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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.
No conflict of interest has been declared by the author(s).
Article published online:
10 May 2022
© 2022. World Association of Radiopharmaceutical and Molecular Therapy (WARMTH). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)
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