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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.

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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.
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