Simulations Plus and the University of Florida Awarded New FDA Contract to Support Development and Regulatory Assessment of Inhaled Products

Collaboration combines novel in vitro experimental methods and mechanistic modeling to accelerate development of orally inhaled drug products (OIDPs) and propose alternative approaches for bioequivalence

Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced that, through a joint proposal with the University of Florida’s College of Pharmacy, it has been awarded a new funded contract from the U.S. 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 award, Dr. Rodrigo Cristofoletti, Assistant Professor in the Department of Pharmaceutics, and his lab at the University of Florida will generate in vitro data from different systems, including cells from healthy subjects as well as asthmatic and COPD patients, to assess the mechanistic components of pulmonary absorption for different drugs. The scientific team at Simulations Plus will apply these datasets, along with additional pathophysiology information for asthma and COPD populations, to validate the enhanced Pulmonary Compartmental Absorption and Transit (PCAT™) model within the GastroPlus® platform for different orally inhaled drug products (OIDPs). The resulting outcome will provide the foundation of a viable alternative to in vivo studies for the establishment of bioequivalence (BE) for OIDPs.

Mr. James Mullin, Associate Research Fellow at Simulations Plus and co-Principal Investigator for this project, said: “Our novel physiologically based biopharmaceutics (PBBM)/PBPK modeling approach within GastroPlus for pulmonary delivery was initiated in 2009 through an industry-funded collaboration, and to date there have been over 25 peer-reviewed journal publications validating the platform across a wide range of drugs and chemicals. This partnership with Dr. Cristofoletti, his team, and the FDA will expand and improve upon our current cutting-edge technology. Ultimately, the strategies that we are outlining and implementing for applying in vitro systems and in silico models hold potential to lower 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 assistance from Dr. Maxime Le Merdy, Ms. Farah AlQaraghuli, and Dr. Viera Lukacova, will coordinate modeling and simulation activities of the contract.

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

“To be partnering with the FDA on five different funding programs going into 2023 is a testament to the confidence and trust the agency has in the people and technology at Simulations Plus, and the accelerating utilization of simulation and modeling technology industry-wide,” 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, innovative solutions to support innovator and complex generic development of ocular, dermal, oral cavity, long-acting injectable, and inhaled products. Simulations Plus is committed to ensuring all improvements to the GastroPlus platform which come out of the funded programs are accessible for all customers to apply to their own research activities. We continue to welcome future collaborations that will further advance modeling and simulation science, benefiting our user community, and above all, the patients that we serve.”

Funding for this collaboration is made possible by the Food and Drug Administration through contract 75F40122C00182. 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 Cristofoletti Laboratory in the College of Pharmacy at the University of Florida

The research in Dr. Cristofoletti’s laboratory focuses on integrating in vitro systems and quantitative methods and modeling to inform drug discovery and drug product development with focus on: (a) mechanistic absorption models for IVIVC, IVIVE, and virtual bioequivalence trials; (b) metabolic- and transport-mediated drug-drug interaction; and (c) disease-based models. Dr. Cristofoletti’s lab has also been applying stem cell technology, co-culture techniques and microfluidics to develop microphysiological systems to investigate drug- and disease-related mechanisms affecting membrane integrity and predict drug absorption/tissue disposition. A major recent emphasis has been on developing a segment-specific intestine-on-a-chip to investigate drug- and disease-related mechanisms affecting intestinal membrane integrity (leaky gut) as well as transport-mediated kinetics and drug-drug interactions. His group is also interested in applying organ-on-a-chip technology to study drug penetration in brain parenchyma and cerebrospinal fluid. Dr. Cristofoletti has published more than 50 peer-reviewed articles in highly respected journals in the pharmaceutics field as well as 5 book chapters.

About Simulations Plus

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 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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