Simulations Plus, Inc. (AMEX:SLP), a leading provider of software for pharmaceutical discovery and development, today announced that it has received a purchase order from the U.S. Food and Drug Administration to license the Company’s GastroPlus simulation software.
Ron Creeley, vice president of marketing and sales for Simulations Plus, said: “We’re very pleased that the FDA has licensed GastroPlus for use in its internal research. We believe this license is an indication of the utility of GastroPlus as one of the tools the FDA and industry use in various research projects.”
Walt Woltosz, chairman and chief executive officer of Simulations Plus, said: “We recently worked on a few projects with FDA scientists using GastroPlus that resulted in joint publication of scientific posters. The FDA’s position in advocating for better simulation and modeling tools was expressed in its well-known white paper entitled “Innovation or Stagnation, Challenge and Opportunity on the Critical Path to New Medical Products” released in March 2004. In it, the FDA stated: . . . a new product development toolkit containing powerful new . . . methods such as . . . computer-based predictive models . . . is urgently needed. . . . The medical product development process is no longer able to keep pace with basic scientific innovation. Only a concerted effort to apply the new biomedical science to medical product development will succeed in modernizing the critical path.'”