Certara says its drug development software supported 95 percent of the 20 novel drugs given the OK by the Food and Drug Administration in the first half of 2018, according to a Fierce Biotech report.
The company added that the number shows in silico tools are playing an increasingly important role in regulatory submissions.
“Modeling and simulation play critical role in organizing diverse data sets and exploring alternate study designs,” FDA Commissioner Scott Gottlieb said in a blog past last summer. “This enables safe and effective new therapeutics to advance more efficiently through the different stages of clinical trial.”
On the home court, Certara has also bolstered its offerings after having not only recently acquired Analytica Laser, but having also ramped up its efforts in real-world effectiveness prediction, value assessments and health economics and outcomes research, according to Fierce Biotech.
“Our mission is to revolutionize the drug development paradigm by leveraging modern quantitative approaches such as modeling and simulation and real-world evidence solutions to optimize R&D productivity, commercial value and patient outcomes,” Certara CEO Edmundo Muniz said in a statement. “These technologies’ positive impact is evident in the accelerated development cycles for these approved drugs and the innovation adoption by the FDA.”
