Biotechnology Elective Courses

This course covers cell organization and subcellular structure. Students examine the evolution of the cell, chromosome, and plasma membrane structures and behaviors, as well as the mechanics of cell division, sites of macromolecular synthesis and processing, transport across cell membranes, cell dynamics, organelle biogenesis, and cell specialization. Students are also introduced to the experimental techniques used in cell biology to study cell growth, manipulation, and evaluation. Special Note: This course is not required for M.S. in Biotechnology students starting in the 2026-2027 Academic Year. The core courses for these students are 410.604, 410.605, 410.606, and 410.607.

Students examine cell-to-cell signaling that involves hormones and receptors, signal transduction pathways, second messenger molecules, cell adhesion, extracellular matrix, cell cycle, programmed cell death, methylation of DNA, modification of chromatin structure, and mechanisms of the cell. The roles that defects in signal transduction pathways play in the development of cancer and other disease states will be stressed. Prerequisites: 410.603 Advanced Cell Biology or equivalent.

This foundational biotechnology course provides the biotechnology student with an introduction to the business of biotechnology, from scientific discovery through product launch and subsequent organizational and scientific pipeline growth. The course introduces the biotechnology student to various disciplines and activities (such as funding, research and development, biomanufacturing, and commercialization) for the formation, development, and operation of a biotechnology enterprise. A course-long project involving several assignments that include aspects of a biotechnology organizational simulation is reflected in a Technology Feasibility Research Study. The biotechnology student will improve their communication skills across a variety of modalities and disciplines in preparation for entering the biotechnology enterprise environment and engaging relevant industry stakeholders. Course Prerequisites: AS.410.603 Advanced Cell Biology or admissions equivalent, or approval of the program committee.

This course is designed for students and researchers working in laboratory settings who are eager to integrate Artificial Intelligence (AI) into experimental biotechnology workflows. With the rapid advancement of AI, laboratories are increasingly leveraging machine learning, computational imaging, and automation to accelerate discovery and enhance data interpretation. This course bridges foundational AI concepts with hands-on laboratory applications, focusing on real-world use cases in laboratory analysis, preclinical research, and translational science. Emphasis will be placed on improving laboratory reproducibility and clinical translatability by using AI models that extract meaningful signals while minimizing confounders. Prerequisites: 410.604 Cellular Signal Transduction, 410.605 Experimental Design in Biotechnology, 410.606 Emerging Applications in Biotechnology.

This course provides an in-depth examination of microbiological agents that pose threats to public health, national security, and global stability. Emphasizing both naturally emerging pathogens and potential bioterrorism agents, the course integrates principles of immunology, microbiology, epidemiology, and public health preparedness. Students will explore the biological characteristics, transmission dynamics, and pathogenesis of high-priority pathogens—including select agents—as well as recent and emerging infectious diseases like SARS-CoV-2, MERS, and novel influenza strains. Case studies and scenario-based exercises will reinforce the application of scientific knowledge to real-world threat assessment and mitigation efforts.

This course will expand on foundational knowledge in immunology and explore advanced applications in biotechnology, infectious and genetic diseases, vaccines, cancer immunotherapies, and issues of government regulation. The etiology, treatment, and genetic components of disease will be explored using case studies from the primary research literature, freely available immunologically relevant databases, and online bioinformatics tools. Lectures will provide a summary of the immunological concepts and introduce the databases or bioinformatics tools to be used for each module. Activities include case studies, in-silico experiments, group discussions, and individual presentations. Prerequisites: 410.604 Cellular Signal Transduction, 410.606 Emerging Applications in Biotechnology, a previous immunology course.

This laboratory course covers the principles of various processes associated with the production and recovery of different bioproducts derived from prokaryotes. Topics include the classification of microorganisms, media development, instrumentation, fermentation principles, microbial cell propagation, product recovery, protein purification, and the principles of Current Good Manufacturing Practices. Emphasis is on large-scale production methods and the production of recombinant proteins for diagnostic and clinical applications. Prerequisites: 410.606 Emerging Applications in Biotechnology.

This course provides a framework for understanding the molecular physiology of neuronal structure, signaling, and circuitry, and how this cellular design is ultimately integrated to achieve higher cognitive functions, such as perception, control of movement, learning, and memory. The course introduces the students to various current neuroscience topics, including but not limited to membrane physiology and electrical excitability of neurons, neurotransmitters and synaptic transmission, signaling at the neuromuscular junction, cellular and higher-order aspects of perception and motor control, molecular mechanisms of neural development, and the molecular basis of learning and memory. This course places particular emphasis on the genetic and molecular bases of a wide variety of neurological and neurodegenerative diseases, such as multiple sclerosis, amyotrophic lateral sclerosis, Parkinson’s, and Alzheimer’s. Prerequisites: 410.603 Advanced Cell Biology or equivalent, 410.604 Cellular Signal Transduction or equivalent.

In this course, students learn about how gene therapy can be used to treat or prevent genetic disease in the human population. This course is centered around how disease-causing variations in the human genome, including inherited diseases, mutations, epigenetic modifications, and viral infections, can be targeted using molecular technologies. Students will learn about the benefits and limitations of gene therapy and the bioethical concerns involved with this field of research and medicine. Prerequisites: 410.603 Advanced Cell Biology or equivalent.

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.

This course covers basic concepts and practical applications of modern laboratory diagnostic techniques. Topics include the principles of testing methodology, quality assurance, and the process of translating data into a diagnosis. Clinical and research test methods to be covered include nucleic acid-based methods, such as hybridization, amplification, and sequencing, non-nucleic acid methods, such as liquid chromatography, biomarker detection, and protein analysis, and technologies such as gel electrophoresis, ribotyping, imaging analyses, and serological testing methodologies. In addition to the test procedures, students are exposed to aspects of statistics, quality control, and regulatory issues to highlight the oversight required to ensure reliable data. A special emphasis will be placed on host-donor matching for transplantations, epidemiological tracking for infectious diseases, and identity analysis for lineage and forensics testing. Prerequisites: Students should have the equivalent of at least one of the following courses: AS.410.604 Cellular Signal Transduction, AS.410.612 Human Molecular Genetics, AS.410.615 Applied Microbiology, AS.410.629 Genes & Disease, AS.410.631 Infectious Diseases, AS.410.660 Immunological Techniques in Biotechnology, AS.410.692 Biological & Chemical Threat Response & Forensics, AS.410.696 Bioassay Development, AS.410.709 Cancer Genomics, or AS.410.750 Molecular Targets & Cancer

Governments around the world are beginning a long-term process that reviews and redesigns their health care systems, addressing concerns of innovation, cost, equitable access, and sustained quality of health care. As a result, health care is undergoing significant changes globally in R&D, marketing, pricing, sales, and distribution. This course helps students to understand these processes and the new business opportunities and new business models they will create. It provides some of the basics of macro and microeconomics to clarify how economic and social forces drive changes in the pharmaceutical, biotech, and genetic industry. Emphasis will be placed on the application of economics.

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 covers the basic ethical issues associated with the responsible conduct of biomedical research using animals and human subjects. Students explore ethical dilemmas and decisions central to these issues, such as the appropriate use of animals in research, misconduct in science, informed consent for human subjects, the role of institutional review boards (IRBs), authorship, data integrity, peer review, intellectual property, and biosecurity.

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 laboratory course illustrates the use of basic mammalian cell culture techniques for bioscience research and commercial applications. Students are introduced to mammalian cell cultivation methods, including proper use of a biological safety cabinet, sterile technique, cell enumeration and media preparation, cultivation of mammalian cell lines, detection of contamination, cryopreservation, transfection, mammalian cell culture scale-up, and bioassays. This course is designed for students with no prior knowledge or with limited knowledge of mammalian cell culture methods. Prerequisites: 410.603 Advanced Cell Biology or equivalent

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 explores how engineered tissues and organotypic models are revolutionizing the drug development process. Students will learn about scaffold design for drug testing, 3D cultures, organoids, organ-on-chip technologies, and how these systems improve translational research outcomes. The course emphasizes applications in pharmacology, toxicology, and personalized medicine. Prerequisites: 410.603 Advanced Cell Biology or equivalent; 410.653 Regenerative Medicine: from Bench to Bedside.

This graduate-level virtual laboratory immerses students in the computational techniques that drive modern drug discovery and target validation. Through a series of hands-on modules, students will learn to design, implement, and interpret computational workflows used across academia, biotech, and pharmaceutical R&D. The course emphasizes practical skill-building in molecular modeling, structure preparation, ligand design, docking, virtual screening, cheminformatics, and ADMET prediction. Students will work with real protein structures, chemical libraries, and biological datasets to evaluate target druggability, identify potential lead compounds, and assess pharmacological properties. Using industry-standard and open-source tools, students will gain experience constructing reproducible computational pipelines that mirror early-stage discovery processes. The course integrates structural biology, medicinal chemistry principles, and data-driven decision-making to provide a comprehensive understanding of how computational methods support and accelerate drug development. By the end of the course, students will be able to independently execute computational experiments, critically analyze results, and communicate findings in formats aligned with professional scientific practice. Prerequisites: 410.751 Drug Design and Chemical Libraries.

This course covers basic ethical notions in the conduct of research into regenerative medicine. Specific case studies involving informed consent, gene editing, organ transplantation, animal research, sources of stem cell lines, the use of placebos, and eugenics will be covered. Students will examine navigating the institutional research boards of different universities, hospitals, and institutions. Authorship, peer review, conflict of interest, and copyright law will be discussed. Students will explore international differences and approaches to the ethics of regenerative medicine and how that affects practice and how patients are treated.

Researchers must communicate effectively so their discoveries can be shared with others. In this course, students learn how to communicate their ideas to other researchers, their scientific peers, and investment communities. Students master both written and verbal communication skills, hone their expertise at making both formal and informal oral presentations, prepare poster presentations, and develop their own public speaking strategies. The course also presents personal strategies for improving daily communications, cross-cultural communications, and nonverbal skills. Students improve their written communication, editing, and informal writing skills. Participants also learn effective email strategies for getting their message across and learn how effective writing can improve their chances of getting grant applications approved. Class assignments include preparation of scientific papers, general science writing, oral presentations, PowerPoint presentations, and scientific posters.

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.

Pharmaceutical/biotechnology product approval and marketing requires a good understanding of international regulatory affairs in order to successfully compete in today’s global marketplace. It is important for tomorrow’s leaders to understand and follow the regulatory differences to ensure optimum product development strategies, regulatory approvals, and designs for exports conforming to the foreign regulatory bodies. There are various product development strategies that industry is using to shorten the product development time by conducting preclinical programs outside the U.S., but the strategies require careful planning and interaction with the U.S. and foreign regulatory agencies. With the increased globalization of economy and exports, international regulations will have a bigger impact on the biotechnology business in the future. The course provides a review and analysis of the pharmaceutical/biotechnology product approval processes within the world’s major markets. The key strategies required in phases from preclinical product development to marketing approval of the products in Europe, Japan, and the U.S. will be compared and discussed. Students will explore the European Union regulations and their overall importance to international markets. The course will cover the salient features of common technical and regulatory documents required for submission and approval to the leading regulatory bodies in the world, general guidance documents, international harmonization, and the General Agreement on Tariffs and Trade.

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 integrative, case-based course will focus on applying knowledge gained from previous courses in the Master of Science in Regulatory Science program to actual cases from the FDA. For each case, students will assume the role of a regulatory specialist, an FDA reviewer or senior-level policy-maker, or other involved stakeholders, such as a consumer group or an advocacy group. Students will be expected to research, evaluate, and present scientifically and legally justifiable positions on case studies from the perspective of their assigned roles. Students will present their perspectives to the class and be asked to debate the issues with the other students from the perspective of their assigned roles. The major responsibility of the students in this course will be to make scientifically and legally defensible recommendations and to justify them through oral and written communication.

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.

Understanding validation and applying a comprehensive validation philosophy are essential in today’s biotechnology industry. First and foremost, validation allows a company to operate in compliance with the regulations and guidance set forth by the FDA. Perhaps more importantly, it results in equipment assays and processes that are well-understood and robust, less prone to failure, and more cost-effective. This course will introduce the fundamentals of validation, validation master planning, resource management, types of validation and the associated documentation, departmental roles and interactions, and the differences between commissioning and validation. Students will have the opportunity to solve real-world problems, generate actual validation documents, and develop validation program elements that balance regulatory requirements, operational needs, and business expectations.

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.

Biotechnology impacts the world and our social, political, and physical environment in ways that many both inside and outside the industry may not fully understand or appreciate. It is critical to ensure that advances in biotechnology be accompanied by important public, political, and social considerations and discussions. This course will cover issues including domestic and global public perception of biotechnology, its benefits and risks, advances in bio-agriculture and genetically modified food, the impact of recombinant therapeutics on the pharmaceutic and health care industry, ways in which advances in biotechnology have and will continue to change our views of what life is, and how the political climate impacts advances in biotechnology discoveries. This highly interactive course will include thought-provoking debate and discussion with industry leaders, both proponents and opponents of biotechnology.

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.

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.

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.

As artificial intelligence (AI) and software play an increasingly critical role in biomedical science and healthcare, understanding their regulatory landscape is essential. This course explores how the U.S. government, particularly the FDA and other regulatory agencies, oversees AI/ML-based technologies, digital health solutions, and software used in biomedical applications. Topics include the regulation of software as a medical device (SaMD), model-informed drug discovery (MIDD), AI-driven diagnostics and imaging, telehealth platforms, electronic health records, clinical trial technologies, and laboratory information management systems. Additionally, the course examines HIPAA privacy rules, cybersecurity considerations, real-world evidence applications, and evolving policies for AI in regulatory decision-making.

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 will explore how biotechnology innovators are solving social issues, including developing medical diagnostics, discovering effective and safer medicine, producing cleaner energy, remediating environmental contamination, and improving crop yields. Students will think broadly in terms of the roles required to tackle these social, economic, health, and environmental issues and how these roles can add value to society.

This course will cover social entrepreneurship principles and practices in a range of sectors, including corporate social responsibility and public value missions in emerging markets. Students will have the opportunity to define their role in advancing biotechnology as it relates to the top global challenges.

Medical products brought to market need to have a sound payment, coding, and coverage strategy.  Medicare covers over 100 million Americans and it leads the way in all United States insurance policies.  This course will provide insight into how medical product reimbursement works and allow students to understand how the Centers for Medicare & Medicaid Services (CMS) considers medical products for coverage, coding, and payment.  We’ll review the history of Medicare coverage and the regulations.  We’ll focus primarily on strategies used to get reimbursement for medical products—both at the national and local levels.

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.

The global food supply relies on shared confidence amongst retailers, manufacturers, consumers, and governments, that food is sourced, produced, and distributed in a safe manner. Auditing of food safety programs, whether by 3rd parties, internal auditors, or regulators, is critical to maintaining industry credibility, efficiency, and safety. A brief overview of food law, a review of HACCP, and the principles and practices of auditing are included. Assessment of Food Defense, Foreign Supplier Verification, organic food certification, labeling, and recall plans is also covered. This course is designed to help strengthen the fundamentals of auditing skills to ensure that food safety standards are being adhered to on a consistent basis.

This course addresses regulations that govern the manufacturing practices of dietary supplements, labeling compliance, ingredient safety, permitted claims and enforcement/litigation trends, adverse event reporting, the implications of FTC and FDA regulations, emerging issues and solutions, and relevant regulatory practices around the world. This course will enhance students’ abilities to manage the regulation of dietary supplements in human food and animal food/feed manufacturing sectors.

This course examines American food policy and regulation through the lens of USDA, FSIS. Students will (1) examine federal inspection of food from its birth in the 19th Century to the rise of the Food Safety Inspection Service as a single regulatory agency; (2) examine the use of ‘adulterated’ and ‘misbranded’ as the foundational standard for all food safety policy, and (3) apply those standards in a 21st Century federal inspection system. Coursework is built around a project in which students work through the policy and regulatory hurdles to obtaining federal inspection services. Course work concludes with an examination of federal enforcement authority and state inspection programs.

The Food Safety Regulation course is designed to provide students with in-depth knowledge and practical skills in ensuring the safety and quality of cannabis-infused food products. The course will cover regulatory compliance, food safety protocols, and the unique challenges associated with the cannabis industry, preparing students for leadership roles in this emerging field.

Given the costly drug development process and the limited resources of emerging biopharmaceutical companies, developing an early regulatory strategy - starting well before clinical trials are initiated - is extremely important for the success of a company. This course will discuss different regulatory strategies that several players of the U.S. biopharmaceutical industry have employed. Students will learn about interacting with regulatory agencies, the orphan drug development, accelerated approval, fast track, priority review, and other regulatory mechanisms, pharmacogenomics and biomarkers, adaptive clinical trials, animal rule, generic drug development, and biosimilars. Using case studies, the impact of these regulatory strategies on drug development, and how these strategies have helped many biopharmaceutical companies will be discussed. At the end of this course, students will better understand federal regulations and the aspects involved in developing efficient regulatory strategies.

Innovation is the creation of value from new ideas, concepts, methods, materials, and organizational structures. Life sciences organizations that seek to create value for their stakeholders must do so using available capital resources, including financial capital, human capital, intellectual capital, and physical capital. They should manage those resources to gain leverage and maximize value realized. They then seek to defend and control the value created. Why, then, do most organizations treat innovation (and innovators) in ways similar to the body’s immune system (i.e., by identifying the innovators, isolating them, “killing” them, and ejecting them from the organization? This course will explore innovation, invention, and value creation as a driving force in the biotechnology or life sciences enterprise as well as the ways in which managers should plan to take full advantage of innovation as the only true competitive weapon for long-term success. A special emphasis will be placed on innovation as applied to life science applications (biotechnology, medical devices, health care delivery, drug discovery, development and packaging, bioinformatics, etc.). Topics include invention, ROI, disruption, creative destruction, types of innovation, technology brokering, organizational structures that foster innovation, planning, and managing for innovation. Students are required to read extensively, participate actively in discussions, do case studies, and develop a convincing pitch for an innovation project.

This course examines manufacturing processes of current and emerging treatments that utilize therapies derived from biological sources as treatment for injury or disease, including cell and gene therapies. Students will become familiar with the state-of-the-art in biomanufacturing, stem cell differentiation, purification of biological materials, drug delivery, and explore challenges/gaps in current biological-based treatments. The course will explore processes at the development, pilot, and industrial scale. Prerequisites: 410.603 Advanced Cell Biology or equivalent; 410.653 Regenerative Medicine: from Bench to Bedside.

In this course, we study the nuts and bolts of putting together a new company and explore financial markets and the economics of life science companies. The course includes weekly discussions based upon textbook and outside reading materials; the latter are often topical and speak to the issues of the day and how they may affect investor’s confidence and funding. Video presentations on the part of all students are required. We will examine the roles of corporate officers and the venture community. The students will learn what makes the startup process both attractive and difficult, and will work through that process in a realistic manner.

Next-generation sequencing (NGS) technology has revolutionized the field of genomics, enabling high-throughput analysis of DNA and RNA at unprecedented depths and speeds. However, the quality of NGS data is heavily dependent on the quality of the starting material and sample preparation methods used. This laboratory course aims to provide students with hands-on training in the most widely used NGS sample preparation techniques. The course will cover topics such as DNA and RNA extraction, library preparation, quality control, and quantification methods for NGS samples. The course will consist of both theoretical and practical sessions. In the theoretical sessions, students will learn about the underlying principles and theories behind each sample preparation method. In the practical sessions, students will be trained on laboratory techniques involved in NGS sample preparation, including the use of relevant equipment and software. Prerequisites: 410.656 Recombinant DNA Laboratory or approval of academic advisor.

This course will provide students with knowledge of the basic laws and regulations affecting the advertising and promotion of drugs, biologics, and medical devices. This course is specifically designed to illustrate how the law and regulations are applied on an everyday basis using case study examples as well as provide historical context on regulations and strategies used in the past.

Drug Design and Chemical Libraries explores pharmacological space with an emphasis on disciplines related to drug discovery, and an understanding of the properties desirable in a drug. Medicinal chemistry, natural product chemistry, focused synthetic libraries, and combinatorial chemistry will be covered. The application of Lipinski's rules for assessing drug-like molecules will be discussed in detail, as well as methods for chemical analysis, in silico drug design, molecular modeling, and compound storage and handling. Also, techniques used for assessing and harnessing chemical diversity for drug discovery will be discussed. Students will gain a fundamental understanding of small molecules at the atomic level as well as insights into the structure-activity relationship. Both are critical to the design and synthesis of chemical libraries that efficiently explore therapeutically useful chemical space and to drug design. Prerequisites: 410.603 Advanced Cell Biology or equivalent.

This course is designed to help students working for life sciences companies understand the fundamentals of obtaining government funding for product/technology research and development. While the emphasis will be on grant funding from the National Institutes of Health, other Federal and state funding mechanisms will also be covered. Students will learn how to search for funding opportunities and receive an overview of the NIH funding mechanisms as well as explore the background and history of the Small Business Innovation Research (SBIR) program. The course will provide insights on preparing an SBIR proposal and submission procedure. Fundamentals of government contracting law will also be covered.

The ability to successfully navigate the intersections of law, regulation, guidance, and policy has never been more critical to the success of entities engaged in medical product development and commercial marketing. The entities that make up this industry are very sophisticated in their abilities to innovate at a blazing speed. In contrast, regulators must use a regulatory model that evolves and adapts much slower than their industry counterparts. As a result, regulators are relying more heavily on policy to drive their strategy, actions, and outcomes. Therefore, a clear understanding of regulatory policy is an essential consideration for individuals engaged in the medical product development industry. This course provides an introduction to several key areas of government regulatory policy (both old and new) and regulatory science. The topics covered in this course will serve as a road map for students who want to successfully navigate within this complex and changing regulatory model.

Students in Center for Biotechnology Education (CBE) MS programs have the opportunity to enroll in an independent research course. This elective course is an option after a student has completed at least eight graduate-level courses and has compiled a strong academic record. Prior to proposing a project, interested students must have identified a research topic and a mentor who is familiar with their prospective inquiry and is willing to provide guidance and oversee the project. The research project must be independent of current work-related responsibilities as determined by the project mentor. The mentor may be a faculty member teaching in the biotechnology program, a supervisor from the student’s place of work, or any expert with appropriate credentials. Students are required to submit a formal proposal for review and approval by the biotechnology program committee. The proposal must be received by the instructors ideally one month prior to, and no later than one week after, the beginning of the term in which the student wants to enroll in the course. Students must meet with a member of the program committee periodically for discussion of the project’s progress, and a written document, poster, and oral presentation must be completed and approved by the program committee and project mentor for the student to receive graduate credit. Additional guidelines can be obtained from the AAP administrative office. Prerequisites: Full-time students - six classes counting toward degree completion, Part-time students - eight classes counting toward degree completion

This course is only open to students in one of the programs in the Center for Biotechnology Education and may be taken only after the student has completed seven classes toward degree completion (including all core classes). Before enrolling in this class, interested students must (1) identified a study topic, (2) secure a mentor who is familiar with the prospective inquiry, a recognized expert in the field, and has agreed to provide guidance and oversee the project, and (3) submit a proposal to the Center’s program committee (Program Directors and the Center Director) at least one month before the start of the semester in which the student wants to enroll in the course. The study project must be independent of current work-related responsibilities as determined by the project mentor. The goal of the study project is to produce publishable quality data/information. During the semester, students must (1) meet often with the mentor to give updates on progress, (2) periodically interact with a member of the program committee to discuss the project's progress, and (3) submit a written document or file(s) containing the completed work, which must be approved by the program committee and project mentor for the student to receive any credit hours. The study project must be independent of current work-related responsibilities as determined by the project mentor. The goal of the study project is to produce publishable quality data/information. During the semester, students must (1) meet often with the mentor to give updates on progress, (2) periodically interact with a member of the program committee to discuss the project's progress, and (3) submit a written document or file(s) containing the completed work, which must be approved by the program committee and project mentor for the student to receive any credit hours.

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 is open only to students in the MBEE or the MS in Biotechnology with a concentration in Enterprise and may be taken only after the student has completed five courses and has compiled a strong academic record. Prior to proposing a project, interested students must have identified a study topic and a mentor who is familiar with their prospective inquiry and who is willing to provide guidance and oversee the project. The study project must be independent of current work-related responsibilities as determined by the project mentor. The mentor may be a faculty member, a supervisor from the student's place of work, or any expert with appropriate credentials. The goal of the study project should be a "publishable" article. Students are required to submit a formal proposal for review and approval by the enterprise/regulatory program committee. The proposal must be received by the Advanced Academic Programs office no later than one month prior to the beginning of the term in which the student wants to enroll in the course. Students must interact with a member of the program committee periodically for discussion of the project's progress, and a written document must be completed and approved by the program committee and project mentor for the student to receive graduate credit. Additional guidelines can be obtained from the AAP administrative office.