Radiopharmaceuticals are reshaping oncology trials through integrated imaging, dosimetry, and therapeutic precision. Following SNMMI, Medpace experts share considerations for biopharma Sponsors navigating the scientific, operational, and regulatory complexities of this evolving field.
Radiopharmaceuticals are Reshaping Oncology Drug Development
Radiopharmaceuticals are rapidly reshaping oncology drug development. This year’s Society of Nuclear Medicine & Molecular Imaging (SNMMI) 2025 Annual Meeting reinforced their growing role as precision therapies capable of targeting solid tumors and hematologic malignancies with unprecedented accuracy.
Investment is accelerating across both biotechnology and pharmaceutical pipelines, driven by a surge in theragnostic innovation—therapies that pair diagnostic imaging with targeted radiation delivery—and a renewed focus on precision approaches for treating solid tumors and hematologic malignancies.
“Radiopharmaceuticals are shifting the paradigm in oncology. These therapies demand a development strategy that integrates imaging, dosimetry, and therapeutic precision—aligning clinical insight with scientific complexity,” shares Mariko DeWire-Schottmiller, MD, Hematology & Oncology.
As these therapies gain momentum, Sponsors face a dual challenge: advancing scientific innovation while navigating the complex operational and regulatory demands unique to radiopharmaceutical clinical trials.
The Convergence of Nuclear Medicine and Oncology
The rapid growth of radiopharmaceuticals reflects more than a commercial opportunity—it signals a convergence of disciplines. These agents sit at the intersection of diagnostic imaging and therapeutic precision, blurring traditional boundaries between nuclear medicine, radiation oncology, and medical oncology.
Increasingly, radiopharmaceuticals are being developed as fully integrated treatment modalities that demand interdisciplinary collaboration across imaging, radiation physics, and clinical oncology. The scientific shift carries significant implications for trial design and execution: imaging biomarkers now play a central role in patient selection, dosimetry informs not only safety but personalized dosing, and companion diagnostics are evolving into core components of development strategy. Critically, these advancements introduce trial requirements that traditional oncology protocols were never designed to accommodate.
While oncology remains a primary focus, the field is rapidly expanding. Radiopharmaceutical innovation is now reaching into other high-impact areas, including Alzheimer’s disease and other CNS indications, broadening the scope of both clinical research and therapeutic potential.
Designing Radiopharmaceutical Trials – Scientific and Operational Considerations
Radiopharmaceutical studies introduce unique demands on protocol development, driven by physics, pharmacokinetics, and regulatory controls surrounding radioactive agents. Protocols must be engineered to address isotope half-life, dosimetry planning, diagnostic imaging schedules, radiation burden, and radiation safety compliance, all while preserving scientific integrity and regulatory alignment.
From an operational standpoint, feasibility challenges are amplified. Many sites lack the infrastructure to store or administer radiopharmaceuticals, and specialized training is often required. Delays can arise during radiation safety review boards or when navigating country-specific regulations. Medpace addresses these challenges through a global network of experienced sites and cross-functional feasibility assessments that account for radiation capabilities.
“Radiopharmaceutical trials introduce operational intricacies that many Sponsors underestimate, including site infrastructure, regulatory variance, and radioactive material handling. Our teams bring deep experience in navigating these complexities globally, with a disciplined approach that supports speed, compliance, and scientific integrity,” explains Deb Hirscher, BSN, MS, MBA, Senior Director, Clinical Trial Management.
The success of these trials often hinges on seamless collaboration across clinical operations, regulatory teams, and imaging experts. Medpace’s cross-functional teams, embedded medical leadership, and wholly-owned imaging core lab enable this high degree of coordination, critical to ensuring protocol adherence and data reliability in radiopharmaceutical trials. As trial design becomes more complex, navigating the regulatory landscape and it’s evolving expectations requires foresight and specialized expertise.
Navigating Regulatory Pathways and Imaging Endpoints
Radiopharmaceutical trials face heightened regulatory inspection, especially as agencies refine expectations around dosimetry data, companion diagnostics, and imaging-based endpoints. Both the FDA and EMA have emphasized the need for comprehensive justifications of radiation dose and exposure, often requiring early regulatory engagement and robust preclinical modeling.
One of the most defining features of these studies is the reliance on imaging as a surrogate or co-primary endpoint. Imaging plays as a dual function (a selection tool and a measurement strategy) introducing statistical and operational complexity. Centralized image acquisition, blinded reads, and validated response criteria are all essential for regulatory acceptance.
Medpace provides Sponsors with expert support at every stage of the trial journey—from pre-IND consultations to imaging endpoint validation and NDA submissions. Our in-house imaging core lab ensures that Sponsors maintain control over imaging consistency, quality, and timing—critical elements in demonstrating efficacy and achieving regulatory approval.
With the European Association of Nuclear Medicine (EANM) 2025 Annual Congress on the horizon, the nuclear medicine community will be watching closely for signals on where radiopharmaceutical innovation is headed next.
Connect With Our Experts at EANM
Medpace is an industry leader in radiation therapies and imaging, and the only CRO combining global reach, full-service, and in-house dosimetry and medical physics expertise. We don’t just manage radiation oncology trials—we set the threshold for how they should be conducted.
With the global infrastructure, specialized teams, and deep therapeutic focus, Medpace delivers unmatched quality, foresight, and coordination where it matters most.
Request a meeting to connect with our nuclear medicine and radiopharmaceutical clinical development experts at the EANM 2025 Annual Congress. Our dedicated team will be there to discuss how to support your upcoming study from trial design and delivery to commercial optimization.