University of Florida Simulations Plus (SLP) Wins New FDA Contract to Support Development and Regulatory Evaluation of Inhaled Products

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Simulations Plus, Inc.. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced that, as part of a joint proposal with the College of Pharmacy of the University of Florida, he was awarded a new contract funded by the United States Food and Drug Administration (FDA) to advance in vitro and (patho)physiology-based pharmacokinetics (PBPK) models to understand and predict pulmonary absorption and tissue retention of inhaled drugs.

For this price, Dr. Rodrigo Cristofolettiassistant professor in the department of pharmacy, and his lab at the University of Florida will generate in vitro data from different systems, including cells from healthy subjects as well as asthma and COPD patients, to assess the mechanistic components of pulmonary absorption of different drugs. The Simulations Plus science team will apply these datasets, along with additional pathophysiological information for populations with asthma and COPD, to validate the Enhanced Pulmonary Compartment Absorption and Transit (PCAT™) model in the framework of GastroPlus® platform for different orally inhaled drug products (OIDP). The resulting outcome will provide the basis for a viable alternative to live studies for the establishment of bioequivalence (BE) of OIDPs.

Mr. James Mullin, Research Associate at Simulations Plus and Co-Principal Investigator for this project, said: “Our novel Physiologically Based Biopharmaceutical Modeling (PBBM)/PBPK approach within GastroPlus for pulmonary delivery was launched in 2009 through a industry-funded collaboration, and to date there have been over 25 publications in peer-reviewed journals validating the platform for a wide range of drugs and chemicals. This partnership with Dr. Cristofoletti, his team, and the FDA will expand and enhance our current state-of-the-art technology. Ultimately, the strategies we develop and implement to apply in vitro systems and silicone models have the potential to reduce regulatory burden and minimize the need for animal and human studies.

FDA scientific and program staff will actively collaborate with the University of Florida and Simulations Plus. Mr. Mullin, with the assistance of Dr. Maxime Le Merdy, Ms. Farah AlQaraghuliand Dr. Viera Lukacovacoordinate contract modeling and simulation activities.

“We are delighted with the funding of this contract with the FDA which allows us to collaborate with Dr. Guenther Hochhaus, Dr. Jürgen Bulitta and Simulations Plus,” said Dr. Cristofoletti. “Our goal is to enable the realization of new models that will bridge the gap between in vitro and human data and guide the development of biopredictive methods to improve mechanistic understanding of drug performance locally in the lung.

“Partnering with the FDA on five different funding programs through 2023 is a testament to the agency’s confidence in the people and technology of Simulations Plus, and accelerating the use of simulation and industry-wide modeling,” added Dr. Le Merdy, Associate Director, Research and Collaborations. “We will work tirelessly with the FDA and our industry and academic partners to provide validated and innovative solutions to support innovative and complex generic development of eye, dermal, oral, long-acting injectable and inhaled products. Simulations Plus is committed to ensuring that all enhancements to the GastroPlus platform resulting from funded programs are available to all customers to apply to their own research activities. We continue to welcome future collaborations that will advance the science of modeling and simulation, to the benefit of our user community and, most importantly, the patients we serve.

Funding for this collaboration is made possible by the Food and Drug Administration through contract 75F40122C00182. The views expressed in this press release do not necessarily reflect the official policies of the Department of Health and Human Services; and no mention of trade names, trade practices, or organizations implies endorsement by the United States Government.

About the University of Florida College of Pharmacy Cristofoletti Lab

Research in Dr. Cristofoletti’s laboratory focuses on the integration in vitro Quantitative systems and methods and modeling to inform drug discovery and drug product development with an emphasis on: (a) mechanistic uptake models for IVIVC, IVIVE, and virtual bioequivalence assays; (b) drug-drug interaction mediated by metabolism and transport; and (c) disease-based models. Dr. Cristofoletti’s lab has also applied stem cell technology, co-culture techniques, and microfluidics to develop microphysiological systems to study drug and disease-related mechanisms affecting membrane integrity and to predict drug absorption/tissue disposition. Recently, emphasis has been placed on the development of a segment-specific gut-on-chip to study drug- and disease-related mechanisms affecting gut membrane integrity (leaky gut) as well as kinetics mediated by transportation and drug interactions. His group is also interested in applying organ-on-a-chip technology to study drug penetration into brain parenchyma and cerebrospinal fluid. Dr. Cristofoletti has published over 50 peer-reviewed articles in highly respected pharmaceutical journals as well as 5 book chapters.

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