Simulations Plus, Inc. (Nasdaq: SLP), the leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemicals, and consumer goods industries, today announced that, through a joint proposal with the St. Louis College of Pharmacy at University of Health Sciences and Pharmacy in St. Louis, it has been awarded a new funded cooperative agreement from the U.S. Food and Drug Administration (FDA) to establish novel in vitro/in silico models for the oral cavity route of administration in GastroPlus® to accelerate pharmaceutical research and regulatory assessment of innovative and generic drug products delivered intraorally.
For this award, researchers at the University of Health Sciences and Pharmacy in St. Louis will generate data for marketed buccal and sublingual products using both standard in vitro systems and the innovative Dynamic In Vitro Dissolution and Absorption Model (DIVDAM) designed in their labs. The team at Simulations Plus will apply these data sets, along with additional information provided by scientists at the FDA and partner companies within the consortium, to build and validate mechanistic in vitro/in vivo correlations (IVIVCs) via physiologically based biopharmaceutics (PBBM) / pharmacokinetic (PBPK) oral cavity models within GastroPlus.
“The current state-of-the-art Oral Cavity Compartmental Absorption and Transit™ (OCCAT™) module in GastroPlus – the only model of its kind for this administration route – was created several years ago in collaboration with a large pharmaceutical company using limited in vitro data,” said Dr. Viera Lukacova, chief scientist at Simulations Plus. “Using the novel database generated by the University of Health Sciences and Pharmacy in St. Louis, the improved machine learning and PBBM / PBPK models will provide a better characterization of formulation effects and enhance regulatory assessments for innovator and generic products.”
Under the cooperative agreement, FDA scientific and program staff will assist and participate in project activities in a partnership role with the St. Louis College of Pharmacy at University of Health Sciences and Pharmacy in St. Louis, Simulations Plus, and several leading pharmaceutical and generic drug companies. Drs. Haiying Zhou and Maxime Le Merdy will serve as project leads from Simulations Plus and contribute to various aspects of the award.
“We are excited to initiate this FDA-funded project in collaboration with our colleagues at Simulations Plus. The value of this partnership between academia and industry is that it has the potential to accelerate translation of innovative discoveries into tangible patient benefits,” said Dr. Giovanni Pauletti, Associate Dean for Graduate Studies, Gustavus & Henry Pfeiffer Chair, Department of Pharmaceutical and Administrative Sciences, and Professor of Biopharmaceutics & Pharmacokinetics, University of Health Sciences and Pharmacy in St. Louis. “Specifically, for this research project, we aim to develop a novel in vitro/in silico model that will facilitate greater access to safe and effective generic drug products designed for administration within the oral cavity.”
John DiBella, Lancaster division president, added: “To now enter our third funded collaboration with the FDA in 2020 is an amazing accomplishment and speaks to the relationships forged and the reputation earned. Like recent awards for the ocular and dermal delivery routes, Simulations Plus will own all intellectual property developed within the GastroPlus program, and updates will be integrated into future versions and made available to clients. We continue to invite future collaborations to drive advances to modeling and simulation science which benefit our entire user community and, most importantly, the patients that we serve.”
Funding for this collaboration is made possible by the Food and Drug Administration through grant 75F40120C00150. 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.