The BAMF Health Podcast

How Are Radiopharmaceuticals Made? Inside a Modern Radiopharmacy

BAMF Health Season 1 Episode 10

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0:00 | 34:54

We sit down with Matt DeLong, BAMF Health Vice President of Radiopharmacy, to pull back the curtain on one of the most important—but least understood—parts of modern precision medicine: the radiopharmacy.

How are radioactive drugs actually made? What is a cyclotron? Why do these medications have to be delivered within hours of production? And what makes BAMF Health's radiopharmacy different from traditional facilities?

Matt shares how radiopharmaceuticals are manufactured, how they safely travel from the cyclotron to patients, and why radiopharmacies are becoming increasingly important as theranostics continues to transform cancer care. He also explains the logistics, safety measures, and culture that allow BAMF Health to deliver these time-sensitive therapies while expanding access to patients across the country.

Whether you're a patient, healthcare professional, student, or simply curious about the science behind precision medicine, this episode offers an inside look at the technology and people helping make theranostics possible every day. 

Chapters

00:00 Introduction
 00:40 Meet Matt DeLong & His Career Journey
 03:54 Supporting Patients, Health Systems & Clinical Trials
 05:22 How Are Radioactive Drugs Made?
 09:23 Why Radiopharmaceuticals Have to Be Used Quickly
 11:13 What Makes BAMF Health's Radiopharmacy Different?
 14:31 Seeing the Patient Impact Firsthand
 15:55 Inside a 24-Hour Radiopharmacy Operation
 17:29 How Radiation Safety Works
 20:31 The "Banana Perspective" on Radiation
 21:53 Expanding Access Across the Country
 23:43 Building a Replicable Radiopharmacy Network
 24:55 The Evolution of Modern Radiopharmacy
 28:54 Matt's Passion for Patient Care
 30:56 The BAMF Difference
 31:50 Closing Thoughts

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Dr. Brandon Mancini
Christine VanTimmeren

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Christine VanTimmeren

Welcome to another episode of the BAMF Health Podcast. If you've listened to previous episodes, you've heard us talk about radi opharmaceuticals and radioactive drugs. But what we have not heard from is someone in a radio pharmacy making said radioactive drugs and managing a radio pharmacy. So we felt like, hey, let's bring our VP of radi opharmacy, Matt DeLong, to join us today to talk about radi opharmacy and everything having to do with radi opharmaceuticals from the source. So thanks for joining us.

Matt DeLong

Yeah, thanks for having me. Looking forward to it.

Christine VanTimmeren

So the first thing I'm super curious about, and I'm sure a lot of people are curious about, is how does one get into a career in radi opharmacy?

Matt DeLong

Yeah, yeah. We get that question a lot. So I'm a pharmacist. I grew up in West Michigan, went to pharmacy school at Ferris State University. And, you know, throughout our fourth year of radio of pharmacy school, we do rotations. And one of the rotations I had was in nuclear pharmacy. And that was really the first exposure I had to it. And I really liked the puzzle. So the two things that really excited me in pharmacy, one of them was emergency medicine. I and the other one was nuclear pharmacy. And I think both of them, the commonality between it is you've got you've got a problem that needs to be solved right away. And I just ended up picking nuclear pharmacy as the path uh to go. So left Grand Rapids in West Michigan, moved down to West Virginia and Cincinnati, and started my career um in 2009. So it's been a while, and then just continue to figure out new ways to do different things within the industry.

Christine VanTimmeren

And your role now at BAMF, then what does that entail?

Matt DeLong

So that uh so BAMF's a really cool opportunity because I I oversee all of the manufacturing and all of the business development and and support the supply chain and every piece of getting drugs to patients uh for our clinic um and for the community around us. And so that's really fun. The the thing that I like the most about radi opharmacy at you know at this stage in my career is working with people outside of us to try to solve problems. So I get to work with pharma companies. Um BAMF is it's called a CDMO. So we're a contract development or contract development manufacturing organization. And so pharma companies, because these drugs are short half-lives, so two hours, I think, is the most that we make uh generally. Since these drugs are short half-lives, these drug companies have to rely on external manufacturing in order to make them available to patients. And so BAMF operates in that space. And because we built the facility to be flexible and uh able to make a wide variety of drugs, we do a lot of clinical trial products all the way down to phase one. And and through that, we get to work with pharma companies to help them make their drug better so that they can bring it to more patients as it progresses through clinical trials. So that's a lot of my work now. Um, I've got an awesome team that works with me that makes it uh makes me able to focus on kind of the external part of the business. And so they just do an awesome job at making sure everything works. Um, and they, you know, execute on the things that I caught. Yeah, and and that. So that's kind of very different than what I did when I first got out of school. But all of that fed into my ability to do what I'm doing now. So awesome.

Dr. Brandon Mancini

And obviously, you kind of touched on the majority of what we were gonna ask next, which is outstanding. But as far as other things a radio pharmacy does or are specific radio pharmacy, so obviously the interaction with pharma companies, making short half-life uh imaging radio tracers, et cetera, um, who else do we interact with or what other kind of things go on on a day-to-day basis?

Matt DeLong

Yeah, so we do a lot, you know, the the BAMF radio pharmacy is an asset to the community. And so we do a lot of work uh with uh the community health systems, whether it's providing them with radio pharmaceuticals or working with them to see if we can bring a clinical trial product to their uh to their portfolio, to their patients and their clinicians, and not necessarily putting them through the BAMF clinic if they've got uh the infrastructure and stuff in there. And so a lot of it is is working within the community. And then a big part of BAMF, we we know that one facility in Grand Rapids isn't going to solve the access problem that that the industry and the patients have. And so a lot of what I do is working with health systems around the United States and solving kind of that supply and access problem, whether that's through partnerships or just as a friend. Um, you know, the position I get to be in is just kind of the guy, uh, which is really cool. So yeah.

Christine VanTimmeren

So one thing I was super curious about when I started at Banff, having no knowledge of theronostics and radio pharmaceuticals, was how do you make something radioactive? And and what does it mean to be radioactive? So walk us through kind of the basics of a radioactive drug, how it works, how it's created, and and what's needed.

Matt DeLong

Yeah. So I think the first thing to clarify is we use a cyclotron, which is a particle accelerator, and it's not a nuclear reactor. And so at least for what we do. So within BAMF in our Grand Rapids facility, we've got two cyclotrons. And the way a cyclotron works is you introduce a charged particle, a hydrogen particle, and accelerate it in a circular path up to about a quarter speed of light. Uh, the way we accelerate it is very similar to, you know, if you've ever tubed or water skied, the further away from the boat you get, the faster you go. So we keep increasing the circumference of the path and get it accelerated to that high speed and then smash it into a target material. So everything, at least what we do right now, starts with that charged hydrogen particle. And then what radioactive isotope we make is determined by what target material we put on the cyclotron. And the target material is usually liquid, and it's like a teaspoon of a teaspoon of material. So it's not very much.

Christine VanTimmeren

Even the particle, I mean the particle itself is at the molecular... subatomic, right?

Matt DeLong

Yeah. Yeah. So, um, and and so we end up with a teaspoon of liquid that is radioactive, and it's got the target isotope, the isotope that we wanted to make, whether it's fluorine 18 or gallium 68, um, or any of those kind of common isotopes. And then it gets transferred underground, under concrete, up into a shielded uh with lead uh synthesis unit cabinet. And it looks like it looks like a refrigerator. Um, it's smarter than that. Yeah. And then it gets it gets introduced to uh an automated chemistry system that takes the isotope, goes through several steps, and ends up attaching the isotope to the drug. Um the drug then is what carries the isotope to uh the target organ or cancer or any of that. So another thing that I really liked about radi opharmacy is it's using really simple processes that are already present in your body and just applying them in a really intelligent way. And so it was very much, you know, you can see it, it we think it's going on, let's put this radioactive drug in, and then you can see it, and like, yep, that's going on. Um, the cool part about Theronostics and why the BAMF radio pharmacy is so critical as we grow, is we're moving from see it alone to see it and treat it. And so using the same concept of radioactive drug going or radioactive isotope going through a chemistry process, attaching it to a structure that becomes a radioactive drug, we then inject it into a patient, and then they can treat whatever the target is as well. So we don't at the moment support the treatment beyond just helping facilitate diagnosis. Um, but we are uh playing a really critical part in that. Um, but yeah, long answer to how you make something radioactive, but it's essentially just exciting a molecule by adding a proton to it. And so you just make it unstable in a very safe and controlled way.

Christine VanTimmeren

And then you have to use it within a certain period of time. It's not like a normal pharmacy where drugs sit on a shelf for a while. Yeah. You have to make it and then you have to use it.

Matt DeLong

Yeah, exactly. So we've got the main isotope we use is fluorine 18, so F18. Um, and that is the main isotope that is in FDG, which is a uh oncology scan that's been around forever, you know, 50 years. And that's the if anybody's had cancer, right, and you know better than I do, if anybody's had cancer, they've probably gotten a PET scan. So that's using a fluorinated uh glucose molecule. And back to the simple processes, a lot of cancers are hyper hypermetabolic. A lot of cancers or all cancers are hypermetabolic. A lot of cancers use glucose as their food source. And so if we give a cancer glucose, it eats it. If we give a cancer radioactive glucose, it also eats it, and now we can see where it went. Um and so the F in FDG fluorine has a two-hour, less than two hour half-life, 110 minutes. And so, meaning, um, you know, I we had to teach our CFO about radiopharmaceuticals. And so the analogy we use is we're making ice, and you know, and that demonstrates what half-life look like and stuff like that. So you've got a block of ice and it's a pound of ice, and then if the half-life is two hours, that means in two hours you'll have a half a pound of ice. Um, if we need a drug to get from here to Detroit, it's a two and a half hour drive. So we need to plan appropriately and do that. So yeah, we can't produce things on a shelf. Um, it truly is just in time manufacturing, which back to the puzzle that kind of brought me into this.

Dr. Brandon Mancini

Yeah. No, that's great. And we've talked about specifically like BAMF Health in the Theranostic space as this vertically integrated center. We have the the clinic, the imaging, the radiopharmacy, but specifically to radio pharmacy, what makes it so unique, different, or better than other radio pharmacies that are around?

Matt DeLong

Yeah. So, you know, we all all the radio pharmacies that we that exist that make pet drugs um use cyclotrons. And a lot of them use the GE cyclotrons that we have. Um, what is very different about our facility is we built it in a way that we could bring flexibility in. And our goal is to make you know every diagnostic PET drug available. Um, right now there are you know a half dozen or so that are commercially approved and commercially available, and we do a lot of those. Um when we build our facility, we built it so that we can continue to grow, we can continue to add. Um, that gives us the ability to support clinical trials. So the the space that we put our radio pharmacy in is to kind of bridge the gap between what an academic radio pharmacy does, U of M's got an incredible one, um, and we're really close friends with them, and and then what a traditional commercial PET radio pharmacy does. And so we can kind of bridge that gap, um, which, you know, because we're so close with the clinic and vertically integrated with clinical trials and everything, um, work real closely with Dan, who you had on previously, uh, to make sure that everything is syncing up so that when a drug is needed for a clinical trial, we're there. Um, and so we create just a single source for either a clinician or for a drug company who needs a thing done. We do the thing and we do that thing. And so it those are kind of the pieces. The other part that really matters is culture. And so what's important to me is caring about the patient and caring about the clinician who's helping the patient, caring about the nuclear medicine techs who are helping the patient. And how does the pharmacy play a part in that process? And so basically um making sure that we're listening to what the problem is and doing everything we can to make it better. Um approaching it like a service industry. So we talk a lot about unreasonable hospitality. Um, we talk a lot about removing friction and creating this terrific customer experience. And as if the team does an awesome job of putting that together. And you know, the partners we serve, we talk about your radio pharmacy because it is a BAMF radio pharmacy, but it's also your radio pharmacy because we are that critical piece of your process. So the infrastructure is really important. I think the culture of the team that operates it is even more important.

Christine VanTimmeren

Now, speaking to the vertical integration, that's another thing that makes our radio pharmacy unique is radio pharmacists and a lot of other facilities never get to see a patient. They never get to go into a clinic, they never get to see the drug started here and then went upstairs, and I was able to see the full process. So, what does it mean for them to be able to see that full process?

Matt DeLong

Yeah. And that's so you walk in and we share the same lobby as our patients do. We walk by uh Ryan, our valet guy, and we get to see him. And uh, and so everybody within that particular building gets to play a part in the patient role and they see it. Um, having physicians like Brandon or Dr. Kulkarni available to talk to the team about like what they did and why this particular clinical trial that is an absolute pain to make is important and is helping people, um, I think that really makes a difference. You know, what we do is hard. We do we do hard things in the middle of the night. And it takes a certain person, but I think being able to demonstrate that there's value in it um in a really meaningful way is is what sets that apart. So yeah, having you know patient care and not just making a drug and then shipping it out and never hearing from it, I think makes a huge difference.

Christine VanTimmeren

And you're you just mentioned that we're doing things in the middle of the night. So you have a really unique team, really unique skill sets, and they're working, I mean, almost 24 hours a day. So talk to us about when they work.

Matt DeLong

Yeah. So each batch of drug takes each takes around four hours to make, give or take. Um, we've got a team that comes in, you know, 11 o'clock at night. So 10, 11 o'clock to get the facility ready, turn the cyclotrons on, um, and make sure that we're ready to go. The uh a lot of the health systems want orders delivered for their first patient. Actually, all of them want them delivered before their first patient. A lot of their first patients are seven o'clock. And so that means we need to have the drug done and out the door and in their hands, you know, before seven, six thirty, six o'clock, and back to the just in time manufacturing. Um, the shelf life of the drug is is longer, 12 hours, whatever. So it's good for a period of time. But if we let it sit for uh the 10 or 12 hours, that means the ice cube needs to be that much bigger. And so that ice cube is that much harder to make, it takes that much more energy and all of those things. So we want to compress it uh to get it as close to patient care that we possibly can. So yeah, the way we do that is we do it overnight. Yeah. And yeah.

Dr. Brandon Mancini

So and obviously with the whole radio pharmacy functioning, not only in the clinic, uh, but more so in the radio pharmacy because you're handling the radioactive drugs. What are some of the things that are done on a daily basis just to minimize exposure and make sure everyone's safe uh as it's going from our clinic to the next and so forth?

Matt DeLong

Yeah. So we use a lot of lead shielding. So there the key principles to protecting yourself from radiation exposure are time, distance, and shielding. And then a fourth one is common sense. Um probably in order. Um but we use a lot of shielding. And so all of our cyclotrons are within six foot thick concrete bunkers and you know, just on the first floor of our of our facility. And so that provides the shielding we need to be able to run those. Um I talked about everything runs underground, so everything runs under concrete, you know, 18 to 24 inches of concrete. Um, where it isn't under 18 to 24 inches of concrete, it's under four inches of lead bricks, um, and making sure that that's there. It goes into lead-shielded uh synthesis unit cabinets or the refrigerators I mentioned early. Um we use uh robotic manipulator arms to draw doses. So if you've seen any of our um our press releases or anything like that, there's a lot of photographs of people using these robotic arms to do everything. Because it looks so cool, it is really cool, yeah. Um and then we also wear uh uh dosimeters, and so it measures the radiation both on a cumulative basis over a wear period, whatever, month, week, any of that. And then we wear uh real-time dosimeters too, so we can know if we entered into a space that maybe is a little bit more radioactive than we want to be. Um, and so there's continuous and monitoring as well, both of our exhaust, so we don't make or so we make sure that everything is good for the community around us um as well as for the team members that are there. So relying on all of those things is is kind of how we do it. We also we've got uh an excellent radiation safety officer in Colten, and he really focused on how to make radiation protection user-friendly. Um, he was an operator previously, uh, he's been with us for five years now. And so he brought the understanding of how to do it, the understanding of how to work around it and why you needed to do that, and made sure that we were building something that is at least deployable. Um and then he brings, particularly with visitors, he brings a different approach to uh radiation and he uses what he calls the banana perspective.

Christine VanTimmeren

We just talked about that.

Matt DeLong

Which is really cool. Yeah, so it's catching on.

Christine VanTimmeren

Yeah.

Matt DeLong

Um, it's appealing, you could say. Yeah, right. Right. Nice.

Christine VanTimmeren

Good job.

Matt DeLong

Yeah. But yeah, so that's really cool. Um, back to the cultural piece. So those are kind of the ways to do it. And because we're bringing people, you know, I talked about culture being so important. There are the industry's growing rapidly. There are other places that are deploying radio pharmacies. Um the workforce also needs to grow. And so we made a decision early on of we could either try to go get everybody from all of these other companies, or we can teach our own people how to do the thing we needed to do. And so we've kind of got a mix. Recently, we've been hiring people who just have the right attitude and have kind of a base understanding of science. And then that gives us the ability to just teach them the way that we need to teach them. And so that's where kind of the banana perspective comes in of like teaching somebody like, hey, it's safe, and here's why it's safe, and here's what we do to make you safe. So that's a good question.

Christine VanTimmeren

We'll give a shout-out to Colten again because I think we've had a lot of guests on the show who always outline the principles that I think he's reinforcing, the acronyms and things like that. So he must be doing a good job because everyone talks about it and they've got it right. So I think we're doing a good job there in the safety aspect.

Speaker 2

Yep.

Christine VanTimmeren

Um back to this idea of you have to have radio pharmacies close. Or within a certain proximity of patients because of the decay over time. Part of what BAMF Health is trying to do is expand across the country so everyone has access. And part of that is because you can't just build a few centers that people fly to. Radio pharmacy has to be a part of that because of the decay of the drug. So, what are you trying to do to ensure everyone across the country has that access? What is BAMF trying to do?

Matt DeLong

Yeah. So the main things for us, so the facility in Grand Rapids can reach Detroit, Chicago, Indianapolis. So we've got a pretty good breadth up into, you know, northern Michigan, Traverse City, stuff like that. What we're focused on right now is both expanding the isotopes that we offer, because there are other isotopes that have longer half-lives. One of the ones we work or that we're we're looking at and bringing up has a 12-hour half-life. Another one's got a three-day half-life. So now all of a sudden, um, you can ship it. Um, and then the other piece that we're focusing on that we can control right now is standardizing our operations and making sure everything is working well and working correctly so that we can quickly bring them to new facilities. You know, we talk of Detroit is coming soon. Um, and so making sure that we've got something worth replicating here so that we can wash, rinse, repeat at a new site and do so quickly. Uh, because that's truly how we get access is the standardization across the entire network.

Dr. Brandon Mancini

And I think just the BAMF culture, like the ability to your point, to bring in the right people and to kind of learn, grow, figure out the way that we want to do it, right? A lot of times there's a lot of right answers or a lot of right ways to do something, but what's going to kind of check all the boxes from uh efficiency, safety, and everything when it's a lot of and the cus uh the biggest difference that I see is the customer experience piece.

Matt DeLong

Like that's a new, it's just a different approach.

Christine VanTimmeren

And it's industry hasn't really focused on that.

Matt DeLong

It does not seem like it. You know, they do, but at the end of the day, it's a business. And we're a business too. But you know, the core is that we can do the right thing and to be a successful business. And it just is it takes some deliberateness in the process.

Dr. Brandon Mancini

I think that proximity to the patients, uh, I mean, it has to play a role because it's just not that often that to your point, like I would not normally see a radio pharmacist in the hospital or in a separate clinic. So bringing that all together and seeing your work in action, I think it's just a different feel.

Matt DeLong

You're part of a care team. Yeah. There's no other, no other environment that you can be that and work in radio pharmacy.

Christine VanTimmeren

So and I'll just ask you a question real quick about how long radio pharmacies have been in existence. Theronostics, you know, started in what the 1940s.

Dr. Brandon Mancini

Yeah, with the thyroid treatment, the radioactive iodine can be.

Christine VanTimmeren

So it sort of started there and it's slowly gained, and now in the last, I don't know, five to ten years, it's really exploded. Radio pharmacies have existed that whole time as well. But the extent to which they've the amount of drugs they've had to make has started increasing. So I guess the point is radio pharmacies have been around for a while. It's not like BAMF invented the radio pharmacy.

Matt DeLong

Yeah. I mean, they gosh, they've probably been around 50 years, give or take. Um, you know, Ernest Lawrence invented the cyclotron. I don't remember the year, but it was a while ago. The photos are black and white. Yeah. So um so he invented a cyclotron, which is what we use. And, you know, in the the late 1900s, right, they had a lot of health systems had academic cyclotrons, and they would use it to make either cardiac imaging drugs or the FDG that we talked about, and would just use it for their own use. Um in the early 2000s, the FDA began concerning themselves with the production of these drugs just to make sure that patient care was safe and everything. So um what that did is it kind of created an industry that focused on pet drug manufacturing. So we're an FDA manufacturing facility. We call it a radio pharmacy because that's shorter somehow. Um but the only place that we do pharmacy work is we dispense a dose. Um we don't dispense a dose to a patient, we dispense a dose to Brandon or a public person cannot come into the radio pharmacy in order. Yeah. Um and but yeah, so once the FDA started regulating it, it got, you know, most health systems were like, ah, we can't do that. And so then it kind of created an industry uh where um, you know, PET Net and Cardinal kind of moved in. And there were a few others that have been bought and sold and stuff like that a few times, moved in and were like, hey, we can help you, and then and then that kind of did that. And it sleppily increased, you know, just grew as PET scans grew um for 30 years, 20 years. And then really over the last decade or the last not even, um, it's really taken off with the you know, Net Spot and Lutathera. So now all of a sudden we can diagnose people, but now we can do something with it. Um amyloid drugs have been a lot around for a long time. Um, but there wasn't really any, they they never really took off. And the reason they never took off is because you could differentiate a patient between dementia and Alzheimer's, but you really couldn't do much with the information because you probably were going to treat them. I mean, I'm not a neurologist, but we're probably gonna treat them the same way either way. Um, and it helped you make better decisions, but it really didn't change a lot of things. Now that we've got drugs on the market that can treat you know, Alzheimer's, now all of a sudden you see amyloid imaging grow. So at the same time that theronostics and oncology treatments are growing, there's also this neuro thing that we're doing things with. So, you know, a clinical trial. Um, there are clinical trials in Parkinson's disease and you know, different aspects of that. And so there's a lot of really cool ways that we can use radio pharmacy. And that I think is what has really caused the industry to flourish is um they're just more opportunities, more ways to apply this.

Christine VanTimmeren

Very cool.

Dr. Brandon Mancini

And obviously, overall, your wealth of knowledge, your passion is very clear, like as we've talked about it. But kind of what is that source inside of you? Like, what's that why? Uh, what do you love about coming to work every day and being a part of managing everything and so forth?

Matt DeLong

So um my first pharmacy job was when I was like 14. Uh and I grew up south of Kalamazoo at and it was with Fred's pharmacy, and I was like a cashier. Um and I I worked there and I learned like I worked with Fred and I watched Fred um go change tires of you know his customers' cars when they needed help. He would go buy them groceries if they couldn't afford it. Like he just he met his patients where they needed to be met, and every single one of them. And so that's like how I cut my teeth in pharmacy, and I've brought that with me throughout the entire career. Um, you know, and I I figured out how to apply it to, you know, helping clinicians and helping health systems. And, you know, it's just caring. And it's not hard, but figuring out how to care in the right way. And so that, you know, at the end of the day, that's what brings me to work every day is the ability to care and to care about a pharma company's drug and to care about a health system and a technologist who is struggling to get their drugs on time. And so um, you know, if it's really just kind of one word, that's the main point. Um, and the puzzle and you know, BAMF gives us the opportunity to do so many different things in so many different ways. And um, connecting the dots as to like how does this make the most sense at this point in time with the resources we have is is really fun and challenging and exhausting, but fulfilling at the same time.

Christine VanTimmeren

I mean, it all goes back to the structure that BAMF has created. This vertically integrated structure gives you the ability to see the whole process, to be a part of the whole process. Therefore, even the person that comes in at 11 o'clock at night has a sense of where what their work does, who it's going to, the impact it has, and that sort of customer experience mindset, all the way to when you're sitting in the patient room. It when you have that integration, everyone that's a part of it feels that spirit that you were mentioning.

Dr. Brandon Mancini

The BAMF difference.

Christine VanTimmeren

I think so. Yeah, let's coin that. Well, thanks so much, Matt. Yeah, this has been great. Really appreciate you joining us. We learned a lot about radio pharmacy. Um, we might have to bring you back because there were probably a lot of things we didn't dive into that we could have dove deeper into, but really appreciate it.

Matt DeLong

Awesome. We'd love to. Thanks for having me. Yeah, thank you.

Christine VanTimmeren

All right, thanks for joining us. We'll see you next time.