Healthcare Unfiltered
Healthcare Unfiltered is an honest, raw, timely podcast tackling any and all topics in healthcare that affect stakeholders. Dr. Chadi Nabhan uses his dynamic conversational skills to challenge his guests to address controversial and important topics. He also brings on world renowned experts to discuss clinical advances in medicine.
Healthcare Unfiltered
Episode 279 - CGT in the Community: Challenges and Solutions
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Gary L. Simmons, DO, MSHA—physician and entrepreneur in a Virginia community practice—dives into the rapidly evolving world of cell and gene therapy (CGT), including bone marrow transplant, CAR-T, and TILs, and what it takes to bring these cutting-edge treatments safely into the community setting. He unpacks the operational, financial, and workforce challenges of building and scaling a CGT program outside of academia, from payer hesitancy and 340B pressures to the infrastructure and staffing required for success. The conversation also explores the future of CGT, how innovation may reshape access, and why community practices could play a critical role as demand outpaces traditional academic centers.
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Folks, welcome to Healthcare Unfiltered. This is your host, Shadi Nabhan. Thank you for joining me on today's podcast. It is year number six, season number six of Healthcare Unfiltered, and I appreciate your support and being on this podcast every Tuesday morning. Today's podcast is about cell and gene therapy and how we can really improve access of community, of these cell and gene therapies in the community. As you know, the majority of patients with cancer are treated in the community setting. In fact, many statistics would propose that 80 to 85% of patients with cancer are treated in community practices, and about 15 to 20% of patients are treated in academic practices. So, with that, cell and gene therapies, these are treatments that could be life-saving to a lot of patients. They need to be present in the community. We should be able to deliver them in the community in order for patients to get access to these therapies. But because they're very sophisticated, very complex, there are a lot of logistical and operational challenges, there are many that have questioned whether these types of therapies could be given and delivered in the community safely and effectively. So today's podcast, I host Dr. Gary Simmons, an amazing physician, entrepreneur, who really is delivering cell and gene therapy in the community, in a community practice in Virginia. But Gary's background, he was in academic practice before, before he moved to a community practice. So he has really the lens of both worlds, the world of community practice and the world of an academic institution. And he's going to share with us what it takes to build a program of cell and gene therapy in the community and what it takes to deliver these therapies effectively, safely, in a way that patients get access to potentially life-saving therapies. So thank you, Gary, for everything that you're doing, and thank you for joining me on today's podcast. Folks, you can find my podcast on all outlets, on Apple, on Spotify, pretty much everywhere you consume podcasts. Don't forget to watch all of my podcast episodes on my YouTube channel, Shadi Nabhan and Healthcare and Filter. You can follow me on Twitter and Instagram, TikTok, Facebook, and everywhere else. Also check out my books, Toxic Exposure, The True Story Behind the Monsanto Trials and the Search for Justice, and The Cancer Journey, Understanding, Diagnosis, Treatment, Recovery, and Prevention. Actually, in The Cancer Journey, I have an entire chapter on bone marrow transplant and cell therapy. I have two more books coming out in 2026. One is called AI and Cancer Care, When Machines Meet Modern Medicine. And the fourth book is a medical thriller fiction book that I won't tell you about right now, but you will know about it very soon. Well, Dr. Gary Simmons on Healthcare Unfiltered, talking cell and gene therapy in the community. It's the first timer. Dr. Gary Simmons, welcome to Healthcare Unfiltered. Really happy to have you on. Happy to be here. I can't believe I've been doing this for six years, and uh, it's the first time we actually get you on the podcast. But I'm a big fan because you're doing really amazing things in cell and gene therapy. And the topic of today's podcast is really trying to understand better what when we talk about cell and gene therapy, what we're talking about, as well as uh the challenges that we face to really get this novel technologies and therapies to patients. But first, a bit about you. Tell us a bit about you and how did you start and what got you interested in cell and gene therapy? Not a lot of people are doing this. You guys are kind of a rare commodity.
SPEAKER_00Sure. Yeah. Well, again, thanks for having me on. I'm happy to share our story and maybe uh lend some insight in from the from the battlegrounds that we're in. So uh so again, Gary Simmons, uh physician, trained in Virginia at Virginia Commonwealth University VCU. That's where I did my fellowship in oncology. And my career started out in halogenetic stem cell transplants, doing bone marrow transplant for leukemia lymphoma. This was about 2015, 2016. And at that time, uh we're doing transplants, but the FDA was starting to approve CAR T cells for um malignant hematology. And at VCU, we were the first kind of program in the country, uh, I'm sorry, the first program in the state to build a CAR T cell program. And uh the folks there, Dr. McCarty was the program director, and a lot of my colleagues there were really uh, I was really fortunate that they were like, you know, okay with me kind of taking the bull by the horns a little bit there with their mentorship and really trying to dig in and how to bring CAR T cells to VCU in Virginia. So that's kind of how I got my my mouth wet a little bit in the field of CAR T cells. And I was at VCU for about seven years, uh, doing allogenic transplants and um cellular therapy, CAR T cells, as you as you mentioned, and then transitioned to a pro uh a practice called Virginia Oncology Associates VOA, part of uh US Oncology Network. And so in 2023, I left VCU and moved to VOA, where I was hired to kind of help um you know bring CAR T cells to the community, you know, for the first time. It's really not been in the community, there's a lot of barriers there, but VOA was always very um forward-thinking, novel, uh, well-run uh physician group that that was very excited to kind of have me come and try to help uh get some stuff together to see if we can do this in the community. So long kind of segue, but started in academics, really got my feet wet, and then transitioned to the community. And I've been here now three years.
SPEAKER_01Gary, when when you were doing obviously allogenic transplant, CAR T, cell therapy, and and so on, in an academic setting, you have uh obviously a lot of resources, although you were building the program. Did you have some concerns transitioning to fairly a community practice, but you are you're doing this highly specialized type of thing that sometimes community practices are not well equipped. Tell me about that transition. Like what things did you have to check to make sure they're in existence versus things you need to build to make sure you still continue to do what you wanted to do?
SPEAKER_00Yeah, it's a good question. I think you got to kind of know. I I I kind of use a swimming pool analogy, you got to kind of know how deep the water is that you're jumping into. And so, you know, I felt good about my position with VOA because I knew VOA. VOA and VCU were about two hours apart. Um, and I knew the group here, I knew how good they were, I knew how forward-thinking they were, they were fact-accredited to do autologous stem cell transplants, so they had some infrastructure. Dr. Cross is my partner, and he was really trying uh to bring CAR T cell clinical trials here. So I knew they they they they knew what they wanted, and then I had the value of a lot of mentorship and experience in academia, and I and I did think if you had some infrastructure, we could move this to the outpatient safely. But uh, when I got here, I realized um that the delivery of cell therapy from the science and the opera in the clinical side of things is probably the easiest component. It's all these other layers that um you don't really know until you're starting to live it.
SPEAKER_01So when I think, I mean, when when we talk about cell and gene therapy, we're talking about bone marrow transplant, that's part of that. We're talking about CART cellular therapy, but also it's emerging TEL therapy, gene therapy, and so on. Maybe share with the audience, viewers and listeners, the breadth of when we talk about cell gene therapy, what are we really talking about? So at least folks can understand the breadth and the depth of this type of technology.
SPEAKER_00Sure. Yeah, so I think um, you know, when we you know, as an oncologist, uh, you know, we're historically we've used drugs, chemotherapies, radiation, surgery to treat cancer. Um, and and over time and decades, science has really evolved to sort of look at using cells, T cells, natural killer cells, other cells of the immune system to fight fight cancer. And that that research and science has been going on for a long time in the 80s at the NIH with TILS, tumor infiltrating lymphocytes, and car T cells with Dr. Carl June and and others working from the 80s and 90s. So the science and the concept of using T cells and cells to fight cancer has has been ongoing for quite some time. It's it's making, you know, kind of putting it all together. And it's now become put together for hematological malignancies. And so when we talk about cell therapy, traditionally we talk about car T cells or chimeric antigen receptors, but it is far bigger than that. It's um it's far bigger than that. It's TILS, which are tumor infiltrating lymphocytes, it's CAR T cells maybe moving in the autoimmune space, it's gene therapies replacing one gene with you know, taking a bad gene out, putting a good gene in for hemophilia or or sickle cell disease. So cellular and gene therapies are going to continue to evolve and grow and have far more implications uh than oncology.
SPEAKER_01Yeah, and and is it fair to say that there are you know more of this is gonna come down the pike? Like are you are you envisioning or maybe not? Are you envisioning that the we're gonna have new things? When I was in training, there was no CAR T or TIL, I mean, or even gene therapy. Uh I don't know, put your futuristic hat. Are we gonna see some different kind of technologies coming in?
SPEAKER_00Yeah, I do. I mean, I think with you know things like CRISPR and gene editing, I think the techno I I think the future is forward thinking of cellular therapies. Let's use a disease like multiple myeloma. You know, we're we're seeing, you know, you know, I this might be too deep for the audience, but we're we've seen, you know, clinical trials, CART-24, where, you know, people that have six lines of therapy for their multiple myeloma getting a CAR T cell, and one third of them five years later still in remission off all therapy. So I see those therapies moving way up and maybe avoiding things like stem cell transplant, and maybe people are getting CAR T cells one and done up front. Um, we've seen some data now published on using cellular uh gene therapies, excuse me, for uh high cholesterol. Uh, we've seen it for uh hemolytic anemia, we've seen it for autoimmune diseases like B cell um B cell processes like lupus and other autoimmune processes, CAR T cells could be very effective there. So the answer is yes, I do think the future is bright with these therapies, but you know, however, I worry again about the operational components of these therapies. So I think long term, yes, it's gonna be a very um common therapy, but right now I think it's still very novel. And even in the next five or even 10 years, it's going to be still, it's still difficult to implement and get these things covered, paid for, operationalized.
SPEAKER_01So let's talk about operations. That's really a perfect segue um uh to better understand, I guess, the barriers or the problems and maybe propose solutions. What are the operational issues that you face as you're trying to get these cell and gene therapy? Frankly, whether it's academia or community, you actually have great lenses into both sides.
SPEAKER_00Yeah, I think the academic side um is well equipped for it. They have you know big staff, they have uh stem cell transplant units, they have uh contracting, they have name recognition, right? Um, and so Aetna and other third-party payers are willing to work with them. They they know them, they have good rapport, they have case rates. So the academic side is kind of well positioned um to go forward, and they've been doing great with it. And and the problem though is that 85% of cancer patients are in the community, and not everybody can get access to these academic centers, and as indications increase, there will be huge constraints on the academic center's ability to keep up with volume as more indications come out. So, so I think it's very important for the community to take this on, and uh when you look at the community, there are lots of barriers. Uh, for example, I'll name I'll just name a few. You know, our site was again well positioned to start this because they had already been fact accredited. Fact is the regulatory sort of body for um stem cell transplant. Now, is fact required? No, but when you want to do CAR T cells for third-party payers, a lot of times they're asking if you're fact accredited or not. They want to know that the product is being done in a safe sort of environment. So so fact accreditation could be a bit of a barrier or not. Um, I think that's getting easier. Uh, the fact community consulting board has come out with some publications to make it a little easier to get like a like an accreditation. So, so fact accreditation, staffing. Do you have doctors in your practice that want to really commit to this cellular therapy thing and be responsible for cellular therapy 24-7 when you infuse those cells in the outpatient space because you're not under the safety net of the hospital, you're sending patients home. So you need doctors and nurses and coordinators, uh, you need payers to allow you to do it. Um, you know, there's been a lot of challenges in that because we, you know, it's not really well known to the community. So in the very beginning years here, three years ago, it was very difficult and some sometimes still is, where third-party payers will say, you know, you no, we can't do it. You got you got to send them somewhere else. And they'll ask them to travel, you know, 200, 300 miles away for a therapy that we could give right here. So, and then the reason for that is they're they don't understand that it can be done in the community. Now, we our paper will be published this week, uh, this month, excuse me, in in Frontier Oncology, which will demonstrate the ability to safely do this in the community. But um, until this stuff starts to shed uh shed light on payers, payers have still sort of allocated or requested patients to be shifted else to academic centers. Um, so there's lots of barriers there. And then let's talk about economics, right? I think economics are important. The price of these products are five, six hundred, sometimes millions of dollars in the gene therapy space. And who's gonna who's gonna cover that cost? Um, you know, if if it's a government payer, you may be underwater a little bit. Um, and so these are high risk um, you know, things to kind of take on, you know, six hundred thousand dollar products. You do 10 of those, your practice is coming up with six million dollars, and you're kind of hoping you get reimbursed fully for this. So there's a tremendous amount of barriers. And lastly, and then I'll stop talking, is is uh sometimes these patients get very sick and do need hospitalizations. And so what's your hospital situation set up? Is it close? Do you are the staff is the staff in the hospital trained? Do you trust you know that everything will go well? Can you get them into the ICU? Does the ICU understand toxicity management, things like that? So a lot of work has to be done, but it can be done, and I think that's the message.
SPEAKER_01And I want to dig deep into each of these components that you mentioned, but but I really want to highlight one critical issue you said, which is patients want to get care closer to home. And telling a patient to go 200, 300 miles away to get their care, sometimes they have to do it because it could be life or death, but it's certainly not something that is um easily done. I I I I there's no patient that would like to travel. Uh I think the there was some paper saying the average is 25, 30 miles, that's really the most that a patient wants to do that. But let's let's go through all of this. I think the first thing you mentioned is the staff. Uh you need the nurses, the farm, and so on. So when you when you came into a community practice, um what do you do? Do you do educational programs? Do you try to hire someone from academia? Like it's how do you even start to get people to become familiar? I mean, it's a it's an amazing effort what you're doing. And I want to try to give more of a glimpse into how much this, you know, what it takes to do.
SPEAKER_00Well, the first thing you do is you've got, I mean, if you want to go this kind of step by step, I mean, one of the first things you've got to do is have your, you know, we're talking about the community. Your practice needs to be full, fully supportive of this endeavor. Uh, the physician group, you know, this is a physician group-led practice. So that that that group of doctors and executives were fully committed to allow uh me to do this, but but you, you know, you need buy-in and support from that. Um, you know, if you don't have any nurses or space, you've got to kind of you know think about how to do that. And and and you know, we did have some stem cell transplant nurses. I believe we had two at the time. We were doing about 25 auto-transplants prior to my arrival. So there's some space and some some uh some nursing, but now we we've hired two more nurses, a PA, uh, a coordinator to help with financials and and getting people staffed up. Yeah, so so I think you can start with a low staff, but if you're gonna expand, you've got to build uh build your staff up to scale up your ability. And those come with big costs, and those costs will chip kind of into the practice. The practice again has to be like, you know, okay, all right, we're willing to we believe in these therapies for the future, um, and we wanna we wanna support you, so we're we're okay kind of doing this. Um, so yeah, you know, my suggestion is get a working group together, get nurses, get pharmacists, get, you know, executives, get get admin staff together, get a doctor, get a PA, get people that see things from a different lens, formal working group, and then you start to, you know, kind of chip away from that.
SPEAKER_01And it and educating and staying up to date is very critical. Let me ask you a quick question because we alluded to this a little bit, which is you know, CART, tail therapy, tumor inflating lymphocyte type of approach, and CRISPR or gene therapy. Um are the challenges the same? Logistical challenges? Are uh in other words, if you kind of solve for one, did you solve for all three, or you need to have three separate solutions?
SPEAKER_00Yeah, that's actually a very good question. Um, I think I think they're similar. Um I think they're similar. I think if you solve for one, you can solve for them all, but you've got to be able to pivot. So I'll give you an example. So we have there's you know, I forget exactly six or seven FDA-approved CAR T cell products, right? And we have all the ones that we want, okay. I think five or so. Um to and that because that's because we can now treat all the all the indicated FDA approved indications to give CAR T cells. And as we try to now want to bring tumor infiltrating lymphocytes and TILs into our practice, we are the infrastructure in the way we do CAR T cells is exactly how we would give TILS in the outpatient space. We would give chemotherapy before we get currently we give chemotherapy for three days before we give CARS, then we put the CAR T cells in, and then we monitor the patients every day for seven days, including weekends and holidays. And if there's a toxicity, we admit them to the hospital. And that is exactly the infrastructure that we will use with tumor infiltrating lymphocytes, but with tills, you give chemotherapy for a few days, you put the tills in, and then afterwards you have to give I L2 for up to six doses to grow the T cells. So that's a bit of a change compared to a car. So we would have to think about how to infuse IL2 in a certain time frame because we have that's high dose, high dose IL2? Yeah, it's uh it's a it's not the traditional high dose. I think it's 600,000 IUs. Don't quote me on the number, but I think it's 600,000 international units. Um, and it's given every eight to twelve hours up to six doses after cell infusion. So that's how you do till so it's very a little different than car, but we could use that infrastructure and just have to make some changes. Now, currently the FDA, there's no uh label to give tills in the outpatient space, it's an inpatient cell infusion, and that's a barrier for. For us. That's a barrier for a lot of folks in the community. When you mandate that cells be given into the hospital, now you as a community practice have your hands tied. You have to go to the hospital and ask permission. And you really don't have a lot of say into what hospital X does or allows. So now I've gone back to the company and iOvans, and now we're saying, you know, can we work something out? Can we do a clinical trial in the outpatient space to give these tills? So to answer your question directly, you can, I think with cellular therapies, you the the core infrastructure and how you do things can be the same, but you will have to make adjustments based on the product and what you're trying to achieve.
SPEAKER_01Yeah, that's that's that's actually really interesting to to to to look at the logistical piece. Um payers. Um I can understand, like if you wear your payer's hat, obviously you're gonna say, well, you know, I mean, I've been working with VCU or University of Virginia forever, so I can understand their hesitancy, and I'm sure you can as well. How do you how do you overcome that? Because there would be a period before you can produce data and so on. How do you get that like initial buy-in?
SPEAKER_00Yeah, that's a great question. I mean, so I I you know, when we came when I came here, you know, one of the first things we wanted to do was meet with all the payers. And some were willing to meet, and some were not willing to meet. And you try to show them that you're a real program. You know, you set up slide decks, you you show PowerPoints of your transplants in your program and your your cancer center and your hospital. You try to use your own credentials and you say, look, I've I've been doing this for you know many years at VCU. I have you know X amount of publications. Dr. My friend or my partner, Dr. Cross, similarly, and you just you got to keep trying to bang the drum with with the payers and letting them know that, you know, look, we we can do this. And then I think it's important to gather data. Uh, and you can gather data with government payers first, uh, and then you have to publish things to show. And I that's why over the last two years we've been working very hard to get our paper work uh written and published. And I'm I'm glad to see it coming out soon. Because again, you can then reference that to the payers. You can say, look, we've done 60 car T cells outpatient last year, and look at the data here. Real world data. You've got it. So to answer your question, I think it requires a lot of meeting and meeting and meeting and talking and talking. Um, you know, as you know, you know, me joining with InspireGene and working with Joe and them pushing the envelope forward for us a little bit, going to meetings, uh always just kind of banging the drum. So I think in 2027, 28, 29, 30, it becomes a lot easier for the oncology practices. But yes, it's a it's a long, arduous road in the beginning.
SPEAKER_01Are you able to share a little bit of what the paper is going to tell? By the time we air this, by the way, I'm sure the paper will be published. So you've got uh it will not be embargoed.
SPEAKER_00Yeah, sure. No, I mean I think the paper just demonstrates like it's a real-world evidence of a community, standalone community practice. This is not affiliated with a with a big healthcare system or a university or anything else. It's a community practice, uh, physician group led that has demonstrated how to build a CAR T cell program and then show how we, you know, and infuse. I think our paper publishes, I think it's 41 patients with four or five different products, uh, being uh the the Lysa cell and Axis cell and uh Brexitel and Ida cell. And at the time that was all the CAR T cells we had. So we've given all those CAR T cells and we show that our data is no different than what's been reported in the clinical trial outcomes, no safety events. And I think it helps, and then we talk a little bit about some of the barriers that we've that we've experienced. We talk about the need for these things to be in the community. Uh the American Society of TCT, ASTCT paper uh has already been published, demonstrates and shows that if you live 120 miles away from a CAR T cell program, you are 50% less likely to get it. You are more than less, more than that, less likely to get it if you're Hispanic, African American, or socioeconomic, uh lower socioeconomic status. So we know we need to build these programs for the patients that are locally right here uh in your community or in the community elsewhere. And so that's kind of what the paper talks about and some of the challenges that we've had to overcome.
SPEAKER_01Very nice and very, very timely. I want to pivot a little bit into the economics of operating this, and just because you know, in medicine, we obviously all strive to do the best for our patients. At the same time, you've got a practice and overhead and business to operate. And these are no cheap therapies. You just threw numbers, you know, between 500,000 to a million, it could be. How do you manage that from just a business perspective? Do you have to upfront all of the cost? Because I could imagine, I mean, it's not like you know, you can not every practice can have a million dollars uh uh upfront before they get paid. You may get paid, and but the cash flow piece, take me through the business aspect when you just sit down and try to make sure that you can deliver the best of care, but without going under.
SPEAKER_00Yeah, well, you may go under a little bit, you know. I think that's that's part of the problem. And I think that's where, you know, uh, you know, my discussions with payers and manufacturers. Um, you know, everyone has kind of not everyone, but a lot of people have sort of asked our advice over the last several years of like, you know, we're thinking about building this program, and and how did you guys worth it?
SPEAKER_01They will ask you, is it worth it?
SPEAKER_00Is it worth it? And you know, I think you've got to really self-analyze that question. So let's just use program X. And if I'm program X and I've got, you know, two academic centers 10 miles away from me, I'm not sure today's the right time to do that. Now, you may you may want to look at it from a different lens. You may say, you know, we're willing to be a little underwater on CAR T cells, but we're gonna retain our patients. So if they relapse, will we still have them? If we send them away and they relapse, they're gone. So there's some there's some opportunities to think through why you would still want to do a car build a CAR T cell program, even if it's not a blockbuster up front. And you might say, you know, the cell therapy in the future is rheumatoid is in rheumatology, and we've got huge room practice here that we're good with. So I think again, everyone's got to kind of self-analyze their their area and figure out what's best for them. But if you're looking about pure economics, it is very difficult to build it and sustain it. Because let's be very frank with with what it what it really is, is that the cost of the drug, let's just use an example, cost of these drugs might be $500,000 just for simple math. And then, you know, payers are difficult to allow you to do them in the community. So who can you do? You can use government payers, CMS, Medicare, Medicaid, right? And those, you know, the CMS allowable, if the cost of the drug is $500, CMS allowable might be $490. Okay, they may give you $490. So you're underwater $10,000. Every time, so when you buy that drug and you infuse that cell, you are you're down $10,000. Now you've got to also assume cost to deliver that therapy, right? You need nurses and infusion space and equipment, and even if the doctors are the practice doctors are doing it, you're not hiring doctors. These are all costs that add into the therapy. So when you add all that up, you might be down $20,000, $30,000 per car. Well, if you do 30 cars, that's a million dollars lost to the practice. Um, so that's why I think it's important that that we show the communities that can be done, that payers are willing to allow it to be done. I think you can then have potential negotiations with payers and you can work on case rates, and you can work on, you know, a lot of other avenues are opened up. But if you if and then the other thing that happens, and I don't want to be too long-winded, but the other thing that happens is what we've seen and what I've noticed is you know, every year the cost of the drug goes up nine percent, but CMS allowable will not recoup for another six months. So now you don't lose ten thousand dollars, you might lose twenty thousand dollars for Q1, Q2, Q3, and then the CMS allowable will come up, so now you're losing 10 again. So those are real, that's not exact numbers, but those are really close to what we kind of see in the community space. Now, in the non-community space, in the sort of academic world, and I'm not, you know, I'm not there right now, but uh other people can take advantage of 340B pricing, right? 340B pricing is a huge discount on the cost of the drug, and it can be given in the outpatient space and in the 340b area. And now the cost of that drug is that it's a 27% discount that that that they achieve. So very financially sustainable in that model, but in the community space, we've we've noticed some big, big, big struggles, and we've got to try to iron that out here, or else I don't see it, I don't see it moving forward easily.
SPEAKER_01Yeah, yeah, the 340B is a whole uh different thing. And I actually did a podcast on that in terms of uh the impact. It's yeah, it's an interesting program. There's you know, there are a lot of flaws, frankly, in that program as well as as you know, in terms of how the hospitals took advantage of it and so on. Um and I think it's interesting when you start putting the numbers because I was gonna ask you, you know, when you put on your business hat, do you say, look, it is the cost of delivering the best care of my patients? So I will take the margin that I will get from other types of therapies, and I'll just accept the loss here because this is really what we need to do. And I can imagine you and other community practices doing that, but I can't imagine that this is sustainable. I can imagine it being done in the short term. I struggle in imagining how this could be sustainable longer term, to be honest.
SPEAKER_00No, million, I agree a million percent. Agree. You know, I think again, you've got to kind of assess your position. I mean, uh for us here in this, what we'll call the Hampton Roads area where we deliver these therapies, there's about 2.5 million people in this area, and VOA uh is the only oncology practice here, and there's no academic center that's less than 120 miles away. So I, you know, we feel very um, we feel uh responsible to to deliver these therapies. We also feel like a few other things. I mean, I also feel pretty passionate about the field and you know, having done allogenic transplants and seeing people with really bad, you know, graph versus host disease and long-term immune suppression for you know a lymphoma. And now within two weeks we're we're you know, CAR T cells, we've got you know complete remissions and maybe curability on some of our lymphoma patients. Like, I love that stuff. And I also feel very strongly that when you have the infrastructure of the CAR T cell program, now you've opened your program up and your practice up to bringing in CAR T cell clinical trials, right? Which would generate revenue for you know, generates revenue, but there's also great practice care for you know, great care for the practice and for the patients. And then thirdly, I would say you just you really don't know the future, and I do think the future isn't cell and genes. So so I think it's important to to do it early on, especially if you're kind of in a cellular therapy island, if you will, for multiple reasons. Um, but it's got to be the right fit. It's not gonna be for every practice. I also think that the economics uh will have to work itself out, and I I think it will, it just takes time. Um, but we're we've made progress. I'll give you an example. So I won't use the name, but there was a payer who who who would not allow us to do CAR T cells for their patients, okay? And uh, you know, the long and short of it is they for two years they they would not allow anybody that came in with that payer, they they were shipped elsewhere. And uh one of my patients was sort of prominent in the community, and he he was being told he had to go um elsewhere, and he he couldn't. His wife was a nurse here, and um he just couldn't up and leave. So he wrote an incredible letter to this payer and it rippled some feathers. And since that, um we've been allowed to do the next the next two people.
SPEAKER_01Copy paste that letter and send it to all of the payers.
SPEAKER_00I know, I know. So, so the point of the story is over time, again, back to what I said earlier, as you continue just banging the drum, the drum starts to make some noise and you start to get some uh get some position. I think I won't share too deep numbers, but I in the first year we were really negative, and in year two we were break-even, and I think we'll be in a better position in year three. So there's things you can do.
SPEAKER_01Yeah, and and what you're doing is amazing. I didn't realize, Gary, actually, that I think when you put the numbers of two and a half million in a catchment area with the closest uh place is 100 miles away. I I I um I could imagine this is true responsibility, and I think what you guys are doing is amazing. Maybe my last question to you is I'm curious as you transitioned from a pure academic setting to a community practice and you're delivering academic style care to these patients. What was the thing that surprised you the most? Like what were you know, whether it's challenge, whether it's a good thing, but you know, there's there's you could always do so much research, but until you're entrenched and until you get your feet wet, uh, there are surprises that could emerge. Can you think of things that surprise you the most?
SPEAKER_00Yeah, it's a good question. I'm thinking through that a little bit. I mean, you know, I would say I was surprised by two things. One that it really is financial. A lot of this unfortunately comes down to the just the the the money of it all. And um, and that's that's just you know, in as one practice, boa is our practice, and we don't have a lot of say in what hospital systems say they can do or don't do, or payers, and it is a lot of money. I was a little surprised by that. And secondly, I was a little surprised at how hard it was to get a hold of certain payers, just to navigate the tree of them. And just I just wanted to talk to somebody and just say, listen, this guy really needs CART cells. I we can do it, we've done all these, and and and why are you asking him to go to New York City? Like, he can't do that. He's got myeloma and he's got two broken hips. Like, why can't, but I could never get that person on the phone. So I was a little surprised at how hard it was. And you know, I would I don't know if I would say how how much I was surprised, but what I will say is how much respect and appreciation I had for um my prior uh my prior institution at VCU and and how much they had uh done and how much they had going for them. And I was grateful to be part of that and how grateful I was to come to VOA and be given sort of a white canvas to kind of go about it with without many without any micromanaging, but just support. So I don't know if a lot, I don't know if I answered your question directly. Nothing really jumps out of me, but I was very um I was surprised a lot about a lot of the whole thing. Yeah, it's kind of all in your 20s.
SPEAKER_01So you did, you did. Um really congrats, Gary. I think I I I really think what you guys are doing is amazing, and what you're doing specifically is so important. I I'm always fascinated by the ability of community practices to deliver the highest, most sophisticated care to patients, no matter how complex it is. And um, and you know, it really fulfills the mission because most patients just want to stay with their doctor. So, congrats on everything you're doing. I really appreciate you coming on the show, my friend.
SPEAKER_00Thank you so much. I appreciate you.
SPEAKER_01Folks, thank you so much for joining. Thank you, Gary, for coming on the show. I appreciate everything that you are doing, and congrats on the for the patients that are under your care and they are receiving the best of care. Uh, before I let you go, folks, I want to remind you to subscribe to the show and share it with your friends and colleagues and join the conversation, have a comment on the YouTube, on just reach out to me. I would love to hear your thoughts so we could have a dialogue, because through dialogue and discussion, we can deliver the best of care to our patients. And before I let you go, I'm gonna leave you with a saying by Rumi. Let the beauty of what you love be what you do. Until next time, take care.