Simulations Plus, Inc. develops drug discovery and development software for modeling and simulation, and prediction of molecular properties utilizing artificial intelligence and machine learning based technology worldwide. It operates through four segments: Simulations Plus, Cognigen, DILIsym, and Lixoft. The company offers GastroPlus, which simulates the absorption and drug interaction of compounds administered to humans and animals; and DDDPlus and MembranePlus simulation products. It also provides products based on mechanistic and mathematical models, such as DILIsym, a quantitative systems pharmacology software; NAFLDsym; IPFsym; RENAsym; and MITOsym. In addition, the company provides Absorption, Distribution, Metabolism, Excretion, and Toxicity Predictor for chemistry-based computer program that takes molecular structures as inputs and predicts their properties; and MedChem Designer, as well as modeling and simulation products comprising MonolixSuite and PKPlus. Further, it provides population modeling and simulation contract research services; training and consulting services designed to accelerate pharmacometrics studies; and clinical-pharmacology-based consulting services in support of regulatory submissions. The company serves pharmaceutical, biotechnology, agrochemical, cosmetics, and food companies, as well as academic and regulatory agencies. Simulations Plus, Inc. was incorporated in 1996 and is headquartered in Lancaster, California.

Simulations Plus, Inc.

Simulations Plus provides modeling and simulation software and consulting services for drug discovery, clinical development research, and regulatory submissions. The company claims a significant amount of experience and has a wide range of software products.

Simulations Plus

Pharmaceutical Manufacturing

GastroPlus®

Chemical Manufacturing

ADMET Predictor®

DDDPlus™

PKPlus™

MembranePlus™

MedChem Designer™

Simulations Plus, Inc. | 10,305 followers on LinkedIn. Where are you in the drug development process? Save resources &amp; get to market faster with our solutions! | Simulations Plus is a leading provider of modeling and simulation software and consulting services supporting drug discovery, development research, and regulatory submissions. We offer solutions that bridge artificial intelligence (AI) and machine learning (ML), physiologically based pharmacokinetics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. Our technology is licensed and applied by major pharmaceutical, biotechnology, chemical, and consumer goods companies, and regulatory agencies worldwide.

Sharlene Evans

Partnering with clients to provide data-driven, strategic modeling methodology that streamlines success!

Daniel J. O'Connor, Sr.

John K. Paglia, Ph.D., CFA, CPA

Partnering with clients to provide a data-driven, strategic modeling methodology that streamlines success.

John DiBella

Are you wrapping up Day 1 at ACoP 15? Don’t miss out on these posters and talks on Day 3. Wednesday, November 13th: - 7:00 AM: Physiologically Based Pharmacokinetic Models for Infliximab, Ipilimumab, and Nivolumab Developed with GastroPlus® to Predict Hepatic Concentrations Presenter: Celeste Vallejo , Scientist II - 7:00 AM: Eculizumab as a Key Comparator for the Evaluation of Complement-Targeted Novel Therapeutic Strategies with a QSP Model Presenter: Lara Clemens , Senior Scientist, Simulations Plus - 10:45 Roller Coaster Session II Title: Hitting the Sweet Spot: Mechanism-Based Modeling to Evaluate the Interplay of Liver Compound Exposure and Liver Toxicity to Identify Safe Dosing Regimens Presenter: Lisl Shoda , Associate Vice President and Director of Immunology, QSP Meet the team in booth #27 to find out how to enhance your drug development strategies:

Are you at ACoP 2024? Be sure to stop by booth #27 today! This year we’re featuring: - Live demos of MonolixSuite with Monika Twarogowska - Answers to your regulatory questions with Xinyuan (Susie) Zhang - Insight about how to utilize QSP for predicting nausea in weight loss drugs with Zackary Kenz - A chance to talk all things PBPK with John DiBella We look forward to connecting with you!

If you find the complexities of developing ophthalmic drug products challenging, you're not alone. Join Associate Professor of Pharmacology and Pharmaceutical Sciences at USC Alfred E. Mann School of Pharmacy and Pharmaceutcial Sciences. Dr. Hovik Gukasyan, PhD and Director, Reserach and Collaborations at Simulations Plus, Dr. Maxime Le Merdy as they demonstrate innovative solutions using ocular absorption and transit (OCAT™) models. Learn how these models can better understand drug partitioning in eye tissues, facilitating the development of safer and more effective ophthalmic products. https://lnkd.in/g7WGNFSC ?

Are you attending ACoP 15? Add our posters and talks from Day 2 to your agenda. Stop by booth #27 to find out how to enhance your drug development strategies: Tuesday, November 12th: - 7:00 AM: Comparison of Sensitivity Analysis Methods in the Context of a QSP Model for Gout, Presenter: An Do Dela , Scientist I - 7:00 AM: Weight Loss and Nausea from Subcutaneous and Oral Semaglutide Accurately Simulated with a QSP Model, Presenter: Zackary Kenz , Principal Scientist - 7:00 AM Modeling progression and treatment of mCRPC using the Thales QSP software platform C, Presenter: Cameron Meaney , Scientist I - 7:00 AM Simulated CD8+ T Cell-Mediated Liver Injury During Ipilimumab Administration in a Simulated Population (SimPops®) Demonstrates Profiles Consistent with Observed Clinical Data Simulated CD8+ T Cell-Mediated Liver Injury Presenter: Conner Sandefur , PhD – Senior Scientist

The U.S. is facing a dire opioid overdose crisis, with over 74,000 deaths linked to synthetic opioids like fentanyl in just the past year. With opioid overdose deaths surging, it's crucial to explore effective reversal options. Join our upcoming webinar to explore how the FDA’s validated translational model was used to evaluate the effectiveness of intranasal nalmefene as a reversal agent, alongside naloxone. Experts will discuss key insights from recent simulations and research on opioid-induced respiratory depression and cardiac arrest, providing valuable information on clinical needs and treatment comparisons. Register here: https://lnkd.in/gVrf8j7B

Headed to ACoP 15? Stop by booth #27 to meet our team. We’ll be kicking off the fun with a lunch & learn on Monday along with a panel discussion and poster presentation. Make sure to work these into your schedule. Monday, November 11th: 7:00 AM: Quantitative Systems Toxicology Modeling of Otenaproxesul Liver Enzyme Elevations Leads to Prediction of Liver Safety for Acute Otenaproxesul Dosing, Presenter: Jeff Woodhead , PhD, Senior Principal Scientist, Simulations Plus 12:30 PM: Lunch & Learn Location: Ocotillo B room – Arizona Grand Resort & Spa 3:15 PM: Panel Discussion: Harnessing Efficiency in Quantitative Systems Pharmacology (QSP) Modeling: Integrating Workflows, Automation, and Visualization Tools for Enhanced Cross-Functional Communication, Presenter: Ryan Suderman , Associate Director and Senior Principal Scientist, QSP in Room: Ocotillo B Let our team help you reach new horizons in Pharmacometrics. We can’t wait to see you there! https://lnkd.in/dmWR6N7X

We are committed to supporting the advancement of scientific development and our industry. Find out how we can work together on your next project: https://lnkd.in/gZvXRCXk

The new generation of weight loss drugs are highly effective, but the nausea patients often experience can deter from proper adherence. Luckily, OBESITYsym is now available to help researchers develop effective treatments for patients with obesity while avoiding nausea as a side effect. Learn more from our own Chief Science Officer, Scott Siler during his poster presentation at Obesity week. https://lnkd.in/g9wj4hr2

Você fala português e quer saber mais sobre o CIVIV? Then this webinar is for you, explore the IVIVC (in vitro–in vivo correlation) module on the innovative GPX platform. We’ll go over case studies that show how new features can transform your work. Register here: https://lnkd.in/gittbm7G

The prolongation of gastric emptying caused by GLP-1 agonists is a well-known effect that can impact the absorption and disposition of concomitant oral medications. Sponsors are typically required to conduct several DDI studies to comprehensively assess these interactions. In this blog post, Dr. Xinyuan (Susie) Zhang , Vice President of Regulatory Strategies, draws upon her 12 years as an expert at the FDA in PBPK modeling and DDI risk assessment to outline the key benefits and considerations for using in silico methods for meeting regulatory requirements. https://lnkd.in/gm5qdKga

COM:SIMULATIONS-PLUS