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The Scientific World Journal
Volume 2014, Article ID 269605, 9 pages
Review Article

Why Are We Failing to Implement Imaging Studies with Radiolabelled New Molecular Entities in Early Oncology Drug Development?

1Imanova Ltd., Centre for Imaging Sciences, Imperial College Hammersmith Hospital, Du Cane Road, London W12 0NN, UK
2GlaxoSmithKline Global Imaging Unit, Stockley Park West, 1-3 Ironbridge Road, Uxbridge, Middlesex UB11 1BT, UK
3Early Phase Oncology Clinical Investigation, Eli Lilly Corporate Center, Building 31/4, 893 S. Delaware Street, Indianapolis, IN 46285, USA

Received 6 June 2014; Accepted 18 July 2014; Published 18 August 2014

Academic Editor: Masahiro Ono

Copyright © 2014 Azeem Saleem et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


In early drug development advanced imaging techniques can help with progressing new molecular entities (NME) to subsequent phases of drug development and thus reduce attrition. However, several organizational, operational, and regulatory hurdles pose a significant barrier, potentially limiting the impact these techniques can have on modern drug development. Positron emission tomography (PET) of radiolabelled NME is arguably the best example of a complex technique with a potential to deliver unique decision-making data in small cohorts of subjects. However, to realise this potential the impediments to timely inclusion of PET into the drug development process must be overcome. In the present paper, we discuss the value of PET imaging with radiolabelled NME during early anticancer drug development, as exemplified with one such NME. We outline the multiple hurdles and propose options on how to streamline the organizational steps for future studies.