Simulations Plus, Inc.

Simulations Plus, Inc. Simulations Plus, Inc. Founded in 1996, Simulations Plus employs over 60 employees and is publicly traded on the NASDAQ stock exchange (ticker symbol = SLP).

develops absorption, distribution, metabolism, excretion, and toxicity (ADMET) modeling & simulation software and provides consulting services for the pharmaceutical, biotechnology, chemical, cosmetics, & food ingredient industries. Our headquarters are based in Lancaster, California, with our pharmacometrics consulting team located in Buffalo, New York. Trusted distributors handle sales and scien

tific support in Asian territories. 19 of the top 20 pharmaceutical companies, plus numerous mid- and small-sized companies and all major regulatory agencies, license our modeling & simulation technology.

As drug development has expanded to include biologic treatments, it’s important that our ability to model and predict po...
05/08/2026

As drug development has expanded to include biologic treatments, it’s important that our ability to model and predict potential biologic-induced liver injury (BILI) also evolves.

However, modeling BILI presents unique challenges driven by extracellular targets and non-hepatocyte involvement.

In this poster, researchers demonstrate how mechanistic data from microphysiological systems can be incorporated into QST models to assess liver risk across biologics in both healthy and MASLD contexts.

Download the poster to explore the approach: https://www.simulations-plus.com/resource/qst-modeling-using-biologxsym-informed-by-liver-microphysiology-data-predicts-biologics-induced-liver-injury-and-enhanced-susceptibility-in-masld/

05/08/2026

As AI tools gain traction in drug development, there is growing enthusiasm around their potential to predict drug-induced liver injury (DILI). However, the reality is more nuanced.

While AI-based models bring value in recognizing patterns across large datasets, they often fall short when it comes to mechanistic understanding and physiological realism.

In this blog post from Scott Siler, James Beaudoin and Christina Battista you’ll learn why traditional QST modeling is still the preferred approach to DILI prediction—as well as how you can leverage the best of AI and mechanistic modeling, together.

https://www.simulations-plus.com/resource/drug-induced-liver-injury-a-look-at-qst-modeling-and-ai-predictions/

“For three decades, Simulations Plus has helped pharmaceutical and biotechnology organizations apply modeling and simula...
05/06/2026

“For three decades, Simulations Plus has helped pharmaceutical and biotechnology organizations apply modeling and simulation with confidence across drug development. Our collaboration with NVIDIA brings together validated science, accelerated computing, and AI capabilities in a way that expands what scientific teams are able to explore and accomplish,” said Shawn O’Connor, Chief Executive Officer of Simulations Plus

Read more about our collaboration with NVIDIA here: https://www.simulations-plus.com/resource/simulations-plus-and-nvidia-collaborate-to-scale-gpu-accelerated-ai-assisted-modeling-workflows/

05/05/2026

Join us for our next webinar—we’ll have special guests , Dr. Hao Zhu, Director of the Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Science, Center of Drug Evaluation and Research, FDA; and Dr. Brian Booth, Director of the Division of Cancer Pharmacology I, Office of Clinical Pharmacology, FDA discussing Project Optimus.

Moderated by Yu-Nien (Tom) Sun, PhD, Vice President of Strategic Consulting, the webinar will cover a range of topics, including the next big hurdle in dose selection: combination regimens. The presenters will also address questions about how to select the dose of a new therapeutic added to another approved agent, to established regimens with multiple agents, and two novel therapeutics. Additionally, they’ll share examples of some of the modeling work that has been conducted for dose selection of novel modalities.

Attendees will have the opportunity to get their questions answered in real-time during the Q&A following the presentation.

This is a can’t miss webinar—mark your calendar and register now. https://go.slp-marketing.com/2026-05-26-Project-Optimus-Oncology-Dose-Optimization-Based-on-Clinical-Pharmacology-Strategy-and-MIDD-Approach_LP-Registration.html?mtm_campaign=2026-05-26-Project-Optimus-Oncology-Dose-Optimization-Based-on-Clinical-Pharmacology-Strategy-and-MIDD-Approach&mtm_source=Social%20Media&mtm_medium=cpc

Are your digital lab tools accelerating discovery or slowing it down? Electronic lab notebooks have come a long way, but...
05/04/2026

Are your digital lab tools accelerating discovery or slowing it down?

Electronic lab notebooks have come a long way, but many R&D teams still face fragmented workflows, disconnected systems, and too much time spent managing data instead of generating insight.

Michael Lawless, Director of Scientific Product at Simulations Plus, will join a panel of innovators exploring how AI-infused ELNs can reduce friction, preserve traceability, and allow teams to focus on discovery instead of software.

Register here: https://www.simulations-plus.com/events/ai-powered-electronic-lab-notebook/

If you’ve led clinical pharmacology strategy and enjoy working directly with clients, this role may be a strong fit.We’r...
04/24/2026

If you’ve led clinical pharmacology strategy and enjoy working directly with clients, this role may be a strong fit.

We’re hiring an Assistant Vice President, Quantitative Clinical Pharmacology at Simulations Plus (remote, US).

This is a senior leadership role focused on:
• Guiding MIDD-based clinical pharmacology strategies
• Leading multidisciplinary project teams
• Engaging directly with clients and regulatory agencies

We’re looking for someone with deep experience in:
• PK/PD, PBPK, and population modeling
• Clinical pharmacology strategy across drug development
• Leading projects and mentoring scientific teams

You’ll play a key role in shaping strategy, delivering high-quality analyses, and supporting clients through critical development and regulatory decisions.
Learn more and apply: https://www.simulations-plus.com/career-center/

“Complex oral formulations such as amorphous solid dispersions present significant scientific and regulatory challenges ...
04/22/2026

“Complex oral formulations such as amorphous solid dispersions present significant scientific and regulatory challenges due to their sensitivity to physiological and manufacturing variables. Through this funded collaboration, we aim to integrate advanced in vitro systems with mechanistic modeling to improve prediction of in vivo performance, support regulatory decision-making, and enable more efficient development pathways for these high-impact therapies that deliver faster dissolution and more drug absorption.” - Dr. Viera Lukacova, Chief Scientific Officer of Simulations Plus

Read more about our collaboration with Lonza and the U.S. FDA here: https://www.simulations-plus.com/resource/simulations-plus-announces-collaboration-with-lonza-and-u-s-fda-to-advance-predictive-frameworks-for-complex-oral-drug-products/

04/17/2026

We’ve been recognized by Comparably as a Best Company for Women for 4 out of the 5 past years!

If you’re considering a career change and want a positive work environment with great benefits, take a look at our open roles. https://www.simulations-plus.com/career-center/

At , we’re hosting three MonolixSuite workshops—each focused on a different part of modern pharmacometric practice: tac...
04/16/2026

At , we’re hosting three MonolixSuite workshops—each focused on a different part of modern pharmacometric practice: tackling complex models, building reproducible workflows, and applying AI in a way that holds up in a regulated setting.

Each session is grounded in real challenges teams face today:

MonolixSuite Modeling Lab https://lnkd.in/gBkD6tsN
A hands-on look at complex PK/PD modeling—estimation behavior, diagnostics, and troubleshooting based on real support cases.

MonolixSuite Workflow Lab https://lnkd.in/eWvTejT5
From manual analyses to automated, submission-ready workflows—standardizing outputs, improving traceability, and supporting regulatory review.

MonolixSuite AI Lab https://lnkd.in/etD2KXds
Moving beyond AI concepts to practical use—how to work with specialized assistants, generate reproducible outputs, and understand where AI fits (and where it doesn’t).

These sessions are designed for pharmacometricians and modeling scientists who want to strengthen how their work is built, reviewed, and trusted.

If you’re attending PAGE, we encourage you to register early.

Address

42505 10th Street W
Lancaster, CA
93534

Opening Hours

Monday 8am - 5pm
Tuesday 8am - 5pm
Wednesday 8am - 5pm
Thursday 8am - 5pm
Friday 8am - 5pm

Telephone

(661) 723-7723

Website

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