Biotech Business Law & Regulation
Rapid advances in biotechnology bring new benefits and controversies. At the same time, the
commercialization of bioscience innovations relies on venture capital, start-up companies, and strategic
alliances with large corporations and universities. This half-semester course focuses on what non-lawyers – KGI students who are destined to become leaders of tomorrow’s biotechnology (and other
bioscience) companies – need to know to navigate this new business terrain. We follow the life of a
fictitious biotech company from its pre-organizational planning to “exit strategies” such as an
acquisition or initial public offering. Along the way, we focus on three areas of concern: (i) the
corporate form, and the corporate and securities laws issues faced by biotechnology companies as they
seek crucial funding from private and public sources; (ii) an overview of issues related to the valuation,
development, protection, use and licensing of intellectual property as a key business asset (issues which
are explored in detail in ALS 451 Biotechnology Intellectual Property and Licensing); and (iii) FDA and
other regulatory issues which the company’s products must satisfy before they can be brought to market.
Additional topics may include the history and regulation of biotechnology; optimizing interactions
among scientists, businesspeople and attorneys; the “care and feeding of lawyers;” the coordinated
regulatory framework in the United States and possible overlapping and occasionally conflicting
activities of the Environmental Protection Agency, Food and Drug Administration, National Institutes of
Health, and Department of Agriculture; the international regulation of biotechnology; the Human
Genome Project and issues related to the use of genomics information, privacy and confidentiality.
Students will draft and/or “mark up” legal documents or memoranda for the various stages of an
emerging biotechnology company.
