Certara Releases Simcyp™ PBPK Simulator Version 20, Including Newly Expanded Biologics Software

Rhea-AI Summary

Certara, a leader in biosimulation, announced the launch of version 20 of its Simcyp™ Physiologically-based Pharmacokinetic (PBPK) Simulator. This version includes new models for maternal health, virtual bioequivalence, and long-acting injectable drugs. The simulator has informed the FDA approval of over 75 drugs, enhancing clinical trial efficiency. The expanded Simcyp Biologics Simulator aids in predicting pharmacokinetics for biologic drugs, crucial for their development. This software is pivotal for optimizing drug safety and efficacy in a vibrant biopharmaceutical R&D landscape.

Positive

• Launch of version 20 of Simcyp PBPK Simulator enhances drug development efficiency.
• Introduces models for maternal health, virtual bioequivalence, and long-acting injectables.
• Has informed FDA approval for over 75 drugs, reducing reliance on human trials.
• Expanded Biologics Simulator provides critical PK predictions for complex biologics.

Negative

• None.

Certara, Inc., the global leader in biosimulation, today announced the release of version 20 of its Simcyp™ Physiologically-based Pharmacokinetic (PBPK) Simulator platform. Simcyp PBPK Simulator version 20 provides new models for maternal health, virtual bioequivalence to attain biowaivers, and analysis of long-acting injectable drugs. It also delivers a newly expanded biologics module, Simcyp Biologics Simulator, that enables scientists to model a wider range of biologic modalities to accelerate drug development.

Certara’s industry-leading Simcyp PBPK Simulator improves clinical trial efficiency and outcomes through the modeling and simulation of pharmacokinetics (PK) and pharmacodynamics (PD) using virtual patient populations. The Simcyp PBPK Simulator’s in silico models have informed the label claims of more than 75 novel FDA-approved drugs, reducing the need to conduct human clinical studies. This mechanistic modeling approach, developed over the past 20 years, is well established in predicting the PK of small molecules and is now increasingly being applied to biologic drug development.

Simcyp PBPK Simulator version 20 offers new and enhanced models for maternal health, such as assessing drug performance during pregnancy and lactation. It also automates the assessment of virtual bioequivalence to attain biowaivers and analyzes drugs delivered via long-acting injectable delivery. Additional upgrades have been made to the Simcyp PBPK Simulator’s animal, liver, absorption, and skin models.

“We are thrilled to offer new capabilities that accelerate modern drug development with the launch of our latest Simcyp Simulator,” said William F. Feehery, Ph.D., chief executive officer of Certara. “Our Simcyp team, working with the world’s most innovative biopharmaceutical companies, has expanded the applicability of PBPK modeling and simulation to advance small molecules and biologics in key therapeutic areas such as oncology, autoimmune diseases, and rare diseases.”

The expanded Simcyp Biologics Simulator delivers first-in-human PK prediction and dose selection, target selection and validation by linking PK to pharmacology, tumor penetration of proteins, target shedding, and the impact on tumor receptor occupancy. Pharmacokinetic properties of biologics are structurally complex, requiring specific mechanistic models to explore potential clinical complexities before human testing. Simcyp Biologics Simulator is also available as a standalone software.

“The information and conclusions generated by Simcyp Biologics Simulator will support mission critical decisions as customers look to optimize a biologic drug’s safety and efficacy profile,” said Masoud Jamei, Ph.D., senior vice president of research and development of Certara’s Simcyp division. “To support these advanced medicines, which comprise 40% of the global biopharmaceutical R&D pipeline, Certara has broadened access to Simcyp Biologics Simulator by offering it as a standalone software.”

For more information, please visit: https://www.certara.com/software/simcyp-pbpk/.

About Certara

Certara accelerates medicines to patients using proprietary biosimulation software and technology to transform traditional drug discovery and development. Its clients include 1,600 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210127005301/en/

FAQ

What new features are included in Certara's Simcyp PBPK Simulator version 20?

The new features include models for maternal health, virtual bioequivalence, and long-acting injectable drugs.

How does the Simcyp PBPK Simulator improve clinical trial outcomes?

It enhances clinical trial outcomes by modeling pharmacokinetics using virtual patient populations and has informed FDA approvals for over 75 drugs.

What is the significance of the expanded Simcyp Biologics Simulator?

The expanded Biologics Simulator aids in predicting pharmacokinetics for biologic drugs, crucial for their development and optimizing safety and efficacy.

Which companies benefit from Certara's Simcyp Simulator?

The Simcyp Simulator is utilized by biopharmaceutical companies, academic institutions, and regulatory agencies worldwide.

What percentage of the global biopharmaceutical R&D pipeline does Certara's Simcyp Simulator support?

Certara's Simcyp Simulator supports advanced medicines that comprise 40% of the global biopharmaceutical R&D pipeline.