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Oliver Sartor: Hi, I'm Dr. Oliver Sartor. I'm here with UroToday. I'm a medical oncologist, but in this particular session, we're going to be focusing on radiopharmaceuticals.

Very pleased to have Sergio Calvo join us today. He's the Global General Manager for Theranostics at GE, a really big company; not that well-known, I might say, to the medical oncologist, but that's okay.

So welcome, Sergio.

Sergio Calvo: Thank you, Dr. Sartor. A pleasure to be here.

Oliver Sartor: You know, we're going to be talking about radiopharmaceuticals, and the first thing I would like to ask is about your personal passion for the topic. And I'd like to hear in your own words why this area has attracted you, and how do you think it'll make a difference?

Sergio Calvo: So I started working with nuclear medicine in '99, and since I started, I never quit, because nuclear medicine is a field that mixes physics, biology, medicine, and it was always fascinating to me.

I came in and out of the field, but I worked with nuclear medicine equipment, radiopharmaceuticals, and now I'm working in this fascinating field of theranostics. So I think that once an engineer is exposed to nuclear medicine, it's very hard to get out of it.

Oliver Sartor: You know, I can understand that because it really is an amazing confluence of physics, biology, medicine, and engineering, all of which has to come together in order to deliver on the promise.

Now, you're working with a really big company, GE Healthcare. But interestingly, I think in medical oncology, we're not very familiar with GE Healthcare. And I wonder from a theranostics perspective, if you can help our group, our understanding of what GE is doing now and what GE's vision is going forward.

Sergio Calvo: Yeah, the interesting thing about GE Healthcare is that in its evolutionary process, they acquired Amersham back in 2003. And Amersham was a pharma company, the leading company in contrast media and molecular imaging agents. So we brought that knowledge into GE. And we also invested, we made several investments in the digital space. So today we are the leading company in artificial intelligence space, medical devices with more than 70 systems approved by the FDA.

So we are qualified as a med tech company, but we have a very strong footprint in medical devices, diagnostic imaging, imaging agents, and molecular imaging agents, and also the digital space. And this combination makes us very suitable to serve the theranostics space.

Oliver Sartor: Again, you're probably known for your hardware. Everybody knows about the GE scanners. But a little less familiar with perhaps your devotion to theranostics and some of the radiopharmaceuticals. But now you're in the process of actually acquiring radiopharmaceuticals as part of your overall strategy. And I wonder if you can help our readers and listeners understand this sort of acquisitional nature in the radiopharmaceutical space.

Sergio Calvo: We are in the space of molecular imaging agents. We've been for a long time. And molecular imaging agents are evolving to serve theranostics; and other areas, but the theranostics space is the one that's growing the most: prostate cancer with the PSMA imaging agents and the neuroendocrine tumors.

So this space is growing at unprecedented rates, and we serve the theranostics space, the radioligand therapy space, in multiple ways. It's not only molecular imaging agents. We have cyclotrons producing radioisotopes, radiosynthesis modules. We have PET scanners and SPECT scanners, which are essential to this value chain.

And the demand for more therapies will grow demand for more imaging devices and imaging agents. So we are absolutely engaged and invested in the future of radioligand therapies because we have a strong presence, perhaps the largest portfolio in the industry, with 10 products and services that touch the theranostics value chain in some way.

We don't make the radioligand therapies. This role we believe belongs to pharma companies. But we make a lot of other elements that enable the delivery of those radioligand therapies.

Oliver Sartor: Absolutely. And everything from the cyclotrons to the synthesis modules into the actual imaging.

But one acquisition that was relatively recent caught my eye, and that was in the software area. And I wonder if you might talk about software and how that applies. Because actually, I think it's very interesting, but I'd like to hear your perspective.

Sergio Calvo: Yeah, the acquisition of MIM Software was extremely strategic in this process of serving the radioligand therapy space.

One of the evolutions that we expect is the fast pace of innovation. Besides growth, we expect it to grow twentyfold. We also expect it to be more diverse: more applications, more medical specialties involved. And with this, there will be more paradigms to read the images, more ways to report, more ways to communicate. And they will be different because urology is going to be different than oncology and different than other areas that may be touched by diagnostics.

So being a very diversified, complex space, we need flexibility, adaptability, and agility. And the reason we acquired MIM Software; one of the reasons. There are many; is that they're known to be user-friendly, they're known to be adaptable, they're known to be fast evolving. So we can easily design new protocols, we can easily teach new people how to use it, and we can integrate images from SPECT and PET systems and analyze those images together.

And this type of flexibility, this type of vendor-agnostic environment in software, is super critical to cater to the upcoming complexity of radioligand therapies.

Oliver Sartor: Now, you'd mentioned a little bit earlier, AI, which is of course infusing all of our conversations today. But it seems in many ways that AI may be particularly suited for this complex digital imagery that requires interpretation.

So just for a brief moment, I wonder if you could tell us about how AI is being integrated into your software. And is it going to be making a difference in the near term, long term, or perhaps even now?

Sergio Calvo: It's going to make a major interest in our area for a few reasons.

Number one is the automation of tasks. So when you do a visual interpretation of an image and issue a report, usually the physician doesn't have to account for every aspect of the image. But if we truly would like to extract more information using algorithms, you do have to analyze the image thoroughly and extract all possible biomarkers that you can find in the image; the location of each artifact, lesions or not lesions, the size, position, and so on. And this type of work to extract more information from the images is very labor-intensive. That can be facilitated by algorithms.

But I think that the interpretation part is something that may help because it will facilitate the current work of the physicians, but the true role of AI, in my view, is going to be making predictions that are much more powerful than the ones we see today using the images and other clinical information about the patient on how the therapies will perform.

Today in the radioligand therapy space, there's pretty much one degree of freedom. It's to treat or not to treat. And during the therapy itself, the tactical decisions are very simple. It's pause, stop, or continue. But those decisions can evolve into much more complex decisions. If there are multiple options to treat with alpha therapies, beta therapies, and combination therapies, different types of molecules with different properties, small molecules, biologics—if they all coexist, understanding the best way to treat a patient will require a lot of analytical work. And this type of analysis can certainly be supported by algorithms.

Oliver Sartor: Yeah. Very, very interesting. And I completely agree. The image contains an enormous amount of information, and I have a feeling when I'm looking at an image that there's more information than I can personally integrate and incorporate into my practice. But I see that there's a promise to do more, and I hear your words with the same vision.

So I'd like to move on to your crystal ball, which may or may not be clear or cloudy. I don't know. But I'd like to ask, if you think about five years into the future, how do you think that future will be different than where we are today? What are these important transformational steps in the next five years that you see developing?

Sergio Calvo: Well, our predictions are based on the research that we do with our key opinion leaders; luminary scientists and physicians and nuclear medicine professionals that we work with, and medical oncologists as well. We reach out to a large network of experts to make up our opinions. So they're not necessarily an opinion from our company, but a view from our own clients.

So in the next five years, we do expect new indications, but the growth in radioligand therapies will be driven by prostate cancer because that has a lot of momentum right now. The lutetium PSMA therapies are growing fast in the United States and around the world. There are many programs. The majority of the clinical trials today are in prostate cancer. So the five-year window, at least the next three or so, will be driven by growth in this area.

But we do expect to see, within five years, alpha therapies being approved by the FDA. It's receiving a lot of attention, a lot of support, a lot of investment. We expect two or three more indications besides prostate and neuroendocrine tumors within the next five years. If we open the window to 10, that number is much bigger.

And we don't see a way to reverse this trend. There are too many indicators that lead us to believe that this is going to happen. Number one, cancer biology is evolving fast. So all targeted therapies, not only radioligand therapies, are evolving faster than other approaches to cancer. Number two, there is a lot of attention from the scientific world in this area, meaning more minds thinking about it and knowledge developing solutions. Number three, there is a lot of money and investments going in, billions of dollars.

Those examples are well known in our world, but perhaps for your audience: in the last 10 years, big pharma entered nuclear medicine. They were not here before. Two companies entered in the last decade, and three in the last 12 months. So now it's a total of five large pharma companies investing in radioligand therapies. That is not the underlying reason why it's growing. The underlying reason is biology and knowledge and science. But that's definitely something that will foster growth, because there's more attention and investment coming into the field.

Oliver Sartor: Without a doubt.

Sergio, we're going to be wrapping up here in just a moment, but I wonder if you might have any final comments that you would like our audience to hear.

Sergio Calvo: I think that the radioligand therapy space is very complex, and in order to understand what's going on, you have to be connected to multiple disciplines to understand it. Our company is trying to do that, and we follow very closely those trends.

We do expect the volumes to increase fast. We expect 20 times more patients treated in less than 10 years. So when we make decisions about companies to acquire or how to design the products, we take that into account—things such as upgradability, things like designing systems with ultra-high sensitivity to scan very fast. It's catering to that trend.

The other trend is complexity, as I mentioned, and the third one, we touched on all three, is the growing role of artificial intelligence. Those expectations, those trends that we observe, we correlate them directly to decisions that we make today, like making the systems more accurate from a quantitation perspective, making the systems with as high as possible resolution in order to draw and extract more information from the images.

Everything we do today is to cater to the future of radioligand therapies. And that's why our company is so devoted to making this field grow. We root for the success of medical oncologists like you making better use of those technologies to better treat patients.

Oliver Sartor: That's a lovely concluding statement.

I'd like to thank Sergio Calvo, Global General Manager for Theranostics at GE Healthcare for joining us today. Very insightful comments and very interesting for our listeners. Thank you very much.

Sergio Calvo: Thank you, Dr. Sartor. A pleasure.