Are you attending BioTechX Europe on October 9th-10th? If so, don’t miss the chance to hear from Sean McGee, Director of Product, Certara.AI, as he presents in the Large Language Model track on "Moving from Hype to Reality in Pharmaceutical AI Applications." Discover how cutting-edge AI technology can be harnessed to accelerate the development of safer and more effective therapeutics. 📅 Date: October 9th 🕛 Time: 12:45 PM CEST 📍 Track: Large Language Models For more details and to register, visit: https://lnkd.in/eXcq2nas #BioTechXEU #PharmaceuticalAI #CertaraAI #AIApplications #MedicalWriting #DataTransformation
About us
Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries.
- Website
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https://www.certara.com
External link for Certara
- Industry
- Business Consulting and Services
- Company size
- 1,001-5,000 employees
- Headquarters
- Radnor, Pennsylvania
- Type
- Public Company
- Specialties
- model-based drug discovery and development, scientific informatics, PK/PD modeling and simulation, PBPK modeling and simulation, trial design, drug development, regulatory writing, quantitative systems pharmacology, clinical pharmacology, quantitative systems toxicology, transparency and disclosure, model-based meta-analysis, regulatory strategy, regulatory publishing, market access, health economics and outcomes research, and real world evidence solutions
Locations
Employees at Certara
Updates
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Don’t get left behind as GPTs begin to change medical and regulatory writing! Our upcoming webinar shares best practices for creating prompts to accelerate text and study data summarization while ensuring accurate output. Join this webinar to take your place among regulatory leaders ensuring the best results when using GenAI! https://ow.ly/SnpU50SX6kJ #GenAI #SmartAuthoring #RegulatoryWriting #MedicalWriting #Innovation #Pharma #MedicalWritingSoftware #MedicalAffairs #RegulatoryAffairs #AI
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Meet Ian Templeton, Senior Director of PBPK Consultancy at Simcyp! With a passion for providing scientific guidance that directly influences drug development and labeling decisions, Ian finds great satisfaction in helping clients navigate complex challenges. His expertise in PBPK modeling not only helps identify opportunities to address potential development issues but also offers alternatives to planned clinical studies. Ian’s recent success stories include refining clinical DDI studies, eliminating unnecessary trials, and accelerating enrollment by increasing allowed concomitant medications in Phase 2. Over the past five years, his contributions have been pivotal in numerous regulatory approvals and favorable label outcomes for drugs like Camzyos, Fruzaqla, and Tukysa. Connect with Ian today: https://lnkd.in/eAiyUyzV
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Certara's Dr. Fran Brown, Senior Vice President of Drug Development Science, is quoted in this BioSpace article about the FDA’s Complete Response Letter for the Lykos Therapeutics’s MDMA therapy for PTSD. Read the article to get her thoughts on the gaps in Lykos’ data package and how psychedelic drug developers can avoid these pitfalls. #psychedelics #drugdevelopment #FDA #PTSD
Psychedelic drug developers are undeterred by the FDA’s Complete Response Letter for the company’s MDMA therapy for PTSD, and experts expect Lykos Therapeutics will ultimately obtain approval. https://hubs.li/Q02LHLwm0 #pharma #biospace
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Heading to the 15th APS PharmSci International Conference next week? Don’t miss the insightful Plenary Lecture by Sibylle Neuhoff, PhD, Senior Scientific Advisor and Deputy Head of Translational Science in DMPK. She will explore "PBPK 2024-2044: bRo5 – different compounds, different models, different system and drug data." For more information, visit: https://lnkd.in/eATfB4Qy #PharmSci2024 #Conference #PharmaceuticalScience #Biopharmaceutics #PBPK #DrugDevelopment
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Hear from our experts, Krithika Shetty and Fei Hua, about using Quantitative Systems Pharmacology (QSP) modeling for oncology dose optimization. We'll discuss examples of QSP applications for Project Optimus, the FDA's perspective on QSP modeling, and how QSP modelers and clinical pharmacologists can collaborate to ensure successful applications of QSP. Learn more and register at: https://ow.ly/6bRQ50T54hZ #ProjectOptimus #DrugDevelopment #QuantitativeSystemsPharmacology #ClinicalPharmacology
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Accelerate your drug development with a well-crafted Clinical Development Plan (CDP). A CDP can help you reduce development costs and increase your chances of regulatory and commercial success. Learn practical strategies in our latest blog post by Certara expert Dr. Rajesh Krishna. Read more: https://lnkd.in/gj7DyPN7 #Certara #DrugDevelopment #ClinicalTrials #Biotech #RegulatoryAffairs #ClinicalDevelopmentPlan #Biomarkers #PharmaIndustry #Pharma #DrugDevelopmentStrategy #TargetProductProfile
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Navigating the complex world of payer relations can be a daunting challenge. But what if there was a secret weapon to streamline communication and accelerate market access? Daria Lavrentev, Product Manager at Certara, shares invaluable insights on how digital payer portals are transforming the industry. Discover how these innovative platforms can help you build stronger payer relationships, improve decision-making, and drive better business outcomes. Get insights from Daria's latest blog: https://ow.ly/Q6Cy50T39qR
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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
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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
After the FDA rejected its proposed MDMA treatment, Lykos Therapeutics is laying off 75 percent of its staff and its founder has left the company.
The Uncertain Path Forward for Psychedelic Medicine
wired.com