Certara Achieves Historic EMA Qualification for Simcyp® Simulator
Certara Achieves a Milestone in Regulatory Qualifications
Certara, Inc., a pioneering leader in biosimulation technology, has reached an exceptional milestone with its Simcyp® Simulator, having received formal qualification from the European Medicines Agency (EMA). This recognition marks Certara as the first company to obtain EMA qualification for a physiologically-based pharmacokinetic (PBPK) modeling platform. The achievement highlights the rigorous collaboration between Certara and EMA over a multi-year period.
Transforming Drug Development with Simcyp Simulator
The qualification of the Simcyp Simulator is a significant advancement for sponsors aiming to enhance their regulatory submissions across Europe. With this esteemed validation, drug developers can leverage the Simcyp Simulator to assess drug-drug interaction (DDI) risks without needing to repeatedly establish the credibility of the platform for defined use cases. Recognized as a frontrunner in biosimulation, Simcyp now simplifies and expedites the drug submission process.
Impact on Drug-Drug Interaction Studies
DDI studies are crucial in evaluating the safety and efficacy of drug combinations, where one drug may influence the metabolism of another. The newly qualified opinion encompasses three specific use scenarios where the simulations provided by Simcyp can effectively replace the need for clinical DDI studies. This capability covers six cytochrome P450 (CYP) enzymes and two types of inhibition mechanisms, considerably alleviating the burden of conducting extensive clinical trials.
Industry Perspective on Model-Informed Drug Development
As drug development evolves, there is a clear trend towards model-informed drug development (MIDD). Certara's President of Predictive Technologies, Rob Asbury, states that this validation by EMA reinforces the trust and opportunities that have been built over many years. This is a pivotal moment as Certara continues to empower drug developers with advanced modeling techniques to enhance decision-making processes, leading to faster delivery of innovative medicines to patients.
The Vision of Certara
At its core, Certara is dedicated to accelerating the journey of medicines through the intelligent application of biosimulation. Their tools and technologies are transforming the traditional landscape of drug discovery and development. With a broad client base, spanning over 2,400 biopharmaceutical companies, academic institutions, and regulatory bodies in 70 countries, Certara is spearheading a new era in pharmaceutical innovation.
Contact Information for Certara
For inquiries regarding Certara and its innovative solutions, you may reach out to Sheila Rocchio via email at sheila.rocchio@certara.com. For media-related queries, Alyssa Horowitz can be contacted at certara@pancomm.com.
Frequently Asked Questions
What does the EMA qualification mean for the Simcyp® Simulator?
The EMA qualification allows the Simcyp® Simulator to be used in regulatory submissions without the need for additional validation in specified contexts.
How does Simcyp Simulator impact DDI testing?
Simcyp Simulator can replace clinical DDI studies in certain scenarios, significantly easing the burden of drug testing for sponsors.
What is model-informed drug development (MIDD)?
MIDD is an approach that uses modeling and simulation to inform and optimize drug development processes.
What is the role of Certara in the pharmaceutical industry?
Certara accelerates drug development through biosimulation software and technology, aiding clients worldwide in navigating regulatory landscapes.
How can I learn more about Certara's offerings?
For more information, visit Certara's official website to explore their innovative solutions and services.
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