuck in last minute to make it like an even three and three. 3:39 - Dragomir-Daescu, Kristin E. It's easier for us if we're just all in one room, so we can kind of collaborate a little easier. For sure. 3:46 - Raleigh Gallina (UTAK Laboratories) So, yeah, thanks so much. We just want to make sure that we got this quote right for you. Just with new parts, we've been asked to connect with the team. Yeah, usually Kevin, who's your account manager, would. Be on these calls if deemed needed, but I don't think we'll use the full-time, and it's just so nice to meet all of you, too. So, and, Kristin, I know you're pretty familiar with the layout of our quotes as well. Are you able to see my screen? 4:15 - Dragomir-Daescu, Kristin E. Absolutely. Okay, beautiful. 4:17 - Raleigh Gallina (UTAK Laboratories) So we do have the quotation number here for reference at top, too. Your customer account number is always here as well. So we do have the product here, so you'll see the Benzo levels one, two, three. As well as the validation samples. So, as you're aware, once we manufacture the product, we'll go ahead and, as per quality agreements, send the validation samples to you to ensure that it is within your specified criteria. If not, as always, come back to us with any adjustments, as well as what you're seeing, too. We're happy to make those. So for the pack sizes, we do have the 81 vials at the 0.4 mil, fill count, and then the quantity of those packs as well. Price per pack. Thank you. Extended price here, too. And in terms of stability, Nicole, would I be able to ask you just to speak to the NA? And does it mean that, you know, we don't have that? We just are being mindful of specific commitments. 5:14 - Nicole Miller So, yeah, the only one that we have validated stability for is diazepam in serum. All the other ones we work with in serum, we just don't have the data to necessarily make the claims to say that it's 25 days. But I believe on the last product, the version one of this product that you got before was the same stability days that were on there. I'm not sure if you guys have any feedback from what stability data you were actually seeing or if you're using them single time use or using a thawed state for any period of time. But that's why we just don't have the ability to say that it is going to be 25 days. 5:47 - Dragomir-Daescu, Kristin E. We are using these frozen single time and then we essentially toss them, right? We'll use them, freeze them again, use them the next day and they're fine. Very limited. Like, you have them a couple days and that's it. Yeah. Yeah. So that's why we go to smaller volume. Okay. I was actually curious. You guys increased the fill size on this. 6:10 - Andrew Hartmann Is there a reason for that? 6:13 - Dragomir-Daescu, Kristin E. You guys explained that to me because this was a request by you. Yeah. Our Hamiltons have a specific dead volume that they need in the, like, the 1.5 mil vials, and the 200 mics just wasn't enough to accommodate for that dead space volume. So we were having to add, like, mix two of, like, controls together just to get a bigger volume in a vial. We were finding that we were combining two and then popping them on the instrument. Gotcha. 6:44 - Andrew Hartmann Oh, fair. 6:45 - Raleigh Gallina (UTAK Laboratories) Awesome. Yeah. Yeah. And then the remainder of the quote, too, so just highlights the matrix, form, temperature, as well as I know we have some specific packaging requirements from AO2. these two items. Okay. So all of that's on there. And I'll go ahead and I'll be sending this to you after our call. Did you have any questions? Does this look good as expected? 7:12 - Dragomir-Daescu, Kristin E. Do you want to request amber tubes? Yes, that is a fantastic thing. Can we, do you have amber vials? We are finding that some of these are probably light sensitive. And we have transitioned all of our other, everything else for this assay to amber vials. Perfect. 7:36 - Nicole Miller Yeah, so we do, I think it's a 1.5 amber, I think that's the size that we have. It potentially is a 2, but I know that we use the amber, like, version of this vial for some of the other Mayo products too. If we could get those instead, that would be great. 7:52 - Dragomir-Daescu, Kristin E. Nice catch. Perfect. Yeah, we'll submit that request to make that change. 7:57 - Nicole Miller Thank you. 7:59 - Dragomir-Daescu, Kristin E. I was kind of... 8:00 - Andrew Hartmann I'm are you guys doing your calibrators for this in-house, or are you getting those from someplace else? We do make them in-house. Okay. Are guys using any other external controls in your benzo panels or just UTAK? Right now it's just UTAK. Awesome. 8:18 - Dragomir-Daescu, Kristin E. It's a new assay for us, so we're still figuring some things out. But we do try to have a mix of some internal stuff, some external, so we know we're hitting our targets as well. It's just kind of having a little mix into things. That makes sense. 8:39 - Raleigh Gallina (UTAK Laboratories) Awesome. Okay, well, we'll go ahead and adjust the vial type and then send this your way. Beautiful. 8:50 - Dragomir-Daescu, Kristin E. Approximately, what's the time frame of getting these made, getting those testers in? Do you know? Yeah, so the lead time that we have on this... 9:00 - Nicole Miller There's 15 business days, but we've been running a little bit ahead of lead time. So, I mean, as long as everything's in stock and we're good to go, which we should for all these analytes, then we'd expect to be quicker than 15 business days. 9:13 - Dragomir-Daescu, Kristin E. Okay, that would be great. Awesome. Yeah, once you get that send over, I can get our supply chain team on getting a POO. 9:23 - Raleigh Gallina (UTAK Laboratories) And Nicole, do you think we could turn this quote with updated vial type today? Definitely, yes. 9:28 - Nicole Miller We'll send that back. Beautiful. 9:30 - Dragomir-Daescu, Kristin E. Awesome. 9:31 - Raleigh Gallina (UTAK Laboratories) Hey, well, it's so lovely to meet all of you and you'll hear from us before end of day today. Well, thank you so much. 9:37 - Dragomir-Daescu, Kristin E. It was nice to meet you. Bye. Bye.