Director of Product Certara Ithaca, New York, United States
Disclosure(s):
Joshua F. Apgar, PhD: No financial relationships to disclose
With hundreds of FDA and EMA submissions supported by QSP models, QSP has finally come of age. The now proven high return of investment from QSP has led to every major pharma company, and a significant number of biotechs investing in QSP groups or partnering with QSP vendors. However, the vast majority of preclinical and clinical programs are still not supported by QSP. At this point we see this not as a limitation of the value of QSP but as a challenge for implementing QSP at scale. This workshop will unveil Certara IQ, an innovative QSP environment that enables the scaling of QSP from only supporting a small minority of projects, to supporting the entire pipeline. We will focus on four key decision points in the drug development pipeline:
New Target Feasibility
Determining Best in Class Properties
First In Human Dose Projection
Recommended Phase 2 Dose
For each we will demonstrate how to use Certara IQ to efficiently answer these questions with worked practical examples.
