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How To Rule the World – Twice Over

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Darshan

Hey, everyone. So we, as you guys know, on this podcast, we land up talking a lot about the life sciences. And we talk about things that impact on life sciences, including clinical trials. today's podcast is going to be talking about what is what are clinical trials, like, from the perspective of a site, who is doing oncology? It's a multi multi location site, if you will. And we have with us, Kathleen ritardo. Kathy, I believe I know you're a pharmacist, but is it PharmD or is it RPh?

Kathleen

RPh.

Darshan

Okay. So we have Kathleen with us and Kathleen is unusually a pharmacist, which I know for me at least that for something when I was going to pharmacy school, I always wanted to ask to talk to people who've done the goi ng down that pathway of being a pharmacist and clinical research. I've never found one. And the ones that I did find really ended up being more people who mix up the drugs as opposed to people who actually administer the site. So a Kathleen is what I think of as a unicorn. So welcome, thank you. And this is my name is Darshan Kulkarni, this is Darshan talks. This is Kathleen Hurtado. Happy to introduce yourself, please.

Kathleen

So thank you, Darshan. Really nice to be here with you today. So you kind of already did it. My name is Kathleen Hurtado, and I am the VP of research administration for Cancer Treatment Centers of America. And I've had a very, you know, blessed career very varied career, but started started out as a oncology pharmacist at MD Anderson, my first job out of pharmacy school. So, and I've had lots of different things all the way around and kind of ended up serendipitously here. So

Darshan

I'm not gonna let you go that or that easily. Okay, go from pharmacy school to run your clinical research site. Because, personally, like I said, You're the unicorn. How did you even think, did you think you'd land up here?

Kathleen

Oh, no, never. I love being a pharmacist and thought that's what you know, I would, I would, you know, do for the rest of my life, but it was just very serendipitous. So I am working at MD Anderson, we, I was worked in pediatrics, and we had a lot of, you know, sales reps come and call on us. And so one of them was we I got to be, you know, friends with her. And she kept saying, Oh, you should come into sales, you should come to sales. And I was like, no way. So I'm, I'm really pretty much an introvert by nature. And so it was something I could just never see myself doing. And so at the time, they were starting, that company was starting in oncology, Salesforce. And so they were looking for people that knew oncology, oncology, pharmacist, psychology nurses, because they knew that to go out to doctors, you had to be able to speak the science speak to the science. So I thought, Well, you know what, I'm going to go interview because what's the worst possible thing that can happen? The worst possible thing that can happen is I go, I tried to do it. I don't like it. I go back to being a pharmacist. You know, I knew I could I love that. I could always go back and do that. And as it turns out, I was actually good at it. Yeah, I wish I would never ever, ever have expected. And I think I was I started out as a surprise, I started out carrying the bag. So yeah, in fact, I had a five state territory. So I had Minnesota, Iowa, Wisconsin, North and South Dakota and the Upper Peninsula of Michigan. And so yeah, and so for somebody who had never driven in snow in their entire life, it was kind of a rude awakening. And I used to scare my district manager half to death. Because I was a little bit crazy, it was like, as a company car, let's, you know, spin it and see what happens. So but, um, but it was great, because it got me out of my comfort zone. So what I learned from that was that, you know, sometimes you have to, you know, you take a risk and do something different. And I always encourage people to, you know, try try something new, like, you know, be the one that volunteers to do something in your place, if they're, they're looking for somebody even know, you know, it might be extra work or whatever you may not know, but you're not going to find out and it's actually turned out to be great for me. And I ended up going from a sales rep to a district manager to head of pharmacy relations to sales and marketing for international us. And then when I left there, I did a startup biotech, so went out and raised venture capital. And then serendipitously after doing a startup, I was a in line at the airport, getting ready to fly to Singapore to beg for more money. And I met who I met with my ultimately married my husband in line at the airport. And after we'd sold the assets to a larger biotech company, I decided, Okay, well, maybe it was time to at 45 to settle down. And so I moved to Southern California. And through all my interactions, throughout my career, I've met lots and lots of people, and I've met some doctors, and they knew me, and they said, Hey, you know, we have an opening at USC, we need somebody that you know, understands how to run this as a business. And a lot of people don't like thinking about clinical trials, as a business, it makes it sound like oh, but you know, it's, it's a dirty word. Like, it's, it's a business. And what I try to tell people is, you know, in anything that you do, you, you could be non for profit, or whatever, but if you don't make money at it, you're not going to be in it for a long time. And I don't care if you're, you know, selling lemonade on the corner, or, you know, all, you know, are drugs or clinical trials, you have to treat it as a business, or you are not going to be successful, you're not going to be able to do that. And, you know, I've never, I didn't, I don't have an MBA, I never, you know, took those kind of classes in school, I learned along the way. And I did take some classes online for myself, because I was in these positions where, you know, now you're all of a sudden having to go beg for money, you need to understand how to read a p&l and all that kind of stuff. So, again, push me out of my comfort zone, because I'm one of those people that always had to write out all the math questions, because I didn't want to rely on doing it in my head. And, but so I would say, you know, just get involved in things. And, in fact, one of the things I did when I was at the pharmaceutical company, as they always had an internship for pharmacists, in drug information and manufacturing, right, you know, snooze fest, right. So I actually started started

an internship in marketing and sales and marketing, so that so that pharmacists, students could get to see a different side of what happens in a pharmaceutical company. And I'm very proud to say that a couple of my students are now like, you know, directors and vice presidents, at pharmaceutical companies. So yeah, very gratifying. Yeah. So I don't know that they continued it after I left, because I think you need somebody that's passionate about it. And I sat on the board of my alma mater. So I was able to get those students, but I think they had a really fun time. In fact, I know after the first year, we had a ton of people that wanted to, you know, wanted to do it. And so I would say, you know, what, if you're interested, call somebody that, you know, and say, Hey, can I just come in, you know, hang out with you guys for a while to see what's going on. But don't be afraid to take some risks, which is what I did I, and I look at everything in life that way. It's like, okay, I'll do this. What's the worst possible thing that can happen? No, I don't like it. I'll go back. You know, as long as nobody gets hurt, you don't like, you know, mortgaged your house and you know, lose money or something, taking a risk. It's worth it to try something new.

Darshan

So So did you do a similar internship, when you started running that multicenter location, you just mentioned running their clinical facility? Yeah, I'm what sort of was it just was it difficult to do? Like, are you just at that point, you've done it once you knew the hurdles? Just fine. Move on to something different?

Kathleen

Yeah, actually, the way I got here is, so when I took the job at USC, so if you've ever worked in academia, you know that when new Dean's come in, new Dean's bring, you know, all of their own people most of the time. And so for the first time in my life, which was like soul crushing to me, I got laid off, and I thought about was the end of the world. And I realized, okay, this is not the end of the world. But I started consulting and with a very good friend of mine had same thing happened to her. She was at a an academic institution and got laid off, and she started a consulting business and needed some help. And so I started doing that. And cgca happened to be one of the clients. And I was interview helping them interview for somebody that was doing the work that we were doing as consultants, and I made a joke about, well, you're never gonna find anybody as good as me. And they said, you know, you're right, will you come work for us? So I, that's how I did it. And, you know, managing research, especially the administrative parts of it, it's no different doing it for one site, then for five sites. And in fact, it makes more sense, you know, when we so having the five sites to centralize all of those administrative functions, because you don't have the redundancies. In fact, one of the things that we were able to show by centralizing the administration is, you know, the budgets were much better, the startup was much faster, because you don't have, you know, somebody that doesn't know how to how to negotiate a budget or negotiate a contract doing that at the site level. You've got the extra purchase at a central level. And we did it once we have one budget one contract for all of our sites. So there's a, you know, definitely some efficiencies in that process. And so once you've done at one place, it really is transferable knowledge.

Darshan

So people always say that I mean, that was the whole point of the entire SM o model, which was we will add efficiencies. The result? I think this is why SM O's ended up getting a bad name. Was that Atlanta becoming become a bureaucracy? How did you prevent the bureaucracy?

Kathleen

So we don't get involved in the operations. So we're bookended right? So we do all the upfront. Yeah. And then we do all the back end. So all the claim adjudication and all the financial reconciliation, reconciliation, all that stuff, and then we help with it in the middle. But when you start trying to put embed your own staff, or or start dictating to a clinic or hospital, you must do these things this way. It just doesn't work. It just doesn't work. Well. And it's very hard to especially say, I mean, we just have five sites, right? But there are five different they're there in five different states, right, just trying to get, you know, kind of something standardized, it's really hard. So we just don't get into the operations. We say, okay, it's your trial. Now, either you enroll or you don't, we're going to we're going to report out the financials, we're going to give you all of that, but we can't get into the weeds in terms of how you operationalize that trial at the site. Because they have, you know, different doctors, they have different, you know, different states have different rules, some places, nurses can input orders, some places they can't, some places that have, you know, the pharmacists have to be more involved someplace they don't. So we stay out of those things. We provide all of this infrastructure and support. Now if they need somebody, we can help them find somebody. But we're not going to dictate how how things happen at the site level, train them, support them do all of that, but just not get into that weeds. And I think that was, you know, part of the issue is that if you try to go in and and start changing the processes and workflows that they've already laid out themselves, I think that there's not there's not a recipe for success.

Darshan

So if that's true, which is that's where the problems end up happening, which is people going to get all involved? How do you handle things like a sponsor audit, or a CRL? audit? Do they come to you because you have a lot of the paperwork? Or do they go to the actual site? And how does that manage?

Kathleen

Well, so they're gonna have to do a little bit of both, I mean, but we have, again, everything done electronically. So so we have that regulatory and the data are centralized. Yeah. So you know, the two most important parts, right, where in terms of an audit, because they're looking at the data, so they're looking at their EDC, they're looking at the EMR. And, and, in fact, I mean, you could say, is there a silver lining to COVID, which is kind of hard to even think about, but one of those has been that it has forced the pharmaceutical companies to do remote monitoring, which they've been very reticent to do, even though we've offered it all along. And, you know, so, so now, they and now they love it, and, and you know, their command, they, they can do it, whenever two o'clock in the morning, if that's what do if they're a night owl, or whatever, so we give them access to the EMR, they're able to go in there whenever they need to know that within a certain period of time, I mean, it's very structured in terms of the access, but they can check everything themselves, and they're done. We have all of the others, all the regulatory documents are electronic, you know, so it's very simple for them to to actually monitor the sites. Now, if when they do have a PSP are those kind of things they want to, you know, go to the site. And, again, they set that up directly with the site. And again, they're doing that all remotely Now, one of the companies has like these fancy glasses that you walk around in and everything's videotaped from the glasses, it's kind of like out of the a James Bond movie or something, but so, you know, I mean, technology's definitely helped that a lot. But, but yeah, to monitor if it now the FDA came in, they're gonna want to see that you know, the physician, and you know, meet those people directly, but a lot of the data elements and the things that they are going to just want to monitor, we would handle

Darshan

something. So so because of the unique structure you have at cgca, you've been able to get into some really interesting studies. And you and I were speaking about that just a few minutes ago. You recently were involved in a Justin time trial. You talk a little bit more about what adjustment time trial is, and what makes it unique and what makes it different, and why you guys are the right fit. For

Kathleen

sure. So just in time studies, typically they've the the manufacturers have only used the Justin time model for those trials that have been really difficult to enroll, or they're kind of add, they need like 25 more patients, right? Like, how do we get these last 25 patients in? And so they, they haven't necessarily used it for, you know, that kind of their whole portfolio of studies. And we like it, because of, you know, now with the, especially with cancer trials, the inclusion criteria that is has such specificity, especially when you're using, you know, genomics, you know, you see, okay, well, this gene is only present in 3% of patients that have this particular type of disease. So your your pool of patients is, you know, shrinks down to like hardly any. So, you win. If you were to do that, in a normal feasibility, we'd look at and say, Okay, yeah, we only show two paces across the enterprise. Well, every once a while, you might be one of those two patients. But if I'm doing this as a regular, you know, traditional trial, they probably wouldn't aboard me that trial, because we're honest. And we so we don't add like the, you know, the inflation factor, like, Oh, it's cheap. So maybe we put six on the on the feasibility, if we only saw two patients we put down that we would only ever be able to enroll two patients, because there's no sense, you know, opening something we can enroll to. So because of that, you know, you'll sometimes open these trials, and they languish, they, they're ease, they stay open, and you get nine months, 12 months and no patients, right. And that takes, even though you think, Oh, well, how much work Can it really be? Well, it is, every time there's an amendment every time you know, there's any kind of change, you still have to keep up maintenance on that study. So just in time model is you don't do anything, you don't open the trial. There's no feasibility process. When you get a patient, you fill out a form, you send it in, they say, Yep, the patient qualifies and buya. It's now all hands on deck. And so we can have a study from the time we've identified the patient, to the time that the patient is actually dosed in three weeks, less than three weeks with budget, contract, regulatory, everything completed Siv, everything done, activation, patient and chair. And we actually did that for a first hand, man, Phase One study, this trial that we just did, we've had three patients this week identified was a, it's a basket trial. So it's got it, it's based on the mutation and based on the mutation, patients get a certain type of therapy. And so serendipitously, when we had the study now, like several months, three months, and this week, we found three pages. So go figure that it all, you know, all happens, it usually happens right during the holidays. So they actually spared us this time, it was a month later. Because that normally, the last two years, we've had adjust in time trial right at the holidays, but we like it, because then we're opening a trial that we know we already have a patient, you know, patient is identified. And so it's not just opening this thing, and then having it sitting and you know, languishing so and then things get done faster, because everyone's aligned around the same goal. Because there's a patient sitting there waiting to be dosed.

Darshan

Now, here's the question, though, when you're telling the sponsor that you have a patient, are you saying that I have a patient qualifies? Are you saying your patient who actually wants the drug? Or wants to be in the study? Both? Okay, so so you're not doing? I have 100 potential patients 30 of them actually want to participate? You're saying, I have four patients, all who are interested?

Kathleen

Right? We all Yeah, we we only contact them when we because they you know, you have a it's the inclusion exclusion, but it's all there. And that we've already approached the patient. So we only send that in when we know the patient DEP definitely wants to participate. And from our perspective, they meet all the criteria, it always has to be approved by the sponsor first.

Darshan

So have you been in a situation where you spoke the patient? They were interested? And now the sponsor goes, I'm not interested? No, no. Okay, fair enough. So, so it's one of those situations that sponsors are going I'll take the patient because I need the information. And I just wonder if that's an awkward conversation. I know. That was my

Kathleen

Yeah, no, I think that they do that put it in that model. Now, it may be that the patient may not qualify, there might be some nuance about Oh, you guys, like we did have one where we read it because some of these mutational things you read these reports and and I mean, they're beyond me, right? Like it this is rearrangement, and it's an act you know, but axon 14, but it should have been in Tron 13. You're like, Oh my god, I wish I would have paid better attention during all that expose classes. But so every once in a while, even though The report like the foundation reporter, everyone, it'll say like, here's a study for this patient, when you actually get down and really into the specificity of that mutation, that genomic mutation, and I say, yeah, now this one doesn't qualify, a range of rearrangement is not a fusion or a fusion is not a rearrangement or whatever. So, but that ever that happens, just, you know, every once in a while, not often, thankfully. Oh,

Darshan

how do you handle a conversation at that end? Because the patient, obviously, at this point is going speed on one of my last options?

Kathleen

Yeah, it's difficult. It's difficult, but you know, but then we say to them, okay, well, with a couple things, we can look for another study, or we'll try to get you this drug, because of a lot of cases, you know, like, like the taper strap trial, for instance, with ASCO, although it's on it, that's on it just in time, but in a lot of cases, those drugs are already FDA approved. And so we'll say, Okay, we'll try to get you that drug. off label, we have a through our precision medicine group, we have a medic medication Acquisition Program, where we help patients, you get a drug, and we we put together the whole, you know, package that shows, you know, their foundation report, and then data that's would support the drug in that particular indication. So we will have them help them that way if we can't get them into the study.

Darshan

So I don't know if you follow the clinical trial guru, but there's a guy called danza Farah. Looking at this right now he's loving it. So thank you, Dan, for participating. To keep it going, is what he's saying. Um, the other thing that you guys have going on, based on the conversation we just had was you guys are looking at new CTMS system, a clinical trial management system, right? How has that being one of the changes been like?

Kathleen

So?

Well, one of the things I told somebody ever saying, Oh, is this the right system, I just said, Well, if you guys want me to retire early, you will get an he will have me do another CTMS implementation, because that will be my key cue to, to retirement. The CTMS itself is great. It's just, you know, when you going when you are integrating an old system into a new system, the the integration did not was not optimal. I mean, it probably in retrospect, in hindsight, it probably would have been better just to rebuild those trials in the new system, individually, as opposed to try to get all that data coming over because it it just did not that part did not go well. But we love the system itself. It is a suite of products. And so we've got the CTMS, we've got the regulatory, we're going to do e source, and it has e PE, and it's got a consent. So our next one is E source, then we go to E consent. And then we can do e PE any at any point in time, we just haven't done it yet. Because of you know, the some banking things are anyway, organizational things but but it's got that as well and very simple to implement. But it's got it can be overwhelming, because it's got so much functionality that you want to do everything at one time, right. And so you have to, especially when you've got people that love technology on your team, so to keep them like focused, alright, let's first we're going to learn how to build a study in here. And then we're going to learn how to add a patient. And then we're going to, you know, click on that completed visits. And then let's get to the scheduling and doing it for pre screening, and adding in, you know, the notes and doing all this other stuff. So, I and we found like we've been playing with reports and stuff. And I mean, you can do it in anything that you want to report on. As long as there's a data element in the system, you can pull out a report on it. So that's part of it's really cool, because I have a boss who loves reports, and, you know, pie charts, graphs or anything, you can make it so that it's all pretty she loves so it's perfect for somebody like that. So that the transition was painful. But as we're getting through there and cleaning things up, things are definitely getting much better. And it's our source of truth for everything financial. So you know, that's, we have to have it has to work.

Darshan

But when you were By the way, I have a question already from Dan. I see your question. I do. Okay, do you know the answer?

Kathleen

I don't know if I can do it in five minutes. I can try. so damn just is basically you know, how big your tumor is, what stage it is and whether or not it's metastasized, and if you got any, you know, node involvement, so it really just tells you the extent of disease for that particular tumor. And we use resist as a way to be able to standardize Measurements across all studies so that you can compare one trial to another trial to say, Okay, in this study, they use this drug from this sponsor in this study, they use this drug from this sponsor. And you can see the response rates because they were all measured using the same methodology, you know, for those radiology, radiological measurements, so it allows you to do comparisons across trials, because, you know, if you talk about if you talk to one doctor, if you look at clinical response, versus you know, resist response, they could say, Oh, yeah, the patient has stable disease. But when you actually measure the tumor with resist measurements, it could have been an increase that would have demonstrated progressive disease. So that standardization allows you to then compare, you know, patients within a study and then compare study to study, so, but it's a very specific way to measure the tumors.

Darshan

Pretty sure you made under five minutes.

Kathleen

And there we go. Hey, I'm remarkable.

Darshan

I'm gonna ask one more question. I know, we originally aim for about 1520 minutes. But I'm just curious, when you are dealing with pharmacy, is there a different engagement that you have, then when someone else has only because you've done the job that they were doing? How was that? How is that different? How's that played out?

Kathleen

So I always take care of my pharmacist. So one of the things that I'm very, you know, cognizant of is I make sure I budget really well for them. When we're talking about startup costs, and things like that, I always make sure we've got money in there for the pharmacy, I try to be very realistic about how much time it's going to take them to do things. And so again, we want to account for that in the budget. And then even in looking at feasibility, you know, I look at something and think, okay, like, we had a drug, well, we could even look at the vaccine, but we haven't we had a drug where it once it was thawed, it only had like four hour shelf life? Well, do you really want to be playing beat the clock, you know, with an investigational product, when there's a lot of things going on in a pharmacy. And so I always look at those kinds of things. And and, and I encourage the pharmacist to get out and you know, talk to the patients, if they're willing to do all the the conmed stuff, well, we build it in the budget so that it's at a rate that the pharmacist will do the con meds and not a coordinator. And so it's at a different price. But I think it's better for them. Because you know, pharmacists do this much better, they're not gonna have to go look up like a one or what this drug was used for, you know, like, why, why is this here? So? Yeah, so I try to always take care of my piece.

Darshan

No, I love it. Do you find that? So this is the question. I've always wondered if you're, if you're taking care of pharmacists, how do you actually have a relationship with them that they know that you're the one taking care of them? And how, because usually the clinical trial site is in one building, and the pharmacies in the basement of another building? I don't know how it is well, in your case is actually in different different states almost. So how does that play itself out?

Kathleen

So I have routine calls with them? Also? Yes. So we have a call, we'll talk about, you know, kind of other, you know, any issues. If there's a new study coming out, I'll make sure that, you know, okay, guys, we're gonna know about this. We build out order sets, so that we put those into the EMR so that things are ordered correctly. So we'll make sure that it'll send that out. Does anybody have any comments? We alert them? Okay, here's, here's New Order sets every year. So we're getting into that season of budgeting. So I will reach out to them like, Hey, how are you guys doing? Do you guys need a new freezer, you need to refrigerator Are you all set for, you know, USP? 100, you know, all the things that you might, you know, just to make sure that they've got the resources, you know, that they need, that they because what can sometimes happen is if I can maybe intervene on their behalf to try to, you know, get new equipment, or I can show you know, workload we can do we show kind of productivity measures. So, you know, how many monitor visits, drug shipments, you know, things like that, that can help with, you know, productivity measures. So, we come back and say, No, we really do need another pharmacists here. This is why so, you know, but we do have a standing meeting, where we just talk about issues and there's anything else coming up like the big one now is whether or not you know, all the texts, do they all need GCP training? Should they all get it? Or should there just be one or is it really necessary? Can we just try them on the on the protocol. So that's our that was a topic this last week. So

Darshan

last week, what did you guys do? And why

Kathleen

we decided no, but they did not all need to be it. Where we came out was if there is one particular tech that is involved and the studies and so they're kind of designated is that then yeah, then maybe that person that would make sense. If it's somebody that wants to again, you know, do more things, learn more remember, like getting out of the box and learning more that absolutely, you know, we'll pay for the GCP, if they want to be GCP trains, let's go for it. But if it if it's really, you know, just somebody that you know, if they're helping out, it's really the pharmacist is doing the mixing. So they're hardly ever in here, then we just say no, just on an on an as needed basis to train them on the on the particular protocol if you need to, and then we just document that. So

Darshan

very cool. I'm going to summarize what we just discussed. So we talked about your background, we then spoke about just the fact that you went from the oncology pharmacist to a sales rep, which I would never have guessed, writing all the way up to the top in, in selling a company. I couldn't tell who's a pharmaceutical company or was it boy, okay, what's a partial company, then going in and starting in clinical research, and essentially writing all the way to the top and clinical research now at your AVP cancer treatment center of America. You talk about your experience doing justifying studies, we've talked about the challenges associated with having a new CTMS system and what were the advantages of that and the disadvantages and then talk about your engagement with pharmacy didn't miss anything?

I don't think so.

Okay. If they want to reach you, Kathleen and go You know what, I need to work with Kathleen, I need to work with Cancer Treatment Centers of America because you guys do just in time studies which are tough to recruit for. How do they find you?

Kathleen

Oh, they can just get email me.

Darshan

Okay, and your email addresses.

Kathleen

Oh, Kathleen dot Hurtado at CTC a dash hope, calm.

Darshan

Perfect. This is Darshan Kulkarni with Darshan talks. And Kathleen, thank you so much. I know you did mention you're an introvert. So I appreciate you coming on. Absolutely. Wonderful. That's as good as I thought it would be.

Thank you.

Thank you.

Kathleen

All righty. Bye.

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