Simulations Plus and Partners Awarded New FDA Grant to Validate In Vitro-In Vivo Extrapolation Methods for Complex Formulations

Simulations Plus, Inc. (Nasdaq: SLP) ("Simulations Plus”), a leading provider of biosimulation, simulation-enabled performance and intelligence solutions, and medical communications to the biopharma industry, today announced a newly funded grant from the U.S. Food and Drug Administration (FDA), secured in partnership with the University of Strathclyde and InnoGI Technologies. The project is expected to improve the understanding of amorphous solid dispersion (ASD) formulations in different conditions and predict the impact of food and pH-dependent drug-drug interactions (DDIs) through the combination of novel in vitro testing and mechanistic modeling and simulation.

For this award, Professor Hannah Batchelor, through her lab at the University of Strathclyde, will analyze ASD drug products and their respective formulation variants. InnoGI Technologies will then test the different ASD formulations under fasted, fed, and higher gastric pH conditions utilizing the tiny-TIMsg, part of the SurroGUT™ Platform, in vitro system. Next, physiologically based pharmacokinetic (PBPK) models will be developed in the GastroPlus® platform to link in vitro dissolution with in vivo pharmacokinetic data and develop in vitro-in vivo extrapolations (IVIVEs). Finally, virtual bioequivalence (VBE) trial simulations will be conducted in GastroPlus to assess the clinical performance of ASD formulation variants to validate the approaches. The resulting outcomes are anticipated to help speed up formulation adjustments, reduce costs, and accelerate time-to-market for both innovator and generic ASD products.

"We are delighted to be at the forefront of this important research, which has the potential to significantly advance PBPK science and revolutionize how we predict drug product performance,” said Dr. Maxime Le Merdy, Director of PBPK Collaborations at Simulations Plus and principal investigator for this grant. "Developing a novel IVIVE methodology for ASD drug products will play a crucial role in optimizing formulation development, fine-tuning process parameters, and supporting bioequivalence assessments by offering key insights into the factors that impact in vivo performance.”

FDA scientific and program staff will actively collaborate with the University of Strathclyde, InnoGI Technologies, and Simulations Plus. Dr. Le Merdy, with assistance from scientists at Simulations Plus, will coordinate the modeling and simulation activities of the contract.

"By leveraging the power of this industry-academia-regulatory collaboration, we will push the boundaries of innovation and accelerate the development of safer, more effective therapies,” said Prof. Batchelor. "This unique partnership allows us to combine InnoGI’s cutting-edge in vitro technologies, GastroPlus’s mechanistic modeling, and real-world clinical insights, driving greater efficiency and confidence in drug development decisions.”

"As oral formulation development grows increasingly complex, evaluating drug product performance while studying luminal events in real time demands the integration of advanced technologies to bridge in vitro and in vivo testing gaps, thus reducing development risks for more efficient drug development,” said Susann Bellmann, CTO of InnoGI Technologies.

Funding for this collaboration is made possible by the Food and Drug Administration through grant award 1U01FD008388-01. 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 the Batchelor laboratory at the University of Strathclyde

Hannah Batchelor, a professor of Pharmaceutics within the Strathclyde Institute of Pharmacy and Biomedical Sciences at the University of Strathclyde, and her team have broad research interests which focus on the development of age-appropriate medicines for children. Specific research areas include pediatric biopharmaceutics and development of appropriate in vitro testing strategies to predict in vivo performance, along with the application of in silico modeling in pediatric populations to optimize pharmacokinetic study design and evaluate the impact of drug-food interactions. She is currently the director of the GIBio facility at Strathclyde (https://cmac.ac.uk/gibio) and her work, supported by federal and industrial funding, has led to many peer-reviewed publications and invited presentations in these areas.

About InnoGI Technologies

InnoGI Technologies, formerly known as The TIM Company, is a global leader in the development of advanced in vitro gastrointestinal models and expert services, building on decades of expertise in oral drug testing. Based in Delft, The Netherlands, InnoGI Technologies offers a comprehensive suite of services designed to simulate the complex processes of the human gastrointestinal (GI) tract leveraging its SurroGUT™ platform mimicking the human GI tract with high fidelity. These services include advanced dissolution testing, absorption modeling, and the prediction of drug release and bioavailability. By using highly realistic, scientifically validated GI models, InnoGI helps clients optimize formulations, de-risk clinical trials, and streamline product development. The company's solutions reduce formulation iterations, accelerate time-to-market, and support critical decision-making throughout the stages of oral drug development. Serving clients in both the pharmaceutical and food industries, InnoGI’s innovative approaches are supported by more than 250 scientific publications, positioning the company as a trusted partner in advancing oral drug delivery and improving therapeutic outcomes worldwide. For more information, visit our website at www.innogitechnologies.com and follow us on LinkedIn.

About Simulations Plus, Inc.

With more than 25 years of experience serving clients globally, Simulations Plus stands as a premier provider in the biopharma sector, offering advanced software and consulting services that enhance drug discovery, development, research, clinical trial operations, regulatory submissions, and commercialization. Our comprehensive biosimulation solutions integrate artificial intelligence/machine learning (AI/ML), physiologically based pharmacokinetics, physiologically based biopharmaceutics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. We also deliver simulation-enabled performance and intelligence solutions alongside medical communications support for clinical and commercial drug development. Our cutting-edge technology is licensed and utilized by leading pharmaceutical, biotechnology, and regulatory agencies worldwide. For more information, visit our website at www.simulations-plus.com. Follow us on LinkedIn | X | YouTube

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