Certara announces the release of Simcyp™ PBPK Simulator Version 22, expanding ability to simulate untested scenarios for new patient and therapeutic types

Rhea-AI Summary

Certara, Inc. (CERT) announced the launch of Simcyp Simulator Version 22, enhancing its capabilities for drug development. This advanced platform has been utilized to support over 300 label claims for more than 90 FDA-approved novel drugs, allowing for comprehensive analysis without human clinical trials. Key upgrades include enhanced subcutaneous dosing predictions, expanded compound libraries, and additional ethnic populations for improved therapeutic applications. Certara aims to facilitate faster medicine delivery through its continuing commitment to advanced biosimulation technologies.

Positive

• Enhanced drug development capabilities with Simcyp Simulator Version 22.
• Utilization for over 300 label claims and 90 FDA-approved drugs.
• Expansion of the compound library for better drug-drug interaction assessments.
• Improved predictions for subcutaneous dosing and special populations.

Negative

• None.

Simcyp Simulator has been utilized to inform more than 300 label claims for 90+ novel drugs in lieu of conducting clinical studies

PRINCETON, N.J., March 07, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced the release of Simcyp Simulator Version 22, which includes new capabilities and updated features to the Company’s population-based modeling and simulation platform. The Simcyp Simulator is the pharmaceutical industry’s most sophisticated physiologically based pharmacokinetics (PBPK) platform and is being applied to small and large molecule drug candidates. The Simcyp Simulator has proven use cases across drug development, including first-in-human dosing, extrapolation to special populations, bioequivalence testing, optimizing clinical study design and predicting drug-drug interactions (DDIs).

“We are excited to expand and improve upon the Simcyp Simulator capabilities to advance modern drug development with the launch of our latest version,” said Masoud Jamei, Ph. D, SVP of Simcyp R&D at Certara. “These novel capabilities address a wider set of scientific analyses by expanding the range of populations, compounds, therapeutic types, and drug delivery approaches.”

New capabilities in Version 22 include:

• Additional ethnic populations to reflect the diversity of patient types that would be prescribed new drugs
• Expansion of compound library allowing expedited assessment of DDIs for a wider variety of therapeutic compounds
• Enhancement of subcutaneous dosing capabilities to improve bioavailability predictions after sub-cutaneous dosing of large and small molecules
• Upgraded capabilities for simulating drugs PK during pregnancy, lactation, and pediatric for small and large molecule drugs
• Expanding and enhancing mechanistic modelling of kidney transporters, dermal absorption for new skin types, long acting injectables (LAI), excipients modelling and virtual bioequivalence, cross trials and species fitting, and mechanism-based inhibition (MBI) of metabolism.
  

Certara also unveiled Simcyp™ Designer, an intuitive environment for users to develop Pharmacodynamic (PD) and Quantitative Systems Pharmacology (QSP) models linked to Simcyp PBPK models. Simcyp Designer is available as an add-on module to the Simcyp simulator.

“Biosimulation, specifically PBPK continues to grow in regulatory adoption, as evidenced by the growth of guidance documents and drug approvals that depict its value. Certara’s Simcyp Simulator has been leveraged for more than 90 FDA-approved novel drugs, with >300 label claims using the Simulator in lieu of human clinical trials. Our commitment to continually enhancing the simulator is a commitment to accelerating medicines to patients who need them most,” said William F. Feehery, Ph.D., CEO of Certara.

For more information about the Simcyp PBPK Simulator and Simcyp Designer, please visit: https://www.certara.com/software/simcyp-pbpk/

About Certara

Certara accelerates medicines using proprietary biosimulation software, technology, and teams of pharmaceutical development experts with broad and complementary expertise to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries.

Investor Relations Contact:

David Deuchler
Gilmartin Group
ir@certara.com

Media Contact:

Daniel Yunger
Kekst CNC
daniel.yunger@kekstcnc.com

FAQ

What is Certara's Simcyp Simulator Version 22?

Simcyp Simulator Version 22 is an advanced biosimulation platform launched by Certara to enhance drug development by simulating pharmacokinetics for a diverse range of populations and therapeutic compounds.

How many FDA-approved novel drugs has Certara's Simcyp Simulator been used for?

Certara's Simcyp Simulator has been utilized for over 90 FDA-approved novel drugs.

What are the new features of Simcyp Simulator Version 22?

New features in Version 22 include enhanced dosing capabilities, expanded ethnic populations, and updated drug interaction assessments.

How does Simcyp Simulator impact drug development timelines?

Simcyp Simulator helps accelerate drug development by providing insights that reduce the need for extensive human clinical trials.