The Certara Blog: Systems Pharmacology

Optimize Immuno-oncology Drug Discovery and Development Using Quantitative Systems Pharmacology

Immuno-oncology – The Breakthrough in Cancer Therapeutics Cancer immuno-oncology (IO) uses the body’s natural defenses to combat cancer. These therapies stimulate an individual’s immune system and restore its ability to identify and destroy cancer cells. Anti-cancer immune responses are often inhibited during the spread of cancer. Ultimately, IO therapy expedites long term responses against cancer […]

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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 […]

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FDA Reauthorization Act (FDARA) Affirms Commitment to Innovative MIDD Strategies

FDA Reauthorization Act (FDARA) Affirms Commitment to Innovative MIDD Strategies

Quietly, without any political rancor, the FDA Reauthorization Act of 2017 (FDARA) was passed by the US Congress and was signed into law by President Trump in late August. The FDARA reauthorizes the Prescription Drug User Act Fee Amendments (PDUFA) for the fifth time, the Medical Device User Act Fee Amendments (MDUFA) for the third […]

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7 Savvy Ways to Reduce Quantitative Systems Pharmacology Models

7 Savvy Ways to Reduce Quantitative Systems Pharmacology Models

Modeling and simulation has become an indispensable part of drug development. Historically, the type of modeling employed changes as a drug moves through the stages of drug development—from discovery to pre-clinical testing to clinical trials. At the early stages of drug discovery, we may use systems biology models to identify drug targets and possible compounds, […]

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Taming Complex Quantitative Systems Pharmacology Models with Model Reduction

Taming Complex Quantitative Systems Pharmacology Models with Model Reduction

Quantitative systems pharmacology (QSP) combines computational modeling and experimental data to examine the relationships between a drug, the biological system, and the disease process. This emerging discipline integrates quantitative drug data with knowledge of its mechanism of action. QSP models predict how drugs modify cellular networks in space and time and how they impact and […]

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Quantitative Systems Toxicology—Taking the Cue from Aristotle

Quantitative Systems Toxicology—Taking the Cue from Aristotle

“The whole is greater than the sum of its parts” -Aristotle This quote from the great 4th century BCE Greek philosopher and scientist has become the mantra for many endeavors, sectors, organizations, and disciplines. From biology, chemistry, and physics to agriculture, engineering, and business, it is the foundation for synergy. What is the connection between […]

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Using Model Reduction to Bridge the QSP-Pharmacometrics Divide

Using Model Reduction to Bridge the QSP-Pharmacometrics Divide

Quantitative systems pharmacology (QSP) models are generally too large to be validated or fit in a traditional sense and they can become intractable to standard methods of analysis or even to the modeler’s own intuition. Model reduction can alleviate these issues of complexity by eliminating portions of a system that have minimal effect upon the […]

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