Simulations Plus, Inc.

The global obesity drug market is projected to grow to $37.94 billion by 2032, driven largely by the drugs currently in development. The pace of development is fierce, and sponsors aiming to compete must leverage all available tools to optimize efficacy, minimize side effects, and accelerate development timelines. If you’re interested in learning how to achieve those goals in your own program, join us next week at ASCPT for our one-hour Learning Lab, “Recipe for Success: How Integrated MIDD & AI Approaches Can Accelerate Obesity Drug Development.” Experts will explain the technology and methodologies available to design and prioritize drug candidates, identify dosing strategies that optimize efficacy and minimize safety concerns, and design protocols that increase the likelihood of clinical success and regulatory approval. Panelists: Feng Yang, Ph.D., Executive Director, Head of Pharmacometrics, Structure Therapeutics David Sperry, Ph.D., Executive Director, Synthetic Molecule Design & Development, Eli Lilly & Co. Amparo de la Peña, Ph.D., Vice President, Pharmacometric Services, Simulations Plus Scott Siler, Ph.D., Chief Science Officer, QSP, Simulations Plus Maxime Le Merdy, Ph.D., Director, PBPK Research & Collaborations, Simulations Plus Sandra Suarez-Sharp, Ph.D., President, Regulatory Center of Excellence, Simulations Plus Moderator: Jill Fiedler-Kelly, MS, FISoP, President, CPP Services, Simulations Plus https://lnkd.in/gM-a_zJv

There is growing enthusiasm for AI’s potential to predict drug-induced liver injury (DILI)—but 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 new blog post, our experts outline 6 reasons traditional QST modeling provides more comprehensive and clinically actionable predictions of DILI risk than current AI-only models. Read it here: https://lnkd.in/gTcKb3dN

ADMET Predictor 13 is almost here—and in this webinar, you’ll see how it gives your organization the First-to-Invent Advantage! Dr. David Miller, Vice President, ADMET Cheminformatics, will walk you through the latest version of the software, showing you how to begin leveraging the new and expanded functionality to drive your pipelines forward. He will cover the… - Enhanced HT-PBPK (driven by GastroPlus®) + AIDD integration to accelerate novel compound design and lead selection - New & improved ADMET models/descriptors + AI/ML science for boosted accuracy - Expanded APIs and scripting capabilities to support seamless deployment and enterprise-ready automation - And more. This is your chance to see the new version of ADMET Predictor and get your AI/ML software and discovery questions answered in real-time by a Simulations Plus expert. Register now to save your seat. https://lnkd.in/gcjA4gmp

Need help navigating the MonolixSuite documentation? Our new AI assistant makes it easier to find the answers you need - try it out here: https://lnkd.in/eUjdv-hN

The FDA has released a new roadmap outlining a path toward reducing—and ultimately replacing—animal studies in pharmaceutical development with new approach methodologies (NAMs), beginning with monoclonal antibodies. This evolving regulatory landscape presents exciting opportunities and both scientific and operational implications for drug developers. In this webinar, experts from Simulations Plus will provide an overview of the FDA’s roadmap, discuss its relevance to current development practices, and examine what is achievable today with modeling and simulation (M&S) tools in support of this transition. Presenters will share practical approaches for integrating M&S into development programs, with a particular focus on biologics and monoclonal antibodies. Topics will include: • Key elements of the FDA’s roadmap and their impact on development strategies • Incorporating model-informed approaches into early- and late-stage development • Case studies demonstrating the use of M&S in lieu of animal studies • Regulatory considerations and alignment with MIDD initiatives At the end of the discussion, attendees will have the opportunity to ask questions during a live Q&A. This session is intended for professionals involved in preclinical and clinical development who are seeking to understand how in silico tools can contribute to scientifically sound and regulatory-aligned alternatives to animal testing. WEBINAR PANELISTS: - Sandra Suarez-Sharp (moderator), President, Regulatory Strategies Center of Excellence, Simulations Plus - Xinyuan (Susie) Zhang, Vice President, Regulatory Strategies, Simulations Plus - Scott Siler, Chief Scientific Officer, QSP, Simulations Plus - Viera Lukacova, Chief Scientist, PBPK, Simulations Plus - Timothy McGovern, Co-Founder, Principal Consultant at White Oak Regulatory Tox, LLC Register today to attend: https://lnkd.in/gdJfuzs7

DILIsym® v11 introduces a major advancement: a new model of CD8+ T cell-mediated drug-induced liver injury (DILI). This model, while not yet predictive, offers researchers a powerful tool to retrospectively investigate idiosyncratic DILI signals and identify key areas for further data collection. It represents an important step forward in mechanistic understanding of T cell-mediated liver injury. Check out this journal article to learn more: https://lnkd.in/gBEiY9Wc

Check out the latest updates in the newest version of DILIsym® 11 including new pediatric representation for exploratory predictions, a new CD8+ T cell submodel, improved representations of bile acid and cholestatic liver injury and more. https://lnkd.in/ghBgn7bR

Join us for an exclusive webinar exploring how adaptive learning technologies are transforming clinical trial execution. In this webinar, Dr. Brad Stefanovic, VP, Head of Clinical Innovation at Simulations Plus, will discuss how biotechs and big pharma alike can stretch their clinical trials dollars while optimizing key areas for compliance and success. Brad will cover how simulation tools can identify and mitigate protocol deviations before they occur, ensuring increased protocol compliance and drastically reducing the number of costly errors in the administration of your protocol by the clinical sites. Attendees will also learn how AI-powered avatars can improve content drafting, leading to enhanced global scalability by streamlining processes across multiple regions—therefore improving cultural competency and engagement throughout your program without sacrificing the quality of your training. This session is designed for biotech leaders seeking to: ✔ Improve clinical trial success rates with proactive risk mitigation ✔ Reduce trial costs by minimizing protocol deviations and inefficiencies ✔ Enhance acquisition potential by demonstrating a scalable, AI-assisted approach to trial management Don't miss this opportunity to gain actionable insights into the future of clinical trial optimization. Register now! https://lnkd.in/gNEJR62m

Planning to attend CSPS 2025 in Montreal? Meet us there! Get to know our experts May 27–29, 2025, at the Pavillon Jean-Coutu, Université de Montréal: Jasmina Novakovic, Principal Scientist, will be on hand to discuss how simulation and modeling are transforming pharmaceutical sciences. Arlene Padron, Senior Director of Business Development, will be available to explore potential collaborations and partnerships. https://lnkd.in/gM-a_zJv

ADMET Predictor 13 is almost here—and in this webinar, you’ll see how it gives your organization the First-to-Invent Advantage! Dr. David Miller, Vice President, ADMET Cheminformatics, will walk you through the latest version of the software, showing you how to begin leveraging the new and expanded functionality to drive your pipelines forward. He will cover the… - Enhanced HT-PBPK (driven by GastroPlus®) + AIDD integration to accelerate novel compound design and lead selection - New & improved ADMET models/descriptors + AI/ML science for boosted accuracy - Expanded APIs and scripting capabilities to support seamless deployment and enterprise-ready automation - And more. This is your chance to see the new version of ADMET Predictor and get your AI/ML software and discovery questions answered in real-time by a Simulations Plus expert. Register now to save your seat. https://lnkd.in/gcjA4gmp