Simulations Plus and Enabling Technologies Consortium: A Strategic Partnership for Drug Development Advancements

Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of biosimulation, simulation-enabled performance and intelligence solutions, and medical communications to the biopharma industry, has announced a strategic collaboration with the Enabling Technologies Consortium (ETC). This partnership aims to advance in vitro-in vivo correlation (IVIVC) approaches for oral drug delivery and expand the functionality of the GastroPlus platform. The collaboration focuses on enhancing the predictive capabilities of the GastroPlus advanced compartmental absorption and transit (ACAT™) model to support the development of immediate release (IR) oral drug products.

The collaboration will focus on implementing novel product-particle size distribution (P-PSD) methodologies and enhanced food effect modeling features. These advancements aim to improve drug product development, reduce reliance on animal studies, and streamline regulatory submissions. Throughout the project, Simulations Plus will deliver beta versions of the enhanced GastroPlus platform to ETC members for testing. Upon completion, the updated software will be accessible to the broader user community, with Simulations Plus retaining intellectual property rights from the partnership.

The strategic collaboration with ETC, which represents major pharmaceutical companies, demonstrates strong industry validation of the GastroPlus platform and creates a significant competitive moat for Simulations Plus. The technical enhancements being developed, particularly the novel P-PSD methodologies and enhanced food effect modeling, address critical pain points in drug development. These improvements could potentially accelerate drug development timelines and reduce development costs by minimizing the need for extensive animal studies. For pharmaceutical companies, this translates to faster time-to-market and improved ROI on drug development investments.

From a market perspective, this collaboration strengthens Simulations Plus's position in several ways. Retention of intellectual property rights ensures long-term competitive advantages, while direct involvement of major pharmaceutical companies provides immediate market validation. Enhanced platform capabilities could drive increased adoption and user base expansion, with the potential for premium pricing on advanced features. The focus on improving regulatory submission processes is particularly strategic, as it addresses a major industry bottleneck. Success in this area could position Simulations Plus as an essential partner in the drug development process, potentially leading to expanded market share and stronger customer relationships.

Industry partners will provide funding and data to support ACAT™ model improvements, further solidifying the partnership's potential for success. As the collaboration progresses, Simulations Plus and ETC members will work together to deliver beta versions of the enhanced GastroPlus platform for testing. Upon completion, the updated software will be accessible to the broader user community, enabling researchers to improve drug product development, reduce reliance on animal studies, and streamline regulatory submissions.

In conclusion, the strategic collaboration between Simulations Plus and the Enabling Technologies Consortium represents a significant advancement in the biosimulation space. By leveraging the combined expertise of both parties, this partnership aims to enhance the predictive capabilities of the GastroPlus platform, ultimately accelerating drug development timelines and reducing costs for pharmaceutical companies. As the collaboration progresses, Simulations Plus stands to gain long-term competitive advantages, market validation, and expanded user base, further solidifying its position as a leader in the biosimulation industry.