The questions shaping radiopharmaceutical therapy are changing. The field is no longer focused only on whether targeted radiation can effectively reach and treat disease. Researchers are exploring new biological targets, evaluating a broader range of radionuclides, investigating combination strategies, advancing personalized dosimetry, and considering how molecular imaging can play a greater role in treatment decisions.
That evolution is reflected in the opening plenary at EANM’26: “THERANOSTICS: The Next Level.” Across the broader scientific program, discussions will examine the continued evolution of theranostics, dosimetry, radiopharmaceutical science, and other questions pointing toward a more sophisticated future for the field.
Taking theranostics to the next level, however, will require more than scientific advancement. As the possibilities for radiopharmaceutical therapy expand, the development model supporting those possibilities must be prepared to evolve with them.
New Targets Are Expanding the Possibilities for Radiopharmaceutical Therapy
Much of radiopharmaceutical therapy’s recent clinical and commercial growth has been driven by a relatively concentrated group of biological targets and indications. Today, researchers are exploring a broader landscape that includes fibroblast activation protein (FAP), integrins, carbonic anhydrase IX (CAIX), Nectin-4, DLL3, HER2, and other tumor-associated targets.
The growing diversity of targets creates opportunities to reach cancers and patient populations that may not be addressed by established radiopharmaceutical approaches. It also introduces new development considerations. Targeting vectors can range from small molecules and peptides to antibodies and other constructs, each with different pharmacokinetic, biodistribution, radiochemistry, stability, and manufacturing characteristics.
As a result, the expansion of radiopharmaceutical biology also expands the questions developers must answer. Analytical methods, formulation strategies, manufacturing processes, quality controls, and specifications must reflect the characteristics of the individual product rather than a standardized development template.
A Broader Radionuclide Landscape Requires Greater Flexibility
The radionuclide landscape is evolving alongside the biology. Beta emitters such as lutetium-177 have helped establish radiopharmaceutical therapy in oncology, while alpha emitters and other radionuclides continue to broaden the range of therapeutic approaches under investigation.
Different radionuclides offer different physical properties and potential clinical applications, but those differences extend well beyond the mechanism of treatment. For developers, radionuclide selection can influence:
- Supply and availability, including production methods, sourcing strategies, transportation, and shelf-life considerations
- Radiochemistry and manufacturing, including labeling processes, equipment, and facility requirements
- Analytical development and quality control, including methods and specifications appropriate to the individual product
- Radiation safety and waste management, which can vary based on the radionuclide and its decay characteristics
- Clinical logistics, where half-life, handling requirements, and treatment schedules can influence how a therapy reaches the patient
The future of radiopharmaceutical therapy may therefore be less about identifying a single radionuclide that is best for the field and more about determining which characteristics are best suited to a particular target, disease, and therapeutic objective.
For developers, that shift makes flexibility increasingly valuable. Isotope sourcing, facility design, analytical methods, radiation safety, manufacturing, and logistics must be considered in the context of the specific program rather than a narrow set of assumptions.
Personalization Is Moving Beyond the Target
Theranostics has always carried the promise of greater precision by using molecular imaging to identify relevant biological targets and help guide treatment. Researchers are now exploring how much further that personalization can extend.
Dosimetry is one important example. A 2026 review published in Nuclear Medicine and Molecular Imaging describes radiopharmaceutical dosimetry as evolving from a primarily physics-based calculation into a more central component of precision nuclear medicine. The authors point to growing interest in patient-specific dose estimation, prediction of therapeutic efficacy, and mitigation of organ toxicity, while also identifying persistent challenges involving standardization, quantitative imaging, computational demands, and clinical implementation.
A September 2026 review in The Journal of Nuclear Medicine further examines evidence for dosimetry-driven personalization, including the heterogeneity of absorbed dose among patients and opportunities to use dosimetry to inform treatment optimization. The authors also highlight variability in absorbed-dose measurement and the importance of greater standardization.
This evolution raises questions that extend beyond dosimetry itself. More individualized treatment can affect imaging workflows, data requirements, treatment planning, scheduling, and clinical operations. For drug developers, it also reinforces the importance of understanding how product characteristics, analytical control, and manufacturing consistency ultimately connect with clinical use.
Personalized medicine does not reduce the need for repeatable development and manufacturing systems. It places greater demands on those systems to reliably support therapies that may become increasingly individualized at the point of care.
More Sophisticated Therapies Create New Development Considerations
Combination therapy offers another example of how scientific advancement can reshape development requirements. Radiopharmaceuticals are increasingly being investigated alongside DNA damage response inhibitors, immunotherapies, cell therapies, hormonal therapies, chemotherapy, and other treatment modalities to determine whether complementary biological mechanisms can improve outcomes.
As we explored in our September article, combination therapy is not inherently better therapy, and the maturity of the evidence varies considerably by approach. These strategies do, however, demonstrate the growing sophistication of the questions being asked across the field.
A program involving multiple therapeutic mechanisms may introduce considerations involving sequencing, clinical protocols, regulatory strategy, manufacturing schedules, supply coordination, and trial design. The challenge is not to eliminate that complexity, but to ensure the development model can accommodate it without creating unnecessary friction or risk.
The Development Model Must Be Designed to Evolve
One of the defining realities of drug development is that not every requirement can be known at the beginning of a program. Clinical evidence can change strategy, manufacturing processes mature, new radionuclides and suppliers become available, and regulatory expectations become clearer. Successful programs also progress from relatively small early-phase studies toward larger trials and, eventually, commercial demand.
Radiopharmaceuticals add another layer to that evolution because the drug, radionuclide, manufacturing process, supply chain, logistics, and clinical delivery model are closely interconnected.
1. Plan for What Comes Next
A resilient development strategy needs to consider not only what a program requires today, but what it may require next. Decisions involving analytical development, isotope supply, process design, technology transfer, quality systems, manufacturing capacity, and regulatory planning can have consequences well beyond the phase in which they are initially made.
This does not mean attempting to predict every future requirement at the outset. It means making early development decisions with enough foresight and flexibility to support a program as the science, clinical evidence, and scale requirements evolve.
2. Connect Science and Operations Earlier
That convergence is reflected in the upcoming EANM’26 program. Alongside scientific discussions about next-generation theranostics, an industry symposium will focus specifically on scaling radiopharmaceutical therapeutics for commercial manufacturing, including GMP requirements, aseptic processing, facility controls, quality systems, manufacturing capacity, and supply chain coordination.
That convergence matters because scientific development and operational development cannot remain separate conversations indefinitely. Choices involving radionuclides, targeting molecules, formulation, dosimetry, or therapeutic strategy can ultimately affect how a product is manufactured, characterized, supplied, and delivered.
Bringing those considerations together earlier can help developers identify potential challenges before they become barriers later in development.
3. Build for a Reproducible Medicine
A promising radiopharmaceutical must ultimately become more than a scientifically compelling concept. It must become a reproducible medicine that can be manufactured, tested, released, transported, and delivered reliably as clinical demand grows.
Reproducibility requires more than manufacturing capacity alone. It depends on analytical methods capable of consistently characterizing the product, quality systems appropriate to the stage of development, reliable isotope and material supply, well-controlled processes, regulatory planning, and a clear path for transferring and scaling those processes as the program advances.
The goal is not to remove every variable from radiopharmaceutical development. It is to build a model capable of managing those variables as the program changes.
The Next Level Requires More Than the Next Breakthrough
Radiopharmaceutical therapy is asking bigger questions because the field is capable of pursuing stronger possibilities. As researchers investigate new targets, radionuclides, personalized treatment approaches, and combination strategies, the next generation of RPT is likely to be characterized by greater diversity in both therapeutic strategy and patient care.
The development model supporting those programs must be capable of managing that diversity without allowing scientific sophistication to become operational friction. That means building flexibility into development earlier, connecting scientific and manufacturing decisions more closely, and considering the path from initial development through clinical and commercial manufacturing as a continuum rather than a series of disconnected stages.
At Nucleus RadioPharma, our integrated CDMO capabilities are designed to support radiopharmaceutical programs as they evolve, bringing together development, analytical, manufacturing, quality, regulatory, and supply chain expertise from early-stage development through clinical and commercial manufacturing.
The next level of theranostics will not be defined by scientific sophistication alone. It will also depend on whether the development model surrounding that science is ready to advance with it.
Ready to discuss what the next stage of your radiopharmaceutical program requires? Connect with Nucleus RadioPharma to explore how our integrated CDMO capabilities can support your path from development through commercial delivery.
