Biotechnology Enterprise and Entrepreneurship Degree Details & Courses

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.

Students will build an understanding of the basics of contemporary global monetary systems and the essentials of financial management. This course will include the means to develop a working knowledge of the critical financial factors for decision-makers from the perspectives of key stakeholders. The syllabus is designed to provide students with limited or no background in finance an opportunity to establish an understanding of financial basics and communicate clearly in financial terms when conducting business. This course is uniquely designed to meet the current needs of those leading the global life science industry.

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).

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.

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.

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 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 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

This course explores the role of microorganisms in food systems and biotechnology, emphasizing both their beneficial and detrimental impacts. Students will study the diversity, physiology, and genetics of microorganisms relevant to food production, processing, and safety, while also examining their applications in modern biotechnology. Topics include microbial growth and control, food spoilage organisms, foodborne pathogens, and microbial ecology in food environments. Special emphasis will be given to the use of microbes in bioprocessing, fermentation, probiotics, bioengineered foods, and novel bioproducts, as well as the regulatory and safety frameworks governing their use. Case studies will highlight microbial applications in biotechnology industries, including production of enzymes, nutraceuticals, bioactive compounds, and functional foods. By the end of the course, students will gain a strong foundation in both classical food microbiology and its integration with biotechnology, enabling them to critically assess microbial roles in innovation, safety, and regulation of food and bioproducts.

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.

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.

Good Food Production Practices are production and farm level approaches to ensure the safety of food for human consumption. Good food production and post-harvest guidelines are designed to reduce the risk of foodborne disease contamination. These good food production procedures can be tailored to any production system and are directed toward the primary sources of contamination: soil, water, hands, and surfaces. Good food production protocols were developed in response to the increase in the number of outbreaks of foodborne diseases resulting from contaminated food. Students will learn to develop good food production regulatory protocols using case studies.

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.

This course provides a comprehensive overview of the U.S. Food and Drug Administration’s (FDA’s) regulation of the research and development, and marketing of new drugs, biologics, and medical devices. The regulatory requirements for investigational (Investigational New Drug (IND) and Investigational Device Exemption (IDE)) and premarket approval (New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Biologics License Application (BLA), premarket notification (510(k)), Premarket Approval (PMA)) applications will be addressed. The content and format requirements for the preparation, submission, and maintenance of these applications will be covered.

Regulatory requirements for labeling food and beverage products in the United States are established in the United States Code of Federal Regulation for many elements included on retail packages. These requirements, and their enforcement, are primarily the responsibility of the Food & Drug Administration and/or the United States Department of Agriculture. Food labeling is required for packaged foods sold directly to consumers and includes mandatory features such as a statement of identity, net quantity of contents, nutrition labeling, ingredient statements, allergen labeling, and contact information. Additional features on many food labels, including claims, ad-copy, cooking instructions, bioengineered disclosures statements, and more, can also be subject to specific regulations. This course addresses the regulations for each mandatory feature commonly required on food labels, reviews requirements for claims and marketing statements, and discusses future trends and expectations in food policy and regulation.

This introductory course is designed to provide students with a high-level understanding of the complex legal and regulatory requirements for foods. The United States will be the primary focus, but other country regulations will be discussed as contrasts. The history of food regulations will be presented along with the progression to current regulations. Discussions regarding the multitude of agencies overseeing regulations and how they interact will be covered. Regulatory impact on product development, supply chains and food safety culture with be among several topics to introduce foundations for effective communication and collaboration with stakeholders to ensure brand and consumer trust.

This course provides a comprehensive introduction to medical devices and how they are regulated by the FDA. Topics that will be covered include an overview of the laws and regulations that govern medical devices, the FDA’s organizational structure and responsibilities for medical device regulation, and administrative and legal requirements for medical devices throughout the full product life cycle. Particular focus will be placed on the premarket review, post-market programs enforcement (e.g., Quality Systems Regulation, and FDA inspectional programs). Included will be discussions on the responsible offices and major program requirements and resources. Students will be given various case studies to examine the application of regulations and participate in a 510(k)/PMA workshop, mock inspectional audit, and mock enforcement action. Upon completion of this course, the student will have a working knowledge of the requirements and policies of FDA regulation of medical devices.

This course provides an in-depth exploration of the principles and applications of toxicology as they relate to food, biotechnology, and bioproducts. Students will examine the biochemical and molecular mechanisms of toxic agents, natural and synthetic toxins, food contaminants, and processing byproducts. Special emphasis will be placed on emerging biotechnologies, such as genetically modified organisms (GMOs), novel proteins, bioengineered foods, and nutraceuticals. The course integrates toxicological science with food safety and regulatory frameworks, highlighting global standards (FDA, EFSA, Codex Alimentarius) and risk assessment methodologies used in evaluating food and biotech products. Topics will also cover toxicokinetics, dose-response relationships, biomarkers of exposure, carcinogenicity, and endocrine disruption, with case studies linking toxicological data to regulatory decision-making. By the end of the course, students will gain a strong foundation to critically evaluate toxicological risks in food and biotechnology, understand regulatory approval pathways, and apply safety principles in research, product development, and industry practice.

Risk analysis is composed of three separate but integrated elements, namely, risk assessment, risk management, and risk communication. Risk communication is an interactive process of exchange of information and opinion on risk among risk assessors, risk managers, and other interested parties. Risk management is the process of weighing policy alternatives in light of the results of risk assessment and, if required, selecting and implementing appropriate control options, including regulatory measures. Students will learn how to integrate risk assessment, risk management, and risk communication using case studies.