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Certara Launches Phoenix™ Version 8.5 Drug Development Software

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Certara (Nasdaq: CERT) has launched Phoenix™ version 8.5, an upgraded drug development software used by top pharmaceutical companies and regulatory agencies worldwide. This release aims to improve the efficiency, quality, and speed of pharmacokinetic/pharmacodynamic (PK/PD) workflows. Key features include:

1. Sign-in via Certara Cloud for simplified license management and enhanced access control
2. Reporting enhancements for better data presentation and analysis
3. NLME improvements for more precise modeling and interpretation

Phoenix 8.5 was developed based on customer feedback to streamline drug development processes and potentially reduce the high failure rate of new medicines in clinical trials. The software is available as a hosted solution for improved performance and cost-effectiveness.

Certara (Nasdaq: CERT) ha lanciato Phoenix™ versione 8.5, un software avanzato per lo sviluppo di farmaci utilizzato dalle principali aziende farmaceutiche e agenzie regolatorie in tutto il mondo. Questa versione mira a migliorare l'efficienza, la qualità e la velocità dei flussi di lavoro farmacocinetici/farmacodinamici (PK/PD). Le funzionalità principali includono:

1. Accesso tramite Certara Cloud per una gestione semplificata delle licenze e un controllo degli accessi migliorato
2. Miglioramenti nei report per una migliore presentazione e analisi dei dati
3. Miglioramenti nel NLME per una modellazione e interpretazione più precise

Phoenix 8.5 è stato sviluppato sulla base del feedback dei clienti per semplificare i processi di sviluppo dei farmaci e potenzialmente ridurre l'alto tasso di fallimento dei nuovi medicinali nei trial clinici. Il software è disponibile come soluzione ospitata per migliorare le prestazioni e l'efficacia dei costi.

Certara (Nasdaq: CERT) ha lanzado la versión 8.5 de Phoenix™, un software de desarrollo farmacéutico avanzado utilizado por las principales empresas farmacéuticas y agencias regulatorias a nivel mundial. Esta versión tiene como objetivo mejorar la eficiencia, calidad y velocidad de los flujos de trabajo de farmacocinética/farmacodinámica (PK/PD). Las características clave incluyen:

1. Acceso a través de Certara Cloud para una gestión de licencias simplificada y un control de acceso mejorado
2. Mejoras en los informes para una mejor presentación y análisis de datos
3. Mejoras en NLME para una modelación e interpretación más precisas

Phoenix 8.5 se desarrolló en base a los comentarios de los clientes para agilizar los procesos de desarrollo de medicamentos y potencialmente reducir la alta tasa de fracaso de nuevos medicamentos en ensayos clínicos. El software está disponible como una solución alojada para mejorar el rendimiento y la rentabilidad.

Certara(Nasdaq: CERT)는 세계적인 제약 회사 및 규제 기관에서 사용되는 약물 개발 소프트웨어 Phoenix™ 버전 8.5를 출시했습니다. 이번 릴리스는 약리학적 동태( pharmacokinetic)/약리학적 동작( pharmacodynamic) 작업 흐름의 효율성, 품질 및 속도를 개선하는 것을 목표로 합니다. 주요 기능은 다음과 같습니다:

1. 라이센스 관리를 간소화하고 접근 제어를 향상시키기 위해 Certara Cloud를 통한 로그인
2. 데이터 프레젠테이션 및 분석 개선을 위한 보고 기능 개선
3. 보다 정확한 모델링 및 해석을 위한 NLME 개선

Phoenix 8.5는 고객 피드백을 바탕으로 약물 개발 프로세스를 간소화하고 임상 시험에서 신약의 높은 실패율을 잠재적으로 줄일 수 있도록 개발되었습니다. 이 소프트웨어는 성능과 비용 효율성을 개선하기 위해 호스팅 솔루션으로 제공됩니다.

Certara (Nasdaq: CERT) a lancé la version 8.5 de Phoenix™, un logiciel avancé de développement de médicaments utilisé par les principales entreprises pharmaceutiques et agences réglementaires du monde entier. Cette version vise à améliorer l'efficacité, la qualité et la rapidité des flux de travail pharmacocinétiques/pharmacodynamiques (PK/PD). Les caractéristiques clés incluent :

1. Connexion via Certara Cloud pour une gestion simplifiée des licences et un meilleur contrôle d'accès
2. Améliorations des rapports pour une meilleure présentation et analyse des données
3. Améliorations du NLME pour un modélisation et une interprétation plus précises

Phoenix 8.5 a été développé sur la base des retours clients pour rationaliser les processus de développement des médicaments et potentiellement réduire le taux d'échec élevé des nouveaux médicaments dans les essais cliniques. Le logiciel est disponible sous forme de solution hébergée pour améliorer les performances et la rentabilité.

Certara (Nasdaq: CERT) hat die Phoenix™ Version 8.5, eine verbesserte Software für die Arzneimittelentwicklung, die von führenden Pharmaunternehmen und Regulierungsbehörden weltweit eingesetzt wird, auf den Markt gebracht. Dieses Release zielt darauf ab, die Effizienz, Qualität und Geschwindigkeit der pharmakokinetischen/pharmakodynamischen (PK/PD) Arbeitsabläufe zu verbessern. Zu den wichtigsten Funktionen gehören:

1. Anmeldung über Certara Cloud für eine vereinfachte Lizenzverwaltung und besseren Zugriffsschutz
2. Verbesserungen der Berichterstattung für eine bessere Datenpräsentation und Analyse
3. NLME-Verbesserungen für genauere Modellierung und Interpretation

Phoenix 8.5 wurde auf der Grundlage von Kundenfeedback entwickelt, um die Arzneimittelentwicklungsprozesse zu optimieren und möglicherweise die hohe Ausfallrate neuer Medikamente in klinischen Studien zu reduzieren. Die Software ist als gehostete Lösung verfügbar, um die Leistung und Rentabilität zu verbessern.

Positive
  • Launch of Phoenix™ version 8.5, enhancing PK/PD modeling and simulation capabilities
  • Used by 75 of the top 100 pharmaceutical companies worldwide
  • Adopted by 11 regulatory agencies, including U.S. FDA, Japan PMDA, and China NMPA
  • New features improve efficiency, quality, and speed of PK/PD workflows
  • Simplified license management and enhanced access control through Certara Cloud sign-in
Negative
  • None.

Insights

The launch of Phoenix™ version 8.5 by Certara represents a significant advancement in drug development software. The new features, including Single Sign-On and centralized authentication, address key IT concerns in the pharmaceutical industry. These improvements will likely enhance security and streamline user management, potentially reducing IT overhead costs for Certara's clients.

The reporting enhancements and NLME improvements are particularly noteworthy. These upgrades could significantly accelerate the drug development process by allowing for more efficient data analysis and interpretation. This could potentially lead to faster time-to-market for new drugs, which is important in the pharmaceutical industry where time is often of the essence.

However, the true impact of these improvements will depend on user adoption and the software's performance in real-world scenarios. It's also worth noting that while these updates are valuable, they are incremental rather than revolutionary, which is typical for established software platforms.

Certara's Phoenix™ software update is a notable development in the pharmaceutical industry's drug development toolkit. With 88% of new medicines failing in clinical trials, any improvement in the efficiency and accuracy of PK/PD modeling could have substantial impacts on drug development success rates and costs.

The software's adoption by 75% of top 100 pharmaceutical companies and 11 regulatory agencies underscores its importance in the industry. This widespread use suggests that improvements to Phoenix could have far-reaching effects on global drug development processes.

However, it's important to note that while software improvements can enhance efficiency, they don't directly address the fundamental challenges of drug discovery and development, such as biological complexity and regulatory hurdles. Investors should view this update as a positive step for Certara, potentially strengthening its market position, but not as a game-changer for the industry's overall success rates.

RADNOR, Pa., Aug. 15, 2024 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announced the launch of Phoenix™ version 8.5. Phoenix is the pharmaceutical industry's gold standard in pharmacokinetic/pharmacodynamic (PK/PD) and toxicokinetic modeling and simulation software. The Phoenix Platform is used by more than 75 of the top 100 pharmaceutical companies worldwide. Eleven regulatory agencies, including the U.S. FDA, Japan PMDA, and China NMPA, rely on Phoenix to evaluate life-saving drug candidates. Version 8.5 is the latest release from Certara’s Phoenix Platform, available as a hosted solution for maximum performance and lower total cost of ownership.

Today, 88% of new medicines that enter clinical trials fail, indicating a need for improved processes. Certara’s Phoenix platform expedites everything from data preparation to report generation – a time-consuming process that drug developers rely on.

“Certara develops software solutions that transform research data into trustworthy insights for scientists and regulators with the goal of bringing new medicines to market faster,” said Max Kanevsky, Chief Technology Officer at Certara. “The latest version of Phoenix includes new capabilities requested by existing clients and their IT business partners that streamline the comprehensive PK/PD data workflow.”

Version 8.5 delivers new features driven by customer demand. These features improve the efficiency, quality, and speed of PK/PD workflows within Phoenix.

  • Sign-in via Certara Cloud - Phoenix 8.5 introduces user sign-in via Certara Central Admin, offering Single Sign-On and centralized authentication. This simplifies license management, streamlines assignments, enhances access control, and improves the user experience by providing easier access to resources, training and support.
  • Reporting Enhancements for Tables, Plotting, Reporting: Updates are designed to offer increased customization and efficiency in data presentation in tables and plots, along with advancing capabilities for visual data analysis. These improvements aim to streamline the reporting process and enable more detailed and readily interpretable reports.
  • NLME (Non-linear mixed effects) Enhancements: Phoenix NLME is a population modeling and simulation software solution for scientists with varying levels of experience—from novice PK/PD scientists to the most advanced modelers. The 8.5 update improves the precision of modeling, increases the adaptability for users, and provides tools to enhance the interpretability of models.

Developed with feedback from clients that participate in the Phoenix customer advisory board and user group communities, Phoenix 8.5 will improve users' access and experience, allowing for more effective analysis, interpretation, and visualization of data. To learn more, visit https://www.certara.com/software/phoenix-pkpd/.

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


FAQ

What new features does Phoenix™ version 8.5 offer for Certara (CERT) users?

Phoenix™ version 8.5 offers sign-in via Certara Cloud for simplified license management, reporting enhancements for better data presentation, and NLME improvements for more precise modeling and interpretation. These features aim to improve the efficiency, quality, and speed of PK/PD workflows.

How widely is Certara's (CERT) Phoenix software used in the pharmaceutical industry?

Certara's Phoenix software is used by more than 75 of the top 100 pharmaceutical companies worldwide. Additionally, 11 regulatory agencies, including the U.S. FDA, Japan PMDA, and China NMPA, rely on Phoenix to evaluate drug candidates.

What problem in drug development is Certara (CERT) addressing with Phoenix 8.5?

Certara is addressing the high failure rate of new medicines in clinical trials, which currently stands at 88%. Phoenix 8.5 aims to expedite and improve various processes from data preparation to report generation, potentially increasing the success rate of drug candidates.

How does Certara (CERT) incorporate customer feedback into Phoenix 8.5?

Certara developed Phoenix 8.5 based on feedback from clients participating in the Phoenix customer advisory board and user group communities. This approach ensures that the software improvements align with user needs and enhance their experience in data analysis, interpretation, and visualization.

Certara, Inc.

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