Certara's Simcyp® Simulator receives EMA qualification for regulatory submissions, enhancing drug interaction assessment efficiency in the EU.
Quiver AI Summary
Certara, Inc. has announced that the European Medicines Agency (EMA) has officially qualified its Simcyp® Simulator for use in regulatory submissions throughout the EU, marking a significant achievement as Certara becomes the first to receive such qualification for a physiologically-based pharmacokinetic (PBPK) modeling platform. This designation allows sponsors to use the Simcyp Simulator to assess drug-drug interaction (DDI) risks without having to re-establish its credibility for specific scenarios. The qualification opinion includes various contexts of use that cover multiple bioactive substances, thus reducing the necessity for extensive clinical studies. Certara's CEO, William F Feehery, highlighted the scientific value of biosimulation in drug development, while President Rob Asbury emphasized the growing importance of model-informed drug development in the industry. This qualification is expected to streamline the drug submission process, ultimately helping to expedite the delivery of innovative medicines to patients.
Potential Positives
- Certara is the first company to receive EMA qualification for a physiologically-based pharmacokinetic (PBPK) modeling platform, highlighting its leadership in the biosimulation industry.
- The Simcyp Simulator's qualification simplifies the regulatory submission process in the EU, allowing drug developers to assess drug-drug interaction (DDI) risks more efficiently without the need for additional credibility demonstrations.
- This qualification underscores the growing regulatory acceptance of model-informed drug development (MIDD), positioning Certara and its technology at the forefront of innovative drug development methodologies.
- The recognition by the EMA reinforces Certara's reputation for scientific leadership and innovation in the biopharmaceutical sector, potentially attracting more clients and partnerships.
Potential Negatives
- While the qualification from the EMA is a significant achievement, it may raise expectations for Certara to continuously innovate and maintain the high standards associated with this recognition, putting pressure on their future performance.
- The reliance on the Simcyp Simulator for drug-drug interaction assessments could introduce risks if any issues arise with the software, potentially leading to regulatory scrutiny or loss of credibility.
- The press release does not mention any competitive landscape or potential challenges from other companies that may also be advancing in biosimulation technologies, which could indicate Certara's vulnerability in an evolving market.
FAQ
What is the Simcyp® Simulator?
The Simcyp® Simulator is a biosimulation software platform used for drug development, particularly in assessing drug-drug interaction risks.
Why is the EMA qualification significant for Certara?
This qualification is significant as Certara becomes the first company to receive EMA approval for a PBPK modeling platform, enhancing their regulatory credibility.
How does the Simcyp Simulator impact drug submission processes?
The Simcyp Simulator streamlines the drug submission process by allowing sponsors to assess DDI risks without additional credibility checks.
What are the benefits of model-informed drug development (MIDD)?
MIDD uses mechanistic modeling to expedite decision-making, improve scientific insights, and accelerate the delivery of innovative medicines to patients.
How can one learn more about the Simcyp Simulator?
To learn more about the Simcyp Simulator and its role in MIDD strategies, visit www.certara.com/simcyp.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
RADNOR, Pa., Aug. 04, 2025 (GLOBE NEWSWIRE) -- Certara, Inc., a global leader in biosimulation, today announced that the European Medicines Agency (EMA) has formally qualified the Simcyp® Simulator for use in regulatory submissions across the EU. Certara is the first company to receive EMA qualification for a PBPK modeling platform, and Simcyp is the only software to hold this designation. The recognition follows a rigorous multi-year, collaborative engagement between Certara and the EMA.
With this qualification in place, sponsors can now use the Simcyp Simulator in regulatory submissions across the EU to assess drug-drug interaction (DDI) risk without needing to re-establish the platform’s credibility for the specified context of use (COU) scenarios. Simcyp has long been the leading biosimulation software used in submissions to the EU and other regulatory agencies, and this qualification makes the drug submission process easier and faster. “This first of its kind qualification by EMA regulators of a new approach methodology further demonstrates the scientific value biosimulation provides to drug development scientists,” said William F Feehery, Chief Executive Officer. “This milestone reflects the value of Certara’s scientific leadership, innovation, and technical expertise.”
Drug-drug interaction (DDI) studies typically involve the co-administration of two or more drugs, where one acts as a substrate and the other as a perpetrator. The qualification opinion covers various scenarios (3 COUs) where Simcyp simulations can replace clinical DDI studies using a range of verified substrates and perpetrators integrated within the platform. The COUs span 6 CYP enzymes and 2 inhibition mechanisms, thereby significantly reducing the number of clinical studies a sponsor has to conduct.
“We’re at an inflection point in drug development as the industry and regulators increasingly prioritize model-informed drug development (MIDD). This recognition and regulatory trust from the EMA further solidify the future we’ve been working towards for numerous years,” said Rob Asbury, President, Certara Predictive Technologies. “This is yet another exciting stepping stone as we continue to empower drug developers to utilize mechanistic modeling to speed decision making, further scientific insights, and bring innovative medicines to patients faster.”
To learn more about the Simcyp Simulator and how it supports MIDD strategies, visit www.certara.com/simcyp .
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 70 countries. Learn more at certara.com.
Certara contact:
Sheila Rocchio
[email protected]
Media contact:
Alyssa Horowitz
[email protected]
