Molecular imaging may streamline drug development, reduce costs

Cancer drug development is rapidly expanding. Although crucial for treatment, it also eats up healthcare dollars and resources.

A study published in the Journal of Nuclear Medicine found molecular imaging can play a role in providing critical information to develop these drugs and potentially save money spent on clinical trials.

Many drugs fail to get clinical approval, and only around 12 percent of compounds entering the clinical trial phase reach regulatory submission. Median cost estimates of $648 million have been associated with single drug approvals, making those that don’t receive approval extremely costly.

Researchers from the Netherlands examined this issue in a Jan. 25 online study. They argue molecular imaging is “increasingly perceived as a tool to support go/no-go decisions early during drug development,” wrote corresponding author Elisabeth G.E. de Vries, MD, PhD, with the department of medical oncology at the University Medical Center in Groningen, Netherlands, and colleagues.

Molecular imaging can aide in informing the Pharmacological Audit Trail, a set of key questions to be asked during drug discovery and development. These questions seek to address population identification, pharmacokinetics, pharmacodynamics and combination therapy to improve cancer drug development.

Among the answers molecular imaging can help provide are: additional information about target validation, tumor targeting, whole body target expression including heterogeneity, whole body drug distribution, pharmacokinetic features such as central nervous system penetration and pharmacodynamics effects.

“Although these studies are expensive, require time and expertise, valuable information regarding drug development can be extracted. However, molecular imaging should be complemented when relevant by other techniques such as pharmacokinetic analysis as well as radiomics (analysis extracted from PET, computed tomography or MRI images) or analysis of tumor biopsies, circulating tumor DNA, or circulating tumor cells by genomics, transcriptomics, or proteomics,” de Vries et al. wrote. “This toolbox of techniques has gained interest in cancer drug development and allows biomarker exploration, patient selection and insight in mechanism of action."