Mechanistic modeling approaches like Quantitative Systems Pharmacology (QSP) and Physiologically-Based Pharmacokinetics (PBPK) are increasingly used to make biopharmaceutical R&D more efficient and effective and to improve regulatory decision making.
QSP modeling workflows involve developing a Biological Map which captures the expert opinions on the mechanistic details of the model to be developed, followed by implementation into a mathematical framework, typically based on ordinary differential equations. This involves input from and collaboration between scientists with wide-ranging technical expertise and scientific backgrounds. However, currently-available software has not been effective in facilitating this process. Based on our own experience and our clients’ feedback that this has been a major impediment in QSP becoming an integral part of model-informed drug development (MIDD), we decided to develop a unique new software platform, QSP Designer.
QSP Designer facilitates QSP model building by teams that include QSP experts and non-technical scientists. Diagram node arrays handle combinatorial complexity of models with repeated motifs (e.g., T-cell clones, binding of multiple ligands/receptors). Whereas the software includes powerful simulation and fitting engines, full model code can be generated in MATLAB, R, C, and Julia to facilitate model sharing, validation, and regulatory submissions.
Simcyp Designer brings together the power of the QSP Designer and the Simcyp PBPK Simulator, so merging QSP and PBPK models is now a few clicks away. Simcyp Designer is an ideal tool for harnessing the power of the Simcyp Simulator in QSP models as well as adding new mechanistic processes to the Simcyp Simulator. This provides an integrated collaborative environment for PK/PD, QSP, and PBPK scientists implementing MIDD from early discovery to late clinical development, thus saving considerable time and money.
By attending this interactive webinar, you will learn:
- How QSP Designer facilitates developing QSP models through the Modular Biological Process Map interface with enhanced graphical notation.
- How Simcyp Designer uses the QSP Designer editor to expand PBPK models available in Simcyp Simulator.
- How integrated models developed in Simcyp Designer can include feedback between the Simcyp Simulator and mechanistic model extension.
