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 将计算机建模与实验数据相结合，探索药物、生物系统和疾病过程之间的关系。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.
