Commercialization of a Graphical Pharmacokinetic-Pharmacodynamic Display

DESCRIPTION (provided by applicant): Applied Medical Visualizations L.L.C. has developed a pharmacokinetic-pharmacodynamic display (PkPd Display) intended for anesthesia care providers. In Phase I, we designed a display that was based on a two drug interaction model, which was previously developed for an opioid (remifentanil) and a sedative hypnotic (propofol) in human volunteers. The measures for this PkPd interaction model include the probability of loss of consciousness and loss of response to various noxious stimuli. The model was evaluated in the operating room on its ability to predict loss and regain of consciousness and to predict non-responsiveness to noxious stimuli in a wide variety of patients. The results were positive. The models adequately predicted clinical endpoints of interest to an anesthetist and is hence, commercially viable. For Phase II, several aspects of the PkPd Display merit development and further evaluation prior to commercialization: 1. we will evaluate the usability of the PkPd Display and ensure it will not interfere with other critical aspects of anesthetic delivery and appropriate patient care. The display will be evaluated in both patient simulator and operating room settings. 2. We will expand the number of interaction models used within the PkPd Display to include other commonly used anesthetics, such as inhaled agents and additional opioids. 3. We will characterize differences in the drug-drug interaction in patients scheduled for elective surgery who chronically consume opioids, and update the PkPd Display with these results 4. We will implement optimization techniques so that the display's models predict drug combinations that will result in a rapid wakeup by the patient while maintaining adequate analgesia during recovery. If successfully implemented, use of the PkPd Display could result in fewer hypertensive and hypotensive episodes, fewer adjuvant drug interventions, a lower incidence of patient movement, a lower incidence of the need for pharmacologic reversal of opioid effect to restore spontaneous ventilation, and more rapid wakeup at the end of surgery. By generalizing the PkPd models for use with inhaled agents and opioids, the display will be usable in a significantly larger portion of administered anesthetics worldwide. By accounting for additional model covariates, such as the opioid tolerant patient, the display can provide accurate predictions for outliers beyond the normal population, possibly reducing risk of respiratory depression and inadequate analgesia. Optimizing the display will bring intelligence into the display, providing complex optimizations with a simple presentation to the user. 7. PROJECT NARRATIVE Applied Medical Visualizations L.L.C. has developed a graphical drug display intended for anesthesia care providers. This display is intended to help anesthesiologists visualize a patient's level of sedation and analgesia during surgery, resulting in more effective anesthetics and less episodes of inadequate analgesia experienced by the patient.