Overview

A new drug is developed over 12-15 years, on the average, at a capitalized cost of more than one billion dollars. A considerable portion of this sum is lost to experimentation failures, a clinical trial failure rate being over 80%. To replace the inefficient trial-and-error methods the pharmaceutical and biotechnology industries must undergo a significant change in the drug development paradigm. This need was explicitly addressed by the Critical Path Opportunities Report of the FDA (March, 2006), aimed at encouraging efforts to revolutionize clinical trial design. Optimata's technology addresses precisely this need and has been successfully tested and implemented.

Created by a professional interdisciplinary R&D team of scientists, including experts in molecular biology, biomathematics, medicine, pharmacology, operations research, applied mathematics and computer science, Optimata's answer to the costly and inefficient trial-and-error dilemma is their innovative product, Optimata Virtual Patient.

Optimata Virtual Patient is a predictive software tool based on simulating, or mimicking, disease and physiological processes in the computer. Optimata Virtual Patient encapsulates data from thousands of peer-reviewed papers on relevant topics, and synthesizes it into a cohesive mathematical description, or mathematical model, which is then computer implemented. It provides predictions for numerous disease behaviors. For example, if we consider solid tumor cancer, an area in which Optimata has acquired exceptional expertise, changes in tumor size are an important indicator of the disease status. Optimata Virtual Patient predicts changes in tumor size over time, as affected by a particular treatment alternative, taking into account the treatment’s pre-specified goals and imposed toxicity limitations.

The drug development path traverses numerous decision-point junctions at which the drug developer must decide how to proceed. This involves decisions, such as selection of the most responsive sub-population and clinical indication, the most promising drug schedule, and so on. Today, these decisions are heavily based on trial-and-error, causing promising trials to be led astray. Optimata's technology provides a navigational tool for the drug development industry, pointing out the optimal path for arriving at their destination.

Optimata Virtual Patient offers a rational planning and decision-making alternative for the various clinical trial phases. It considers innumerable computer-simulated treatment scenarios for a range of indications and patient-populations. Only those simulated treatments with the most promising outcomes are then actually tested in clinical trials, using the treatment schedule, indication, and patient-population of the winning simulated scenario. Consequently, clinical trials that are based on Optimata Virtual Patient have a substantially increased success rate, shortening drug development process by an estimated 30%.

This makes Optimata Virtual Patient, applied at the critical decision-points along the critical path, the ideal tool for expediting and better navigating the drug development process.