Certara’s Post

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 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

Exciting Posters at ACCP! If you're interested in the applications of PBPK in pregnant populations or the modeling of oral solutions for solubility and DDI evaluation, don't miss these featured posters: 📌 Predicting Metoprolol Exposure-Response in Pregnant Populations Using Physiologically Based Pharmacokinetic Modeling Presented by Khaled Abduljalil, PhD, Sr. Principal Scientist 📌 Mechanistic PBPK Modelling of Itraconazole Oral Solutions: Evaluating HP-β-CD Impact on Solubility and Drug-Drug Interactions Presented by Ali Tabatabaian Nimavardi, PhD, Research Scientist These posters will provide valuable insights into cutting-edge modeling techniques in drug development. To view our complete list of presence visit: https://lnkd.in/ejbWKB-n Stop by booth #3 and say hello! #PBPK #DrugDevelopment #ACCP2024 #Pharmacokinetics #DrugSafety

Join Steve Sibley, Vice President of Regulatory Strategy, and Rachel Bombara, Senior Manager of Regulatory Services at Certara, on September 10 at 11AM ET as they share invaluable insights and strategies to streamline your regulatory submissions. Secure your spot today and ensure your submissions are timely and successful: https://ow.ly/abPb50TeWa4 #RegulatoryAffairs #Webinar #EMA #FDA #SimultaneousSubmissions #Certara #eCTD #Pharma #Biotech

Meet Bill Poland, VP & Lead Scientist at Certara Drug Development Solutions! Bill is originally trained as a decision analyst and is most excited by the high-value acceleration of drug development. He has a keen interest in combining pharmacometric and probabilistic economic models to make better strategic decisions, such as program-level design and go/no-go decisions in the context of competing compounds and market dynamics. Additionally, he finds great satisfaction in seeing the drugs that his team supports through development get approved. Connect with Bill today: https://lnkd.in/dHVyDETd