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Using Quantitative Systems Pharmacology Modelling to Accelerate Drug Development

Model informed drug development (in silico modelling) continues to be a game changer in accelerating drug development. Quantitative Systems Pharmacology (QSP) is one such technology, which employs virtual patients in virtual clinical trials, allowing more approaches to be investigated than would be possible in the real world. Examples described here demonstrate the impact on some … Continued

Mind-blowing applications of QSP in drug development: Part 2

Part 2 of this blog series dives further into the June 2022 podcast with R&D World editors, Paul Heney and Aimee Kalnoskas, having their minds blown — multiple times! — which explores Certara’s Simcyp COVID-19 Vaccine Model, a 2021 R&D 100 Awards winner, revealing the genesis of the model, as well as some stunning possible … Continued

Mind-blowing applications of QSP in drug development: Part 1

R&D World editors, Paul Heney and Aimee Kalnoskas, have their minds blown — multiple times! — in this June 2022 Podcast, which delves into Certara’s Simcyp COVID-19 Vaccine Model, a 2021 R&D 100 Awards winner… about the genesis of the model, as well as some stunning possible future uses for it. Developed within a few … Continued

Leveraging Biosimulation to Inform Optimal Use of COVID-19 Vaccines

Being a team of results-oriented scientists working to address the medical challenges of an unprecedented pandemic has fueled Certara’s propensity for innovation. Since the early days of COVID-19, we have been working alongside pharmaceutical companies, global health foundations, academia, and regulators to advance therapies and vaccines. Key to our work has been building upon our … Continued

Managing Immunogenicity Using Quantitative Systems Pharmacology

The Challenge of Immunogenicity in Biologics Drug Development Biologic drug development is a rapidly evolving sector in the biopharmaceutical industry. Biologically-based therapeutic drugs comprise monoclonal antibodies (MAbs), vaccines, recombinant hormones and proteins, antibody-drug conjugates, RNAi, antisense, blood factors, and other large molecules. Although the success of biologics has been demonstrated, there are inherent operational and … Continued

Immunogenicity Prediction and Dose Optimization using Clinically-Validated In Silico Modeling and Simulation

Biologic drug development is a rapidly evolving sector in the biopharmaceutical industry. Immunogenicity is an inherent challenge with this complex class of drugs. A quantitative systems pharmacology approach can be used to predict and better manage immunogenicity, and as a tool to guide clinical and regulatory decision-making in biologics drug development.

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