LAW 5456 - Biotechnology: Law, Business, and Regulations

Credit(s): 3
An opportunity to learn about pre-implantation genetic screening of embryos, stem cell research, human cloning, predictive genetic testing for adult onset of breast and other cancers, and other coupling of biotechnology and information technology (“bioinformatics”) to decipher the human genome and to personalize the delivery of pharmaceuticals, and a range of areas in law, business, and bioethics along the R&D continuum from the laboratory bench to the marketplace. Through utilization of biotechnology as an industry application, this course will survey a broad range of law/regulatory fields, including patent law, licensing, regulation to protect human subjects, clinical research, product review and approval processes, and market oversight. Rather than mastering each of these areas, students will be expected to develop a “critical mass” of knowledge in the overall subject matter.