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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 months of the pandemic, Certara leveraged its multi-year work with a group of leading pharma companies developing its Immunogenicity Simulator (IG) to address this global health challenge. By flipping the concept of simulating unwanted IG adverse events to amplifying desired vaccine effects, we were able to simulate the impacts of dosing intervals, age, and ethnicity related dosing and other critical steps to accelerating COVID-19 vaccines using Quantitative Systems Pharmacology (QSP) —virtual patients in virtual trials (listen to the podcast here).

What is QSP?

Only about 10 years old, QSP has already demonstrated its vast potential to improve biopharmaceutical R&D and inform decision-making across drug development. QSP combines computational modeling and experimental data to examine the relationships between a drug, the biological system, and the disease process. With the ability to leverage big data (biological and pharmacological), it enables the understanding of disease pathophysiology and identification and testing of therapeutic strategies in virtual trials with virtual patients. QSP improves confidence in both the compound and the target.

The Big 3 for QSP: IG, IO, NDD

  • Immunogenicity (IG): IG is a multi-factorial challenge in biologics, with ~90% incidence rate, half of which can impact efficacy. To address this issue, Certara has developed a simulator, in partnership with eight leading pharmaceutical companies. The IG Simulator now licensed by the US FDA to assess, predict, and manage the IG of a wide range of biologics, including monoclonal antibodies, bi-and multi-specifics, complex proteins, cell, and gene therapies. Recently, together with Certara, Roche presented an evaluation of the IG Simulator with clinical data from 10 of their projects, which has provided invaluable insights that are being implemented into the next version.
  • Immuno-oncology (IO): From a logistics and ethical perspective, the vast number of possible IO combination targets, therapies, and dosing regimens is impossible to assess via clinical studies alone. Certara’s IO Simulator enables researchers to assess combination therapies (including IO, chemotherapy, and radiotherapy), 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. To learn more, read this paper published in Clinical Pharmacology & Therapeutics on using QSP for IO.
  • Neurodegenerative Disease Development (NDD): NDDs are complex and usually involve dysregulation in multiple biochemical pathways. Understanding the disease and potential treatments requires the combination of genetics, expression and mRNA, cell diversity, cellular networks, brain networks and science networks into one comprehensive QSP model. Further, as NDD and neuroinflammation are intrinsically linked, our team is focused on markers of inflammation in the brain and the gut, including cytokines as potential causes of Alzheimer’s Disease, Parkinson’s Disease, and Multiple Sclerosis. For more info, check out the keynote presentation I delivered at the Neurodegenerative Drug Development Summit.

QSP at Certara is always ready to take the next R&D step and continue to blow minds.

Part 2 of this blog will cover the mind-blowing work being done in the areas of novel modalities and therapeutic approaches.

About the author

Piet van der Graaf, PharmD, PhD
By: Piet van der Graaf, PharmD, PhD

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.