Introduction: The high attrition rate during drug development remains a challenge that costs a significant amount of time and money. Improving the probabilities of success during the early stages of radiation medical countermeasure (MCM) development for approval by the United States Food and Drug Administration (US FDA) following the Animal Rule will reduce this burden.
Area covered: This article focuses on new technologies involving various organ-on-chip platforms. Of late, there has been rapid development of these technologies, especially in terms of mimicking both normal and abnormal physiological conditions. Here, we suggest possible applications of these novel systems for the discovery and development of radiation MCMs for the acute radiation syndrome (ARS).
Expert opinion: Each organ-on-a-chip system has its own strengths and shortcomings. As such, the system selected for MCM discovery, development, and regulatory approval should be carefully considered and optimized to the fullest extent in order to augment successful drug testing and the minimization of attrition rates of candidate agents. The recent encouraging progress with organ-on-a-chip technology will likely lead to additional radiation MCMs for ARS. The acceptance of organ-on-a-chip technology may be a promising step toward improving the success rate of pharmaceuticals in MCM development.
Keywords: Acute radiation syndrome; animal models; drug development; organs-on-chips; radiation injury; radiation medical countermeasures.