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

Prerequisites & course information

Requisites: Declared in Pharmaceutical Sciences: Applied Drug Development MS or Capstone Certificate in Applied Drug Development Course Designation: Grad 50% - Counts toward 50% graduate coursework requirement Repeatable for Credit: No Last Taught: Fall 2026 Learning Outcomes: 1. Describe the phases of drug development from target discovery to investigational new drug (IND) submission and the different functional areas involved. Audience: Graduate 2. Explain how target pharmacology and drug safety are assessed using both in vitro and in vivo preclinical models. Audience: Graduate 3. Explain the chemistry, manufacturing, and controls (CMC) activities that take place during discovery and preclinical development. Audience: Graduate 4. Apply the knowledge learned throughout the course to address specific drug development challenges and propose novel solutions. Audience: Graduate 5. Evaluate how preclinical development might differ between small molecule drugs and protein therapeutics. Audience: Graduate 6. Create a preclinical drug development strategy for a specific drug modality and disease combination. Audience: Graduate Learning Outcomes: 1. Describe the phases of drug development from target discovery to investigational new drug (IND) submission and the different functional areas involved. Audience: Graduate 2. Explain how target pharmacology and drug safety are assessed using both in vitro and in vivo preclinical models. Audience: Graduate 3. Explain the chemistry, manufacturing, and controls (CMC) activities that take place during discovery and preclinical development. Audience: Graduate 4. Apply the knowledge learned throughout the course to address specific drug development challenges and propose novel solutions. Audience: Graduate 5. Evaluate how preclinical development might differ between small molecule drugs and protein therapeutics. Audience: Graduate 6. Create a preclinical drug development strategy for a specific drug modality and disease combination. Audience: Graduate