Piet van der Graaf is Senior Vice President and Head of Quantitative Systems Pharmacology at Certara and Professor of Systems Pharmacology at Leiden University. From 2013-2016 he was the Director of Research of the Leiden Academic Centre for Drug Research. From 1999-2013 he held various leadership positions at Pfizer in Discovery Biology, Pharmacokinetics and Drug Metabolism and Clinical Pharmacology. He was the founding Editor-in-Chief of CPT: Pharmacometrics & Systems Pharmacology from 2012-2018 before becoming Editor-in-Chief of Clinical Pharmacology & Therapeutics. Piet received his doctorate training in clinical medicine with Nobel prize laureate Sir James Black at King’s College London. He has been awarded the 2024 Gary Neil Prize for Innovation in Drug Development from the American Society of Clinical Pharmacology and Therapeutics (ASCPT) and was the recipient of the 2021 Leadership Award from the International Society of Pharmacometrics (ISoP). Piet is an elected Fellow of the British Pharmacological Society and has published >200 articles in the area of quantitative pharmacology and 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.
Certara® describes the important role that quantitative systems pharmacology (QSP) can play in defining dosing criteria for first-in-human clinical trials
R&D World editors Paul Heney and Aimee Kalnoskas have their minds blown — multiple times! — in this episode, which delves into Certara’s Simcyp COVID-19 Vaccine Model, a 2021 R&D 100 Awards winner. Paul interviews Piet van der Graaf, Senior Vice President and Head of Quantitative Systems Pharmacology for Certara and learns about the genesis…
2024 was a transformational growth year for Quantitative Systems Pharmacology (QSP) modeling, and we’ll only see continued interest and investments in this technology in 2025. When I first started in the field, QSP was still an emerging discipline, but it has seen an exponential uptick in industry investment and regulatory support with QSP-based submissions to the U.S. FDA doubling every 1.4 years. Over the last decade, the biotech industry continued to move further toward a biology-informed paradigm and sought better methods to address the fact that 90% of new drugs do not make it from Phase 1 to approval. As part of this trend, the industry realized QSP has the potential to support model-informed drug development beyond the pre-clinical stage into clinical development and submission, allowing for better-informed decision making throughout the entire process. We’re also seeing new applications for QSP gain momentum, such as rare disease and pediatric drug development.