Certara

🤝 A Partnership That Redefines Pharmaceutical Advancement. Biohaven and Certara have pioneered a unique collaboration in the development of Rimegepant for migraine therapy. Learn how our combined expertise made a significant impact on bringing a much-needed treatment to patients. 📺 Watch our webinar to hear from the experts behind the innovation: https://ow.ly/repj50U3f45 #PartnershipExcellence #MigraineRelief #PharmaceuticalIndustry #Certara #Biohaven #DrugDevelopment

Meet Kate Gill, Director of PBPK Consulting - Simcyp! For the past 12 years, Kate has been an integral part of Simcyp’s journey, starting with the development of our cutting-edge PBPK software—encompassing both biologics and small molecule models. Today, Kate applies her expertise to lead consultancy projects, developing PBPK models to address key development and regulatory questions. Kate has oversight of all large molecule projects in the PBPK consultancy team and is responsible for predicting drug-drug interactions (DDIs) for not only small molecule projects but also for antibody-drug conjugates (ADC) and cytokine-mediated interactions as well as for predicting the PK of large molecule drugs in special populations including pediatrics.  With a background in metabolism and a commitment to accelerating drug development, Kate’s ultimate goal is to ensure that life-changing treatments reach patients as quickly as possible.  Connect with Kate today: https://lnkd.in/eAiyUyzV #PBPK #Pharmacokinetics #Biologics #DrugDevelopment #Simcyp #Consulting #RegulatoryScience

The future of rare disease drug development calls for innovation, collaboration, and patient-focused science. On December 5th, Certara and leading voices in rare diseases are discussing how tools like Quantitative Systems Pharmacology (QSP) and Model-Informed Drug Development (MIDD) are paving the way for faster, more effective treatments. 💻 Register now to join us: https://lnkd.in/eb7jsbHZ Let’s bridge the gap between science and patient outcomes for rare diseases! #RareDiseases #DrugDevelopmentInnovation #Certara #Pharma #Webinar #HealthcareSolutions

Recap of the GMP Annual Symposium The recent Groupe de Métabolisme et Pharmacocinétique (GMP) annual symposium in France was a resounding success, bringing together experts to discuss pivotal advancements in pharmacokinetics and metabolism. Our team was involved in several sessions to include a workshop on drug-drug interactions (DDIs), where Eva Gil Berglund, Isabelle Ragueneau-Majlessi, and Isabelle Deprez shared insights on navigating the changing regulatory landscape. Isabelle Deprez also chaired a session focused on pharmacokinetic models designed to support medicine use in special populations, emphasizing the importance of equitable access to treatments. Justin H. contributed to the discussions with a presentation on pediatric drug development, highlighting how model-informed strategies can effectively address regulatory challenges. Qier WU and Maïlys De Sousa were also in attendance. Amandine Manon wrapped up the symposium by exploring biodistribution and its relevance to targeted radiation therapies, discussing key clinical pharmacology considerations. The symposium fostered engaging discussions and valuable knowledge exchange, setting the stage for future innovations in the field. We look forward to continuing these important conversations! For more information on the GMP Symposium visit: https://lnkd.in/duryZdjP

eCTD 4.0 is now available with Certara's GlobalSubmit™ software! https://ow.ly/w4Z750Uf8be GlobalSubmit is used by regulatory affairs, medical writing teams, and scientists to efficiently publish, validate, and review Electronic Common Technical Document (eCTD) submissions of new drugs and biologics to health authorities. The latest version supports the FDA’s new version 4.0 submission standard, improving the submission process while increasing harmonization across health authorities’ requirements. In addition to the GlobalSubmit software, Certara’s expert regulatory operations team provides the assurance needed to navigate the new standard seamlessly. Read the full announcement here: https://ow.ly/w4Z750Uf8be #eCTD #regulatory #regulatorytechnology

Pharmacometric and systems pharmacology approaches are transforming drug development for pregnant and lactating women with Certara’s scientific and thought leadership.  The November edition of CPT: Pharmacometrics & Systems Pharmacology is here, and we’re proud to share that 𝐞𝐢𝐠𝐡𝐭 𝐂𝐞𝐫𝐭𝐚𝐫𝐚 𝐬𝐜𝐢𝐞𝐧𝐭𝐢𝐬𝐭𝐬 contributed to seven innovative articles.   ✨ Meet the contributors: • Karen Rowland Yeo • Paola Coppola • Eva Gil Berglund • Amin Rostami-Hodjegan • Lisa Almond • Xian Pan • Amita Pansari • Krithika Shetty 𝐅𝐞𝐚𝐭𝐮𝐫𝐞𝐝 𝐑𝐞𝐬𝐞𝐚𝐫𝐜𝐡 𝐇𝐢𝐠𝐡𝐥𝐢𝐠𝐡𝐭𝐬: • 𝐄𝐝𝐢𝐭𝐨𝐫𝐢𝐚𝐥: Optimizing drug therapy for pregnant and lactating women through personalized dosing and safety. • 𝐏𝐞𝐫𝐬𝐩𝐞𝐜𝐭𝐢𝐯𝐞: Bridging knowledge gaps in pregnancy drug safety with clinical pharmacology frameworks. • 𝐓𝐮𝐭𝐨𝐫𝐢𝐚𝐥: Using PBPK modeling in lactation studies. • 𝐑𝐞𝐯𝐢𝐞𝐰: Role of BCRP in lactation and drug distribution predictions. • 𝐒𝐲𝐬𝐭𝐞𝐦𝐚𝐭𝐢𝐜 𝐑𝐞𝐯𝐢𝐞𝐰: Exploring drug transport complexities during lactation. • 𝐀𝐫𝐭𝐢𝐜𝐥𝐞: PBPK modeling for safe dolutegravir use in pregnant and lactating women. • 𝐀𝐫𝐭𝐢𝐜𝐥𝐞: Optimizing pregnancy dosing for monoclonal antibodies. 📖 Access these articles here: https://lnkd.in/e6j7-BcA #MaternalHealth #Pharmacometrics #PBPK #DrugDevelopment #LactationResearch #Pharmacology #ASCPT

Are you ready to explore the latest case studies in clinical pharmacology? Visit Certara’s booth #3 on December 13-14 at JSCPT. Our expert team in Japan will guide you on accelerating drug development using Modeling & Simulation software, scientific database solutions, and tech-enabled services. Learn more: https://lnkd.in/dWAQnuDs #JSCPT #CertaraJapan #MIDD #ClinicalPharmacology

The drug development literature landscape is changing. Is your scientific communication keeping up? New publication trends, formats, and technologies are emerging. Our blog post explores how Certara’s medical publications professionals adapt to ensure your research reaches the right audience in the correct format. Read more: https://ow.ly/uvXm50TQ8JQ #ScientificPublishing #MedicalWriting #DrugDevelopment

The inaugural Certainty Europe conference showcased transformative stories in drug development, from prioritizing science over trends to leveraging advanced modeling and fostering meaningful connections. Explore our latest Inner Circle newsletter for key takeaways shaping the future of patient care. #InnerCircle #Certainty #Newsletter #DrugDevelopment

🔬 𝗘𝘅𝗰𝗶𝘁𝗶𝗻𝗴 𝗡𝗲𝘄 𝗣𝘂𝗯𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝗔𝗹𝗲𝗿𝘁: Our team of experts has made significant strides in advancing the understanding of monoclonal antibody pharmacokinetics during pregnancy!   In our latest article published in CPT Pharmacometrics & Systems Pharmacology, "Informing pregnancy dose via target-mediated drug disposition modeling and simulations for a recombinant human monoclonal antibody", we optimized the dosing regimen for RLYB212 using target-mediated drug disposition (TMDD) modeling to ensure safe and effective exposure for pregnant women. This work demonstrates how TMDD modeling can significantly enhance our clinical pharmacology toolkit, specifically for monoclonal antibodies in the context of pregnancy.   💡 𝗞𝗲𝘆 𝗛𝗶𝗴𝗵𝗹𝗶𝗴𝗵𝘁𝘀: - TMDD modeling informs dosing in unique clinical populations - Accounts for physiological changes during pregnancy - Identified optimal dosing for RLYB212 in preventing FNAIT   Thank you to our authors who contributed to this wonderful team effort: Courtney Moc Willeford, PharmD, MS, BCIDP Krithika Shetty 🔗 Read more to see how this work advances precision medicine! https://lnkd.in/dGpY9xBi   #Pharmacokinetics #DrugModeling #PregnancyResearch #ClinicalPharmacology #MonoclonalAntibodies #TMDD