Simulations Plus, Inc.

If you’re new to using #PBBM, check out this recently published journal article that recaps key points from the recent workshop “Physiologically Based Biopharmaceutics Models (PBBM) Best Practices for Drug Product Quality: Regulatory and Industry Perspectives.” It offers case studies from regulatory authorities, frameworks for credibility assessment, and strategies to address barriers such as model validation and the establishment of safe spaces and failure edges in drug product development. https://lnkd.in/gngWJDEw

The number of quantitative systems pharmacology (QSP) submissions to the U.S. Food and Drug Administration has more than doubled since 2021. In this recent article published in CPT: Pharmacometrics & Systems Pharmacology, the authors outline how researchers are using QSP to inform their drug development programs and strengthen their regulatory submissions. Read more: https://lnkd.in/gGX5y9UE And if you're ready to incorporate QSP into your program, let us know: https://lnkd.in/gi-fSzs

Thanks to everyone who joined us at our Lunch and Learn at the American College of Toxicology’s annual meeting!?We discussed how advances in modeling and simulation tools can enable structure-based safety assessment, increase throughput, and power use of QST earlier in small molecule development.? ? If you missed it--or want to talk more--swing by booth #414.??

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/gjz2uBQR?

Join us for the American College of Toxicology Annual Meeting! We’ll be hosting a lunch & learn on November 18th, where you’ll get to hear about the latest advances in modeling and simulation tools. Simulations Plus’ James Beaudoin, Senior Scientist of QSP will be presenting a talk entitled “Machine Learning ADMET Predictor Workflow for DILIsym Use Enables Earlier, Higher Throughput Use Session,” so be sure to catch his presentation! Can’t make lunch? Stop by and see us at booth #414. https://lnkd.in/gMSun4GX

Thank you to everyone who joined us at #ACoP 15! There are always so many great conversations to have and presentations to attend—if you weren’t able to make it to everything, here’s a recap of ours (link at the end of the post): Quantitative Systems Toxicology Modeling of Otenaproxesul Liver Enzyme Elevations – Jeff Woodhead, PhD, Senior Principal Scientist Panel Discussion: Harnessing Efficiency in QSP Modeling – Ryan Suderman, Associate Director, Senior Principal Scientist, led a productive discussion on integrating workflows, automation, and visualization tools. Sensitivity Analysis Methods for QSP Model of Gout – An Do Dela, Scientist I, presented on various analysis methods for QSP models in gout. Semaglutide: Weight Loss & Nausea Simulation – Zackary Kenz, Principal Scientist, showcased simulations of semaglutide’s effects on weight loss and nausea. Modeling mCRPC with Thales QSP Platform – Cameron Meaney, Scientist I, presented insights into modeling metastatic castration-resistant prostate cancer (mCRPC). Simulating CD8+ T Cell-Mediated Liver Injury in Ipilimumab Therapy – Conner Sandefur, PhD, Senior Scientist, shared findings on liver injury simulations. PBPK Models for Infliximab, Ipilimumab, Nivolumab – Celeste Vallejo, Scientist II, discussed PBPK models predicting hepatic concentrations for key immunotherapies. Eculizumab in Complement-Targeted Therapies – Lara Clemens, Senior Scientist, presented on using eculizumab as a comparator for novel therapies. Mechanism-Based Modeling for Safe Dosing Regimens – Lisl Shoda, Associate VP & Director of Immunology, QSP, wrapped up with a session on safe dosing regimens. Check out our resource center to download these today: https://lnkd.in/gZQX_msQ

If you’re currently developing a drug for weight loss, you won’t want to miss Dr. Scott Siler presentation at the AASLD Liver Meeting about the OBESITYsym model—the only model commercially available to predict both weight loss and nausea side effects. You can catch the presentation on November 17, 2024, from 8:00 AM – 5:00 PM PST in the poster hall at the San Diego Convention Center. Not attending the Liver Meeting, but want to learn more? Schedule a meeting with one of our experts. https://lnkd.in/gi-fSzs

What if you could get liver safety predictions in the discovery stage? De-risking clinical hepatotoxicity early in the drug development process has never been possible—until now. In this webinar, attendees will learn how to use the only available software equipped to make clinically relevant liver safety predictions, permissive for early and later-stage drug discovery applications, involving multiple DILI mechanisms: oxidative stress, mitochondrial dysfunction, and inhibition of bile acid and phospholipid transporters. https://lnkd.in/giFTbrcH

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!