Quantitative Systems Pharmacology (QSP) consulting
When the clinical or in-vivo data isn’t enough to support your drug development decisions, Quantitative Systems Pharmacology (QSP) integrates data and knowledge about the drug, target and disease mechanisms that underpin the therapeutic hypothesis. It sits at the interphase between biology, natural history of disease and pharmacology.
Way of working
At Pharmetheus, our clients’ needs are at the centre of all our projects. This is why we develop fit-for-purpose QSP models, tailored to the specific Drug Development decisions that need to be informed. We scope the QSP projects upfront, and during the life of the project we draw on the expertise of Pharmetheus MIDD consultants, as well as biologists and physicians.
In line with Pharmetheus valued reputation for its reproducible simulations and excellent regulatory report quality, QSP projects are conducted according to rigorous ways of working, led by integrity, collaboration and dedication.
Tools
Thanks to Pharmetheus long experience in supporting MIDD plans for the pharmaceutical industry, our QSP platform is in a privileged position to rapidly identify with its client’s situation and help them extract maximum value from QSP, without the need to commit to expensive, heavy-weight and closed licensed tools.
This approach also gives us the agility to evolve our QSP models with our client’s needs, or to integrate our simulations with emerging innovative approaches, such as machine learning analyses or generative AI.
QSP benefits
Capitalise on the totality of evidence that supports your therapeutic hypothesis
By virtue of its multiscale and mechanistic nature, QSP analyses can support a wide range of drug development decisions.
There are 3 main areas where it can really complement other Pharmacometrics methods:
- Personalised medicine: QSP can help identify novel patient response biomarkers, design optimal sample collection schedules of existing ones, or integrate a Digital Twin strategy with the overall study design.
- Novel drug modalities and unprecedented targets: QSP offers a sandpit to optimise the selection of doses & dosing schedules to include in study designs of e.g. drug combinations, bispecific antibodies, cell therapies or mRNA vaccines.
- Translational medicine: QSP can make a difference as part of the regulatory evidence package when existing clinical or in vivo model data is scarce or inconclusive.
Recommended solutions
The Pharmetheus QSP analyses offer a variety of solutions to inform clinical development decisions in 3 key scenarios:
- Design of study protocols and clinical development plans: including patient selection criteria, dosing levels and schedules, or go/no-go decision criteria
- Prioritisation of business investment areas: drug combination selection, differentiation from competitors or standard of care, or portfolio prioritisation
- Regulatory submission packages: dose justification, label recommendations or efficacy/safety supplements for PMRs and PMCs
Get in touch
How can we help you?
Contact us to discuss how we can help you, or request a proposal
Explore our collaboration forms
At Pharmetheus, we understand that each organization has unique challenges and objectives in drug development. That’s why we offer a range of collaboration models designed to provide flexible, high-impact support tailored to your specific needs. Whether you require comprehensive QSP solutions, targeted scientific insights, or hands-on training, our expert team is ready to collaborate in a way that best suits your project.
