Simulations Plus Embarks on Collaboration with Northeastern University and The TIM Company Through New FDA Grant

Partnership aims to integrate experimental data and PBPK modeling to identify key formulation factors to accelerate modified-release product development

Lancaster, CA — Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemicals, and consumer goods industries, today 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.”

“The research efforts of our team and Dr. Shen have the potential to accelerate the availability of critical treatments to patients across the world, with minimized need for clinical trials,” said Susann Bellmann, Chief Technology Officer at The TIM Company. “We are proud to support those efforts and this collaboration through the use of our dynamic in vitro gastrointestinal model, tiny-TIMsg.”

FDA scientific and program staff will actively collaborate with Northeastern University, The TIM Company, and Simulations Plus. Dr. Pepin, with assistance from Dr. Maxime Le Merdy at Simulations Plus, will oversee the modeling and simulation activities of the contract.

Funding for this collaboration is made possible by the Food and Drug Administration through grant award 1U01FD007959-01. Views expressed in this press release do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.