Simulations Plus Unveils AI Ecosystem to Reshape Drug Development

RESEARCH TRIANGLE PARK, N.C. – January 21, 2026 – Simulations Plus, Inc. (Nasdaq: SLP) today detailed an ambitious strategic shift, outlining plans to evolve its portfolio of scientific software into a single, integrated AI-enabled platform designed to accelerate drug development. During its 2026 Virtual Investor Day, the company presented its vision for an orchestrated ecosystem that aims to tackle the mounting challenges of complexity, cost, and regulatory scrutiny facing the pharmaceutical industry.

The announcement positions Simulations Plus at the center of a major industry trend: the fusion of traditional biosimulation with modern artificial intelligence. The company is betting that by unifying its best-in-class tools on a cloud-based platform, it can offer pharmaceutical clients a more efficient, reliable, and regulator-friendly path from drug discovery to commercialization.

An Industry at an Inflection Point

The strategic pivot comes as the pharmaceutical industry grapples with what Simulations Plus CEO Shawn O’Connor described as an “inflection point.” Drug development has become a progressively difficult endeavor, marked by staggering costs and protracted timelines. Recent industry analyses estimate the average cost to bring a new drug to market has soared to over $2.2 billion, with the process frequently spanning 10 to 15 years. This immense pressure is compounded by the increasing biological complexity of new therapeutic targets and a global regulatory landscape that demands more evidence than ever before.

“Scientific complexity is increasing, regulatory expectations are evolving, and our clients are under pressure to move faster without compromising rigor,” O’Connor stated during the presentation. “Our strategy is intended to address these challenges by combining trusted science with modern, integrated technology—so teams can make better decisions with confidence.”

This challenging environment has created a clear need for transformative solutions. Inefficient workflows, siloed data systems, and the sheer volume of information generated during R&D often hinder productivity. Simulations Plus aims to directly address these pain points by creating a unified environment where data and insights can flow seamlessly across the drug development lifecycle.

From a Portfolio of Tools to an Orchestrated Ecosystem

The central theme of the Investor Day was the company's evolution from a provider of disparate, though highly regarded, software tools into the architect of a comprehensive modeling ecosystem. For years, scientists have relied on individual Simulations Plus products like GastroPlus® for pharmacokinetic modeling and ADMET Predictor® for toxicity prediction. The new strategy involves weaving these capabilities, along with others, into a cohesive, cloud-native platform.

“Drug development is entering a new phase—one where scale, integration, and scientific trust matter more than isolated tools,” said Jonathan Chauvin, Co-Chief Product & Technology Officer. “Our focus is on evolving our software and services into a unified modeling ecosystem that connects validated science, AI-assisted workflows, and enterprise-ready infrastructure in a way our clients and regulators can rely on.”

This integrated platform promises to enhance productivity through reusable workflow patterns and cloud-enabled execution, allowing for complex simulations to be run at scale. The goal is to break down the walls between discovery, preclinical, and clinical development teams, fostering collaboration and enabling a more holistic view of a drug candidate's potential.

Building Trust with 'Grounded Intelligence'

A cornerstone of the company’s strategy is its commitment to responsible AI, a concept it terms “grounded intelligence.” In a field where patient safety is paramount, the “black box” nature of some AI models has been a significant barrier to adoption. Simulations Plus is directly confronting this issue by aligning its development with emerging principles for good AI practice from regulatory bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

These agencies have increasingly signaled their support for Model-Informed Drug Development (MIDD) and Non-Animal Methodologies (NAMs), both of which rely heavily on computational modeling. However, they have also stressed the importance of transparency, traceability, and scientific accountability for any AI used in regulatory submissions. Simulations Plus is building its platform to meet these standards.

“At the core of our approach is grounded intelligence,” explained Erik Guffrey, Co-Chief Product & Technology Officer. “We are following the FDA and EMA guiding principles of good AI practice in drug development—using AI to augment, not replace, mechanistic modeling, and ensuring outputs remain explainable, auditable, and anchored in validated science.”

This hybrid approach, which pairs the predictive power of machine learning with the explanatory power of established mechanistic models, is designed to build confidence with both users and regulators. By ensuring that AI-driven insights can be traced back to underlying scientific principles, the company hopes to create a trusted framework for making critical development decisions.

A Strategic Move in a Competitive Field

Simulations Plus's strategic pivot is also a calculated move within a competitive market. The company competes with other specialized software firms like Certara and Dassault Systèmes, as well as a growing number of AI-native drug discovery startups. By creating an integrated ecosystem, the company is moving beyond simply selling tools and is instead offering a comprehensive platform solution.

This strategy could provide a significant competitive advantage. Pharmaceutical companies are increasingly looking to consolidate vendors and adopt platform-based solutions that can support end-to-end workflows. By offering a one-stop shop that is built with regulatory compliance in mind, Simulations Plus could capture a larger share of its clients' R&D technology budgets.

The success of this orchestrated ecosystem will ultimately be measured by its ability to help clients navigate the treacherous waters of drug development, enabling them to bring safer, more effective medicines to patients faster—a goal that remains the ultimate benchmark in the pharmaceutical industry.