Biotechnology Enterprise

This course provides an extensive overview of a process for the development of a pharmaceutical by a biotechnology company or pharmaceutical company. The course emphasizes the importance of intellectual property, the basic sciences underpinning the development of a product, and the importance of the interaction between a company and the Food and Drug Administration. Students learn to appreciate the importance of quality control and assurance, good manufacturing practices, preclinical and clinical testing, and the lengthy regulatory processes that govern the development, manufacturing, and eventual sale of biotechnological products. Hands-on solving of practical problems and guest lecturers who are experts in the field familiarize students with the intricacies of the process. Prerequisites: 410.607 The Biotechnology Enterprise, or admission to one of the business/regulatory programs

Students in this course analyze and discuss traditional philosophical theories regarding the nature of the moral good. They then apply these theories to critical issues and selected cases involving experiments with human subjects, organ transplantation, in vitro fertilization, the use of animals in research, the collection and publication of research data, peer review, conflicts of interest, and other topics of current concern.

The roles of managers and leaders within biotechnology companies undergo constant change. Biotechnology managers and leaders must engage in new and innovative problem-solving strategies, lead a diverse and global workforce, develop partnerships with other businesses, customers, and competitors, manage horizontally and across teams, and utilize technology to a competitive advantage. The student is able to address and cure challenges in his/her own organization and learn methods of implementing change, such as negotiation techniques and motivation. The course includes in-depth discussions of leadership skills, communication, conflict resolution, and goal integration. Students research a biotechnology organization, analyze what is working and not working within its management systems, and suggest alternatives.

This course introduces students to the strategic and tactical approaches used in the marketing of biotechnological produce and services. Students gain a thorough understanding of the research and planning necessary to develop a marketing plan, the relationship between the marketing and sales functions, the difference between marketing a scientific product and a scientific service, pricing strategies, distribution alternatives, communications, promotion, and the importance of perception. Knowledge of marketing terminology and techniques proves helpful to anyone in the industry.

This course provides a foundation to start or help guide a young biotechnology company from inception through early growth. Topics include market assessment of innovative technology, patents and licensing, corporate law, preparing a business plan, raising money from angels and venture capitalists, government grants, strategic alliances, sales and marketing, real estate, human resources, and regulatory affairs. The course provides a survey and overview of the key tasks and challenges typically faced by biotech entrepreneurs, their management team, and directors. Students will prepare a business plan for a biotech startup and present the plan to a panel of industry experts and financiers. Leaders from our local bioscience community will be guest lecturers for many of the classes.

This course will cover basic design issues, conduct, and execution of clinical trials for drugs and biologics. Clinical trial design will be analyzed to better understand various clinical trial study designs along with concepts such as endpoint definition, control group selection, and eligibility criteria. Other areas of emphasis will include informed consent, safety monitoring, ICH Good Clinical Practice (GCP), basic statistical concepts, data collection and integrity, trial implementation and regulatory strategy. Various challenges and points to consider for conducting clinical trials in the 21st century will be highlighted along with a close look at regulations. There will be three hands-on projects which will include authoring an informed consent, designing a case report form, and creating a presentation on clinical trial strategy. Prerequisites: 410.651 Clinical Development of Drugs and Biologics (recommended).

This course introduces students to the regulatory frameworks governing the development, approval, and post-market surveillance of medical products including drugs, biologics, and medical devices. Students will explore the historical context of pharmaceutical regulation, the structure of the FDA, and the processes associated with product development. By examining regulatory submissions, case studies, and enforcement actions, students will gain the foundational knowledge and practical skills required for careers in regulatory affairs.

This course introduces students to the planning and work required to develop potential new drugs and biologics efficiently. Students gain a thorough appreciation of FDA and International Council for Harmonisation regulations and guidelines. Because the course emphasizes the importance of planning before the execution of any of the necessary steps, lectures use a “backward” approach, discussing the final analysis and report before developing protocols. Topics also include an overview of preclinical investigations, NDA/BLA format and content, clinical development plans, product and assay development, the IND, and trial design, implementation, and management. Prerequisites: 410.607 The Biotechnology Enterprise, or admission to one of the business/regulatory programs

This course provides a comprehensive overview of the critical legal and ethical issues pertaining to the full lifecycle of data science and biotechnology. Students will learn to navigate the complexities of data ethics, exploring how decisions and inferences based on data impact society. Through real and hypothetical case studies and articles, students will examine important cases and laws shaping the data science field.

This course provides an overview of the biological processes and laboratory techniques utilized for the discovery, development, and evaluation of therapeutic drugs. Students investigate drug development processes, such as gene cloning, culture scale-up, downstream processing, and product purification. Emphasis is placed on the theory and application of laboratory methods used in drug development, such as recombinant DNA techniques, antibody technology, protein purification, immunoassays, high-throughput drug screening, chromatography, electrophoresis cell receptor characterization, pharmacokinetics, drug toxicity testing and evaluation of therapeutic drugs, diagnostics, and vaccines. Prerequisites: 410.607 The Biotechnology Enterprise, or admission to one of the business/regulatory programs

The Food, Drug, and Cosmetic Act governs the regulatory approval process for bringing a drug, biologic, medical device, food, or cosmetic to market. The class will discuss administrative procedures followed by the FDA. The course includes an overview of the drug, biologic, and medical device approval processes and the regulation of food and dietary supplements. Students then will be exposed to the enforcement activities of the FDA, including searches, seizure actions, injunctions, criminal prosecutions, and civil penalties authorized under the FD&C Act as well as other statutes, like the Public Health Service Act, which regulates the development and approval of biologics.

This course provides an immersive introduction to the financial and business foundations that drive the biotechnology sector. It is designed for both students with no prior exposure to finance or business and those with experience seeking to deepen their expertise. The goal is to build a platform of knowledge and essential skills that allow students to confidently engage in financial and strategic decision-making. Core finance topics include the time value of money, valuation of stocks and bonds, the cost of capital, capital budgeting, investment evaluation, and financial statement analysis. These are integrated with business fundamentals such as strategic planning, competitive advantage, business model design, and financial forecasting. Together, these frameworks establish a powerful toolkit for understanding value creation in biotechnology. Learning is hands-on. Students gain experience by analyzing biotech case studies, building financial models, running scenario analyses, and developing business plans. These applied exercises connect finance and business concepts to real-world decisions. Attention is also given to broader forces—including interest rates, regulation, artificial intelligence, and digital assets—that influence value creation and strategic decisions in the sector. By the end of the course, students will have sharpened their financial knowledge and business mindset, strengthened their ability to communicate across disciplines, and developed the confidence to add value by evaluating opportunities, shaping strategies and driving innovation from lab to leadership.

Current Good Manufacturing Practice regulations are the minimum standards for the design, production, and distribution of drug products manufactured in the U.S. and internationally. In the U.S., they are codified at the federal level in the FD&C Act and the Code of Federal Regulations and are actively enforced by the FDA. These regulations, however, only begin to describe the practices used in the pharmaceutic and biotech industries. Additional sources of insight and guidance include the FDA’s guidance documents and training manuals, industry trade publications, international compendia, and standards-setting organizations. Students will learn the scope and history of the regulations, industry-standard implementation strategies and “best-practices” approaches, and the FDA’s current expectations. Students will also learn to apply practical solutions to the regulatory issues faced in the pharmaceutical and biotech industries today.

This course is an introduction to the multidisciplinary aspect involved in the process of translating innovations in technology into commercial use, particularly research discoveries emanating from universities and other nonprofit organizations.

This course provides an overview of the important ethical, legal, and regulatory issues that are critical to the biotechnology industry. The course shares current trends and essential elements of ethics, legal issues, and regulations in a way that allows for an appreciation of how each influences the others. Students will examine core ethical values that guide the practice of science in the biotechnology industry. The course will provide an overview of legal issues, such as protecting inventions, intellectual property, licensing, and the range of regulatory oversight mechanisms with which the biotech industry must comply. This course will review the implications of strategic ethical, legal, and regulatory choices that add value to the biotechnology firm, customers, and society.

Today, many organizations use a disciplined “project management” approach to manage activities that have a limited life span as opposed to routine, ongoing operations. The modules in this class will provide guidance for project management success by considering each phase in the life of a typical project, from concept to closeout. We will discuss the nature of project management, the structure of projects, working with teams of technical experts, and all the other activities that make project management different from any other discipline. The course will introduce these concepts in readings, lectures and videos. It will rely heavily on group discussions to challenge you to critically think about these concepts in practice. We will discuss essential tools for effective decision making, developing a project plan, risk management, team leadership and motivation, monitoring and controlling during the project, scope change control, and traditional and modern approaches to project closeout. The concepts presented will be consistent with the Project Management Institute’s “Guide to the Project Management Body of Knowledge,” a widely used framework and guide to project management recognized by the American National Standards Institute (ANSI).

As bioscience companies grow and mature, leadership needs to evolve. Students will learn how to identify their company’s position in the “Leadership Life Cycle” and learn how to select the right leadership capabilities based on their current organizational needs. Research shows that the right leaders at the right time dramatically improve organizational success. Bioscience leaders need to lead change to include knowledge paradigm shifts, role of Artificial Intelligence, external environmental research climate. Leaders need skills of resilience, adaptability, and growth mindset. Transformative leadership skills to manage mergers, downsizing, disruptions, remote work, and succession planning will be covered. Use of measurements KPI (Key Performance Indicators) and SMART goals for long-term decision making will be explored.

Strategic Planning for the Biotechnology Enterprise is an overview of strategy, Life Sciences product research and development planning, regulatory pathways and tactical business execution. It focuses on creating value through strategy formulation and market implementation. Topics covered include venture investments, acquisitions and integrations, leadership and technology competencies, intellectual property, regulatory strategy, competitive differentiation, and clinical and financial value creation. Best practices in strategic planning are explored through real life published case studies of companies such as Genentech / Roche, Gilead, Alnylam, Moderna and Tempus AI. The class will also evaluate the impact and implications of policy, such as the Inflation Reduction Act, and technology, such as artificial intelligence and machine learning, on current and future initiatives of biotechnology ventures.

Whether tackling small business challenges in a community or creating global initiatives, innovators are problem solvers. This course focuses on equipping students with problem-solving strategies and innovation models necessary to be the solution. Students will develop an understanding of design thinking principles, apply an innovation framework to develop user-driven solutions, practice communicating complex ideas with clarity, and collaborate on cross-functional teams utilizing tools to create positive change in any context. While evaluating real-world problems, students will consider how these techniques can be utilized to turn an innovative idea into an effective solution. Student assessments include driving results for real-world projects, turning their ideas into practical action, and demonstrating their ability to leverage social innovation through community-based and global initiatives.

This course synthesizes the knowledge and skills acquired in the Masters of Biotechnology Enterprise and Entrepreneurship program while offering a real-world examination of a bioscience organization and the issues it faces. Students will form interdisciplinary teams and work with faculty and industry professionals on an authentic and current project from a local bioscience public or private company, an entrepreneurial startup, or a nonprofit organization. This course description allows MBEE students and Biotechnology students with concentrations in Regulatory Affairs/Business Enterprise.