Translational Biomedical Product Development. 1 Credit Hour

Catalog description

Translational Biomedical Product Development is a course that will provide students with an understanding of the overall process of translating basic research into innovative, market-driven biomedical products (therapeutics, biologics, diagnostics, and devices). It covers the complex pathways of intellectual property management and the regulatory processes by which a bioscience product is developed and brought to commercialization. Focused lectures will include pre-clinical development, patenting, FDA and regulatory requirements, clinical trials, marketing, funding, licensing, and commercialization strategies. Case studies of both successful and unsuccessful biomedical products will be presented to explore various business development opportunities. Upon successful completion of this course, students will have a comprehensive knowledge of the complex regulatory ecosystem of biomedical product development and management. Prerequisites include appropriate undergraduate courses in Biochemistry, Molecular Biology or Pharmacology, as assessed by the course director. Prerequisites: BIOC 6035 Open for Cross Enrollment on Space Available Basis.