Medical modeling and simulation software company Simulations Plus has been awarded a grant from the Food and Drug Administration through a joint proposal with the University of Bath’s Department of Life Sciences.
The grant was awarded to advance biopharmaceutical and pharmacokinetics modeling approaches that if executed correctly can inform regulatory decisions on products for drugs in the gastrointestinal tract and minimize animal and human studies. The amount of the grant was not disclosed.
Founded in 1996, Simulations Plus provides simulation software applications to clients in the pharmaceutical and medical research fields among others. The company is publicly traded and has posted revenues around $13 million in each quarter this year, beating analyst expectations.
The work funded by the grant will be split between Simulations Plus and the University of Bath, which will work on different parts of the project.
Dr. Nikoletta Fotaki and collaborators at the University of Bath will generate in-vitro data for commercial drug formulations to assess how they work in environments such as healthy human bodies and those with ulcerative colitis and Crohn’s disease. The result of the data and assessments will be the creation and evaluation of drug-formulation variants that can work within such environments.
Simulations Plus will then apply the data sets to strengthen one of the simulation models within its Gastroplus platform.
Gastroplus is a software package that simulates properties of drugs or chemicals in several parts of the body.
The result will provide the foundation for an alternative to in-vivo studies, which is research done with or within living organisms, for the establishment of bioequivalence for gastrointestinal products.
According to the FDA, “products are considered to be bioequivalent when they are equal in the rate and extent to which the active pharmaceutical ingredient becomes available at the site(s) of drug action.”
“The story of GastroPlus started in 1998, and for nearly 25 years it has been, time and time again, independently verified as the preeminent software for predicting oral drug absorption for pharmaceuticals and chemicals alike,” Dr. Haiying Zhou, senior director of simulation technologies at Simulations Plus and co-principal investigator of the project, said in a statement.
Dr. Maxime Le Merdy, associate director of research and collaborations at Simulations Plus, said the award achieves a significant objective for the company.