Name: The State of Radiopharmaceuticals: Growth, Challenges & What’s Ahead
Uploaded: 2025-10-01T03:16:15.219Z
Duration: 1 h 12 s
Description: The State of Radiopharmaceuticals: Growth, Challenges & What’s Ahead

Transcript for "The State of Radiopharmaceuticals: Growth, Challenges & What’s Ahead": Hello, everyone, and welcome. My name is Dylan Stoy, and I'm the global director of therapeutic strategy at PSI CRO. But more specifically, I've spent the last number of years overseeing the growth and development of our radiopharmaceutical portfolio and developing capabilities which aim to address the specific nuances that radiopharm trials pose to the traditional approach in clinical research. I'm honestly thrilled to have the chance to talk about some of the things that I've seen working in this space over the years as well as some of the things that the industry at large has realized. Let's take a look at what we'll be covering today in this webinar. So first, I plan to talk about radiopharma as a whole and why it's important as well as some of the a quick look at sort of some of the things that got us here. Next, we'll take a quick look at the current trends in the space. We'll discuss how the industry is evolving and what the data shows us is coming next. We'll review the challenges that the current landscape poses and how we need to grow and scale to meet the needs of this maturing drug class, and then we'll kind of wrap things up at the end with a quick summary. So without any further delay, let's dive right in. We'll get started with the importance of Radiopharm and how we got here. What is it exactly that makes Radiopharm hot? And, yes, pun definitely intended. Now for me, if I think about why Radiopharm is so special, I don't have to look much further than the patient impact and the scientific interest. Let me explain. First of all, at its very core, radiopharma allows us a very unique opportunity to see what we treat. Now being able to apply this diagnostic approach to characterize and observe the potential activity of a therapeutic to the extent which this intervention allows is something that's truly unprecedented. It creates an environment where high efficacy outcomes with relatively low adverse effects can be achieved and conceptually takes this idea of precision medicine to a whole new level. And this was shown early on with some of the trailblazers and first comers into the space. So if we look at trials like the NETTER program, showing a reduction in risk of progression by nearly seventy two percent in patients with neuroendocrine tumors when adding Lutathera to octreotide regimens versus using octreotide alone. Also, we see similar things in the VISION trial where mCRPC patients using Pluvicto saw an improved overall survival of nearly four months over standard of care alone and a much more durable response in RPFS, with a median of about eight point seven months. Additionally, the mechanism lends itself well to combination therapies, and in composition, these products are relatively easily adaptable. Various parts and pieces acting almost like Lego blocks where isotopes targeting molecules and the various components can be swapped out and changed to achieve a very specific outcome. Some are even looking into the use of other vehicle molecules to multiply that therapeutic potential using things like antibodies and other components in place of base peptide tracers. Now this is all very exciting, but let's take a moment to see how we got here. And as much as I'd like to take a stroll through the comprehensive history of radiation research and start to analyze the various discoveries that allowed us to get to this point, that would require a much longer webinar, and nobody wants to sit through that with me. Trust me. So instead, I'll borrow this figure from Zhang and the group out of Beijing, that they put out in their nature publication on radiopharmaceuticals and their applications in medicine, because I think it does a pretty good job of illustrating the point, which is that I think it serves as a humbling reminder that we are in a very exciting time of discovery and development, but it's important to recognize and understand that we're operating off of a long and fruitful history of brilliant research in a field that can be terribly difficult to care for us. So if we continue to collaborate and work together to overcome some of the challenges in this space that is put in front of us, some of which we'll talk about a little bit later, we can ensure that the next hundred years is just as busy and fruitful as what we see on this timeline. Alright. So now that we have some of the background and a good look at why we're here in the first place, let's start to review some of the trends of the space. Again, with some of those early blockbusters really leading the way and setting the stage, showing that there is promise to be had in therapeutic applications for radiopharmaceuticals, we've seen a lot of activity since then. A lot of those early studies were exploring the application of products in prostate cancer with a few others scattered in neuroendocrine tumors and bone myths. However, recently, we see a lot of activity to push to apply this same approach to other indications, currently largely within oncology, but seeing a lot of other cellular targets or even in some cases, pan targeting agents, for instance, the use of FAP as a precursor. In recent publications, we even see a push for the application of targeted radiopharmaceuticals in other therapeutic areas altogether outside of oncology, like cardiology or in neurology, exploring their use in neurodegenerative disorders and CNS conditions. Familiarity and better characterized activity has also led to the utilization of new isotopes, and exploring even more isotopes or isotope combos to diversify the current menu of options and provide better, more tailored solutions for theranostic research in these other disease types. And as mentioned before, we also see this trend to push the limits of the basic structure of radiopharmaceuticals themselves, looking at tethering radio molecules to monoclonal antibodies or using them in combination with other therapeutics or small molecules, even introducing these products to earlier lines of therapy to see if we can set patients up for even better and more durable responses earlier in their disease journey. And these are all great points and they sound awesome, but what does the data actually show? This graph represents overall growth of radiopharm trials year over year from 2000 to 02/2024. You'll notice quite a few pronounced peaks, and if you look closely, many of those correspond directly with some of the discoveries noted on that historical timeline slide earlier, that groundbreaking work that formed the basis which we're building off of now. The largest and most dramatic period of growth thus far can be seen in the late twenty teens, and I think we all know what kind of started that upward trajectory and really helped to put radiopharmaceuticals on the map and just really led to an accelerated rate of growth since then. And next, we can take a look at trial distribution by disease area. And this confirms one of our earlier theories about pushing beyond the limits of neuroendocrine tumors and prostate cancer. We see a pretty robust distribution of trials here, although still skewed heavily towards prostate, but definitely building out through other malignancies as well. And if we go to the next slide, we can see exhibited growth in areas altogether outside of oncology. So here we see that, again, although skewed towards oncology in a big way, we're starting to see planned and trial planned trials and trials and conduct that are branching outside of oncology and applying this same mechanism in their own diseases. Leading the non oncology pack, we have CNS and neurodegenerative disorders, followed by general cardiac, infectious disease, and autoimmune disorders. We also talked a little bit earlier about diversifying the available studied isotopes as well. Early on, the space was focused and dominated by lutetium one seventy seven, and when used in a theranostic pair, most commonly with gallium sixty eight as a diagnostic agent. Although this is still a very common pairing, as you can see, we have a lot of new comers showing their face and really gaining traction in the space. And this is very important for a multitude of reasons. So first of all, as I'm sure you all know, the isotope we use has a significant impact on the outcomes we aim to achieve, all with very different physical and chemical characteristics that allow us to continue to refine and tailor our approach to specific disease types and disease environments, as well as strategically map that those isotope characteristics to the kinetics of the tracer molecules themselves. Second, and something that we'll elaborate on later, one of the biggest challenges in this space is supply chain. So having a diverse listing of isotopes that are in use can alleviate some of that stress on the supply and demand. Now to kind of put a nice bow on this piece covering trends and growth, I'd like to end this part of the discussion with a visual to bring it all together. This is a radar chart that some of you may have seen. It's been developed by the folks at X Cancer, and it's published on their theranostictrials.org site. And all the companies that are actively developing in the space are listed on the perimeter, and the components of their products are represented by colors and shapes in the phase of their development as indicated by the progression from preclinical in the outer rim to approved part or approved products for market use in the center. And to me, this is a truly inspiring visual because it just shows how vast the space has become in such a short amount of time. And if we as an industry have been able to achieve this level of development at this stage of maturity within targeted radiopharmaceuticals, imagine what we can achieve if we move forward collectively. I think we all share that common goal of getting as many of these shapes into the middle of a circle as possible because that means access to meaningful diagnostic and therapeutic products for patients who desperately need it. So now to shift things over a little bit, we'll get to the part of the conversation that a lot of people consider as the bad news, the challenges. Well, I'd like to challenge that mindset altogether. I think that this is the most inspiring part of it all because as researchers and as scientists, it's in our nature to solve problems, to explore the unknown. If there were no more challenges and no more questions that needed answered, that would be a pretty bad day for science. So let's take a look at some of the challenges and growing pains that we're facing that need attention as we continue to venture forth on this radiopharm journey. First, we'll take a look at supply chain. Now I don't think it's any secret that supply chain and drug product logistics are the first and biggest set of questions that need answered in developing any new radiopharm product. The very same properties that make these products so effective and interesting are the exact same thing that make them nearly impossible to work with at scale. So due to things like their short half lives, the emission characteristics, and their stability, radiopharm products can't be stockpiling. They have to be produced with just in time dosing plans, making small batch or even single doses for specific patients at specific times. And the urgency of this and the stability window that we're granted is largely driven by the isotopes half life. And on top of that, isotopes must be generated and subsequently conjugated at very specific facilities, of which there are limited numbers across the globe. Not every drug manufacturer has access to nuclear reactors and cyclotrons to develop these products. And these equipment needed to produce radiopharmaceuticals and subsequently test them for purity and activity are not cheap either, and therefore, it creates a pretty significant barrier to expansion and developing capabilities for new regions and facilities across the globe. Not to mention that the special requirements to handling, transporting, receiving, and distributing drug products containing radioactive materials is quite extensive. I think we can all agree that this is a challenge that we're gonna continuously need to address as the field grows and as the need to expand and scale access to these products becomes more of a reality. Expand and scale access to these products becomes more of a reality. Next, we'll dive into the regulatory landscape. And this is a tedious aspect to any clinical trial, but I think radiopharmaceuticals have a special place on that list of complications. Due to due to the still novel nature of these products and all the stakeholders involved in their management, their oversight, the controls, there tends to be a heavily regulated yet incredibly asynchronous landscape for getting these products tested, distributed, and ultimately to market. There has been attention been given to identifying working instructions and standard assumptions and expectations around radiopharma clinical trials, but even this preliminary work is being done largely at local and regional levels, which still leaves a huge gap and a need to harmonize global working instructions. Outside of the standard handling and design of research surrounding the drug products themselves, we're also addressing this discussion over the need and extent for things like dosimetry evaluations. Again, this is something that's not standard from country to country, region to region, or even from site to site, but it has an incredible impact on the design of a study, the operational challenges that you will inevitably face, and the, ultimately, the timelines, for study completion, not to mention the additional, considerations that this will put forth for patients and managing them on study. All of this tends to create a highly complex regulatory environment where a close and careful analysis from a very experienced team on each and every country and region that you plan to include in a given study geography is going to be paramount. And proactivity in addressing those needs specifically is gonna be key for, your program your program success. So as an industry, it's gonna be important to collaborate on harmonizing global requirements if we wanna continue to achieve the level of growth and success in radiopharmaceuticals that we've observed thus far. Here, I wanna turn my attention to some very practical challenges and considerations. So radiopharm research requires the collaboration of large multidisciplinary teams and the involvement of some very specific highly trained functional roles. The recent influx and attention on this space has created a situation where over years, graduates in these highly specialized disciplines has not been equal to the growing demand. This has led to a shortage in critical staff and expertise. Now the recent buzz around nuclear medicine certainly helps, but it will be important for those of us in industry to walk hand in hand with our academic counterparts to ensure that the message gets out there that these are promising careers with a wealth of opportunity in this new evolution of nuclear medicine. And adaptation of bridge programs will be very important to help draw scientists and technologists in adjacent disciplines to fast track their ability to participate in this area of work as well. Some of these exist, but more work can definitely be done to support. Also, redefining scope and roles of key nuclear medicine staff has helped stave some of that initial need. But, again, this can only take us so far because we're still relying on a largely understaffed workforce. Additionally, the nuclear medicine teams have historically been poorly integrated into the overall patient care team at many institutions, serving a very crucial purpose, no doubt, but not as often included in initial care discussions and decision making, more used as a tool to further understand and diagnose the nature and extent of disease. And this is something that institutions need to address and ensure that these core functions are included earlier on in the patient journey so that there's an opportunity for these next generation drug products to permeate into the standard medical practice at that institution. And again, due to the highly specialized nature of the roles involved in this type of care, along with the required facilities and equipment needed, such as specialized measuring devices like well counters or gamma counters or dose calibrators, facilities like hot labs, equipment like nuclear medicine imaging detectors and software, the list goes on and on, the development and subsequent commercial use of these products tends to skew heavily toward large academic centers and hospital chains. So decentralizing radiopharmaceutical use to more community centers will also be critical to the future of the field, but it will require further research and advances in technology for the equipment needed to use radiopharmaceuticals and more support through grants and opportunities for personnel to find their way to more community centers. Again, this is gonna be really important if we ever wanna make this a truly global and equitable source of care for patients. It's really up to us to spread awareness to these deficits and to be part of the solution to expand access and care and lead to a more inclusive landscape, not only for clinical trials, but for the commercial applications within radiopharma. And on that same vein for barriers to entry, we can also consider the cost for research in this drug class relative to others like it. So the high cost of r and d can lead to limited access from new companies or stakeholders in the space, not just in the required design and assessments related to the trials to test the radiopharm products, but also in the specialized equipment, the licensing, the various plans, and the vendors needed to manufacture, distribute, and ultimately test them. Lastly, the components to these products themselves are incredibly costly, so doses, even when in the investigational phase, are very expensive to make. Early success in this space certainly caught the attention of investors and larger companies, which helped create an influx of capital that was available to those looking to get involved, but again, there's a long way to go to develop a truly diverse landscape. Once through the research phase, the challenges don't end there either. So even in the commercial landscape, there's a high cost for treatment, and inconsistent reimbursement practices globally can make it challenging to penetrate some markets in the worldwide arena. Standardizing such practices and providing more assistance plans will certainly help with global access. And finally, I wanna touch on an area that's often overlooked. So as someone who's worked in this space from many different perspectives, working directly with patients and their families that are considering the use of these products to developing them on the industry side, I've seen that there's a general common perception about anything that has to do with radiation or nuclear and a fear that goes along with that. So even in the clinical space and within highly trained clinical teams, there's generally a gap in understanding of the full breadth and potential of radiopharmaceuticals, especially in the theranostic approach. Patients and their families, even more so, have apprehensive thoughts about pursuing some of these treatments or imaging modalities at least at first. So really, it's up to us as an industry developing these products to do our part in not just getting these options to patients and providers, but making sure that the population at large understands how they work and can make more informed decisions about if this is the right care for them and allowing them to do so more so objectively and less out of fear. Okay. So now we have a pretty good understanding of some of the big challenges we're facing in radiopharm and how we can start to address them. Let's take a look at what's next. What are those things that we should have on our radar? So first of all, expanding to new targets, really breaking out of that traditional SSTR and PSMA agent. There are many new targets on the rise, and it's gonna be important to continue expanding upon that and where radiopharmaceuticals can be applied. Explore patient specific dosing plans. By using dosimetry data collected on these products, we have the opportunity to consider more personalized dosing schedules for patients based on biometrics and specific disease burden. This isn't science fiction, but a probable next step, something that could make these interventions even more tolerable and effective. There's already studies underway exploring just this type of dosing flexibility. For instance, the group out of UCLA looking at alternative dosing schemas for Pluvicto as noted in their 2024 J and M publication. Also, the utilization of new isotopes to be more tailored and specific in the outcomes we're searching for. Also to alleviate some of that stress on the current supply and demand on the products in circulation, again, whether commercial or investigation, spending some time with the idea of expanding regimens, using combination therapies, or even introducing radiopharmaceuticals into earlier lines of treatment, continuing to harmonize the landscape for global regulation, sample handling, and dosimetry requirements, building up a more extensive network of global sites to expand access and really diversify our trials and commercial use for the products in this space. Really, the final note here being that more work needs to be done. But if you're attending this webinar, I think it's safe to say that you're a big part of the solution. It's really things like this, coming together to discuss the challenges and find solutions to growing this space that will take it to new heights. So that takes us to the end of the discussion. And I apologize I wasn't able to be here at the webinar in person, but I sincerely appreciate all of you attending and listening to the content. I hope you enjoyed the material in today's discussion, and I hope that if nothing else, it's piqued your curiosity and starts to get you thinking about the role that you'll play in taking Radiopharm to the next stage. If there's any questions, concerns, or if you just wanna connect and see how PSI can support your radiopharma journey, please don't hesitate to reach out to me. I'd definitely love to talk to you about this. And with that, I wanna thank you all for your time, and I hope you all have a wonderful day.