Medicines Discovery Catapult and Crown Bioscience Create Alliance for Radiopharmaceuticals

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Medicines Discovery Catapult (MDC), a national life sciences service dedicated to drug discovery, and Crown Bioscience, a contract research organization, announced on Sept. 11, 2025 that they are working together to create an integrated translational biology platform to be used to develop radiopharmaceuticals. The collaboration will support the advancement of radiopharmaceuticals, including new isotopes and optimizing targeting agents, and will enable testing of how radiopharmaceuticals perform in the body.

How will the collaboration help developers of radiopharmaceuticals?

The expertise and technology platforms of MDC and Crown Bioscience will be leveraged to provide the integrated platform that can be used to evaluate radiopharmaceutical therapies. MDC will provide knowledge in cell biology, high-resolution microscopy, radiochemistry, preclinical imaging, mass spectrometry, and multi-omic tissue analysis. Crown Bioscience provides discovery, preclinical, and translations platforms and services for oncology and immune-oncology products.

A preclinical workflow will provide more efficient studies and generate high-quality translational data to support precision medicine strategies, according to the company, accelerating development and improving patient outcomes.

“MDC operates an advanced preclinical drug discovery facility, including world-class radiochemistry capabilities and a translational suite of imaging technologies, to support the growing demand for novel radiopharmaceuticals,” Francesca Sadler, PhD, chief commercial officer at Medicines Discovery Catapult, said in a press release (1). “Our partnership with Crown Bioscience means MDC can expand its current end-to-end translational biology offering even further. Combining the expertise of our two organizations provides a comprehensive platform for drug innovators developing radiopharmaceuticals, helping to accelerate the progress of these novel medicines that have the potential to transform patient outcomes.”

“Advanced radiopharmaceuticals are poised to redefine how we treat cancer, but their successful development requires translational platforms that are both scientifically rigorous and clinically relevant,” John Gu, chief executive officer at Crown Bioscience, said in the release. “By combining MDC’s radiochemistry and imaging capabilities with Crown Bioscience’s preclinical oncology expertise, we are creating a truly integrated solution for innovators in this field. This collaboration reflects our shared commitment to accelerating the delivery of next generation targeted therapies to patients worldwide.”

What other advancements are happening in the field of radiopharmaceuticals?

In August 2025, FDA published a guidance document created to assist drug sponsors with identifying an optimized dosage for radiopharmaceutical therapies for oncology indications during clinical development (2). The guidance addresses clinical development before submitting a marketing application for a new indication and usage. The new draft guidance provides considerations for dosage optimization. According to the document, if there is adequate rationale that the optimized dose of a radiopharmaceutical therapy (RPT) cannot be identified at lower dosages, administered activities per cycle and/or cumulative RPT-administered activities that result in absorbed dosages exceeding external beam radiation therapy (EBRT) organ tolerances can be studied in clinical trials of radiopharmaceutical therapies.

Pharmaceutical Technology® spoke with Michael Ritchie from Champions Oncology about the FDA guidance and other advancements in radiopharmaceuticals in two interviews (3,4). “Radio pharmaceuticals have been around for about 100 years, and classical radiopharma relied on something called EBRT, or external beam radiotherapy, and that is essentially delivering a radio beam to the patient from an external source,” Ritchie said in the interview (3). “But we're now looking at a new wave of therapies which are injected systemically, and quite frankly, we just don't know enough about them. FDA has released new guidance that has said, hey, we want you to come to the table with a better understanding of pharmacodynamics potential liabilities from a toxicity perspective, therapeutic window. But we also want you to design your clinical trials in such a way that we can get an idea on dosimetry.”

References

1. MDC and Crown Bioscience. Medicines Discovery Catapult and Crown Bioscience Form Strategic Global Alliance for Radiopharmaceutical Innovation. Press Release. Sept. 11, 2025. https://www.businesswire.com/news/home/20250911458780/en/Medicines-Discovery-Catapult-and-Crown-Bioscience-Form-Strategic-Global-Alliance-for-Radiopharmaceutical-Innovation
2. FDA. Draft Guidance for Industry, Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development. (OCE, CDER, August 2025). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/oncology-therapeutic-radiopharmaceuticals-dosage-optimization-during-clinical-development
3. Haigney, S. The Impact of FDA’s Guidance on Clinical Trials for Radiopharmaceuticals. PharmTech.com. Aug. 25, 2025. https://www.pharmtech.com/view/the-impact-of-fda-s-guidance-on-clinical-trials-for-radiopharmaceuticals
4. Haigney, S. The Evolving Field of Radiopharmaceuticals. PharmTech.com. Aug. 4, 2025. https://www.pharmtech.com/view/the-evolving-field-of-radiopharmaceuticals