Activity

Nilay Bhavsar - November 17 VIEW RECORDING - 32 mins (No highlights): https://fathom.video/share/7dXissp7s_MTNfmWngSsFDwAwvwtS4ze --- 0:06 - Andrew Hartmann (UTAK Laboratories) Are you able to hear me? Thank you. Thank you. Hello? Hello? Can you hear me? I cannot hear you. Thank you. you. you. Thank All right, try number two. Can you hear me now? You are talking. I still cannot hear you. If you want to drop a phone number in chat, I can also give you a call if that works better. 3:20 - Nilay Bhavsar (sonicreferencelab.com) Hi, Nilay, welcome. 3:21 - Andrew Hartmann (UTAK Laboratories) Hey, can you hear me all right? 3:24 - Nilay Bhavsar (sonicreferencelab.com) Hey, can hear you. 3:25 - Andrew Hartmann (UTAK Laboratories) I'm having trouble with Amber's sound. I think she can hear me, but I cannot hear her. Okay. 3:32 - Nilay Bhavsar (sonicreferencelab.com) Let me take a look at who Amber's doing. she wants, she can just hang out in here. Perfect. Thank you. 3:49 - Andrew Hartmann (UTAK Laboratories) Hey, welcome. Hello. Can you hear us? I can hear you. Can you hear me? I can hear you. 3:55 - Jamie V We were trying from Amber's office and it wasn't working, so we popped over to... My office. Amber is in the room. 4:03 - Andrew Hartmann (UTAK Laboratories) Perfect. Exiting and joining doesn't work. Sometimes getting to a new terminal is the best solution. It's the fastest. I'm amazed with how long we've been doing these digital meetings. Still, at least 80% of them start with some level of IT. Can you hear me now? Yeah, the first 15 minutes of pretty much every meeting starts with, hey, can you hear me? My internet's down. froze. Yep. How are things going for you guys this morning? Good, good. 4:35 - Jamie V I've definitely had worse Mondays coming into the lab, so we're good. 4:42 - Andrew Hartmann (UTAK Laboratories) Awesome. Yeah. 4:44 - Nilay Bhavsar (sonicreferencelab.com) So, Andrew, thanks for reaching out earlier. Sorry we couldn't touch base and connect sooner. I was kind of in the midst of wrapping up a project, and I know the supervisors, Jamie and Amber, are busy just doing their supervising thing. And kind of getting the lab in order and workflows associated and things like that. So we finally were able to find some time, set aside some time and kind of talk. And I know we wanted to talk a little bit about the QCs, the custom QCs that you guys are preparing for us. And we have a little bit of feedback that we would like to provide as far as how things have gone so far. So we want to give that feedback to you and provide any data you guys might want to look at to kind of just assess things on your end, see if there's things you guys would want to do for process improvement, things like that. So first of all, I wanted to ask you something real quick because somebody else from UTAK reached out to me. 5:47 - Andrew Hartmann (UTAK Laboratories) And I was a little confused. 5:49 - Nilay Bhavsar (sonicreferencelab.com) So his name is Quinton Reed? Yes. Okay, so he said, he basically said he was the, I guess he's a. Business Development Rep, or Business Development Manager, or New Account Manager. That's correct. 6:07 - Andrew Hartmann (UTAK Laboratories) Okay. It is no longer correct. Please feel free to direct anything to me. Quentin has left, so he's no longer with UTAK. But we do have kind of a business development team that we've been doing some reach-outs, so I think that's kind of how they ended up reaching out to you. But you guys are always welcome to kind of pick if you have a rep you prefer to work with, so if you'd like to. So you're still a primary point of contact. I didn't know if there was something in the hierarchical structure that changed. 6:32 - Nilay Bhavsar (sonicreferencelab.com) So that's what I kind of want to get at. But okay, perfect. So we got that one out of the way. So as far as the UTAK QCs, I know we're kind of on our second iteration or prep of this QC. And from my perspective, and I'll let the supervisors give their two cents on it as well, I think with the first batch that we had, I think everything went pretty smoothly with it. really good. you. We got them in. We were able to kind of run them in-house, establish our own means. We kind of took the liberty of doing some internal stability studies with it on our end just to kind of reassure ourselves of the stability of the analytes and the SMX matrix. So from that perspective, everything went well. And then, you know, we I think we ran through the lots. We ran through that batch sooner than we anticipated, partly because I think the volume had just started to increase with the testing. And it was just a basically outgrew what our forecast was for when we initially designed the QC and the prep. So, you know, we were kind of, we ran, we almost kind of ran low on QC, so we had to kind of set aside and get the order taken care of for the second batch. We did notice some observations with the second And we're, what we, from our end, what we were seeing was we were seeing about a more, like a 15, 25% bias than what the target concentrations were for the design of the QC. So, for estrogens, fractionated estrogens, estrogens, the estrone estradiol, our QC3, which the target concentration was 350 nanograms picograms per milliliter, our values were extrapolated above our AMR. They were coming in above 500. So, we had to do some further investigation on that to see, okay, was it something on our end with our calibrators, anything with the methodology on our end, or was this just some kind of prep in the bias, bias due to the prep for QC? So, what we ended up doing, basically, is we took aliquots, we aliquot that QC out, we sent it to another reference laboratory. And the external reference laboratory that we Sent it to. Their values were matching with us. So that caused a little mind if I ask which lab you sent that to? 9:08 - Andrew Hartmann (UTAK Laboratories) Yeah, it was ARUP Laboratories. Oh, perfect. Yeah, we like their results. 9:15 - Nilay Bhavsar (sonicreferencelab.com) So those QC3s, they were coming in above 500. I think Estrone was higher than Estradiol. And Amber, Jamie, guys can correct me if I'm wrong, but we ran... Across... Across nine different batches, we ran about 30 replicates. Yes. for that QC3, we were... Our mean was 550 picograms per milliliter for Estrone, and 472 picograms for picograms per That is definitely outside of what our normal expected range would be. 10:14 - Jamie V Did you see that with any other laboratories, the QC coming in high for this loss? 10:23 - Andrew Hartmann (UTAK Laboratories) This is a custom product, so it's being made just for you guys, so there is no other laboratories or anyone else that's using using like this exact lot. We do use these analytes regularly. I've not seen any kind of like history of issues with these, so I think this would be kind of a one-off sort of situation or something with this lot, particularly. Okay, thank you. Yeah, if you could share with me the results that you're getting and the results you got from Arup, I'll start a conversation with our team. Technically speaking, we say that these are Like NA Analyte, so we don't guarantee stability, which usually means there's a little bit of a barrier to getting like a no charge remake done. But generally, when we think of stability issues, we think of things being lower than expected concentration and not higher than expected concentration. So at a minimum, what I want to do is open up a product complaint investigation on RN. That's going to trigger our team to do a deep dive through the manufacturing paperwork. So they're going to check all of the calculations, they're going to check junk standards, calibration of all of our equipment, you know, everything that was used in that process, and see if we can identify anything within our process that might indicate a potential nonconformity. Since you guys have already sent it out for third-party results to Arup, that kind of takes care of step number two from us, which is kind of that independent verification of, you know, is this something particular to the customer's machine or method or something more with our product? So kind of everything I'm hearing right now, it does sound like our product is manufactured at a higher than expected concentration. So I will definitely try to work with our team to see if I can push through a remake if it's not usable for you. 12:06 - Nilay Bhavsar (sonicreferencelab.com) Yeah, so I would greatly appreciate that, at least in an internal look and see if there's something that turns up in that investigation. The other thing was we did see kind of across the board for some of the other drugs as well that they were biased. So, you know, even the QC1s and 2s were kind of biased, but those didn't impact the lab as much because they weren't really outside the AMR. So they were at least still within the measurement range of the assay and acceptable for use. But we did see also for DHT the same issue that we saw for Estro and Estradiol, which is the QC3 was extrapolated above our AMR. So the mean was coming in at about 1250, which is right at our AMR, our ULOQ for that test. And the targets, I'll have to go back and look at the target, I thought the target was supposed to be 1,000. That's what I'm showing on our end, target 1,000. 13:10 - Andrew Hartmann (UTAK Laboratories) 1,000, yeah. 13:14 - Nilay Bhavsar (sonicreferencelab.com) So what we had to do is basically we had to do some additional experimentation where we had to dilute those QC3s down a bit into the AMR and reestablish the means for them. And now they're, Jamie and Amber, guys can, if you guys want to give them kind of an overview of what that process is and what we're doing to at least utilize those QCs in the assay. 13:41 - Jamie V Yeah, so right now we're doing a set dilution on each of the bottles where we're using SMX, since that's what you're creating is to kind of keep the matrix the same. So we're diluting down the QC3s with SMX to get them into an acceptable range for us so that we're able to use them currently. we're definitely having to put in more. We're into them than we would like to and kind of, I don't want to say playing with fire, but, you know, there's going to be variances from bottle to bottle. So there is, you know, risk that we've put into our process now because of the values. Yeah, definitely understand that. 14:16 - Nilay Bhavsar (sonicreferencelab.com) Yeah, we did send the DHT QCs out because we kind of felt like there was at least some circumstantial evidence that from the estrogen send out that it kind of, it lined up with the biases that we were seeing with the other data that we were seeing from the other analytes. So, yeah, we'll be happy to share mean data for the, for the drugs that, for these compounds and whatever data we've got from ARAP for the estrogen send outs. Okay. 14:52 - Andrew Hartmann (UTAK Laboratories) And as far as like, you know, desired path forward, I know you guys are having a workaround. Are you kind of wanting to just continue? With that work around until the next lot, are you looking for like a full replacement? Would you just want like a secondary product with just the analytes that are affected? What's kind of ideal solution in your mind? 15:14 - Jamie V I mean, for us, I definitely, I want it figured out before I buy my next lot. I guess that's the big part to me right now. We're kind of cruising through it. I think realistically, it makes more sense for us to kind of just burn through this lot at this point. I don't think that it needs to be necessary that we do a switch out. That's actually just going to cause more issues, I think, within our workflow, trying to get new means and everything for everything that we're running it on. But I definitely need to see some kind of documentation or potentially even maybe once the new lot is prepped, we can get it sent and tested to us prior to us, you know, just to make sure everything's right on it. I don't know how that works for you guys, but I definitely need to see something. I guess, to me, it's potentially like a calculation issue. Yeah, I'll definitely look into that. 16:02 - Andrew Hartmann (UTAK Laboratories) And I think also as a proactive step, what I want to do is have your quote updated. So the next time that you guys order, we're going to add what's called a validation sample to it. What that's going to mean is we're going to manufacture that whole product. But before we ship it to you, we're going to send you a vial of each level. That's going to give you guys an opportunity to try it out. And if there is any issues, we can kind of catch it right at that point. And then, you know, we can kind of figure out from there, can we adjust concentration? Do we need to remake it? Or, you know, what's the path forward from there? But that way, you know, we can address it before you have all of the product. 16:38 - Jamie V Yes, I think that would be an excellent kind of going forward with it. I would say one bottle of each might be kind of close, maybe two bottles of each, if you could spare that. 16:47 - Andrew Hartmann (UTAK Laboratories) We just have a lot of tests. 16:48 - Jamie V We're running like six different assays and they take quite a bit of volume. 16:56 - Andrew Hartmann (UTAK Laboratories) Do you have an idea on when you would be looking to have a new lot? We can do a count and we could probably get that information to you this afternoon of when we're looking at the next round for ordering. Perfect. Yeah, that would be helpful if we can get that plus the data of what's going on. And then I'll have our team kind of get that investigation going. We'll go ahead and get the quote updated. We'll add two validation samples for each. So we'll send you two vials of each. And then, yeah, I'm hoping they can find something, but it does occasionally happen, you know, like all the math works out on our end. You know, this thing's happened. Usually we don't see it continuing lot to lot. If it happens in the next lot, I definitely think we get a little more concerned there. But from what I'm hearing right now, it does sound more than likely it is our product. And I think our team should be able to kind of get that taken care of through our investigation. Beautiful. Yeah. 17:50 - Jamie V I mean, that's that's kind of what we're looking for is just I want, I guess, a little little security going into the next round of it. You know, they're they're quite expensive. They're very helpful to us. But if we end up having to go and manipulate. if you It's really not saving us as much as what the whole point of the process was. 18:05 - Andrew Hartmann (UTAK Laboratories) We certainly don't want you guys having to do that either. mean, that's kind of the point of getting it from us is you just saw it and use it. I'm definitely in your court on this one. 18:15 - Nilay Bhavsar (sonicreferencelab.com) Yeah, and we, you know, we took the liberty of establishing those target ranges to make sure that we were below the AMR, especially with the high-level QCs. So, yeah, it was a little bit of an eye-opener for what we saw, but we will gather all the data together for all the analytes of interest, and then we'll send the data from the external refresh laboratory your way as well, and then kind of give you an assessment of, like Amber said, the counts, and where we're projecting that we would need to, you know, place the order for a new lot. yeah. So, So, yeah. yeah. So, Just to give you a kind of a heads up, that way we can kind of focus on seeing if can remedy and rectify whatever may cause them bias. 19:10 - Andrew Hartmann (UTAK Laboratories) And now with the other two levels, are you guys seeing like a similar percentage different from target or is it, you are they closer to target? Just kind of curious, you know, as far as like expected results versus what they're receiving for these. They're still elevated. They're still a bias. 19:26 - Jamie V They're Yeah. 19:33 - Nilay Bhavsar (sonicreferencelab.com) And those levels are not giving you trouble as far as like AMR and stuff. 19:37 - Andrew Hartmann (UTAK Laboratories) The values that they're at are usable for you. Yes. Okay. Yeah. 19:44 - Nilay Bhavsar (sonicreferencelab.com) So, for example, I will tell you the QC2 for Estrone, which I believe the target was 75. 19:59 - Jamie V 75? Yeah, 75. 75, that means coming in at 105. 20:06 - Nilay Bhavsar (sonicreferencelab.com) They're still running high, just not as high as... Yeah, just on that one. 20:11 - Jamie V Once you get too low or too high on a curve, now that QC is actually unusable. So the point of our targets is to be close to our reference range is where we're trying to make decision points. So we do need them tighter than what we got. So they are, there's a very clear bias across all of them, all assays that are being put into this, Let me just one minute here to pull up some manufacturing paperwork and just give it a quick glance over and see if I can see anything that might jump out at me. 20:49 - Andrew Hartmann (UTAK Laboratories) Kind of curious to see if we made these in dilution somehow or if we made each of these batches individually because that might give us some insight. Thank you. you. Thank you. Thank you. You Of course, since I'm on a call, my system seems to be freezing up. My apologies. It seems to always know when there's somebody there. It's Monday and you're doing it. 21:20 - Nilay Bhavsar (sonicreferencelab.com) Okay. 21:38 - Andrew Hartmann (UTAK Laboratories) It does look like we made each lot individually. I'll have to have our team kind of do the official confirmation, but I'm not seeing the indications on the paperwork that I normally see when we do something in dilution. So it does at this point look like each was likely made with an individual, you know, individual spikes for all of the levels. So I'll have our team kind of do a deep dive onto this one, because we definitely want Make sure that you guys stay happy with this product. I do need that data in order to kick this off. So once I get that, I'll open that ticket. I'll also work on getting that quote updated. So whenever we're ready for the next slot, we have that, you know, ready to go and we've got those validation samples on there. Is there any other specific actions or anything you're looking that we could do to kind of further support from here? 22:24 - Jamie V I mean, from our standpoint, it's really just a thorough investigation and it not be something where it's like, oh, it's just something happened and we don't know. And then the next slot come out and do the same thing. think that's the big part. So putting in that we're going to get these prior to it would be a great first step for me, just for a little bit more reassurance prior to it. Because like I said, once we start running these, we're running quite a bit of the means for all these different assays. Each bottle goes to a different, different kind of subject in the lab. So we need to make sure that they're going to be able to be copacetic. can't run them for just three of them and not the other four. 22:58 - Andrew Hartmann (UTAK Laboratories) Right. So having that is like. 23:00 - Jamie V The big part for us is the reassurance that the amount of money we're paying to have these prep for us is going to pay off and it not be us having to go back and rework them. Yeah, definitely. 23:09 - Andrew Hartmann (UTAK Laboratories) Just to be kind of transparent about our investigation, I'm pretty certain that they're probably going to come back and say that, you know, they didn't find anything just based on our prior, you know, history of complaints and kind of what happens. It's pretty rare that we find that we made like a mistake in calculations. It's always possible because they do check like drug factors and all of that stuff. But typically, they do kind of come back and say like, hey, everything on RN looks good. But with that validation sample process, I think that's going to be our way of getting out in front of this and making sure that anything else you guys receive is fully workable. Because at that point, you can reject that sample. And then that kind of, you know, forces us into either a remake or an adjustment or something like that. Okay. 23:51 - Jamie V Yeah, I think I think I would like that the ability to just reject it, because if I had that data beforehand with this lot, I would have rejected it and sent it back to you all. Yeah, I'll take a, I'll take kind of a deep dive with our team. 24:03 - Andrew Hartmann (UTAK Laboratories) Sometimes we can offer what's called like an in-process sample. So it's done before we've actually aliquoted it out. So we basically, we make it, we keep it as a large pool, and then we send you a sample, and then that allows us, you know, the flexibility to adjust it. Yeah, prior to handling. Yeah, I'll have to see, because depending on analytes and stuff, sometimes our team's not comfortable and that kind of stuff. So I'll have to see if that, that path is there. But if they're open to that, would that be a process you guys would be interested in looking into as well? Absolutely. Anything that we can share prior would be amazing. 24:36 - Jamie V Yeah, that's fine. 24:38 - Nilay Bhavsar (sonicreferencelab.com) As long as, you know, your development team feels comfortable that they can, you know, keep it homogenized in bulk before they aliquot it out for, for, for the testing and then for, for the production use. And, you know, anything. Anything you can do after we kind of conclude this investigation, you know, anything you can do to work with us, I'm sure we can come to some sort of agreement, like, as far as maybe an additional discount on the next purchase, kind of compensate for the issues with this lot. 25:16 - Jamie V Yeah, I would say specifically if we can be refunded for the two bottles of SMX that we've now had to buy just to maintain these QCs has been, you know, that's $1,400, $1,500 extra dollars towards it. 25:28 - Andrew Hartmann (UTAK Laboratories) Yeah, that I can go ahead and just approve, so I'll put that in, and we'll just credit you guys for, you said it was two bottles of SMX? 25:36 - Jamie V Yes, so far we've used two bottles of SMX, just diluting down. Do you need any more bottles to get through the lot you currently have? Let me get the numbers, because I can tell you exactly how long it's going to take us to burn through them, and then I can get you that number for it as well, yes. Yeah, I think… So I would assume that it's probably at least another two to three bottles, because I think we're about halfway through the lot-ish. Okay. 25:58 - Andrew Hartmann (UTAK Laboratories) Yeah, I think that's… Probably going to be easier for our team to kind of digest and incorporate into our process, so I'd rather just credit what you bought, and then if you guys need another bottle or two, I can just kind of send those to you at no charge. That would be great. So, yeah, if you could let me know when you send me those results, kind of when you're going to need the new lot, and then how many, you know, additional bottles of the SMX you might need to get through that. Perfect. 26:23 - Jamie V Awesome. 26:24 - Andrew Hartmann (UTAK Laboratories) So I'm crediting now for two bottles of SMX. I'm going to get your quote updated to add the validation samples or see if we can do the in-process. And then once we get your data, we'll get that investigation started and have our quality team do a review, and then I'll let you know once we have those results as well. Awesome. I think that's the steps in the right direction, for sure. Yeah. 26:46 - Nilay Bhavsar (sonicreferencelab.com) Perfect. So, yeah, we'll get that data to you. Amber, Jamie, do you guys have anything else? 26:54 - Jamie V I mean, like I said, think definitely being able to see the QCs prior and having the authority. We're ready to reject rather than us scrambling on the backside is what we need, especially for this type of purchase. is a large, expensive purchase, so I would like to ensure that I'm not getting ourselves into more trouble than us prepping them ourselves. 27:16 - Andrew Hartmann (UTAK Laboratories) Yeah, and just kind of for your own insight, too, you know, these processes, it does kind of extend the lead time a little bit, so we're going to want to make sure that we get the order placed kind of well in advance of when you need it, because if we do, you know, manufacture it, and there is something wrong, and we have to remanufacture it, we want to make sure that, you you guys are running out of material, and we're putting you in kind of a position. So it might kind of, you know, be wise on your end to start the process a couple of weeks ahead of where you We're going to start doing it two months. 27:43 - Jamie V It's kind of where our count is right now, where we would like two months to be able to get it in, get it tested, and before we're launching it, so it would be two months prior to us running out that we would start asking for the new lot. Perfect. In our lead time right now on this one, it's going to be about 15 business days. 28:00 - Andrew Hartmann (UTAK Laboratories) Three weeks, so two months should give us more than enough time to make a batch, send you the validation samples, and worst case, make another batch and make some adjustments. Yes, I think that's fair on both ends. 28:12 - Jamie V Perfect. 28:14 - Andrew Hartmann (UTAK Laboratories) Also, any other questions, anything else I can do while you guys have me? I think that's my big stuff. 28:22 - Jamie V What about you, Nilay? You got anything? I don't have anything at the moment. 28:25 - Nilay Bhavsar (sonicreferencelab.com) We'll get that data. We'll get the counts and what the projection is when we may be starting to request the next lot. And then we'll look forward to seeing, hearing what you guys find on your end. Presumably, I think on paper, everything's probably going to check out just fine. Yeah, paperwork magically does that sometimes. Oh, we have the same issue here, too. 28:49 - Andrew Hartmann (UTAK Laboratories) I get it sometimes. 28:51 - Nilay Bhavsar (sonicreferencelab.com) Yeah, I've seen it Documentation on paper's fine, but then somebody makes a mistake. You know, they've got a number in their head that they want to spike with. It's easy for a pipette to slide to 1200. 29:05 - Andrew Hartmann (UTAK Laboratories) Yeah, we use Bluetooth pipettes, so I think they might even have a way of going back and tracing that down. think that's kind of part of what we do in our process. I'm not sure if that's fully functional yet. I know that we've been trying to get that working. There's just some difficulties in connecting it with our ERP, but I can definitely have them check into that. They have these fancy, I think it's Andrew Alliance, electronic pipettes that you can program and all that. That goes over my head. don't know all that stuff. Yeah. I just know they're pretty fancy looking. That's an audit trial right there. 29:38 - Nilay Bhavsar (sonicreferencelab.com) Yes. 29:39 - Andrew Hartmann (UTAK Laboratories) Yeah, we have very good documentation on our end, so we're going to be able to trace it down to the exact pipettes used, all of the scales used, the pumps used, all of that stuff. So our process for any kind of complaint like that is checking each of these individual equipment pieces, looking at calibration. We look if there's a trend. So we Take a look at, like, our other product complaints and say, hey, you know, is there a similar manufacturing tech or a similar, you know, pump or a pipette that was used in those? So they have a pretty good system of flagging these kinds of things, but just, you know, being transparent, it's not often that we find, like, you know, here's this exact problem or something like that. 30:19 - Jamie V Okay. 30:21 - Nilay Bhavsar (sonicreferencelab.com) Well, Andrew, thanks for the time. We'll get that data sent over to you, all that information sent over to you, and then we'll look forward to, you know, collaborating and try to see how we can move forward with the next lot. Yeah, appreciate it so much. 30:36 - Andrew Hartmann (UTAK Laboratories) Thank you for bringing this to our attention and giving us the opportunity to work with you. Yeah. And if you ever have problems with our products, reach out. 30:43 - Nilay Bhavsar (sonicreferencelab.com) couldn't connect sooner on this. We wanted to, but then I think it was what they were trying to implement the lot, Amber and Jamie, so they were tied up with that. And then I was kind of tied up with my own thing, so I had to wait until. 31:00 - Andrew Hartmann (UTAK Laboratories) Now to get that feedback to you, but no, we'll get everything started on our end, so I'll wait for your email, and then I'll probably reply back and just kind of, you know, minimize what we talked about, what the deliverables are, and then we'll go from there. Okay, that sounds great. 31:15 - Nilay Bhavsar (sonicreferencelab.com) All right. Well, I hope you enjoy next week, next Thanksgiving holiday, and we'll look forward to hearing back from you. Perfect. 31:24 - Andrew Hartmann (UTAK Laboratories) Yeah, I should definitely be in touch within a couple of days once I get your data. Okay. No. Yeah, we'll work on getting all that to you, hopefully by this afternoon or early tomorrow. 31:33 - Jamie V All right. Well, thank you so much. 31:34 - Andrew Hartmann (UTAK Laboratories) Thank you. 31:35 - Nilay Bhavsar (sonicreferencelab.com) again. Bye. 31:37 - Andrew Hartmann (UTAK Laboratories) Bye.