THE DRUG DEVELOPMENT PROCESS FROM DISCOVERY TO INVESTIGATIONAL NEW DRUG APPLICATION (IND)

PHMSCI 756

Provides a high-level overview of how data analysis techniques augment the drug discovery and development process. Focuses on project-based skills-building through the application of industry-standard software and use of public databases. Explores best practices for data processing and management to ensure experimental reproducibility. Develops troubleshooting skills through critical evaluation of data analysis results and root cause analysis.

PHMSCI 763

Overview of the drug development process from first-in-human (FIH) to submission of a new drug application (NDA) or biologics license application (BLA). Phases of clinical development and the role of biomarkers, companion diagnostics, statistical analysis, and CMC in clinical trials. Both small molecule and protein therapeutics will be addressed.

PHMSCI 759

Provides the experience and skill to find, read and critically analyze scientific and regulatory literature in the field of drug discovery and development.

BIOMDSCI 820

Examine the early drug discovery process, including target identification and validation, generation of diverse chemical libraries, assay development and high throughput screening, lead optimization by compound profiling, and drug targeting and delivery.

PHMSCI 757

Scientific process of drug development from discovery through clinical trials. Brief history of drug development, along with an overview of drug discovery, preclinical, and clinical activities that take place during development. Application to real-world drug development scenarios and challenges, especially as they apply to development of drugs to treat neurological diseases.