Certara

Going to BioTechX USA, Sept 17-18? Don’t miss Nick Brown, Director and Global Portfolio Leader, as he explores how life science companies can harness AI to drive better therapeutic outcomes. https://lnkd.in/eRBbcQGu In his talk, "Moving from Hype to Reality in Pharmaceutical AI Applications," Nick will cover: - Utilizing GPTs for structured content authoring in medical writing and regulatory submissions - Automating data transformation for eCTD standardization - Enhancing and validating quantitative systems pharmacology (QSP) models for better target identification, PK/PD, and clinical trial design 📅 Date: September 17th 🕛 Time: 12:45pm 📍 Track: Large Language Models Learn how these approaches can address the challenges pharmaceutical companies face in adopting AI. Find out more about BioTechX USA and register here: https://lnkd.in/eRBbcQGu #BioTechXUS #PharmaceuticalAI #CertaraAI #AIApplications #MedicalWriting #DataTransformation

Certara's Dr. Fran Brown, Senior Vice President of Drug Development Science, is quoted in this WIRED article about the FDA's recent rejection of Lykos Therapeutics' proposed MDMA treatment for post-traumatic stress disorder. Read the article for her insights into the challenges of designing clinical trials to assess the therapeutic potential of psychedelics. #drugdevelopment #psychedelics #FDA #MDMA #PTSD

eCTD 4.0 isn't on the horizon: it's at your doorstep. The submission format is already available in Japan, with the PMDA planning to make it mandatory in 2026. The FDA, EC, and other agencies aren't far behind. Don't fear the unknown. Get your questions answered on our September 24 webinar. https://lnkd.in/eUTca_im

Attention #Phoenix community! The latest release of the world’s most trusted platform for PK/PD analysis and modeling is here. Phoenix 8.5 offers enhanced user access and a more streamlined experience, enabling even more powerful analysis, interpretation, and data visualization. Discover the new features and download the update today. https://ow.ly/JVfv50T4sMU

𝗖𝗼𝗔𝘂𝘁𝗵𝗼𝗿 𝗯𝗿𝗶𝗻𝗴𝘀 𝗔𝗜 𝘁𝗼 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝘄𝗿𝗶𝘁𝗶𝗻𝗴. Medical writing requires precision and accuracy. Learn how CoAuthor can streamline producing regulatory documents, enhance compliance, and reduce the time and effort needed for manual writing tasks. Read more in this blog: https://ow.ly/Rt2p50Soen0 #RegulatoryWriting #MedicalWriting #AI #DrugDevelopment #MedicalWritingSoftware #QualityControl #RegulatoryAffairs #MedicalAffairs #Pharma

We’re excited to announce that Andreas Wallnoefer from Jeito Capital will be presenting at CERTAINTY Europe this fall in Mainz, Germany! Don’t miss his exclusive talk, "Impact of MIDD and the Role in Decision-Making," on October 29, 2024. Discover how biosimulation is revolutionizing patient care. Register today to secure your seat: https://lnkd.in/ejDR83h5 #CertaintyEurope #CertaintyByCertara #DrugDevelopment #Biosimulation

Join Certara at the 15th APS PharmSci International Conference from September 4th to 6th, 2024, and hear David B. Turner, PhD, discuss 'Simcyp Biopharmaceutics and Model Informed Formulation Development'. Learn more and register today: https://lnkd.in/eATfB4Qy #PharmSci2024 #Conference #PharmaceuticalScience #Biopharmaceutics #PBPK #DrugDevelopment

𝗗𝗜𝗗𝗕 𝗗𝗮𝘁𝗮 𝗖𝘂𝗿𝗮𝘁𝗶𝗼𝗻 𝗮𝗻𝗱 𝗘𝗻𝘁𝗿𝘆 𝗝𝘂𝗹𝘆 𝟮𝟬𝟮𝟰 𝗦𝘂𝗺𝗺𝗮𝗿𝘆 In July, we added 127 citations in DIDB, including 70 in vitro (with 17 articles published in July 2024) and 57 in vivo articles (with 41 articles published in July 2024). The following NDAs/BLAs were also curated as part of the July 2024 DIDB update: crovalimab (PIASKY) imetelstat (RYTELO) sofpironium (SOFDRA) tarlatamab (IMDELLTRA) 🔍 View recently published citations and all the NDAs/BLAs in DIDB: https://lnkd.in/e85ggSFr #druginteractions #drugdiscovery #drugdevelopment #drugsafety #clinicalresearch #clinicaldevelopment #clinicaltrials #riskassessment #pharmacovigilance #pharmaceuticals

Physiologically-based pharmacokinetic (PBPK) modeling can help accelerate the development of antibody-drug conjugates (ADCs). Our webinar gives you insights into how researchers are using these models to predict drug-drug interactions for ADCs without having to conduct a clinical DDI trial! Learn more: https://lnkd.in/ehHZ6mvD #Certara, #ADCs #PBPK #DrugDevelopment #ClinicalTrials #Pharma #DrugLabeling #ClinicalDDIs #PBPKModeling #PatientSafety #OncologyResearch #ClinicalPharmacology #OncologyInnovation #PharmaInnovation #SimcypSimulator #CancerTherapy

🌟 Announcing Speaker for Certainty by Certara! We're thrilled to announce an exclusive presentation at Certainty by Certara, happening in Mainz, Germany, this fall. Join us for, "Early Development Decision Making for Joint Clinical Assessment (JCA) Success." https://lnkd.in/ejDR83h5 In this talk, Elvira Mueller, PhD, MPH, Vice President, HTA Strategy & Access, will discuss the implications of JCA for product development and how cross-functional teams should collaborate from the early development planning phase to ensure broad market access post-approval. 📅 Dates: October 29th - 30th, 2024 📍 Location: Mainz, Germany Join us for this exclusive client event—register today to secure your seat! https://lnkd.in/ejDR83h5 #CertaintyEurope #CertaintyByCertara #DrugDevelopment