The Master of Bioscience (MBS) program at KGI prepares a new generation of scientifically skilled, business-minded and ethically-aware leaders — hybrids, if you will — for the bioscience industry. KGI's BioIndustry Ethics courses are core requirements for the MBS degree. In addition, the MBS curriculum includes two law courses -- a biotechnology business law and regulation course; and a follow-on course, on biotech intellectual property and licensing.
ALS 341 -- Introduction to BioIndustry Ethics
This half-semester course aims to provide high-level but practical information for first-year KGI masters degree students who, upon graduation, will join the ranks of bioscience leaders. The course covers key ethical theories and moral principles – in general, and as applied to select problems in bioethics and business ethics. Topics covered range from business ethics (including compliance, corporate governance and risk management); research ethics (including science authorship and inventorship; preclinical (animal research) ethics; conflicts of interest); human subjects research (including ethics and clinical data presentation; the collection and use of human biological materials); ethical issues in for-profit healthcare (including industrial research choices; pharmaceutical and device marketing and sales practices); and ethics and corporate decision-making, especially regarding product affordability and accessibility.
ALS 442 -- Advanced BioIndustry Ethics xxxxxxxxxxxxxxxxxx
This half-semester course, designed to complement ALS 341 Introduction to Bioethics, provides second-year KGI masters degree students with an opportunity to extend and apply their developing understanding of “bioindustry ethics” to scenarios they may well confront (and need to resolve) when they join the ranks of bioscience leaders. Building on case studies developed at the Stanford University Graduate School of Business, the Center for Biomedical Ethics at the Stanford School of Medicine, the Association of Schools of Public Health, and the Keck Graduate Institute, students will debate key moral issues in the biotechnology, pharmaceutical and device industries.
Class sessions consist of a combination of lectures, case presentation, background readings, and discussion of cases and the issues they generate.
ALS 452 -- Biotechnology 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 (taught in 2007) 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.
ALS 451 -- Biotechnology Intellectual Property & Licensing
This half-semester course (taught in 2006 and 2008) aims to provide high-level but practical information for KGI students who soon will join the ranks of biotechnology inventors, entrepreneurs, businesspeople and policy-makers. The course covers established principles of biotechnology patent law, but emphasizes current developments in this rapidly-changing area of the law. Beginning with a fictional scientist-colleague’s important (but imperfect) entry in a hypothetical laboratory notebook, students will steer their colleague’s “eureka” moment through the creation of intellectual property protection, and beyond - is the invention patentable subject matter? May the invention freely be practiced? What “prior art” stands between the presumed inventor and a government grant of a patent monopoly? What is required to in-license blocking patents, cross-license mutually-competing patents, or out-license the patented invention entirely, perhaps to a better-resourced pharmaceutical company? Should attempts to out-license fail, what are the risks (and costs) associated with patent litigation? What are the factors which companies should consider when entering a know-how collaboration? Finally, is patent protection a moral “good,” to be valued over all other competing interests? Is it ethical to patent “the natural and the human?”
A stellar group of biotech’s leading intellectual property lawyers, transactional attorneys and businesspeople were involved with course design and presented several of the semester’s lectures.
