Scaling Regenerative Medicine Production With PolarityBio’s Nikolai Sopko, MD, Ph.D.

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Nikolai Sopko, MD, Ph.D., chief operating officer, chief scientific officer, and director at PolarityBio, a biotech company developing SkinTE, an investigational autologous regenerative skin therapy for diabetic foot ulcers. The two discuss the challenges of scaling autologous therapy manufacturing, as well as the success PolarityBio has found in doing so through its parallel processing approach.

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Transcript

SPEAKER_00 0:16

Hello, and welcome back to Better Biopharma, the official podcast of Bioprocess Online. I'm your host, Tyler Menechello, and today I'm joined by Dr. Nikolai Sopko, Chief Operating Officer, Chief Scientific Officer, and Director at Polarity Bio, a regenerative medicine company. Dr. Sopko, thank you so much for joining me today.

SPEAKER_01 0:34

My pleasure. Thank you for having me.

SPEAKER_00 0:36

Of course. Thank you. So, real quick to get started, why don't you just give our audience a bit of background about yourself in Polarity Bio, and then we can lead into uh talking about the company's lead asset, Skin TE.

SPEAKER_01 0:50

Sure. Yeah. As you mentioned, I'm chief operating officer and chief scientific officer here at Polarity Bio. I've been with the company uh for about nine years since its inception. Um my background is I'm an MV PhD by training. Um, have a PhD in stem cell biology at the Cleveland Clinic, and that was part of a medical scientist training program funded by the NIH with my uh MV degree, which I got from Case Western Reserve University. After that, I went on to um residency training in urologic surgery at Johns Hopkins Hospital. Um, and they're obviously focused on urology. I've always been very interested in regenerative medicine and um really trying to incorporate these uh advanced cellular uh therapeutics in the practice of surgery uh in order to better treat patients. Um, through that process at residency, um, met uh a couple other individuals also interested in regenerative medicine. And um from there, the company got started, um, uh, which is Polarity Bio, where we're developing a product for skin regeneration. Um, and then after residency, um, left and have joined the company. Um, I still practice uh part-time um just for the inspiration and to be able to help people. And um, you know, it's really enjoyable, especially after 20 years of training to be able to do that. Um, but really um hyper focused on getting our first-in-class novel ethologus multicellular biologic uh approved with the FDA for our BLA, uh, which we're hoping to achieve by the end of this year.

SPEAKER_00 2:15

Yeah. Thank you so much for that, for that throw background. Uh, I think you might be the first person I've met that moonlights as a doctor on the side part-time.

SPEAKER_01 2:23

Um, I tell everyone I'm the happiest doctor in the hospital, I'm doing it because I I like it.

SPEAKER_00 2:27

So Yeah. Yeah, I like what you you said about uh you went through all this training, so you may as well you know, treat patients, right? Kind of be a what is something. Yeah. Yeah. Yeah. So Nick, you mentioned before skin TE, that autologus, regenerative cell therapy, skin graph for diabetic foot ulcers. Is that correct?

SPEAKER_01 2:46

That's correct. Yeah, our first indication is in Wagner 1, diabetic foot ulcers, um, you know, will eventually broaden to really address any uh wound, any uh wound defect. Um and how the technology works is, you know, especially with diabetic foot ulcers in these chronic wounds, you know, that by definition have been open for weeks at a time, um, is that, you know, by definition, a wound is a lack of cells. And, you know, especially when you imagine like a large burn wound or a large traumatic wound, it's really easy to see that, you know, hey, look, you know, the cells, you know, on the the healthy cells on the edge of that wound can only move so fast to cover a large surface area before things like infection, desiccation, scarring really set in. Um, and with these uh chronic wounds, which tend to be a little bit smaller, so diabetic foot ulcers are on the feet. So they're inherently going to be limited on just how big they can get. Um, but these wounds are often uh incredibly challenging to treat. Um, part of uh having uh diabetes, especially long-standing diabetes, is that patients lose the ability to feel um their feet. The nerves get impacted by the elevated blood sugars and they uh tend to die off. And so they both lose sensation. And then our feet as we walk are constantly contracting in order to be able to propel us forward and balance our feet out. And those muscles also lose their enervation. And so their foot dynamics completely change. And because of that, they actually start to rub against their shoes and develop blisters, but these patients can't feel it. Um, they're they're relatively asensate at the bottom of the foot, and then they'll develop a wound that can erode all the way down to the bone that are also very difficult to treat because of their underlying biology of their diabetes, their you know, wounds are healing on average, you know, less than half as quickly. Um, and you know, because of their altered foot mechanics, they're a they're not really able to protect those wounds as you know, you or I might be able to do so with our feet. And so these wounds will persist open and then have a high probability of getting infected. And an infected diabetic foot ulcer is the number one leading cause uh for a lower limb amputation, you know, in the world right now. And then once you have a foot amputation or a cartial amputation, you can imagine that greatly impacts the patient's quality of life. And so what we have sought out is um to develop a technology where we're leveraging skin, which is our third most regenerative uh organ in our body, and our skin's basically replacing itself at a tune of 10 million cells a day, you know, and our skin is is being replaced almost once a month. Um, and um, but being able to then take that innate regenerative ability, but really optimize it for these conditions that our body has simply not evolved to deal with. You know, we haven't evolved to deal with, you know, the chronic diabetes, uh, burn woods, traumatic wounds. Um, and so our our uh approach was, you know, we don't have to reinvent Mother Nature, we don't have to re-engineer Mother Nature, but how can we take what she's already provided and really optimize it for these really challenging wounds and these biologically bankrupt chronic wounds? And so how we do that is we get, you know, and this will kind of I think dovetail nicely into our conversation about manufacturing, is our raw material actually comes from the patient. And so the provider, you know, this is, for example, like a little stencil that we provide them, you know, it's a little ellipse, like a little football. This they'll just trace onto the patient's skin. It's about three by one centimeters, um, and they'll take a full thickness skin harvest um from the patient in a healthy area. So this isn't near the wound or anything. Um, this can be really taken anywhere. Oftentimes it's taken from, you know, the medial calf area or maybe up in the thigh or groin or abdomen. And they're taking a full thickness skin harvest. They just kind of suture that closed uh with some sutures. So, kind of like, you know, a way to practically think about it would be like getting a mole excised at a dermatology office, um, a little bit of lidocaine, you know, this is all done in the outpatient. And then that skin harvest gets shipped to our facility here in Salt Lake City. Um, and then we manufacture it to our into our product Skin TE. And then that uh comes back to the provider basically, like in a three-milliliter syringe. There's nothing in this syringe, it's just empty, but this is just our syringe that we use. Um, and it kind of looks like an oatmeal paste. And it's comprised of these multicellular units that's made from the patient's uh tissue. And they um contain um all the important stem cells and epithelial and fibroblast cells uh found in our normal skin. Um, and then that gets um put onto the wound. And, you know, as you mentioned, it's sort of like a liquid skin graft. And um, because it's an autologous therapy, which is very critical, those cells are actually able to engraft within the wound bed. So now we're directly contributing cellular material to avoid. Um, and then they're able to migrate and proliferate. Um, and additionally, they're signaling to the surrounding cells to also respond because the wound, by definition, a chronic wound, is sort of stalled. And so um our product not only providing fresh troops as we like to think of it, kind of being dropped into the middle of the wound, but they're also signaling to the exhausted troops, hey, we're here, let's let's let's pick it up and get the wound closed.

SPEAKER_00 7:40

Yeah. Thank you for that thorough explanation. Um, I think that that visual of of oatmeal is gonna stick with me for sure. That's not how I imagine it, actually, the as a as a slurry, but I mean it's an interesting descriptor, but everyone kind of can visualize it. So yeah, no, I have a clear picture of of what you described. Thank you. Um and yeah, that was the more I mean I've heard of diabetic foot ulcers before, but I hadn't heard about the actual mechanical pathology at work there. So that was thank you. That was interesting to hear.

SPEAKER_01 8:08

Incredibly common disease, it impacts you know over a million Americans a year. So it's it's the most common chronic wound. It's it's a lot more prevalent than uh oftentimes we'll think of.

SPEAKER_00 8:18

Yeah. Yeah, no, it's it's definitely great work you guys are doing, and I like the the analogy of troops you know revitalizing the the the whole team on the battlefield, so to speak, right? And fresh troops being dropped into uh to complete that mission of closing the wound. Um so in our in our earlier conversations, we talked a bit about um obviously there's a huge benefit to autologous cell therapies, the least of which being the reduced grapherous host disease. I mean, that's that's huge, and that's one of the the main points that you hear touched on, but I'm curious to hear from you because there also are challenges with autologous cell therapies, um, like sourcing. I know, especially in the CAR T space, uh the raw cells and raw material you're getting aren't always going to be top quality. I mean, they're coming from from sick patients. So do you bump into any of that? Or did you think that there are market challenges in autologous that you you contend with, or is it is it different being a skin indication?

SPEAKER_01 9:16

Yeah, I mean, I think we we, you know, I think all autologous therapy is ultimately are limited by, like you said, the the source material and the patient that they're coming from. Um, our patients um having had diabetic foot ulcers tend to be, you know, quite ill themselves, a lot of comorbidities, advanced age. Um, and so there's gonna be some inherent, you know, um limitations um in their skin than let's say a healthy, you know, young adult who doesn't have all those comorbidities. Um, you know, we know just from literature that, you know, diabetic um individuals with diabetes, their wounds, you know, heal less than you know, two times as fast as a non-diabetic patient. So there's always gonna be some of those inherent limitations. Um, you know, part of our manufacturing process um is to um address that. Um, and part of our manufacturing process is to actually sort of stimulate and activate those cells, uh kind of wake them up, if you will. Um, and then I think key in our scenario is that we're really taking that healthy skin from the patient and not, you know, uh from an area that's really impacted by their disease. So I think for other cell therapies, you know, as they're maybe looking at different organ or tissue types, you know, they'll probably have to take similar scenarios where if you're treating a disease tissue, you know, where can you get either your cell source? Maybe it's not even that direct cell tissue type. I mean, we're fortunate with skin that you have a lot of access to it. You know, it's easy to get to skin, you know, versus, you know, let's say hepatic cells or something like that, which would require more invasive harvest. Um, and so in that case, we we do have some options uh for that.

unknown 10:47

Yeah.

SPEAKER_00 10:48

Yeah, thank you. Um earlier you mentioned to me, not on this recording, but in our in our pre-call, you talked about Polarity's parallel processing approach to manufacturing. For those unfamiliar, would you mind explaining that a bit? Yeah, you mentioned how it's difficult to scale comparatively. I'm curious why that is and what factors or constraints exist in that in that type of system.

SPEAKER_01 11:09

Yeah, absolutely. And I think this is another um, you know, just reality of autologous therapies is that every single lot that we manufacture, every product that's going out the door is its own lot and it's unique to a patient. So instead of being able to make, you know, thousands of pills, let's say, or vials, you know, at a given time, um, you know, we're getting a source material in for that single patient. And um, we really have to follow that chain of custody to make sure that that tissue is being manufactured and then sent back, you know, to that physician's office to go back to that patient. Um, and um, because of that, you know, you can't scale up in the traditional, you know, um, pharma sense where, okay, instead of making a liter of product, I'm making 10 liters of product. Um, in this case, you know, we we can't really scale up in that fashion because we're only going to get that one small piece of skin from that patient for that particular application. And so instead, when you're trying to manufacture more of these lots at a given time, you're really scaling out, you know, where you're you're increasing your multiple parallel throughputs in order to manufacture all these individual lots, you know, simultaneously in a shift-like fashion. And so I think that tends to um, you know, really require more personnel. Um, our manufacturing process, you know, is is sophisticated, but um, you know, our turnaround time from time of uh skin receipt to the product going out the door is, you know, roughly about 36 hours or so, um, depending on when shipping comes and things like that. Um, and that's largely in part because um one of our aha moments was not trying to expand these cells in vitro. Um, because there's so many cell types that we incorporate into our multicellular segments, if you would really try to proliferate these cells out in vitro, you need totally different bioreactors. And then you're trying to do a recombination event. And through all that manipulation, you just lose, you know, some of the important relationships and potency to these uh cell types. And so one of our how moments was we could make these multicellular units and then get it back onto the patient's wound where their body can culture these cells themselves. Um, and so you know, that was realizing, you know what, the patient's body is going to be able to do this way better than we ever could in plastic. Um, but because of that, um, you know, we're able to do you know these multiple uh parallel processing events. And so that then requires expanding both your manufacturing personnel, your um, you know, quality assurance personnel, and your quality control personnel in order to do all those release assays testing. Because another challenging um, you know, part of itologist therapy is again, being each patient is their own lot, is that you're doing a lot more release assay testing than let's say you would if you were making a large VAT of a drug, you know, where you can make liters of a drug, you can take some of that um, you know, off to test, it's gonna get destroyed, but it's a you know, single percentage, let's say, of your entire lot that's representative of it. Um, and you can sit on that drug um until you're ready to um, you know, to until it passes all of its uh uh you know release assay testings. You know, for us, these are viable cells. We want to get these cells back onto the patient as soon as possible. So our expiration is 10 days from time of um skin excision. And so we really want to get that turnaround and get those cells back. And we're trying to keep those cells as viable as possible, where you know, time off the body is an important aspect of that. Um, and so we had to develop release assays that would meet all the regulatory requirements and CGMP requirements, um, but we're able to do with a very small amount of tissue because no matter what, when you're doing your release assay testing, you have to destroy some of your source material. And we're dealing with a precious resource. If you mess up, you know, oh, someone drops the vial on the floor, um, you know, you can't just go back to the shelf and grab some more of your um, you know, raw source material. You have to go back to a patient who has to go through another procedure to get this removed. Um, and so, you know, everyone was very much um, you know, aware of the implications of really doing things thorough, precise, and right the first time around to minimize that.

SPEAKER_00 15:14

Yeah. Yeah, I that's that's curious. You know, you made a good point. It sounds like to scale, you need to scale the number of people working in your facility, not necessarily the size of the equipment batches, which is I don't know if I've heard that before, that that paradigm there. And and you mentioned this other point I wanted to talk on, which is what you described with uh the patient cell kind of finishing the the manufacturing, as you put it earlier, uh, which I think is just it's it's amazing that we can we can rely on this to happen in medicine. And it it reminds me of something that I heard uh some time ago from Dr. Michael Hofford, who I interviewed for bioprocess online, and he he said about his philosophy of letting nature kind of guide the therapeutic development. I mean, it sounds like polarity leaned into that quite a bit. What was that was that always the case that you knew that the body would just take care of the rest? And so you kind of integrated that into the manufacturing off the top, or what did you come to that through kind of iterative design and some some failure?

SPEAKER_01 16:19

Yeah, I mean, it's it's a bit of both. Um I mean, I think we had a uh, you know, in in a deep respect for the capability of Mother Nature and the regenerative potential, especially of skin. Um, you know, when we were first really designing this product, um, we took probably a little bit more of your classic um tissue engineering approach, where we were, you know, getting into the you know smaller cell populations and in trying to do um more um in vitro propagation um and manipulation, and um which just adds a lot of complexity and what we found didn't add um a ton of value. And as we were able to see that, you know, these cells are able to do a lot of work um by them, you know, by themselves, if you will, with in conjunction with the body, um, without us having to proliferate them extensively, ex vivo, um, that for us was a lot of reassurance that you know we just have to really provide that starting spark with the right cell populations in a properly, you know, uh prepared wound bed, and that these cells have a tremendous potential to really um engraft and grow within the wound bed and and uh uh heal that wound.

SPEAKER_00 17:28

Thank you. Thank you. Um you you mentioned in our earlier call that clarity incorporates aspects of allogenaic therapies, but you said that autologous is always going to be the focus. Um in what ways would you say the company is taking inspiration from allogenaic therapies? And what are the biggest hurdles? I mean, we talked about we touched on a few with the material, raw material, starting material challenges, but what are the biggest hurdles you think autologous therapies need to clear to improve generally?

SPEAKER_01 18:03

Yeah, yeah, that's a great question. And you know, we're we're we're interested in halogenaic therapies in our current iteration of Skin TE, it is 100% autologous at this point, but we've always been interested in how we can use um potentially some allogenaic material, you know, down you know, in the future at this point. We're we're not there quite yet. We're really just you know laser focused on getting that first approval with the FDA, which is you know the most important. Um, but you know, as far as the challenges that face autologous therapies, um, you know, I think we've we've hit on a lot of them. Um, you know, it just comes down to um the source material um and you know the manufacturing controls around making your product um and in being able to address and be rigorous enough um to be a true drug product and and meet the CGMP and and you know FDA uh requirements, um, but have the flexibility to account for this this different variability in incoming tissue, um, and you know, trying to assign sort of traditional uh concepts of potency, um, you know, especially and you know, even identity to a certain extent, uh, for some of these uh complicated cellular products that are are doing more than just binding to a single receptor, um, you know, which is a lot easier to define. Um, and so for us, it's yeah, how do you define the potency of our product, right? You know, when when we know the mechanism of action is engraftment, proliferation, um, you know, as well as chemicine release. Um, and you know, that's where um having those discussions with the FDA, and and and quite frankly, we've had a lot of tremendous interactions with the FDA. They've been they've been great to work with. Um, you know, I think they're very much interested in uh therapies like ours uh to come out, especially for diseases that haven't really had innovation. There hasn't been a drug approved in chronic wounds in over 30 years, you know. Um, and so I think um they've been great to work with. And having early discussions with them, providing them the data, the rationale, and uh our experience has been that they'll work with you on getting a rigorous process uh put through. Uh, we're very fortunate that we have a very, very talented team of researchers here. I'd like the, you know, I think that they're by far the the best, hardworking, smartest uh scientists that I've ever um worked with in my whole life. And I've had the fortune of working at really great institutions. And um, we had to be creative and develop uh new potency assays that, you know, weren't really being used by other companies. And so in that scenario, the FDA is open, but are definitely going to want that rigor and data to make sure that, you know, what you are putting forth is, you know, adequate enough. Um, I think and you know, foremost in their mind is making sure that they are releasing and approving safe products and that, you know, they're not, you know, we're not taking shortcuts that that might potentially harm patients. And so for our potency assays um and our assay development, we looked at, you know, cell viability. That's a clear one. Um now that's that's you know one that's been around for quite a long time. Our product's slightly different because it's not a two-dimensional single cell suspension. Um, so you can't just do a dye exclusion test or a tripan blue, you know, and we have to do this in rapid time too. And so we looked at using some metabolic assays, um, you know, because our constructs are three-dimensional in order to assess uh potency. And then you have to do a lot of extensive experiments to then set your thresholds. You know, what, you know, okay, fine, sure, yeah, viable cells, but what's really the lowest amount of viable cells that you need in order for your product to work? And so we had to do extensive animal experiments where we're looking at, you know, uh on this curve of viability, where do we see an inflection point of wound closure? Um, and so that took an extensive amount of development. And additionally, as we mentioned, In our manufacturing process, we stimulate, we activate the cells in those multicellular segments. You know, skin, skin always has this pretty, you know, this steady state replicative uh process. That's why it's always replacing our skin. Um, but when we actually get injured, a totally different uh process occurs in this in that local area of injury changes from this homeostasis to this repair response. And we wanted to take advantage of that so that you're not just sending in sleepy troops, you're really sending in these um, you know, active troops, if you will. And so part of our uh other part of our orthogonal uh potency matrix is testing that we are uh causing this upregulation and stimulation. And again, for every cell product that that's gonna be different, you know, you need to identify what are you know these key regulatory path, you know, key sort of cellular regulatory pathways are relevant um to your cell types and to your outcomes and um being able to measure those effectively.

SPEAKER_00 22:58

Thank you. Thank you. That was that was great. I and I was gonna ask you about potency. I'm glad that you you you shared all that. Um you definitely don't want sleepy troops on the field, so it's good to have that multifaceted, that multifaceted um what you call it, orthogonal uh assay development. Are there any um I mean you mentioned working with regulators, and I'm sure that they were very helpful in focusing your scope and as you develop these assays, but are there any lessons that you learned the hard way or had to learn the hard way when it comes to release testing or assay development that um you know you might have you could go back, you would do it differently, or that you'd impart to our audience and give them advice in terms of developing their potency in release assays?

SPEAKER_01 23:44

Yeah, that's that's a great question. Um I mean it's all felt kind of hard to be honest, I'm sure. We steadily progressed, but it's you know, it's all you know, I mean, this this is a challenging field, right? Like, I mean, it's it's this isn't the easy stuff. Um and um, but um, you know, I think generally um, you know, young companies, new technologies, everyone is so eager to get this thing forward and pushing forward. And um, you know, yeah, I I think it's uh a natural tendency to want to have this done and be like, this is good enough. Um, you know, not necessarily like good enough as you're not, you know, doing all the work, but you know, thinking to yourself, this has to be you know sufficient for the FDA. And um, and they'll give you feedback whether whether they think that's the case. And we we we by no means fought it, you know, where the FDA would would give us a decision and we'd be like, no, absolutely not, you know, but we definitely a herd of companies that did do that. You know, we spoke with several companies, and it just it just doesn't seem like it's worth it. Um, you know, so um when a company is finding them the themselves in a situation, you know, where the path forward for a particular potency assay or another release assay isn't quite clear. Um, you have to do the work yourself. The FDA isn't there to, you know, you can't go to them and say, hey, what what potentate potency assay should I do? They go, No, that's your job. You know, we're here to guide you when you tell us what you want to do, but you need to do that that hard work. And so spending that time up front, really thinking about it critically, um, and you know, designing the experience and and collecting that data is worth it. Um, and you know, we found that the agency will work with you um to get those through, as long as you know you're you're taking the the right approach.

SPEAKER_00 25:33

Got it. Thank you. Thank you. Uh, before we get to the the main question of the show, the homework question, I I did want to pull a little bit more on that autologous versus allo thread because I don't want to add fuel to the fire, but it's very ongoing debate uh at most conferences and conversations I've had. And I feel like it's pretty split. You know, people are diehard aloe or they're diehard auto, and then there's this new uh growing segment of in vivo folks in the self therapy and regenerative medicine medicine space. So I'm curious if you think there will ever uh if if the industry will if you think the industry will ever effectively move past autologous uh cell therapies is the predominant type. Yes, donor or or in vivo approaches.

SPEAKER_01 26:18

Yeah, I mean it's a it's a great question. And you know, I think it's it's such a complex topic, it's hard to um to give just like sort of a yes-no, you know, answer to because it is highly contextual. I think ultimately it's gonna come down to um, you know, what's what are what are your options available? Um, I mean, look, if we could use allergen AXLs that are off the shelf, that we could really um have really consistent source material and that flexibility and control, um, we we would do that. Um, but there just really isn't that option out there for us. I think probably in other disease states, you know, those options are available. Um, in which case, yeah, aloe would be um a great use. You know, if we get to the point where we can start genetically modifying our cells, um, you know, so that, you know, there's not a rejection, you know, when especially when you're dealing with cells you want to incorporate. Sometimes you're just giving a cell therapy. Some of these cell therapies, you know, approaches, you know, the cells are really just serving as extended release um drug vehicles. You know, they're they're releasing proteins or something and they're they're sort of like that extended release mechanism for it, and they're not necessarily having to engraft. Um, you know, in those scenarios, yeah, you probably in ontologous therapy isn't necessary. But for us, where your tissue is really incorporating and becoming part of that um lasting structure, um, you're just going to be dealing with rejection. And um, you know, could you try to genetically modify these down the roads? That's possible. You know, you need a really high um uh, you know, efficiency rate of you know, transfection or transduction at that point in order to be able to manipulate all of your cell types, you know, or all your cells in your construct so that you're not having half of them reject and half and half of them not. And, you know, even if some of them are rejecting and some of them are not, rejection causes a large inflammatory cascade that can knock out all the cells, even the ones that you know aren't necessarily eliciting a rejection response. Um, so I, you know, I think I think autologous therapies are going to be around um, you know, for a while, especially for certain applications. Um, but you know, I think as um manipulation of tissues gets better, you know, or you know, there's the you know, the the swine models um that are being bred, you know, to to not elicit as much of a a rejection response that they're constantly refining, you know, those as as potential source materials um, you know, I think will become more and more important.

SPEAKER_00 28:44

Yeah. Yeah, thank you. It was uh intentionally gotcha question because it's very it's highly contextual and and I I like your uh your extended release analogy. I thought for a second you were gonna say that cell therapies are kind of like the delivery of gene therapies in a roundabout way. But no, that was a that was a great metaphor. Thank you for the explanation. Uh and now, Nick, I'm gonna ask you the question that I ask all my guests here on Better Biopharma, and that is how do you think we can better biopharma?

SPEAKER_01 29:14

Great question. Um, you know, I think biopharma is an exciting space. It continues to expand. I think our technologies get better. Um, you know, we're constantly getting smarter. I think it's a very exciting field of growth. It's taking a totally different concept of just stopping disease and really trying to reverse disease in many ways. And I think that's uh another evolution in medicine that draw me, you know, drew me towards it. Um, you know, and if in a real nuts and bolts answer, I think funding, you know, I think um we need to really promote the funding in this space, and that starts all the way, you know, at the NIH level, um, making sure that, you know, our government's funding the NIH, which is the premier, you know, biomedical research institute in the in the world. Um, and you know, how many spin outs have come out from that is probably, you know, you can't count them. Um, and then all the way to the startup and you know, beyond level, it's just, you know, it's a it's a tough market right now to raise money. I think investors, you know, everyone always wants uh a more sure and safe bet, you know, with the biggest return possible, you know, a little bit of these unicorns that don't necessarily exist. Um, and I think, you know, whatever we can do to really promote funding from that A to Z, especially that valley of death, where it's not hard to get some SBIR, you know, uh phase one, you know, seed funding, you know, up to 300 grand, let's say. And then um, and then there's just that void until you're you know really well developed where you're getting, you know, larger tranches of multiple millions of dollars. Because for a lot of these institutes, you know, small million dollar amounts and investment groups isn't really worth their effort. Um, and so I think, you know, trying to find creative ways, be it other um organizations, um nonprofit organizations, state-based, you know, you're seeing an expansion of some state-based um funding agencies to help that. Um, and you know, really looking at biotech as, you know, not just, you know, a return on investment for a drug product, which is incredibly important and, you know, a key aspect to it, but also as something that can build the local economy and region and provide really good jobs, I think, um, is an important way to consider it.

SPEAKER_00 31:26

Yeah. I couldn't agree more. Thank you so much, Nick, for joining me on this episode of Better Biopharma, the official podcast of Bioprocess Online. And thank you out there for tuning in. We'll see you next time.