Cancer and the World of Drug Development

The Role of Regulatory Science in Drug Development is a case study activity that exposes students to cancer and the various steps and departments involved in cancer drug approval. It is based on the drug, acalabrutinib, which was developed by Acerta Pharma. It includes clinical trials, data analysis, medical writing and labeling, risk-benefit analysis, and FDA licensing strategies. The activity includes pre-lab questions, steps in the drug approval process, and how drugs are assessed for effectiveness and safety. Using a fictitious CLL Lymphoma case study, students use modern online research tools to learn what cancer is, how particular drugs target cancer cells, and how clinical trials work.