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Why are we failing to implement imaging studies with radiolabelled new molecular entities in early oncology drug
Azeem Saleem1, Philip Murphy2, Christophe Plisson1
1Imanova Ltd., Centre for Imaging Sciences, Imperial College Hammersmith Hospital, Du Cane Road, London W12 0NN, UK.
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.
Insights
Advanced imaging, like Positron Emission Tomography (PET), aids early drug development by assessing new molecular entities (NME). Overcoming hurdles is key to leveraging PET
Area of Science:
- Pharmacology and Drug Development
- Medical Imaging
- Oncology
Background:
- Advanced imaging techniques are crucial for advancing new molecular entities (NME) in early drug development.
- Organizational, operational, and regulatory challenges can limit the impact of these imaging techniques.
- Positron Emission Tomography (PET) using radiolabeled NME offers unique decision-making data but faces implementation barriers.
Purpose of the Study:
- To discuss the value of PET imaging with radiolabeled NME in early anticancer drug development.
- To highlight the impediments hindering the timely integration of PET into drug development workflows.
- To propose solutions for streamlining organizational processes for future PET studies.
Main Methods:
- Review of the application of PET imaging in early-phase anticancer drug development.
- Case example of a specific radiolabeled NME utilized in PET studies.
- Analysis of organizational, operational, and regulatory hurdles associated with PET implementation.
Main Results:
- PET imaging provides valuable decision-making data for NME progression in early drug development.
- Significant organizational and regulatory hurdles impede the widespread adoption and timely use of PET.
- Streamlining processes is essential to fully realize the potential of PET in drug development.
Conclusions:
- PET imaging holds significant promise for enhancing early anticancer drug development by providing critical data.
- Addressing identified hurdles is imperative for the successful and efficient integration of PET into drug development pipelines.
- Proactive strategies to streamline organizational steps can facilitate the broader application of PET in future studies.
