Accelerating Theranostic Development through EU-Sponsor/U.S. CDMO Partnership

• Areas of Interest: Theragnostics

Background: U.S. drug approval typically involves clinical trials performed at U.S.-based administration sites. This presentation focuses on factors in the EU sponsor-U.S. CDMO relationship proven critical to the success of an EU theranostic drug development program.

Methods: This work is based on a review of the legal (Eudralex, U.S. Food and Drug Act), regulatory (ICH, U.S, Code of Federal Regulations), compliance enforcement (Guidance, FDA Policies), business operations and U.S. CDMO logistics and capabilities/experience (CDMO-radiopharmacies network) to identify key theranostic success factors behind EU sponsor-U.S. CDMO partnership.

Results: The EU and U.S. nuclear pharmacy/drug dispensing spaces differ significantly to meet different expectations and business realities of health care providers. The areas of nuclear pharmacy ownership and nuclear pharmacy practice differed substantially, resulting in different health care provider business needs and sets of relationships. The U.S. development and commercial success factors critical to an EU entity sponsoring a Global/U.S. theranostic program were as follows: (1) health care provider service level from the U.S. CMO (reliable, on-time, traceability, logistics, and nuclear waste management), (2) manufacturer-nuclear pharmacy systems integration, (3) CDMO phase-appropriate based quality system (risk management, speed, and flexibility), (4) CDMO technical expertise (technology transfer, optimization, and scale-up), and (5) CDMO supply chain (isotope supply, cold-chain, and transportation).

Conclusion: Early identification of a U.S. CDMO with comprehensive and integrated manufacturing and pharmacy services, strong (isotope) supply chain, sophisticated logistics and quality system, and a substantial track record has been critical to the U.S. success of EU sponsor programs.

Publication History

Article published online:
10 May 2022