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Course Descriptions

Prerequisite Courses

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 master's degree in biotechnology.
Prerequisite: Two semesters of general or inorganic college chemistry

410.303 – Bioscience for Regulatory Affairs
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 master's degree in either biotechnology or bioscience regulatory affairs.

Core Science Courses

Students must complete four core courses before they are allowed to enroll in most of the science electives. A student who has mastered some or all of the material covered in the core courses in previous academic work may request that one or more of these courses be waived. After reviewing the student's request, the program committee may approve a waiver. The student then is required to replace the waived core course(s) with science electives. Electives should be chosen in consultation with the student's adviser and should accommodate individual career goals.

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 of chemistry and the living world of biology.

410.602 – Molecular Biology
This course provides a comprehensive overview of the key concepts in molecular biology. Topics 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 include methods in recombinant DNA technology, microarrays, and microRNA.
Prerequisite: 410.601 Biochemistry

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 also are introduced to the experimental techniques used in cell biology to study cell growth, manipulation, and evaluation.

410.604 – Advanced Cell Biology II
This course is a continuation of 410.603 (Advanced Cell Biology I) and further explores cell organization and subcellular structure. Students examine cell-to-cell signaling that involves hormones and receptors, signal transduction pathways, second messenger molecules, cell adhesion, extracellular matrix, cell cycle, programmed cell death, methylation of DNA and modification of chromatic structure, and mechanisms of the cell. The involvement of abnormalities in signal transduction pathways to oncogenesis and other disease states will be stressed.
Prerequisites: 410.601 Biochemistry; 410.602 Molecular Biology; 410.603 Advanced Cell Biology I

Science Elective Courses

Please note that many of the elective courses require prior completion of most core courses.

410.610 – Gene Organization and 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

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; 410.613 Principles of Immunology

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, dis-equilibrium mapping, and ethical dilemmas associated with the Human Genome Project.
Prerequisites: 410.601 Biochemistry; 410.602 Molecular Biology

410.613 – Principles of Immunology
 This course covers molecular and cellular immunology, including antigen and antibody structure and function, effector mechanisms, complement, major histocompatibility complexes, B- and T-cell receptors, antibody formation and immunity, cytotoxic responses, and regulation of the immune response. Students are also introduced to the applied aspects of immunology, which include immunoassay design and flow cytometry. Special topics include immunomodulation, immunosuppression, immunotherapy, autoimmunity, and vaccination.
Prerequisites: 410.601 Biochemistry; 410.602 Molecular Biology; 410.603 Advanced Cell Biology I

410.614 – Pathogenic Bacteriology
Lecture and discussion augmented by guided readings on pathogenic bacteria that cause human disease. Course material focuses on the history, epidemiology, growth, morphology, biochemistry, immunology, pathology 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

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 measures.
Prerequisites: 410.601 Biochemistry; 410.602 Molecular Biology; 410.603 Advanced Cell Biology I

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, viroids, 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, virion structure, virus cycle, pathogenesis, clinical features, epidemiology, immunity, and control. The viral vectors and their applications in biotechnology are discussed.
Prerequisites: 410.601 Biochemistry; 410.602 Molecular Biology; 410.603 Advanced Cell Biology I

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 macroorganisms, biodiversity, bioremediation, molecular approaches in aquaculture, the role of marine microbes in global carbon cycling, and genomics of marine organisms.
Prerequisites: All four core courses

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.

410.619 – Molecular Evolution
 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

410.621 – 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, 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

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 receptor's 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

410.623 – Molecular and 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, there 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 Cell Biology I

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 systems.
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 associated with the production and recovery of different bioproducts 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 (cGMP). Emphasis is on large-scale production methods and production of recombinant proteins for diagnostic and clinical applications.
Prerequisites: 410.601 Biochemistry; 410.602 Molecular Biology; 410.603 Advanced Cell Biology I

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: All four core courses

410.627 – Product Development: From Intellectual Property to Licensing
This course provides an extensive overview of a process for development of a pharmaceutical by a biotechnology 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 biotechnology company and the Food and Drug Administration (FDA). Students learn to appreciate the importance of quality control and assurance, good manufacturing practices, preclinical and clinical testing, and the lengthy regulatory processes which 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

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, Parkinson's, and Alzheimer's.
Prerequisites: All four core courses

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: All four core courses

410.630 – Gene Therapy
Students are introduced to gene transfer, its technical evolution, and its testing through clinical studies. Gene therapy holds promise for both genetic diseases and acquired diseases such as cancer and AIDS. The health, safety, and ethical issues surrounding gene therapy are discussed, together with the review and oversight systems established to regulate this therapy. Students also consider how industry is developing these techniques, both in new start-up companies as well as in established biotechnology and pharmaceutical companies. An overview of proprietary and patent issues in gene therapy is part of the course.
Prerequisites: All four core courses

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 of pathogenesis and epidemiology will be covered. More cursory 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 that our bodies are subjected to on an ongoing basis.
Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, and 410.603 Advanced Cell Biology I

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 the 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 can 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

410.633 – Introduction to Bioinformatics (formerly Computers in Molecular Biology)
Retrieval and analysis of electronic information are essential in today's research environment. 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 World Wide Web access. Information retrieval as well as 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, protein sequence motif analysis, and several genome analytical methods. Classes are held in a computer laboratory. Acquaintance with computers is required.
Prerequisites: 410.601 Biochemistry; 410.602 Molecular Biology

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 Perl 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

410.635 – Bioinformatics: Tools for Genome Analysis
Several large-scale DNA sequencing efforts have resulted in megabase amounts of DNA sequences being deposited in public databases. As such, the sequences are of less use than those sequences that are fully annotated. To assign annotations such as exon boundaries, repeat regions, and other biologicallyrelevant 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. Students complete two large sequence analysis projects during the course.
410.601 Biochemistry, 410.602 Molecular Biology, 410.633 Introduction to Bioinformatics or all Bioinformatics core courses

410.636 – Biology of HIV and AIDS
This course includes an overview of the biology and life cycle of the immunodeficiency virus, including the simian viruses (SIVs). 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

410.638 – Cancer Biology
This course provides students with knowledge of the fundamental principles of the molecular and cellular biology of cancer cells. Lectures and demonstrations explain the role of growth factors, oncogenes, tumor suppressor genes, angiogenesis, and signal transduction mechanisms in tumor formation. Discussion of aspects of cancer epidemiology, prevention, and principles of drug action in cancer management is part of the course.
Prerequisites: All four core courses

410.639 – Protein Bioinformatics
Because the gap between the number of protein sequences and 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, and statistical verification. Also covered are graphic visualization of 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 or all Bioinformatics core courses

410.640 – Phylogenetics and Comparative Genomics
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 or all Bioinformatics core courses

410.641 – Clinical and 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, and 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

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; the chi-square statistic; categorical data analysis; linear correlation and regression model; 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); scientific calculator

410.648 – Clinical Trial Design and Conduct
Through a case study approach, this course will cover the basic design issues of clinical trials. The design of specific trials will be studied to illustrate the major issues in the design of these studies, such as end point definition, control group selection, and eligibility criteria. The course also covers the analysis of these studies, including approaches that are central to clinical trials, such as stratified analysis, adjustment factors, and "intention-to-treat" analysis. The 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. The course will also cover various aspects of statistical computing, including organizing data, data management, and performing analysis using computer software. The ethical reporting of clinical trial results will also be covered with reference to the medical research literature.
Prerequisites: 410.651 Clinical Development of Drugs and Biologics; 410-645 Biostatistics (or equivalent)

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 ICH regulations and guidelines. Because the course emphasizes the importance of planning before the execution of any of the necessary steps, lectures use a "backwards" 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 Bioscience for Regulatory Affairs, OR 410.601 Biochemistry and 410.602 Molecular Biology

410.653 – Tissue Engineering
 Tissue engineering is a highly multidisciplinary field that involves cell biology, chemistry, materials science, engineering, and medicine. This course will be a survey that introduces students to the field from scientific, clinical, manufacturing, and regulatory perspectives. Roughly the first half of the course will be devoted to background material, and the second half will focus on applications. Readings will be drawn from books and journals.
Prerequisites: 410.601 Biochemistry; 410.602 Molecular Biology; 410.603 Advanced Cell Biology I

410.655 – Radiation Biology
This course will review types of ionizing radiation and their differences, physical and chemical interactions of radiation with key biological molecules, effects on living matter beginning with molecular and cellular interactions and proceeding to tissue, organ, and organism levels, emphasizing the human system. Radiation's 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 of exposure to the US population, and other practical situations involving radiation.
Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I

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

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.

410.663 – Current Topics in Molecular and 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),"knock-down" with RNAi, the use of transgenic and knock-out 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: Prerequisites: 410.601 Biochemistry; 410.602 Molecular Biology; 410.603 Advanced Cell Biology I

410.666 – Genomic Sequencing and Analysis
The completion of the human genome sequence is just the latest achievement in genome sequencing. Armed with the complete genome sequence, scientists need to identify the genes encoded within, to assign functions to the genes, and to put these into functional and metabolic pathways. This course will provide an overview of the laboratory and computational techniques beginning with genome sequencing and annotation, extending to bioinformatics analysis and comparative genomics and including functional genomics.
Prerequisites: Bioinformatics core courses

410.667 – Theory and Applications of 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
Immunology of Infectious Diseases 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 topics 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

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 and 410.603 Adv .Cellular Biology I.

410.671 – Microarrays and Analysis
This course will focus on the analysis and visualization of microarray data. The general aim is to introduce students to the various techniques and issues involved with analyzing multivariate expression data. Additionally, students will visualize the results in modern statistical scripting software. Topics include detecting and attributing sources of data variability, determining differentially expressed genes with relevant statistical tests, and controlling for false positive discovery (multiple test corrections, permutations, etc.). An introduction to linear and non-linear dimension reduction methods (PCA, PLS, isometric feature mapping, etc.) and an introduction to common pattern recognition (clustering), classification, and discrimination techniques will be included. Assignments and concepts will make use of publicly available Affymetrix and cDNA microarray data sets. Examples will mostly be demonstrated in S-plus and R (publicly available) code, with some in SAS. Free demo software tools such as Minitab, Spotfire, TreeView, Expression Profiler, and web UIs will also be utilized.
Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.645 Biostatistics or undergraduate Probability and Statistics, or all Bioinformatics core courses

410.673 – Biological Processes in Regulatory Affairs
This course provides an overview of the biological processes and laboratory techniques utilized for the discovery, development and evaluation of therapeutic drugs. Students investigate drug development processes such as gene cloning, culture scale-up, downstream processing, and product purification. Emphasis is placed on the theory and application of laboratory methods used 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: 410.601 Biochemistry; 410.603 Cell Biology or admissions to the MS in Bioscience Regulatory Affairs

410.692 – Biological & Chemical Threat Response and Forensics
 This course introduces the methods and techniques used for biothreat detection, identification, and medical intervention. Methods to protect the health and safety of responders, the proper procedures for threat containment, decontamination, removal, and establishment of a chain of custody for evidentiary materials are all discussed. Students will learn rapid methods for biothreat detection (using various biodetection platforms) and conventional methods such as culture, PCR, DNA fingerprinting, phage typing, microarrays, and proteomics. Procedures for working in Biosafety Levels 3 and 4 environments are presented, as well as the immunological responses to biothreat exposure, and the preventive and therapeutic options available.
Prerequisites: 410.601 Biochemistry; 410.602 Molecular Biology; 410.603 Advanced Cell Biology I; undergraduate Microbiology or 410.615 Microbiology.

410.693 – Science, Medicine, and 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.

410.695 – Applied Molecular Biology
This course will cover applied concepts and research techniques in molecular biology. It is designed for students with a good basic knowledge of molecular biology who want to study more advanced concepts and how they may be applied in biotechnology. Topics for discussion include; applied PCR techniques, vector construction and modification, affinity chromatography, two-hybrid screening, iRNA, site-directed-mutagenesis /protein engineering, microarrays, prokaryotic and eukaryotic expression systems.
Prerequisites: 410.601 Biochemistry; 410.602 Molecular Biology; and 410.603 Adv. Cellular Biology I.

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 promise 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 and 410.603 Advanced Cell Biology I

410.697 – Microfluidics and Biosensors
 Microfluidics (Lab-on-a-chip technology) is the miniaturization of laboratory operations for micro-scale chemistry, high-throughput drug screening, environmental sensors, biothreat 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, analyte detection, single-cell analysis, microarray design & 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.

410.698 – Bioperl
This course builds on the Perl concepts taught in 410.634 Practical Computer Concepts for Bioinformatics. 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: Bioinformatics core courses

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 anticancer 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.

410.712 – Advanced Practical Computer Concepts for Bioinformatics
This intermediate to advanced-level course, intended as a follow-on to 410.634 Practical Computer Concepts for Bioinformatics (a prerequisite for this new class), will integrate and expand on the concepts from that introductory class to allow students to create working, Web-based bioinformatics applications in a project-based course format. After a review of the concepts covered in 410.634, students will learn how to create functional Web applications on a UNIX system, using Perl and CGI to create forms that can be acted upon, and using the Perl DBI module to interface with MySQL relational databases that they will create and populate to retrieve and present information. This will be demonstrated by building an in-class, instructor led project. More advanced SQL concepts and database modeling will also be covered, as well as a brief introduction to the PHP scripting language. Class time in the latter weeks of the class will be devoted to individual assistance on student projects as well as to short lectures on advanced Perl topics, object-oriented Perl, and installing Perl modules. The last two weeks will be devoted to student presentations and a peer critique of their project. Once again, whenever possible, this course will emphasize relevance to solving problems in molecular biology and bioinformatics.
Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.634 Practical Computer Concepts for Bioinformatics with a grade of A- or above or permission of associate program chair

410.750 – Molecular Targets and Cancer
 This course will investigate potential molecular targets in cancer including receptor tyrosine kinases, G-Protein coupled receptors, the TGF beta signaling pathway, cell cycle check points, kinases and phosphatases, chemokine and chemokine receptors, nuclear receptors, suppressor proteins, metastasis and angiogenesis targets, integrins, and matrix metalloproteinases. Discussion will also include topics on what defines a molecular target and the methods by which they are evaluated.
Prerequisites : All four core courses

410.751 – Chemical Libraries & Diversity
 Chemical diversity and "pharmacological space" 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. Lipinski's rules for drug-like molecules will be discussed in detail, as well as methods for chemical analysis, in silico drug design, molecular modeling, and compound storage and handling. 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

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 & cell biology, stem cell characteristics, stem cell preparation & 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: All four core courses.

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 Bioinformatics core courses

410.777 – BioFuels
In this course, students are introduced to the current technologies used in the production of biofuels. These technologies include ethanol distillation using a variety of biomass raw materials such as corn, sugar cane, cellulosic waste materials, and beer waste. Students will also study the methods used to produce biodiesel using agricultural products, such as soybeans and canola, used vegetable oil, and algae. They will also investigate the production of hydrogen from algae and bacterial sources. Students will also study the biodigester and how it can be used to transform waste into energy. In addition to studying the techniques used to produce biofuels, students will also discuss the economic and environmental impacts of using agricultural biomass sources, since many of these are also food sources.
Pre-requisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 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 graduate-level courses and has compiled a strong academic record. Prior to proposing a project, interested students must have identified a research topic and a mentor who is familiar with their prospective inquiry and 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 student's place of work, or any expert with appropriate credentials. Students are required to submit a formal proposal for review and approval by the biotechnology program committee. The proposal must be received by the 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 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.
Download the Guidelines for Proposal.
Download Sample IRPs.
Prerequisites : All four core courses and four elective courses.

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 advisor and biotechnology program committee one month prior to the beginning of the term. Students must meet the faculty advisor periodically for discussion of the project's progress. Graduation with a thesis is subject to approval by the thesis committee and program committee, and requires the student to present their project to a faculty committee both orally and in writing.
Prerequisites: All four core science courses and six elective courses, which must include 410.800 Independent Research Project and 410.645 Biostatistics.

Thesis Guidelines:
If students work on sponsored research, the thesis advisor (or sponsoring institution) and the student should sign a letter of agreement on publication rights and authorship before work on the thesis begins.

Research expenses, such as lab supplies, related travel, and services essential to the collecting and processing of data, are paid for by the thesis advisor or sponsoring organization. Special costs of thesis production are the student’s responsibility, such as typing, art work, and duplicating of the thesis.

 

Thesis Format:
The student must follow the University's "Guidelines for the Preparation of Dissertations and Theses," to ensure thesis acceptance. The Guidelines are available at www.library.jhu.edu/services/cbo/guidelines.html.

Prerequisites: All four core science courses and six elective courses, which must include 410.800 Independent Research Project and 410.645 Biostatistics.

Thesis Committee:
The thesis committee includes the thesis advisor (mentor), faculty advisor, and a member of the program committee (or their designate).

Laboratory Elective Courses

All the following electives are wet lab courses. Students must bring lab coat and safety glasses to all meetings of the course.

410.652 – Cell Culture Techniques
 This laboratory course illustrates the use of basic cell culture techniques used in 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, primary cultures, cultivation of cell lines, detection of contamination, cryopreservation, transfection, 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; 410.602 Molecular Biology; 410.603 Advanced Cell Biology I

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, as well as applications of the polymerase chain reaction. This course is not recommended for students with substantial experience in these methodologies.
Prerequisites: 410.601 Biochemistry; 410.602 Molecular Biology

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

410.658 – Biodefense Laboratory Methods
This laboratory course introduces students to the methods and techniques used for biothreat detection, surveillance and identification. Using bio-simulants and demonstrations, various biodetection platforms will be discussed and presented, such as point-of-detection devices and methods, laboratory based screening and identification technologies (culture, RT-PCR, ECL, immunoassays, biosensors), and high-throughput environmental surveillance methods. Statistical methods for determining diagnostic sensitivity & 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).

410.659 – Advanced Recombinant DNA Laboratory
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 course consists of a series of integrated laboratory exercises designed to give students hands-on experience with a variety of advanced recombinant DNA techniques. Exercises include molecular cloning; PCR optimization; site directed mutagenesis; mutation detection; measuring gene expression by quantative real time PCR (qRT-PCR); and control of gene expression by RNA interference (RNAi). Students will be introduced to high throughput/high content screening procedures such as robotic liquid handling, microarray analysis, and utilization of bioinformatic techniques.
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 hybridoma technology, phage antibody libraries, therapeutic monoclonal antibodies, and flow cytometry.
Prerequisites: 410.601 Biochemistry; 410.602 Molecular Biology; 410.603 Advanced Cell Biology I; 410.613 Principles of Immunology or undergraduate immunology course highly recommended; or consent of program committee

410.752 – High Throughput Screening and Automation Laboratory
 This course will utilize hands-on instruction in automated bioassay systems for high throughput screening (HTS) 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: All four core courses and 410.696 Bioassay Development

Enterprise and Regulatory Affairs Elective Courses

410.606 – Clinical Trial Management
This course provides an overview of the planning and management of clinical trials in the US and internationally.  Students learn about the processes involved in planning the trial, creating case report forms, developing the clinical database, selecting and initiating sites, monitoring sites, cleaning the database, analyzing the data, and writing the final study report.  At the end of this course students will better understand the aspects involved in managing clinical trials under federal regulations, international (ICH) guidelines, and good clinical practices.

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.
The Proseminar course is required of all MS Biotechnology/MBA students  and  is  a non-science elective to  all  other students.

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 healthcare systems addressing concerns of innovation, cost, equitable access, and sustained quality of healthcare. As a result healthcare is undergoing significant changes globally in R&D, marketing, pricing, sales and distribution. In order to understand these processes and the new business opportunities and new business
models they create this course will provide some of the basics of macro and micro economics to clarify how economic and social forces drive changes in the pharmaceutical, biotech, and generic industry. Emphasis will be placed on the application of economics to current decision making in the new global economy as it impacts biotechnology.

410.643 – Managing and Leading Biotechnology Professionals
The roles of managers and leaders within biotechnology companies undergo constant change. Biotechnology managers and leaders must engage in new and innovative problem-solving strategies; lead a diverse and global workforce; develop partnerships with other businesses, customers, and competitors; manage horizontally and across teams; and utilize technology as a competitive advantage. The student is able to address current challenges in his/her own organization and learn methods of implementing change, such as negotiation techniques and motivation. The course includes in-depth discussions of leadership skills, communication, conflict resolution, and goal integration. Students research a biotechnology organization and 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 products 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 addressed shall include market assessment of innovative technology, patents and licensing, corporate law, preparing a business plan, raising money from angels and venture capitalists, government grants, strategic alliances, sales and marketing, real estate, human resources, and regulatory affairs. The course provides a survey and overview of the key tasks and challenges typically faced by biotech entrepreneurs, their management team, and directors. Students will prepare a business plan for a biotech start-up and present the plan to a panel of industry experts and financiers. Leaders from our local bioscience community will be guest lecturers for many of the classes.

410.647 – Research Ethics
This course covers fundamental concepts in ethical decision-making in research through discussions of case studies, videos, and film. Students explore issues central to these areas, such as the appropriate use of animals in research, protections against risk in human subjects research, and topics related to integrity of the research process such as: authorship, peer review, and the ethics of the business of science.

410.649 – Introduction to Regulatory Affairs
Regulatory affairs (RA) comprise the rules and regulations governing product development and post-approval marketing of medical products. 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, foods, or combinations. Each type is regulated by a different center within the FDA. This course provides an overview of RA, its affect on product development, and how to use the rules to your advantage. Topics include: RA history, regulatory agencies, how to access regulatory information, drug submissions, biologics submissions, medical device submissions, GXP, FDA inspections, exclusivity, and regulatory strategy. Students are given case studies that allow them to apply what they have learned about regulatory affairs to "real-world" type situations.

410.650 – Legal Aspects of Biotechnology
 In this course students gain a thorough understanding of the legal steps necessary to protect and market biotechnological inventions and of the procedures required to obtain the necessary permits and licenses from government agencies. Topics include inventorship and ownership issues in academia and industry; what can and should be patented in the United States and in other countries; how patents are granted; how to avoid losing patent rights; how to enforce and defend patents; and how to transfer rights to technology.

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; they hone their expertise at making both formal and informal oral presentations; they prepare poster presentations, and develop their own public speaking strategies. The course also presents personal strategies for improving daily communications, cross-cultural communications, and non-verbal skills. Students improve their written communication, editing, and informal writing skills. Participants also learn effective e-mail 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
 The pharmaceutical/biotechnology product approval and marketing requires a good understanding of international regulatory affairs in order to successfully compete in today's global market place. It is important for tomorrow's leaders to understand and follow the regulatory differences to ensure optimum product development strategies, regulatory approvals and designs for exports conforming to the foreign regulatory bodies. There are various product development strategies that industry is using to shorten the product development time by conducting preclinical programs outside the US, however, the strategy requires a careful planning and interaction with the US 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.

410.676 – Food And Drug Law
The Food, Drug, and Cosmetic Act (FDCA) 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 FDC 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
In the United States, the FDA clears products to market through submissions by sponsors. These submissions are the pathway to market for regulated drugs, devices, biologics, and well-defined biotechnology products. Each submission type is reviewed by one or more of several different centers within the FDA. This course provides an overview of these submissions and the effect of submission type on product development. Topics include biological and biotech submissions as well as drug and medical device submissions, the review procedures and approval standards applied to each type, the guidance that applies to these submissions, and any FDA inspections required for approval.

410.678 – Marketing in a Regulated Environment
This course is designed to help students, both on the reglatory and on the marketing side, understand, use, and comply with the laws, regulations, and policy guidance documents governing advertising and promotion of products regulated by the Food and Drug Administration (FDA). The course provides an overview of how marketing and regulatory departments at biopharmaceutical, diagnostic, and other regulated organizations can work effectively together to assure compliance with appropriate regulations, while still achieving corporate goals. In addition to providing an overview of how marketing is done in a regulated environment, the class includes extensive discussion of FDA's advertising oversight, and FDA enforcement activities. The course content introduces students to advertising, marketing and promotion of approved products. It provided insights on preparing a strategic marketing program, comparing competitor products, pricing, and the need for head-to-head comparative data, Rx products, OTC products, unapproved investigational products, and unapproved research products.

410.679 – Practicum in Bioscience Regulatory Affairs (Open only to Students in MS BSRA)
This integrative case-based course will focus on applying knowledge gained from previous courses in the MS Bioscience Regulatory Affairs program to actual cases from the U.S. Food and Drug Administration. For each case, students will assume the role of either a regulatory specialist, an FDA reviewer or senior-level policy-maker, or other involved stakeholders, such as a consumer group or an advocacy group. Students will be expected to research, evaluate, and present scientifically and legally justifiable positions on case studies from the perspective of their assigned roles. Students will present their perspectives to the class and be asked to debate the issues with the other students from the perspective of their assigned roles. The major responsibility of the students in this course will be to make scientifically and legally defensible recommendations and to justify them through oral and written communication.
This course is only open to students in the MS in Bioscience Regulatory Affairs who have completed 8 courses. This course is intended to be either the 9th or 10th course in the program.

410.680 – Managerial Finance for Biotechnology I (formerly Financial Development for Biotechnology)
 This course integrates the tools of financial analysis with real-world problems in the technology industries. Topics include modeling, costs and benefits, and ratio and break-even analysis. Students will read, prepare, and analyze financial statements. The difference between management financial and tax financial statements will also be covered.

410.681 – Commercializing Biotech
 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 company's 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 today's 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 distribution of drugs, biologics and medical devices in the US and internationally. In the US, they are codified at the Federal level, in the FD&C Act and the CFR, and actively enforced by FDA. These regulations, however, only begin to describe the practices used in the pharmaceutical and biotech industries. Additional sources of insight and guidance include FDA's guidance documents and training manuals, industry trade publications, international compendia, and standards-setting organizations. Students will learn the scope and history of the regulations, industry-standard implementation strategies and "best-practices" approaches, and FDA's 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 and Commercialization
 This course is an introduction to the multidisciplinary aspects involved in the process of bringing technical developments, particularly research emanating from universities and other nonprofit organizations, into commercial use. The course will provide an overview of the key policies, concepts, tools, issues, practices, and trends that are shaping the technology transfer field, with an emphasis on the life sciences sector.

410.685 – Emerging Issues in Biotechnology
This course will focus on new global public-private partnerships in the biotechnology and pharmaceutical industry and the new business opportunities and new business models they create.

The drive towards better global health has been slowed by the emergence of virulent diseases such as HIV/AIDS, SARS, Malaria, Tuberculosis, and West Nile virus; rapidly changing microbial resistance to many drugs; and by an expanding global travel network that has shown the world how quickly a local disease in a developing country can transform into an international public health threat.

As part of this process global leaders are reevaluating the healthcare needs of their citizens and the advances in science that offer new opportunities for society. As a consequence, critical health legislation has been promulgated to redesign and restructure healthcare and social infrastructures. Emerging from this global effort are exciting new partnerships that engage the biotechnology and pharmaceutical industry, governments, and the non-profit sector in accelerating and advancing product development and the manufacturing of drugs, vaccines, and microbicides for pandemic diseases.

Over the past few years, in response to the demands from G8 leaders, the healthcare industry has been increasingly engaging in new global initiatives that are breaking through boundaries within government sectors, between government and nongovernmental organizations and between the public and private sectors. Implicit in this engagement are new business opportunities and new business models that are coupled with heightened levels of global corporate social responsibility found in 'public-private' partnerships.

This course focuses on new global public-private partnerships as they have important implications for senior level decision makers in the biotechnology and pharmaceutical industries. More about this course.

410.686 – QA/QC for the Pharmaceutical and Biotechnology Industries
 Many new quality initiatives for drugs, biotech products, and medical devices recently have been introduced. These include risk-based, science-based and systems-based assessments. Students will be presented with a comprehensive overview of the current best practices in quality assurance and quality control. Students will also be exposed to the most recent theories and expectations from the Food and Drug Administration.

410.687 – Ethical, Legal, and 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 is divided into the three sections of ethics, legal issues, and regulations, each section taught by a faculty member who specializes in the area. The three sections are organized to provide basic material in a way that allows for an appreciation of how each influences the others. The section on ethics introduces students to core ethical values that guide the practice of science in the biotechnology industry. The section on legal issues focuses on key legal concepts, such as protecting inventions and intellectual property, and licensing. The section on regulation addresses the range of regulatory oversight mechanisms with which the biotech industry must comply and strategies for doing so.

410.689 – Leading Change in Biotechnology
As bioscience companies grow and mature, leadership needs evolve. Students will learn how to identify their company's position in the "Leadership Life Cycle" and learn how to select the right leadership capabilities based on their current organizational needs. Research shows that the right leaders at the right time dramatically improve organizational success. Discussions will address the leadership needs of organizations from early stage research-based companies through fully integrated bio-pharmaceuticals. General leadership practices and strategies, moving ideas from research bench to the consumer, and strategies to prevent failure will all be discussed.

410.690 – Technical Writing in a Regulated Environment
In this practical course, students will learn both the basic concepts and the steps involved in writing documents and reports commonly associated with compliance and regulatory requirements in the Biotech and Pharmaceutical industries. Through course lectures and interactive exercises, students will learn how to write and revise clear, instructive and readable regulatory documents, policies and reports. This course will cover what to write, how to write, and why documents should be written in certain terms to assure successful communication as well as compliance in a regulated environment.

410.715 – Medical Device Regulation
This course provides a comprehensive introduction into medical devices and how they are regulated by the US Food and Drug Administration (FDA). Topics that will be covered include: (1) an overview of the laws and regulations that govern medical devices; (2) FDA's organizational structure and responsibilities for medical device regulation; and (3) administrative and legal requirements for medical devices throughout the full product life-cycle. Particular focus will be placed on the premarket review, postmarket programs enforcement (e.g., Quality System 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, as well as, 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 and policies of FDA regulation of medical devices.

410.802 – Independent Studies in Regulatory Affairs
Students in the bioscience regulatory affairs program have the opportunity to enroll in an independent study course. This elective course is an option after a student has completed at least five graduate-level 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 teaching in the bioscience regulatory affairs program, 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 bioscience regulatory affairs 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 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.
Download the Guidelines for Proposal.
Sample IRPs.
This course is open only to students in the MS in Bioscience Regulatory Affairs program or the MS in Biotechnology with a concentration in Regulatory Affairs and may be taken only after 5 courses have been completed. 

410.803 – Bioscience Regulatory Affairs 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 Affairs Project and 410.803 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 advisor and biotechnology program committee one month prior to the beginning of the term. Students must meet the faculty advisor periodically for discussion of the project's progress. Graduation with a thesis is subject to approval by the thesis committee and program committee, and requires the student to present their project to a faculty committee both orally and in writing.
Prerequisites: All required Regulatory Affairs courses and three elective courses, which must include 410.802 Independent Studies in Regulatory Affairs and if hypothesis driven, 410.645 Biostatistics.

Thesis Guidelines:
If students work on sponsored research, the thesis advisor (or sponsoring institution) and the student should sign a letter of agreement on publication rights and authorship before work on the thesis begins. Research expenses, such as lab supplies, related travel, and services essential to the collecting and processing of data, are paid for by the thesis advisor or sponsoring organization. Special costs of thesis production are the student's responsibility, such as typing, art work, and duplicating of the thesis.

Thesis Format:
The general format should follow APA style guidelines.

Thesis Committee:
The thesis committee includes the thesis advisor (mentor), faculty advisor, and a member of the program committee (or their designate).

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