Expanding Radiopharmaceuticals for Cancer Treatment: Addressing Supply and Manufacturing Challenges - Charles Conroy

September 5, 2024

Oliver Sartor interviews Chuck Conroy about Nucleus RadioPharma’s role in radiopharmaceutical manufacturing and distribution. Mr. Conroy explains that Nucleus RadioPharma aims to support both small and large pharmaceutical companies in developing and delivering radioligand therapies. The company is building extensive manufacturing facilities across the US, with plans to create more capacity than currently exists worldwide. Mr. Conroy discusses Nucleus RadioPharmas' approach to isotope procurement, emphasizing their ability to work with multiple suppliers to ensure consistent availability. He highlights the company's partnerships with major players like GE and AstraZeneca, and their collaboration with ARTBIO on lead-212 production. Mr/ Conroy expresses optimism about the future of radiopharmaceuticals in cancer treatment, citing their potential to revolutionize patient care across various cancer types. He emphasizes Nucleus RadioPharma's' commitment to facilitating the growth and accessibility of these innovative therapies.

Biographies:

Charles Conroy, RPh, MBA, Chief Executive Officer, Nucleus Radiopharma, Rochester, MN

Oliver Sartor, MD, Medical Oncologist, Professor of Medicine, Urology and Radiology, Director, Radiopharmaceutical Trials, Mayo Clinic, Rochester, MN


Read the Full Video Transcript

Oliver Sartor: Hi, I'm Dr. Oliver Sartor at the Mayo Clinic, here with UroToday, and I have a special guest, Chuck Conroy. Chuck is the Founding CEO of Nucleus RadioPharma, and we're delighted to have you here on the program, Chuck.

Chuck Conroy: Yeah. Thank you so much for taking the time. Really appreciate the opportunity.

Oliver Sartor: Yeah. Tell us a little more about yourself. People who are not familiar with Nucleus RadioPharma may not be familiar with Chuck Conroy. Tell us a little bit more about yourself, and then we'll take that into Nucleus.

Chuck Conroy: Sure. As you mentioned, I'm Chuck Conroy. I'm the CEO of Nucleus RadioPharma. I've been with the company since we founded it back in September of 2022. I'm actually a board-certified nuclear pharmacist by training, so I spent the first 10 years or so of my career doing that. I spent the next 10 years or so after I got out of business school working in big pharma at Eli Lilly, and then back into the nuclear medicine world at the company that's now Curium. But I've spent the last 10 years of my career really in startups and turnarounds focused in the field of radiopharmacy.

Before starting Nucleus RadioPharma, I was CEO of a company called ARTMS that makes solid-state targetry that goes onto cyclotrons to be able to make more isotopes. Before that, I ran the Jubilant RadioPharmacy distribution network, who are the folks that deliver these radioisotopes across the country.

Certainly in those two roles, I was able to see and really wanted to form Nucleus because we were able to see that the science of radioligand therapy was advancing rapidly, but didn't see that the infrastructure was actually going to be there to be able to support it. Alongside Mayo Clinic and a fine investor team out of Eclipse in the Palo Alto area, we're happy to get this company up and running.

Oliver Sartor: Terrific. So Nucleus is not focused on developing drugs; you're focused on developing the ability for companies to deliver these novel radiopharmaceuticals. Is that the right way to put it?

Chuck Conroy: That's 100% correct. We actually are formed with really two goals in mind. One is that we see many different companies ... There have been about 80 companies that have come up in this radioligand therapy space within the last five years ... We want to help them get through the clinical and regulatory process to make sure that their ideas that are fantastic in this field can actually go from ideas to sometimes being a commercial agent. And then additionally, because these drugs are so difficult to manufacture and also to ship, we want to make sure that we can build out the infrastructure across the country to make sure that these drugs can get from the plant to the patient. So that's really the two goals and objectives that we have as a corporation.

Oliver Sartor: I think some of the big players like Novartis have probably brought attention to this supply chain issue by having a big rollout and then, how shall we say it, not quite delivering on the promise. But you mentioned about 80 companies that might be sort of entering the space. How many of these actually have manufacturing in place? I think I'll begin to see your opportunity when you expound on this.

Chuck Conroy: Yeah, really very few. Even the ones that do wouldn't have the capabilities to produce anything at scale. So certainly we see that the need is to get there to help these companies get through the clinical and regulatory process to get approved. But more importantly, when we get a few years down the road, and certainly Novartis has a great drug out in the marketplace in Pluvicto today, but as more of those agents come to the market, it's really such a specialized methodology to be able to make and produce these drugs that we don't think ... It's not what a pharma company is used to doing.

I worked at Eli Lilly for a period of time. We just didn't handle radioactive materials. That's not something a company of that size, even with a great skill set, is used to doing. A completely different regulatory and staffing process and a different shipping and receiving process. So we think that specialization in this area is really going to be a more effective way for these companies to be able to deliver this.

Then of course, we'll spend about $100 million over the next year just building our facilities. That's not something that a smaller, innovative company that's coming up from a benchtop can actually do. So we think that we're going to play a very big role in the marketplace, making sure ... As you mentioned, we don't see ourselves as being the innovators of these drugs, but we really see us playing a key role in making sure that when the drugs do become developed, that they can actually be delivered.

Oliver Sartor: Yeah. It's, to me, obviously, an opportunity that you have. If I can kind of read between the lines, you see opportunities not only for the little companies that don't have the manufacturers, but maybe even the bigger companies that currently do. Is that kind of a correct way to phrase it?

Chuck Conroy: That's 100% correct again, so you're batting 1000. We really see the opportunities across the entire spectrum of delivery. We can help small and large companies, whether it's in the very early stages of the drugs being developed. The CMC stage is kind of the phase zero, if you will, of the drugs being developed. But also when agents come to market, we can act as either the primary supplier or suppliers for larger companies as they get new indications and as they expand. We think that some of these companies for sure are going to go and have some of their own manufacturing capabilities, but we don't believe that they'll be able to expand as rapidly as they'd like to or be able to treat new patients in different areas without some help from other folks like ourselves.

Oliver Sartor: It's a little bit interesting, you're going to be taking drugs and you're going to be taking isotopes and putting them together. Let's talk a little bit on the isotopic side. Recently there's been a lot of publicity about shortages of isotopes. Now that's going to be your basis for generating revenue. If you don't have the isotopes, you're not going to have the drug. So what are you guys doing to be able to procure the isotopes that you need? Particularly some of these things like actinium-225 that are currently problematic?

Chuck Conroy: Mm-hmm. For us, we don't see ourselves as being an isotope producer, but we do work with all of the very strong manufacturers that are out there and some of whom are just coming to market now. Whether it's our agreement with NorthStar or partnership with SHINE, we look at making sure that we can get these isotopes into different molecules as they're able to come to market.

One of the things that we think we can help pharma with that they're just not able to do as easily or as efficiently as we are, is we'll work across the spectrum with all manufacturers to make sure that they can get tested and approved for uses in different types of drugs. What you'll see often with a pharma company is they'll contract with one type of isotope manufacturer, one isotope manufacturing company, but because of kind of the difficulty and the scale of going out to five or six other companies that may produce the same isotope but in a different fashion because of some of the regulatory hurdles that are there, they won't go through and complete that process. That's one of the things that we're helping those companies do, and that way if a different manufacturer has isotope available that is not the main supplier for that pharma company, we do go through and make sure that we've cleared the clinical and regulatory hurdles so that those different isotopes from different manufacturers can be used.

Oliver Sartor: I know you're setting up initially in Rochester, but I wonder if you might give us a little bit of a vision about where you see Nucleus developing because some of the short-lived isotopes, and I'll say lead-212, you're not going to be able to just have one spot, you're going to have to have multiple. How is that going to work out?

Chuck Conroy: Yeah. So we're currently finishing out our Rochester facility. The Rochester facility is located very close to the Mayo Clinic, within a half a mile or so, and that's about a 15,000-square-foot facility for us, and we'll have that completely ... We'll have our development lab done by the end of this year and be producing GMP doses out of there very early next year. In addition to that, we're building out two very large facilities that we'll be announcing very soon, one on the East Coast and one on the West Coast that will significantly alter the state of manufacturing capabilities across North America. So we'll actually be putting into the ground more manufacturing capacity than exists across the world today.

So very excited about the expansion that we will have, and that's in partnership ... We've had some very good investors, we have some nice strategic investors, and it's in a good partnership to make sure that we can meet the needs of the market as it continues to develop. Those facilities will come online in '26, if you will, in 2026, and we look forward to the commercial market developing by that time so we can make sure that they're used to their full capacity.

Oliver Sartor: Did I hear that your ambition is the world's largest manufacturing for radiopharma?

Chuck Conroy: Yeah. So we certainly look at it being that way. I think across the facilities that we'll have in Rochester plus these other two facilities, that's kind of the first wave of development for us. Then we're looking to continue expansion across the United States and North America as well as into other countries as we head down into '26 and '27.

Oliver Sartor: Very interesting. I noted in your Series A, which you haven't mentioned was really quite successful. You've been oversubscribed, and you got some big hitters like GE to come in, so I think that's a pretty strong endorsement of the vision right there.

Chuck Conroy: Yeah, thank you. We were very happy with having GE along with AstraZeneca in there, I think as strategic folks as well as a nice mixture of other folks that are capital and some other. I'll say folks that are also related to this field. We have a very good relationship with our investors, and we continue to look at how we're going to expand and how we're going to expand alongside those companies and others as we continue to grow.

Oliver Sartor: Terrific. You have one announced partnership with ARTBIO that I'm aware of. I'm not going to ask about anything that's underway, that'd be proprietary. But ARTBIO has the lead-212 platform, and that seems to me in huge need of a distribution network. Are you going to be able to create distribution networks from just three sites, or is it going to take more?

Chuck Conroy: Well, I think initially it's going to be coming out of the three sites, but we are looking at additional facilities as we continue to grow. I will mention too that we really enjoy our relationship with ARTBIO. We see a great future for lead, but as we continue to develop these facilities, we're looking at becoming and remaining isotope agnostic. So all of our facilities are able to handle a broad spectrum of the therapeutics, whether they're alpha or beta, as well as the diagnostic agents as well.

We spend a lot of time, effort, and money to make sure that we can handle kind of whatever comes up, either what's on the radar now or what will be in the future. So whether it be actinium, lutetium, lead, any type of isotope that comes in, we can actually handle that across any facility that we're designing.

Oliver Sartor: The next question is maybe kind of going back to the beginning, but you've had a broad background in radiopharmacy and more, but why radiopharmaceuticals? Why do you see the particular opportunity in radiopharmaceuticals now?

Chuck Conroy: Yeah, so I think the success is going to lie in the idea that if you're able to see it, you can treat it. One of the things that we find when we're working either with payers or with physicians is this idea when you give the diagnostic agent, you can actually get a pretty clear linear path to the therapeutic agent, and that inspires a lot of hope for the patients. So they can go in, receive a scan of a diagnostic agent, they know that the treatment that they're going to get tends to be very effective and efficient versus some of the chemotherapies that you can run or other treatments that you can run where the patient can be treated and not have much of an effect. Additionally, and as you know better than I, they just seem to be very effective treatments if we're targeting the right patients.

Oliver Sartor: Yeah, absolutely. Chuck, we're going to be wrapping up here in a second. I wonder if there's anything else that you might want to say to our viewers, our listeners, so that they can appreciate what you and Nucleus Radiopharma are doing today.

Chuck Conroy: Yeah, I think the biggest takeaway for us is we truly believe that the way that cancer is being looked at and being treated over the next 10 years is going to shift drastically. We do think that these types of diagnostic agents paired with the therapeutic agents are going to be a major revolution and a major evolution in what we're actually seeing out in the marketplace. So we look forward to continuing the growth with the types of tumors that we've identified today in the solid tumor area, but also see a lot of potential for this therapy.

Right now, we're certainly looking at prostate cancer and other things, but as we expand into breast, renal, and other large areas, we think that this field is going to continue to grow, and more importantly, we're going to be able to help millions of patients across the world be treated in a manner that I think is much less invasive than some of the treatments that are out there today.

Oliver Sartor: Well said, Chuck. Thank you very much for being here with UroToday. Appreciate your insights, appreciate your vision, and I think I can see the need quite readily. We've got lots and lots of companies, lots and lots of ideas, which you're going to be providing the manufacturing that'll turn this into reality. So again, thank you for being here on UroToday.

Chuck Conroy: Yeah, thank you again for the time. We truly appreciate it.

Oliver Sartor: Okay.