Patient Access to Radiopharmaceuticals

The development of and access to radiopharmaceuticals depends on a well-defined strategy. PharmTech spoke with Nicholas Richardson, vice president of clinical development at Precision for Medicine, to find out more about how these products are used to treat cancer and what developers should know about bringing these treatments to patients.

PharmTech: What is unique about the use of radiopharmaceuticals to treat cancer?

Richardson: For radiopharmaceuticals, we're talking about products that have the precision of targeted therapy with the cytotoxicity of radiation that is able to be delivered systemically. And what this does is allows for an effect at the site of disease, given all these novel components coming together in one therapeutic product.

And so, when we think about radiopharmaceutical programs, the other thing that is unique about them is they often pair diagnostic and therapeutic aspects to their product. And what that does is it supports diagnostic imaging for the patient, real-time biodistribution assessment, and personalized dose optimization based on dosimetry, which again, is very unique to radiopharmaceuticals. And then lastly, we think about radiopharmaceuticals in that they really do need a specific operational and infrastructural dependence.

Because they are linked to nuclear medicine infrastructure, they have imaging capabilities that are needed to be able to conduct trials for radiopharmaceuticals. And then you also need that radiation safety expertise.

And so, these are really the reasons that set radiopharmaceuticals apart when you think about them and the development of these products compared to other drug products for patients with cancer.

What are some of the specific challenges associated with patient access to radiopharmaceuticals?

It's always great to think about access, and especially in the context of radiopharmaceuticals. When we think about access for patients, it's really multi-dimensional when we are talking about a radiopharma product, and that is because it relies on supply, infrastructure, the regulatory oversight that's needed, and also the healthcare system readiness.

And so, because these products are governed by radioactive decay, this requires a very specific delivery paradigm with just-in-time delivery.

And when you think about this, this type of delivery is very dependent on the isotope production and the capability of producing this isotope, and then taking that and needing rigorous coordination across manufacturing, radiolabeling, distribution, and getting it actually to the site so the site can administer it to the patient.

And then when you think about it from the site standpoint, they need to have nuclear medicine licensing. They need to have radiopharmacy capabilities, radiation safety infrastructure, and trained personnel, which right now there is a shortage of trained personnel when we are talking about radiopharmaceuticals and the ability to administer these products to patients.

And then lastly, when we think about regulations, the regulations embody both drug regulatory frameworks, along with nuclear and radiation regulations and safety oversight.

And so, taking those two together, it really creates a very complex system that the developers have to navigate in order to be able to be successful in conducting clinical trials with radiopharmaceuticals in patients with cancer.

How can patient access planning be incorporated into the development of radiopharmaceuticals?

When we think about clinical development of radiopharmaceuticals, I think a lot of it does come back to what we were just talking about with patient access and the ability to get patients to enroll on these clinical trials.

And so really, what do you need?

I think it comes down to your site strategy along with an integrated supply chain, because we know that these products have really transformative potential benefit for patients. I think it really does come down to that infrastructure that you can set up in your development program. The way that you can think about that is can you identify centers of excellence with nuclear medicine capability that also would afford site readiness?

Is there a paired isotope that affords the ability to scale when you think about these products and the need to be able to produce the product for that just-in-time delivery, and whether you can actually scale it as your program continues to expand.

And then we had mentioned this before, but again, the co-development of a radiopharmaceutical that supports diagnostic and therapeutic implications is very patient-centric when you think about the real-time capabilities of these products with a patient going in, getting very specific imaging for the radiopharmaceutical diagnostic.

You get information on biodistribution that's specific to that patient. And then for the therapeutic standpoint, you're able to have individualized dosing.

When you think about patient access and the ability to support development, these are really benefits that are patient-centric, that are going to allow you to enroll and successfully conduct your trial.

And I would just say as a last point, the thing I think that also is needed when you think about development of these products is a patient's time, and that being a really important factor when you think about a radiopharmaceutical, because the schedule of assessments does need to take into account the unique aspects of these products.

There often is a need for inpatient hospitalization, so trying to balance that time where a patient is spending in the hospital versus are there opportunities for outpatient aspects of your schedule of assessments.

And then also the frequency of testing required, which a lot of time is dictated by the half-life of the isotope and what stage of development you're in.

But that patient burden and schedule of assessments I do think is critical when you think about radiopharmaceuticals and the successful ability to incorporate some of these aspects into the development to ensure success of your program.

You know, when we think about radiopharmaceuticals, they are unique. They do require an integrated therapeutic system when we are trying to ensure access and safe administration for patients with cancer.

And it really comes down to that we know that these products have transformative potential, and it's being realized more and more with the products that are currently approved and the number of products that are being developed, which we've really seen a surge in the last few years of radiopharmaceutical products, especially in the field of patients with cancer.

And so, I think as a community, we really just need to come together, ensure that our strategies are in place, and that we have a plan to be systematic, allow these products to be scalable, and really allow patients to receive the benefit that there is for these products, given the unique aspects of radiopharmaceuticals and the ability to target, patients with, you know, serious and life-threatening diseases with these cancers that we are, trying to develop in.

About the Speaker

Nicholas Richardson is a hematologist oncologist and vice president of clinical development at Precision for Medicine, an oncology and rare disease-focused contract research organization. Prior to joining Precision, Richardson was formerly at the FDA for nearly 10 years as a prior FDA oncology, deputy director.