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Simulations Plus Receives New Grant Award from the FDA
Novel PBPK/PD modeling strategies for ophthalmic drug products will inform regulatory decision-making LANCASTER, Calif.--(BUSINESS WIRE)-- Simulations Plus,
About this update from Simulations Plus, Inc.
[{"type":"text","content":"\nNovel PBPK/PD modeling strategies for ophthalmic drug products will inform regulatory decision-making\n\n LANCASTER, Calif.--(BUSINESS WIRE)--\nSimulations Plus, Inc. (Nasdaq: SLP), the leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemicals, and consumer goods industries, today announced that it has received notice from the U.S. Food and Drug Administration (FDA) that it has been awarded a new funded cooperative agreement, for up to $400,000 over three years, to develop physiologically based pharmacokinetics/pharmacodynamics (PBPK/PD) approaches to support interspecies translation for ocular drug delivery in GastroPlus®.\n\n\n“The FDA’s Office of Generic Drugs (OGD) continuously evaluates alternatives to conventional bioequivalence approaches to determine the likelihood that a new locally-acting formulation will be bioequivalent to an approved dosage form in the target patient population,” said Dr. Viera Lukacova, Director of Simulation Sciences for Simulations Plus. “Through this grant, we will work with the FDA to improve the well-established Ocular Compartmental Absorption and Transit™ (OCAT™) model within the GastroPlus software platform to validate new strategies to establish scientific and regulatory standards for supporting innovative development and performing bioequivalence assessments for ocular drug products through PBPK/PD modeling and simulation. We look forward to working with the FDA and our industry partners on this important project.”\n\n\nUnder the cooperative agreement, FDA scientific and program staff will assist and participate in project activities in a partnership role with several leading pharmaceutical and generic drug companies. Drs. Jessica Spires and Maxime Le Merdy will serve as project leads and have primary responsibility for the scientific, technical, and programmatic aspects of the award.\n\n\nJohn DiBella, President of the Lancaster division for Simulations Plus, added: “Our relationship with the FDA on enhancements to the OCAT model dates back to 2014, and the funding, scientific interactions, and resulting publications have established it as the preeminent in silico approach in the area of absorption of drugs applied to the eye. Similar to previous awards, Simulations Plus will own all intellectual property developed within the GastroPlus progr...