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

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.

About Professor Jie Shen’s Laboratory at Northeastern University

Professor Jie Shen’s laboratory at Northeastern University is dedicated to innovative and collaborative interdisciplinary pharmaceutical and biomedical research to enhance public access to high quality and cost-effective medications to ultimately improve public health. Professor Shen’s laboratory is specialized in the formulation development and characterization, bioequivalence assessment strategies, and IVIVC (in vitro-in vivo correlation) of complex drug products (such as long-acting or locally-acting dosage forms, nanomedicines, modified release formulations). For more information, visit our website or follow us on LinkedIn. Founded in 1898, Northeastern is a global research university and the recognized leader in experience-driven lifelong learning. Our world-renowned experiential approach empowers our students, faculty, alumni, and partners to create impact far beyond the confines of discipline, degree, and campus.

About The TIM Company

The TIM Company expands its legacy of expertise within in vitro gastrointestinal models, combining over 35 years of experience. Headquartered in Delft, The Netherlands, The TIM Company is driven by the goal of developing alternative technologies to dissolution methods and animal research. Through its highly predictive technologies, it strongly contributes to the successful evaluation of oral formulation behavior and formulation performance prior to entering clinical trials. Data from TIM have guided clients worldwide with decision-making in different stages of oral drug development, i.e., led to the decrease in formulation reiterations, effectively de-risked clinical trials, and shortened time-to-market. For more information, visit our website at www.theTIMcompany.com or follow us on LinkedIn.

About Simulations Plus, Inc.

Serving clients worldwide for more than 25 years, Simulations Plus is a leading provider in the biosimulation market providing software and consulting services supporting drug discovery, development, research, and regulatory submissions. We offer solutions that bridge artificial intelligence (AI)/machine learning, physiologically based pharmacokinetics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. Our technology is licensed and applied by major pharmaceutical, biotechnology, and regulatory agencies worldwide. For more information, visit our website at www.simulations-plus.com. Follow us on LinkedIn | Twitter | YouTube.

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Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995 – With the exception of historical information, the matters discussed in this press release are forward-looking statements that involve a number of risks and uncertainties. Words like “believe,” “expect” and “anticipate” mean that these are our best estimates as of this writing, but that there can be no assurances that expected or anticipated results or events will actually take place, so our actual future results could differ significantly from those statements. Factors that could cause or contribute to such differences include, but are not limited to: our ability to maintain our competitive advantages, acceptance of new software and improved versions of our existing software by our customers, the general economics of the pharmaceutical industry, our ability to finance growth, our ability to continue to attract and retain highly qualified technical staff, our ability to identify and close acquisitions on terms favorable to the Company, and a sustainable market. Further information on our risk factors is contained in our quarterly and annual reports and filed with the U.S. Securities and Exchange Commission.

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