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. Prerequisites: 410.601 Biochemistry or equivalent.

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: 410.601 Biochemistry or equivalent; 410.602 Molecular Biology or equivalent; 410.603 Advanced Cell Biology or equivalent.

This foundational biotechnology course provides the biotechnology student 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, commercialization) for biotechnology enterprise formation, development, and operation. A course-long project involving several assignments that include aspects of a biotechnology organizational simulation is reflected in a student learning organization (SLO) construct. Course Prerequisites: AS.410.601 Biochemistry or equivalent, AS.410.602 Molecular Biology or equivalent, AS.410.603 Advanced Cell Biology or equivalent, or approval of program committee.

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.

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.

Regulatory affairs are comprised of the rules and regulations that govern product development and post-approval marketing. In the U.S., the FDA establishes and oversees the applicable regulations under several statutes, many regulations, and partnerships with legislators, patients, and customers. Biotechnology products may be classified as drugs, biologics, or medical devices. Each type is regulated by a different center within the FDA. This course provides an overview of RA and its effect on product development. Topics include RA history, regulatory agencies, how to access regulatory information, drug submissions, biologics submissions, medical device submissions, GLP, GCP, GMP, and FDA inspections.

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.

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.

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. SCI

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 drugs, biologics, and medical devices 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 the approach called project management to handle activities that have a limited life span as opposed to routine, ongoing operations. This course will answer the question, “What do I do to be successful?” The units 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 rely heavily on group discussions. Topics will include deciding making decisions, developing a project plan, risk management, team leadership, monitoring and controlling during the project, scope change control, and traditional and modern approaches to project closeout. Concepts presented will be consistent with the Project Management Institute’s “Guide to the Project Management Body of Knowledge,” the U.S. standard for project management.

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. Discussions will address the leadership needs of organizations from early-stage, research-based companies through fully integrated biopharmaceuticals. General leadership practices and strategies, moving ideas from the research bench to the consumer, and strategies to prevent failure will all be discussed.

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.

Software continually grows more complex and is becoming relied upon by health care professionals in the treatment of patients. This course describes how the U.S. government regulates software used in delivering health care, including the regulations utilized by the FDA and the Centers for Medicare and Medicaid Services. This course covers a wide range of topics, including FDA regulation of software as a medical device and software validation, medical imaging software regulation, electronic record keeping and software used in clinical trials, laboratory information management systems, and HIPAA privacy rules and security standards.

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.

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.

Food safety audits provide a credible verification system to the entire food processing industry, including retail environments, meat, fish, and poultry, vegetable, and produce suppliers. Having a HACCP plan in place is often the first step to a successful food safety program, but is not entirely enough to ensure that food safety standards are being adhered to on a consistent basis. In this course, students will learn how to adequately plan for a food crisis situation.

While review of devices prior to marketing plays a significant role in ensuring that patients and providers have access to safe and effective medical devices, continued post market surveillance of devices after they reach the market is crucial to protecting public health. The Office of Surveillance and Biometrics (OSB) within the FDA’s Center for Devices and Radiologic Health (CDRH) is responsible for overseeing the continued post market surveillance of medical devices. This course covers regulatory requirements for industry once a device reaches the market as well as the post market surveillance requirements and activities performed by the FDA. Students will discover the multifaceted approach to medical device post market surveillance through topics including Post market Surveillance Studies, 522 Studies, Registries, Medical Device Reporting (MDR) & Complaint Handling, the MedSun Program, Medical Device Tracking, Unique Device Identification (UDI), MDEpiNet, and Real-World Data/Evidence & the National Evaluation System for health Technology (NEST).

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.

This course provides a comprehensive overview of in vitro diagnostic (IVD) devices and how they are regulated by the U.S. Food and Drug Administration (FDA) and by international organizations such as the European Union (E.U.). Topics that will be covered include: (1) a summary of the U.S. and international laws, regulations, and policies that govern IVD devices, (2) administrative and legal requirements and resources for IVD devices throughout the full product life-cycle, (3) types of IVD devices, (4) coverage and reimbursement of laboratory tests, and (5) current issues and developments. Upon completion of this course, the student will have a working knowledge of the requirements and policies of the regulation of IVD devices.

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.

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.

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.

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: All core courses for your degree program and four additional courses.

This course is open only to students in the MS in Regulatory Science program or the MS in Biotechnology with a concentration in Regulatory Affairs and may be taken only after the student has completed 5 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 regulatory science 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.

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 is only open to students completing the Master of Biotechnology Enterprise and Entrepreneurship program.

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.