This course introduces students to the real-world processes of drug development following the selection of a new chemical entity (NCE). Emphasizing the practical application of pharmaceutical sciences, it covers formulation development, manufacturing, regulatory submission, and approval pathways. Designed for graduate students and potentially fourth-year undergraduate students, the course challenges students to apply core principles of pharmaceutics and drug delivery to address contemporary issues in the pharmaceutical industry.

The course features weekly guest lectures by pharmaceutical industry professionals, complemented with case-based discussions and interactive Q&A sessions. Key topics include quality-by-design (QbD) and artificial intelligence in drug product development, formulation strategies for preclinical and clinical stages, prediction of formulation performance (in vitro and in vivo), regulatory and Chemistry, Manufacturing and Controls (CMC) filing requirements, and current development challenges faced by the industry.