6 min read
3 min read
Radiopharmaceuticals have been around for decades, but their role in oncology is expanding rapidly. With the increasing focus on targeted therapies, the ability to precisely deliver radiation to tumors through radiopharmaceutical therapy is becoming an essential element of clinical research. Unlike traditional external beam radiation therapy—where an energy source is directed at a tumor and may damage non-target tissues or organs—radiopharmaceuticals combine a radionuclide payload with a targeted ligand, ensuring the radiation reaches its intended site within the body.
This innovation allows for more precise treatment, minimizing collateral damage to surrounding healthy tissues. Lutetium and actinium-based therapies, for example, attach to specific antigens or proteins associated with tumors, delivering a controlled radiation dose directly where it's needed. As clinical research advances, the potential for these therapies to improve outcomes for cancer patients is greater than ever.
John Balser, Ph.D., Veristat’s Founder, President, and Chief Statistical Officer, shares his perspective on how radiopharmaceuticals are transforming the clinical trial landscape, requiring a deeper understanding of targeted delivery, dosing strategies, and long-term patient outcomes.
👉 Overcoming Key Challenges in Radiopharmaceutical Development
While the benefits of radiopharmaceuticals are becoming clear, their development presents unique challenges. One of the most significant concerns is ensuring that the therapy effectively targets the tumor while minimizing radiation exposure to non-target organs such as the kidneys or liver. The selection of the right targeting molecule—whether an antibody or another agent—is critical in directing the radionuclide to the tumor site.
Safety considerations also extend to dosing strategies. Unlike chemotherapy or immunotherapy, where increased dosing often results in unavoidable systemic effects, radiopharmaceutical dosing must balance therapeutic efficacy with radiation exposure risks. The half-life of the chosen radionuclide plays a significant role in determining how long the radiation remains active in the body. Additionally, repeat dosing strategies must be carefully assessed, as some patients may require multiple treatments over time.
👉 A Strategic Approach to Advancing Radiopharmaceuticals
At Veristat, we work closely with our sponsors to navigate these complexities. A key part of our approach is leveraging targeted literature reviews to analyze prior research, identify potential pitfalls, and optimize trial design. Understanding how similar products have addressed issues such as off-target distribution or dosage limitations allows us to provide scientifically sound recommendations to our sponsors.
Endpoints in radiopharmaceutical trials can also differ from those in traditional oncology studies. While tumor response and progression-free survival remain crucial, factors such as radiopharmaceutical uptake, distribution, and clearance play a role in determining both safety and efficacy. Addressing these nuances requires a deeper understanding of radiopharmaceutical behavior within the body—insights that we prioritize in our collaborations with sponsor companies.
As the field of radiopharmaceuticals continues to evolve, strategic research and development will be increasingly important in bringing new therapies to market. By asking the right scientific questions, applying data-driven methodologies, rigorous statistical analysis and innovative trial designs, we help our biopharmaceutical sponsors navigate the complexities of radiopharmaceutical innovation, ensuring that these promising therapies reach the patients who need them most.
👉 Expert Guidance for Every Stage of Your Radiopharmaceutical Journey
For 30 years, Veristat teams have helped biopharmaceutical companies bring drugs, biologics, and diagnostics to market in almost every major area of therapy, including Cancers, Rare Diseases, Neurological Disorders, Endocrine/Metabolic Disorders, Inflammation/Autoimmune Diseases, Infectious Diseases, and more.
To learn more about our radiopharmaceutical expertise, contact us here: LET'S TALK
John P. Balser, PhD
Founder, President, and Chief Statistical Officer
John Balser, PhD, co-founder, President & Chief Statistical Officer of Veristat, has developed the company as industry leaders in areas of clinical monitoring, data management, biostatistics and programming, medical writing, and project management. John is actively involved with clinical projects in his role as one of Veristat’s principal statistical consultants. In this role, he assists clients with clinical study design and program development based on his many years of experience in the statistical aspects of clinical research. He is often called upon to aid clients on a variety of statistical issues at meetings with regulatory agencies.
Prior to founding Veristat in 1994, John served as Vice President, Biostatistics, and Data Management at Medical & Technical Research Associates, Inc. He has held positions of increasing responsibility in the biostatistics departments at various pharmaceutical companies including E.R. Squibb, Biogen, and Miles.
John received his MS and PhD in Biometrics from Cornell University, and has been actively engaged in clinical biostatistics for over 30 years. John is an avid runner and has competed in the Boston Marathon.
Prior to founding Veristat in 1994, John served as Vice President, Biostatistics, and Data Management at Medical & Technical Research Associates, Inc. He has held positions of increasing responsibility in the biostatistics departments at various pharmaceutical companies including E.R. Squibb, Biogen, and Miles.
John received his MS and PhD in Biometrics from Cornell University, and has been actively engaged in clinical biostatistics for over 30 years. John is an avid runner and has competed in the Boston Marathon.