The development of imaging biomarkers both for the pre-clinic and the clinic has the potential to advance safety evaluation. However, in order for imaging biomarkers to become more mainstream, impacting the drug discovery process more widely, there needs to be technical advances, as well as a better standardization across the imaging community to ensure protocols, biomarkers, analysis and data interpretation are well recognized and equivalent. If properly validated, imaging methods will support establishment of the ADME concept and estimation of toxic effects of drug candidates and could additionally strongly support the efforts to identify the minimal (i.e. safest) dose providing useful therapeutic efficacy.
Please refer to the full topic text on the IMI2 Call 7 section of the IMI website.Scope:
The overall aim of the proposal is to leverage the potential of available imaging techniques in order to improve drug safety analysis and translatability of findings from animals to humans by validating imaging procedures as biomarker. The output from the resulting project should provide clear evidence that state-of-the-art imaging techniques, when validated properly, can support pre-clinical and clinical drug development and improve safety for individual patients. The following three areas are in scope: the assessment of liver toxicity; lung toxicity and the bio-distribution of biologicals.Expected Impact:
The information and knowledge acquired will be of outmost value for further improving safety evaluation of novel drug candidates, small molecules as well as biologics. Imaging biomarkers have a strong potential to improve translatability of pre-clinical results to healthy volunteers and patients and thus help to avoid late stage attrition of development programs. In addition, functional diagnostic imaging methods used as biomarkers would offer the possibility to confirm drug toxicity mechanisms in humans, including the potential to determine drug-drug interactions.
The possibility to follow a drugs bio-distribution and its effect on tissues or molecules longitudinally by means of imaging intrinsically includes the potential to reduce animal numbers in pre-clinical studies. Hence the work in this program strongly supports the 3R principle (refinement, reduction, replacement) in substantially reducing the number of animals needed in pre-clinical research.
Please refer to the full topic text on the IMI2 Call 7 section of the IMI website.