Celebrating World Theranostics Day with Theranostics Expert Dr. Harshad Kulkarni

In this special World Theranostics Day episode, Christine VanTimmeren and Dr. Brandon Mancini are joined by Dr. Harshad Kulkarni, Chief Medical Advisor at BAMF Health and a global leader in theranostics, to discuss how this innovative approach is transforming cancer care and beyond.

We break down what theranostics is, how it combines diagnostics and targeted therapy, and why it represents one of the most powerful shifts toward truly personalized medicine. Dr. Kulkarni shares his global experience, insights from early adoption in Europe, and how theranostics is rapidly expanding in the United States.

We also explore the growing pipeline of clinical trials, the role of imaging in selecting the right patients, and how this approach is improving patient outcomes, quality of life, and survival. Finally, we look ahead to the future—where theranostics could extend beyond cancer into diseases like cardiovascular disease, Parkinson's, and more.

00:00 Intro & World Theranostics Day
 00:41 What Theranostics Means
 02:19 Meet Dr. Harshad Kulkarni
 02:54 How Dr. Kulkarni Entered Theranostics
 04:20 How Europe Advanced Theranostics Earlier Than the U.S.
 08:12 Why Imaging Is Essential to Theranostics
 09:59 “See What You Treat, Treat What You See”
 12:30 FDA-Approved Theranostics Today
 15:59 Beyond Cancer: Alzheimer’s, Cardiology, and More
 17:43 Why Theranostics Isn’t Available for Every Cancer Yet
 21:46 Real Patient Outcomes & Quality of Life
 25:34 What’s Next for Theranostics
 27:11 Closing Thoughts & Learn More

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Transcript

Christine VanTimmeren 0:05

Hello and welcome to the BAMF Health Podcast. We're your hosts, Christine Van Timmeren.

Dr. Brandon Mancini 0:10

And I'm Dr. Brandon Mancini.

Christine VanTimmeren 0:12

And today is a very special episode because today, in fact, is World Theranostics Day, and our guest is an OG in Theranostics. This is a big deal for BAMF.

Dr. Brandon Mancini 0:26

Absolutely, yeah. Kind of as the world leaders in Theranostics, right? One day per year, March 31st, kind of a dedicated time to celebrate what Theranostics is, what it means, raise awareness, uh, and make sure that we're educating the world in this space.

Christine VanTimmeren 0:41

So, in the most simplest terms for those who don't know theranostics, never heard of the word, don't know what theranostics is, explain it for us.

Dr. Brandon Mancini 0:50

Sure. So Theranostics is literally the combination of the term therapy and diagnostics. And so what does that mean? So a diagnostic is things like CTs, MRIs, kind of scans that show us the inside of the body. And so for Theranostics, that diagnostic is a PET scan. In a PET scan, you get a little injection. And what it is doing is a radioactive material is circulating the body and it's adhering to a target that is on a cancer cell, kind of in the primary space that we work, or in the environment of the cancer cell, but it's not really expressed elsewhere in the body in high concentrations. And so it's identifying a unique target that's unique to that cancer or in that cancer environment. And so after the diagnostic confirms that the thing is there, uh the theranostic or the therapy that goes along with that swaps out the imaging tracer that is showing us where it is for a therapeutic radio tracer. And so when you get that injection for the therapy portion of it, that therapy is engineered to go stick to that same target we already proved existed.

Christine VanTimmeren 1:55

Okay. So you need both.

Dr. Brandon Mancini 1:57

Yeah. So it's literally this precision-based medicine kind of by definition, right? It's find target, ensure it's there, give treatment that only goes to target. And so when you combine that, that's Theranostics. And it's really this rapidly emerging subset and subspecialty of medicine here in the United States, but really hasn't been that kind of new throughout the world. And so we're very, very blessed today to have uh a world expert with us today, Dr. Harshad Kulkarni, BAMF Health's chief medical advisor. So thank you so much for being with us today.

Dr. Harshad Kulkarni 2:29

Thank you so much, Brandan and Christine, for having me here on the historical day.

Christine VanTimmeren 2:33

It is World Theranostics Day, and on World Theranostics Day, like I said, we truly have an OG in Theranostics. The expert in Theranostics. So you speak around the globe about theranostics. You've practiced it for many years, you have decades of experience. Um, like we said, theranostics isn't new. It's been practiced for a while. Um tell me about what brought you to Theranostics in the first place. There's all sorts of fields of medicine. This one is sort of still new and emerging. So, how did you end up in Theranostics?

Dr. Harshad Kulkarni 3:11

That's that's really uh good. So, when I was in medicine, what really uh fascinated me and what I fell in love with is seeing the biology in action. Uh, and uh, you know, once I saw a uh radioiodine scan, which uh where the tumors lit up like a like a Christmas tree, and the patient received the iodine treatment, and then uh in the in the follow-up scan, uh the uh the the scan was completely clear. So uh so it's just not only seeing the biology in action, historically, imaging has relied on seeing the anatomy of the disease, uh, but this was uh this was a functional imaging of the disease, and then also targeting uh the fundamental uh uh fundamentals of that particular disease, which uh which was not uh previously uh the case. And then uh um because this unique field also combines physics, chemistry, and patient care. So uh that was that was my uh foray. This is exactly what I I was going to do, is what I decided 20 years ago.

Christine VanTimmeren 4:15

20 years ago. And that the field has changed quite a bit.

Dr. Brandon Mancini 4:19

A lot, yeah.

Christine VanTimmeren 4:20

Yeah, yeah.

Dr. Brandon Mancini 4:21

No, it's an amazing because your experience kind of supersedes what the American experience has been, right? Uh can you explain some of your time in Germany and kind of ultimately how you saw things evolve even in those early years? Certainly.

Dr. Harshad Kulkarni 4:34

Uh, I mean, uh the there are obviously regulatory differences between Germany and the US. Um the way in which novel techniques, whether it is for imaging as well as therapy, are adopted in Germany, uh, is also there are special clauses in which uh for patients uh who have uh exhausted all their treatments, one can actually uh do a um compassionate use imaging as well as therapy. And these sort of options really help to bring the rapid translation from the bench to the bedside, so from the lab directly into the patient. Um now what we have seen in the US is obviously with this increasing trend of uh as the theranostics becomes more and more, or people become aware of the theranostics, especially after um PSMA targeted radioligand therapy got the FDA approval, uh, we are seeing that this translation becoming more and more rapid. There is industry taking part in the development of different clinical trials for really hundreds of thousands of uh of radio pharmaceuticals or promising radio pharmaceuticals for targeted imaging and therapy. But coming back to Germany, Brandon, uh so this particular uh um this particular concept of uh of you know compassionate use that uh that that really uh you know promoted um the development of a lot of uh a lot of imaging as well as therapy modalities. Uh, I was I was also uh fortunate to to work with uh with with Professor Richard Baum, who's also considered a pioneer in theranostics. Uh and and uh I also developed a mindset in which you look at not only um not only treating the disease, but treating the patient as a whole. Um and the training of nuclear medicine for which I was really um fortunate in Germany is it's uh it's much more internal medicine oriented. So one has to look at, and Brandon, you're a radiation oncologist, so you look at uh, you know, when you're treating the patient, you look at different facets of of the disease or or this or managing the side effects. And that's how that's how it uh it really came into being.

Christine VanTimmeren 6:41

And so you heard about this field of medicine, medical approach. It's sort of referred to in both ways. So you hear about it, you think, wow, this is cool. You end up in Germany where you were then able to practice it. And the reason we're talking about Germany is because it wasn't in the United States, right? You could only do it, practice it, get it over there.

Dr. Harshad Kulkarni 7:02

That's correct. So um essentially, you know, you mentioned radioactive iodine, which was uh first administered uh by Saul Hurtz uh on this day, actually, uh in 1941. Um so uh so it has come a long way. So the concept of theranostics is has always been there. Uh what really triggered or uh this particular uh revolution is uh is is using uh you know uh the same molecule uh as you explained in your opening statement for uh for imaging as well as uh therapy. And and essentially uh because of these compassionate use or or other adoption techniques, these uh treatments were available only in in Germany. And it took a long time. Um, so in 2017, the first uh uh the first phase three uh clinical trial for uh for the FD approval, which led to the FDA approval of uh Lutathera for neuroendocrine tumors. And then eventually in 2022, we got uh Pluvicto, which got FDA approved. And since then, uh since about um uh two to five years, I think there's been a lot of interest in this particular field.

Christine VanTimmeren 8:11

We hear a lot. Uh I I think I thought this when I first started working at BAMF, and then other people who get introduced to this field of medicine, medical approach, they think, okay, you're providing a treatment. Yes, we're providing a treatment. What they don't understand is that connection to the molecular imaging and the imaging that has to happen first, and that they're they're one in the same, they're connected. So talk to us more about why it isn't just we deliver this theranostic treatment, it's just a therapy, why the imaging part is essential.

Dr. Harshad Kulkarni 8:45

That's a great question, Christine. So most most uh people uh you know uh associate theranostics with treatment only, which is which is partially true because theranostics is really the combination of imaging and therapy. So imaging is the the the foundation stone, really. Once you once you see the target, once you characterize the disease, you are actually seeing the uh the biology. And then as a next step, you can actually make sure that there is target is present and then use the therapeutic uh missile. So uh so it's it's uh it's it really is like it's like a GPS that you send the GPS first, you localize, and then you send the missile, right? So uh so it's really uh yeah imaging forms uh an important integral part of theranostics, which really helps you to uh select the patients who can benefit the most for the treatment. You can uh use that imaging modality for follow-up after the patient has received the treatment because the concept is the same. So you can you can actually assess how the target is changing over time, and then you can you can um uh really adapt your treatment and it's not uh and not make it a one size fits all. So imaging is what really permits that.

Dr. Brandon Mancini 9:59

Yeah. I remember the phrase when I was working with you in Germany, right? See what you treat, treat what you see. And so that phrase you hear at national and international meetings. So it's one of the only therapies in the world that has that phrase applied to it, right? You can literally see where the treatment went, and that's pretty remarkable and it resonates well with patients. You can see your treatment working with each treatment delivered. And it is much different than chemotherapies or other types of medicines that we give, where you give a therapy because it was proven effective, um, but you never had to prove that that was going to work before kind of embarking on that. So we try to utilize imaging to Dr. Kulkarni's um uh statement, where you're selecting patients that are deemed most likely to benefit uh by undergoing that scan first and then embarking on treatment. So again, that personalization, that making sure that what we're about to uh give you from a therapy perspective has high chances of working and improving your life. So yeah, great point.

Dr. Harshad Kulkarni 10:59

And uh and you you uh but you know, uh on on this particular day at least one has to emphasize we see what we treat and treat what you see. So uh so you know the the beauty of uh theranostics or radio theranostics or theranostics using radiopharmaceuticals is you can also uh see what you're treating, right? Not only treat what you're seeing, but uh but under the treatment, the patient can undergo uh what we call SPECT scans or you know, imaging uh of what or really assess where this therapeutic radio pharmacy is going, which is which is like unparalleled, right? You cannot see where chemotherapy has gone, where you cannot see where a targeted antibody therapy is gone. But having said that, I think that uh uh that seeing what you're treating is of course important, but more important than that is also treating what you're actually seeing. If there is a target, then you treat it. If there's none, then the patient's not g oing to be uh going to benefit. So it's really personalized medicine.

Dr. Brandon Mancini 11:56

Yeah, and I think we use those treatment scans, right? The patient gets a treatment today, for example, they come back tomorrow and get a scan. We can use that to provide rapid feedback as to how the treatment is going. Sometimes it modifies what those next few weeks would look like for that patient. It might mean that they should go see another physician for help in a different way. And um, so it's just that instant feedback that really resonates well with people undergoing that therapy. Um, and yeah, it's just revolutionizing the way we approach it because we can see so much and uh make sure everybody's on the same page each and every day.

Christine VanTimmeren 12:29

So right now there are two FDA-approved treatments for two types of cancer. We have prostate cancer and then neuroendocrine tumors. However, it will not always be that way. What is happening in the industry is that there's all these other drugs in the pipeline for all of these different types of diseases, not even only cancer. So talk to us about where this field is headed, sort of where it is now, and then where it's headed in terms of its expansion into other conditions.

Dr. Harshad Kulkarni 13:02

Yeah, that's a that's a great question. So we are just just at the start, as you mentioned, right? Um that it has to expand into multiple other diseases. So Theranostics has really made it possible to really not concentrate on one or two diseases, but the concept can be really generalized and also reaches uh kind of a lot more patients than uh than these two diseases. So you're talking about novel targets, you're you're talking about uh novel isotopes, which have got better properties for for uh for targeting, that is killing the cells at the same time sparing the normal tissue. You're talking about uh, you know, also development of novel ways in which you can you can target these particular diseases. So it's uh so the question is uh it's gonna be less. Uh can we treat? The question is gonna be how smart or how intelligently, how precisely we can treat moving forward. And that's really what excites me for the coming uh two to five years and five to ten years as well.

Dr. Brandon Mancini 14:00

And really in the pipeline, like for clinical trials, right? At BAMF Health, we have dozens and dozens of clinical trials addressing roughly about 15 different cancer types. So those are all early phase trials where we're kind of going down that same pathway, right? They've developed a molecule that can identify a unique target. And then you have the diagnostic and the therapeutic combined to really understand how impactful, how many people can uh have their disease status improve as a result of these novel therapies. Um, and so it's gonna be exciting to see kind of how many new targets. And to your point, I mean, there's literally hundreds of trials from a lot of different uh pharmaceutical companies and academic institutions and beyond. Because of the success of the prostate cancer and neurondocrine treatments, the investment scientifically into finding more targets, better targets, improving these treatments has been exponential in these last couple of years, right? Some people have even deemed that theranostics will be the next pillar in oncologic care because of what kind of global broad impact they're anticipating. So it's pretty remarkable when it's all said and done.

Dr. Harshad Kulkarni 15:08

Absolutely. And uh and then, you know, uh centers like it is expanding um to centers, to community centers, which can reach many more uh patients, not just limited to the academic centers. And and then, you know, uh with with these clinical trials, that is, that is definitely a revolution. And previously, uh it was um, you know, once once you see one particular successful treatment, and then obviously there is uh there's really all boats rise. So, you know, industry, uh pharma, even the regulatory FDA is also becoming more and more aware of these uh these successes in and and making sure that these trials are are are getting uh you know initiated start uh fast as well as you know the the trials which have got positive results also turn into FDA approvals uh fast. So I think it's it's it's it's a great time to be in theranostics.

Dr. Brandon Mancini 15:58

Yeah.

Christine VanTimmeren 15:59

So there's oh go ahead.

Dr. Brandon Mancini 16:00

I was gonna say just go even going beyond, right? Because the majority of what we do is cancer-related therapies and theranostics kind of are in that space. But how do you see things evolving like in non-cancer related treatments? That's a great question.

Dr. Harshad Kulkarni 16:14

So theranostics essentially, you know, uh relies on using a particular target on the disease. Once we uh identify that molecular target on the disease, the same concept can be applied. Uh to what extent it would be both imaging as well as therapy is for time to see. But one uh thing which uh instantly applies is the imaging part of it. So that you can actually treat only what you're what you're seeing. So um so things like um cardiovascular diseases, inflammatory diseases, fibrosis, uh, neurodegenerative disease. One classical example is your Alzheimer's disease, right? Where you're using a targeted PET, an amyloid PET for localizing and making sure that the that the target is present, and then the patient uh comes in uh later on to get a targeted therapy. Now, one one might say it's it's not a radio pharmaceutical therapy, it doesn't have to be, right? The whole concept is uh to make it more personalized, to make sure that that the that only the patients who have the target really uh really get that particular treatment. And and and that way um it'll reduce the side effects, it will make the uh make the treatment more uh beneficial for the patients because we have we have cleverly selected the patients. It also permits follow-up. Uh and and eventually uh this paradigm can be uh can be really expanded to to all the diseases once you identify a particular target or a particular mechanism in that particular disease.

Christine VanTimmeren 17:44

So you've got people saying, okay, cool, this works really well in prostate cancer, neuroendocrine tumor. Okay, let me get it for breast cancer, let me get it for colon cancer. Like, why can't I do that yet? And I think the clinical trial pipeline and sort of the struggles and obstacles of moving them fast are what's holding us back. So talk to us about yes, we know this could be applicable to other diseases, and yes, we want to be able to offer it right now, but there is a problem in getting it over the hump fast enough for people.

Dr. Harshad Kulkarni 18:20

Yeah. Um, I think again, I'll uh go back to the fact that in the clinical trials, like we have uh, you know, there has been a revolution in the in the past two years, we have really seen exponential rise in the in the clinical trials, investigating novel targets, novel isotopes, novel diseases, uh, a large number of cancers. So we have got uh trials uh which are which are targeting at least 50 different uh types of cancers, including breast cancer, by the way. So uh so essentially um you know one has to one has to uh of course uh patiently wait until we really prove the uh the uh that these treatments are are safe and effective. Um one of one I would like to definitely emphasize that clinical trials always offer the opportunity to the patient to have an access to these novel treatments at an earlier stage, which otherwise was not possible uh 10 years ago, because these clinical trials, the radio pharmaceutical clinical trials did not exist. But now with uh with with um with the regulatory as well as the the industry uh bringing in all these clinical trials and of course you know supporting the scientists and the researchers who have who have uh invented and discovered all these all these novel techniques. So I think um uh that way uh clinical trials offers you a very good option of uh um of really access to these novel imaging as well as therapeutic techniques.

Dr. Brandon Mancini 19:41

Yeah, and I think it's been neat to see like there's still a ton of investment in the prostate cancer and neuroendocrine space, right? We have the two FDA-approved treatments, but people want to get better within that space too. And obviously they're ahead of the curve in the sense that they had the two FDA-approved medications, so you can start iterating. Can we do better than what we've been able to prove? And then a lot of the new trials are more what are called basket trials. And so you find a target that's actually more applicable to a large number of different tumors. And so it extends the access to a lot of different diagnoses. So it's not just a breast cancer treatment or a lung cancer treatment. It's a treatment that targets this unique protein, which is overly expressed on all of these different tumors. And so it's more opportunities to understand how well and in what tumor type. So that's that whole biologically driven therapy. It's not just a diagnosis. It's like if you, if the target's there, you should be eligible or you should have that chance, which we've seen a lot of momentum in that last year or two in that space.

Dr. Harshad Kulkarni 20:44

And then one thing I'll I would also add on to that is you know, we we see what we treat and treat what we see. So again, you know, one one should also ask, if you're seeing it, why not treat it? So and and that's what's really happening uh also in prostate cancer where uh where you know experience from uh from Germany and and other countries also uh also proved that these these two treatments can be safe and also more effective, perhaps, when started early on. So we've already seen uh one particular clinical trial uh called PSMA 4, resulting in the pre-chemotherapy approval of the PSMA targeted radioligand therapy of Pluvicto. And now we now we are uh we are uh on on the on the uh on the brink uh of getting this even in earlier or more sensitive phase of a prostate cancer, in which uh it can it can possibly be even more effective. So clinical trials is uh really are important to really prove uh these. And I think this shift of offering an earlier radio pharmaceutical therapy is really promising.

Christine VanTimmeren 21:46

So, speaking of effectiveness, we've said this works really well in the two uh cancers that currently have FDA approved therapies. Tell us about that effectiveness and the the patient outcomes. we're seeing and and you've seen throughout your career.

Dr. Harshad Kulkarni 22:03

Yeah, I mean uh the the clinical trials would would mention overall survival, progression free survival. But as a as a clinician, as a as a caregiver of a patient as well, when you see uh that the patient who was not able to walk before, uh, was was wheelchair bound um as a late stage prostate cancer after the treatment can actually walk. I mean I've seen we have we had one particular patient uh who came to us from Romania uh to Germany so that's about 1600 kilometers I don't recall in miles but maybe a thousand miles. Um so he drove uh so so he was wheelchair bound and and and and he had to be driven uh so he came for the first uh first treatment uh he had to be driven and for the second treatment he actually drove most of that 1000 miles so that so seeing these kind of changes uh really make this uh make this game changing so uh improvement of the quality of life it's ultimately about um you know uh it's it's not just offering treatment it is offering a hope so um of course it it prolongs the life so for neuroendocrine tumors which which typically is a slow growing tumor but you can see that with the targeted radio pharmaceutical therapy you see years of remission and and years of survival same patients uh you know living for uh for 22 25 years with this particular so it becomes more like a chronic disease like hypertension um and and so it's it's all making that that impact and the quality of life spending more happy uh uh you know moments with your friends and family is is is what is really motivating but of course uh safety and and effectiveness in terms of uh you know very minimal side effects uh as compared to uh to to other treatments as well as you know longevity of life is is something which which is of course uh has been well documented yeah and I think it's rare to have a treatment that works well in most people also simultaneously not have many side effects and so that's that big kind of therapeutic uh kind of gain in that space so again a treatment that works well in most people and they're able to have improved quality of life as a result of that is what makes it suit uh very revolutionary, right?

Dr. Brandon Mancini 24:19

And um it's all about that precision medicine, right? Treatment goes exactly where the targets are. You kind of excrete out what you don't need and then it's uniquely treating those spots kind of for for several weeks. And so um it's been exciting we've even seen some of those similar type of um experiences for patients treated in the US at BAMF Health where people have substantial improvement in pain and baseline kind of functional day-to-day status. And I think the beauty is it's just the beginning, right? This is a whole new added tool to the toolbox of treatments that didn't even exist here in the US four years ago, which isn't that long and now it is there and it's getting better and it's prolonging quality and quantity that didn't exist. And I think that's the conversation we have each and every day with patients cancer is becoming something that hopefully can continue to expand on being managed like a chronic disease. We do it every day high blood pressure diabetes people are on medicines for that they might need to switch them but the more effective treatments you have with high quality of life and adding that months and years that's how you continue to kind of uh improve people's lives and uh make a big impact and that's exactly what Theranostics seems to be doing.

Christine VanTimmeren 25:32

So it's an exciting time to be in this field and I think you said that uh we have a few more minutes so where what are you excited for as you think about where this field of medicine is going, your role in it, BAMF's role in it. What are you excited for?

Dr. Harshad Kulkarni 25:50

I'm I'm really uh excited about the fact that it's it's it's going to reach many more patients uh and and of course BAMF as a vertically integrated theranostics center is really uh with its expansion as well is making sure our mission is really to to make sure that this uh the theranostics reach every reaches every nook and corner between the US and eventually uh in the world so uh so I mean accessibility is is definitely one one limiting factor uh at the moment and and currently it is as you mentioned you know there are two diseases in which FDA uh has approved the treatments for so I'm really extra excited about the next two to five years where where we can actually uh offer this treatment to a lot more uh patients a lot more diseases a lot uh including of course uh cancer and of course at an earlier stage and offer a personalized treatment uh so um the clinical trials the way in which these are designed is typically to test a one particular dose or or one size fits all uh and and and one has already seen in in many of the trials which we are doing Brandon uh in which you know it is more adaptive so um so I I truly see the field in which uh the uh the way in which we deliver theranostics is going to become more and more personalized. So we are here for precision medicine.

Christine VanTimmeren 27:11

It's exciting all right you've heard about theranostics you've never heard of it before today World Theranostics Day go out do some in uh some research go to our website bamfealth.com go to our YouTube page we have lots of information about theranostics um yeah do yourself a favor learn more about this incredible field of medicine that's emerging and gaining in popularity and really making a difference in patients' life so thank you we really appreciate you being here it's my pleasure and happy World Theranostics Day. Happy World Theranostics Day. We'll see you next time