Simulations Plus teams with NEU and The TIM Company through new FDA grant

Simulations Plus announced that, through a joint proposal with Northeastern University and The TIM Company, it has been awarded a new funded grant from the U.S. Food and Drug Administration FDA . The project will aid in the understanding of oral modified-release MR formulations and advance the development and approval of generic oral MR drug products through the combination of novel in vitro testing and mechanistic modeling and simulation. For this award, Dr. Jie Shen, Associate Professor of Pharmaceutical Sciences, and her lab at Northeastern University, along with partners at The TIM Company, will generate in vitro data characterizing the critical quality attributes CQAs and dissolution of multiple strengths of MR formulations. The newly generated data will be used to parameterize physiologically based pharmacokinetic/physiologically based biopharmaceutic PBPK/PBBM models predicting clinical pharmacokinetics of those MR formulations following their oral administration. The combination of in vitro and in silico studies will support the identification of the appropriate factors to scale the MR formulation for additional strengths, and to identify the CQAs and formulation design spaces for oral MR tablets. “This collaboration is an exciting step forward, as we combine our PBPK/PBBM modeling and simulation expertise with Northeastern University’s research excellence and The TIM Company’s groundbreaking tiny-TIMsg model,” said Dr. Xavier Pepin, Associate Vice President, Regulatory Strategies and lead investigator for this grant for Simulations Plus. “Together, we are charting a course towards more efficient drug development and safer healthcare solutions. We believe the comprehensive framework established through this collaboration will have value for both the FDA and the companies involved in developing oral MR formulations.”