Certificate Requirements

1 credits | Fall Semester
Prerequisites: None

Course Directors: Robert Burleson, Phil Philips & Michael Kowler

The course focuses on the importance of financials and how it directs various aspects of a biotechnology company. Emphasis will be on the basics of accounting and establishing a company budget.

2 credits | Fall Semester
Prerequisites: None

Course Directors: Arthur House, Larry Millstein & Richard Kjeldgaard

The course provides an opportunity for students to learn about intellectual property rights and their uses in biotechnology. Topics addressed include: rights conferred by different types of intellectual property; the uses of biotechnology patents; determining “patentability,” interpreting the rights conferred by a patent; the patent-granting system in the US and elsewhere, patent costs and values; and the post-grant processes for enforcing and challenging US patents.

1 credit | Spring Semester
Prerequisites: None

Course Directors: Matthew Arnold

The complex, multi-disciplinary nature of the biotechnology industry requires that managers develop effective strategies for key aspects of their business. This course examines how biotechnology company executives approach strategic issues that are critical to their firm’s success: Developing pipeline assets, making portfolio investment decisions, creating a culture of high-performing individuals and cross-functional teams, and ensuring supply of clinical and commercial product while continually driving process innovation.

1 credit | Spring Semester
Prerequisites: None

Course Directors: Stephanie Duatschek

The course will provide an overview of the commercialization process for complex biologics. It will focus on the key tools, analytics, strategies and tactics that apply in healthcare sales and marketing. By the end of the course students will have a basic understanding of the following: The role of Commercial Operations in a biopharmaceutical company; The relationship between marketing, sales, commercial operations and managed markets; How commercial operations impact research and development as early as Candidate Drug nomination; The differences in promoting medicines versus consumer goods; How technology drives disease awareness and product choice by educating the provider and patient communities.

1 credit | Fall Semester
Prerequisites: None

Course Directors: Michael Gove

Discovery drives the life science industry but how value is determined in the inventor’s laboratory can be different than in the marketplace. The role of marketing allows for the value of a product to be described in terms of the customer. The value of that product is key to projecting sales, obtaining investments, finding partners and launching the product. This course provides an introduction to the strategic and tactical considerations employed by marketing to create customer value. Students will be exposed to basic marketing and sales concepts with examples that draw from participants and situations in the life science industry. The course provides an approach for understanding the marketplace as a basis for developing, pricing, promoting and distributing products and services that satisfy customer needs

1 credit | Fall Semester
Prerequisites: None

Course Directors: Charles Dormer

This course is designed to give an overview of strategic leadership in science and technology and prepare individuals to take on these roles. An understanding and appreciation of Strategic Leadership in Science and Technology will position students to make the most of their career opportunities starting at the MS level and in the future. Therefore, this program is aimed at Master-level students who aspire to leadership roles in research. The program is based on the 5R’s model (Dormer) of Scientific and Technology leadership and will include learning concepts of strategic thinking, organizational context, understanding your leadership style, team dynamics, decision-making, conflict management, change management and project and portfolio management.

1 credit | Spring Semester
Prerequisites: Basic background in Biochemistry and/or Biotechnology

Course Directors: Clifford Mintz

This course is designed to familiarize students with Current Good Manufacturing Practices (cGMP), Current Good Laboratory Practices (cGLP), and the regulations that guide the manufacture of FDA-approved biopharmaceutical and biotechnology products.

1 credit | Spring Semester
Prerequisites: None

Course Directors: Matthew Portnoy & Ken Wasserman

Our Federal Government has an important regulatory role regarding how biotechnology companies maintain their viability, as well as how taxpayer dollars are distributed such that humanity benefits from scientific research in tangible ways. The National Institutes of Health (NIH), for example, is responsible for the distribution of nearly $30 billion in financial support for research, clinical trials, and many other health-related activities. Guest speakers from other agencies such as the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), the National Institute of Standards and Technology (NIST), and the United States Patent and Trademark Office are also invited to share their perspectives. Our guest speakers will share information regarding career opportunities and tell us how they arrived at their current positions. *US Citizenship or Residency Required

1 credit | Spring Semester
Prerequisites: None

Course Directors: Stephen Sullivan

This course is designed to give an overview of the entire drug development process beginning with the discovery of new drugs to the successful commercialization and post-market surveillance of drugs in the market. Students will develop the perspective needed to serve the drug development industry as a participant, service provider, financier or board member, develop insights to improve the development process, learn the nomenclature, terms and demarcation lines for this complex process, Develop a working knowledge of current issues in drug development, and become an informed investor. This one-credit course will meet over two weekends and 14 hours of class time; 2 assignments covering two of the segments of development. No textbook. Assignments and research from a rich public domain. The instructor will guide students in research and provide relevant articles, cases, and personal experience.

1 credit | Spring Semester
Prerequisites: None

Course Directors: Sarah Tanksley

To work in the pharmaceutical industry, familiarity with the Federal Regulations that govern the field is required. Final drug product regulations from 21 CFR 211, otherwise known as the current Good Manufacturing Practices and other regulations, will be covered using real-life examples from the pharmaceutical industry. Current hot topics and FDA areas of concern will be highlighted.

1 credit | Spring Semester
Prerequisites: None

Course Director: Mark Mlynarczyk

Biopharmaceutical companies frequently face a strategic dilemma – too many potential projects and not enough resources to pursue them all. This course will provide students with an overview of the key analyses, processes, and decisions companies take to optimize their portfolio of product development projects. It will draw from real-world examples and incorporate industry professionals as guest lecturers, and students will gain “hands-on” experience from simulations and small group project teams.