Certara Expands the Simcyp™ Simulator Platform Advancing Biopharmaceutics, Drug-Drug Interaction & Biologic Capabilities
Certara (Nasdaq: CERT) has released Version 24 of its Simcyp™ 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™, migliorando la sua piattaforma di modellazione farmacocinetica basata sulla fisiologia (PBPK). L'aggiornamento include miglioramenti significativi in biopharmaceutica, interazioni farmaco-farmaco e capacità relative ai biologici.
Tra le principali novità 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, capacità 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. È 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 Versión 24 de su Simulador Simcyp™, mejorando su plataforma de modelado farmacocinético basado en fisiología (PBPK). La actualización incluye mejoras significativas en biofarmacéutica, interacciones entre fármacos y capacidades de biológicos.
Las actualizaciones clave incluyen predicciones mejoradas del efecto de los alimentos en el módulo de Bioequivalencia Virtual, bibliotecas ampliadas de interacciones entre fármacos, modelado mejorado de biológicos y un soporte mejorado para el diseño de ensayos. La plataforma también cuenta con una interfaz de usuario modernizada, capacidades de computación en la nube y asistencia habilitada por IA.
El Simulador Simcyp, guiado por un consorcio de más de 30 compañías farmacéuticas, ha contribuido a más de 120 nuevos medicamentos aprobados por la FDA. Notablemente, 4 de cada 5 medicamentos que utilizaron PBPK para la aprobación de la FDA en los últimos años utilizaron el Simulador Simcyp.
Certara (Nasdaq: CERT)는 생리학 기반 약물동태학(PBPK) 모델링 플랫폼을 개선한 Simcyp™ 시뮬레이터의 24버전을 출시했습니다. 이번 업데이트는 약물 생물학, 약물 간 상호작용 및 생물학적 제제의 기능에서 중요한 개선 사항을 포함합니다.
주요 업데이트에는 가상 생물학적 동등성 모듈에서 음식 효과 예측 개선, 확장된 약물 간 상호작용 라이브러리, 향상된 생물학적 제제 모델링 및 임상 시험 설계 지원 강화가 포함됩니다. 이 플랫폼은 또한 현대화된 UI, 클라우드 컴퓨팅 기능 및 AI 지원을 제공합니다.
30개 이상의 제약 회사로 구성된 컨소시엄에 의해 안내되는 Simcyp 시뮬레이터는 FDA에서 승인한 120개 이상의 신약에 기여했습니다. 특히, 최근 몇 년 동안 FDA 승인을 위해 PBPK를 사용한 약물 5개 중 4개가 Simcyp 시뮬레이터를 활용했습니다.
Certara (Nasdaq: CERT) a lancé la Version 24 de son Simulateur Simcyp™, améliorant ainsi sa plateforme de modélisation pharmacocinétique basée sur la physiologie (PBPK). La mise à jour comprend des améliorations significatives en bio-pharmaceutique, en interactions médicamenteuses et en capacités biologiques.
Les mises à jour clés incluent des prévisions améliorées des effets alimentaires dans le module d'équivalence biologique virtuelle, des bibliothèques élargies d'interactions médicamenteuses, une modélisation améliorée des biologiques et un soutien renforcé pour la conception des essais. La plateforme dispose également d'une interface utilisateur modernisée, de capacités de cloud computing et d'une assistance alimentée par l'IA.
Le Simulateur Simcyp, guidé par un consortium de plus de 30 entreprises pharmaceutiques, a contribué à l'approbation de plus de 120 nouveaux médicaments par la FDA. Notamment, 4 médicaments sur 5 ayant utilisé le PBPK pour l'approbation de la FDA ces dernières années ont utilisé le Simulateur Simcyp.
Certara (Nasdaq: CERT) hat die Version 24 seines Simcyp™-Simulators veröffentlicht und damit seine physiologisch basierte pharmakokinetische (PBPK) Modellierungsplattform verbessert. Das Update umfasst bedeutende Verbesserungen in der Bio-Pharmazeutik, bei Arzneimittelwechselwirkungen und in den biologischen Fähigkeiten.
Wesentliche Neuerungen sind verbesserte Vorhersagen der Nahrungsmittelwirkungen im Modul zur virtuellen Bioäquivalenz, erweiterte Bibliotheken für Arzneimittelwechselwirkungen, verbesserte Modellierung von Biologika und verbesserte Unterstützung bei der Studiengestaltung. Die Plattform bietet zudem eine modernisierte Benutzeroberfläche, Cloud-Computing-Funktionen und KI-gestützte Assistenz.
Der Simcyp-Simulator, der von einem Konsortium von über 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 für 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’s 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 Simcyp™ Simulator for 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.
“We’re advancing the Simcyp Simulator to address the evolving needs of our pharmaceutical collaborators and regulators,” Rob Aspbury, President, Certara Predictive Technologies said. “Simcyp 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.”
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. Masoud Jamei, Ph.D., Senior Vice President of Simcyp R&D at Certara added, “We’re proud of the Simulator’s continuous advancement of innovative technology. Currently, 4 out of 5 drugs leveraging PBPK for FDA approval in recent years used the Simcyp Simulator.”
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, ‘Ask Simcyp’ 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.
For more insights on the latest developments, register for the Simcyp V24 release webinar.
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
sheila.rocchio@certara.com
Media Contact:
Alyssa Horowitz
certara@pancomm.com
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