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Course Descriptions

Biotechnology Course Offerings

BTGY 504 - REGULATORY ASPECTS OF MEDICAL PRODUCT DEVELOPMENT (3 CREDITS)

The regulatory pathway for a company to commercialize and sustain new products or services can significantly impact executive decision making process. This course examines the aspects of FDA and European regulations on a company's decision process to develop and commercialize products. The course exposes students to various aspects of regulation, specifically focusing on medical devices and in vitro diagnostics companies. Regulatory strategies for commercialization are developed based on the intended market, geographic location, stage of a company (startup to mature), and funding of the project. In addition, regulatory impact of FDA oversight and European Union oversight via Notified Bodies is explored. FDA, ISO 13485, ISO 14971, Good Laboratory Practice (GLP) and Clinical Laboratory Improvement Amendments (CLIA) compliant quality system are examined. Hybrid Course, Lecture, Online. Offered spring only.



BTGY 508 - BIOTECHNOLOGY (3 CREDITS)

Biotechnology represents one of the significant growth industries for professionals in the biological sciences. The field extends from the areas of biopharmaceuticals through medical devices, diagnostics, and the burgeoning field of tissue engineering. This course is the first in a two course series designed to provide the professional master's student instruction in fundamental aspects of the commercial application of the life sciences. The course will cover the broad field of biotechnology and examine those factors which influence the industry including: scientific innovation, access to technology, entrepreneurship, intellectual property, regulatory compliance, reimbursement and funding. Hybrid Course.



BTGY 509 BIOTECHNOLOGY PRODUCT DEVELOPMENT (3 CREDITS)

Product development is one of the primary activities for small and large life sciences companies and the success or failure of the firm often hinges on its ability to successfully bring products to market which address critical medical needs. Too often the success of product development relies on the skills of the laboratory professionals to understand the business goals, prepare budgets, develop plans and milestones, form internal and external teams, meet objectives, and move developments into manufacturing. Hybrid Course, Lecture, Online. Offered spring only.



BTGY 510 INDEPENDENT STUDY BIOTECHNOLOGY (2 CREDITS)

This course is designed for students in the graduate program leading to a Master of Science in Biotechnology. The students will be required to meet with faculty and define an agreed upon study topic in either basic or applied biotechnology. The student will be expected to complete an extensive literature survey of the selected topic and develop a scholarly document which uses primary literature to demonstrate an exemplary understanding of both the topic and its relation to the field of biotechnology. Independent Study. Offered fall and spring.



BTGY 511 BIOANALYTICAL CHEMISTRY (3 CREDITS)

Bioanalytical Chemistry is an introduction to methods and instrumentation used in the analysis of bio-molecules including DNA, proteins, and metabolites. The course centers on methods useful to research and industrial laboratories working in molecular biology, genomics, proteomics, metabolomics, biopharmaceutics, biotechnology and bio-medicine. The focus of the course is on applications rather than in depth theory. Lecture. Offered fall only.


BTGY 515 CURRENT TOPICS IN BIOTECHNOLOGY (1 CREDIT)

This course involves lecture and discussion of select topics in the field of biotechnology including issues related to advances in the technology such as; drug discovery, diagnostics, personalized medicine, bioinformatics, tissue engineering, and the companies which are leading the commercialization of these technologies. The class will be an opportunity for students to listen to comments by leaders from industry and academia on current issues in biomedicine and to discuss topics related to the field with some of the local and national thought leaders. This course will meet once per week and can include live as well as online sessions. Hybrid Course, Lecture, Online. Offered spring only.


BTGY 516 CELLULAR AND MOLECULAR BIOLOGY I (3 CREDITS)

This course is the first of a two-semester requirement for graduate students in the MS in Biotechnology program. The course covers of advanced topics in cellular and molecular biology with an emphasis on the applications of cellular and molecular knowledge to the development of the new technologies in biotechnology and biomedicine. Topics will include an examination of cellular structure and function with an emphasis on the control and manipulation of cellular and molecular processes. The course will cover molecular genetics, gene regulation, translation, trafficking, and signal transduction. Course materials will include review articles and journal publications. Lecture. Offered fall only.



BTGY 517 CELLULAR AND MOLECULAR BIOLOGY II (3 CREDITS)

This course extends Cellular and Molecular Biotechnology I to include manipulation and genetic modification of cells for therapeutic, scientific, and commercial applications. The course will include the use of genetic and immunological tools for the exploration of cell processes, target discovery, genetic engineering and tissue engineering. The course will cover use of such technologies as immunochemistry, RNAi, Genome Wide Sequencing, Vector modification, and CRISPR technologies.



BTGY 574 ETHICS IN BIOTECHNOLOGY (1 CREDIT)

In this course, students consider ethical issues related to the responsible conduct of research such as fraud in science, bias in interpretation, the use of animals in research, the use of human embryos, human cells, genetic engineering and therapy, protection of human subjects and patient care. This course will also discuss ethical issues found in commercial R&D including technology ownership, use of intellectual property, confidentiality, and business ethics. Weekly case discussions are led by various professionals. Online. Offered fall only.


BTGY 663 ENTREPRENEURSHIP (3 CREDITS)

This course deals with the overall management of the small business enterprise. Coverage includes entering the small business arena, organizing and financing a business, operation of the small firm, growth planning, and problems associated with the small business size. Specific emphasis will be placed on development of the formal business plan. Online.



BTGY 679 RESEARCH/INTERNSHIP (1-2 CREDITS)

Laboratory research directed by a faculty member or in conjunction with an external internship (Biotechnology students) and jointly directed by a faculty member and/or external advisor. This course is for students in the MS program in either Biology (Non-thesis students only) or Biotechnology. Internship, Laboratory, Practicum. Offered every semester.


BTGY 699 FUNDAMENTALS OF INTELLECTUAL PROPERTY (3 CREDITS)

This course surveys the basics of United States intellectual property law, including patents, copyrights, trademarks, and trade secrets. Lecture.


BTGY 705 STRATEGIC LEADERSHIP (3 CREDITS)

Organizational leaders want to have maximum impact using the limited talents, resources, and opportunities they have. Yet the world is becoming more complex, the pace of change is increasing, and it is harder to anticipate what the future will be like. The challenge for leaders is to leverage core organizational competencies to gain strategic advantage in an uncertain and ever-changing environment. This course explores strategic thinking and planning as key leader skills, and culminates in the creation of an actual strategic plan. Students will also learn how organizations can cultivate leadership at multiple levels and become more effective in generating and executing strategy. Online.


BTGY 714 CONFLICT RESOLUTION (3 CREDITS)

Conflict is a fact of everyday professional and personal life. If conflict is mishandled, it can be a source of considerable stress and lead to lost productivity. Much of the success and satisfaction we find in life is determined by how we respond to conflict. Leaders especially must respond well in conflict situations and should willingly accept the consequences of their conflict responses. Additionally, leaders are often asked to help resolve conflict among others. What does it take to be "response able" in conflict situations? This course explores theories, methods, skills, and practices associated with successfully engaging in the dynamics of conflict interactions. Online.


BTGY 717 LEADING PEOPLE AND MANAGING RELATIONSHIPS (3 CREDITS)

Bringing about change in an organization, no matter what one's position, requires a unique set of skills. Leaders must be effective in working in multiple contexts and directions simultaneously. As organizational roles shift frequently and more work is done through virtual teams or is performed by those outside the organization, managing relationships with team members, contractors, and volunteers becomes critical. This course builds on emerging theories of emotional intelligence and self-leadership as they are applied in today's fluid organizational contexts. Online.