title: Why are we failing to implement imaging studies with radiolabelled new molecular entities in early oncology drug development?
abstract: 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.
authors.affiliation: Imanova Ltd., Centre for Imaging Sciences, Imperial College Hammersmith Hospital, Du Cane Road, London W12 0NN, UK.
authors.forename: Azeem
authors.identifier: 0000-0002-5747-7577
authors.initials: A
authors.lastname: Saleem
authors.affiliation: GlaxoSmithKline Global Imaging Unit, Stockley Park West, 1-3 Ironbridge Road, Uxbridge, Middlesex UB11 1BT, UK.
authors.forename: Philip
authors.identifier: 0000-0001-5773-5161
authors.initials: P
authors.lastname: Murphy
authors.affiliation: Imanova Ltd., Centre for Imaging Sciences, Imperial College Hammersmith Hospital, Du Cane Road, London W12 0NN, UK.
authors.forename: Christophe
authors.identifier: 0000-0003-0688-1358
authors.initials: C
authors.lastname: Plisson
authors.affiliation: Early Phase Oncology Clinical Investigation, Eli Lilly Corporate Center, Building 31/4, 893 S. Delaware Street, Indianapolis, IN 46285, USA.
authors.forename: Michael
authors.identifier: 0000-0002-0173-0158
authors.initials: M
authors.lastname: Lahn
mesh_terms: D000818:Animals; D000970:Antineoplastic Agents / Q000494:pharmacology / Q000627:therapeutic use; D051017:Apoptosis Regulatory Proteins / Q000235:genetics; D055808:Drug Discovery; D006801:Humans; D051034:Inhibitor of Apoptosis Proteins / Q000235:genetics; D009369:Neoplasms / Q000175:diagnosis / Q000188:drug therapy; D016376:Oligonucleotides, Antisense / Q000235:genetics; D049268:Positron-Emission Tomography; D019275:Radiopharmaceuticals; D000077022:Survivin; D014018:Tissue Distribution
chemical_list: D000970:Antineoplastic Agents; D051017:Apoptosis Regulatory Proteins; C107489:BIRC5 protein, human; D051034:Inhibitor of Apoptosis Proteins; D016376:Oligonucleotides, Antisense; D019275:Radiopharmaceuticals; D000077022:Survivin