Why Experience Matters: Choosing the Right Partner for Preclinical Radiopharmaceutical Development

Radiopharmaceutical development is a highly specialized field that requires more than standard preclinical study execution. From isotope handling and radiochemistry to quantitative imaging and translational study design, every phase demands deep technical expertise and seamless integration across disciplines.

For drug developers entering or expanding in the radiopharmaceutical space, selecting the right preclinical partner can significantly impact timelines, data quality, and regulatory success. Here’s why experience matters, and what to look for when evaluating a contract research organization (CRO) to support radiopharmaceutical development.

Radiopharmaceuticals Aren’t Like Other Therapeutics

Radiopharmaceuticals introduce a layer of complexity that most traditional CROs aren’t equipped to manage. Key differentiators include:

• Radiochemistry & Isotope Handling: Developing and optimizing labeling strategies for therapeutic or diagnostic isotopes (e.g., Actinium-225, Lutetium-177, Zirconium-89, Astatine-211) requires highly trained radiochemists and access to isotope supply chains.
• Quantitative Imaging Expertise: Interpreting PET/SPECT data for biodistribution, dosimetry, and pharmacokinetics demands experience with tracer kinetics, species scaling, and regulatory expectations.
• Specialized Infrastructure: Safe, compliant handling of radioactive materials calls for shielded facilities, dedicated animal housing, and traceability across the entire workflow.

In short: radiopharmaceutical development is not plug-and-play. CROs that lack deep domain expertise may struggle to deliver reliable results or may require costly rework.

The Value of an Experienced Radiopharmaceutical Partner

An experienced CRO doesn’t just execute studies, they proactively guide strategy. Here’s how:

• Study Design Optimization: Seasoned partners understand how to align study endpoints with regulatory expectations, reducing risk at IND submission.
• Efficiency in Execution: From isotope procurement to image analysis, familiarity with radioactive workflows minimizes delays and prevents common pitfalls.
• Cross-Disciplinary Integration: Radiopharmaceutical development spans chemistry, biology, pharmacology, and imaging. A partner with integrated teams across these domains streamlines communication and ensures data coherence.
• Proven Regulatory Success: Experience navigating the regulatory landscape, including dosimetry, modeling and radiation safety documentation, accelerates time to IND and mitigates risk.

What to Look for in a Preclinical Radiopharmaceutical CRO

As you evaluate CROs, consider these core capabilities and differentiators:

• In-house radiochemistry labs with capacity for custom synthesis and isotope labeling
• Quantitative PET/SPECT imaging across small and large animal models
• Expertise with therapeutic and diagnostic isotopes including emerging ones like Astatine-211, Lead-212 and Actinium-225
• Experience in IND-enabling studies for radiopharmaceuticals, including dosimetry and PK/PD
• Integrated data management and image analysis tools built specifically for radiolabeled compounds
• Demonstrated track record supporting radiopharmaceutical programs from discovery through clinical translation

Final Thoughts

In a field where nuance and precision are critical, experience isn’t optional, it’s essential. Partnering with a CRO that deeply understands the unique requirements of radiopharmaceutical development can reduce risk, improve study quality, and accelerate your program’s path to the clinic.

Whether you’re advancing a new radiopharmaceutical or refining an established platform, make sure your preclinical partner brings more than services, they bring strategy, insight, and proven expertise.

At Perceptive Discovery, our experienced team recognizes that every drug candidate is unique and customizes and executes on innovative study designs, experimental approaches, and analytical methods to align with your program’s specific needs.