click here to listen to this episode:
Click Here to Listen to this Podcast
Vivian Juter Frankel 0:05
Hi, welcome to Compounding Pharmacies Podcast. This is your host Vivian Juter Frankel. We feature discussions on regulatory policy compliance and business issues specifically for the compounding pharmacy industry. The podcast covers topics related to 503As 503B’s, hospital, pharmacies, and vetinary. I hope you’ll tune into all of our discussions as you never know when and where an idea will germinate that will take your business to the next level. Welcome back to our series on Partnering for Business Growth. My guest today is from Infuserve America, a 503A. That has a division that focuses on investigational drugs, otherwise known as clinical trials. I was first introduced to this idea by some associates at a pharmaceutical company, they told me how they struggled to find 503A’s to work with due to a variety of reasons. Some are because of misconceptions on the regulatory issues. Some are due to perceived GMP standards that they think a 503A couldn’t possibly attain. So I was really looking forward to this conversation. They’ve been working in this space for years and was able to shed light on how they got into this area, and what it’s been like working on clinical trials with a variety of organizations.
Alexander Pytlarz 1:17
Hello, my name is Alexander Pytlarz, and I’m a pharmacist at Infuserve America in St. Petersburg, Florida. We are a traditional 503A compounding pharmacy doing sterile and non sterile compounding. But a big part of our business is clinical trial work. We facilitate clinical trials with sponsors with pharma companies with CROs or contract research organizations, and are involved in about 20 to 25 different clinical trials at this moment, I’m happy to share a little insight into what we do and how to get started.
Vivian Juter Frankel 1:56
Great. Alex, why don’t you tell me how you guys first got into this. I know you came in after they had already started but I’m sure you’ve heard the lore of how it began.
Alexander Pytlarz 2:07
Yeah, yeah, I did come in afterwards started Infuserve been facilitating clinical trials for almost 10 years now. And the the company got started and the division I should say of this, this business got started with clinical trials really by by luck. We had a client who we’re now now using that was looking for a nurse about 100 miles from our facility. And they called multiple people, they couldn’t find a nurse and they spoke to our owner, David Kazarian is still our owner. And he shared, okay, I can get you a nurse in an hour. And he basically did, he basically got this nurse. And that company was kind of so impressed with how quickly he was able to turn things around how quickly he was able to respond to them, that they started providing him business. And that first trial in that first client really was the foundation of who we are today by providing services to nursing organizations or contract resource to organizations that need a pharmacy to do dispensing to do storage to do shipping of drug not only in the state of Florida, but throughout the country. And we’ve kind of grown not only from from a regulatory standpoint, from an operational standpoint, from a quality standpoint, but from a client standpoint.
Vivian Juter Frankel 3:27
Alex, you mentioned working with CRO’s, I learned about this topic when I was doing events for Big Pharma, talking about manufacturing and compliance very much the same things that we talk about. So I was wondering do have a targeted market? Do you work mostly with CRO’s? Do you work with pharma or is it a mix of the two?
Alexander Pytlarz 3:49
I would say a bigger portion of our business does come from the CRO. They the industry in the clinical trial world has come up with this term and Infuserve has been participating in it for a long time but with called Virtual trials, decentralized trials, direct to patient trials and what they have what the industry has developed because of that is the spot pharma companies are now working more closely with contract research organizations CROs to facilitate those the pharma companies either don’t want to do it don’t have the bandwidth, probably a conflict of interest in controlling all that. And a lot of times if there’s nursing services that need to be involved, the CROs have created these business opportunities to be able to facilitate that. And part of that facilitation is now looking for partners. They will look for shipping partners. They will look for storage depots, they will look for pharmacies to assist in that that clinical trial.
Vivian Juter Frankel 4:51
I know that some of the hesitancies I think that 503A’s worry about is the regulatory stuff which you mentioned. Did you get have to jump through any hoops? What are the challenges? I know that 503A is supposed to be very patient specific. So if you’re only allowed to create drugs on a one to one basis, how are you able to work with these companies, and do these clinical trials or investigative drug trials?
Alexander Pytlarz 5:20
we operate as a traditional 503A. We process all of our income subjects in the in the clinical trial world, so they reprocess all of our subject prescriptions as patient specific, we will share that with any sponsor that comes to us any CRO that says, okay, we need a prescription, it might not have the the subjects name and a lot of times, and the majority of times it doesn’t, because it’s blinded, or it’s confidential, or whatnot. So we’re taking care of patients 00167, or 101102. And these subjects obviously have an identified name, but we will process a prescription that’s signed by a physician and has the prescription information on it, so we can dispense it, we put a pharmacy label on it, and we dispense it as that from from the jumping through hoops standpoint, that’s probably a little bit of a leap, sometimes for maybe new clients or maybe pharma directly. They’re not used to that. So we have to work with the other areas, we are licensed in all 50 states, including the District of Columbia. So it gives us that ability to be able to say, we’re prepared to do this, we’re prepared to assist and facilitate that, because of our regulatory and our licensure.
Vivian Juter Frankel 6:40
I’ve got a couple of questions. So when you say you’re licensed in all 50 states, does that mean that you do a mail order visit? Because you said a lot of these are virtual trials. So if they have a patient over in Maine, your license to be able to send them a prescription in Maine? It doesn’t mean you have facilities out there, right? Correct. Correct.
Alexander Pytlarz 6:59
We are one location out here in St. Petersburg, Florida, and have pharmacy licenses as any mail order compounding nationwide pharmacy would have. So we can ship to Maine. And we operate, I guess as a mail order pharmacy, if you will. And it’s very basic capacity, we get a prescription here, we’re going to process it, we’re going to fill it, we’re going to check it. And then we’re going to we’re going to ship it to Maine either on a national carrier or a courier service that works directly. These virtual direct virtual clinical trials and direct to patient clinical trials have really resulted in patients being at home. So a lot of our drugs are home delivered, but a lot of our drugs are site delivery, so we might be delivered to the clinical research site in Maine or in California or in Texas. And then the patient’s going to come into there, and they may come in there for one visit or every fourth visit or something like that.
Vivian Juter Frankel 7:56
So one of the other questions is always going to be I guess about facilities. I know when you’re doing drug batch runs and things like that you have two larger ones, you have to comply with CGMP standards. Are you guys held to those standards? Or can you still do USP 797.
Alexander Pytlarz 8:13
So I think it’s a it’s a mirror of both narrative, both. It’s a representation of both the Pharma company does not understand USP or they may not understand USP and they expect GMP. So some of the things that we do are very GMP facility is 24 seven monitor for temperature and humidity, automatic notification of excursions that go out of that automatic notification of approaching an excursion point. When receiving a drug, we follow certain CGMP processes when dispensing we follow more traditional pharmacy dispensing processes. If we have to be involved in the mixing side of it that’s an easier conversation to have with the pharma companies or CROs because they recognize that, okay, if I’m doing any kind of manipulation of a drug, then they’re going to expect 797 795 requirements. But some of the other things they are expecting a higher level of quality, if you will, within our operations.
Vivian Juter Frankel 9:15
And did you guys have to, was there adjustments that you had to make? Are we already because I know that’s like a big issue, especially again, with the 503As is conforming to CGMP standards. So if somebody is thinking about this, what would your advice be? Is it is it a big thing? Is it just once you get used to it It’s not that much. I mean, I know there’s Is there a large investment in the facilities.
Alexander Pytlarz 9:38
There’s a there is an investment, you know, large might be an inappropriate word to use because everything’s relative in terms of you know, I have we have friends and colleagues that are running larger facilities then Infuserve but there is an investment from a number of areas from a facility basic building standpoint, having the ability to receive drugs having the ability to store materials, boxes, shippers, anything like that. So having a warehouse associated with all that storage of IP, we’ve got two walk-in refrigerators and two walk-in freezers on top of the other standalone equipment that we have. So we can maintain capacity, because you might be getting 500 600 700 SKUs of one drug that you’re working with in a clinical trial. So facility setup is critical. Operational setup is important too, because quality is, is really needed. So they will come in, and they will look at that your SOPs is your procedures, your processes in what you’re doing. And so having that background of, of a quality department that can support those things that can improve on those things. And that’s probably you know, somebody would ask me how to get started. Before I would even tell them how to get started into getting the clientele, I think what’s more important is starting at the facility level at your pharmacy level, and be prepared for that. Because what’s going to happen is, if you get started without that the sponsor comes in and does a qualification visit which 95% of the time it happens, they’re gonna find areas that they may be questioning whether they should continue to work with you on that. So one of the areas that you can do is go through accreditation processes go through inspections, complete gap analysis that are above and beyond just pharmacy licensure, but some of those higher level, like pPCAB, or NABP or if you want to bring in, you know, some GMP consultants, I like to say we kind of operate a GMP light environment, because some things we’re doing very GMP and other things we’re not.
Vivian Juter Frankel 11:46
I was gonna ask you, regarding the consultants, if you’re thinking if you know, an organization is thinking of doing this, are there consultants that specialize in getting you up to speed to work in clinical trials? Or would you just bring in a GMP consultant and then kind of work with them on it.
Alexander Pytlarz 12:01
I’m not familiar with any not to say that there isn’t any out there I’m not familiar with. But if you would fall, you know, one of the things that I’ve learned and it’s been an eye opener, as a pharmacist, you know, you work in an operation as a pharmacy. And as the pharmacist, you think the most if you were if you had a rank something, the most critical step and prescription going out is making sure that pharmacist has done complete verification of that drug before it goes out, right drug, right patient, all those all those things that we as pharmacists know. And I’ve come to learn that, that in the clinical trial world, it’s that plus everything else, it was all or at the highest end at the same level, they come in and they say, Show me your security, show me your temperature monitor, show me your SOPs, and if those aren’t to that top level. And those are GMP type things, right? If you if you see a pharma company getting a 483 for poor documentation or not having the temperature area monitored, that that’s a big deal to them. And that’s a big deal to clinical trials as well.
Vivian Juter Frankel 13:10
I want to back up a little bit is, you know, we talked about talked a little bit about the investment. What percentage of your business would you say comes from clinical trials?
Alexander Pytlarz 13:19
About 50% of our business right now is clinical trials, what what you’ll find is that the staff that’s needed to support it may may not be as high and then there’s going to be some overlap. So we’ve got dedicated staff that are working on clinical trials that are doing the work. But if things require manipulation, mixing, compounding or anything like that, we’re using some of our our non clinical trial staff, just compounding technicians and compounding pharmacists to be involved in either manipulating checking those areas. So there’s a little bit of crossover that’s used there, which actually brings another important point, training is a huge, huge, important thing for these clinical trials. They want to see your training processes, your procedures, they want to see documentation of those training. And so as you start to cross that level of Okay, I’ve maybe have X amount of people working on this clinical trial day in and day out. But if I’ve got a technician now that’s involved with that, I need to make sure their training is to their level. And so now it’s not just basic pharmacy tech training, or pharmacist training. But now it’s all those other training like good clinical trials, good documentation, practices, anything related to that clinical trial world that training now involves those types of people.
Vivian Juter Frankel 14:36
So is it easier to, I’m just curious than do you just train the whole staff at the same time? Make sure everybody’s up to those standards? Or do you mostly just train your dedicated staff and then occasionally train the other people that might have crossover?
Alexander Pytlarz 14:49
Yeah, we don’t train the entire staff. You know, we’ve got areas and departments that have zero interaction with the clinical trial department and therefore don’t need that. But yeah, well We have found is a lot of the training has resulted in better training of our employees that aren’t doing even clinical trial work. So for instance, good documentation practices, right. So the importance of clear and concise and accurate information on clinical trial work is critical. And now we’ve implemented that to our technicians. So if they’re writing a date, that data needs to be written in a specific format, if they make a mistake, it has to be written in a specific format, and it’s made them better people.
Vivian Juter Frankel 15:29
I know some of the, you know, again, going back to some of the GMP struggles that the smaller pharmacies have, would you say that it sounds like what you’re saying is having that driving for the GMP is also then enhanced or helps the other side of the business?
Alexander Pytlarz 15:38
Yeah, it really has. It really you when you when you have that perspective, and you start to see some of those things and the importance that outside people put it on it, then you start to appreciate that in a good example, is the investigational process, right? So say a mistake is made the the level that is a clinical trial clients of what we do to investigate it, find out what happened, determine that there was a root cause, complete the investigation, complete a gap analysis, and ensure that whatever new measures you’ve put in place are effective, or something that a lot of 503A’s aren’t doing. But when you’ve done that, and when you put those processes in place, you realize that you’re going to always improve, you’re always everything, and nothing but good is going to come out it’s going to improve your processes. Now, what you need for that is, unfortunately, not unfortunately, fortunately, but maybe difficult info is difficult to have is the personnel behind that, right? So we’ve got three or four dedicated quality staff members, quality department members that work on these types of things, so that they’re readily available and turned around in a timely manner.
Vivian Juter Frankel 17:00
Do you have any thoughts on what you would need to do to prepare to get into the space? I know, we kind of touched on it. But I’m just wondering, there are a couple things. I’m like wondering any sort of advice or tips that you would want to give people. And the other kind of thing I would like to touch on a little bit is how do you connect with the CROs or the pharma if you’ve got any thoughts on that, for somebody who wants to get into this,
Alexander Pytlarz 17:21
kind of reiterating what I shared before as far as creating the facility and the environment, the procedures, SOPs those are things that they’re going to ask for and get into. I think another thing is, and maybe because I’m on, and I’ve actively searched and look for them, I get daily emails, or notices about meetings, or webinars or anything like that around decentralized clinical trials, or virtual clinical trials. And so I’m reading about what their expectations are, and their needs are, and learning more about it. So I think, understanding industry, as you and I both know, and the listeners, sometimes talking the talk is just as important. So when you use words that they are familiar with the builds confidence, I think an area really get started that that that is beneficial that I’ve recently learned, quite honestly, is there are a lot of local in your own town or in your own area or in your own state, clinical research sites that are occurring, or maybe doctors offices that are doing clinical research and even just reaching out and starting there to see what is needed. What are they doing, do they do they operate in this realm, can they help you with a small study and develop those things and learn those things from those kind of hands on type of activity. Universities are another good example that are places that you might be able to start and partner with. But that’s a good area where it’s local, where it’s it’s more intimate, and it’s a good learning opportunity versus the larger groups where they may have a certain level of expectation that just getting started you won’t meet. To connect in the world and I smile when you brought that up earlier and I still smile because that’s probably the areas as a you know, working in this industry now for a while sales and growth were so critical on part of my business and in the past in continues to be with here and I’ve struggled to find out how to get new clientele or to to get you know, new new trials outside of the current business that you’re working with. We get a lot of repeat business, I would say I regularly hear from the same five or six clients say hey, got a new study, hey, got a new study because they’re doing that. But where I’ve struggled is to connect with new CROs because there’s many more that I don’t work with that are out there or pharma companies in general, you know, we’ve worked with with some but not all of them and how do I connect more with there? I do a lot of calling but you know, if I read an article, if I read about a new trial, or if I’m on clinical trials.gov, if I see something that kind of is in line with what I’m doing, I’m reaching out to them and seeing if they need something and see if an opportunity gets created out of that.
Vivian Juter Frankel 20:18
Do you know if the big companies put out RFPs? Like, is there? Is that a goal to get on an RFP list? Do they do that work like that?
Alexander Pytlarz 20:26
Well, an RFP list is interesting, I’m going to actually write that down for myself to look into. But we get a lot of RFPs from our clients say, hey, create an RFP for this study. And we’re doing that, but I don’t know if there’s any kind of RFP list out there. The other area in this may be tying right into that I have not had a lot of success in but I have not put a lot of effort into it is that organizations that represented right, so there’s a decentralized clinical trial association that just got started very recently. And they’ve got all the big players in it. And so is that an area there’s the Association for clinical research organizations, so maybe maybe connecting within these Association groups getting your name and within them is an area away to to maybe they have, you know, RF RFP lists or whatever. The other thing is, there are meetings, there are meetings that you can go to or clinical trials as the main focus, and you can be a sponsor there, you can be an attendee there, you can have a booth there. And that’s always opportunistic,
Vivian Juter Frankel 21:37
right. So basically, the tried and true sales and marketing techniques, just start reaching out.
Alexander Pytlarz 21:42
Yeah, you have to go start reaching out and getting your name out there. I remember. Several months ago, we got a new client and we’re like curiosity, how did you get us? They were like we googled. I was like, Okay, I gotta be better than that.
Vivian Juter Frankel 21:58
I think that’s covers all my questions. Anything else you think people should know?
Alexander Pytlarz 22:03
No, I welcome. You know, I’ve learned from from colleagues from past mentors, that sharing is a critical part of what we do and how we can make each other stronger. And I welcome anybody that wants to discuss this more to contact me personally, and I’d be happy to, to assist and help and see where we can work together.
Vivian Juter Frankel 22:22
Great. Well, thank you very much. I really appreciate it. Thank you. Thank you for joining us today. I hope that you will join us again next week. At PharmaSalon we produce content and conferences for the compounding pharmacy industry that focuses on learning through conversation. It is our mantra that everyone’s experience is worth hearing and can benefit someone else in the industry and we are the ones to facilitate those discussions. Our next event is the compounding pharmacies grand salon. pre recorded presentations will be released on September 20. And live sessions will be October 5 through eight CE credits will be offered to both pharmacists and technicians. For more information go to www.pharmasalon.com/compounding
