Certara

Ready to Revolutionize Drug Development? Join us for #CERTAINTY Europe on 29-30 October in Mainz, Germany! This exclusive client event is designed for trailblazers in biosimulation, clinical pharmacology, AI, and regulatory science. Be at the forefront of drug development—connect with peers, gain invaluable insights, and drive the conversation forward. https://lnkd.in/ejDR83h5 Engage in discussions on critical topics such as: - The Impact of MIDD in Decision-Making - Generative AI in Non-Clinical Development - Accelerating Insights with Digital Data Flow Let's achieve greater certainty in drug development together. Register today while spots are still available: https://lnkd.in/ey8Avaub #globalCertainty #CertaintyEurope #CERTAINTY2024 #drugdevelopment

We're excited to attend EUROTOX 2024 in Copenhagen, Denmark, from September 8-11!   Catch our sessions on September 10: - 2:00-4:30 PM: Dr. Elias Zgheib on “Advances and Applications in Quantitative Systems Toxicology to Support Chemical Safety Assessment” (#286). - 4:00-6:00 PM: Dr. Barira Islam on “Bringing NGRA to life – A global joint effort for putting Next-Generation Risk Assessment into practice” (#194). Plus, check out our posters on September 9 at Tivoli Congress Hall: - 9:30 AM: “An extended in vitro CALUX read-out panel for the assessment of steroidogenesis modulation by endocrine disrupting chemicals on 4 hormonal modalities in the H295R steroidogenesis assay” (#329). - 9:30 AM: “ASPIS Academy: Empowering the Next Generation of Toxicologists” (#241). For more details on #EUROTOX2024, visit: https://lnkd.in/d256ERQp

We're thrilled to announce two brand-new courses designed in collaboration with the University of Florida to enhance your expertise in pharmacokinetics and pharmacometrics! Whether you're looking for flexible learning or an immersive in-person experience, Certara has you covered. 𝗜𝗻𝘁𝗿𝗼𝗱𝘂𝗰𝘁𝗶𝗼𝗻 𝘁𝗼 𝗔𝗽𝗽𝗹𝗶𝗲𝗱 𝗣𝗵𝗮𝗿𝗺𝗮𝗰𝗼𝗸𝗶𝗻𝗲𝘁𝗶𝗰𝘀: Dive into the intricate science of pharmacokinetics and its practical applications. This on-demand course is available all year-round, allowing you to register at your convenience and learn at your own pace. 𝗣𝗵𝗮𝗿𝗺𝗮𝗰𝗼𝗺𝗲𝘁𝗿𝗶𝗰𝘀 𝗨𝘀𝗶𝗻𝗴 𝗣𝗶𝗿𝗮𝗻𝗮-𝗡𝗢𝗡𝗠𝗘𝗠 𝗮𝗻𝗱 𝗥𝗦𝗡𝗟𝗠𝗘: Join us for a 5-day in-person course where you will gain hands-on experience with nonlinear mixed effects modeling and learn to analyze population pharmacokinetic data using NONMEM and RsNLME, all while keeping track of model-building steps with the Pirana workbench. This 5-day immersive experience will take place Monday, 9/23 and end Friday, 9/27. Sessions will run from 9:00 AM to 5:00 PM, with plenty of breaks. We will conclude with an evening social event. *Please note: Completion of Course 1: Introduction to Applied Pharmacokinetics is a prerequisite for enrolling in this course. Bundle these courses or register individually! If you're interested in the 5-day in-person course, hurry to secure your spot—registration closes on September 1st! Learn more and register below: 👉 On-Demand Course: https://ow.ly/N0q450TcIqn 👉 5-Day In-Person Course: https://ow.ly/sBSR50TgLq2 Don't miss out on these incredible opportunities to advance your knowledge and skills!

Join us at CERTAINTY Europe for a special presentation featuring Dr. Paolo Bettica, Chief Medical Officer at Italfarmaco! Dr. Bettica will highlight the collaborative work with Certara on Givinostat - the first nonsteroidal drug approved by the FDA for the treatment of Duchenne muscular dystrophy in children. Learn how biosimulation has played a crucial role in advancing clinical outcomes and optimizing patient dosing for this transformative treatment. 📅 Dates: October 29th - 30th, 2024 📍 Location: Mainz, Germany Be part of this exclusive client event and see how biosimulation is revolutionizing patient care. Register today to secure your seat: https://lnkd.in/ejDR83h5 #CertaintyEurope #CertaintyByCertara #DrugDevelopment #DuchenneMuscularDystrophy #Givinostat #Biosimulation

We wrapped up CERTAINTY APAC in China today, diving into the latest drug development innovations with top experts and peers. The excitement continues next week at CERTAINTY Korea and Japan—can’t wait to see you there!

This week, our CSO, Amin Rostami-Hodjegan, participated in the “Executive Roundtable” at Avicenna Day 2024, hosted by the Avicenna Alliance. This prestigious annual event brings together industry and academic leaders to drive innovation in in silico medicine. Amin shared his insights alongside experts like Mark Palmer, M.D., Ph.D. (Ansys), Jan Hertwig (Simq GmbH), Jean Colombel (Dassault Systèmes), and Martha De Cunha Maluf-Burgman (Edwards Lifesciences), with moderation by Thierry Marchal (Avicenna Alliance/Ansys). He discussed the counter-intuitive philosophies related to transitioning modeling and simulation from academic endeavors to industrial tools and regulatory assessments. Key topics included the challenges of using open-source codes for regulatory purposes and the acceptance of models when no alternatives exist. The panel explored the transformative impact of digital simulations on medicine and technology, and how in silico medicine can bridge the gap between the scientific community, industry, and policymakers. For more on the Avicenna Alliance and the importance of integrating modeling and simulation into broader scientific practice, check out this article: https://ow.ly/XcLo50TfOtu, and visit: https://ow.ly/MnPS50TfOtt. #Innovation #InSilicoMedicine #AvicennaDay2024 #DigitalHealth #ModelingAndSimulation #PharmaTech

Join us in Copenhagen, Denmark at the annual ASPIS Open Symposium! This event brings together members of the ASPIS cluster (formed by the Horizon 2020 consortia: ONTOX, PrecisionTox, and RISK-HUNT3R) and the wider scientific community to discuss initiatives on advancing the safety assessment of chemicals without animal testing. Our Sr. Research Scientist, Barira Islam, PhD, will present in the session “Kinetics & Exposure, & Computational Approaches Working Groups,” and provide updates on the recent activities of the ASPIS kinetics working group. 🗓️ Date: Thursday, September 12, 2024 🕛Time: 12:55 PM CET For more information on this event and the topics covered, visit: https://lnkd.in/eNpk2SYJ

Heading to BioTechX USA on Sept 17-18? Join Nick Brown, Director, Global Portfolio Leader, as he dives into the transformative power of AI in life sciences with his talk, "Moving from Hype to Reality in Pharmaceutical AI Applications." Here’s what you can expect: - Utilizing GPTs to support structured content authoring in medical writing and regulatory submissions - Automating Data Transformation for eCTD standardization - Enhancing QSP Models for better target identification, PK/PD, and clinical trial design   📅 Date: September 17th 🕛 Time: 12:45pm 📍 Track: Large Language Models   Join us to explore practical AI solutions that tackle today’s pharmaceutical challenges.   Learn more and register: https://lnkd.in/eRBbcQGu #BioTechXUS #PharmaceuticalAI #CertaraAI #AIApplications #MedicalWriting #DataTransformation

Are you caught up with the FDA's recently announced, final guidance on oncology dose optimization? Model-informed drug development (MIDD) approaches can support the FDA's Project Optimus in a variety of ways. In this webinar, hear from our experts Krithika Shetty and Fei Hua, about the FDA's perspective on Quantitative Systems Pharmacology (QSP) modeling and examples of QSP applications for Project Optimus. 📅 Date: October 2nd 🕛 Time: 11:00am ET Learn more and register here: https://ow.ly/WtnO50TeBVa #ProjectOptimus #DrugDevelopment #QuantitativeSystemsPharmacology #ClinicalPharmacology

The Certara U.S. Market Access team's research on the Inflation Reduction Act (IRA) and its impact on Biosimilar uptake is currently featured as an Editor's Choice in Fierce Pharma. If you're developing biosimilar products, we can help with strategic guidance on access and reimbursement. In addition, our drug development experts can help you design clinical trials that meet regulatory standards for showing biosimilarity to the reference product. Looking for more information on biosimilar drug development best practices? Check out our blog, 'What are biosimilars & how are they developed?' https://lnkd.in/egf-Pgk9