Quantitative Systems Pharmacology (QSP) consulting services
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 center of all our projects. This is why we develop fit-for-purpose QSP models, tailored to the specific drug development and regulatory MIDD 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, physicians, and regulatory affairs experts.
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 services are in a privileged position to rapidly understand our clients’ situations and help them extract maximum value from QSP, without the need to commit to expensive, heavyweight and proprietary licensed tools.
This approach also gives us the agility to evolve our QSP models with our clients needs, or to integrate our simulations with emerging innovative approaches, such as machine learning analyses or generative AI. In addition, we proactively adapt our QSP ways of working, analysis plans and reports to the newest regulatory guidelines, such as the recent guidances to assess MIDD evidence for drug development decisions by the ICH and the US FDA, or the US FDA draft guidance on QSP-based dose selection for MABEL in FIH trials.
QSP benefits
Capitalize 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 and regulatory decisions.
There are three main areas where it can really complement other pharmacometrics methods for MIDD evidence generation
- Personalized 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 optimize 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. Our approach is fully aligned with the ICH M15 guidelines and US FDA expectations regarding the use of QSP to estimate MABEL dose selection for FIH studies
Recommended solutions
The Pharmetheus QSP analyses offer a variety of solutions to inform clinical development decisions in 3 key scenarios:
- Design of study protocols (e.g., with QSP-based MABEL dose selection in FIH) and clinical development plans: including patient selection criteria, dosage levels and schedules, or go/no-go decision criteria
- Prioritization of business investment areas: drug combination selection, differentiation from competitors or standard of care, or portfolio prioritization
- Regulatory submission packages: dose justification, label recommendations, or efficacy/safety supplements for PMRs and PMCs, in alignment with the MIDD-evidence expectations summarized in the ICH M15 guidance
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.
