Translating a radiolabeled imaging agent to the clinic

Molecular Imaging is entering the most fruitful, exciting period in its history with many new agents under development, and several reaching the clinic in recent years. While it is unusual for just one lab-oratory to take an agent from initial discovery through to full clinical approval the steps along the way are important to understand for all interested participants even if one is not involved in the entire process. Here, we provide an overview of these processes beginning at discovery and preclinical validation of a new molecular imaging agent and using as an exemplar a low molecular weight disease-specific targeted positron emission tomography (PET) agent. Compared to standard drug development requirements, molecular imaging agents may benefit from a regulatory standpoint from their low mass administered doses, they nonetheless still need to go through a series of well-defined steps before they can be consid-ered for Phase 1 human testing. After outlining the discovery and preclinical validation approaches, we will also discuss the nuances of Phase 1, Phase 2 and Phase 3 studies that may culminate in an FDA gen-eral use approval. Finally, some post-approval aspects of novel molecular imaging agents are considered. (c) 2021 Published by Elsevier B.V.

Automated summary

Molecular Imaging is in an exciting period of its history, with many new agents under development and some already reaching the clinic. This article provides an overview of the processes involved in discovering and validating a new molecular imaging agent, using a low molecular weight disease-specific targeted PET agent as an example. It also discusses the different phases of studies and the post-approval aspects of novel molecular imaging agents.