Certara

📢 It’s almost time for the 2025 SCDM EMEA Conference! Stop by Booth 9 for your chance to see how well-governed metadata is the key to achieving standardization. Pinnacle 21 Enterprise allows you to effectively manage vendor data transfers, eCRFs, and submission datasets like SDTM and ADaM ✨ Learn from our standards expert Ben Mant about “Unlocking the Power of Metadata with Pinnacle 21 Enterprise”. 📅 Thursday April 10th | 3:00PM - 3:30pm Find out more 👉 https://lnkd.in/esQg7S5t #SCDM #ClinicalDataManagement #Clinicaltrials #Certara #Pinnacle21

Heading to PAGE 2025? Let’s Connect! Curious about how Certara’s expertise can support your drug development projects? Meet our experts 1:1 at PAGE 2025 to explore how we apply mechanistic modeling, quantitative and statistical modeling, and strategic drug development—from lead optimization and early development (toxicology, CMC) to clinical pharmacology, regulatory strategy, and advanced data analysis through pharmacometrics. Request a personalized meeting with our specialists by filling out the form, and we’ll set up a time to chat: https://lnkd.in/eGnuMC_9 Check out our complete scope of presence here: https://lnkd.in/eQpKiw2F #PAGE2025 #DrugDevelopment #Pharmacometrics #MechanisticModeling #Toxicology #ClinicalPharmacology #RegulatoryStrategy

We’re excited to share a recent publication in 𝗖𝗣𝗧: 𝗣𝗵𝗮𝗿𝗺𝗮𝗰𝗼𝗺𝗲𝘁𝗿𝗶𝗰𝘀 & 𝗦𝘆𝘀𝘁𝗲𝗺𝘀 𝗣𝗵𝗮𝗿𝗺𝗮𝗰𝗼𝗹𝗼𝗴𝘆, “PBPK-Led Assessment of Antimalarial Drug Concentrations in Breastmilk: A Strategy for Optimal Use of Prediction Methods to Guide Decision Making in an Understudied Population.” This publication highlights how PBPK modeling can be used to predict milk exposure and infant dose of antimalarials to support decision-making and establishes the critical role of model-informed drug development (MIDD) approaches in advancing global health equity. Read the full publication: https://lnkd.in/ecx-ubmn   Register for our upcoming global health webinar: https://lnkd.in/ePH7mrmd

The Pinnacle 21 resources you know and love are on the move... 🚀 That’s right, the pinnacle21.com website content and community forum are moving to their new home on Certara.com. You’ll find all the same helpful tools, resources, and community support on the unified Certara platform, with an enhanced user experience. Stay tuned for updates and if you have any questions, please don't hesitate to contact your Customer Success representative 😊 #pinnacle21 #certara #validation #sdtm

🎉👏Congratulations to Shinichi Kijima from the Office of New Drug V, PMDA, and HASEGAWA Mayumi, VP of Drug Development Solutions, Certara! Their coauthored publication, "MIDD in Japan – Implementations, Challenges, and Opportunities," has been approved for publication in Advanced Drug Delivery Reviews of Science Direct. This groundbreaking work sheds light on the transformative advancements in Japan's drug development landscape. By adopting Model Informed Drug Development (MIDD), we can significantly enhance the risk-benefit profiles of new therapeutics while creating more efficient regulatory pathways. Recent guidelines are fostering collaboration between pharmaceutical companies and regulators, which is essential for innovation and global harmonization in drug development. 📖Don't miss out on reading their insightful publication here: https://lnkd.in/d8NugWbM  #DrugDevelopment #MIDD #Japan #Innovation #RegulatoryScience

Innovation thrives through collaboration, and the #Simcyp Consortium is a prime example of this in action. With over 35 leading biopharmaceutical companies from around the globe, the 25-year-long Simcyp Consortium is transforming the industry landscape by: ✅ Shaping the scientific direction of the Simcyp PBPK Simulator, ensuring it evolves to address the dynamic needs of the industry. ✅ Empowering the global scientific community through academic grants and awards, fostering growth and innovation. ✅ Collaborating with regulators worldwide to exchange insights and advance modeling adoption in regulatory submissions.  Discover how the Simcyp Consortium is revolutionizing biopharmaceutical science: https://lnkd.in/dqrgNmrY

𝗕𝗹𝗲𝗻𝗱𝗶𝗻𝗴 𝗦𝗰𝗶𝗲𝗻𝗰𝗲 & 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝘆 𝗶𝗻 𝗣𝗿𝗼𝗷𝗲𝗰𝘁 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 Meet Chantal Morin, Senior Project Manager at Certara! With a background in biochemistry and a passion for science, Chantal transitioned into project management to bridge her expertise in quality assurance, manufacturing, and formulation development. Inspired by her sibling’s journey with Duchenne muscular dystrophy, she’s driven to advance medicine through impactful projects. At Certara, Chantal leads complex initiatives—from pre-IND projects to regulatory gap analyses and modeling studies—ensuring seamless execution and collaboration. 🎥 Learn more about Chantal in her full interview: https://lnkd.in/e9k2VC7P 📩 Connect with Chantal: https://lnkd.in/dqR6isfv #ProjectManagement #DrugDevelopment #RegulatoryScience #Pharmacometrics #ClinicalTrials #Certara

We're pleased to announce that Dr. Amitava Mitra, PhD, FAAPS is joining us as a speaker at #Certainty by Certara this May in Philadelphia! Dr. Mitra brings 17 years of experience in global drug development supporting various therapeutic areas. He has published over 50 research and review articles, with his main research interests including clinical pharmacology, modeling & simulation, pharmacokinetics, and biopharmaceutics. Join us on May 7th as he presents, "Leveraging QSP and PBPK Modeling to Guide Development Strategy." Reserve your spot today! Register now: https://lnkd.in/eg38yJvc

There's much to consider when building a health economic model that decision makers will use to assess the value of new treatments and allocate scare resources. Authored by health economics experts Mohsen Yaghoubi and @Kinga Pacocha, the first in our series of four articles dedicated to all things health economic modeling explores the key components that go into a fit-for-purpose model. Read the full article now and let us know if there's anything else you consider essential when building an effective model. Read now: https://lnkd.in/gZ23dqVE #HEOR #RealWorldEvidence #Healthcare #HealthEconomics #OutcomesResearch

Skip the hype—see how GPTs and other deep learning models are accelerating the design-make-test-analyze cycle. Hear from Bryan Farrow and Sean McGee in this quick video at BioIT World 2025. Visit us at Booth 105 at BioIT World! Learn more: www.certara.com/discovery #BioITWorld #DrugDevelopment #DesignMakeTestAnalyze #AIinBiotech