Of mice and men: Correlation and clinical relevance of animal models and non-clinical tests for inhaled pharmaceuticals
Daniela Traini1,2
1Respiratory Technology, Woolcock Institute of Medical Research, Sydney, NSW 2037, Australia
2Macquarie Medical School, Department of Biological Sciences, Faculty of Medicine, Health and Human Sciences, Macquarie University, NSW 2109, Australia
Summary
With the new FDA Modernization Act of 2022, the agency now has the option to approve drugs and biomolecules that are tested in only non-clinical studies, including those that use cells and lab-grown tissues, such as organs on a chip, or computer models, before being tested in human clinical trials. Although this is probably going to be a slow change and not a tsunami that will transform the drug approval process overnight, now is probably the time to start reviewing the status quo on what are the reasons behind current inhalation drug development preclinical models, what alternative models are available and how the research community is considering this field moving forward. For many years, we have been stuck in a particular conceptual mode of doing research, but with this amendment in policy change will arise as the weight of the evidence for alternative tools becomes more robust and uniformly accepted and validated. In this paper, a review of current and novel research on this topic will be presented, and the author provide possible future directions in this exciting field.