This course focuses on understanding what it means to advise, do business with, or be involved in the development of` a heavily regulated industry. It is aimed at attracting a group of interested students who believe they will be likely to have banking or consulting clients in the Life Sciences industry or who aspire to take a role in the creation of new enterprises in this sector. In this industry, whether Biotech or Devices, the consumer of products, the patient, does not choose the product, pay for it, or have any say about what products are available. This is a unique environment in which anyone involved needs to have a working knowledge of the philosophy, terminology, and processes their clients, companies, or products will have to follow. The course is not designed to make students regulatory experts but to show them ways to navigate the regulatory pathways and related issues, which impact every phase of the creation and growth of a Life Sciences company. For the most part, students will not examine the issues surrounding the growth of provider or service businesses such as hospitals but instead explore the issues related to businesses built around proprietary technology. Topic samples: the history and evolution of regulation in this country and why it has evolved differently in other countries; cosmetics, cosmeceuticals, and food and how these areas are coming under increasing scrutiny by regulators; how to finance a drug versus a device company; and emerging technologies’ issues. Course content will include cases, class discussions, background reading, guest lectures, and individual and student team projects. Students will have an opportunity to follow an actual company’s evolving strategy.


Academic course objectives:


·         Provide students with a working understanding of the impact of regulation on the Life Sciences business

·         Provide students with a historic context to understand the origin of regulation

·         Furnish students with working knowledge of the terminology, sequencing of product development, and commercialization in a Life Sciences company

·         Give students the opportunity to confront the difficult tradeoffs of choosing a regulatory, development, and commercialization pathway

·         Enable students to understand the financing alternatives and the impact those choices have on a company’s ability to grow


Elements of the course grade:


Class contribution       40%

Group project              25%

Individual work          35%