Certara

Join us and leading industry experts on December 5th for an in-depth look at how innovative strategies like Model-Informed Drug Development (MIDD) are changing the landscape of rare diseases. From overcoming limited trial populations to advancing patient-centric study designs, learn the tools and insights making a difference in rare disease drug development. Don’t miss this opportunity to explore how science and strategy are unlocking new paths to rare disease breakthroughs. 🔗 Register now: https://ow.ly/nzjP50U7qLM #RareDiseases #Innovation #DrugDevelopment #Certara #Takeda #KuraOncology #Pharma #Collaboration

Conducting bioequivalence (BE) studies for complex generics can be both costly and time-consuming. Traditional methods often involve extensive clinical trials, which may delay access to affordable medications. Physiologically-Based Pharmacokinetic (PBPK) modeling streamlines the approval process and improves our understanding of product quality and efficacy. A key example is the FDA’s approval of a generic diclofenac sodium topical gel, which effectively linked formulation properties to local bioavailability. To learn how PBPK modeling can minimize clinical trials and speed up market access, check out our latest blog on its impact on bioequivalence and generic product approvals. https://ow.ly/rWcf50U5HVZ #Pharmaceuticals #Bioequivalence #PBPKModeling #GenericDrugs #Innovation

Join William Feehery, CEO at Certara and Richard Jones , President at Chemaxon on a webinar where they explain their vision for model-informed drug development and how the newly joined companies will work together to make it a reality. It is scheduled for November 20th, 8:00AM PST/11:00 EST/17:00 CET. Register here: https://lnkd.in/eq_gpepB #Chemaxon #Certara #MIDD

Are you caught up with the FDA's recently announced, final guidance on oncology dose optimization? Hear from our experts, Krithika Shetty and Fei Hua, to learn how Model-informed Drug Development (MIDD) approaches such as Quantitative Systems Pharmacology (QSP) can transform oncology drug development by optimizing dosing strategies and improving therapeutic outcomes. View the full webinar: https://ow.ly/5vUZ50U1pJj

Properly structuring clinical trial data starts with understanding SDTM domains. Our new guide explains these domains and their role in clinical data standardization. We cover everything from general observation classes to special purpose domains, ensuring your data collection meets regulatory standards. Learn how mastering SDTM domains can make a difference in your clinical trials. Download your guide here: https://lnkd.in/eyWpuUsp #ClinicalTrials #SDTM #SDTMDomains #Certara

With most clinical study data now originating from external vendors, a manual approach to validation and issue management can compromise quality, and cause delays. Take a look at the video below for a more efficient way to manage and reconcile your non-CRF data. #DataManagement #certara #pinnacle21 #DrugDevelopment #clinicaldata

Join us March 3-5, 2025, in Washington, DC for the Simcyp Focus Group Workshop on PBPK Modeling – perfect for industry, academic, and regulatory professionals. https://ow.ly/bE9p50U1vIC Workshop Highlights: ✔️ PBPK Modeling Fundamentals: Understand how various factors impact drug exposure. ✔️ Best Practices: Efficiently integrate data and prepare for regulatory submissions. ✔️ Case Studies: Real-world applications in drug interactions and special populations. Limited spots—register today! https://ow.ly/bE9p50U1vIC #PBPK #DrugDevelopment #Simcyp #Workshop #ClinicalPharmacology

It's Day 3 at #AcoP15 and we had the pleasure of catching up with Matt Zierhut, VP of Certara’s Drug Development Solutions. Matt has enjoyed reconnecting with colleagues and meeting new faces. He’s been most interested to see the latest advancements in pharmacokinetics, particularly in meta-analysis and decision-making. Tomorrow, he’ll be presenting on MBMA methodologies, and we can’t wait to hear his insights! #Pharmacokinetics #DrugDevelopment #MetaAnalysis #MBMA #MIDD #DrugDiscovery

A new white paper from Certara's drug interaction experts Jingjing Yu and Isabelle Ragueneau-Majlessi examines the complexities of transporter-mediated drug-drug interactions (DDIs) and highlights how Certara's Drug Interaction Database (DIDB) can help streamline the evaluation process. This is a must read for anyone evaluating DDIs early in development as you think about potential concomitant medication risk for your target patient population and assess whether a dedicated DDI clinical study is necessary. Download a copy of the white paper today: https://ow.ly/olwE50TQNby #DrugDevelopment #DrugInteractions #ClinicalPharmacology #PatientSafety

Certara recently reached an exciting milestone in our work with the #raredisease community! Supporting a recent submission, our team of regulatory experts ensured every step was backed by strategic leadership, flexibility, and diligence. Together, we’re paving the way for critical treatments to reach those who need them most. Check out our recent press release for more on how we’re advancing regulatory success in rare diseases and supporting innovative treatments that make an impact. https://ow.ly/1QRq50TBbj2 #RareDiseases #Milestone #CertaraTeamwork #PatientImpact #regulatorywriting #medicalwriting