Certara

𝗦𝗲𝗲 𝘄𝗵𝗮𝘁’𝘀 𝗻𝗲𝘄 𝗶𝗻 𝗦𝗶𝗺𝗰𝘆𝗽 𝗦𝗶𝗺𝘂𝗹𝗮𝘁𝗼𝗿 𝗩𝗲𝗿𝘀𝗶𝗼𝗻 𝟮𝟱! Join us February 4th at 11am ET for a live webinar on the latest Simcyp®️ Simulator release and discover key updates such as: · Transporter-mediated DDI expansion · Enhanced biopharmaceutics capabilities · Improved usability and efficiency Version 25 builds on years of scientific rigor to accelerate decision-making across drug development. Don’t miss this opportunity to see the industry-leading PBPK platform in action. Register now: https://ow.ly/FIxt50Y3VNe

𝗪𝗵𝗮𝘁 𝗱𝗼𝗲𝘀 𝗶𝘁 𝘁𝗮𝗸𝗲 𝘁𝗼 𝘁𝘂𝗿𝗻 𝗰𝗼𝗺𝗽𝗹𝗲𝘅 𝘀𝗰𝗶𝗲𝗻𝗰𝗲 𝗶𝗻𝘁𝗼 𝗱𝗲𝗰𝗶𝘀𝗶𝗼𝗻𝘀 𝘁𝗵𝗮𝘁 𝗱𝗿𝗶𝘃𝗲 𝗿𝗲𝗮𝗹-𝘄𝗼𝗿𝗹𝗱 𝗶𝗺𝗽𝗮𝗰𝘁 𝗮𝗻𝗱 𝗲𝗾𝘂𝗶𝘁𝘆 𝗶𝗻 𝗱𝗿𝘂𝗴 𝗱𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁? At 𝗔𝗦𝗖𝗣𝗧 𝟮𝟬𝟮𝟲, as a featured speaker 𝗥𝗮𝗷𝗲𝘀𝗵 𝗞𝗿𝗶𝘀𝗵𝗻𝗮, 𝗠𝗕𝗔, 𝗣𝗵𝗗, Senior Distinguished Scientist and Global Head Innovation Engines at Certara, will share how pharmacology is reshaping the way we think about development across modalities and populations, including payer value. With more than three decades in the field and contributions to 20+ NDA/BLA approvals, Rajesh is known for cutting through complexity and delivering insights that translate directly into action. 𝗜𝗳 𝘆𝗼𝘂’𝗿𝗲 𝗮𝘁𝘁𝗲𝗻𝗱𝗶𝗻𝗴 𝗔𝗦𝗖𝗣𝗧, 𝘄𝗲’𝗱 𝗹𝗼𝘃𝗲 𝘁𝗼 𝗰𝗼𝗻𝗻𝗲𝗰𝘁 𝗶𝗻 𝗽𝗲𝗿𝘀𝗼𝗻. Explore our full presence, sessions, and ways to meet with the Certara team: 🔗 https://ow.ly/VGSH50Y4hA8 #ASCPT2026 #ClinicalPharmacology #DrugDevelopment #Pharmacoequity #Certara

In 2026, regulatory success won’t come from checking the box. Former FDA, EMA, and PMDA reviewers join Certara to discuss what actually builds trust in clinical pharmacology submissions and what quietly derails them. 𝗗𝗮𝘁𝗲: February 10, 2026 𝗧𝗶𝗺𝗲: 10:00-11:00 ET | 16:00-17:00 CET 𝗥𝗲𝗴𝗶𝘀𝘁𝗲𝗿 𝗻𝗼𝘄: https://ow.ly/vqG250XXgKM

𝗡𝗲𝘄 𝗖𝗣𝗧 𝗣𝘂𝗯𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻 Pediatric drug development has historically lagged behind adult programs because clinical research in children is scientifically and operationally complex. This new CPT publication shows how that is beginning to change. Authored by Certara’s S. Y. Amy Cheung and James Yates, chairs of the IQ Consortium TALG/CPLG Pediatric PBPK group, together with a distinguished team of researchers, “𝙋𝙝𝙮𝙨𝙞𝙤𝙡𝙤𝙜𝙞𝙘𝙖𝙡𝙡𝙮 𝘽𝙖𝙨𝙚𝙙 𝙋𝙝𝙖𝙧𝙢𝙖𝙘𝙤𝙠𝙞𝙣𝙚𝙩𝙞𝙘 𝙈𝙤𝙙𝙚𝙡𝙞𝙣𝙜 𝙩𝙤 𝙎𝙪𝙥𝙥𝙤𝙧𝙩 𝙋𝙚𝙙𝙞𝙖𝙩𝙧𝙞𝙘 𝘾𝙡𝙞𝙣𝙞𝙘𝙖𝙡 𝘿𝙚𝙫𝙚𝙡𝙤𝙥𝙢𝙚𝙣𝙩” (CPT: Pharmacometrics & Systems Pharmacology) explores the growing impact of physiologically based pharmacokinetic (PBPK) modeling in pediatric development. The paper demonstrates how #PBPK modeling is enabling earlier and more confident pediatric decision-making by: - Extrapolating from adult data - Informing first-in-children dose selection - Reducing reliance on extensive pediatric clinical trials Read the publication here https://ow.ly/8K6x50Y3Tiu The authors also identify priority areas for advancing pediatric PBPK, including early-life absorption, tissue distribution and CNS exposure, enzyme and transporter ontogeny, and qualification datasets for the youngest patients. Continued collaboration across industry, academia, and regulators will be critical to accelerating safe and effective access to therapies for children. 𝗖𝗼𝗻𝘁𝗿𝗶𝗯𝘂𝘁𝗶𝗻𝗴 𝗮𝘂𝘁𝗵𝗼𝗿𝘀 𝗶𝗻𝗰𝗹𝘂𝗱𝗲: Michael Zientek, Kunal Taskar, PhD., Wen Lin, Tycho Heimbach, Ph.D., FAAPS, Stefan Willmann, Jessica Rehmel, Neil Parrott, Michael Hanley, Justine Badée, Yuan Chen, Susan Cole, Loeckie de Zwart, Sebastian Haertter, Rongrong Jiang, Masakatsu Kotsuma, Guiqing Liang, Yu-Wei Wayne Lin, Jing Liu, Ying Ou, Juliane Rascher, Naveed Shaik, Ph.D., Jan Wahlstrom, Xiaofeng Wang, Guangqing Xiao, Ka Lai Yee.

Reimbursement success doesn’t start at launch; it begins early in development even in the absence of mature pivotal trial data. Join this 𝗖𝗲𝗿𝘁𝗮𝗿𝗮 𝗖𝗶𝘁𝗲𝗹𝗶𝗻𝗲 𝘄𝗲𝗯𝗶𝗻𝗮𝗿 to learn how advanced modeling approaches, including 𝗠𝗼𝗱𝗲𝗹-𝗕𝗮𝘀𝗲𝗱 𝗠𝗲𝘁𝗮-𝗔𝗻𝗮𝗹𝘆𝘀𝗶𝘀 (𝗠𝗕𝗠𝗔) and 𝗤𝘂𝗮𝗻𝘁𝗶𝘁𝗮𝘁𝗶𝘃𝗲 𝗦𝘆𝘀𝘁𝗲𝗺𝘀 𝗣𝗵𝗮𝗿𝗺𝗮𝗰𝗼𝗹𝗼𝗴𝘆 (𝗤𝗦𝗣), can shape earlier, higher-confidence access and reimbursement strategy when development decisions are still flexible.    Hear from Certara experts on how modeling insights can drive market access success:  - Ananth Kadambi, PhD –Why access strategy must begin earlier  - Matt Zierhut, PhD, MBA – Reducing early uncertainty with MBMA  - Douglas Chung, MS – Strengthening mechanistic confidence through QSP  - Roman Casciano, MEng – Translating modeling findings into value-maximizing development decisions 𝗥𝗲𝗴𝗶𝘀𝘁𝗲𝗿 𝗵𝗲𝗿𝗲: https://ow.ly/C30O50Y3SgW   #HEOR #MarketAccess #EarlyReimbursement #AdvancedModeling #Certara #Citeline #ASCPT

𝗝𝗼𝗶𝗻 𝘂𝘀 𝗳𝗼𝗿 𝗮 𝗣𝗕𝗣𝗞 𝘄𝗼𝗿𝗸𝘀𝗵𝗼𝗽 𝘁𝗵𝗶𝘀 𝗠𝗮𝗿𝗰𝗵! Whether you're new to physiologically based pharmacokinetic (PBPK) modeling or looking to deepen your knowledge, Simcyp workshops offer hands-on learning with real-world use cases. 𝗠𝗮𝗿𝗰𝗵 𝗵𝗶𝗴𝗵𝗹𝗶𝗴𝗵𝘁𝘀 ∙ PBPK Modeling – Best Practices and Applications – March 2-4 (Washington, D.C.) ∙ Biopharmaceutics Applications of PBPK modeling – March 2-3 (Washington, D.C. ∙ Biologics II – March 16-20 – Online Advance your modeling skills with guidance from our expert scientists. Learn more and register for an upcoming workshop: https://ow.ly/b7yP50Y2Vsi

𝗔𝗔𝗣𝗦 𝗢𝗻-𝗗𝗲𝗺𝗮𝗻𝗱 𝗪𝗲𝗯𝗶𝗻𝗮𝗿 Pediatric drug development comes with unique challenges, from small patient populations and ethical considerations to evolving regulatory expectations and dose selection uncertainty. That’s why our 𝗔𝗔𝗣𝗦 𝘄𝗲𝗯𝗶𝗻𝗮𝗿, 𝘗𝘦𝘥𝘪𝘢𝘵𝘳𝘪𝘤 𝘋𝘳𝘶𝘨 𝘋𝘦𝘷𝘦𝘭𝘰𝘱𝘮𝘦𝘯𝘵: 𝘞𝘩𝘺 𝘐𝘵’𝘴 𝘊𝘳𝘪𝘵𝘪𝘤𝘢𝘭 𝘵𝘰 𝘚𝘶𝘣𝘮𝘪𝘴𝘴𝘪𝘰𝘯 𝘚𝘵𝘳𝘢𝘵𝘦𝘨𝘺 𝘢𝘯𝘥 𝘏𝘰𝘸 𝘔𝘰𝘥𝘦𝘭𝘪𝘯𝘨, 𝘙𝘦𝘨𝘶𝘭𝘢𝘵𝘰𝘳𝘺 𝘢𝘯𝘥 𝘊𝘭𝘪𝘯𝘪𝘤𝘢𝘭 𝘐𝘯𝘴𝘪𝘨𝘩𝘵𝘴 𝘚𝘩𝘢𝘱𝘦 𝘚𝘶𝘤𝘤𝘦𝘴𝘴, is a must-watch for pediatric development and submission strategy teams. 𝗙𝗲𝗮𝘁𝘂𝗿𝗲𝗱 𝗦𝗽𝗲𝗮𝗸𝗲𝗿𝘀: ∙ S. Y. Amy Cheung, PhD (Certara) ∙ Justin H., PhD (Certara) ∙ Tomoyuki Mizuno, PhD (Cincinnati Children's) 𝗠𝗶𝘀𝘀𝗲𝗱 𝘁𝗵𝗲 𝗹𝗶𝘃𝗲 𝘄𝗲𝗯𝗶𝗻𝗮𝗿? Watch it on demand to learn how modeling, regulatory, and clinical insights help de-risk pediatric programs. https://ow.ly/3zfH50Y2Vs1 #PediatricDrugDevelopment #ClinicalDevelopment #RegulatoryStrategy #ModelInformedDrugDevelopment #PBPK #Pharmacometrics #DrugDevelopment #LifeSciences #OnDemandWebinar

From GLP-1 breakthroughs to the shift away from animal testing and data challenges, this month we’re highlighting three stories shaping the future of drug development. #IndustryNews #DrugDevelopment #newsletter

Phoenix Cloud just got more powerful. With the introduction of AI PK Reports, generative AI can now transform tables, figures, and listings into fully formatted draft PK reports in minutes, saving scientists weeks of manual effort. This capability accelerates reporting while maintaining consistency, traceability, and scientific rigor. By reducing time spent on formatting and narrative creation, PK teams can focus more on interpretation, decision making, and advancing their programs. Learn more: https://ow.ly/Wm7a50Y0Uiw

Looking to ensure compliance and accelerate regulatory submissions? Certara’s 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗢𝗽𝗲𝗿𝗮𝘁𝗶𝗼𝗻𝘀 𝗲𝘅𝗽𝗲𝗿𝘁𝘀, powered by 𝗚𝗹𝗼𝗯𝗮𝗹𝗦𝘂𝗯𝗺𝗶𝘁™️ 𝗲𝗖𝗧𝗗 𝘀𝗼𝗳𝘁𝘄𝗮𝗿𝗲, help sponsors achieve on-time, on-budget submission success across global markets. Let’s connect at 𝗗𝗜𝗔 𝗥𝗦𝗜𝗗𝗠 𝟮𝟬𝟮𝟲 | 𝗕𝗼𝗼𝘁𝗵 𝟮𝟬𝟮. https://ow.ly/bXkp50Y0U0p #DIARSIDM #Certara