Simulations Plus, Inc. provides model-informed and AI-accelerated drug development software, training, and consulting services for biopharmaceutical research. News about the company centers on its software and services segments, scientific modeling engines, ADMET and other modeling workflows, and financial results tied to software renewals, services bookings, and customer activity.
Recurring developments also include collaborations with pharmaceutical companies, technology providers, and regulatory or public-health agencies. These updates cover GPU-accelerated simulation, AI-assisted modeling, predictive frameworks for complex oral drug products, computational toxicology, new approach methodologies, and education programs that expand use of model-informed drug development practices.
Simulations Plus, Inc. (Nasdaq: SLP) launched version 10.2 of its flagship machine learning platform, ADMET Predictor, now marketed as APX.2. This update introduces significant enhancements, including a High Throughput Pharmacokinetic (HTPK) Simulation Module, new dosing options, and improved mutagenic risk rules. The enhancements boost software performance, making it easier for pharmaceutical companies to predict drug properties. Dr. David Miller highlighted the software's expanded capabilities, while Dr. Eric Jamois noted increased revenue from the product line, indicating strong market adoption.
Simulations Plus, Inc. (Nasdaq: SLP) has renewed access to its DILIsym software platform for the U.S. Food and Drug Administration (FDA). This unlimited licensing package allows FDA employees across various divisions to utilize the software, enhancing drug safety assessments related to drug-induced liver injury (DILI). Key leaders in drug development will discuss the software's application in a panel on April 29, 2021. DILIsym aids in predicting DILI risk, guiding crucial drug development decisions, and has been utilized in several regulatory submissions.
Simulations Plus, Inc. (Nasdaq: SLP) announced successful initial results from a collaborative research with a major pharmaceutical company, evaluating generative chemistry technology via their Artificial Intelligence-driven Drug Design (AIDD) Module. Out of 10 candidate molecules synthesized, 8 exhibited an IC50 below 1 µM, with the most potent showing values below 100 nM. The predictive accuracy for biological activity was noteworthy, and solubility measures closely aligned with estimations, showcasing the potential of the AIDD technology in drug discovery.
Simulations Plus, Inc. (Nasdaq: SLP) will announce its financial results for Q2 FY 2021, ending February 28, after market close on April 12, 2021. A conference call will be held the same day at 4:15 p.m. ET, accessible via registration or by phone. The company, a leading provider of modeling software and consulting services, supports drug discovery and development for pharmaceutical and regulatory sectors worldwide. Further details are available on their website.
Simulations Plus (Nasdaq: SLP) has established a Scientific Advisory Board (SAB) within its DILIsym Services (DSS) division. The SAB will guide the development of RENAsym, a kidney injury quantification software platform. Key members include experts from Rutgers, Georgia University, and UC San Diego. The SAB’s formation follows a decade of success with the DILIsym initiative, which has helped develop the DILIsym software for liver injury assessment. RENAsym version 1A is expected in late 2021, enhancing DSS's capability in kidney safety assessments for drug developers.
Simulations Plus, Inc. (Nasdaq: SLP) successfully launched the 2021 MIDD+ Scientific Conference, a two-day event highlighting customized modeling and simulation for pharmaceutical scientists. Key topics included the drug development process and the integration of machine learning and population PK/PD approaches. Over 1,000 participants registered, featuring speakers from U.S. FDA and international health agencies. The event also focused on gender disparities in science, with awards recognizing outstanding contributions in the field. Simulations Plus continues to lead in providing innovative tools and services for drug development.
Simulations Plus, Inc. (Nasdaq: SLP) announced that CEO Shawn O’Connor will present at Oppenheimer’s 31st Annual Healthcare Conference on March 16, 2021, at 2:30 p.m. ET. The presentation will be webcast live, and one-on-one meetings will also be conducted with CFO Will Frederick. The accompanying slide presentation will be available on the company's Investors page after the event. For more details about the conference, visit the conference website.
Simulations Plus, Inc. (Nasdaq: SLP) has announced a Phase I NIH-funded SBIR grant received jointly with the University of Pittsburgh Drug Discovery Institute. The grant aims to develop a beta version of DILIsym software integrated with UPDDI’s vLAMPS experimental liver model for predicting the safety of large molecules, such as proteins used in new therapies. Success in this phase could lead to a larger Phase II grant for full commercial development.
This collaboration addresses safety concerns related to large molecule therapeutics, enhancing drug development processes.
Simulations Plus, Inc. (Nasdaq: SLP) announced that CEO Shawn O'Connor and CFO Will Frederick will host a fireside chat at the BTIG Virtual Conference on February 18, 2021, at 12:00 p.m. EST. They will also conduct one-on-one meetings throughout the day. A slide presentation will be available on the Company's Investors page afterward. Simulations Plus specializes in simulation and modeling software for pharmaceutical research and development, supporting major pharmaceutical and regulatory agencies worldwide.
Simulations Plus (Nasdaq: SLP) has launched version 9.8.1 of its GastroPlus® software, enhancing its pharmacokinetics modeling capabilities. Key upgrades include improved drug-drug interaction (DDI) models, new options for lung deposition variability, and better data import processes. These advancements aim to streamline regulatory reviews and enhance communication between health authorities and drug sponsors. The updates are expected to expedite the marketing of new drug products, reinforcing GastroPlus as a leading PBPK software platform.