Certara

We’re proud to announce that Honz Slipka will be presenting at EUCROF on the #EMA’s Policy 0070 and the transformation of clinical data transparency and disclosure! If you’re attending the event, don’t miss this opportunity to gain insights from Honz's expertise. Sign up for his presentation here: https://lnkd.in/edJbuiGF #ClinicalDataTransparency #EMA #Policy0070 #DataDisclosure #Certara #RegulatoryAffairs

A big congratulations to Honz Slipka, Certara's Senior Transparency Specialist! Thank you for sharing your expertise and insights into clinical data transparency and disclosure. Your dedication to advancing understanding in this critical area is inspiring. We’re proud to have you on the team! #TransparencyExpert #Certara #ClinicalData

Happy Holidays from all of us at Certara! We are grateful for the opportunity to collaborate with such an inspiring community of scientists, technologists, and drug development leaders. Your dedication to advancing science and improving human health motivates us every day. Here's to more breakthroughs, treatments and cures in 2025! #HappyHolidays #SeasonsGreetings

📈 Elevating Drug Development through Strategic Partnerships. Biohaven and Certara’s close collaboration was essential in the successful development of Rimegepant for migraine therapy. Our combined expertise in model-informed drug development accelerated progress and enhanced the treatment’s effectiveness. 🎥 Don’t miss out on this detailed look at our innovative approach—watch the webinar now. https://lnkd.in/ee3PgRnU #ModelInformedDrugDevelopment #StrategicPartnerships #MigraineSolutions #Certara #Biohaven #PharmaLeadership

Behind the Science: PKPD Analysis in Relapsed/Refractory Multiple Myeloma Relapsed/refractory multiple myeloma remains a challenging disease to treat, with dosing strategies and understanding drug-disease interactions posing significant hurdles. 🌟 In collaboration with GSK Certara conducted a population PKPD analysis of Belantamab Mafodotin, an antibody-drug conjugate targeting BCMA. 🔬 Analyzing data from 500+ patients across four trials, we simplified complex models to evaluate markers like sBCMA and M-Protein, revealing how drug exposure impacts efficacy. 💡 Our model enables simulations that can be used to optimize dosing regimens and provides insight into the drivers of efficacy. Contributors: Inmaculada C. Sorribes John D. Clements Christine Carcillo Neumar, PhD Adekemi Taylor, PhD Taylor Mun Sang Yue Cindy Chen Geraldine Ferron-Brady Herbert Struemper 💡 Explore our latest poster to learn more. https://ow.ly/OnTA50UvZ0O 📅 Struggling with dosing strategies or drug-disease interactions in multiple myeloma? Schedule a complimentary 15-minute consultation and discover how our oncology software and consulting services can help. https://ow.ly/2mcs50UvY7j #DrugDiscovery #MultipleMyeloma #Oncology #PKPDModeling #Collaboration #Biosimulation #ACoP15

𝗖𝗣𝗧 𝗖𝗮𝗹𝗹 𝗳𝗼𝗿 𝗣𝗮𝗽𝗲𝗿𝘀! We are thrilled to announce that the 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗣𝗵𝗮𝗿𝗺𝗮𝗰𝗼𝗹𝗼𝗴𝘆 & 𝗧𝗵𝗲𝗿𝗮𝗽𝗲𝘂𝘁𝗶𝗰𝘀 (𝗔𝗦𝗖𝗣𝗧) journal is now accepting submissions for a special themed issue on "𝗔𝗽𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻𝘀 𝗮𝗻𝗱 𝗜𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝗼𝗻𝘀 𝗶𝗻 𝗠𝗼𝗱𝗲𝗹-𝗕𝗮𝘀𝗲𝗱 𝗠𝗲𝘁𝗮-𝗔𝗻𝗮𝗹𝘆𝘀𝗶𝘀 (𝗠𝗕𝗠𝗔)", scheduled for publication December 2025. Matt Zierhut, VP of Consulting, and his expert MBMA team are at the forefront of contributing efforts in this space, utilizing MBMA with our clinical outcomes (𝗖𝗢𝗗𝗘𝗫) databases to improve critical decision-making. By leveraging advanced statistical modeling, MBMA predicts treatment effects, variability, and patient characteristics, helping pharmaceutical companies to design more efficient clinical trials and reduce the need for additional studies. 𝗞𝗲𝘆 𝗙𝗼𝗰𝘂𝘀 𝗔𝗿𝗲𝗮𝘀: · Innovative MBMA methodologies · Integration into decision-making and regulatory processes · Cross-functional collaborations and use of real-world data (RWD) · Advancements in MIDD with AI/ML Submissions are accepted until 𝘑𝘶𝘯𝘦 15, 2025, welcoming original research, reviews, case reports, and perspectives from industry, academia, and regulatory bodies. To connect with Matt and his team, visit 𝗵𝘁𝘁𝗽𝘀://𝗼𝘄.𝗹𝘆/𝗼𝗝𝗛𝗯𝟱𝟬𝗨𝘂𝗔𝗵𝗞. #MBMA #ModelBasedMetaAnalysis #ClinicalPharmacology #DrugDevelopment #MIDD #AIinPharma #BigData #Pharmacometrics #Certara

Quantitative Systems Pharmacology (QSP) supports rare disease development Pompe disease is a rare and complex condition with severe infantile-onset (IOPD) and late-onset (LOPD) forms. To better understand treatment efficacy for IOPD patients, Sanofi’s team developed a quantitative systems pharmacology (QSP) "digital twin" model, leveraging Certara’s Virtual Twin technology. This innovative approach created virtual patient profiles to compare the effects of avalglucosidase alfa vs. the current standard of care. The findings highlight enhanced tissue glycogen clearance with avalglucosidase alfa, providing new insights into its mechanism of action and showcasing the power of digital twin technology in rare disease drug development.   Check out this recent publication by Sanofi, supported by Certara’s QSP Center of Excellence: https://ow.ly/7UMi50UtB2X #RareDisease #PompeDisease #VirtualTwinTechnology #QuantitativeSystemsPharmacology #DrugDevelopment #PrecisionMedicine

You've seen what the right tools can do to help you build more robust models faster. Now try them for yourself! Visit Pirana on the web to learn more and request your free trial. https://ow.ly/OoFh50UsaAX

Discover Shuai Fu’s project story! Learn how she has overcome the tight schedule for customers' drug submissions and query responses. Certara’s Drug Development Solutions team is ready to help you overcome challenges with the power of biosimulation and regulatory expertise. Connect with our experts today and set your project up for success: https://ow.ly/zPjf50Uu8xh #MIDD #Biosimulation

At last week's Bloomberg's AI and Drug Development Forum, Parexel’s Stephen Pyke joined Bloomberg’s VaNae N. Hamilton, Ph.D. and Certara’s Christopher Bouton, Ph.D. for a panel discussion on AI and the Approval/Post-Approval Process. Together they weighed in on the integration of AI into drug development: ✔ What applications already use AI or machine learning elements ✔ Where we need more regulatory guidance ✔ The future of AI-derived biomarker applications and other innovations   💬 Question for our followers: What area of clinical development do you think could benefit most from AI integration, and why? Comment below with your perspective! #AI #DrugDevelopment #Bloomberg