Global Compliance Officer, Executive Director and Associate General Counsel, Novartis
- Email firstname.lastname@example.org
Representing Life Sciences Companies: Biotechnology, Pharmaceuticals and Medical Devices (S): LAW JD 907
Biotechnology and Pharmaceuticals are two of the fastest growing industries in the U.S., and the legal issues that arise in connection with representing them are complex and evolving. This seminar will focus on the transactional, intellectual property, and regulatory legal issues that challenge lawyers working with clients in these industries. We will begin with an overview of these industries, including a basic review of the sciences underpinning them (intended for non-scientists). We will then delve into complex legal issues such as licensing, collaborations, and consortium building; academic-industry interactions; the drug and biologic regulatory approval process; issues arising in clinical trials; and legal issues arising in the manufacture and distribution of life sciences products. If time permits, we will also examine the medical device industry and the ways in which that industry differs from the biopharmaceutical industry. In lieu of an exam, students will prepare a 25 page, journal-worthy article addressing a legal topic of the student's selection. PREREQUISITE: No scientific background will be required, but students will benefit from prior or contemporaneous coursework in intellectual property. LIMITED WRITING REQUIREMENT OPTION: A limited number of students may be permitted to satisfy the upper-class writing requirement with the approval of the Associate Dean for Academic Affairs. GRADING NOTICE: This course does not offer the CR/NC/H option. OFFERING PATTERN: This class is not offered every year. Students are advised to take this into account when planning their long-term schedule. ** A student who fails to attend the initial meeting of a seminar (designated by an (S) in the title), or to obtain permission to be absent from either the instructor or the Registrar, may be administratively dropped from the seminar. Students who are on a wait list for a seminar are required to attend the first seminar meeting to be considered for enrollment.