US-based drug development consultancy Certara has launched a consortium to assess various treatments, their dose regimens and disease biomarkers.
The Quantitative Systems Pharmacology (QSP) immuno-oncology simulator consortium, which includes multiple biopharmaceutical companies, will work towards the development of a simulator to generate clinical populations of virtual patients.
QSP will use computational modelling and experimental methods to analyse the mechanistic association between a drug, the biological system and the disease process.
The information on a drug’s mechanism of action is expected to provide quantitative drug data and enable the investigation of different heterogeneous conditions, including cancer and central nervous system disorders that need more than one treatment.
To ensure improved clinical development of immuno-oncology treatments, the consortium will integrate relevant, detailed biology, pharmacology and variation information from different individuals into the simulator.
Certara QSP vice-president Piet van der Graaf said: “The QSP Immuno-oncology Simulator will allow researchers to explore different therapeutic combinations, even drugs using different modalities, within a virtual population.
“It will enable sponsors to answer a lot of ‘what-if’ questions, providing input and guidance for clinical development.
“We anticipate that QSP modelling will follow a similar adoption curve to physiologically-based pharmacokinetic modelling, which is now standard practice within the drug development process and an expected component of regulatory submissions.”
The new QSP immuno-oncology simulator joins Centara’s existing range of Simcyp and cardiac safety simulators and QSP immunogenicity consortium.
It is expected that the new technology will help in choosing the right combination therapies, dose regimens and biomarkers for particular cancers and patient populations.
Immuno-oncology is one of the most competitive areas of pharmaceutical R&D. Immuno-oncology therapies work by using the patient’s own immune system to fight cancer.