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Phillip Koo: Hi, my name is Philip Koo. And welcome back to UroToday. Today, we are featuring a special session to learn more about the peer to peer PYLARIFY reader assistance program from Dr. Michael Kipper, who is clinical professor of radiology at UCSD. So thank you very much, Dr. Kipper for joining us.

Michael Kipper: Thank you, Dr. Koo. It is very much a pleasure to be here with you. I have just three slides to introduce the peer to peer program, which we have been using for a number of months now throughout the United States. In by way of program overview, the first thing is that the purpose of the peer to peer program is to educate healthcare providers on how to accurately read and interpret PYLARIFY scans. Our goal is to improve patient care. The program is complimentary to programs developed by the society of nuclear medicine and molecular imaging. The program is not intended to be either an over read of studies or an exercise in curbside consultation. The end result of each interaction is not to stop the thought process with respect to any given individual patient, but to amplify the thought process.

Following each peer-to-peer session, it is anticipated that the reader will be better equipped to evaluate the scan findings in a more systematic and confident manner. All discussions will remain on-label with Lantheus and the healthcare provider's institution will retain complete responsibility for patient decision making. The benefits of the program... And again, we've been doing this for a number of months now, is that one result of these sessions should be an enhanced understanding and comfort with the language of the PYLARIFY report. For example, what we mean by the threshold for malignancy, when we say consistent with malignancy or compatible with malignancy and the value of the SUV measurement, along with many other aspects. This understanding may hopefully lead to harmonization and standardization of reporting with clear benefits for our patients who are studied at multiple sites. So many of our patients are seen at different institutions and if we can develop consistency, it is much better for a clear and concise read of the patient's study.

The interpersonal nature of these sessions will allow Lantheus to share pearls as well as pitfalls, which we have learned to improve interpretations. For example, the critical nature of patient history, the importance of prior studies, the importance of knowing the patient's medication and treatment information and concepts such as, what the PSA doubling time is all about, where leasing score plays in, the effects of radiation surgery and chemotherapy on scan appearance, and other factors which increase or decrease confidence in reporting.

Summarily, the take home points are these. What we are, is an educational program to enhance one's ability to read and interpret PYLARIFY studies. What we are not, is an overread program or a second opinion service. Who can participate in this? Healthcare providers, including nuclear medicine physicians, radiologists, urologists, radiation oncologists, medical oncologists, and even at times, primary care physicians have taken advantage of the program. Is there a charge to the person participating? The answer is, no. Is there a long waiting period for a response? We at Lantheus, understand that physicians and patients are anxious to receive any help they can, as soon as they can. The answer is, no. Finally, is scan sharing an option? The short answer is, yes. Of course, this must be arranged and might add a little bit more time to the entire process. With that, I'll return back to Dr. Koo.

Phillip Koo: Great. Thank you very much for that overview. So maybe could you walk us through how this might work, the logistics of this? So if I'm a healthcare provider, let's say I'm a urologist. I ordered this on a patient before definitive therapy. I get the results. I have the scan. What do I do next if I have a question and I want to speak with you?

Michael Kipper: Yeah. Excellent question. You should notify Lantheus. And they will either put the calling-in physician, in this case, yourself, directly in contact with me. Or if there is some question that it may not be most appropriate to connect with me, they will offer you advice as to what to do next. But typically, it is a very seamless process of the doctor calling-in and saying, "Hey, I've got a question. I need to speak with somebody." And they will then let me know so that I can then make contact with you very quickly. Would it help if I gave you some examples of the things we've seen at least in the last couple weeks so that you know what kind of questions are being asked?

Phillip Koo: Absolutely. So before I get to that, so it'll really be the Lantheus representative who will make that connection to you or someone more appropriate to answer those questions. Correct?

Michael Kipper: Right. And typically, it will be me. Because if you have a question, usually that means you need to speak with me and you're probably better equipped to ask that question, than they are to answer it. So they'll get you in touch with me.

Phillip Koo: Great. And will there be opportunities to maybe be on a zoom and share your screen so you could see some of the images or whatnot?

Michael Kipper: Yeah. And that would be great, but some sites have not had that option and they wind up sending me a CD.

Phillip Koo: I see. All right, great. Yeah, I think that'd be wonderful next for you to share with us some of the questions you've been encountering.

Michael Kipper: Yeah. Some of the examples are, and these are from various sites, is how do we best differentiate small normal areas of uptake from small metastases? Because all imaging studies have normal variations. And of course, the smaller they are, the more problematic they are for the reader and the reader might need some helpful hints as to how to separate malignancy from a benign process, that is number one. Number two, sometimes the urologists would like to know how do they best evaluate the prostate bed if there is either been a prostatectomy or radiation. And along those lines, how long do they need to wait until they can get a good answer about what may be going on. So the prostate bed presents an important issue for us in a lot of patients. Third, a third one is, what does it mean when uptake is present in normal tissues when it is typically not there, or if it is present in increased amounts?

An example might be, we had a patient who had major uptake in the blood pool, in the vessels, and it was much more than we typically see. So the question then becomes, why am I seeing all the blood vessels? And that is a good question to send our way so that we could either give you an immediate answer. Or if we've not seen that before, we can do the research for you and get right back to you. And then probably the most recent one I had that was, it is actually still ongoing, is the radiologist reading the studies notified us because they felt the scans were poor quality. They were grainy. They weren't used to what they saw in the literature when they looked at PLARIFY. So they... Dr. Koo, just like you asked, they decided to send me a couple of CDs for me to look at.

And the first thing we determine is, is it due to the pet component? Is it due to the CT component? And once we saw that, we then get in touch with them and say, "Look. What we're looking at it. The way we look at it and read it, they look beautiful. So now I've got a list of seven things I want you to do to enhance your ability to read these studies, all kinds of tricks. Anything from changing the SUV threshold, using other color tables, just so using the non attenuation corrected images." So there is a lot of hints we can give them and having those images for us to look at, as you mentioned earlier, makes our job easier. And they can actually look at it with us and then improve the quality of their read.

Phillip Koo: So a very comprehensive service that you're providing that can help with image quality, that could help with protocols, help troubleshoot various issues that might occur with image quality, but also help address issues when it comes to image interpretation. I think that sounds like a great resource that is needed in the community. Any other final thoughts you have that you want to convey to the listeners about this peer to peer assistance program?

Michael Kipper: First of all, we take it very seriously. So we work as quickly as we can. Secondly, we feel that the better the readers are around the country, the better we all are. That is why we look for harmonization and standardization. You hit on a very important point, I won't beat it to death. But the protocols are very important because on one of the requests we got to find out what was going on, it was simple that they weren't starting at the prostate area, they were starting up at the top of the skull and moving down. It is not the way we want to do it. We want to start down at the prostate. So there is no bladder in the way.

The dose that somebody was using was a little lower than we recommended, so we asked them to boost the dose. The amount of time they were taking for each bed stop to take their images on at another site was too low, so we asked them to increase that. So it can be absolutely almost anything. And we're hopeful that we have enough expertise to be able to answer everyone's question in a very rapid manner.

Phillip Koo: Well, wonderful. Well, thank you very much for educating us about this great resource. And again, if any of the listeners have questions about this, just contact your local Lantheus representative, and they can get you in touch with Dr. Kipper and whoever else from the team that can provide that support. So, thank you very much for joining us.

Michael Kipper: My pleasure. Thank you very much.