Radioligand Therapy CRO: What sets Perceptive Discovery apart

Perceptive Discovery is a Radioligand Therapy CRO specializing in radiolabeled compound synthesis and preclinical imaging to accelerate drug development.

Introduction

Radiopharmaceuticals are a highly innovative class of radioactive drugs that deliver radionuclides directly to targeted lesions, typically used for the diagnosis and treatment of cancer. Targeting the delivery of radiation in this way has had a remarkable effect on reducing the well-known side effects of traditional radiation therapy. Targeted therapies are changing the way disease treatment is being researched and delivered, enabling the discovery of more precise, disease-specific treatments.

Radioligand Therapy (RLT), a subset of radiopharmaceuticals, couples a therapeutic radioactive isotope with a cancer-specific cell-targeting molecule, the ligand, releasing radioactivity directly into the cancer cell. Radioligand therapy has shown significant promise within the therapeutic area of oncology, with research extending to CNS and other areas. Although there have been some milestone approvals in recent years, translating radiopharmaceutical research from bench to investigational new drug application (IND) remains a scientific and regulatory challenge.

Perceptive Discovery, a well-established Radioligand Therapy CRO, are experts in optimizing and synthesizing radiolabeled compounds to ensure preclinical imaging studies are conducted with scientific rigor, accuracy, and safety. With core expertise in both preclinical imaging and radiopharmaceutical development, partnering with Perceptive is the driving force behind efficient and translational radioligand therapy drug development. 

Milestones and challenges

Two milestone FDA approvals for the use of radioligand therapy include Pluvicto and Lutathera, following results from the NETTER-1 trial, the VISION trial, and the PMSAfore trial. Although these milestone approvals have marked a significant step forward for radiopharmaceutical development, clinical trials involving radiopharmaceutical therapies remain some of the most technically demanding trials across all of drug development.

The entire process of drug development, from target compound identification to FDA approval, can take around 10-15 years, and it is thought that only one in 5000 drugs makes it to market. Radioligand therapy (RLT) is a particularly complex area of research, meaning this estimate may be even lower for this particular research area. 

Challenges unique to radioligand therapy development:

• Strict regulatory frameworks and standardized protocols – Radioligand Therapy must meet drug development requirements, plus additional regulations specific to the use of radioactive materials, including nuclear regulatory guidelines. Early-phase studies typically require compliance with complex radiation safety protocols, dosimetry, and handling protocols. Standardized preclinical models for novel targets can be limited, meaning researchers often need to develop custom models and imaging strategies which may limit translation to human models. 
• Limited availability of certain radioisotopes – A number of therapeutic isotopes used by Radioligand Therapy CROs have short half-lives, and are only produced at a small number of global facilities, including Astatine-211, Actinium-225, and Lutetium-177. Supply shortages can delay preclinical studies, trials, and drug approval. 
• Complex manufacturing and logistics – Distribution of radioisotopes is time-sensitive, requiring clear coordination between sites, trial centres, and radiochemistry expertise with real-time quality control. 
• The need for a specialized workforce and infrastructure – Clinical trial development teams need expertise across a number of different fields, such as radiochemistry, nuclear medicine, oncology, and radiology, with a clear understanding of the complexities and regulatory expectations for each area. Roles required can include nuclear chemists, engineers, radiopharmacists, regulatory scientists, cancer biologists, and nuclear medicine physicians, to name but a few. Limitations in availability or the coordination of required expertise can delay clinical trial development. 

What sets Perceptive Discovery apart

Perceptive is primed and ready to help alleviate radioligand therapy developmental delays, regulatory concerns, and logistical issues. Our radiochemistry team has radiolabeled hundreds of biological agents and small molecules for preclinical and clinical trial imaging. From targeted small molecules to monoclonal antibodies, peptides, and live cell labeling, we provide expertise across a diverse range of chemical entities, offering ligand discovery support and leveraging our in-house expertise to optimize candidate selection.

• 900+ agents radiolabeled
• Extensive experience with the US and UK/EU GMP regulatory requirements
• 80+ IND submissions supported for novel radiotracers
• Significant supply chain capabilities, supporting 300 global production centers
• External manufacturing offering covering US, EU, APAC, and Oceania, including site identification, qualification, set up, validation, and oversight 
• Optimized preclinical study design tailored for regulatory submission
• Complex oncology and CNS imaging capabilities
• 24/7 Support for seamless translation of proof-of-concept to IND

Specialized Expertise in Astatine-211 (²¹¹At)

Perceptive is one of the few imaging and radiochemistry providers with proven radiolabeling capabilities using ²¹¹At, a highly promising alpha emitter in next-generation radiopharmaceutical therapies. Our team brings deep knowledge of its chelation chemistry, stability challenges, and safety protocols—enabling accelerated early-phase research in this emerging class of therapeutics.

Conclusion

Radioligand Therapy development can be complex, highly technical, and heavily regulated. Perceptive offers an array of preclinical services to deliver high-fidelity data and actionable insights which support informed radiopharmaceutical trial decision-making. 

From the intricacies of molecular processes to the complexity of whole-body systems, we utilize advanced technologies and quantitative analysis to develop and validate imaging biomarkers, providing the expertise and infrastructure required to assess target engagement, biodistribution, and preclinical therapeutic efficacy.

Perceptive is a leading Ragioligand Therapy CRO, specializing in radiolabeled compound synthesis and preclinical imaging to accelerate drug development. Our experts across radiochemistry, dosimetry, and translational imaging, combined with our global radiopharmaceutical infrastructure, is prepared to handle challenging isotopes and complex radioligand therapy logistics. 

To see how we’re helping sponsors build smarter, faster radioligand therapy programs, go to: Perceptive Discovery Services today, or Contact a Discovery solutions specialist.

Resources

EORTC. Radioligand Therapy. https://www.eortc.org/scientific-strategy/radioligand-therapy-rlt/ 

Lancet Oncology. Trends in Nuclear Medicine and the Radiopharmaceutical Sciences in Oncology: Workforce Challenges and Training in the Age of Theranostics. https://pmc.ncbi.nlm.nih.gov/articles/PMC11345887/ 

The New England Journal of Medicine. Phase 3 Trial of 177Lu-Dotatate for Midgut Neuroendocrine Tumors. https://www.nejm.org/doi/full/10.1056/NEJMoa1607427 

The New England Journal of Medicine. Lutetium-177–PSMA-617 for Metastatic Castration-Resistant Prostate Cancer. https://www.nejm.org/doi/full/10.1056/NEJMoa2107322 

The New England Journal of Medicine. 177Lu-PSMA-617 versus a change of androgen receptor pathway inhibitor therapy for taxane-naive patients with progressive metastatic castration-resistant prostate cancer (PSMAfore): a phase 3, randomised, controlled trial. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)01653-2/abstract