Certara Expands the Simcyp鈩⒙燬imulator Platform Advancing Biopharmaceutics, Drug-Drug Interaction & Biologic Capabilities
Certara (Nasdaq: CERT) has released Version 24 of its Simcyp鈩� Simulator, enhancing its physiologically-based pharmacokinetic (PBPK) modeling platform. The update includes significant improvements in biopharmaceutics, drug-drug interactions, and biologics capabilities.
Key updates include enhanced food effect predictions in the Virtual Bioequivalence module, expanded drug-drug interaction libraries, improved biologics modeling, and enhanced trial design support. The platform also features modernized UI, cloud computing capabilities, and AI-enabled assistance.
The Simcyp Simulator, guided by a consortium of over 30 pharmaceutical companies, has contributed to more than 120 FDA-approved novel drugs. Notably, 4 out of 5 drugs using PBPK for FDA approval in recent years utilized the Simcyp Simulator.
Certara (Nasdaq: CERT) ha rilasciato la Versione 24 del suo Simulatore Simcyp鈩�, migliorando la sua piattaforma di modellazione farmacocinetica basata sulla fisiologia (PBPK). L'aggiornamento include miglioramenti significativi in biopharmaceutica, interazioni farmaco-farmaco e capacit脿 relative ai biologici.
Tra le principali novit脿 ci sono previsioni migliorate degli effetti del cibo nel modulo di Bioequivalenza Virtuale, librerie ampliate per le interazioni farmaco-farmaco, una modellazione dei biologici migliorata e un supporto avanzato per la progettazione degli studi clinici. La piattaforma presenta anche un'interfaccia utente modernizzata, capacit脿 di cloud computing e assistenza abilitata dall'IA.
Il Simulatore Simcyp, guidato da un consorzio di oltre 30 aziende farmaceutiche, ha contribuito all'approvazione di oltre 120 nuovi farmaci dalla FDA. 脠 interessante notare che 4 dei 5 farmaci che hanno utilizzato il PBPK per l'approvazione della FDA negli ultimi anni hanno impiegato il Simulatore Simcyp.
Certara (Nasdaq: CERT) ha lanzado la Versi贸n 24 de su Simulador Simcyp鈩�, mejorando su plataforma de modelado farmacocin茅tico basado en fisiolog铆a (PBPK). La actualizaci贸n incluye mejoras significativas en biofarmac茅utica, interacciones entre f谩rmacos y capacidades de biol贸gicos.
Las actualizaciones clave incluyen predicciones mejoradas del efecto de los alimentos en el m贸dulo de Bioequivalencia Virtual, bibliotecas ampliadas de interacciones entre f谩rmacos, modelado mejorado de biol贸gicos y un soporte mejorado para el dise帽o de ensayos. La plataforma tambi茅n cuenta con una interfaz de usuario modernizada, capacidades de computaci贸n en la nube y asistencia habilitada por IA.
El Simulador Simcyp, guiado por un consorcio de m谩s de 30 compa帽铆as farmac茅uticas, ha contribuido a m谩s de 120 nuevos medicamentos aprobados por la FDA. Notablemente, 4 de cada 5 medicamentos que utilizaron PBPK para la aprobaci贸n de la FDA en los 煤ltimos a帽os utilizaron el Simulador Simcyp.
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欤检殧 鞐呺嵃鞚错姼鞐愲姅 臧�靸� 靸濍頃欖爜 霃欕摫靹� 氇搱鞐愳劀 鞚岇嫕 須臣 鞓堨浮 臧滌劆, 頇曥灔霅� 鞎诫 臧� 靸來樃鞛戩毄 霛检澊敫岆煬毽�, 頄レ儊霅� 靸濍頃欖爜 鞝滌牅 氇嵏毵� 氚� 鞛勳儊 鞁滍棙 靹り硠 歆�鞗� 臧曧檾臧� 韽暔霅╇媹雼�. 鞚� 頂岆灚韽检潃 霕愴暅 順勲寑頇旊悳 UI, 韥措澕鞖半摐 旎错摠韺� 旮半姤 氚� AI 歆�鞗愳潉 鞝滉车頃╇媹雼�.
30臧� 鞚挫儊鞚� 鞝滌暯 須岇偓搿� 甑劚霅� 旎唽鞁滌梽鞐� 鞚橅暣 鞎堧偞霅橂姅 Simcyp 鞁滊霠堨澊韯半姅 FDA鞐愳劀 鞀轨澑頃� 120臧� 鞚挫儊鞚� 鞁犾暯鞐� 旮办棳頄堨姷雼堧嫟. 韸鬼瀳, 斓滉芳 氇� 雲� 霃欖晥 FDA 鞀轨澑鞚� 鞙勴暣 PBPK毳� 靷毄頃� 鞎诫 5臧� 欷� 4臧滉皜 Simcyp 鞁滊霠堨澊韯半ゼ 頇滌毄頄堨姷雼堧嫟.
Certara (Nasdaq: CERT) a lanc茅 la Version 24 de son Simulateur Simcyp鈩�, am茅liorant ainsi sa plateforme de mod茅lisation pharmacocin茅tique bas茅e sur la physiologie (PBPK). La mise 脿 jour comprend des am茅liorations significatives en bio-pharmaceutique, en interactions m茅dicamenteuses et en capacit茅s biologiques.
Les mises 脿 jour cl茅s incluent des pr茅visions am茅lior茅es des effets alimentaires dans le module d'茅quivalence biologique virtuelle, des biblioth猫ques 茅largies d'interactions m茅dicamenteuses, une mod茅lisation am茅lior茅e des biologiques et un soutien renforc茅 pour la conception des essais. La plateforme dispose 茅galement d'une interface utilisateur modernis茅e, de capacit茅s de cloud computing et d'une assistance aliment茅e par l'IA.
Le Simulateur Simcyp, guid茅 par un consortium de plus de 30 entreprises pharmaceutiques, a contribu茅 脿 l'approbation de plus de 120 nouveaux m茅dicaments par la FDA. Notamment, 4 m茅dicaments sur 5 ayant utilis茅 le PBPK pour l'approbation de la FDA ces derni猫res ann茅es ont utilis茅 le Simulateur Simcyp.
Certara (Nasdaq: CERT) hat die Version 24 seines Simcyp鈩�-Simulators ver枚ffentlicht und damit seine physiologisch basierte pharmakokinetische (PBPK) Modellierungsplattform verbessert. Das Update umfasst bedeutende Verbesserungen in der Bio-Pharmazeutik, bei Arzneimittelwechselwirkungen und in den biologischen F盲higkeiten.
Wesentliche Neuerungen sind verbesserte Vorhersagen der Nahrungsmittelwirkungen im Modul zur virtuellen Bio盲quivalenz, erweiterte Bibliotheken f眉r Arzneimittelwechselwirkungen, verbesserte Modellierung von Biologika und verbesserte Unterst眉tzung bei der Studiengestaltung. Die Plattform bietet zudem eine modernisierte Benutzeroberfl盲che, Cloud-Computing-Funktionen und KI-gest眉tzte Assistenz.
Der Simcyp-Simulator, der von einem Konsortium von 眉ber 30 Pharmaunternehmen geleitet wird, hat zur Genehmigung von mehr als 120 neuartigen Arzneimitteln durch die FDA beigetragen. Bemerkenswerterweise haben 4 von 5 Arzneimitteln, die in den letzten Jahren PBPK f眉r die FDA-Zulassung verwendet haben, den Simcyp-Simulator genutzt.
- Dominant market position with 80% of recent FDA PBPK approvals using Simcyp
- Strong track record with contribution to over 120 FDA-approved drugs
- Collaboration with 30+ leading pharmaceutical companies
- Expansion of product capabilities including cloud computing and AI features
- None.
Insights
Certara's Simcyp Simulator V24 release represents a significant advancement in physiologically-based pharmacokinetic (PBPK) modeling capabilities that could strengthen the company's market position. PBPK modeling is increasingly critical in drug development as it allows companies to predict drug behavior in different tissues before conducting expensive clinical trials.
The validation statistic that 4 out of 5 drugs leveraging PBPK for FDA approval used Certara's simulator indicates dominant market share in this niche. This new version expands capabilities in three strategically important areas: biopharmaceutics, drug-drug interactions, and biologics modeling.
Most valuable are the enhancements to the Virtual Bioequivalence module for food effect predictions and expanded drug-drug interaction libraries. These directly address regulatory requirements that often delay drug approvals. The ability to potentially waive certain clinical trials through simulation represents substantial cost and time savings for pharmaceutical clients.
The consortium model with 30+ pharmaceutical companies provides Certara with both revenue stability and continuous feedback for product improvement, creating a powerful competitive moat. The integration of AI-enabled help features and cloud computing capabilities shows Certara is modernizing its platform infrastructure while maintaining its scientific expertise.
With over 120 FDA-approved drugs supported by their simulator, Certara has established itself as the standard in regulatory-grade PBPK modeling, a position this update further cements.
This product update strengthens Certara's position in its core business of model-informed drug development software. The Simcyp Simulator is clearly a flagship product with substantial market penetration, evidenced by its use in 4 of 5 drugs that leveraged PBPK modeling for FDA approval.
The announcement reveals multiple vectors for potential revenue growth. First, the expanded capabilities across biopharmaceutics, drug-drug interactions, and biologics modeling broaden the platform's applicability across more drug development programs. Second, the new cloud computing add-on suggests a potential shift toward SaaS-based revenue streams that could improve margins and predictability.
Certara's consortium approach with 30+ pharmaceutical companies creates a virtuous cycle: clients fund development, provide requirements, validate results, and become invested users. This model likely drives high customer retention rates while creating significant barriers to entry for competitors.
The enhanced capabilities for predicting food effects and simulating clinical trials directly target expensive pain points in drug development. Each clinical trial waiver secured through simulation represents millions in cost savings for clients, creating strong ROI justification for Certara's software.
While no specific financial projections are provided, this release represents an iterative strengthening of Certara's specialized market position rather than a transformative change. The continued regulatory acceptance of PBPK modeling creates a favorable long-term growth environment for this business segment.
Updates strengthen Certara鈥檚 position as a leader of PBPK modeling in drug development to advance regulatory decision-making
RADNOR, Pa., April 01, 2025 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, has released a new version of the for聽physiologically-based pharmacokinetic (PBPK) modeling. Simcyp PBPK models describe and predict the behavior of drugs in different body tissues. The latest version includes numerous advancements to further support data-driven decision-making at every stage of development.听听
鈥淲e鈥檙e advancing the Simcyp Simulator to address the evolving needs of our pharmaceutical collaborators and regulators,鈥� 聽, President, Certara Predictive Technologies said. 鈥淪imcyp Version 24 supports the growing adoption of PBPK in drug development and regulatory decision-making, as well as the broader applications of PBPK from discovery through clinical development.鈥�
A consortium of more than 30 leading pharmaceutical companies guides the development of the Simcyp Simulator. Version 24 incorporates their feedback, which enhances and expands existing capabilities and databases.聽 Masoud Jamei, Ph.D., Senior Vice President of Simcyp R&D at Certara added, 鈥淲e鈥檙e proud of the Simulator鈥檚 continuous advancement of innovative technology. Currently, 4 out of 5 drugs leveraging PBPK for FDA approval in recent years used the Simcyp Simulator.鈥�
Simcyp Simulator V24 features numerous updates, including:
- Biopharmaceutical capabilities and the Virtual Bioequivalence (VBE) module now include features for predicting food effects that improve the simulation of drug absorption under various meal conditions.
- Expanded library for drug-drug interactions (DDI): New and upgraded compound files for enzymes and transporters cover a broader range of DDI capabilities. These capabilities provide qualification evidence for transporter-mediated DDIs in the gut, liver, and kidney.
- More precise characterization of the behavior of membrane-bound targets across various tissues and plasma in biologics models. These include soluble target movement and drug-target complex dynamics throughout the body, and refinements to the target shedding model. Further, nonlinear protein and plasma binding, and target-mediated drug disposition are incorporated for small molecules.
- Expanded Trial Design support: Enhanced speed and ease of use for designing and simulating clinical trials.
- Special Populations modeling: Enhanced and expanded capabilities for pediatric, pregnancy, and lactation populations.
- Performance and Usability: Modernized UI, cloud computing add-on, 鈥楢sk Simcyp鈥� AI-enabled help chat, and chemical structure-based parameter predictors.
- Routes of Administration: Improved functionality for long-acting injectables, inhalation, and ocular routes.
The Simcyp Simulator has contributed to over 120 FDA-approved novel drugs. It has also supported clinical trial waivers in many areas, including DDI and pediatric trials.聽
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About Certara
Certara accelerates medicines using biosimulation software, technology, and services to transform traditional drug discovery and development. Its clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 66 countries. Learn more at certara.com.
Certara Contact:
Sheila Rocchio
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Media Contact:
Alyssa Horowitz
FAQ
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