Darshan
Hey everyone, welcome to the DarshanTalks podcast. I'm your host, Darshan Kulkarni. It's my mission to help you trust the products you depend on. As you know, I'm an attorney. I'm a pharmacist, and I advise companies with FDA regulated products. So if you think about drugs, wonder about devices or obsessive pharmacy, this is the podcast. This is a live stream for you. I do have to specify I'm an attorney, but I'm not your attorney. I'm a lawyer, I'm a pharmacist, but I'm not your pharmacist. So this is not legal advice. This is not clinical advice. And our guest today is also a pharmacist and he's not giving you clinical advice either. We do these live streams because they're a lot of fun. I personally find myself learning something new every single time. And our guest today has been on several times before. And every time he teaches me something new. But it's always nice to know that someone's listening. So if you like what you hear, please like leave a comment or subscribe. If you want to ask our guests questions, please, please, please ask them in the comment section. We are looking for them and we do try to respond to them. If you actually like the video itself, please share the video. If you want to find me and you want to reach out to me just reach out to me on Twitter, I darsan talks or just go to our website at DarshanTalks calm. Today's live stream is going to be about pharmacy, we're going to talk a little bit about the news from the USB and from the FDA, and how all this ties into kind management ties into reactive versus proactive planning and how it all comes together. Our guest for today is a little bit of an expert isn't he? He is the Vice President of compounding compliance with gates healthcare associates, and he's a subject matter expert in compounding and therapeutics. Our guest for today is Ken spy Dell, Dr. Ken spy Dell. And and again, thank you for coming on Ken, how are you?
Ken
Very good. How are you?
Darshan
I have been well, I have been busy. It's been a few months of sheer craziness mixed with complete and total slowdown. How about you?
Ken
You know, it's a great way to describe it? Yeah. I'd say sometimes unorganized chaos, and then there's chaos. And then there's, there's, there's someone else a quiet wave, and we need that quiet as well. But yeah, certainly, you know, a lot of my my practices, it, you know, it's certainly virtual as well and more and more virtual, but I on site is where it is and where I want it to be, I think where it's most effective, because when you're assessing organizations and clients and trying to be, as you said, more proactive and not reactive, until you physically see it, you can't see a whole lot through these phones. You know, in some ways they take the phone, well, we don't want to take the phones in the cleanroom and all that kind of stuff. So yeah, so that's, that's the hard part trying to do that and trying to make it meaningful to their clients and all that so well. I'm glad you're busy. I'm glad things are moving forward. You're an amazing guy and your diversity of opinion, you diversity of skills. And I'm always kind of said that a little bit about myself as well, my clinical background and also the regulatory side of background and kind of a broader scope. And I think that's very important. Maybe that's why you and I get along so well because we can have this kind of broad, broad discussion. So as you as you have said, You're not everybody's attorney in here, but I would love to be everybody's consultant officially. So I'd love you guys to connect, connect in and work with my my organization gates healthcare associates. So if they thank you and and give them give them a heads and they'll get they'll get a hold of you and, and or text me or were sent excuse me, send me an email. So however, would love to be your subject matter expert and help you kind of through all this turbulence that's going on. And again, let's try to be more premeditated and not reactive.
Darshan
So that's that's really the question though. Right? Can I mean we're talking about being premeditated? So here's my question where we can start off by the news from USB. Could you tell us a little bit about what happened? What did what did USB kind of come out with what is USB for those people who are going Wait, what are you talking about?
Ken
Yeah, no, very good point. Good start. United States pharmacopoeia is a standard setting, organization, essentially, it's nonprofit, but they obviously need to make money on their standards and whatever. And it's been from the American College of Surgeons a years ago, you know, defining monographs and formulations and things and then it gets into This is kind of the standard for Pharmacy Practice while manufacturers use it, and they use various chapters of USP. And USB says this is the standard for this, this and this and well within the sector of compounding pharmacy, whether it's whether it's what we call 503, A, which is traditional compounding, where there's a prescriber, a pharmacy pharmacist and a patient in this, I'll call the Iron Triangle, that's 503. A, and that's traditional compound. And that's very, very important that you are compliant with those regulations. And so there's regulations in USP, specifically, it's called 795. That's a chapter. And that's the non sterile standards of practice. And then there's 797, which is the aseptic or sterile practices, as well as the USP 800. And you should be implemented soon. So back to square, the USP had had made proposals in 2019. And they said, Okay, here's we're going to propose these, these these modifications of our standards. And they, but unfortunately, Well, fortunately, it was kicked back and said, Hey, you know, there's some issues that that the stakeholders have with some of those things. And it predominantly was centered around beyond us states. So those that don't know, that's essentially the compounding way of saying it's an expiry date, but it's entirely different than what you would say a commercial products expiry date. So you say, Well, this is you don't use it beyond these that this date. Well, folks felt that in I agree, folks felt that it should be more extended. So it can actually meet the needs of the public. So the the underserved and the serve, you can have the proper, beyond the use dates, and but without affecting the quality of the preparation, and we don't call them products, we use products and company, we call them preparations. So we want to make sure that we have enough time, and the client has some time to get it, as well as utilize it safely. So it's not going to degrade and have issues. So that was kicked back. And then COVID hits and everything was slowed down, and on and on. And so just last month, the end of last month, so the end of August, they came out with their revisions, and the donlin. There's a lot of individual components, and I've done I've done my review and assessment and and sent that out to my clients. But in this is a proposal so they're waiting for stakeholder comments. So please go on. You see Darshan has the USB, please go on and make your stakeholder comments and find that say, Hey, I don't like this, or I'd like this or whatever, let them know. So make sure that you are a stakeholder in this and it's going to affect you because it will. So there's a lot of different things in here specifically what's changed is more so on a new category called category three. So they proposed in 2019, category one, and category two. And those predominantly are differences in terms of the environment and the environment. It's done on whether whether it was a an ante room, a total cleanroom facility or there is what we call a segregated area. And so the category one is segregated area category two is a cleanroom facility. Well category three has extended the UDS but it's actually closer in my opinion, it's closer to what I would say is 503 B which is more cgmp more in the manufacturing sites. It's not clearly not there. But it's kind of more because there's more requirements in regards to to the aseptic monitoring the facility monitoring environmental controls how you use for sidles and when you use sporicidal Co Op and how often you test your Bibles versus the other categories so it's much more personnel training and validation of the personnel is is is stepped up a bit batch batch size has been reduced.
Ken
And the stability and cutting essays are allowed to be used. Those essentially are assessment to see if this chemical that's in a solution or whatever it Sienna suspension is going to be stable and that stable through forced degradation and stable through container closures. It's stable and it's a pretty expensive process to get stability into Kenya sighs but when those that do and when you do, then the USB says okay if those standards are compliant with our standards, I believe it's 1225 a chapter and it says if that's done accordingly and comply with our chapter and then sterility is done testing is done. And or you do terminal sterilization. In other words, use an autoclave or dry heat oven where they say we're gonna, we're gonna allow you to have an extended beyond the use day and so that's helpful, but it's gonna have some expense. So it's the same thing. Change. You're right.
Darshan
It's a huge change. It is in many ways in the interests of patients. But do you think it raises unique issues of safety? Or do you think that the proposed the proposal addresses the potential safety issues that gray get raised?
Ken
Well, as you as you well know, I mean, even in manufacturing, even in traditional manufacturing, the things happen, and it's it, you can't, you can't eliminate everything and you Okay, you can only back to being more proactive versus reactive. And process validation, validation, validation, validation, if you can validate, do you use live and breathe validation. But the problem is, you know, there's, there's a, there's a business model, you have to meet to say, Candace, this meet this business model. So I, of course, there's a risk, of course, there's a risk to anything. But of course, there's a risk when you're in a hospital and somebody is using a traditional pharmaceutical and taking that reconstituting that and transferring and putting it into a bag, is that the bag have the right pH? Are you going to have a problem with a degradation? Did you look at the five w versus normal sailing and look at the pH of that, and of the pH necessarily affect that chemical, because one is more acidic than the other. And you've got to you can and that's traditional, and so you're just following a traditional approach. So there's a lot of factors and I I just 360s always goes through my head to say, you've got to look around this whole thing, whether it's compounding, or whether it's using traditional manufactured products, extending to be UD is, again, potentially allow the the populace to be served with some unique preparations. And some of those are somewhat orphan type of things that are just not meeting the needs. And so you have this extended bu D option, but you have to do diligence in order to get there. I think they have defined it, have they defined it, as a manufacturer has to define it? No, but I think we're getting a lot closer to it. And we're putting more provisions on. And frankly, a lot of these provisions that they have put on is nothing new to a lot of my clients, because this is where I believe we actually need to go. I think the last time we talked, I've talked about their 503 A plus kind of things jumping forward. Well, I think this is a continuation of that. I think it's extremely important that we just looked good, better, best. I don't even know what best is, but I think we've got to be much better. But trying to forecast this, and I know this is where your question is going to go in terms of trying to forecast this, you know, so much turbulence and so much, you know, and unfortunately we get into politics, and you know, and in this kind of thing, and this, this posturing of this, this, this agency with this agency with the states and all this kind of stuff, it's very, very difficult. So what I tell my clients is, let's cut through all that. Okay, let's try to forecast we can, but we can't. We work with wonderful organizations like eight APC Alliance for pharmacy, compounding and American college apothecaries, and a lot of the the support of organizations that support compounding and compound was putting a lot of effort and a lot of time and energy into this and is paying off. But we certainly don't want to lose access to providing some of these critical therapies in these therapies that are making a quality life difference in the patients. But trying to forecast this out, I tell my clients is okay, let's do what's best. Let's do what's best and try to try to afford now can we do stability and accounting essays and everything we do nonsterile whatever course now, we just don't have the financial model. If you ever done that HPLC and then you know that just the methods themselves can cost 10s of 1000s of dollars, just developing methods. So it's not necessarily realistic. But then towards that looking to see what kind of information is out there to see if we can model that in the better, the better we can be in the safer to our clients and what I call the loved ones. Somebody has a loved one we're taking care of and the loved one that we need to we need to protect. So
Darshan
which I think is interesting because Renee raises the point as you can tell, on best. Yes, I hate Good. Good is a weasel word. Why not try? Her comment goes to the point that you should aim for the best. Why not? I think you're also making the point that you've got to balance that against just the cost of doing that to get from 95 to 98 might be $50 million. I'm making up numbers I've no idea. But the but the idea is, is it worth it? And the answer is very simple to say absolutely a single human life is absolutely worth it. But the realistic cost of how do you do that in a way and still operate is what makes all the difference. When you're advising clients, when you find
Ken
a wonderful, wonderful comment, so. So, Renee, I love your comment, and I actually support your comment. I want to clarify mine. So my point, I think I said it, but when I say these things so fast, who knows? But when I say this, I don't know what best is, it's not that I don't want to be the best for my clients to be the best. Where is the bar? In other words, I like to keep this best bar up here. And we strive and strive and strive because let's say there is a best and it's defined, and we know where it is, Oh, we got there. And we're there. And yes, we put up our arms, we say yes. Can we do better? And so that's my point is, Oh, my gosh, yes, be the best. But if you look at like USP compliancy, or whatever it may be, Okay, that's good. That's good. But that's, you have to be that that's the law. If you're not, then you're probably gonna get shut down or whatever. Better is reaching above that. And again, I just don't know where that bar is, I really don't know. So good. Yeah, that's just law. That's, that's, that's law, nobody, you know, you don't want to just be there. And I think there's things you can do to be better. And I think there's things you can do to reach and reach your reach. And maybe you can define yourself as the best, I would love you to do that. And you talk about competitive advantage. I love people that actually get something tested, they send their own Certificate of analysis out to the prescribers or to the patients or whatever. Now confused, I mean, just say, Hey, we test our staff. Yeah, yeah, it's a goal. And and psychologically, yeah, there is a psychology behind in cost is the reality. And you know, even in manufacturing, manufacturing, there's not an endless and endless tap, they can just keep doing and doing and doing. So I, I think we have to be clearly efficient. But regardless, what we do, we have to be effective. And, and trying to define that is, is very tough, because then you get in, you know, clinical trials and stuff like that. So very, very hard to do. So thank you were in a very well stated.
Darshan
So I love the point Rene raises. And the question I have for you can is as we start getting into a world where we're trying to USB itself is trying to figure out what should 795 797 to 800 look like, and you're advising your clients to be proactive? How do clients respond to the idea of being proactive in that, as we just said, cost is a reality? So do they find that this is a moving target? And rather first find out where the target is going to be stationary? And then shoot at it? Or do you find that clients are going, you know what I want to I'd rather hit the moving target and then keep adjusting, depending on the final write up looks like. So where do you find yourself dealing with, with and managing client expectations? Yeah,
Ken
it all depends on where the client is coming from. And unfortunately, there are some appliances, still fairly naive to things. And different states have different requirements, whether they've enforced things or not. And as things are progressing, more states getting involved in in compliancy, towards standards or their own standards, or USP standards, whatever, it usually what it takes is a visit by a Board of Pharmacy, hopefully not the FDA that that gets these clients coming forward. If they're very naive, it's quite a shock. However, being in that world deeply for many, many, many years. It's it, you have to approach it very simply. And you have to approach it as segmentally. You say, Oh, yeah, there's 52 standard operating procedures, I need you to modify to your organization and this, this, that and then you need to implement it, you know, they freak out. And they say, this is unrealistic, I can't do it. In this model, I'm only one person, I'm only got one tech, whatever it may be. And in underserved areas and rural areas, whenever we have to understand that I actually was just talking to one this week, in an area that's underserved in the rural and they're trying to do their best the best they can. And you know, you have to try to modify and you have to document and do what I call the risk assessment. You have to do a risk assessment, say, we're doing this we're making this whether it's sterile, or non sterile, or whatever. And here's the risk assessment. And here's how we're going to mitigate that risk. And you know, those sound like big terms and whatever. And I'm not saying these aren't bright people, it's just, it's overwhelming to them. So you have to tailor it, these consultants that come in and say, hear you do this, do this and do it as I say, No, we I I'm a big fan. Have pharmacotherapeutic personalization, I think that's where compounding really has a differentiation, you can actually personalize something for specific patients, where there's genomic, whether it's whether it's a delivery system, whether it's an ingredient, whatever it may be a dosage for a dosage amount or whatever, we can personalize. And I think when you're doing subject matter, work or consulting in this world, you have to personalize it, you have to understand where their baseline there's where their knowledge is, where their resources is, and that's financial resources, where they are, and how can we best achieve it, stretching them out to be, again, quote, the best, whatever, that's gonna be hard to do. So let's get them ready. Yeah, I agree. I hate the word good. But let's let's get them to good. So let's get them compliant. And then from there than work them to better a little bit, you know, just find the area. So yeah, sometimes they overreact or they react, and they say, Oh, I can't do this. You just have to tailor it, you just have to keep tailor. It's a lot of work. It's a lot of work on my part, what I love to be able to hand them a template and say, here, here, implement this template is work together. Now everybody's got their own template, but we always have to keep our sight and vision on va. And obviously doing no harm.
Darshan
I love it. So so it's funny. I feel like Rene's statement has become sort of the theme for today's conversation. I love it. I love. What's interesting to me is you actually picked up on the good versus great piece. What I'm fascinated by the cost is reality piece. And what I'm referring to is the only way you can run a business is if you are making 100 put this a profit and doing it in a way that that makes sense. My question for you is from a compounding perspective, do you find yourself dealing more and more with with pharmacists were saying number one, you know what I want to move towards an all cash business. And compounding affords me opportunities to do that. Do you find yourself dealing with pharmacists who are, say, working against like DOJ or pharmacy board issues is going you know what, I don't want to deal with third party payers, I didn't want to deal with any of this, I just want to focus on doing the best my patients and my patients could be vet patients for all I know. And sort of adjusting to that. What is the business model like for pharmacists who are using this is an opportunity to expand, explore or just pivot their business.
Ken
It used to be there's a lot of people that came in and said you know I did maybe a road the student came in did a rotation with someone they loved and they love what they do. And then they opportunity to get some equity and say, I'd like to do my own and they still want to start it up. There's still that there's still that but however I think what what I am seeing or more is you know, I'm not saying the newbies don't come in Come in, but you've got to come in to a clear vision of the expectations on you and what the resource demand is going to be on you to do it right. But I'm dealing more with seasoned people not that I exclusively I love the new starter but with the seasoned people that say okay, I'm acquiring this business and whatever and I'm gonna acquire more. And this this because the way these standards are somewhat going is Centers of Excellence that's that I know, you know, a lot of people use that term, but I'm going to use that so people can just kind of see that the centers of excellence so you can have the resources, the personnel training as a lot of what I do. It's not just training on the regs is training on good practices, you know, aseptic practices, what does good look like I mean, your hand position critical first air, how they're cleaning, you know, if they clean, like some of them clean their homes, if you're invited in there, it's very, very important. They say okay, you don't clean like you're cleaning your home. You have to wear dwell time you have to make sure you have a sporicidal and and disinfectant and you have to write cleaner and those are in the light. So I'm getting more the season type of companies and the season companies say hey, you know, we need to position ourselves and I think that gets back into and I'm gonna, Renee, I see your comment and I'm Tom respond to it. But I want to get into the the regulation that that we're coming out with a Memorandum of Understanding by the FDA, with the state boards of pharmacy, so the FDA can have some oversight and see what's going on these compounding pharmacies, these pharmacies are shipping across state lines. And I understand that it's Interstate and you know, you I'd like to hear your response on that as well there, Shawn. But that was that was held back. So that's another thing that just recently occurred is they, they, they have suspended it for a year, and then they're going to re address it with the state boards because the state boards didn't seem quite ready for it. And so there was a certain 5% only they could send across state lines. And what if you were near a tri state area or something like that, and patients are dependent by so there was a lot of unknowns. But my point is, if you're sending across all these state lines, and you're sending this and you're the center of excellence, it makes sense to have a center of excellence that's sending out here because they have a higher with this new category of compound called category three that they've put, they have a higher standard and expectation. So to that, and I don't I don't see Rene's comment. So you can recite that back.
Darshan
So the comment is I'm startled how Matter of fact, these subjects are amongst professionals in QA, and capital is utterly ignorant of it, which I think is an interesting comment, because it's the it's the distinction between compliance and quality, and what capital is expecting at the same time. So just to be clear, just to clarify capital being venture capitalists, it could be C capitalists, or basically any kind of investor and Renae, if I got that wrong, feel free to tell me but that's what I think she's going down. So yeah, I'd love to hear your sort of response to that, because you are dealing with both mature companies and startups. And how is this playing out?
Ken
Yeah, absolutely. Yeah, as the standards kept growing, obviously, the resource allocation has to be diverted to there and do they have enough capital to do it and still still make the margins they need to make to keep the business running. And that's why I feel bad for these small organizations. Now, my point about these centers of excellence, obviously, they have economies of scale. If you can take advantage of economies of scale and say, you know, I've got more volume, maybe less margin, but I have more volume in order to sustain that, and I have resources and all this equipment you're talking about. Now with this, this category three, they're saying you have to do Bible testing every month, and you're going to bring an organization in to do your Bible error testing and all that, you're probably going to do it yourself. So you're going to have to get it back at the various sampler, then you're going to send it out you're gonna have to realize is microbials, and all these kind of things and data. So how can get capital? Yeah, there's, there's just this not this endless pool. And it's like, well, you keep doing this, this, this and this. And that's why the the newbie the starter, we've got to go and realistic now. It's the newbie, the starter may not be getting into aseptic compounding to start, maybe they want to go there when they get some level of a development of a non sterile component. But they're still that are those standards are getting tighter and harder, and what have you as well. So that may be rough talking to the newbies that may be where you can go, but do understand based on what Renee said, the capital, or what capital, you need to do this, if you have a hazardous drug, you actually have to now vent that room out, you have to have a sealed room. And you have to vent that out. And how much air conditioning are you putting in that you're kicking out 12 air changes per hour, you have to have seamless counters and things that are not going to harbor this hazard, you asked that PP, that's not going to certainly affect you, or your employees, or the caregiver or the or the user with another contaminant or something like that. So if that's all appropriate, but it costs money, you may have to get a separate hbic system, which could be 10s of 1000s of dollars, depending on the size of the facility. So yeah, I agree with your name, this imbalance of capital and quality is what are its like qualities to be here, example those here, and how do I, you know, how do I bring that up until I make me you know, start making some revenue here. And then the margins are shrinking. And so you know, so and that's why a lot of venture capitalism, people are coming in there and saying, Hey, this is a sector we believe in. And, you know, we would like to expand and we would like to grow and we would like to see how we can better serve. I think the mru was kind of a risk for a while because it was going to maybe just restrict people to individual states. So now there's a reprieve but I think ultimately, you've got a plan to say how are you going to be able to take across interstate if that mo you hits because maybe 50% is what they said was going to be the, the the top limb and you can't just do anymore 50% of your state. And well what if you want to do 60%? Well, you know, do you need to become a 503 B or whatever. So Dr. Shawn, my question to you is now we have a variety of people out here and you know You, you were one heck of a JD and your pharmacy background and all of that, what do you what do you think a 503 a should do that's, that's in the game they're playing, and they keep putting in capital, capital capital. And then you've got to some of you out there, you've got this new category three, that's having more requires for stability, indicating essays, which are very costly, more capital to invest in. So you can actually have the stability studies to show it and you have to prove sterility. What do you think? And if you think that some of these folks should make the giant leap and say I want to be a manufacturer, and I'm going to be a 503 B, and I'm going to be compliant with all of those cgmp regulations, and the FDA is going to regularly visit me.
Darshan
So So I have my perspective is very simple. My perspective is do what's in the best interest of patients. If you're a pharmacist, that's what we all went to school for. We all went to school to say, How can we do better for pharmacists? If that's true, whether you're talking on 503? a, you're talking about 503? b, or true blue manufacturing? in all three scenarios, they're just different levels of how can I do better for my patients? If you are already being held up to higher standards, or you already foresee higher standards being required? In that case? I'd say you don't why not make that that leap? Now there's a good reason why not the good reason is because I don't have the cash to pull it off right now. But assuming you can pull that cash together, assuming that's just the cost of doing business at a certain point, does it it might make sense for you to raise your bar and aim for the highest standard. And if you do that, I think it it affords opportunities not just to sell within your state but across the 50 states that that has significant advantages to you as a business that's growing So to answer your question and this is sort of reminds me of the Reddit posts where where they they asked us to sort of too long didn't read too long didn't read short version. Do it. Do it now. But But yeah, that would be my take. I have a comment here from Rene I don't know if we can get into it. We usually aim for about 1520 minutes we're already well past the 30 minute mark, but I'm gonna just put this in here if you can give a quick answer. Can I i lumped GMP cannabinoids for four years across well right actually one thing I humped GMP cannabinoids for four years across Canada why GMP is so expensive Why is pharma biotech more more valuable capital disagree? Nobody else is nobody in QA a farmer disagrees I'm not 100% sure but the point she's making but if you if you know what that's what she's going for, feel free to comment
Ken
Yeah, I think I know where she's going on it in regard to so you know the cannabinoids obviously you know Canada you know they have a different perspective than the US does it as well and it is recreational but you can't compound with with that so obviously you have to in some do but you're not supposed to in Canada and here we can obviously do that in the states and but the if you do them manufacturer then then you have the ability to do that in Canada but then you you have so much validation to do in the validation cost so much money in the terms of the pharma buyouts you Okay, you could you could you could you could acquire one and say, you know, change your line or whatever, but trying to do that, and again, whether you go the total total blue way or you actually just go into a 503 b world well, Canada doesn't have that they do have an outsourcer a perspective of that, but again, you get the cannabinoids and and those are just not approved for for manipulation the company and have that manufactured by these compounding or, excuse me, contract manufacturers. They are under the auspices and Canada of Health Canada and the United States under the FDA. But here in the united United States, it's a whole different regulation when you get into the cannabinoids and modifying the cannabinoids so I think the only way you're gonna do it in the United States is you're gonna be you're gonna have to be a manufacturer of those and trying to get that licensure is so so so hard. It's so controlled. And it's so you know, it's it's so position upon who you knew when this first came out and all that kind of thing so that it's a tough world and there's a lot of capital has to go into it. But sometimes I think what is the criteria for the manufacturer cannabinoids versus the manufacturer of pharmaceuticals? I think I think there's a whole different tier.
Darshan
I think you're right. And I think that the FDA actually came out and said they're not going going to regulate cannabinoids as dietary supplements anymore, they're going to regulate those drugs and what is the implication of a statement like that? So I think that should be interesting. But it's a whole other discussion, we should start sort of closing up because we start losing people around this time. So as you know, I'm gonna ask you four questions. The first question and we've sort of thrown that up there is how can people contact you? And I think you've sort of given the email of can that's my Dell at gates console.com Is there any other way people can reach you? Or is that Yeah, you
Ken
can call the corporate office gates gates I'm sorry go to the go to the website WWE gates, healthcare associates and contact them ask her for Dan creasy great guy and tell them what your need is and tell them you need to get a hold of me or or you need other services Just so you know, gates you know, we do DEA work we do a hospital health system work. We have a new vice president health systems unbelievable guy, he does 540 bees and you You name it, or excuse me, 340 bees, and then on and on and on. And we do a lot of work and health systems and hospitals, a septic facilities and process and all kinds of things. So we have we have people in really much every regard we have FDA people and we have great attorneys. Sorry,
Darshan
somewhere somewhere you know, where their guy next
Ken
to me on the picture. So we have great attorneys that that we can utilize that can they can help so anyway, give them a call, we can help you out. If you're interested in even talking further, just just give us a call. Give us a
Darshan
perfect next question for you. What would you like to ask the audience?
Ken
Great question. You know, anytime you attend one of the things, you You say, Well what do you want to hear about you know, and so pertaining to my subject matter expertise, whether it's, you know, and I we can't get deep into therapeutics, but if it's in the pain management compound and personalization for pain management, personalization of pharmacotherapy, individualization how to get through in certain disease states and conditions. what I call a bio, my many hormone restoration, in other words, various hormones and endocrinology and how compound can help that world and things like that, or just trying to do things better and try to formulate things better education, I do a lot of education, whatever. So if there's some niche or something you want to talk about, you think a larger audience would talk about, please let Darshan know we'll you know, we can maybe queue it up. And we could answer some of your questions.
Darshan
So I'm going to tell you the answer that I want to have have with you a discussion I want to have with you can hopefully soon. But my big question I'm dealing more and more with with clients who are trying to move away from ABMs and from third party payers and they're looking for new business models that enable that so I'm looking forward to having that conversation with you right? Yeah, at some point Yep.
Ken
And most most of the payers are clearing that out anyway form and so if she was asked early on I don't think ever answered you. It's more of a cash business in the 503 a world and B world as well. Yeah, yeah.
Darshan
So next question for you. What's something you've learned in the last month
Ken
you come up with these great little questions. Well, I learned how I really learned how to change change a diaper because you had a grant I know that wasn't where you wanted me to go but I'm going alright that's perfect that's I haven't changed a diaper in an infant for a long time and so I had my mentor was my wife and they the patient was a beautiful new grandbaby yeah yeah he's you know he's some so anyway yeah, yeah, it came back came back and back
Darshan
came back so I bicycle that poops Yeah,
Ken
yeah that not that part hasn't changed and I'm thinking I've got some serious peepee you know I got pepper mask and all these different things I think that scare the heck out of my put a pamper mask on
Darshan
but Yeah, awesome yeah doc your hazardous substances there.
Ken
Yeah, depending on what my daughter ate. Yes,
Darshan
exactly. Next question. Last question. What's something that made you happy in the last
Ken
well I'm going down that same route he was just born three weeks ago so
Darshan
Yeah, awesome. Oh, amazing.
Ken
Oh in the last week um well he you know, he came over he came over and did a little dip in the swimming pool and you know, that made me happy but what made me happy is is actually had a client had a very good good outcome with with a therapeutic suggestion we worked on and and what have you and the patient's doing very, very well. So that that always That always helps. So
Darshan
Oh, that's wonderful. To be clear, when I asked that question, I do intend that it can be a completely personal response as well. And I loved your answer. I liked it. Well, it was as always incredible to have you on. I can't wait for you to come on again next time. And stay tuned everyone. Please, please, please reach out to Ken feel free to reach out to me and we will be in touch shortly.
Ken
This is the DarshanTalks podcast, regulatory guy, irregular podcast with hosts Dr. Shaun Kulkarni. You can find the show on twitter at DarshanTalks or the show's website at DarshanTalks.com
