Collaboration will combine novel experimental techniques and mechanistic modeling strategies

Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation solutions for the pharmaceutical and biotechnology industries, today announced that, through a joint proposal with the University of Connecticut’s Department of Pharmaceutical Sciences, it has been awarded a new funded contract from the U.S. Food and Drug Administration (FDA) to enhance and validate mechanistic in vitro/in vivo correlation (IVIVC) methods for long-acting injectable (LAI) formulations to accelerate innovator and generic product development and regulatory assessment.

For this award, Dr. Diane Burgess, Board of Trustees Distinguished Professor of Pharmaceutics and Pfizer Distinguished Endowed Chair in Pharmaceutical Technology, and her lab at the University of Connecticut, will generate in vitro and in vivo data for marketed LAI products using novel discriminatory systems. The scientific team at Simulations Plus will apply these data sets, along with additional information provided by research collaborators, to build and validate physiologically based biopharmaceutics (PBBM)/pharmacokinetic (PBPK) models and generate IVIVCs. The resulting outcome will provide the foundation of a viable alternative to in vivo studies for the establishment of bioequivalence (BE) for LAI products.

Dr. Viera Lukacova, Chief Scientist at Simulations Plus, said: “Our pioneering PBBM/PBPK modeling approaches in GastroPlus^® for LAI products were kickstarted by an FDA-funded grant award in 2015. This partnership with Dr. Burgess and her team will extend and enhance our current state-of-the-art models to address many client requests. Ultimately, the strategies we outline and implement on the application of in vitro systems and in silico models have the potential to reduce regulatory burden and minimize human studies.”

FDA scientific and program staff will actively collaborate with the University of Connecticut and Simulations Plus. Dr. Lukacova, with assistance from Mr. James Mullin, Dr. Maxime Le Merdy, and Dr. Revathi Chapa, will serve as project lead from Simulations Plus and coordinate modeling and simulation activities of the contract.

“We are excited about the funding of this FDA contract that allows us to collaborate with Simulations Plus,” said Dr. Burgess. “Our laboratory has been working for many years in understanding performance behavior of parenteral formulations, and it is terrific to now combine our expertise with that of Simulations Plus to bring this research to the next level. Our goal is to allow realization of models that will bridge the gap between animal and human data and guide the development of biopredictive dissolution methods.”

“To now be engaged with the FDA on four different funded programs in 2022 is a great accomplishment, validating the widespread embracing of modeling and simulation technology as an important tool in drug development,” said John DiBella, division president, Simulations Plus. “We are appreciative of the confidence the FDA has in the people and technology at Simulations Plus, and we will work tirelessly with our regulatory, industry, and academic partners to deliver validated, groundbreaking solutions to support innovator and complex generic development of ocular, dermal, oral cavity, and long-acting injectable products. Simulations Plus ensures that all improvements made to the GastroPlus platform derived from funded programs are available for all clients to apply to their research activities, and 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 contract 75F40121C00133. 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 Burgess laboratory in the Department of Pharmaceutical Sciences at the University of Connecticut

The Burgess laboratory in the Department of Pharmaceutical Sciences at the University of Connecticut has a research focus on formulation science, drug delivery and manufacturing science of complex parenterals. Research efforts cover the basic science of interfacial chemistry, the application of this in preformulation and formulation development, the development of novel drug delivery systems, and the in vitro and in vivo testing of these drug delivery systems including investigation of biopharmaceutics and pharmacodynamics. This research is applied to solving problems with respect to drug and gene delivery and focuses on microsphere, nanoparticle, liposome, emulsion, hydrogel and in situ forming delivery systems. Efforts are also focused on biocompatible coatings to prevent the foreign body reaction that would otherwise result in loss of functionality of parenteral implantable devices.

Major contributions include: development of novel microcapsule dosage forms; development of “real-time” and accelerated performance tests for complex parenteral dosage forms and development of IVIVCs for these complex dosage forms; modeling of the pharmacokinetics of protein therapeutics from microsphere dosage forms; correlation of interfacial properties with emulsion and nanoparticle stability; development of a novel composite coating for implantable devices that has been shown to prevent the foreign body response in animal models in excess of 6 months; development of a method that allows long-term intracellular and intranuclear tracking of gene therapeutics and gene delivery vectors; design of safe, efficient and stable non-viral gene delivery systems; application of quality-by-design principles to nanoparticles and liposomes; and development of novel manufacturing methods for liposomes and emulsions, including the development of continuous manufacturing methods with inline process analytical technology for complex parenterals.

Dr. Burgess’ laboratory currently has six active grants and contracts with the FDA.

About Simulations Plus, Inc.

Serving clients worldwide for 25 years, Simulations Plus, Inc., is a leading provider of modeling and simulation 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, chemical, consumer goods companies, nonprofit research institutes, universities, and regulatory agencies worldwide. For more information, visit our website at www.simulations-plus.com. Follow us on Twitter | LinkedIn | YouTube. Read our Environmental, Social, and Governance (ESG) Report.

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