Advancing medicines for unmet medical needs through model-informed drug development
Model-informed drug development (MIDD) is an approach in pharmaceutical science by which quantitative solutions are generated to address challenges in the drug development space. These solutions are data-driven, utilizing patient-level data of various sources such as clinical measurements, biomarkers (biological substances measured in the body related to disease), imaging, genetics, and digital sensor signals. As an experienced center for MIDD, the Quantitative Medicine Program at the Critical Path Institute is focused on developing such solutions for addressing challenges in neurological diseases, immunological diseases, and rare diseases. This talk will present a overview of disease specific problems arising in the drug development industry, and the corresponding quantitative methods being utilized to develop solutions, including mixed effects modeling, survival modeling, Bayesian statistics, deep learning for imaging analysis and natural language processing, and signal processing. Additionally, non-technical skills including writing and communication will be emphasized as a critical component of making impactful contributions.