Collaboration Announced Between Simulations Plus and ETC for GastroPlus®

Collaboration Announced Between Simulations Plus and ETC for GastroPlus®

Simulations Plus, Inc. (Nasdaq: SLP), a leader in biosimulation and performance solutions for the biopharma industry, has entered into an exciting new collaboration with the Enabling Technologies Consortium (ETC). This funded partnership is focused on advancing the capabilities of the GastroPlus® platform, particularly in the area of oral drug delivery. The primary goal of the collaboration is to enhance the predictive power of the GastroPlus® advanced compartmental absorption and transit (ACAT™) model, a vital tool in the development of immediate release (IR) oral drug products.

Through this partnership, Simulations Plus will work closely with experts in physiologically based pharmacokinetics (PBPK) and biopharmaceutics modeling (PBBM) to improve drug product development. Utilizing data gathered from both public sources and members of the ETC, the team will focus on several key objectives aimed at refining the platform’s predictive capabilities. Notable advancements will include the incorporation of novel product-particle size distribution (P-PSD) methodologies and the enhancement of food effect modeling features. These updates will empower researchers to better predict the absorption, distribution, metabolism, and excretion (ADME) characteristics of oral drug formulations, ultimately improving drug development timelines and reducing reliance on animal testing.

The improvements will also streamline regulatory submissions by providing more robust and reliable data for regulatory bodies, which is essential for accelerating the approval process for new drugs. According to Dr. Xavier Pepin, Vice President of PBPK R&D at Simulations Plus and principal investigator for the project, this collaboration is a significant step forward in supporting the pharmaceutical industry’s growing need for precision and efficiency in drug development.

“We are honored to collaborate with ETC, a consortium representing leaders in pharmaceutical innovation who recognize the critical role GastroPlus® already plays in drug development,” said Dr. Pepin. “This partnership reflects the trust and confidence the industry places in our platform and the desire to support its continued evolution. By advancing cutting-edge capabilities, we are not only reaffirming our commitment to innovation but also empowering researchers to solve complex biopharmaceutical challenges with even greater precision and efficiency.”

The collaboration will leverage the combined expertise of Simulations Plus and the ETC’s participating members, which include some of the world’s leading pharmaceutical and biotechnology companies. As part of the project, Simulations Plus will provide beta versions of the enhanced GastroPlus® platform to ETC members for testing and feedback. Once the updates are finalized, the enhanced version of GastroPlus® will be made available to the broader user community, extending the benefits of these advancements to a wider audience. This process will ensure that the latest innovations are continually refined through real-world testing and usage.

As with all of its collaborations, Simulations Plus will retain ownership of the intellectual property developed through this partnership, allowing the company to continue its leadership role in PBPK/PBBM science. By maintaining ownership of the new technologies and methodologies, Simulations Plus ensures that future enhancements to the GastroPlus® platform will reflect its commitment to advancing the field and providing researchers with the most powerful tools available. These ongoing improvements will further solidify the company’s reputation as a leader in biosimulation and drug development solutions.

About the Enabling Technologies Consortium (ETC)

The Enabling Technologies Consortium (ETC) plays a critical role in advancing the drug development industry by providing a dynamic platform for collaboration among pharmaceutical and biotechnology companies. ETC serves as a forum where members can exchange ideas, share knowledge, and collaborate on the development of cutting-edge technologies that streamline drug development and manufacturing processes. The consortium focuses on pre-competitive initiatives, which are joint efforts among multiple pharmaceutical organizations and third-party collaborators to create tools, methodologies, or technologies that improve efficiencies across the industry.

The ETC’s mission is to foster partnerships that enable pharmaceutical companies to overcome common challenges in drug development. By uniting industry leaders under a shared vision, the consortium is helping to drive progress in the field and empowering its members to develop innovative, enabling technologies that have the potential to transform drug development and manufacturing. These innovations are made widely accessible through publications, product commercialization, and other dissemination methods, ensuring that the entire industry benefits from the advances achieved by the consortium.

The partnership between Simulations Plus and the Enabling Technologies Consortium promises to bring valuable advancements to the field of drug development, particularly in the area of oral drug delivery. The collaboration will refine and expand the capabilities of the GastroPlus® platform, providing researchers with enhanced tools to accelerate the development of oral drug products, reduce animal testing, and streamline regulatory submissions. Through this innovative partnership, Simulations Plus continues to lead the way in biosimulation and performance solutions, while supporting the broader pharmaceutical industry in its efforts to improve drug development processes and patient outcomes.

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