State-specific Information for Online Programs
Note: Students should be aware of state-specific information for online programs. For more information, please contact an admissions representative.
410.302 - Bio-Organic Chemistry
This course provides a foundation in structural organic chemistry, acid base chemistry, chemical thermodynamics, and reaction mechanisms. Subjects include Lewis structures, atomic and hybridized orbitals, stereochemistry, inter- and intramolecular forces of attraction, neucleophilic reaction mechanisms, functional groups, and the organic chemistry of biological molecules. Please note that this course does not count toward requirements for the masterâs degree in biotechnology. Prerequisite: two semesters of college chemistry. S
410.303 - Foundations in Bioscience
This course examines the fundamental underlying scientific concepts utilized in the creation and development of biomedical products. Topics to be covered include the structure and function of biomolecules, such as proteins, enzymes, carbohydrates, lipids, and DNA, as well as the structure and function of cellular components, such as membranes, vesicles, organelles, and the cytoskeleton. In addition, students will examine the complexities of metabolism, DNA replication, transcription, translation, signal transduction mechanisms, apoptosis, the cell cycle, and cancer. Please note that this course does not count toward requirements for the masterâs degree in either biotechnology or regulatory science and is required as a prerequisite course for some students entering the Master of Science in Regulatory Science. Pre-requisites: one year of college chemistry and one year of college biology or permission of program director. S
Core Courses - MS in Biotechnology
410.601 - Biochemistry
This course explores the roles of essential biological molecules focusing on protein chemistry, while covering lipids and carbohydrates. It provides a systematic and methodical application of general and organic chemistry principles. Students examine the structure of proteins, their function, their binding to other molecules, and the methodologies for the purification and characterization of proteins. Enzymes and their kinetics and mechanisms are covered in detail. Metabolic pathways are examined from thermodynamic and regulatory perspectives. This course provides the linkage between the inanimate world chemistry and the living world of biology. S
410.602 - Molecular Biology
This course provides a comprehensive overview of the key concepts in molecular biology. Topics to be covered include nucleic acid structure and function, DNA replication, transcription, translation, chromosome structure, and remodeling and regulation of gene expression in prokaryotes and eukaryotes. Extended topics to be covered include method in recombinant DNA technology, microarrays, and microRNA. S
410.603 - Advanced Cell Biology I
This course covers cell organization and subcellular structure Students examine the evolution of the cell, chromosome, and plasma membrane structures and behaviors; 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. S
410.604 - Advanced Cell Biology II
This course is a continuation of 410.603 Advanced Cell Biology and further explores cell organization and subcellular structure Students examine cell-to-cell signaling that involves hormone and receptors, signal transduction pathways, second messenger molecules, cell adhesion, extracellular matrix, cell cycle, programmed cell death, methylation of DNA and modification of chromatic structure, and mechanisms of the cell. The involvement of abnormalities in signal transduction pathway to oncogenes is and other disease states will be stressed. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I. S
Enterprise and Regulatory Affairs Courses
410.607 - Proseminar in Biotechnology
The Biotechnology Proseminar introduces students to issues and challenges facing leaders of public and private-sector organizations, and communities seeking to achieve shared goals within the biotechnology industry. The course brings together diverse academic science and business disciplines (science, regulatory affairs, marketing, finance, legal, ethics, communications, etc.). It explores how these disciplines can be used as powerful tools to create effective leadership and productive collaborations within the industry, while improving managerial decision-making.
410.627 - Translational Biotechnology:From Intellectual Property to Licensing
This course provides an extensive overview of a process for 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, manufacture, 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: 410.303 Bioscience for Regulatory Affairs, OR 410.601 Biochemistry and 410.603 Advanced Cell Biology I or admission to the MS in Regulatory Science OR Master of Biotechnology Enterprise and Entrepreneurship programs.
410.637 - Bioethics
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.
410.642 - Economic Dynamics of Change in Biotechnology
Governments around the world are beginning a long-term process that reviews and redesigns its 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.
410.643 - Managing and Leading Biotechnology Professionals
The roles of managers and leaders within biotechnology companies undergo constant change. Biotechnology manager 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 a competitive advantage. The student is able to address 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 goa integration. Students research a biotechnology organization, analyze what is working and not working within the management systems, and suggest alternatives.
410.644 - Marketing Aspects of Biotechnology
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 prove helpful to anyone in the industry.
410.646 - Creating a Biotechnology Enterprise
This course provides a foundation to start or help grow 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 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 guest lecturers for many of the classes.
410.647 - Research Ethics
This course covers the basic ethical notions in the conduct of biomedical research with animals and human subjects that make up the core values of scientific integrity. Students explore issues central to these areas, such as the appropriate use of animals in research, informed consent for human subjects, authorship, peer review, and the ethics of the business of science.
410.649 - Introduction to Regulatory Affairs
Regulatory affairs comprise the rules and regulations 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 partnership 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.
410.650 - Legal Aspects of Biotechnology
This course is a survey of legal topics relevant to a biotech enterprise as it is established, conducts research, and brings innovative products to market. These include property, contracts, regulatory compliance, and patents. Students will be able to analyze common business situations and understand how associated legal risks are managed. Students who have taken 410.687 Ethical, Legal and Regulatory Aspects of the Biotechnology Enterprise will also benefit from this course, as they will analyze contracts, patents, and various statutes and court decisions that impact the biotechnology sector.
410.665 - Bioscience Communication
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.
410.675 - International Regulatory Affairs
Pharmaceutical/biotechnology product approval and marketing requires a good understanding of international regulatory affairs in order to successfully compete in todayâs global marketplace. It is important for tomorrowâs 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 strategy requires careful planning and interaction with the U.S. and foreign regulatory agencies. With the increase in 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 worldâs major markets. The key strategies required in 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 on 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.
410.676 - Food And Drug Law
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.
410.677 - Preparing a Successful Submission
This course provides a comprehensive overview of the U.S. Food and Drug Administrationâs (FDAâs) regulation of the research and development, and marketing of new drugs, biologics, and medical devices.Â 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.Â The content and format requirements for the preparation, submission, and maintenance of these applications will be covered.Â Â
410.678 - Marketing in a Regulated Environment
This course is designed to help students understand how companies can effectively achieve their marketing goals while complying with the laws, regulations, and policy guidance documents governing marketing, advertising, and promotion of products regulated by the FDA. The course provides an overview of marketing, in a context of FDA regulations. We offer perspectives and real-world discussions of the FDAâs advertise and promotion oversight and enforcement responsibilities. The course focuses on types of marketing and promotion activities that are commonly used in the industry for marketing drugs and diagnostics. We cover strategies and activities that can be effectively incorporated into overall marketing, including reimbursement, pricing, distribution, social media, channel management, and others, using current industry best practice The course introduces students to advertising guidelines associated with regulated products. It provides insights on effective marketing research approaches, including analysis to current markets, patient profiles, competition, pricing, the value of comparative data, and issues associated with unapproved investigational products and unapproved research products.
410.679 - Practicum in Regulatory Science
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 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. Please note this course is only open to students in the Master of Science in Regulatory Science and should only be taken after all required courses are completed.
410.680 - Finance for Biotechnology
Students will build an understanding of the basics of contemporary global monetary systems and the essentials of financial management. This course will include a 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 a means to understand 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.Â S
410.681 - Commercializing Biotechnology
This advanced course provides an integrated and practical approach to considering the principal areas of concern an entity faces when commercializing biotechnology, from creating or obtaining the technology through partnering with others to further develop and commercialize the technology, and finally selling the business or business line that incorporates that technology. The focus of this course is to highlight key junctures in a biotechnology companyâs evolution; help students identify key financial, management, and business issues at those junctures; and present practical alternatives for students to consider to resolve those issues. This course builds upon 410.650 Legal Aspects of Biotechnology and 410.646 Creating a Biotechnology Enterprise, but they are not prerequisites for the course.
410.682 - Validation in Biotechnology
Understanding validation and applying a comprehensive validation philosophy are essential in todayâs biotechnology industry. First and foremost, validation allows a company to operate in compliance with the regulations and guidance set forth by 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 interaction and the differences between commissioning and validation. Students will have an opportunity to solve real-world problems generate actual validation documents, and develop validation program elements that balance regulatory requirements, operational needs, and business expectations.
410.683 - Introduction to cGMP Compliance
Current Good Manufacturing Practice regulations are the minimum standards for the design, production, and distribute 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 actively enforced by 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 FDAâs 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 âbest-practicesâ approaches, and the FDAâs current expectations. Students will also learn to apply practical solutions to the regulatory issues faced in the pharmaceutical and biotech industries today.
410.684 - Technology Transfer & Commercialization
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 organization.
410.685 - Emerging Issues in Biotechnology
Biotechnology impacts the world and our social, political, and physical environment in ways many both inside and outside t 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 any risks, advances in bio agriculture and genetically modified foo 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.
410.686 - Regulation of Good Food Production Practices
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.
410.687 - Ethical,Legal & Regulatory Aspects of the Biotechnology Enterprise
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 and intellectual property and 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.
410.688 - Project Management in Biotechnology
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, âWhat do I do to be successful?â 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 what to do, 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 Instituteâs âGuide to the Project Management Body of Knowledge,â the U.S. standard for project management.
410.689 - Leading Change in Biotechnology
As bioscience companies grow and mature, leadership needs to evolve. Students will learn how to identify their companyâs position in the âLeadership Life Cycleâ 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 research bench to the consumer, and strategies to prevent failure will all be discussed.
410.701 - Introduction to Food Safety
This course is designed to understand the legal and regulatory complexities of the regulation of food products in the United States. The prone issues, including regulatory compliance in food safety and Hazard Analysis and Critical Control points (HACCP), are among major issues to control the food-supply. The FDA and the U.S. Department of Agriculture (USDA) have primary responsibility for safety of meat and food products. Based on the principles of HACCP, FDA-issued seafood regulations effective in December 1997. However, the regulation of food additives, labeling, dietary supplements, genetic modifications, and the protection of the food supply will provide the in-depth food regulation in the United States. The FDA and USDA regulate the safe practice of primary and secondary food products to the American public. Depending upon the source and nature of food product, the method of shipment, advertisement of nutritional values, etc., are being governed by FDA and USDA jurisdictions. The Food Safety Modernization Act overhauls the FDA in food surveillance, enforcing regulations on specific targets, inspection records examination, and exemptions. In this course, students will learn the existing food regulations and safety net by examining the product tracing, performance standards, and preventive control plans toward food safety, security, genetic modifications, dietary supplements, and food labeling. Students will have option to design projects to propose an effective food safety net that can assist in the supply chain of the nationâs food safety and security.
410.702 - Biomedical Software Regulation
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.
410.703 - Strategic Planning for the Biotechnology Enterprise
This course is an overview of the strategic planning process of a biotechnology enterprise. It focuses on creating value through strategy formulation and implementation. Topics covered include leadership and technology competencies, performance indicators, intellectual property, corporate governance, regulatory strategy, and appropriating value. The thesis of the course is that effective strategic planning and implementation is critical to success, and that it provides a valuable, structured process to create enterprise value and manage business risks. Best practices in strategic planning and managing the planning process are also provided.
410.704 - Social Entrepreneurship in BioScience
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 roles required in tackling these social, economic, health, and environmental issues, and how they 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 opportunities to define their role in advancing biotechnology as it relates to the top global challenges.
410.710 - Economic Policy and Support Structures the Bio Entrepreneur
This course will explore how key actors are establishing support and advocating legislative priorities for biotechnology innovations. Students will review economic development of biotechnology clusters and local, state and federal policy factors that impact the biosciences and public views on this sector.
Students will have opportunities to explore the services and support available in advancing biotechnology.
410.715 - Medical Device Regulation
This course provides a comprehensive introduction to medical devices and how they are regulated by the FDA. Topics that w be covered include an overview of the laws and regulations that govern medical devices, the FDAâs 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 a mock enforcement action. Upon completion of this course, the student will have a working knowledge of the requirements a policies of FDA regulation of medical devices.
410.717 - Risk Assessment and Management
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 the 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.
410.718 - Food Safety Audits and Surveillance
Food safety audits provide a credible verification system to the entire food processing industry including retail environment meat, fish, and poultry, vegetable and produce suppliers. Having a HACCP plan in place is often a 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.
410.727 - Regulatory Strategies in Biopharmaceuticals
Given the costly drug development process and the limited resources of emerging biopharmaceutical companies, developing an eGiven 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 biosimilar. 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.arly 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.
410.728 - Managing Innovation in the Life Sciences
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: 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 bodyâs immune system (i.e., by identifying the innovators, isolating them, âkillingâ 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, and 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.
410.729 - Regulatory & Economic Fundamentals of Drug Pricing & Reimbursement
The US government is now the single largest purchaser of drugs in the world. As the realities of the economic crisis and long term health care reform take root, pricing of pharmaceutical products and the reimbursement regulations that attach to drugs will shape research and development for years to come. As regulatory hurdles continue to climb, the burden of proof will increasingly continue to be on the pharmaceutical industry to prove the value of an individual pharmaceutical product. This course will examine the elements of pharmaceutical pricing and reimbursement to better understand accepted drug pricing models, and how both government and industry look at drug pricing and reimbursement. This will include cost-efficiency modeling of the drug development and manufacturing process, therapeutic cost utility and cost benefit analysis, US and international pharmaceutical product registration, accepted methods for valuing pharmaceuticals, macro- and microeconomic analysis and drug development decision modeling as part of a framework for health care economic evaluation, and the political and ethical underpinnings of health care reform as it reflects on the need for government and society to define the fundaments of drug pricing and reimbursement. The goal will be to provide the framework for the pharmaceutical industry professional to better understand the regulatory and economic fundamentals of drug pricing and reimbursement.
410.732 - Funding a New Venture
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 investorâs 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.
410.756 - Grants and Federal Funding for Biotechnology Enterprises
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 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.
410.799 - Current Topics in Regulatory Policy
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 the 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 us 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 introduction into 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 change regulatory model.
410.802 - Independent Studies in Regulatory Science
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.
410.803 - Regulatory Science Thesis
Students wishing to complete a thesis may do so by embarking on a two-semester thesis project, which includes 410.802 Independent Studies in Regulatory Science Project and 410.8 Biotechnology Thesis courses. This project must be either a hypothesis-based or research question-based original research study. The student must complete 410.802 Independent Research Project and fulfill the requirements of that course, including submission of project proposal, final paper, and poster presentation, before enrolling in the subsequent thesis course. For the thesis course, students are required to submit a revised proposal (an update of the 410.802 proposal) for review and approval by the faculty adviser and biotechnology program committee one month prior to the beginning of the term. Students must meet the faculty adviser periodically for discussion of the projectâs progress. Graduation with a thesis is subject to approval by the thesis committee and program committee, and requires the student to present his/her project to a faculty committee both orally and in writing. Prerequisites: All required regulatory science courses and three elective courses, which must include 410.802 Independent Studies in Regulatory Science and, if hypothesis driven, 410.645 Biostatistics.
410.804 - Practicum in Biotechnology Enterprise & Entrepreneurship
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.
410.806 - Independent Studies in Biotechnology Enterprise and Entrepreneurship
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 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 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.?
Health Science Intensive Courses
410.705 - Problem-solving for Innovation in Health Care
Whether tackling small business challenges in a clinic or creating global initiatives, being a health care provider means being a problem-solver. This course focuses on helping students develop problem-solving strategy and innovation development models necessary for every health care provider to more effectively tackling challenges. Students will develop a working knowledge of design thinking principles and techniques as well as how they can be utilized to create positive change in any context. While evaluating real-world problems, students will consider how these techniques can be utilized to turn an innovative idea into an effective solution. Students will work collaboratively on real-world projects, turn their ideas into practical action, and demonstrate their ability to leverage health care and social innovation to bring change through community-based and global initiatives.
410.706 - Building and Leading Teams in Health Care
In order to provide the best care possible, health care professionals are working together more now than ever before. As a result, strong leadership and teamwork skills are becoming necessities in joining the health care field. This course will provide hands-on activities to help students develop problem solving skills, learn basic negotiation and mediation strategies and understand their own tendencies as leaders and team members. Using real-world examples, students will explore how strong leadership and teamwork can drive innovative solution to public health issues.
410.707 - The Psychosocial Determinants of Health, Implications on Diagnostics
In this capstone course, students will learn basic diagnostic techniques and use case studies to explore the relationship between physiological illnesses and diagnostic output. Through discussions and guided interviews, students will explore the role of psychology and sociology in patient care choices, as well as physician recommendations to patients. Students will practice cultural sensitivity through group activities and discussion of pressing public health issues. Students will undertake final group projects that identify needs in the local community and attempt to create solutions that could feasible be completed with limited resources.
Laboratory Elective Courses
410.652 - Cell Culture Techniques
This laboratory course illustrates the use of basic cell culture techniques for bioscience research and commercial applications. Students are introduced to cell cultivation methods, including proper use of a biological safety cabinet, sterile technique, cell enumeration and media preparation, cultivation of cell lines, detection of contamination, cryopreservation, transfection, cell culture scale-up, and an introduction to bioassays. This course is designed for students with no prior knowledge or with limited knowledge of cell culture methods. Prerequisites: 410.601 Biochemistry, 410.603 Advanced Cell Biology I. S
410.656 - Recombinant DNA Laboratory
This laboratory course introduces students to methods for manipulating and analyzing nucleic acids. Students gain extensive hands-on experience with plasmid purification, restriction mapping, ligations, bacterial transformations, gel electrophoresis, and applications of the polymerase chain reaction. This course is not recommended for students with substantial experience in these methodologies. Prerequisites: 410.602 Molecular Biology. S
410.657 - Recombinant Protein Expression, Production and Analysis
This laboratory course introduces students to the construction, production, processing, and analysis of recombinant proteins from prokaryotic and eukaryotic sources. Concepts include the design, construction, and delivery of recombinant expression clones, expression of recombinant genes in host cells, protein purification, and protein analysis. Laboratory exercises use current techniques and approaches for the cloning, expression, production, purification, and analysis of recombinant proteins in bacteria and mammalian cells. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.656 Recombinant DNA Laboratory, or consent of program committee. S
410.658 - Biodefense & Infectious Disease Laboratory Methods
This laboratory course introduces students to the methods and techniques used for bio threat detection, surveillance, and identification. Using bio simulants and demonstrations, various bio detection platforms will be discussed and presented, such as point-of-detection devices and methods, laboratory-based screening and identification technologies (culture, quantitative PCR, immunoassays, biosensors), and high-throughput environmental surveillance methods. Statistical methods for determining diagnostic sensitivity and specificity and assay validity will be discussed. Laboratory practices and procedures for working in simulated Biosafety Level 2 and 3 environments will be practiced. Students will be introduced to the current bioinformatics genomic and proteomic databases used for select agent (category A, B, and C) identification and characterization. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I, undergraduate microbiology or 410.615 Microbiology, or approval of program committee. S
410.659 - Advanced Recombinant DNA Lab
This course is a continuation of Recombinant DNA Laboratory (410.656), intended for those who have completed the introductory course, or who have extensive molecular biology laboratory experience. This second course consists of a series of integrated laboratory exercises designed to give students hands-on experience with a variety of molecular techniques. Exercises include molecular cloning; PCR optimization; quantitative real time PCR; control of gene expression by RNA interference (RNAi), CRISPR and DNA sequencing. Students will be introduced microarray analysis, and utilization of bioinformatics pipelines. Prerequisites: 410.601 Biochemistry; 410.602 Molecular Biology; 410.656 Recombinant DNA Laboratory; or consent of program committee.
410.660 - Immunological Techniques in Biotechnology
This laboratory course introduces students to methods for analyzing the immune system. Participants gain experience with various immunologic techniques used in research and biotechnology laboratories, such as immunoassays, immunofluorescence, western blot analysis, SDS-PAGE, antibody purification (protein A), and cytokine assays. Additional topics for discussion include hybridism technology phage antibody libraries, therapeutic monoclonal antibodies, and flow cytometry. Prerequisites: 410.601 Biochemistry, 410.6 Molecular Biology, 410.603 Advanced Cell Biology I, 410.613 Principles of Immunology or undergraduate immunology course highly recommended, or consent of program committee. S
410.731 - Bioprocessing and Scale-up Laboratory
This course will provide students with hands-on experience in process development of biological product from a cell bank through purification. Students will develop two products; one produced in bacteria and the other in a mammalian cell culture system. Students will optimize growth conditions on a small scale and then produce the biologic in a bioreactor. Students then purify the product after optimizing purification condition Topics to be covered include microbial fermentation, cell cult production, bioassays, product purification, and the regulator engineering and business principles associated with scale-up a biologic product. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I. S
410.752 - High Throughput Screening & Automation Lab
This course will utilize hands-on instruction in automated bioassay systems for high-throughput screening as an entry point to covering pertinent aspects of HTS, such as data manipulation, storage, and analysis; liquid handling robotics; microtiter plate washing, manipulation, and bar coding; HTS assay detectors; and automated devices for assay setup, validation, and visualization. Cost considerations, HTS amenable assay systems, and miniaturization and scale-up will also be discussed. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology, and 410.696 Bioassay Development. S
Science Elective Courses
410.606 - Clinical Trial Management
The goal of this course is to provide students with a functional understanding of all the operational aspects of a clinical study. At the end of the course, students will be able to think about a study from the point of view of the Study Manager (primary focus of the course), and also from that of different team members, understand how regulations affect and guide a study, and be exposed to common issues and mistakes made during clinical trial Management. Students will learn what happens at the site level and how and why sites are monitored, emphasizing potential site issues and what a study manager and team could do to resolve/prevent problems. An example study protocol will be used throughout the study and students will be required to write and review clinical site monitoring reports. Prerequisites: 410.648 Clinical Trial Design and Conduct. S
410.610 - Epigenetics, Gene Organization & Expression
Students use genetic analysis and molecular biology techniques to investigate chromosome organization, chromatin structure, functional genomics, and mechanisms of differential gene expression. Other topics include DNA methylation, silencers, enhancers, genomic imprinting, and microarray analysis. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology. S
410.611 - Vaccinology
This course will cover the biological development, immunologic concepts, and methods for vaccine delivery. Specific topics include new technologies for vaccine development, such as DNA vaccines, recombinant mucosal vaccines, dendritic cells for antigen delivery, novel adjuvants, and methods to increase vaccine stability. Delivery systems for vaccines, both time tested and new methodologies, such as lipid-based systems, needle- free injection systems, and novel methods, such as the use of genetically modified foods, will be discussed. The underlying biological role of the innate and adaptive immune systems will be explored in light of new types of vaccines and delivery systems. Finally, the process of bringing vaccines to market will be covered, including government oversight and licensure. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I, 410.613 Principles of Immunology, or undergraduate immunology course. S
410.612 - Human Molecular Genetics
In this course, students learn to use the tools of modern genomics to elucidate phenotypic variation within populations. The course uses human disease (from simple Mendelian disorders to common, complex disorders) to exemplify the types of studies and tools that can be used to characterize cellular pathophysiology as well as to provide genetic diagnostics and therapies. Students become facile with linkage analysis, cancer genetics, microarray analysis (oligo and DNA arrays), gene therapy, SNP studies, imprinting, disequilibrium mapping, and ethical dilemmas associated with the Human Genome Project. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology. S
410.613 - Principles of Immunology
This course covers molecular and cellular immunology. Topics include innate immunity, adaptive immunity, the development and function of B cell and T cell antigen receptors, the major histocompatibility complexes, innate effector mechanisms, humoral and cellular immune responses, and regulation of immune responses. Special topics include immunomodulation, immunodeficiency diseases, autoimmunity, evasion and subversion of the immune system by pathogens, immunotherapies, and vaccines. Students are also introduced to the applied aspects of immunology, which include protein and cellular based immunoassays. Prerequisites: 410.601 Biochemistry; 410.602 Molecular Biology, 410.603 Advanced Cell Biology I. S
410.614 - Pathogenic Bacteriology
Lecture and discussion augmented by guided readings on pathogenic bacteria, with special attention to microorganism that cause human disease. The course is designed to impart to the student an appreciation and knowledge of the history, epidemiology, cultivation, morphology, serology, biochemistry and clinical description of the major disease-producing bacteria Discussion of therapeutic considerations and vaccination will also be included in this course. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, undergraduate microbiology course, or permission of program committee. S
410.615 - Microbiology
This course is an overview of microorganisms important in clinical diseases and biotechnology. Students are introduced to the general concepts concerning the morphology, genetics, and reproduction of these microbial agents. Lectures focus on individual organisms, with emphasis on infectious diseases, biotechnology applications, molecular and biochemical characteristics, and molecular and serological identification methods. Students will also discuss the impact biotechnology and particularly genomics, will have on the development of antibiotics and vaccines as treatment and preventive measure Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology410.603 Advanced Cell Biology I. S
410.616 - Virology
This course covers the advanced study of viruses with regard to the basic, biochemical, molecular, epidemiological, clinical, and biotechnological aspects of animal viruses primarily, and bacteriophage, plant viruses, viroidâs, prions, and unconventional agents secondarily. Specific areas of virology, including viral structure and assembly, viral replication, viral recombination and evolution, virus-host interactions, viral transformation, gene therapy, antiviral drugs, and vaccines, are presented. The major animal virus families are discussed individually with respect to classification, genomic structure, viroid structure, virus cycle, pathogenesis, clinical features, epidemiology, immunity, and control. The viral vectors and their application in biotechnology are discussed. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I. S
410.617 - Marine Biotechnology
This course covers the application of molecular techniques to study the marine environment and obtain useful products from marine systems. Students examine recent progress in discovery of drugs and enzymes from marine microbes and microorganisms, biodiversity, bioremediation, molecular approaches in aquaculture, the role of marine microbes in global carbon cycling, and genomics of marine organisms. Prerequisites: 401.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I. S
410.618 - Parasitology
The field of parasitology is immense. It covers a plethora of organisms and a multitude of disciplines. This course focuses on the parasites of medical importance that cause human morbidity and mortality throughout the world. It also introduces the student to the general aspects of parasitology. The developmental biology, natural history, and cell and molecular biology of the major eukaryotic parasites will be discussed. Also, the fundamental mechanisms of host-parasite relationships, diagnosis, pathogenesis, epidemiology, and control strategies will be emphasized. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I. S
410.619 - Molecular Evolution & Phylogenetics
This course covers the principles of molecular evolution and phylogenetics. Topics include patterns and analyses of DNA polymorphism, genetic evolutionary trees, molecular clocks, the evolution of multigene families, gene duplication and shuffling, transposition and horizontal gene transfer, gene number and genome size, organellar and nuclear genetic markers, genetic mutation and selection, genes in populations, viral evolution, human evolution, and the theoretical background for molecular phylogenetics. Examples of each concept will be drawn from the scientific literature in epidemiology and human or animal genetics. Prerequisites: 410.601 Biochemistry; 410.602 Molecular Biology
410.620 - Advanced Topics in Immunology
This course integrates and expands concepts learned in an introductory immunology course. Students will be presented with advanced topics in immunology through literature reviews, clinical case studies, basic science and clinical research papers, and supported by leading-edge webinars. Topic areas may include, but are not limited to, acellular and cellular innate immunity, adaptive immunity, immune regulation, autoimmunity, immunosuppression, inflammation, neuroimmunology, immunobiology of pregnancy, immunogenomics, tumor immunology, standard and developing therapies for immunopathologies, and immunotherapies. Students will also be introduced to immunological tests used for disease screening and diagnoses. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cellular Biology I, and 410.613 Principles of Immunology or an undergraduate immunology course. S
410.621 - Agricultural Biotechnology
In this course, students are introduced to the application of recombinant DNA technology to agriculture. Studied are methods for the introduction of foreign DNA into plant and animal cells and generation of stably transformed plants and animals. Students consider specific examples of the use of transgenic plants and animals in biotechnology, which can provide protection against insects, diseases, and tolerance to specific herbicides. They also investigate how recombinant growth hormones can result in leaner meat, greater milk yield, and better feed utilization, and how transgenic plants and animals can serve as bioreactors for the production of medicinals or protein pharmaceuticals. Because recombinant agricultural products are released into the environment or consumed as foods, students also need to become familiar with environmental safety issues. Prerequisites: 410.601 Biochemistry 410.602 Molecular Biology, 410.603 Advanced Cell Biology I. S
410.622 - Molecular Basis of Pharmacology
This course begins by reviewing receptor binding and enzyme kinetics. Various cellular receptors and their physiology are discussed, as well as the pharmacological agents used to define and affect the receptorâs function. Students study the pharmacology of cell surface receptors and intracellular receptors. Also considered are the drugs that affect enzymes. Prerequisites: All four core courses. S
410.623 - Molecular & Cellular Physiology
Students in this course gain an understanding of how coordinated regulation of bodily function occurs at the molecular and cellular levels of organization. The focus is on neurons, muscles, and hormones. Specific areas covered for excitable tissue include bioelectric properties of excitable membranes, Hodgkin-Huxley ion currents, voltage-gated ion channels and their structures, synaptic transmission, excitation-contraction coupling, and contractile properties of skeletal, cardiac, and smooth muscle cells. The biotechnological connection is the pharmacological interventions to modulate functioning of excitable tissues. For endocrine physiology, this is an overview of hypothalamic, pituitary, reproductive, and other hormones. The class uses leptin and obesity as a model hormone and pathology, respectively, and examines in detail its action as a putative fat-busting hormone. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced C Biology I. S
410.624 - System and Integrative Physiology
This course is the second half of the physiology sequence and involves the study of organ systems and how they are regulated by the central nervous and endocrine systems. Students will learn the structure and function of the cardiovascular, respiratory, digestive, renal, and reproductive systems, as well as their pathophysiology during disease processes. We will also study metabolic physiology in the context of exercise and diet. The biotechnological connection will be how the drug interventions modulate functioning of many of these system Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology 410.603 Advanced Cell Biology I; 410.623 Molecular and Cellular Physiology is recommended but not required.
410.625 - Industrial Microbiology
This course covers the principles of various processes associate with the production and recovery of different bio products derived from prokaryotes and eukaryotes. Topics include the classification of microorganisms, media development, instrumentation, fermentation principles, mammalian and insect cell propagation, product recovery, protein purification and the principles of Current Good Manufacturing Practices. Emphasis is on large-scale production methods and production of recombinant proteins for diagnostic and clinical application Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology 410.603 Advanced Cell Biology I. S
410.626 - Molecular Development
This course covers the molecular and cellular bases of development in a variety of experimental organisms with special emphasis on mammalian and human models. From the formation of germ cells, fertilization, and early embryonic development to the final formation of organs and tissues, developmental processes are considered in the context of biotechnological applications. Application possibilities include creation of transgenic animals and drug design to combat specific types of cancer. The molecular mechanisms of developmental processes and the identification of targets for therapeutic purposes are central themes. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I, 410.604 Advanced Cell Biology II. S
410.628 - Neurobiology
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, Parkinsonâs, and Alzheimerâs. Prerequisites: All four core courses. S
410.629 - Genes & Disease
Because of recent advances, powerful diagnostic tests now detect genetic diseases, and there is promise of gene replacement therapy. In this course, students cover general genetic principles, DNA tools for genetic analysis, cytogenetics, gene mapping, the molecular basis of genetic diseases, animal models, immunogenetics, genetics of development, genetics of cancer, and treatment of genetic diseases. Molecular methods of analysis are emphasized. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I. S
410.630 - Gene Therapy
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, as well as the bioethical concerns involved with this field of research and medicine.
410.631 - Infectious Diseases
This course focuses on infectious diseases of mankind, presented in a system-by-system format. Basic principles of host defense and microbial virulence will be discussed. Practical, up-to-date information on the clinical presentation, symptoms, physical findings, laboratory diagnosis, treatment and prevention of the general array of diseases caused by bacteria and viruses will be presented. The use of antibiotics, prophylactic agents, and vaccines along with selected aspects pathogenesis and epidemiology will be covered. More cursor coverage will be given to the fungal and parasitic agents of human disease. The student will develop a broad understanding of the many different kinds of infectious processes to which our bodies are subjected to on an ongoing basis. Prerequisites 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I. S
410.632 - Emerging Infectious Diseases
This course focuses on emerging infectious diseases from many different perspectives. The maladies addressed range from diseases that have reappeared in altered genetic forms, such as the influenza virus and West Nile virus, to the lethal hemorrhagic fever caused by the Ebola virus. Also discussed is the threat of recombinant and ancient infectious agents, such as Bacillus anthracis, causative agent of anthrax, which ca be used in biological warfare weapons. Opinions from noted scientists and leaders concerning emerging diseases and the prospects for battling them successfully provide scientific and social perspective. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I. S
410.633 - Introduction to Bioinformatics
This course explores the theory and practice of biological database searching and analysis. In particular, students are introduced to integrated systems where a variety of data sources are connected through internet access. Information retrieval and interpretation are discussed, and many practical examples in a computer laboratory setting enable students to improve their data mining skills. Methods included in the course are searching the biomedical literature, sequence homology searching and multiple alignment, phylogeny, gene prediction, protein sequence motif analysis and secondary structure prediction, and several genome browsing methods. Introductory analysis using the R programming language is introduced. Computer access is required. Prerequisites: 410.601 Biochemistry. Corequisite: 410.602 Molecular Biology. S
410.634 - Practical Computer Concepts for Bioinformatics
This course introduces students with a background in the life sciences to the basic computing concepts of the UNIX operating system, relational databases, structured programming, object-oriented programming, and the Internet. Included is an introduction to SQL and the Pythonl scripting language. The course emphasizes relevance to molecular biology and bioinformatics. It is intended for students with no computer programming background but with a solid knowledge of molecular biology. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology. S
410.635 - Bioinformatics:Tools for Genome Analysis
Large-scale DNA sequencing efforts have resulted in increasingly large numbers of DNA sequences being deposited in public databases. Assigning annotations, such as exon boundaries, repeat regions, and other biologically relevant information, accurately in the feature tables of these sequences requires a significant amount of human intervention. This course instructs students on computer analytical methods for gene identification, promoter analysis, and introductory gene expression analysis using software methods. Additionally, students are introduced to comparative genomics and proteomic analysis methods. Students will become proficient in annotating large genomic DNA sequences. This course covers customizing genome browsers with novel data. Next-generation sequence analysis is covered, through sequence quality control and assembly and analysis of ChIP-seq and RNA-seq data. Students complete two large sequence analysis projects during the course. Prerequisites: 410.601 Biochemistry; 410.602 Molecular Biology; 410.633 Introduction to Bioinformatics or equivalent. S
410.636 - Biology Of HIV & AIDS
This course includes an overview of the biology and life cycle of the immunodeficiency virus, including the simian viruses. Specific areas of HIV immunopathogenesis are emphasized, to include HIV diagnosis, HIV-induced immune dysfunction, and therapeutic breakthroughs in the treatment of HIV-1 disease. Students become familiarized with current methods in biotechnology that have advanced our understanding of the biology of retroviruses. Special topics include international genetic variation (subtypes and clades), HIV vaccine development, and global economic impact. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I. S
410.638 - Cancer Biology
This course provides students with knowledge of the fundamental principles of the molecular and cellular biology of cancer cells. The course explores the role of growth factors and signal transduction mechanisms, oncogenes, tumor suppressor genes, tumor viruses, and angiogenesis in tumorigenesis and metastasis. Special topics include cancer prevention and the array of cancer therapies, which include surgery, chemotherapy, radiation therapy, hormonal therapy, stem cell transplant, and immunotherapies. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cellular Biology I , 410.604 Advanced Cell Biology II. S
410.639 - Protein Bioinformatics
Because the gap between the number of protein sequences the number of protein crystal structures continues to expand protein structural predictions are increasingly important. This course provides a working knowledge of various computer- based tools available for predicting the structure and function of proteins. Topics include protein database searching, protein physicochemical properties, secondary structure prediction, a statistical verification. Also covered are graphic visualization the different types of three-dimensional folds and predicting 3-D structures by homology. Computer laboratories complement material presented in lectures. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.633 Introduction to Bioinformatics. S
410.640 - Molecular Phylogenetic Techniques
This course will provide a practical, hands-on introduction to the study of phylogenetics and comparative genomics. Theoretical background on molecular evolution will be provided only as needed to inform the comparative analysis of genomic data. The emphasis of the course will be placed squarely on the understanding and use of a variety of computational tools designed to extract meaningful biological information from molecular sequences. Lectures will provide information on the conceptual essence of the algorithms that underlie various sequence analysis tools and the rationale behind their use. Only programs that are freely available, as either downloadable executables or as Web servers, will be used in this course. Students will be encouraged to use the programs and approaches introduced in the course to address questions relevant to their own work. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.633 Introduction to Bioinformatics. S
410.641 - Clinical & Molecular Diagnostics
This course covers basic concepts and practical applications of modern laboratory diagnostic techniques. Topics include the principles of testing methodology, quality assurance, and the application of molecular methods to the clinical and research laboratory. The test methods to be covered include nucleic acid-based methods, such as hybridization, amplification, and sequencing; non-nucleic acid methods, such as HPLC, GLC, a protein analysis; and technologies, such as PFGE, ribotyping, RFLP, and serological testing methodologies. In addition to the test procedures, students are exposed to aspects of statistics, quality control, regulatory issues, and applications of these methods to the diagnosis and prognosis of human disease. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology. S
410.645 - Biostatistics
This course introduces statistical concepts and analytical methods as applied to data encountered in biotechnology and biomedical sciences. It emphasizes the basic concepts of experimental design, quantitative analysis of data, and statistical inferences. Topics include probability theory and distributions; population parameters and their sample estimates; descriptive statistics for central tendency and dispersion; hypothesis testing and confidence intervals for means, variances, and proportions; categorical data analysis; linear correlation and regression model; logistic regression; analysis of variance; and nonparametric methods. The course provides students a foundation to evaluate information critically to support research objectives and product claims and a better understanding of statistical design of experimental trials for biological products/devices. Prerequisites: Basic mathematics (algebra). S
410.648 - Clinical Trial Design and Conduct
Through a case study approach, this course will cover the basic design issues of clinical trials, specifically targeting the protocol, case report forms, analysis plan, and informed consent. The design of a specific trial will be studied to illustrate the major issues in the design of a study, such as endpoint definition, control group selection, and eligibility criteria. The course will also cover the analysis plan for a study, including approaches that are central to clinical trials, such as stratified analysis, adjustment factors, and âintention-to-treatâ analysis. The planned analytical techniques will include the analysis of correlated data (i.e., clustered data, longitudinal data), survival analysis using the proportional hazards (Cox) Regression model, and linear models. A semester-long project will include the creation of a protocol, case report forms, and informed consent. Prerequisites: 410.645 Biostatistics or equivalent (recommended), 410.651 Clinical Development of Drugs and Biologics (recommended).
410.651 - Clinical Development of Drugs and Biologics
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 âbackwardâ 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: 410.303 Foundations of Bioscience OR 410.601 Biochemistry and 410.603 Advanced Cell Biology OR admission to the MS in Regulatory Science Program OR Master of Biotechnology Enterprise and Entrepreneurship programs. S
410.653 - Regenerative Medicine: from Bench to Bedside
Regenerative Medicine is a multidisciplinary field developing next-generation therapies that aim to augment, repair, replace or regenerate tissues and organs. This field can be broadly defined by three overlapping technology domains: cell therapy, gene therapy and tissue engineering. In this course, we will explore these regenerative medicines from bench to bedside. We will discuss relevant biological, engineering, clinical, legal, regulatory and ethical principles and perspectives to understand the emerging field of regenerative medicine. Specific topics include induced pluripotent stem cells, bioartificial organs, cell-based immunotherapy, and gene editing techniques such as a CRISPR/Cas-9. In addition to gaining a scientific foundation, students will become familiar with the current state of the industry and the process of bringing these regenerative medicine products to market, including market trends and opportunities, process development and manufacturing, and commercialization challenges and successes. Readings will be drawn primarily from scientific journals. Prerequisites: 410.601 Biochemistry; 410.602 Molecular Biology; 410.603 Advanced Cell Biology I. S
410.655 - Radiation Biology
This course will review types of ionizing radiation and their differences, physical and chemical interactions of radiation w key biological molecules, and effects on living matter beginning with molecular and cellular interactions and proceeding to tissue, organ, and organism levels, emphasizing the human system. Radiationâs beneficial effects in cancer therapy and medicine as well as detrimental and carcinogenic effects will be discussed. Specific units will consider food irradiation, nuclear power plant accidents, radiation terrorism, everyday sources exposure to the U.S. population, and other practical situations involving radiation. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I. S
410.661 - Methods in Proteomics
This course covers the analytical methods used to separate and characterize pharmaceutical compounds (predominantly proteins) derived through biotechnology. While emphasis is placed on the general principles and applicability of the methods, current protocols are discussed and problem sets representing realistic developmental challenges are assigned. Topics include chromatography (HPLC, SEC, IEC), electrophoretic techniques (2-D gel electrophoresis), spectroscopic methods (UV/Vis, fluorescence, CD), analytical ultracentrifugation, microarrays, mass spectroscopy, amino acid analysis, sequencing, and methods to measure protein- protein interactions. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology. S
410.662 - Epidemiology: Diseases in Populations
Epidemiology is the study of the patterns and determinants of disease in populations. It constitutes a basic science for public health and biomedical sciences, and its influence can be felt daily through the presentation of data by government, academic, and industry sources. The goal of this course is to present an introduction to epidemiological methods and inferences to biotechnology professionals with little prior experience in public health. Issues in epidemiological inference and the assessment of causal relationships from epidemiological studies will be discussed, introducing the issues of bias and confounding. Throughout the course, emphasis will be on the practical use of epidemiology, and lectures will be complemented by case studies and published literature. Examples will be drawn from contemporaneous issues in chronic and infectious diseases. At the conclusion of the course, students should have a greater appreciation for the role of the epidemiologic method and be able to evaluate a basic epidemiologic study, including how the study goals and research questions relate to the design, measures, and inferences. Recommended prerequisites: undergraduate statistics course or 410.645 Biostatistics. S
410.663 - Current Topics in Molecular & Cellular Biology
This course is a literature-driven exploration of current topics and methodologies employed in cell biology research. By closely examining both fundamental and innovative experimental approaches, as well as cutting-edge technologies we will explore a broad range of cell biology topics, many of which most students have previously encountered, at least at some level, in the core courses. The particular subjects and technologies discussed may vary widely from semester to semester; topics may include but are not limited to expression profiling (microarray analysis), âknock-downâ with RNAi, the use of transgenic and knockout mice, proteomics and mass spectrometry, microscopy applications (epifluorescence, confocal, and/or EM), characterizing protein/protein interactions, and detection methods for the movement of small molecules and ions. Students enrolling in this course are expected to already have some experience in critical reading and evaluation of the primary scientific literature. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I, 410.604 Advanced Cell Biology II. S
410.666 - Next Generation DNA Sequencing and Analysis
The recent revolution in DNA sequencing technologies has transformed biology within a few short years, dropping the cost and ease of sequencing dramatically to the point where the â$1,000 human genomeâ is in sight. Armed with complete genome sequences, biologists need to identify the genes encoded within and the variation in these genes between individuals, assign functions to the genes, and put these into functional and metabolic pathways. This course will provide an overview of next-generation sequencing technologies in the historical context of DNA sequencing, the pros and cons of each technology, and the bioinformatics techniques used with this sequence information, beginning with quality control assessment, genome assembly, and annotation. Prerequisites: 410.602 Molecular Biology, 410.633 Introduction to Bioinformatics, 410.634 Practical Computer Concepts for Bioinformatics. S
410.667 - Theory/Appl Immunoassays
Antibodies are useful as molecular tools in a variety of applications in biotechnology. They can be produced quickly, inexpensively, and in very large quantities. Students will examine how antibodies can be configured as a measurement tool called an immunoassay. Students design immunoassays for their own laboratory applications such as radio- and enzyme-immunoassays, and competitive and immunometric immunoassays. They learn how to modify antibodies chemically for conjugation of reporter molecules and they become aware that various immunoassay performance issues can affect results. Students also investigate immunoassay formats such as configuration of antibodies as biosensors and surface plasmon resonance signaling. Prerequisites: 410.601 Biochemistry; 410.602 Molecular Biology; 410.603 Advanced Cell Biology I. Prior completion of 410.613 Principles of Immunology is strongly recommended or approval of program committee.
410.669 - Immunology of Infectious Diseases
This course is a lecture-based, advanced topics course designed for students who have a background in immunology and medical microbiology. The course provides a detailed description of specific pathogens (bacterial, viral, parasitic, and fungal) and their interactions with the human immune system, including innate and acquired immunity. Pathogens covered in detail may include mycobacterium (tuberculosis), gram-negative enteric bacteria (bacillary dysentery), paramyxovirus (measles virus), enterovirus (poliovirus), plasmodium parasites (malaria), intestinal protozoa (amoebiasis), trichinella, and candidiasis (thrush) and other opportunistic mycoses. Immunology topic covered in detail include mucosal immune responses, the role of PRR and PAMPs, pathogen regulation of host immune response, pathogen evasion of immune effector mechanisms, polarization of CD4+ T helper cell subsets, mechanisms of immunopathogenesis, and vaccine design. Lectures will be supplemented with talks from scientific experts from the field. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology 410.603 Advanced Cell Biology I. S
410.670 - Biology of Stress
This course explores stress from a multidisciplinary perspective, beginning with a history of stress research, which began in the early 20th century. Because of the interdisciplinary nature of the subject matter, a detailed consideration of anatomy and functioning of the central and peripheral nervous systems will be discussed. In addition, students will examine how stress affects the endocrine, cardiovascular, reproductive, digestive, and immune systems. Students will also learn the role of stress in cognition and complex behaviors such as memory, mood, appetite, sleep, and sexual desire. Animal and human studies will be discussed as well as current pharmacological treatments. Prerequisites: 410.601 Biochemistry ; 410.603 Advanced Cell Biology I.
410.671 - Gene Expression Data Analysis and Visualization
This course will introduce students to various methods for analyzing and interpreting transcriptomics data generated from technologies such as oligonucleotide or two-channel microarrays, qRT-PCR, and RNA sequencing. Topics will include scaling/normalization, outlier analysis, and missing value imputation. Students will learn how to identify differentially expressed genes and correlate their expression with clinical outcomes such as disease activity or survival with relevant statistical tests; methods to control for multiple testing will also be presented. An introduction to linear and nonlinear dimensionality reduction methods and both supervised and unsupervised clustering and classification approaches will be provided. Open source tools and databases for biological interpretation of results will be introduced. Assignments and concepts will make use of publicly available datasets and students will compute and visualize results using the statistical software R. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.645 Biostatistics, 410.634 Practical Computer Concepts for Bioinformatics, or an undergraduate computer programming course. S
410.673 - Biological Processes in Regulatory Affairs
This course provides an overview of the biological processes laboratory techniques utilized for the discovery, development and evaluation of therapeutic drugs. Students investigate drug development processes, such as gene cloning, culture scale-u downstream processing, and product purification. Emphasis is placed on the theory and application of laboratory methods u 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: 410.303 Bioscience for Regulatory Affairs, OR 410.601 Biochemistry and 410.603 Advanced Cell Biology OR admissions to the MS in Regulatory Science OR Master of Biotechnology Enterprise and Entrepreneurship programs. S
410.692 - Biological & Chemical Threat Response & Forensics
This course introduces the methods and techniques used for biological and chemical threat agent characterization; methods of detection, identification, medical intervention, and forensic attribution are also discussed. Lectures cover a broad variety of topics pertaining to the use of biological and chemical agents, including historical background of biological and chemical agents in classic and discretionary warfare, the introduction of scientific evidence in criminal proceedings and chain of custody for evidentiary materials in crimes and terrorism, quality assurance in laboratory operations, threat containment, decontamination and remediation, health and safety of responders and analysts, and risk assessments. Laboratory methods employed in the characterization and forensic analysis of biological (bacterial, viral, biological toxins, agricultural threats) and chemical agents (classic military chemical agents, toxic industrial chemicals, and materials) will also be discussed. General overviews of techniques and sample collection for classic biological and chemical agents (PCR, DNA sequencing methods, immunological analyses), and for chemical agents (gas chromatography and mass spectrometry). Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I, undergraduate microbiology or 410.615 Microbiology. S
410.693 - Science, Medicine & Policy in Biodefense
This course provides a comprehensive introduction to the Concentration in Biodefense. Biological warfare is introduced in its historical context, followed by the properties of the most important biological threat agents, their medical consequences and treatment, diagnostics, and forensics. Relevant international and domestic policy issues are explored, along with defense strategies and the nature of existing dangers to national security. Students should leave the class with a deep understanding of biological warfare and terror agents, the consequences of their potential use, and the available means of protection. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I, undergraduate microbiology or 410.615 Microbiology. S
410.695 - Applied Molecular Biology
This course covers both basic and applied concepts in molecular biology. It is designed for students with a good working knowledge of molecular biology who want to study more advanced concepts and how they may be applied in biotechnology. Topics for discussion include DNA/ RNA structure, DNA replication, transcription, translation, posttranslational modifications, restriction enzymes, general recombinant DNA techniques (DNA ligations, bacterial transformation, DNA/RNA isolation), DNA sequencing, plasmids, and polymerase chain reaction. Prerequisites: 410.601 Biochemistry; 410.602 Molecular Biology, and 410.603 Advance Cell Biology I. S
410.696 - Bioassay Development
This course will cover methodological approaches to bioassay development for high-throughput screening. Both cell-based (cytotoxicity; cytoprotection, high content imaging, and reporter systems) and cell-free assay systems (enzyme, FRET, time resolved fluorescence, quenching assays, and immunological assays) will be included with discussion of the potential prom and pitfalls associated with each assay system. Various assay formats, visualization techniques, and current developments in assay technology will be discussed. Project management techniques will be utilized to aid in the process of assay development. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I. S
410.697 - Microfluidics and Biosensors
Microfluidics (lab-on-a-chip technology) is the miniaturization of laboratory operations for microscale chemistry, high- throughput drug screening, environmental sensors, bio threat detectors, forensics, clinical diagnostics, and proteomics. This course will cover microfluidic implementations of bioassay development, such as sample dilution, cell lysis, chromatography, solid-phase extraction, electrophoresis, nucleic acid amplification and sequencing, analytic detection, single-cell analysis, microarray design and mass spectrometry sample preparation. The materials, design, fabrication, and testing of microfluidic chips and biosensors will be discussed with emphasis on the applications of this technology to detect microbial pathogens and cancer markers. In addition, the course will include case studies from the literature to introduce students to intellectual property issues related to microfluidic technology. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, or approval of program committee. S
410.698 - Bioperl
Perl has emerged as the language of choice for the manipulation of bioinformatics data. Bioperl, a set of object-oriented modules that implements common bioinformatics tasks, has been developed to aid biologists in sequence analysis. The course will include an overview of the principal features of Bioperl and give students extensive opportunity to use Perl and the tools of Bioperl to solve problems in molecular biology sequence analysis. Prerequisites: 410.601 Biochemistry, 410.60 Molecular Biology, 410.634 Practical Computer Concepts for Bioinformatics. S
410.699 - Nanobiotechnology
The emerging field of nanobiotechnology utilizes developments in nanotechnology and molecular biology for applications to biomedical science and clinical practice, as well as fundamental cell biology research and industrial biotechnology. Nanobiotechnology is an interdisciplinary field that exploits the unique functional properties of natural and synthetic biomolecular-sized (nanometer-scale) constructs, such as quantum dots, carbon nanotubes, nanostructured surfaces, liposomes, artificial membranes, and molecular machines for biotechnology and medicine. This course is designed for biotechnology majors and will survey the research, development, and applications of nanotechnology to medical diagnostics, imaging, and therapeutics (including drug delivery and anti-cancer treatments); cell biology and single-cell analysis; nanofluidics; bioassays; biosensors; and bio-inspired engineering. Prerequisites: 410.601 Biochemistry; 410.602 Molecular Biology; 410.603 Advanced Cell Biology I. S
410.712 - Advanced Practical Computer Concepts for Bioinformatics
410.713 - Advanced Genomics and Genetics Analyses
The next generation of array and sequencing technologies provides the ability to investigate large quantities of genomics information with higher sensitivity, greater throughput, and lower costs. This also introduces new challenges in data management, novel algorithmic approaches, and general interpretation. This course builds on the topics in 410.671 Gene Expression Data Analysis and Visualization to address analysis of both genetic variation and genomics content including: splice variants, single nucleotide polymorphisms (SNPs) with family-based and case/control genome-wide association, copy number variation, somatic and germline single nucleotide variants, tumor clonality and ploidy estimates, and transcription factor binding sites. Data types will include array, RNA sequencing, and DNA sequencing (targeted and whole exome) with sequence assembly methods?presented?such as de novo and reference-based.?Prerequisites: 410.602 Molecular Biology, 410.633 Introduction to Bioinformatics, 410.671 Gene Expression Data Analysis and Visualization. S
410.719 - Post-market Surveillance of Medical Devices
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 postmarket surveillance of devices after they reach the market is crucial to protecting public health. The Office of Surveillance and Biometrics (OSB) within FDAâs Center for Devices and Radiologic Health (CDRH) is responsible for overseeing the continued postmarket surveillance of medical devices. This course covers regulatory requirements for industry once a device reaches the market as well as the postmarket surveillance requirements and activities performed by FDA. Students will discover the multifaceted approach to medical device postmarket surveillance through topics including: Postmarket 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).
410.720 - USDA Regulation of Food Safety, Wholesomeness, and Labeling
This course addresses USDA, FSIS regulatory processes ensuring a safe, wholesome, properly labeled food supply. Students will (1) review the history of applicable food law and the rise of the Food Safety Inspection Service as a regulatory agency; (2) evaluate the statutory definitions of adulterated and misbranded as the basis for regulatory requirements, and (3) apply those regulatory requirements to preparation, packaging, and holding of meat and poultry products. Coursework is built around a project in which students prepare a series of documents required to meet food safety, wholesomeness, and labeling requirements. Course work concludes with a review of FSIS enforcement authority and state inspection programs.
410.733 - Comparative Animal Physiology
This class examines animal physiology from an evolutionary and comparative viewpoint. The goal is to examine the commonalities, and unique differences in how various anima organisms address the necessary life functions. Topics will include homeostatic mechanisms as an overarching theme, integrating the following systems: nervous, endocrine, muscle, circulatory, defense, respiratory, excretory, fluid and acid-base balance, digestive, energy balance and thermal, and reproductive. S
410.734 - Practical Introduction to Metagenomics
The emerging field of metagenomics allows for the study of entire communities of microorganisms at once, with far- reaching applications in a wide array of fields, such as medicine, agriculture, and bioremediation. Students will learn the principles of metagenomics through exploration of published project data and guided readings of recent literature. Using d from the Human Microbiome Project, students will explore practical analysis tasks, including sequence assembly, gene prediction and annotation, metabolic reconstruction, taxonomic community profiling, and more. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.633 Introduction to Bioinformatics, 410.634 Practical Computer Concepts for Bioinformatics. S
410.736 - Genomic and Personalized Medicine
With the advent of rapid, low-cost whole genome sequencing, the field of personalized medicine is growing from a niche field, to becoming the new standard of practice in medicine. Already, oncology makes use of genomic sequencing to inform treatment decisions based on tumor types, and patients are seeking knowledge about their genetic and environmental risk factors to make informed health decisions. This class explores the evolving field of personalized medicine, examining genomics, as well as proteomics, metabolomics, epigenetics, and the microbiome. Students will read and discuss new developments in pharmacogenomics, rare and complex diseases, genomics for the healthy person, and the ethical, economic, and social implications of these new technologies. These topics will be approached with a view toward application in clinical practice. Prerequisites: 410.602 Molecular Biology; 410.633 Introduction to Bioinformatics. S
410.737 - Promotion of Biomedical Products: Regulatory Considerations
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.
410.750 - Molecular Targets & Cancer
This course will investigate current and potential molecular targets in cancer including kinases, DNA repair pathways, epigenetic modifications, immunotherapy approaches, hormonal, metastasis and angiogenesis targets. Discussion will also include topics on what defines a molecular target and the methods by which they are evaluated. Prerequisites: 410.601 Biochemistry, 410.602 Molecule Biology, 410.603 Advanced Cell Biology I. Recommended: 410.604. Advanced Cell Biology II. S
410.751 - Chemical Libraries & Diversity
Chemical diversity and âpharmacological spaceâ will be studied, with an emphasis on disciplines related to drug discovery. Medicinal chemistry, natural product chemistry, focused synthetic libraries, and combinatorial chemistry will be covered. Lipinskiâs rules for drug like molecules will be discussed in detail, as well as methods for chemical analysis, in silicon drug design, molecular modeling, and compound storage and handling. In addition, techniques used for assessing and harnessing chemical diversity for drug discovery will be discussed. Prerequisites: All four core courses or approval of program committee. S
410.753 - Stem Cell Biology
This course will involve discussion and debate on current topics concerning stem cell biology and the use of stem cells in biotechnology and therapeutics. Topics will include review and discussion of developmental and cell biology, stem cell characteristics, stem cell preparation and therapeutic uses, tissue engineering, global regulatory and ethical issues, and commercialization of stem cell therapy. Current peer-reviewed literature and guest experts in the field will provide up-to-date information for discussion. Prerequisites: 410.601 Biochemistry, 410.602 Molecule Biology, 410.603 Advanced Cell Biology I, 410.604 Advanced Cell Biology II. S
410.754 - Comparative Microbial Genomics:From Sequence to Significance
Hundreds of bacterial and archaeal genomes have been completely sequenced, and thousands more will follow in near future. In this course we will learn how to make sense of this vast sea of information in order to understand the diversity of microbial life on earth: transforming DNA data into knowledge about the metabolism, biological niche and lifestyle of these organisms. The use and development of bioinformatic platforms for the sensible comparison of genetic function and context are essential for work in modern microbiology. Topics covered will include methods for sequencing, gene finding, functional prediction, metabolic pathway and biological system reconstruction, phylogenomics, ontologies, and high-throughtput functional genomics. Particular attention will be paid to publically available bioinformatics resources and their proper use. Examples will be drawn from microbes of importance to human health, industry, ecology, agriculture and biodefense. Lectures and discussions are integrated with computer exercises where appropriate. Prerequisites: 401.601 Biochemistry; 410.602 Molecular Biology; 410.633 Introduction to Bioinformatics. S
410.777 - Next Generation Alternative Energies
In this course, students are introduced to the current technologies used in the production of alternative energies. These technologies include first and second generation biomass biofuels, carbon-neutral synthetic fuels, microbial fuel cells, algae fuel, and biological hydrogen production. The study of biomass biofuels will include technologies using agriculture, cellulosic, and waste feedstocks. Carbon-neutral synthetic fuels will include biobutanol, acetone-butanol-ethanol, methane, and biogas. Students will study the methods used to produce these types of fuels, the by-products produced, and the sustainability of energy production. In addition, to studying the techniques used to produce alternative energy, students will also discuss the economic and environmental impacts of producing and using alternative sources to produce energy. Prerequisites: 410.601 Biochemistry, 410.602 Molecule Biology, 410.603 Advanced Cell Biology I.
410.800 - Independent Research in Biotechnology
Students in the biotechnology program have the opportunity to enroll in an independent research course. This elective course is an option after a student has completed at least eight-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 who 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 studentâs 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 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 meet with a member of the program committee periodically for discussion of the projectâs 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. Prerequisite: All core courses and four additional courses. S
410.801 - Biotechnology Thesis
Students wishing to complete a thesis may do so by embarking on a two-semester thesis project, which includes 410.800 Independent Research Project and 410.801 Biotechnology Thesis courses. This project must be a hypothesis-based, original research study. The student must complete 410.800 Independent Research Project and fulfill the requirements of that course, including submission of project proposal, final paper, and poster presentation, before enrolling in the subsequent thesis course. For the thesis course, students are required to submit a revised proposal (an update of the 410.800 proposal) for review and approval by the faculty adviser and biotechnology program committee one month prior to the beginning of the term. Students must meet the faculty adviser periodically for discussion of the projectâs progress. Graduation with a thesis is subject to approval by the thesis committee and program committee, and requires the student to present his/her project to a faculty committee both orally and in writing. Prerequisites: Successful completion of 410.800 Independent Research Project and 410.645 Biostatistics.
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