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Ep. 31 Zero G, Crystals and Keytruda: Space MD Builds the New Frontier of Drug Design image

Ep. 31 Zero G, Crystals and Keytruda: Space MD Builds the New Frontier of Drug Design

S1 E31 · Spark Time!
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37 Plays22 days ago

In this episode, we have a, high-energy conversation with Molly Mulligan and Ken Savin from Space MD about how space-made crystals are changing drug development on Earth. Their team grows protein crystals on the International Space Station because in zero gravity, the structures form more perfectly, revealing details that scientists can’t see on the ground. One of their first successes was Keytruda, where space-grown crystals helped refine molecular structures that shaped a blockbuster therapy. We also cover running experiments in orbit, scaling the model for everyday pharma, and what happens when microgravity becomes just another R&D tool. It’s biotech, but cosmic.

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Transcript

Introduction to Sparktime

00:00:00
Speaker
Welcome to Sparktime, where biotech's thought leaders, investors, CEOs, and industry experts break down the evolving story of life sciences. Hosted by Danny Stoltzfus and Will Riedel, two scientists and strategic communicators, we dive deep into how biotech leaders can shape the narrative, win investor confidence, and communicate breakthrough science in ways that truly resonate.
00:00:21
Speaker
From emerging trends and cutting edge technologies to what investors and partners really want to hear, we go beyond the usual echo chamber, bringing you fresh insights, unexpected perspectives, and the strategies that set biotech's top players apart.
00:00:34
Speaker
If you want to sharpen your corporate messaging, decode industry shifts, hear from voices shaping the future of biotech, and get inspired, then you're in the right place. Let's get into it.

Crystallization in Low Earth Orbit

00:00:45
Speaker
Hi everyone, in this episode we're going to explore how crystallization behaves in low Earth orbit, how flight data and return crystals translate into concrete CMC value on the ground, and why space-grown crystals may offer a durable competitive advantage for formulation teams, investors, and patients for years to come. But we're going to talk a lot about space, so I think you're going to enjoy this episode.
00:01:12
Speaker
Take a listen.

Microgravity Research with SpaceMD

00:01:17
Speaker
Today we're joined by Molly Mulligan and Ken Sabin from SpaceMD, venture biotech company and wholly owned subsidiary of Redwire Corporation, the space tech company known for pushing scientific innovation beyond the horizon.
00:01:32
Speaker
Molly's a scientist turned business development leader with deep experience in microgravity research and crystallization, including prior work at Redwire, advancing space-enabled R&D, as well as partnerships across multiple orbital disciplines.
00:01:45
Speaker
platforms. Ken brings a complimentary track record at the interface of both pharma and space with senior roles guiding space-based experiments to inform drug development and leadership at Redwire focused on in-space manufacturing and applied microgravity science.
00:02:02
Speaker
SpaceMD is using the microgravity environment aboard the International Space Station to grow superior drug crystals with the potential to improve potency, stability, and safety back on Earth.
00:02:13
Speaker
Using Redwire's pillbox technology, of the team is opening a new frontier for pharmaceutical R&D by turning space into a laboratory where molecular behavior can be observed and controlled in ways gravity does not permit.
00:02:27
Speaker
Together, Molly and Ken are building a microgravity crystallization platform that produces seed crystals designed to enhance manufacturability, solubility, and overall formulation performance within existing CMC workflows.
00:02:41
Speaker
So Molly, Ken, welcome

History of Space Crystal Growth

00:02:44
Speaker
to Sparktime. How are you today? Great. Thanks for having us. Yeah, excited to be here, Will. Fantastic. Well, I want to start with the spark. What first inspired SpaceMD to take drug development off planet?
00:02:59
Speaker
So people have been doing this, you know growing crystals or doing things in space for a while um because it's ah a whole different environment. there's You get results that you would never get on Earth.
00:03:12
Speaker
And for this particular project, sort of lineage, we trace it back to ah some early results that were done all the way back on Space Shuttle and on Mir, and even on um a on some of the early platforms where people were just trying to understand what was happening when you do things in space, and growing crystals It was kind of a natural thing to do.

Potential of Space-Grown Crystals

00:03:36
Speaker
And they saw different results, and they tried to take advantage of that. And it was back in about 2019 when a crystallographer from Merck decided to try growing crystals of a pharmaceutical product.
00:03:51
Speaker
that he was that was already developed and on the market and making a lot of money for Merck. And he got a drastically different result, one that ultimately, as it turns out, very recently has been ah led to an FDA-approved product.
00:04:05
Speaker
And back in 2019, remember ah both molly and i were at Casis. I think Molly was was there with me and I saw this result and I was like, that that's a game changer for the pharmaceutical industry. And that's what started to at least for me, took me down this path.

Redwire's Role in Biotech Innovations

00:04:24
Speaker
Yeah, I remember Ken looking at me. It was late 2018. And he just looked at me and we both looked at each other and knew that we had found something and no one else in the room understood.
00:04:37
Speaker
No one else in the room understood how exciting this was and what a game changer it was. And while at the time we weren't in a place to start SpaceMD, think it's kind of always been in the back of our mind that this was something we wanted to do together.
00:04:53
Speaker
That is so cool. And I'm honestly surprised that ah CMC advancements came from space. What a cool story. There's not many cool stories about CMC, Will. Yeah, I know. and This one's really out there.
00:05:10
Speaker
Literally. oh It's incredible. So, you know, how did Redwire get involved? and And how did their space engineering expertise evolve into this biotech spin out?
00:05:23
Speaker
Yeah, it's it's ah it's a really great question because you don't think of biotech and space as being ah two things that go together normally. um You know, Ken and i both started Redwire. I guess Ken started four years ago now and I started three and a half years ago. But I was a consultant at the time for a small company called TechShot, which was the company that originally hired Ken.
00:05:47
Speaker
And by the time Ken showed up, they had been acquired by Redwire. And I continued consulting. Shortly thereafter, they were acquired. i came over to the Redwire side and they had been working on a program called the Pharmaceutical in Space Laboratory based on um one of the previous chief scientists at TechShot's work in crystallization.
00:06:09
Speaker
And this was really the first time that anyone had thought about taking crystallization. growing crystal drug crystals in space from the purely academic exercise of looking at these crystals for form and structure to actually trying to make a quantity of crystals. And part of the motivation was what Merck had done previously with Keytruda,
00:06:31
Speaker
And Ken and I both came in and saw what Redwire was trying to do, and it's what I'd been consulting for consulting with them for, and really got excited because instead of just trying to make single crystals or a few crystals for form and structure, they were trying to create a quantity of crystals.

Tracking Crystallization in Space

00:06:47
Speaker
And not only were they trying to create a quantity of crystals or enough crystals to be used as seed crystals, but they were actually tracking the process.
00:06:56
Speaker
which is something no one else has been doing. And so you talk about, you know, there aren't a lot of advancements in CMC, but actually being able to watch the process of your crystals forming in space is really different and game-changing in space. And being able to have that allows us to understand exactly what happened in space and not just have it be a black box.
00:07:17
Speaker
Yeah, was kind of it was kind of a lucky thing because, as Molly pointed out, ah one of our predecessors had been doing bits and pieces of this. And when we arrived, we saw all the parts and said, well, can't you just sort of put these all together and then have it do this?
00:07:33
Speaker
And it was not wasn't straightforward. I don't want to make it sound like it was an easy, yeah, let's just do that. And there was there was pushback. It was going to be um an expensive investment for a company that wasn't used to making those types of investments and doing research. That's, you know, at the time, that's what we were doing is research.
00:07:53
Speaker
ah But...

Financial Support and Microgravity Benefits

00:07:54
Speaker
um We convinced them. We we got some money from ah through NASA, through a NASA grant, and from f some internal funds. And we did it. And i remember the first images that came out of it, and we showed what was happening. And everybody kind of like, okay, now we get it.
00:08:11
Speaker
You know, it makes sense. And ah they got behind it. And Ken, don't forget, we also got some money from ah the place we met, the Center for the Advancement of Science and Space. Who runs the ISS National Lab. We also got some money funding from them. Yeah, that was actually the first money we got.
00:08:28
Speaker
That was the the first funding that we got for this project. That was the second one. Was it? Yeah, it was. only because i Only because I worked on both grants the first and second. Yeah.
00:08:40
Speaker
Yeah, kind of all tell that you guys have worked together for a long time. You're like you like the husband and wife of the space crystal industry. Yeah. I can't know my mom. Oh, I love that. um Okay. So let's, I'm going to take us back to my deep, dark past when I used to have to try and grow crystals, right? And I remember you'd put them in a little vial and you put them in a dark cupboard and you'd hope no one would slam the door and you'd come back like six weeks later and maybe you had a crystal.
00:09:08
Speaker
So clearly things have moved a long way since that point. But tell me like, what is the magic of microgravity? Like how does it make this happen? And what's magic microgravity? Why is it so special? Okay.
00:09:20
Speaker
Okay. So you just described how you did it before, right? You put the yeah put them in and you put them in a cabinet and you wanted to be very delicate about it and you didn't want any perturbations. Well, ah we're trying to do the same thing.
00:09:34
Speaker
But what we have found is Even if you're really careful and you do everything on right on the ground, there are differences. things um There are effects that are caused by gravity that you cannot eliminate.
00:09:46
Speaker
they'll They'll always be there. When you go down to the bottom of the swimming pool, the pressure, you can feel it in your head or in your ears. um or when things fall, if you drop an object, it will fall to the ground.
00:10:00
Speaker
um These are effects of gravity. And when you remove that, all of a sudden, things behave differently. And what we have found is, not only do they behave differently, but you get an even quieter environment. If you do it properly in space, you remove all the perturbations that you described, and then others that are we can't eliminate on the ground.
00:10:22
Speaker
So, um what that does is, it on Earth, when you go to grow crystals like you described, generally you'll form a crystal and when it gets to a certain size, it will fall to the bottom of the flask.
00:10:33
Speaker
And that, in some ways, either ends the process or changes it. But in space, the crystals don't fall. they There's nothing you know forcing them to fall down.
00:10:43
Speaker
So they're just there, stuck there, getting bigger. And heat doesn't rise. So there are none of the thermal effects that we see on the ground in space. it um And you can you see that you can make very large, very perfect crystals ah with very delicate features that on Earth would never survive.
00:11:03
Speaker
It's a remarkable difference and one that I think is so special that even after doing this now for years, I'm still surprised when we do it. And we see things and it's it's remarkable to see. It's almost like we're we're having to learn and the science all over again. It's like a new science.
00:11:21
Speaker
But those benefits are things that we take advantage of and our systems are built to take advantage of when we run these in the microgravity environment of space. That is so cool.
00:11:33
Speaker
And I have a follow on nerd question. So how do you confirm the crystal structures? Like, is that done in space with like diffractometry or do you do that on the ground? Like, how do you, how do you know what the crystal structure you have is?
00:11:47
Speaker
we we Right now, we have to bring them back down to the ground. we We can see, we have a microscope, so you can see in there, but that doesn't really tell you the crystal structure. it just tells you that you made a crystal and you can see what is referred to as its habit, like what it looks like on the macro scale.
00:12:02
Speaker
But how the molecules or atoms all line up in the matrix, you have to do that using spectroscopy. So we can use a Raman spectrometer, which we have on the ground.
00:12:14
Speaker
or you do X-ray diffraction. But those are technologies that right now we only have on the ground. We don't have them in space yet. What you really lead to is the fact that certain molecules can form different forms. So they can sort of stack upon themselves in different ways.
00:12:33
Speaker
It's the same chemical, but the way the crystal forms is different. And that can have a significant impact on the performance of that material, whether it be for an agricultural compound or some crystal for semiconductors or for a pharmaceutical.

Revolutionizing Drug Development in Space

00:12:52
Speaker
So we try to take advantage of that. We try to essentially take products that maybe have already gone to market and are very successful, but had an issue with the way they were manufactured or the way they um were dosed.
00:13:06
Speaker
And by making a new form, we're hoping to essentially... breathe new life and new opportunity into those same already proven molecules. Again, it would behave in many ways the same, but in others it would be different. It would act as a different material and allow other opportunities that the original could not ah perform.
00:13:29
Speaker
And Ken, I just want to highlight something, you know, about that and about how we're how we're going back a little, analyzing results in space, if you will, where we're we're just taking pictures. I think one of the most interesting things we saw in our first, I think it was within our first two flights, we flew glycine. it's ah It's a small molecule. It's a common amino acid, really an academic molecule.
00:13:53
Speaker
endeavor for us, but we did it because on the ground, um, we got two of the three form known forms of glycine. And then when we flew it to space and we took videos, we actually got the third form, which is a needle, a long needle-like form of the crystal.
00:14:09
Speaker
But by the time we had returned it to Earth, it had all converted to the other two forms that kind of look like diamonds and boulders, if you will. So it was really interesting to see that we had actually formed a different crystal in space and it had transitioned. And now it's a known transition. But had we not actually taken the video, we never would have learned this.
00:14:30
Speaker
And no since no one had been taking video or taking images even, aside from a few one-off cases prior to this point, we don't know that there aren't other crystals that you know people published, hey, we got the same result in the grant and in the ground and in space.
00:14:46
Speaker
And maybe they didn't, and they just didn't know that there was a transition. So I'm excited about all the possibilities that even just having pictures allows us to have. yeah It's great as we add more tools to analyze the crystals and really understand their form and their structure.
00:15:03
Speaker
But I'm just excited about the fact that we can actually track the process now. Yeah. Yeah, that's, i mean, chemistry is just so cool. I think you, I know I'm probably the, no, actually, Will, you're probably the only one who doesn't think that I'm this cool. But yeah, that's so cool. Well, not to to nerd out on it, but There's one thing to go to a group, and we've had to do this. we got it We have to go to NASA. There are funders for a lot of this and tell them what we've done.
00:15:29
Speaker
But when you tell them what you've done and then you show them a video of it happening, and they they you i would the first time we did that, we showed them a video and it was it was silence in the room and then somebody said, play it again.
00:15:42
Speaker
it's like... yeah And it's um it's just a beautiful thing to see. um Chemists have always been fascinated by crystals and their formation, but um now you're getting to see it happening. It's a fantastic, maybe um everyday event, but one that very few people get to really see and and in some ways understand, right? We won't ever fully understand it, but to see it, it's it's powerful.
00:16:09
Speaker
Yes. And that makes me think we need to share that video with our listeners when they- Yeah, we'll put it out there for you. Yeah, yeah no definitely. Yeah. So Ken, you spoke about the new forms and Molly, you did as well, the new forms that that can be accessed by ah growing crystals in space. But I'm curious, you know, practically, how does that translate to better drugs? I mean, are we talking about entirely new molecular properties here or is it stability and potency? Is this a CMC shortcut? What are we talking about?
00:16:41
Speaker
So, so, uh, It's a complicated question and a complicated answer. For certain products, um let's say for products that um are on the market today and people are taking, they but it may be expensive, and it may be expensive because of how it's manufactured.
00:17:01
Speaker
And there might be a way to improve its manufacturability, either like improve the stability of an intermediate or ability to purify some intermediate products. that cuts the cost.
00:17:12
Speaker
And that's a cost that would ultimately, hopefully, go directly to the patient. And ultimately, when i when when Molly and I were thinking about SpaceMD and what we do, we're making growing crystals in space, but everything goes back to what are we going to do that is going to improve the lives of our customers, ultimately our patients, because that will translate to us delivering value.
00:17:35
Speaker
So it might be cutting costs through some ability to manufacture it in a new way, Or it might be, hey, the current version is an IV dose and you have to go to a clinic to take it.
00:17:47
Speaker
But if we can make a version that you can take via just a ah standard ah injection that you could do in the privacy of your own home... That would cut the cost.
00:17:59
Speaker
You wouldn't have to go to a clinic, so your insurers don't have to pay as much for that. And it makes it easier and hopefully more likely that a patient would be adherent. So those are the types of things we look for. And you can just go through the list of products that are out on the market and look at them and say, well, that one's more expensive than it should be. Why is it expensive like that? Or that one, those are all products that people take, but they have to go to a clinic for.
00:18:24
Speaker
How can we adjust the form and formulation to make it something that patients could take at home? Or maybe even as an oral dose, maybe it's a pill and not an injection.
00:18:34
Speaker
If we can do that, that is a huge impact on adherence and ultimately the value to the patient. Yeah, and I think it's really important to note that this is still really in its infancy, right?
00:18:48
Speaker
And we're still we're still doing a number of academic crystals just to fully understand the process because there hasn't there just hasn't been ah systematic study prior to this point.
00:19:04
Speaker
And we've we've been really lucky. I think it's been, what, two and a half years since our first flight, and we've been able to fly 35 crystals, I think 14 of which are currently actively on ISS.
00:19:16
Speaker
And we're excited just to start compiling this. We've put out a couple of papers to the community on our first molecules, but now to be able to go through and systematically look at things to understand, hey, this is what changed about the crystals. They're larger, they're ah more...
00:19:34
Speaker
uniform, their, you know, whatever it is, and then figuring out how that translates into the clinic is kind of the next piece. And I think right now it's the piece that only the Merck-Ketruda example has made the translation from space to clinic, and we're hoping to find those next pieces. But Ken described exactly what we believe we're going to find as we translate things from space towards the clinic.
00:20:01
Speaker
I mean... Just like going back to the murky trader example, like if you're a big if you're a big farmer and you have ah a patent cliff rapidly approaching, I'm thinking like, well, maybe this is a way to, you know, extend like my IP, for example, and maybe find a new formulation that can extend my revenue runway. I mean, what are your thoughts on that? That's a big part of what we're hoping to ah get big pharma to buy into and want to to do that.
00:20:33
Speaker
I think like any industry, the first success brings the next successes. And we're we're at the the precipice of the point in time where we're going to have the next version of Keytruda. And maybe it's not a blockbuster drug like Keytruda, but there's still going to be a breakthrough that's going to help people. And as As time goes on and we have more and more of those, I think this will be more readily adopted by big pharma and small pharma alike.
00:21:00
Speaker
Yeah. And then, you know, that totally makes a lot of sense. And, you know, it's the more times you you show that it's repeatable, the more, you know, people see it as a de-risked approach and a value-add approach as well. So I always like, I always think about it in those terms, but tell me like specifically, like when you come back to like, you bring seed crystals back to earth, they've been manufactured on the space station, kind of what happens then and how how does

Scaling Drug Production with Seed Crystals

00:21:26
Speaker
that scale? How do you do that commercially?
00:21:28
Speaker
Yeah, that's the that's a ah key piece of it, right? Because that's taking an idea to a practical product that people you know can go get prescribed. and So that is something that we spend a lot of time thinking about, like how do we fit into that? And ah what we've settled upon is a process where we make crystals and we make a very small batch, maybe a thimble full or less, maybe half a thimble full.
00:21:54
Speaker
But as it turns out, the way ah big pharmaceutical companies operate, when they get to the point where they've got a compound that they have tested and they believe it is what they are going to take to market.
00:22:07
Speaker
So they've done initial studies, maybe even in people. And what they try to do is they try to come up with the form that they're going to take forward. And the the form is important. Again, as we just discussed, it's what gives it its sort of physical properties, how it can be made into a tablet, how big the tablet has to be, how much material is in there, um you know how big the dose has to be, things like that.
00:22:30
Speaker
So ah once they get to the form they like, they will do a ah lot of work to to in ensure that every time they make a new batch and everything in each batch is the same. product They want product uniformity, and they want to keep that form because ultimately that form and formulation is what is approved by the FDA.
00:22:51
Speaker
And it's what they know will operate properly in the population of people that are going to get it. So to ensure that, what they will often do is, once they've got a form they like— they will keep, ah from each batch, they will keep some in reserve.
00:23:06
Speaker
And when they go to make a new batch, they will dump what they made from the previous batch into the next batch so that the material, the crystals that go in there, act as seeds to make more of themselves. You're sort of translating the architecture of...
00:23:23
Speaker
ah the initial batch into the next batch to ensure that you're making the same thing each time. In some cases, they'll hold back as much as 40% of the previous batch to dump into the next batch.
00:23:35
Speaker
So we're sort of feeding into that. So we're giving them the seed crystals, which they would make bigger and bigger batches. And as soon as they get to the scale that they want to, they'll do the same thing. They'll make a batch, but hold some of it back and put it into the next one.
00:23:49
Speaker
So we're trying to fit into their process and not making them come up with a new process that adjusts for our situation. yeah That's kind of the strategy we've taken.
00:24:01
Speaker
Yeah, that is so cool. It's like what's blowing my mind is like that's what you do as like a research scientist, right? is you You figure out like a good crystal that's going to dissolve really well and do what you want it to do and you save some and you use it to see the next batch. So it's kind of wild to me to think that that actually scales. So that's so cool.
00:24:19
Speaker
Yeah, that's it. And, you know, and and the other thing that we have to think about is um the FDA. We have to fit into the guidelines around what the FDA requires. And the process that we are using is um is there's guidance around not doing things in space, but ensuring that you have the right crystal form and you can repeat that and get it every time.
00:24:44
Speaker
And we fit into that process. So we feel very comfortable in that way as well. um And I think not just following FDA guidance, we're doing it because it will work.
00:24:56
Speaker
That's what is really important. And we feel good. We feel pretty confident about that.

Preparing Experiments for the ISS

00:25:00
Speaker
So what is the process for someone partnering with SpaceMD and where do they send their samples and do our favorite cold chain um shippers send send to space? How does this all this work?
00:25:16
Speaker
That's, yeah, it's a great question because it's definitely different than what we do every day on the ground. um So we we we have a couple different ways people can work with us, but once we know the conditions for crystallization in ah standard terrestrial laboratory, then we start working with our partners who are experts at translating people's terrestrial process into the pill hardware, the pharmaceutical and space laboratory.
00:25:46
Speaker
And once that translation has been made and we've settled on conditions we want to use in space, then we start going through ah the NASA process, if you will. Right now, it's NASA. We have the ISS. That's really the only place that we're doing this for a lot of reasons.
00:26:04
Speaker
In the future, in the next four and a half to five years, the ISS will be retired. So we're, of course, already looking at next generation platforms. Right. right Once, you know, once someone has found their conditions and we've we've done all the testing in our hardware that's required, you know, and gone through all the process with NASA saying, okay, these chemicals are safe and not going to hurt an astronaut or these chemicals are risky. so everything needs extra containment. then Then kind of the fun begins where you start preparing everything for flight a few days before down at Kennedy Space Center and you hand over the hardware and get to take pictures and the hardware can be stored.
00:26:43
Speaker
At a specific temperature anywhere from, well, we prefer four to 40, but you could go into, you know, minus four, minus 20, minus 80 if you needed to.
00:26:54
Speaker
We'd probably have to make some hardware changes for that. No one's asked for it yet, but... um You know, mostly we keep things at room temperature or at about four degrees. We fly it up to the space station on either a SpaceX cargo resupply mission or Northrop Grumman cargo resupply mission.
00:27:11
Speaker
Those are the two ways to get there. An astronaut unpacks the pillbox, as we call it, and then puts it into our hardware, our bigger hardware that lives on the ISS that we call the Advanced Space Experiment Processor or ADCEP for short.
00:27:27
Speaker
And that's when we take over. As soon as the astronaut plugs it in, we start the process. We can watch, we make sure that everything's working and we can watch the fluids be injected into what we call the crystallizer or the observation chamber.
00:27:44
Speaker
And from there, even our... partners, whether whoever it is, a pharma company, an academic, can actually watch the initial process in a low-res video of their crystals forming on station.
00:27:57
Speaker
We tend to run things on average for about 21 days, but it could be more and it could be less depending on flight schedules and the the needs of the science. And then we can return and we can run it at between 8 and 40 degrees on the ISS, although 10 and 40 is better.
00:28:13
Speaker
Yeah. But, you know, yeah, we have some wiggle room there. And then we can return it to the customer either um at ambient temperature or, again, between 4 and 40 degrees, depending on what they need.
00:28:27
Speaker
And once we bring it back down to the ground and it gets handed from NASA to us at SpaceMD, that's when we take some video, take some pictures of it on the ground, and then we hand it over for the analysis by the PI. Or if they ask us, we hand it to a different partner to do all the analysis.
00:28:44
Speaker
Okay, so what you just heard was the step-by-step, this is how you do it.

Transformations through Space Research

00:28:50
Speaker
but there So um about 15 years ago, I got called by some people at CASIS, the people who operate the U.S. National Lab and Space Station, asking if I wanted to be an investigator and do science in space.
00:29:04
Speaker
And it is an extremely emotional thing to be a part of, right? It's totally awesome, right? You get to work with NASA and do science in space. You get to go to a launch and watch your experiment, you know, get launched. And they sing the national anthem at these events. And it was a fantastic thing to be a part of.
00:29:27
Speaker
It's, you know, prideful. for your company, for your nation, um but you also get a feeling for the fact that you're at the beginning of something. There's something that's really big, right? That's, ah you know, important for the science that we do and the work we're trying to do for ah the pharmaceutical industry, but also something that you're doing and you're part of ah as a...
00:29:52
Speaker
um a representative of humanity. It's really a ah remarkable thing to have been a part of, and I'm just so blessed to have to have been there and have gotten that call and, in a way, ah changed the trajectory of my career and my life to be a part of this.
00:30:12
Speaker
So freaking cool. Yeah, it's amazing. Yeah, space, I feel like there are people who grew up and they they just want to work in space and they don't care what it is. And yeah then there are the people who always thought space was cool, but there was never a place for them and accidentally end up there. And I know I'm kind of that person.
00:30:31
Speaker
And I think your way is, Ken is, too. Yeah, for sure. it But it really is. It's amazing when you're there for a launch with all these other people and their science on station, and then getting to talk or at least listen to an astronaut talk about your science in space.
00:30:48
Speaker
It really changes your perspective a lot on what you're doing and makes you realize that you're at the forefront of something really big. Wow. That's all I got. Wow.
00:31:00
Speaker
It's incredible. Yeah. You also say that a lot about things, Danny. Wow. Like you're combining my two favorite passions. Like I remember telling my dad, this is going to make sound really old, when I was four years old and we were watching Halley's Comet go over the sky.
00:31:18
Speaker
i was like, I'm going to be an astronaut. Like this was my first career was at four years old. That was what I wanted to be. And then I got a bit older and realized that I wasn't that good at math. And I was like, know what? I'm going be a chemist instead. So like, You're literally living the dream that I've had since I was four years old. So that's why the wow.
00:31:37
Speaker
Yeah, it's awesome. It is. but have to go back your description of step-by-step, how each thing is done, and I've never been so interested logistics before, but it does sound a bit like we've now brought batch records to space, which feels little sad. Yeah.
00:31:58
Speaker
That's not so exciting. I mean, so so how do you ensure the consistency and the in the quality control when your lab is, what, 200-some miles of above the Earth? How does that work? Well, we in a way, we kind of cheat to do it.
00:32:12
Speaker
So the hardware, the the laboratory that we run our experiment in is a small box. Maybe we'll say about the size of a shoebox, give or take.
00:32:25
Speaker
and In that, it has all the pieces and parts of the laboratory that we need. We have our material in solution in a syringe. We have ah the anti-solvent in another syringe. We have a little waste syringe and a little reactor um cell that we're going to run the crystallization in.
00:32:41
Speaker
ah We've got a microscope that's in there with you know the optics and lighting. And it's all sealed up so that we you know we put everything there. It's all loaded. We seal it up.
00:32:52
Speaker
And then that's what gets handed over. So the laboratory is sort of established. And now all we're waiting for is the proper environment. So it gets launched, all put together, plugged into the facility by an astronaut who...
00:33:07
Speaker
plugs it in like a cassette into a player, closes the lid, and then all of a sudden, as Molly said, we see on our operations ah dashboard and our screens down in Indiana, southern Indiana, we see it's on, it's powered on we can see through the microscope, looks good.
00:33:24
Speaker
Okay, initiate one, and you press the button, you can see the material flow into the cell, um So we're we try to remove as many of the ah factors that could affect it one way or another before it even flies.
00:33:40
Speaker
And then what we're hopefully getting is you know a consistent run in space under conditions that ah we can control to the best of our ability. That's really how it's done.
00:33:53
Speaker
Yeah, it's it's I mean, it's really an incredible feat of engineering. um As a recovering engineer, I say this. It seems so simple, but there are all these things you you take for granted about having gravity.
00:34:07
Speaker
Like when I pour liquid into a container, it's going to the bottom of the container and going to force the air out. But that's not necessarily true when I flow fluid from point A to point B. If I'm flowing my fluid from a syringe into a reaction chamber and that reaction chamber is filled with air, there's no guarantee I'm going to push that air out.
00:34:28
Speaker
And so it's it's all these little things that we have to think about and we've had to learn. and And, you know, we talked about TechShot earlier. TechShot has been around for almost four decades.
00:34:39
Speaker
And so that engineering experience being brought to this system has just really allowed us to... To make a difference. I mean, Techshot was building things for the shuttle and now for the ISS and for whatever comes after ISS, both crude platforms and free flyers will still be doing it. And that those decades of experience allow us to kind of make these big changes rather than just small incremental changes to things. And it's exciting.
00:35:07
Speaker
Yeah, we're still learning, though. that's That's the other piece. We're always learning. Yeah, always learning. And things that we don't even, it's the things that we know will work. Absolutely, this is going to work that don't.
00:35:20
Speaker
That's when we learn and we go, okay, so what what happened there? We just ran an experiment um where we sent it up frozen. We warmed it to room temperature, put it into the reactor, heated it to 80 degrees for 20 minutes, cooled it down,
00:35:37
Speaker
And it didn't work. And we what we figured out was, even though had defrosted and we had little temperature monitors, whatever, and then heated it to 80 degrees, it was still frozen in the middle.
00:35:51
Speaker
Now, on Earth, if you took something and you defrosted it to about room temperature and then you heated it to 80 degrees on the stove, you'd see it boiling away and all the you know any ice would disappear and it would heat up.
00:36:03
Speaker
But um in space, the water acted as an insulator and there was nothing while moving it. There was no, you know, that's what we wanted was a perfectly still environment. And what it turned into was the water acted as an insulator and didn't allow the middle of it to warm up or...
00:36:20
Speaker
So it's little things like that that we learn, and then we go back and we do it again. and you have to be a good observer. That's the one thing. The engineers and the scientists who participate in these things are generally very good experimentalists and very good observers to try to figure these things out.
00:36:39
Speaker
Wow. Again, wow. I'm back to the wow. I'm like, where's your stir bar? That's right. Stir bars are really difficult to use in space. I can tell you that one because we, ah in ah in a different different time for me, but when I was still a practicing engineer and building hardware for space, we had a PI who insisted on a stir bar and the number of bubbles that that that would trap and then the they would start to coalesce and just form a bubble around the stir bar.
00:37:08
Speaker
So all the stir bar stirred was air in a bubble. Well, the rest of the reaction chamber was just diffusing, it was just, you know, functioning by diffusion really, as everything sat there in this air bubble with the air in an air bubble was being stirred and that's it.
00:37:24
Speaker
And it's one of those things I expected the stir bar not to work, but I never expected the bubble to encapsulate the whole stir bar. Yeah. and just totally become useless.
00:37:37
Speaker
So, um i I won't go down that rabbit I have a lot of stories about stir bars that don't work, but for a different reason. Yeah, they they tend not to be great.

Promising Areas for Space-Grown Crystals

00:37:48
Speaker
So in terms of therapeutic areas that you think are the most promising, like my mind goes to things that are big and bulky, like biologics, for example, are like the key treater example. But what do you think the most promising areas are for space-grown crystals? Yeah.
00:38:05
Speaker
I think, um so oncology is a big one, but if i think if you looked around, you'd see that ah cancer therapy is probably the biggest. I mean, it's a huge, right?
00:38:16
Speaker
So, and we're going to follow the market and the demand. That's it's just what it's going to come down to. ah But there are certain ah molecules that... um are good targets for us to go after things that are cardiovascular.
00:38:33
Speaker
There's a lot of things there that were big products that are now ah generics but could be improved upon. ah The CNS products are going to be something. Neuroscience is big.
00:38:45
Speaker
We'll continue to be. um So, but that's really what drives us. And ultimately, I think in some ways it will be the demand from pharma, whether they're actually coming to us and saying, Hey, we want this, or we're seeing that that's a big area for them. And we're trying to fit into things that they're going to be interested in. We're,
00:39:05
Speaker
but it's um We are dependent upon them, ultimately. They're the ones who are going to develop these molecules and the new forms and formulations into a product that patients will receive the benefit from. So we have to fit into things that you know work for them.
00:39:22
Speaker
It makes sense to them. And we've talked a lot about the large molecules, and you know in they're the the newer drugs, if you will. But In space, there hasn't been a lot of work done on small molecules.
00:39:36
Speaker
And so it's a really open field still by comparison. I think when we flew those, what was it, first, think four small molecules back in 2024, prior to that, there had been three small molecules flown to space. Mm-hmm.
00:39:53
Speaker
So we successfully doubled it. Yeah. And so, you know, the large molecules, i agree. I think they're really interesting. But I think from a science perspective, the small molecules are still pretty untapped um and going to be an interesting story to follow as we start to understand how microgravity affects the small molecule drugs.
00:40:15
Speaker
So from a, you just talked about, you're going to follow the the de demand, right? So that obviously makes a lot of sense, but I'm curious, I have kind of a two-pronged question.

Demand for SpaceMD's Innovations

00:40:25
Speaker
One is, do you see a lot of demand right now from pharma and or biotech companies to to collaborate with you?
00:40:32
Speaker
and then the other thing is, I'm thinking, you know, do you have ah ambitions to have your own pipeline of things that you develop as well and then, you know, partner at a later stage? Yeah. I mean, i'll I'll jump in on the demand part.
00:40:46
Speaker
I think it's growing. We, we have some partners who were early adopters yeah and are excited to continue to fly molecules. Um, but we're, we're seeing,
00:40:59
Speaker
I think for the first time, and and Ken, you know, I think you experienced this too last year at Bio, we're finally seeing that people recognize what we're doing. You know, we finally have people going, oh, you're the space people I've heard about, or you're the space people I've heard speak before.
00:41:15
Speaker
And that that's a big deal. I mean, 10, 12 years ago, no one had heard of this. And people kind of looked at you like you were crazy. Like, why would I bother doing that? I can just spend the money and do it.
00:41:28
Speaker
in the lab down the hall. um But now we finally have people understanding what we're doing. And while I wouldn't say I've had anyone knock on the door who said, I have to do this.
00:41:40
Speaker
We're having more and more conversations where people are going, you know, that could be really interesting. How do I get involved? And so the demand is is coming. I think there's more recognition. yeah And there are some companies that are doing this and are interested by it.
00:41:57
Speaker
It is not a mainstream by any stretch. um And i think that's okay for where we are and what we're doing. ah and But we have to, that's just the reality of the situation.
00:42:12
Speaker
So in our plan and what we are our strategy has been, that we're not waiting for other people to come to us. We are going to have our own portfolio of products. And we are running our own um selections.
00:42:29
Speaker
ah based on things that we find interesting and that we've got a group of ah partners who are um that we hired to help us select compounds and work out conditions, and um and we've got our own portfolio. Ultimately, that is what we will have is a portfolio of assets that we're bringing forward and that pharmaceutical companies can come to and say, hey we're interested in that one.
00:42:55
Speaker
um you know How do we partner and try to bring it forward together? And there are ways to do that. And um from my time in the pharmaceutical industry, that that was a big deal for us, especially the companies that I had worked for previously,
00:43:12
Speaker
ah You could look at their history of all the products that they brought to market and how many were partnerships or things they in-licensed. So it's it is part of the industry. It's how it works.
00:43:23
Speaker
And we're hoping to fit into that. so that is ah And especially right now, it's a majority of our efforts. Well, the other thing I'm thinking about as you say that, Ken, is that you get you're like literally at the bleeding edge of this this whole new infrastructure. So you are going to be like creating creating the the assets and in the beginning because you are the first ones doing it. So it's kind of, it all makes sense now that you put it into that perspective.
00:43:50
Speaker
Yeah. It's just, it's the, the, it's where we are, where we're at. And yeah I, you know, part of that requires that you convince some people who um have money or resources to help you along And um ah NASA has a special program associated with ah sort of um facilitating small technical businesses to do work that will ultimately have a commercial impact and do this work in space.
00:44:20
Speaker
So we took advantage of that. That's the In Space Production Applications Program. ah And we we got funding from them, ah both like you know dollars and flights and time with astronauts to get the work done.
00:44:35
Speaker
um But ultimately, it's going to take more than that. But we've been ah really were we're grateful to them and in the help that they've provided in allowing us to do this. And I think ah they've been really happy with what we've been able to do.
00:44:49
Speaker
So... think it's working. We've got a ways to go, but it's it's moving.

Democratization of Space Biotech

00:44:55
Speaker
Ken, you mentioned that on the one hand, what you're doing is maybe not a mainstream um approach to to generating crystals.
00:45:06
Speaker
On the other hand, not only yourselves, but also you know a big player like Merck is is interested in this space. um So putting those two things together, i have to think that there are some misconceptions about space biotech. I'm i'm curious, what are the misconceptions that people have about that space?
00:45:25
Speaker
I think the the biggest one is that it's something somebody else does. and right it's a Yeah. um you know molly you know talked about the fact that you know it's yeah it's not something that maybe everybody thought they were going to do and for me it was until that person called me up and said hey you going to do this it was just a dream i was out you know where everybody loves nasa and it was fun to watch and space shuttles and all that stuff but i had no idea that
00:45:57
Speaker
um Normal Americans are being asked to, you know, contribute their expertise to do things in space that um are, ah you know, can benefit from having access to space or will benefit the space program in some way.
00:46:15
Speaker
um And it's now it's even beyond that. it's it's um It's being democratized. You're starting to see um high school students running experiments. so i i My first launch, the first experiment that I had launched, I was at a bar afterwards. The SpaceX guys would have parties after a successful launch.
00:46:37
Speaker
And this very young woman walked up to me and introduced herself. she She was not old enough to be in that bar, but standing right behind her was her mom. And so I start talking to them, and she she is a junior in high school that launched her first experiment to the space station.
00:46:53
Speaker
I mean, that's... Think about that. Just, you know, when I was that age, that is not what I was thinking about, right? So the world changing, my... and um my ah ah My older son, he's 23, 24. We've had a space station in space all his life, and there have been people on it all his life.
00:47:15
Speaker
That's wild. um Yeah, the the world really has changed, and um I think it's a lot of it is not hidden, but it's just missed by the general population, that this is happening And it's going to have an impact on their lives. And even, you know, we look at, ah you know, us do making pharmaceuticals and space and...
00:47:37
Speaker
um I think the that's what the future is, is that someday products that are made in space will impact people's lives and they won't even know it.
00:47:47
Speaker
They won't even know where it came from or that that had occurred or that was part of its production. And I think that's the special time that we're in, the the the missing thing that is happening and people just aren't quite seeing Well, and i think that's, Ken, you pointed out the big the next big breakthrough. Right now, people think about all the things that were invented for space, Tempur-Pedic, soft contact lenses, these things that were invented for the astronauts that now are part of our everyday life. But instead, next, it's going to be these things that are made in space and are part of our everyday life, and people don't even think about it.
00:48:27
Speaker
Scratch resistant glasses, but what glasses, lenses. i mean, these are all things that came from the space program. I didn't even know that. So I thought you guys all use duct tape. I thought duct tape was the answer for everything.
00:48:40
Speaker
We use a special tape ah called Kapton tape. It's much more expensive than duct tape and very orange. Oh, I know that tape. I know that tape.

Future of SpaceMD

00:48:50
Speaker
All right. So let's fast forward.
00:48:53
Speaker
What does it look like in 10 years from now for SpaceMD? Are we we kind of just making drugs? Are we doing something else? How else are we changing lives on Earth? Yeah, it's I mean, I hope to see Space MD have have a great drug pipeline in 10 years with some products on the market or soon to be on the market. i hope we've expanded what we're doing, both in terms of crystals into cosmetics, food, things.
00:49:22
Speaker
even even maybe semiconductors. But I also hope we're starting to work on medical devices, whether that be everything from Janus-based nanoparticles to gold nanoparticles. And you know it's kind of the limit. we I'm hoping that that's where we are. But I do still hope that we're more in the medical field than not, because I think that that just right now is the place that has the biggest impact for all of us here on Earth.
00:49:49
Speaker
Ken, I don't know. I'm sure you have different thoughts. I know i i think that's that's it. I think you you hit it. ah The one addition I would make is that I'm hoping that in 10 years, we are just a another source of innovation for the pharmaceutical industry. In addition, all the other things they do and different types of products and expertise they go to that we're just um you know also contributing in some way and just another outlet for innovation for companies that are trying to deliver better and better products.
00:50:24
Speaker
um In some ways, I'm hoping it gets to the point where it's kind of ah boring and routine. That would be perfect. That would be perfect. I don't know that there has been Sparktime episode where there have been so many wows spoken, but I want to cast a line to see if we can get a couple more.
00:50:49
Speaker
I'm curious what the most wow-inspiring moment you've had watching your experiments operate up there on the ISS have been.
00:51:00
Speaker
Watching an astronaut pull one of the the cassettes, that as we call them, out of the bag, out of the packaging, orient it, and then you know make sure, you know open up the front of our facility, make sure it's all oriented the right way, and then insert and close it up.
00:51:16
Speaker
And just understand that that's happening 250 miles up somewhere over the Earth, That, for me, is a special kind of thing to see.
00:51:29
Speaker
But really, it um all that aside, the most awe-inspiring sort of game-changer for me was showing an old friend of mine who's ah now a professor. We worked together in the pharmaceutical industry. He's now moved on, and he is a professor at a university and Illinois. And he...
00:51:51
Speaker
um works on this type of work. he He has studied the development of crystal crystals for form and formulation for his career. And I showed him the video of one of our crystals growing and um there were some special intricacies associated with it.
00:52:11
Speaker
And when it was all done playing, it was only like 20 seconds, and then ah he was quiet. We were both sort of quiet. And I was like, Chris, are still there? And he's like, Ken, I've studied that all of my professional career, and I've never seen it happen.
00:52:26
Speaker
Wow. And it for me, it was it was a special thing, right? It's time we were you know kind of nerds, been nerds our our whole lives, and we spend a lot of time thinking and trying to understand something that's extremely complicated. Right.
00:52:43
Speaker
But um that was it. He saw it and he's like, it was an important moment for him. That's what he wants to teach his students to study too. So that for me was a powerful event. And it was made possible through the technology that we've developed at Redwire, the access we have to space and ah the work that we do all coming together.
00:53:05
Speaker
So I think that for me is a special thing to be a part of. Yeah. Yeah. I mean, Ken, just echoing that, I feel like every time we launch an experiment and every new PI we bring in, I'm just excited to see it happen.
00:53:25
Speaker
I'm excited when it works because you can do the same experiment 10 times over. And just like on the ground, it may only work eight or nine times. And you you don't know why it didn't work the 10th, but...
00:53:38
Speaker
We just have incredible astronauts who are who are amazing people up there helping us do this. And so every time it's just inspiring to see that it worked and that something different is happening and trying to make sense of it all and learn everything we can from it. Because while we have a lot of opportunities to fly, it's still not like doing things in the lab down the hall or in your own lab.
00:54:04
Speaker
There aren't as many opportunities. So it's just exciting to see it happen. Wow. It's the wow. Yeah, it it worked. Yeah. Really cool. But i I think it's time to finally ask, when are we going to record an episode of Spark Time in orbit?
00:54:24
Speaker
How are we doing it? No pressure. Yeah. So I so i think i think so it's it's going to happen in stages. The first thing is going to happen is we're going to record Sparktime, but we're going to do it with an astronaut.
00:54:37
Speaker
So the astronaut will be on, and well and they have a they have a special telephone. They can call in to anybody they want. Oh, my God. So that will be the first one. But the the second one, the real one, yeah will be the one where we're all up there on a space station and having a conversation like we are here.
00:54:55
Speaker
But in that case, we will all be together in space, ah floating around, talking about what we're seeing and what we're feeling and the significance of it.
00:55:06
Speaker
And the crazy thing is, we can we think about that now and go, that's crazy. That's going to be wild and that's in the future. But um in years to come, generations to come, they'll look back and they'll they'll laugh at it.
00:55:20
Speaker
right It will be old-fashioned. And remember when those people, they didn't know what they were doing. That's part of ah the transition that we're now a part of. the Even just having this conversation, we're bringing people into um that part of our human history and our next big steps, right? Our big steps out into space.
00:55:41
Speaker
This is the beginning of it. Really phenomenal. Thank you both for joining Sparktime. This has been such a phenomenal episode. So I'm sure that our listeners will enjoy it very much. Thanks, guys.
00:55:52
Speaker
Thank you. Thank you. Well, thanks again to our listeners for joining Sparktime. We welcome you to join next time as we continue to explore the ideas, the thinkers and the innovations that drive biotech forward.
00:56:04
Speaker
We hope to see you there.