Simulations Plus, Inc.

Transporters play a critical role in drug absorption, distribution, and elimination, and their involvement in drug-drug interactions (DDIs) can lead to altered drug concentrations and unexpected adverse effects that hamper the effectiveness of the treatment. Significant advancements were seen in the area of PBPK applications in metabolic DDIs to inform program development and regulatory decision making, and the paradigm is slowly shifting towards transporters, thereby increasing the emphasis on the utility of PBPK models to predict the transporter-based DDIs. Transporter-mediated drug-drug interactions (DDIs) present unique challenges in drug development and clinical management, often complicating the prediction and understanding of pharmacokinetic profiles. In this presentation, Drs. Revathi chapa (Senior Scientist, PBPK Solutions), Suvarchala kiranmai Avvari Avvari (Scientist II, PBPK Solutions), and Xinyuan (Susie) Zhang Zhang (Vice President, Regulatory Strategies), will explore the complexities of transporter-mediated DDIs, highlighting cross-validation of multiple compounds for assessing and predicting their risk. Join us to learn how to navigate the challenges of transporter-mediated DDIs and make more informed decisions in drug development and therapeutic management. Register now to secure your spot. https://lnkd.in/guWGmUbY

Why use Pro-ficiency for your training needs? Here's what one customer said drove their selection. “We were looking for a novel training method that could truly capture the user’s attention. We chose to work with Pro-ficiency because it was the only solution that could do this.” – Industry Sponsor Learn more here: https://lnkd.in/gMJwmWrC

Are you attending AAPS NERDG 2025 Annual Meeting in Connecticut? Stop by our booth to chat with Sr. Director Daniel J. O'Connor, Sr. about what’s included in the upcoming release of GPX.2. https://lnkd.in/g4EJKf4D

What advice would you give a scientist just starting in the industry? “Develop you soft skills,” is what Scientist II, Suvarchala Avvari recommends. Watch this short clip to hear the rest of her advice for early career scientists.

Identifying potential DILI risk remains a critical challenge for drug development researchers. In a new article currently in pre-press, the authors review pre-clinical, in silico, and clinical development approaches to screen for DILI potential. DILIsym? was the only quantitative systems toxicology (QST) modeling solution included in the assessment, and was noted to be the “most widely used QST modelling software for DILI prediction.” Of particular note is a table within the publication describing the types of nonclinical data assessed by the DILI team at the US FDA. DILIsym is included as a source of QST modeling-based data that is assessed by the FDA’s DILI team. Read more about current and effective tools for DILI risk assessment: https://lnkd.in/g7H3hB4J

Are you planning to attend the annual ASPET conference in Portland, Oregon? Add this pre-conference workshop to your agenda,“PBPK/PD Modeling: Hands-on Workshop for Drug Development Applications.”? You will learn to build, validate, and apply PBPK/PD models through expert demonstrations and interactive exercises. The workshop aims to enhance attendees’ ability to use PBPK/PD modeling in their research for data-driven decision-making.? https://lnkd.in/gkzucR2d

Are you attending PAGE 2025 Meeting in Thessaloniki, Greece? Enhance your skills with expert-led training in pharmacometrics modeling, simulations, and workflow automation. Workshops we're hosting: - Introductory Course for Pharmacometrics Modeling using Monolix?: Learn the essentials of population modeling—no prior experience required! - Advanced Course for Pharmacometrics Modeling using Monolix?: Dive deep into complex models and advanced strategies for expert-level insights. - From Simple to Complex Simulations in Pharmacometrics using Simulx?: Master pharmacometric simulations, from basics to advanced clinical trial scenarios. - Automating Pharmacometrics Workflows: Scripting using lixoftConnectors: Discover R-API functions to automate MonolixSuite workflows and improve project efficiency. Register for one 1.5-day workshop + one half-day workshop and receive a 50% discount on the shorter course! Enhance your skills—register today! https://lnkd.in/gzAVUUky

Are you at the SOT 64th Annual Meeting & ToxExpo? Make sure to stop by booth #1327 to ask, Senior Principal Scientist, Michael Lawless about his poster presentation, “Clustering of environmental compounds based on structure and toxicokinetic properties." https://lnkd.in/gmX-92fN

In a fast-paced industry with big budget competition, you need every tool and approach to succeed. This is the first installment in our 4-part Biotech Webinar Series. In this series, our experts will walk you through the development stages of an obesity drug, showcasing how AI-powered tools and modeling & simulation software can shorten the development timeline while increasing confidence in a compound’s efficacy and safety. They’ll demonstrate how to address common challenges with obesity (and other) drugs, such as identifying optimal dosing paradigms and minimizing gastrointestinal adverse events. You’ll learn how AI-powered tools and modeling & simulation can help you… ? Accelerate the design & optimization of your drug candidates while prioritizing them based on potential hazards like DILI risk ? Determine the right dosing paradigms in as few iterations as possible ? Set up a clinical development plan to increase likelihood of acquisition and/or out-licensing ? Optimize your clinical trial protocol and training ? And more In this session, Drs. Jeremy Jones and Scott Siler will introduce some of the common challenges in developing drugs targeting obesity. They will then dive into how AI-driven design and mechanistic modeling can shorten the discovery timeline while increasing confidence in the drug candidates selected for development. Register now to secure your spot! https://lnkd.in/gXUvSw8q

We’re at the SOT 64th Annual Meeting & ToxExpo in Orlando! Visit us in booth #1237 and explore our recent advances in predicting drug-Induced liver injury (DILI), a guide to chemical risk assessment and more.