THE DRUG DEVELOPMENT PROCESS FROM FIH TO BLA/NDA

Prerequisites & course information

Requisites: Declared in MS Pharmaceutical Sciences: Applied Drug Development or Capstone Certificate in Applied Drug Development Course Designation: Grad 50% - Counts toward 50% graduate coursework requirement Repeatable for Credit: No Last Taught: Spring 2026 Learning Outcomes: 1. Describe the phases of drug development from first-in-human (FIH) studies to NDA/BLA submission and the different functional areas involved. Audience: Graduate 2. Explain the goals, expectations, and objectives for the different phases of clinical development and describe innovative trial design Audience: Graduate 3. Define a biomarker, a companion diagnostic, and a statistical analysis plan (SAP) and describe the important elements of all three. Audience: Graduate 4. Explain the chemistry, manufacturing, and controls (CMC) activities that take place during clinical phases of drug development and pre-launch. Audience: Graduate 5. Apply the knowledge learned throughout the course to address specific drug development challenges and propose novel solutions. Audience: Graduate 6. Evaluate how clinical trial design and execution might differ between different therapeutic areas and between small molecule drugs and protein therapeutics. Audience: Graduate 7. Create a clinical development strategy for a specific drug modality and disease combination. Audience: Graduate Learning Outcomes: 1. Describe the phases of drug development from first-in-human (FIH) studies to NDA/BLA submission and the different functional areas involved. Audience: Graduate 2. Explain the goals, expectations, and objectives for the different phases of clinical development and describe innovative trial design Audience: Graduate 3. Define a biomarker, a companion diagnostic, and a statistical analysis plan (SAP) and describe the important elements of all three. Audience: Graduate 4. Explain the chemistry, manufacturing, and controls (CMC) activities that take place during clinical phases of drug development and pre-launch. Audience: Graduate 5. Apply the knowledge learned throughout the course to address specific drug development challenges and propose novel solutions. Audience: Graduate 6. Evaluate how clinical trial design and execution might differ between different therapeutic areas and between small molecule drugs and protein therapeutics. Audience: Graduate 7. Create a clinical development strategy for a specific drug modality and disease combination. Audience: Graduate