Certara Announces New Versions of Biosimulation Software for Development of Novel Biologics
“The latest versions of our simulators help tackle some of the toughest challenges in drug discovery and development with complex biologics,” said
The simulators are based on quantitative systems pharmacology (QSP), which combines computational modeling and experimental data to examine the relationships between a drug, the biological system, and the disease process. Researchers use the Simulators to create virtual patients, conduct computer-based trials and predict how drugs work in patients, before testing investigational drugs in clinical trials.
“Our continued innovation in QSP expands use cases of biosimulation and grows adoption by regulators and the pharmaceutical industry,“ said
Developed in partnership with eight leading pharmaceutical companies, Certara’s IG Simulator is used to assess, predict and manage the immunogenicity of a wide range of biologic therapies in development. The latest version (Version 5.0) allows for the evaluation of many different types of biologics, including monoclonal antibodies, bi-and multi-specifics, complex proteins, cell, and gene therapies. Earlier this year, the
Certara’s IO Simulator uses virtual patients to determine the optimal combination of different cancer therapies and dosing regimens. The latest version of the IO Simulator (Version 4.0) expands the number of targets in blood cancers and solid tumors to include 20 different cell types, such as cytotoxic, helper, regulatory T-cells and B-cells, and 10 immunomodulatory cytokine targets. The IO Simulator enables researchers to assess combination therapies, design trials, select patients, and link dosing regimens to biomarkers, which aligns well with Project Optimus, the FDA’s initiative to reform the dose optimization and dose selection paradigm in oncology drug development.
Certara’s Vaccine Simulator answers ‘what-if’ scenarios to determine the best vaccine dosing strategies for various patient populations, including children and the elderly. Version 1.0 of the Vaccine Simulator incorporates a novel lipid nanoparticle administration module and is being used to support the development of next-generation mRNA vaccines and gene therapies. Findings from the Vaccine Simulator have been published and discussed in leading scientific journals, including Nature.
For more information about Certara’s Simulators, please visit:
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