BT 795. Commercialization Strategies. 3 hours. (Take 3 Times)

Focus on growth of a biotechnology company from inception through the early stages of development. Topics will include market assessment, business plan development, raising capital, and regulatory and quality systems requirements for drugs, biologics, medical devices or combination products. This series of courses also include a focus is on the issues and challenges affecting the life cycle of a biotechnology company and product as it progresses through the different stages of development including regulatory strategies, financing strategies, business development, and marketing strategies.

BT 701. Cellular and Molecular Biotechnology I. 3 hours.

A study of prokaryotic systems focusing on structures, functions and replicative processes with particular emphasis on the systems that are used in the Biotechnology Industry, especially bacteria. The students will learn the central dogma in prokaryotes from DNA replication to transcription and translation and the sorting of proteins to various destinations using different transport systems. Bacterial enzymes, including restrictions endonucleases, will be examined and the use of these enzymes to develop innovative products for the life science industry.

BT 702. Cellular and Molecular Biotechnology II. 3 hours.

A study of the principles of cellular and molecular biology using innovative life science technologies to demonstrate the biological mechanisms that were used to develop these products. General topics will include DNA replication, DNA repair, DNA Transcription, Posttranscriptional Modifications, Translation, and Posttranslational Modifications. Existing technologies will be discussed under the appropriate topic in order to enable the students to see how a particular biological process leads to the development of a number of innovative technologies.

BT 725. Creating a Biotechnology Venture. 3 hours.

This course will provide an in-depth look at starting a new biotechnology company. Specifically, the course will provide a roadmap for starting a company with an overview of the challenges and opportunities that biotechnology start-ups face.

BT 730. Managing and Leadership in Biotechnology. 3 hours.

This course will focus on leadership skills, communication, conflict resolution and organizational structures specific to biotechnology companies.

BT 732. Financing a Biotechnology Venture. 3 hours.

This course is designed to provide students with limited knowledge in finance the ability to understand the financial basics that are unique to running a biotechnology company from inception through commercialization.

BT 750. Lab Rotation. 1 hour.

BT 751. Lab Rotation. 1 hour.

BT 752. Lab Rotation. 1 hour.

Series of three laboratory rotations completed during the first two years of graduate study. Each laboratory rotation is 8-12 weeks in duration, and will be designed to allow the student to explore a potential avenue of research for their dissertation and project deliverable.

BT 675. Special Topics. 2-3 hours.

GRD 717. Principles of Scientific Integrity. 3 hours.

Surveys ethical issues and principles in the practice of science. This course is comprised of online modules that the student completes autonomously, then the student attends a one-day workshop and participates in activities and case studies regarding the content learned through the modules. Offered every semester.

GBS 716. Grantsmanship and Scientific Writing. 2-3 hours.

The objective of the course is to teach students how to effectively write grant proposals. This course will provide hands on training in the preparation of a grant application and demonstrate effective strategies for assembling a successful proposal. With guidance from the faculty, the students will write a NIH style proposal on their dissertation research topic. After the proposal is complete, each grant will be reviewed in a mock NIH study section. Based on the comments from the study section, the student will revise the application and submit the proposal to his/her thesis committee as part of the qualifying examination for admittance into candidacy.

GBS 701. Core Concepts in Research: Critical Thinking & Error Analysis. 1 hour.

Do you love to "think science"? Would you enjoy looking at scientific questions through an unusual lens? Do you find stories about scientific discoveries fascinating, and would you like to learn more about what they mean to our scientific practice? Then this course is for you! This course examines the natural and philosophical foundations of science using an interdisciplinary approach that emphasizes critical thinking and storytelling; discusses the principles of good scientific practice (rigor, reproducibility and responsibility; the 3R's) - by exploring revolutionary discoveries in the life, public health and natural sciences; elaborates the relationship between theory, practice and serendipity in scientific discovery, and concludes with a discussion of the role of scientists in society.

BT 745. Research Design and Statistics for Biotechnology. 3 hours.

Issues of contemporary research design and methods in biotechnology; focus on translational research and areas of controversy; application of statistical software with emphasis on interpretation of findings for decision support.

BT 740. Seminar / Journal Club. 1 hour.

Assigned readings, student presentations, and discussion, of current literature and development activity in the life sciences and biotechnology industries. (Take 3 times)

BT 753. Advanced Applications in Biotechnology. 3 hours.

A lab course that will teach the students the basic molecular techniques that are used in research from bacterial culture to gene regulation. These techniques will be taught under the umbrella of a research project which will involve the cloning of a mammalian gene into an expression vector, its purification, sequencing, transfection into a mammalian cell host and the detection of the protein product. The techniques used will include PCR, cloning, transformation, plasmid isolation, DNA sequencing, transfection and protein detection using immunofluorescence and Western blot techniques.

BTR 605. Biotechnology Regulatory & Quality Systems. 3 hours.

U.S. and European Union regulatory affairs frameworks and practices governing the development, approval, manufacturing and surveillance of pharmaceuticals and medical devices, including in vitro diagnostic products. Regulations covered include investigational new drug applications (IND), new drug applications (NDA), good laboratory practices (GLP), good clinical practices (GCP) and current good manufacturing practices (cGMP).

*Nine (9) additional hours in suggested electives and/or certificate requirements must be taken to equal 30 hours of additional required courses (see list of Suggested Electives).

BT 798. Non-dissertation Research. 1 – 9 hours.

Independent student research to prepare dissertation proposal. Mentored by appointed Graduate Study Committee. Continuous registration is required until student is admitted to candidacy. Note: no more than 12 hours count in degree requirements.

BT 799. Dissertation Research. 1 – 18 hours.

Independent student research to complete dissertation project and written report. Mentored by appointed Graduate Study Committee. Must be admitted to doctoral candidacy. NOTE: Must have 2 semesters before graduation; Minimum of 12 hours.

BT 607. Recombinant DNA. 3 hours.

Introductory course for the basic concepts of R-DNA with emphasis on the types of enzymes and vectors used and the various methods of cloning and expression of genes in prokaryotic and eukaryotic systems. – To be developed post-implementation.

BT 770. Drug Discovery. 3 hours.

Overview of pharmaceutical development from target identification through pre-clinical development; focus on small molecule and biological products. – To be developed post-implementation.

BT 772. Medicinal Chemistry. 3 hours.

Comprehensive overview of concepts related to actions and clinical uses of major classes of drugs from their chemical structures; focus on structure-activity relationships, pharmacokinetics, and pharmacodynamics. – To be developed post-implementation.

BT 797. Independent Study. 1 – 3 hours.

Student exploration of topic specific to their research agenda.

BTR 615. Clinical Development of Drugs, Biologics, Diagnostics, and Medical Devices. 3 hours.

Major concepts under which clinical trials are designed and run. Focus on phases of clinical trial development, role of the U.S. Food and Drug Administration, Institutional Review Boards, and the Code of Federal Regulations and ethical principles.

BTR 620. Regulation of Food and Drugs. 3 hours.

Administrative procedures followed by the FDA; enforcement activities of the FDA, including searches, seizure actions, injunctions, criminal prosecutions, and civil penalties authorized by statutes.

BTR 640. Clinical Development of Drugs, Biologics, Diagnostics, and Medical Devices. 3 hours.

Major concepts under which clinical trials are designed and run. Focus on phases of clinical trial development, role of the U.S. Food and Drug Administration, Institutional Review Boards, and the Code of Federal Regulations and ethical principles.

BTR 675. Special Topics in Biotechnology Regulatory Affairs. 1-4 hours.

Exploration of current issues in Biotechnology Regulatory Affairs.

BTR 690. Clinical Trial Implementation. 3 hours.

Activities involved in running a clinical trial from study initiation to study close-out. Complex details and issues associated with study initiation, site and data management, preparation of the final report and study close-out.

GBS 753. Intro to Pharmacology & Toxicology. 2-3 hours.

Students taking this course will be expected to have a thorough understanding of normal and abnormal organ system function as discussed in the three-modules described above. Lectures will build on that foundation to cover recent advances in drug design and development based on approaches of molecular pharmacology and molecular medicine. In addition, drug targeting strategies that take advantage of specificity in cellular structure and cell signaling processes will also be discussed.

GBS 728. JC- Bio-Nano Technology. 1 hour.

This journal club will focus on the use of biological materials as paradigms, structural scaffolds, and active elements of nanoscale materials.

GBS 762. Virology. 2-3 hours.

This course is designed to familiarize students with the general steps involved in viral lifecycles and use this knowledge as a framework for understanding the similarities and differences in the lifecycles of (+) and (-) stranded RNA viruses, DNA viruses, and retroviruses. The course also covers the role of viruses in oncogenesis, the origin and evolution of viruses, the innate immune response to viral infections, and the development of antiviral chemotherapeutics. The goal of the course is to provide a strong foundation for advanced virology classes and to provide students with enough background in virology to be comfortable teaching in a college level microbiology class.