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Dec 26, 2024
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LAW 3733 - Biotechnology: Law, Business, and Regulation
Biotechnology is revolutionizing health care and poised at the forefront of research and development (R&D) for global industries ranging from agriculture to pharmaceuticals, industrial materials (biomaterials), and industrial processes. More than 100 biotechnology based pharmaceuticals have been introduced into the market, and hundreds more – many breakthrough drugs for previously untreatable conditions – are in advanced human clinical trials. Arguably the most regulated commercial endeavor in contemporary society, biotechnology R&D continues to induce changes in science, business, and medicine that raise legal/regulatory, ethical, and social questions. From the unprecedented reliance on intellectual property as a commodity for attracting billions of dollars in financing to the availability of pre-implantation genetic screening of embryos, stem cell research, human cloning, predictive genetic testing for adult onset of breast and other cancers, and the coupling of biotechnology and information technology (bioinformatics) to decipher the human genome and personalize the delivery of pharmaceuticals, biotechnology is changing the world we live in – meaning law, medicine, the economy, and society itself.
This course is an opportunity to learn about this technology and a range of areas in law, business and bioethics along the R&D continuum from the laboratory to the marketplace. Through utilization of biotechnology as an industry application, this course surveys 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 are expected to develop a “critical mass” of knowledge in overall subject matter. In addition, the latter part of the course directly addresses a range of pressing topics selected by the students, which offer the class an opportunity to apply and further develop this knowledge.
Credits: 3
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