Simulations Plus, Inc. (“Simulations Plus”), a leading provider of biosimulation, simulation-enabled performance and intelligence solutions, and medical communications to the biopharma industry, announced a newly funded research project with the International Collaboration on Cosmetics Safety (ICCS) to evaluate the use of physiologically-based kinetic (PBK) modeling approaches to advance animal-free science for cosmetics and other non-pharmaceutical ingredients.
In a competitive bidding process, Simulations Plus was selected for its proposal to establish workflows for probabilistic PBK modeling of new chemicals based on pharmacokinetic (PK) analogs. Simulations Plus will review ICCS-provided data, select target-source pairs based on similarity criteria, build PBK models for source chemicals, and apply these in virtual populations to predict exposure for target chemicals. The results and best practices will be published.
“We are excited to partner with ICCS and its membership, which includes major cosmetics and consumer product companies, ingredient suppliers, trade and research organizations, and animal welfare NGOs. Our mutual goal is to expand the use of PBK models for the safety assessment of new chemicals developed in an animal-free paradigm,” said Dr. Priyata Kalra , Senior Scientist at Simulations Plus and principal investigator for this collaboration. “Using data from ICCS, we will collaboratively develop a PBK-based read-across concept for various chemicals and exposure routes (intravenous, oral, dermal) across virtual populations of different species (humans and rodents). This partnership is expected to result in general workflows and guidance for implementing this approach in animal-free safety assessments.”
“We have pioneered the integration of machine learning with PBK models, coupled with limited in vitro data, to accurately predict safety exposure levels in animals and humans,” added Dr. Maxime Le Merdy, Director of PBPK Research & Collaborations at Simulations Plus. “We believe our expertise in this space, combined with ICCS’s commitment to advancing animal-free research and development, will help drive innovation in the non-pharmaceutical markets we serve. As a recognized global leader in modeling and simulation, we look forward to collaborating on this important research project that will help establish best practices and a comprehensive framework as valuable guidance tools for companies and regulatory agencies.”
