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

Piet van der Graaf and Andrzej Kierzek

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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Topics: Systems Pharmacology

Managing Immunogenicity Using Quantitative Systems Pharmacology

Piet van der Graaf

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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Topics: PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Systems Pharmacology

A Six-stage Workflow for Robust Application of Systems Pharmacology

Quantitative and systems pharmacology (QSP) is increasingly being applied in pharmaceutical research and development. One factor critical to the ultimate success of QSP is the establishment of commonly accepted language, technical criteria, and workflows. We propose an integrated workflow that bridges conceptual objectives with underlying technical detail to support the execution, communication, and evaluation of […]

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Quantitative Systems Pharmacology Brings Value to Drug Development

Quantitative systems pharmacology (QSP) sits at the interface between pharmacometric modeling and simulation, and systems biology. It uses mathematics to describe biological processes. While pharmacokinetics describes what the body does to the drug, pharmacodynamics quantifies what the drug does to the body; the pharmacological response. QSP is a mechanistic modeling approach and an emerging technology, which mathematically integrates pharmacokinetics, pharmacological response and disease progress/modulation.

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