Simulations Plus Receives New Grant Award and Extends Funded Research Collaboration with the FDA

Simulations Plus, Inc. (Nasdaq: SLP), the leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemicals, and consumer goods industries, is pleased to announce that it has received notices of two awards from the U.S. Food and Drug Administration (FDA).

The first award is a new funded cooperative agreement, for $250,000 per year for up to 2 years, to integrate drug product quality attributes into the mechanistic transdermal compartmental absorption and transit (TCAT) model in GastroPlus™. Under this new cooperative agreement, FDA scientific and program staff will assist and participate in project activities in a partnership role with a number of leading pharmaceutical, generic, cosmetic, and contract research organizations as part of the newly formed Consortium for Dermal Absorption Modeling (CDAM).

Dr. Viera Lukacova, director of simulation sciences said, “We have had the pleasure of working with the FDA over the past 4 years on different funded research programs, and we are delighted to have earned their confidence, through a competitive bidding process, to extend our relationship with another project. This grant award will focus on the incorporation of drug product quality attributes into dermal physiologically based pharmacokinetic (PBPK) models developed for dermatological topical dosage forms and transdermal delivery systems. The TCAT model in GastroPlus is already heavily utilized within the different markets we serve to support internal research and development activities. We expect the developments under this new agreement will aid the FDA and other regulatory agencies in developing guidelines and policies in the area of drug absorption from dermal products.”

The second award is a 1 year funded extension to the company’s previous cooperative agreement (grant 1U01FD005211) with the FDA to further develop and validate the mechanistic Ocular Compartmental Absorption and Transit (OCAT™) model in GastroPlus, a new functionality which will support the FDA’s future Innovation Initiative.

Dr. Lukacova continued, “After the successful completion of tasks outlined in the initial 3-year cooperative agreement, we are very pleased to have the opportunity to continue working with the FDA to incorporate additional functionality into our mechanistic ocular absorption model which will aid companies, both innovator and generic, as they design new treatments and products for various eye disorders. The model is already being utilized within the industry to support internal research and development activities, and we anticipate results from our technology will soon be helping to inform regulatory interactions.”

Views expressed in this announcement 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.

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