Course Schedule

The courses below are those offered for the term. (To view the course description, class dates & times, touch on accordion tab by the title.)

State-specific Information for Online Programs

Note: Students should be aware of state-specific information for online programs. For more information, please contact an admissions representative.

  • Homewood Campus

    410.601.01 - Biochemistry

    $4196

    Richa Tyagi

    Monday 6:00 - 9:20; 8/28 - 12/11

    This course explores the roles of essential biological molecules focusing on protein chemistry, while covering lipids and carbohydrates. It provides a systematic and methodical application of general and organic chemistry principles. Students examine the structure of proteins, their function, their binding to other molecules, and the methodologies for the purification and characterization of proteins. Enzymes and their kinetics and mechanisms are covered in detail. Metabolic pathways are examined from thermodynamic and regulatory perspectives. This course provides the linkage between the inanimate world chemistry and the living world of biology.

    410.602.01 - Molecular Biology

    $4196

    Robert Horner

    Tuesday 6:00 - 9:20; 8/29 - 12/12

    This course provides a comprehensive overview of the key concepts in molecular biology. Topics to be covered include nucleic acid structure and function, DNA replication, transcription, translation, chromosome structure, and remodeling and regulation of gene expression in prokaryotes and eukaryotes. Extended topics to be covered include method in recombinant DNA technology, microarrays, and microRNA Prerequisite: 410.601 Biochemistry.

    410.603.01 - Advanced Cell Biology I

    $4196

    Beatrice Kondo

    Thursday 6:00 - 9:20; 8/31 - 12/14

    This course covers cell organization and subcellular structure Students examine the evolution of the cell, chromosome, and plasma membrane structures and behaviors; mechanics of cell division; sites of macromolecular synthesis and processing; transport across cell membranes; cell dynamics; organelle biogenesis; and cell specialization. Students are also introduced to the experimental techniques used in cell biology to study cell growth, manipulation, and evaluation.

    410.604.01 - Advanced Cell Biology II

    $4196

    Michael Lebowitz

    Tuesday 6:00 - 9:20; 8/29 - 12/12

    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.

    410.613.01 - Principles of Immunology

    $4196

    Meredith Safford

    Monday 6:00 - 9:20; 8/28 - 12/11

    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.

    410.631.01 - Infectious Diseases

    $4196

    Sara Ruiz

    Thursday 6:00 - 9:20; 8/31 - 12/14

    This course focuses on infectious diseases of mankind, presented in a system-by-system format. Basic principles of host defense and microbial virulence will be discussed. Practical, up-to-date information on the clinical presentation, symptoms, physical findings, laboratory diagnosis, treatment and prevention of the general array of diseases caused by bacteria and viruses will be presented. The use of antibiotics, prophylactic agents, and vaccines along with selected aspects pathogenesis and epidemiology will be covered. More cursor coverage will be given to the fungal and parasitic agents of human disease. The student will develop a broad understanding of the many different kinds of infectious processes to which our bodies are subjected to on an ongoing basis. Prerequisites 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I.

    410.635.01 - Bioinformatics:Tools for Genome Analysis

    $4196

    Robert Lessick

    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. Assigning annotations, such as exon boundaries, repeat regions, and other biologically relevant information, accurately in the feature tables of these sequences requires a significant amount of human intervention. This course instructs students on computer analytical methods for gene identification, promoter analysis, and introductory gene expression analysis using software methods. Additionally, students are introduced to comparative genomics and proteomic analysis methods. Students will become proficient in annotating large genomic DNA sequences. Students complete two large sequence analysis projects during the course. Prerequisites: 410.601 Biochemistry; 410.602 Molecular Biology; 410.633 Introduction to Bioinformatics; or all Bioinformatics core courses.

    Meeting Dates: September 6 September 20 October 11 November 1 November 15 November 29 December 6

    410.641.01 - Clinical & Molecular Diagnostics

    $4196

    Mathumathi Rajavel

    Wednesday 6:00 - 9:20; 8/30 - 12/13

    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.

    410.645.01 - Biostatistics

    $4196

    Robert Lessick

    Tuesday 6:00 - 9:20; 8/29 - 12/12

    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.

    410.652.01 - Cell Culture Techniques

    $4196

    Mark Verdecia

    Thursday 6:00 - 9:20; 8/31 - 12/14

    This laboratory course illustrates the use of basic cell culture techniques for bioscience research and commercial applications. Students are introduced to cell cultivation methods, including proper use of a biological safety cabinet, sterile technique, ell enumeration and media preparation, cultivation of cell lines,, primary cultures, detection of contamination, cryopreservation, transfection, cell culture scale-up, and an introduction to bioassays. This course is designed for students with no prior knowledge or with limited knowledge of cell culture methods. Prerequisites: 410.601 Biochemistry; 410.603 Advanced Cell Biology I.

    410.692.01 - Biological & Chemical Threat Response & Forensics

    $4196

    Calvin Chue

    Wednesday 6:00 - 9:20; 8/30 - 12/13

    This course introduces the methods and techniques used for biological and chemical threat agent characterization; methods of detection, identification, medical intervention, and forensic attribution are also discussed. Lectures cover a broad variety of topics pertaining to the use of biological and chemical agents, including: historical background of biological and chemical agents in classic and discretionary warfare, the introduction of scientific evidence in criminal proceedings and chain of custody for evidentiary materials in crimes and terrorism, quality assurance in laboratory operations, threat containment, decontamination and remediation, health and safety of responders and analysts, and risk assessments. Laboratory methods employed in the characterization and forensic analysis of biological (bacterial, viral, biological toxins, agricultural threats) and chemical agents (classic military chemical agents, toxic industrial chemicals, and materials) will also be discussed. General overviews of techniques and sample collection for classic biological and chemical agents (PCR, DNA sequencing methods, immunological analyses), and for chemical agents (gas chromatography and mass spectrometry). Prerequisites: 410.601 Biochemistry; 410.602 Molecular Biology; 410.603 Advanced Cell Biology I; undergraduate Microbiology or 410.615 Microbiology.

    410.696.01 - Bioassay Development

    $4196

    Takashi Tsukamoto

    Monday 6:00 - 9:20; 8/28 - 12/11

    This course will cover methodological approaches to bioassay development for high-throughput screening. Both cell-based (cytotoxicity; cytoprotection, high content imaging, and reporter systems) and cell-free assay systems (enzyme, FRET, time resolved fluorescence, quenching assays, and immunological assays) will be included with discussion of the potential prom and pitfalls associated with each assay system. Various assay formats, visualization techniques, and current developments in assay technology will be discussed. Project management techniques will be utilized to aid in the process of assay development. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I.

    410.801.01 - Biotechnology Thesis

    $4196

    Kristina Obom

    Sunday 12:00 - 12:01; 8/28 - 12/16

    Students wishing to complete a thesis may do so by embarking on a two-semester thesis project, which includes 410.800 Independent Research Project and 410.801 Biotechnology Thesis courses. This project must be a hypothesis-based, original research study. The student must complete 410.800 Independent Research Project and fulfill the requirements of that course, including submission of project proposal, final paper, and poster presentation, before enrolling in the subsequent thesis course. For the thesis course, students are required to submit a revised proposal (an update of the 410.800 proposal) for review and approval by the faculty adviser and biotechnology program committee one month prior to the beginning of the term. Students must meet the faculty adviser periodically for discussion of the project’s progress. Graduation with a thesis is subject to approval by the thesis committee and program committee, and requires the student to present his/her project to a faculty committee both orally and in writing. Prerequisites: All four core science courses and six elective courses, which must include 410.800 Independent Research Project and 410.645 Biostatistics.

  • Montgomery County Campus

    410.601.71 - Biochemistry

    $4196

    Elena Schwartz

    Tuesday 6:00 - 9:20; 8/29 - 12/12

    This course explores the roles of essential biological molecules focusing on protein chemistry, while covering lipids and carbohydrates. It provides a systematic and methodical application of general and organic chemistry principles. Students examine the structure of proteins, their function, their binding to other molecules, and the methodologies for the purification and characterization of proteins. Enzymes and their kinetics and mechanisms are covered in detail. Metabolic pathways are examined from thermodynamic and regulatory perspectives. This course provides the linkage between the inanimate world chemistry and the living world of biology.

    410.602.71 - Molecular Biology

    $4196

    Stacy Plum

    Monday 5:30 - 8:50; 8/28 - 12/11

    This course provides a comprehensive overview of the key concepts in molecular biology. Topics to be covered include nucleic acid structure and function, DNA replication, transcription, translation, chromosome structure, and remodeling and regulation of gene expression in prokaryotes and eukaryotes. Extended topics to be covered include method in recombinant DNA technology, microarrays, and microRNA Prerequisite: 410.601 Biochemistry.

    410.602.72 - Molecular Biology

    $4196

    Dr. Arti Varanasi

    Wednesday 4:00 - 7:20; 8/30 - 12/13

    This course provides a comprehensive overview of the key concepts in molecular biology. Topics to be covered include nucleic acid structure and function, DNA replication, transcription, translation, chromosome structure, and remodeling and regulation of gene expression in prokaryotes and eukaryotes. Extended topics to be covered include method in recombinant DNA technology, microarrays, and microRNA Prerequisite: 410.601 Biochemistry.

    410.602.73 - Molecular Biology

    $4196

    Olivia Spicer

    Friday 10:00 - 1:20; 9/1 - 12/15

    This course provides a comprehensive overview of the key concepts in molecular biology. Topics to be covered include nucleic acid structure and function, DNA replication, transcription, translation, chromosome structure, and remodeling and regulation of gene expression in prokaryotes and eukaryotes. Extended topics to be covered include method in recombinant DNA technology, microarrays, and microRNA Prerequisite: 410.601 Biochemistry.

    410.603.71 - Advanced Cell Biology I

    $4196

    Thomas Koval

    Wednesday 6:00 - 9:20; 8/30 - 12/13

    This course covers cell organization and subcellular structure Students examine the evolution of the cell, chromosome, and plasma membrane structures and behaviors; mechanics of cell division; sites of macromolecular synthesis and processing; transport across cell membranes; cell dynamics; organelle biogenesis; and cell specialization. Students are also introduced to the experimental techniques used in cell biology to study cell growth, manipulation, and evaluation.

    410.604.71 - Advanced Cell Biology II

    $4196

    Elena Schwartz

    Wednesday 6:00 - 9:20; 8/30 - 12/13

    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.

    410.612.71 - Human Molecular Genetics

    $4196

    Roza Selimyan

    Wednesday 5:15 - 8:35; 8/30 - 12/13

    In this course, students learn to use the tools of modern genomics to elucidate phenotypic variation within populations. The course uses human disease (from simple Mendelian disorders to common, complex disorders) to exemplify the types of studies and tools that can be used to characterize cellular pathophysiology as well as to provide genetic diagnostics and therapies. Students become facile with linkage analysis, cancer genetics, microarray analysis (oligo and DNA arrays), gene therapy, SNP studies, imprinting, disequilibrium mapping, and ethical dilemmas associated with the Human Genome Project. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology.

    410.613.71 - Principles of Immunology

    $4196

    Robert Kaminski

    Tuesday 6:15 - 9:35; 8/29 - 12/12

    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.

    410.615.71 - Microbiology

    $4196

    Dr. Gregory

    Tuesday 6:00 - 9:20; 8/29 - 12/12

    This course is an overview of microorganisms important in clinical diseases and biotechnology. Students are introduced to the general concepts concerning the morphology, genetics, and reproduction of these microbial agents. Lectures focus on individual organisms, with emphasis on infectious diseases, biotechnology applications, molecular and biochemical characteristics, and molecular and serological identification methods. Students will also discuss the impact biotechnology and particularly genomics, will have on the development of antibiotics and vaccines as treatment and preventive measure Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology410.603 Advanced Cell Biology I.

    410.622.71 - Molecular Basis of Pharmacology

    $4196

    Jason Rohde

    Monday 6:00 - 9:20; 8/28 - 12/11

    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.

    410.627.71 - Translational Biotechnology:From Intellectual Property to Licensing

    $4196

    James Karaszkiewicz

    Thursday 6:00 - 9:20; 8/31 - 12/14

    This course provides an extensive overview of a process for development of a pharmaceutical by a biotechnology company or pharmaceutical company. The course emphasizes the importance of intellectual property, the basic sciences underpinning the development of a product, and the importance of the interaction between a company and the Food and Drug Administration. Students learn to appreciate the importance of quality control and assurance, good manufacturing practices, preclinical and clinical testing, and the lengthy regulatory processes that govern the development, manufacture, and eventual sale of biotechnological products. Hands-on solving of practical problems and guest lecturers who are experts in the field familiarize students with the intricacies of the process. Prerequisites: 410.303 Bioscience for Regulatory Affairs, OR 410.601 Biochemistry and 410.603 Advanced Cell Biology or admission to the MS in Regulatory Science OR Master of Biotechnology Enterprise and Entrepreneurship programs.

    410.629.71 - Genes & Disease

    $4196

    Kristina Obom

    Thursday 5:00 - 8:20; 8/31 - 12/14

    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.

    410.645.71 - Biostatistics

    $4196

    Martha Nason
    Michael Proschan

    Monday 6:00 - 9:20; 8/28 - 12/11

    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.

    410.652.71 - Cell Culture Techniques

    $4196

    Kristin Mullins

    Wednesday 6:00 - 9:20; 8/30 - 12/13

    This laboratory course illustrates the use of basic cell culture techniques for bioscience research and commercial applications. Students are introduced to cell cultivation methods, including proper use of a biological safety cabinet, sterile technique, ell enumeration and media preparation, cultivation of cell lines,, primary cultures, detection of contamination, cryopreservation, transfection, cell culture scale-up, and an introduction to bioassays. This course is designed for students with no prior knowledge or with limited knowledge of cell culture methods. Prerequisites: 410.601 Biochemistry; 410.603 Advanced Cell Biology I.

    410.656.71 - Recombinant DNA Laboratory

    $4196

    Olivia Spicer

    Monday 6:00 - 9:20; 8/28 - 12/11

    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.

    410.675.71 - International Regulatory Affairs

    $4196

    Jonathan Helfgott
    Emil Wang

    Monday 6:00 - 9:20; 8/28 - 12/11

    Pharmaceutical/biotechnology product approval and marketing requires a good understanding of international regulatory affairs in order to successfully compete in today’s global marketplace. It is important for tomorrow’s leaders to understand and follow the regulatory differences to ensure optimum product development strategies, regulatory approvals, and designs for exports conforming to the foreign regulatory bodies. There are various product development strategies that industry is using to shorten the product development time by conducting preclinical programs outside the U.S., but the strategy requires careful planning and interaction with the U.S. and foreign regulatory agencies. With the increase in globalization of economy and exports, international regulations will have a bigger impact on the biotechnology business in the future. The course provides a review and analysis of the pharmaceutical/biotechnology product approval processes within the world’s major markets. The key strategies required in preclinical product development to marketing approval of the products in Europe, Japan, and the U.S. will be compared and discussed. Students will explore the European Union regulations and their overall importance on international markets. The course will cover the salient features of common technical and regulatory documents required for submission and approval to the leading regulatory bodies in the world, general guidance documents, international harmonization, and the General Agreement on Tariffs and Trade.

    410.693.71 - Science, Medicine & Policy in Biodefense

    $4196

    John Carra

    Thursday 6:00 - 9:20; 8/31 - 12/14

    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.

    410.733.71 - Comparative Animal Physiology

    $4196

    Beatrice Kondo

    Tuesday 1:00 - 4:20; 8/29 - 12/12

    This class examines animal physiology from an evolutionary and comparative viewpoint. The goal is to examine the commonalities, as well as unique differences, in how various animal organisms address the necessary life functions. Topics will include homeostatic mechanisms as an overarching theme, integrating the following systems: nervous, endocrine, muscle, circulatory, defense, respiratory, excretory, fluid and acid-base balance, digestive, energy balance and thermal, reproductive.

    410.750.71 - Molecular Targets & Cancer

    $4196

    Jessica Faupel-Badger

    Tuesday 6:00 - 9:20; 8/29 - 12/12

    This course will investigate current and potential molecular targets in cancer including kinases, DNA repair pathways, epigenetic modifications, immunotherapy approaches, hormonal, metastasis and angiogenesis targets. Discussion will also include topics on what defines a molecular target and the methods by which they are evaluated. Prerequisites: All four core courses.

    410.751.71 - Chemical Libraries & Diversity

    $4196

    Matthew Hall

    Wednesday 6:00 - 9:20; 8/30 - 12/13

    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 silicon drug design, molecular modeling, and compound storage and handling. In addition, techniques used for assessing and harnessing chemical diversity for drug discovery will be discussed. Prerequisites: All four core courses or approval of program committee.

    410.800.71 - Independent Research in Biotechnology

    $4196

    Thomas Koval

    Sunday 12:00 - 12:01; 8/28 - 12/16

    Students in the biotechnology program have the opportunity to enroll in an independent research course. This elective course is an option after a student has completed at least eight-level courses and has compiled a strong academic record. Prior to proposing a project, interested students must have identified a research topic and a mentor who is familiar with their prospective inquiry, and who is willing to provide guidance and oversee the project. The research project must be independent of current work-related responsibilities as determined by the project mentor. The mentor may be a faculty member teaching in the biotechnology program, a supervisor from the 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. Prerequisite: All four core courses and four elective courses.

  • Online Courses

    410.302.81 - Bio-Organic Chemistry

    $4196

    Kenneth Thompson

    Online 8/28 - 12/16

    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 college chemistry.

    Technology Fee: $175.00

    410.303.81 - Foundations in Bioscience

    $4196

    Weiying Pan

    Online 8/28 - 12/16

    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 and is required as a prerequisite course for some students entering the Master of Science in Regulatory Science.

    Technology Fee: $175.00

    410.601.81 - Biochemistry

    $4196

    Satarupa Das

    Online 8/28 - 12/16

    This course explores the roles of essential biological molecules focusing on protein chemistry, while covering lipids and carbohydrates. It provides a systematic and methodical application of general and organic chemistry principles. Students examine the structure of proteins, their function, their binding to other molecules, and the methodologies for the purification and characterization of proteins. Enzymes and their kinetics and mechanisms are covered in detail. Metabolic pathways are examined from thermodynamic and regulatory perspectives. This course provides the linkage between the inanimate world chemistry and the living world of biology.

    Technology Fee: $175.00

    410.601.82 - Biochemistry

    $4196

    Karen Wells

    Online 8/28 - 12/16

    This course explores the roles of essential biological molecules focusing on protein chemistry, while covering lipids and carbohydrates. It provides a systematic and methodical application of general and organic chemistry principles. Students examine the structure of proteins, their function, their binding to other molecules, and the methodologies for the purification and characterization of proteins. Enzymes and their kinetics and mechanisms are covered in detail. Metabolic pathways are examined from thermodynamic and regulatory perspectives. This course provides the linkage between the inanimate world chemistry and the living world of biology.

    Technology Fee: $175.00

    410.601.83 - Biochemistry

    $4196

    Karen Wells

    Online 8/28 - 12/16

    This course explores the roles of essential biological molecules focusing on protein chemistry, while covering lipids and carbohydrates. It provides a systematic and methodical application of general and organic chemistry principles. Students examine the structure of proteins, their function, their binding to other molecules, and the methodologies for the purification and characterization of proteins. Enzymes and their kinetics and mechanisms are covered in detail. Metabolic pathways are examined from thermodynamic and regulatory perspectives. This course provides the linkage between the inanimate world chemistry and the living world of biology.

    Technology Fee: $175.00

    410.601.84 - Biochemistry

    $4196

    Michael Lebowitz

    Online 8/28 - 12/16

    This course explores the roles of essential biological molecules focusing on protein chemistry, while covering lipids and carbohydrates. It provides a systematic and methodical application of general and organic chemistry principles. Students examine the structure of proteins, their function, their binding to other molecules, and the methodologies for the purification and characterization of proteins. Enzymes and their kinetics and mechanisms are covered in detail. Metabolic pathways are examined from thermodynamic and regulatory perspectives. This course provides the linkage between the inanimate world chemistry and the living world of biology.

    Technology Fee: $175.00

    410.601.85 - Biochemistry

    $4196

    John Hope

    Online 8/28 - 12/16

    This course explores the roles of essential biological molecules focusing on protein chemistry, while covering lipids and carbohydrates. It provides a systematic and methodical application of general and organic chemistry principles. Students examine the structure of proteins, their function, their binding to other molecules, and the methodologies for the purification and characterization of proteins. Enzymes and their kinetics and mechanisms are covered in detail. Metabolic pathways are examined from thermodynamic and regulatory perspectives. This course provides the linkage between the inanimate world chemistry and the living world of biology.

    Technology Fee: $175.00

    410.602.81 - Molecular Biology

    $4196

    Melinda Maris

    Online 8/28 - 12/16

    This course provides a comprehensive overview of the key concepts in molecular biology. Topics to be covered include nucleic acid structure and function, DNA replication, transcription, translation, chromosome structure, and remodeling and regulation of gene expression in prokaryotes and eukaryotes. Extended topics to be covered include method in recombinant DNA technology, microarrays, and microRNA Prerequisite: 410.601 Biochemistry.

    Technology Fee: $175.00

    410.602.82 - Molecular Biology

    $4196

    Sherry Ogg

    Online 8/28 - 12/16

    This course provides a comprehensive overview of the key concepts in molecular biology. Topics to be covered include nucleic acid structure and function, DNA replication, transcription, translation, chromosome structure, and remodeling and regulation of gene expression in prokaryotes and eukaryotes. Extended topics to be covered include method in recombinant DNA technology, microarrays, and microRNA Prerequisite: 410.601 Biochemistry.

    Technology Fee: $175.00

    410.602.83 - Molecular Biology

    $4196

    Dr. Jonathon Bennett

    Online 8/28 - 12/16

    This course provides a comprehensive overview of the key concepts in molecular biology. Topics to be covered include nucleic acid structure and function, DNA replication, transcription, translation, chromosome structure, and remodeling and regulation of gene expression in prokaryotes and eukaryotes. Extended topics to be covered include method in recombinant DNA technology, microarrays, and microRNA Prerequisite: 410.601 Biochemistry.

    Technology Fee: $175.00

    410.602.84 - Molecular Biology

    $4196

    Melinda Maris

    Online 8/28 - 12/16

    This course provides a comprehensive overview of the key concepts in molecular biology. Topics to be covered include nucleic acid structure and function, DNA replication, transcription, translation, chromosome structure, and remodeling and regulation of gene expression in prokaryotes and eukaryotes. Extended topics to be covered include method in recombinant DNA technology, microarrays, and microRNA Prerequisite: 410.601 Biochemistry.

    Technology Fee: $175.00

    410.602.85 - Molecular Biology

    $4196

    Valerie Trabosh

    Online 8/28 - 12/16

    This course provides a comprehensive overview of the key concepts in molecular biology. Topics to be covered include nucleic acid structure and function, DNA replication, transcription, translation, chromosome structure, and remodeling and regulation of gene expression in prokaryotes and eukaryotes. Extended topics to be covered include method in recombinant DNA technology, microarrays, and microRNA Prerequisite: 410.601 Biochemistry.

    Technology Fee: $175.00

    410.602.86 - Molecular Biology

    $4196

    Dr. Mark Hollier

    Online 8/28 - 12/16

    This course provides a comprehensive overview of the key concepts in molecular biology. Topics to be covered include nucleic acid structure and function, DNA replication, transcription, translation, chromosome structure, and remodeling and regulation of gene expression in prokaryotes and eukaryotes. Extended topics to be covered include method in recombinant DNA technology, microarrays, and microRNA Prerequisite: 410.601 Biochemistry.

    Technology Fee: $175.00

    410.603.81 - Advanced Cell Biology I

    $4196

    Thomas Koval

    Online 8/28 - 12/16

    This course covers cell organization and subcellular structure Students examine the evolution of the cell, chromosome, and plasma membrane structures and behaviors; mechanics of cell division; sites of macromolecular synthesis and processing; transport across cell membranes; cell dynamics; organelle biogenesis; and cell specialization. Students are also introduced to the experimental techniques used in cell biology to study cell growth, manipulation, and evaluation.

    Technology Fee: $175.00

    410.603.82 - Advanced Cell Biology I

    $4196

    Nicole Glaser-George

    Online 8/28 - 12/16

    This course covers cell organization and subcellular structure Students examine the evolution of the cell, chromosome, and plasma membrane structures and behaviors; mechanics of cell division; sites of macromolecular synthesis and processing; transport across cell membranes; cell dynamics; organelle biogenesis; and cell specialization. Students are also introduced to the experimental techniques used in cell biology to study cell growth, manipulation, and evaluation.

    Technology Fee: $175.00

    410.603.83 - Advanced Cell Biology I

    $4196

    Mark Verdecia

    Online 8/28 - 12/16

    This course covers cell organization and subcellular structure Students examine the evolution of the cell, chromosome, and plasma membrane structures and behaviors; mechanics of cell division; sites of macromolecular synthesis and processing; transport across cell membranes; cell dynamics; organelle biogenesis; and cell specialization. Students are also introduced to the experimental techniques used in cell biology to study cell growth, manipulation, and evaluation.

    Technology Fee: $175.00

    410.603.84 - Advanced Cell Biology I

    $4196

    Lisa Selbie

    Online 8/28 - 12/16

    This course covers cell organization and subcellular structure Students examine the evolution of the cell, chromosome, and plasma membrane structures and behaviors; mechanics of cell division; sites of macromolecular synthesis and processing; transport across cell membranes; cell dynamics; organelle biogenesis; and cell specialization. Students are also introduced to the experimental techniques used in cell biology to study cell growth, manipulation, and evaluation.

    Technology Fee: $175.00

    410.603.85 - Advanced Cell Biology I

    $4196

    Jeffrey Mahr

    Online 8/28 - 12/16

    This course covers cell organization and subcellular structure Students examine the evolution of the cell, chromosome, and plasma membrane structures and behaviors; mechanics of cell division; sites of macromolecular synthesis and processing; transport across cell membranes; cell dynamics; organelle biogenesis; and cell specialization. Students are also introduced to the experimental techniques used in cell biology to study cell growth, manipulation, and evaluation.

    Technology Fee: $175.00

    410.604.81 - Advanced Cell Biology II

    $4196

    Thomas Koval

    Online 8/28 - 12/16

    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.

    Technology Fee: $175.00

    410.604.82 - Advanced Cell Biology II

    $4196

    Lisa Selbie

    Online 8/28 - 12/16

    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.

    Technology Fee: $175.00

    410.604.83 - Advanced Cell Biology II

    $4196

    Nicole Glaser-George

    Online 8/28 - 12/16

    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.

    Technology Fee: $175.00

    410.604.84 - Advanced Cell Biology II

    $4196

    Dr. Jonathon Bennett

    Online 8/28 - 12/16

    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.

    Technology Fee: $175.00

    410.607.81 - Proseminar in Biotechnology

    $4196

    Katherine Wellman

    Online 8/28 - 12/16

    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 frames and integrates the combined MS/MBA Biotechnology content, methods, and tools of inquiry and analysis.

    Technology Fee: $175.00

    410.607.82 - Proseminar in Biotechnology

    $4196

    Katherine Wellman

    Online 8/28 - 12/16

    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 frames and integrates the combined MS/MBA Biotechnology content, methods, and tools of inquiry and analysis.

    Technology Fee: $175.00

    410.610.81 - Epigenetics, Gene Organization & Expression

    $4196

    Jonathan Lochamy

    Online 8/28 - 12/16

    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.

    Technology Fee: $175.00

    410.610.82 - Epigenetics, Gene Organization & Expression

    $4196

    Md Mizanur Rahman

    Online 8/28 - 12/16

    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.

    Technology Fee $175.00

    410.612.81 - Human Molecular Genetics

    $4196

    Erin Morrey

    Online 8/28 - 12/16

    In this course, students learn to use the tools of modern genomics to elucidate phenotypic variation within populations. The course uses human disease (from simple Mendelian disorders to common, complex disorders) to exemplify the types of studies and tools that can be used to characterize cellular pathophysiology as well as to provide genetic diagnostics and therapies. Students become facile with linkage analysis, cancer genetics, microarray analysis (oligo and DNA arrays), gene therapy, SNP studies, imprinting, disequilibrium mapping, and ethical dilemmas associated with the Human Genome Project. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology.

    Technology Fee: $175.00

    410.613.81 - Principles of Immunology

    $4196

    Richa Tyagi

    Online 8/28 - 12/16

    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.

    Technology Fee: $175.00

    410.614.81 - Pathogenic Bacteriology

    $4196

    Kristin Mullins

    Online 8/28 - 12/16

    Lecture and discussion augmented by guided readings on pathogenic bacteria, with special attention to microorganism that cause human disease. The course is designed to impart to the student an appreciation and knowledge of the history, epidemiology, cultivation, morphology, serology, biochemistry and clinical description of the major disease-producing bacteria Discussion of therapeutic considerations and vaccination will also be included in this course. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, undergraduate microbiology course, or permission of program committee.

    Technology Fee: $175.00

    410.616.81 - Virology

    $4196

    Bruce Brown

    Online 8/28 - 12/16

    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, viroid’s, prions, and unconventional agents secondarily. Specific areas of virology, including viral structure and assembly, viral replication, viral recombination and evolution, virus-host interactions, viral transformation, gene therapy, antiviral drugs, and vaccines, are presented. The major animal virus families are discussed individually with respect to classification, genomic structure, viroid structure, virus cycle, pathogenesis, clinical features, epidemiology, immunity, and control. The viral vectors and their application in biotechnology are discussed. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I.

    Technology Fee: $175.00

    410.627.81 - Translational Biotechnology:From Intellectual Property to Licensing

    $4196

    Timothy Alcorn

    Online 8/28 - 12/16

    This course provides an extensive overview of a process for development of a pharmaceutical by a biotechnology company or pharmaceutical company. The course emphasizes the importance of intellectual property, the basic sciences underpinning the development of a product, and the importance of the interaction between a company and the Food and Drug Administration. Students learn to appreciate the importance of quality control and assurance, good manufacturing practices, preclinical and clinical testing, and the lengthy regulatory processes that govern the development, manufacture, and eventual sale of biotechnological products. Hands-on solving of practical problems and guest lecturers who are experts in the field familiarize students with the intricacies of the process. Prerequisites: 410.303 Bioscience for Regulatory Affairs, OR 410.601 Biochemistry and 410.603 Advanced Cell Biology or admission to the MS in Regulatory Science OR Master of Biotechnology Enterprise and Entrepreneurship programs.

    Technology Fee: $175.00

    410.627.82 - Translational Biotechnology:From Intellectual Property to Licensing

    $4196

    Timothy Alcorn

    Online 8/28 - 12/16

    This course provides an extensive overview of a process for development of a pharmaceutical by a biotechnology company or pharmaceutical company. The course emphasizes the importance of intellectual property, the basic sciences underpinning the development of a product, and the importance of the interaction between a company and the Food and Drug Administration. Students learn to appreciate the importance of quality control and assurance, good manufacturing practices, preclinical and clinical testing, and the lengthy regulatory processes that govern the development, manufacture, and eventual sale of biotechnological products. Hands-on solving of practical problems and guest lecturers who are experts in the field familiarize students with the intricacies of the process. Prerequisites: 410.303 Bioscience for Regulatory Affairs, OR 410.601 Biochemistry and 410.603 Advanced Cell Biology or admission to the MS in Regulatory Science OR Master of Biotechnology Enterprise and Entrepreneurship programs.

    Technology Fee: $175.00

    410.627.83 - Translational Biotechnology:From Intellectual Property to Licensing

    $4196

    Bonnie Robeson

    Online 8/28 - 12/16

    This course provides an extensive overview of a process for development of a pharmaceutical by a biotechnology company or pharmaceutical company. The course emphasizes the importance of intellectual property, the basic sciences underpinning the development of a product, and the importance of the interaction between a company and the Food and Drug Administration. Students learn to appreciate the importance of quality control and assurance, good manufacturing practices, preclinical and clinical testing, and the lengthy regulatory processes that govern the development, manufacture, and eventual sale of biotechnological products. Hands-on solving of practical problems and guest lecturers who are experts in the field familiarize students with the intricacies of the process. Prerequisites: 410.303 Bioscience for Regulatory Affairs, OR 410.601 Biochemistry and 410.603 Advanced Cell Biology or admission to the MS in Regulatory Science OR Master of Biotechnology Enterprise and Entrepreneurship programs.

    Technology Fee: $175.00

    410.628.81 - Neurobiology

    $4196

    Karen Wells

    Online 8/28 - 12/16

    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.

    Technology Fee: $175.00

    410.633.81 - Introduction to Bioinformatics

    $4196

    Sherry Ogg

    Online 8/28 - 12/16

    Retrieval and analysis of electronic information are essential 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 and interpretation are discussed, and many practical examples in a computer laboratory setting enable students to improve their data mining skills. Methods included in the course are searching the biomedical literature, sequence homology searching and multiple alignment, protein sequence motif analysis, and several genome analytical methods. Classes are held in a computer laboratory. Acquaintance with computers is require Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology.

    Technology Fee: $175.00

    410.633.82 - Introduction to Bioinformatics

    $4196

    Jarrett Morrow

    Online 8/28 - 12/16

    Retrieval and analysis of electronic information are essential 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 and interpretation are discussed, and many practical examples in a computer laboratory setting enable students to improve their data mining skills. Methods included in the course are searching the biomedical literature, sequence homology searching and multiple alignment, protein sequence motif analysis, and several genome analytical methods. Classes are held in a computer laboratory. Acquaintance with computers is require Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology.

    Technology Fee: $175.00

    410.634.81 - Practical Computer Concepts for Bioinformatics

    $4196

    Joshua Orvis

    Online 8/28 - 12/16

    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 Python 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.

    Technology Fee: $175.00

    410.634.82 - Practical Computer Concepts for Bioinformatics

    $4196

    John Greene

    Online 8/28 - 12/16

    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 Python 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.

    Technology Fee: $175.00

    410.635.81 - Bioinformatics:Tools for Genome Analysis

    $4196

    -STAFF-

    Online 8/28 - 12/16

    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. Assigning annotations, such as exon boundaries, repeat regions, and other biologically relevant information, accurately in the feature tables of these sequences requires a significant amount of human intervention. This course instructs students on computer analytical methods for gene identification, promoter analysis, and introductory gene expression analysis using software methods. Additionally, students are introduced to comparative genomics and proteomic analysis methods. Students will become proficient in annotating large genomic DNA sequences. Students complete two large sequence analysis projects during the course. Prerequisites: 410.601 Biochemistry; 410.602 Molecular Biology; 410.633 Introduction to Bioinformatics; or all Bioinformatics core courses.

    Technology Fee: $175.00

    410.635.82 - Bioinformatics:Tools for Genome Analysis

    $4196

    -STAFF-

    Online 8/28 - 12/16

    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. Assigning annotations, such as exon boundaries, repeat regions, and other biologically relevant information, accurately in the feature tables of these sequences requires a significant amount of human intervention. This course instructs students on computer analytical methods for gene identification, promoter analysis, and introductory gene expression analysis using software methods. Additionally, students are introduced to comparative genomics and proteomic analysis methods. Students will become proficient in annotating large genomic DNA sequences. Students complete two large sequence analysis projects during the course. Prerequisites: 410.601 Biochemistry; 410.602 Molecular Biology; 410.633 Introduction to Bioinformatics; or all Bioinformatics core courses.

    Technology Fee: $175.00

    410.638.81 - Cancer Biology

    $4196

    Meredith Safford

    Online 8/28 - 12/16

    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.

    Technology Fee: $175.00

    410.639.81 - Protein Bioinformatics

    $4196

    Frank Lebeda
    Mark Olson

    Online 8/28 - 12/16

    Because the gap between the number of protein sequences the number of protein crystal structures continues to expand protein structural predictions are increasingly important. This course provides a working knowledge of various computer- based tools available for predicting the structure and function of proteins. Topics include protein database searching, protein physicochemical properties, secondary structure prediction, a statistical verification. Also covered are graphic visualization the different types of three-dimensional folds and predicting 3-D structures by homology. Computer laboratories complement material presented in lectures. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.633 Introduction to Bioinformatics.

    Technology Fee: $175.00

    410.643.81 - Managing and Leading Biotechnology Professionals

    $4196

    Lynn Johnson Langer

    Online 8/28 - 12/16

    The roles of managers and leaders within biotechnology companies undergo constant change. Biotechnology manager and leaders must engage in new and innovative problem- solving strategies; lead a diverse and global workforce; develop partnerships with other businesses, customers, and competitors manage horizontally and across teams; and utilize technology a competitive advantage. The student is able to address cure challenges in his/her own organization and learn methods of implementing change, such as negotiation techniques and motivation. The course includes in-depth discussions of leadership skills, communication, conflict resolution, and goa integration. Students research a biotechnology organization, analyze what is working and not working within the management systems, and suggest alternatives.

    Technology Fee: $175.00

    410.643.82 - Managing and Leading Biotechnology Professionals

    $4196

    Lynn Johnson Langer

    Online 8/28 - 12/16

    The roles of managers and leaders within biotechnology companies undergo constant change. Biotechnology manager and leaders must engage in new and innovative problem- solving strategies; lead a diverse and global workforce; develop partnerships with other businesses, customers, and competitors manage horizontally and across teams; and utilize technology a competitive advantage. The student is able to address cure challenges in his/her own organization and learn methods of implementing change, such as negotiation techniques and motivation. The course includes in-depth discussions of leadership skills, communication, conflict resolution, and goa integration. Students research a biotechnology organization, analyze what is working and not working within the management systems, and suggest alternatives.

    Technology Fee: $175.00

    410.644.81 - Marketing Aspects of Biotechnology

    $4196

    Barry Datlof

    Online 8/28 - 12/16

    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.

    Technology Fee: $175.00

    410.644.82 - Marketing Aspects of Biotechnology

    $4196

    Barry Datlof

    Online 8/28 - 12/16

    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.

    Technology Fee: $175.00

    410.644.83 - Marketing Aspects of Biotechnology

    $4196

    -STAFF-

    Online 8/28 - 12/21

    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.

    Technology Fee: $175.00

    410.645.81 - Biostatistics

    $4196

    William McCarthy

    Online 8/28 - 12/16

    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.

    Technology Fee: $175.00

    410.645.82 - Biostatistics

    $4196

    William McCarthy

    Online 8/28 - 12/16

    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.

    Technology Fee: $175.00

    410.649.81 - Introduction to Regulatory Affairs

    $4196

    Susan Zecchini

    Online 8/28 - 12/16

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

    Technology Fee: $175.00

    410.649.82 - Introduction to Regulatory Affairs

    $4196

    Suzanne Fitzpatrick

    Online 8/28 - 12/16

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

    Technology Fee: $175.00

    410.651.81 - Clinical Development of Drugs and Biologics

    $4196

    Jonathan Helfgott
    Michael Marcarelli

    Online 8/28 - 12/16

    This course introduces students to the planning and work required to develop potential new drugs and biologics efficiently. Students gain a thorough appreciation of FDA and International Council for Harmonisation regulations and guidelines. Because the course emphasizes the importance of planning before the execution of any of the necessary steps, lectures use a “backward” approach, discussing the final analysis and report before developing protocols. Topics also include an overview of preclinical investigations; NDA/BLA format and content; clinical development plans; product and assay development; the IND; and trial design, implementation, and management. Prerequisites: 410.303 Foundations of Bioscience OR 410.601 Biochemistry and 410.603 Advanced Cell Biology OR admission to the MS in Regulatory Science Program OR Master of Biotechnology Enterprise and Entrepreneurship programs.

    Technology Fee: $175.00

    410.651.82 - Clinical Development of Drugs and Biologics

    $4196

    Christopher Breder

    Online 8/28 - 12/16

    This course introduces students to the planning and work required to develop potential new drugs and biologics efficiently. Students gain a thorough appreciation of FDA and International Council for Harmonisation regulations and guidelines. Because the course emphasizes the importance of planning before the execution of any of the necessary steps, lectures use a “backward” approach, discussing the final analysis and report before developing protocols. Topics also include an overview of preclinical investigations; NDA/BLA format and content; clinical development plans; product and assay development; the IND; and trial design, implementation, and management. Prerequisites: 410.303 Foundations of Bioscience OR 410.601 Biochemistry and 410.603 Advanced Cell Biology OR admission to the MS in Regulatory Science Program OR Master of Biotechnology Enterprise and Entrepreneurship programs.

    Technology Fee: $175.00

    410.651.83 - Clinical Development of Drugs and Biologics

    $4196

    Bharat Khurana

    Online 8/28 - 12/21

    This course introduces students to the planning and work required to develop potential new drugs and biologics efficiently. Students gain a thorough appreciation of FDA and International Council for Harmonisation regulations and guidelines. Because the course emphasizes the importance of planning before the execution of any of the necessary steps, lectures use a “backward” approach, discussing the final analysis and report before developing protocols. Topics also include an overview of preclinical investigations; NDA/BLA format and content; clinical development plans; product and assay development; the IND; and trial design, implementation, and management. Prerequisites: 410.303 Foundations of Bioscience OR 410.601 Biochemistry and 410.603 Advanced Cell Biology OR admission to the MS in Regulatory Science Program OR Master of Biotechnology Enterprise and Entrepreneurship programs.

    Technology Fee: $175.00

    410.662.81 - Epidemiology: Diseases in Populations

    $4196

    Elizabeth Golub

    Online 8/28 - 12/16

    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.

    Technology Fee: $175.00

    410.665.81 - Bioscience Communication

    $4196

    Manojit Basu

    Online 8/28 - 12/16

    Researchers must communicate effectively so their discoveries can be shared with others. In this course, students learn how to communicate their ideas to other researchers, their scientific peers, and investment communities. Students master both written and verbal communication skills, hone their expertise at making both formal and informal oral presentations, prepare poster presentations, and develop their own public speaking strategies. The course also presents personal strategies for improving daily communications, cross-cultural communications, and nonverbal skills. Students improve their written communication, editing, and informal writing skills. Participants also learn effective email strategies for getting their message across and learn how effective writing can improve their chances of getting grant applications approved. Class assignments include preparation of scientific papers, general science writing, oral presentations, PowerPoint presentations, and scientific posters.

    Technology Fee: $175.00

    410.671.81 - Gene Expression Data Analysis and Visualization

    $4196

    Brandon Higgs

    Online 8/28 - 12/16

    This course will introduce students to various methods for analyzing and interpreting transcriptomics data generated from technologies such as oligonucleotide or two-channel microarrays, qRT-PCR, and RNA sequencing. Topics will include scaling/normalization, outlier analysis, and missing value imputation. Students will learn how to identify differentially expressed genes and correlate their expression with clinical outcomes such as disease activity or survival with relevant statistical tests; methods to control for multiple testing will also be presented. An introduction to linear and nonlinear dimensionality reduction methods and both supervised and unsupervised clustering and classification approaches will be provided. Open source tools and databases for biological interpretation of results will be introduced. Assignments and concepts will make use of publicly available datasets and students will compute and visualize results using the statistical software R. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.645 Biostatistics, 410.634 Practical Computer Concepts for Bioinformatics, or an undergraduate computer programming course.

    Technology Fee: $175.00

    410.671.82 - Gene Expression Data Analysis and Visualization

    $4196

    Brandon Higgs

    Online 8/28 - 12/16

    This course will introduce students to various methods for analyzing and interpreting transcriptomics data generated from technologies such as oligonucleotide or two-channel microarrays, qRT-PCR, and RNA sequencing. Topics will include scaling/normalization, outlier analysis, and missing value imputation. Students will learn how to identify differentially expressed genes and correlate their expression with clinical outcomes such as disease activity or survival with relevant statistical tests; methods to control for multiple testing will also be presented. An introduction to linear and nonlinear dimensionality reduction methods and both supervised and unsupervised clustering and classification approaches will be provided. Open source tools and databases for biological interpretation of results will be introduced. Assignments and concepts will make use of publicly available datasets and students will compute and visualize results using the statistical software R. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.645 Biostatistics, 410.634 Practical Computer Concepts for Bioinformatics, or an undergraduate computer programming course.

    Technology Fee: $175.00

    410.673.81 - Biological Processes in Regulatory Affairs

    $4196

    Jamie Austin

    Online 8/28 - 12/16

    This course provides an overview of the biological processes laboratory techniques utilized for the discovery, development and evaluation of therapeutic drugs. Students investigate drug development processes, such as gene cloning, culture scale-u downstream processing, and product purification. Emphasis is placed on the theory and application of laboratory methods u in drug development, such as recombinant DNA techniques, antibody technology, protein purification, immunoassays, high throughput drug screening, chromatography, electrophoresis cell receptor characterization, pharmacokinetics, drug toxicity testing and evaluation of therapeutic drugs, diagnostics, and vaccines. Prerequisites: 410.303 Bioscience for Regulatory Affairs, OR 410.601 Biochemistry and 410.603 Advanced Cell Biology OR admissions to the MS in Regulatory Science OR Master of Biotechnology Enterprise and Entrepreneurship programs.

    Technology Fee: $175.00

    410.673.82 - Biological Processes in Regulatory Affairs

    $4196

    Markus Yap

    Online 8/28 - 12/16

    This course provides an overview of the biological processes laboratory techniques utilized for the discovery, development and evaluation of therapeutic drugs. Students investigate drug development processes, such as gene cloning, culture scale-u downstream processing, and product purification. Emphasis is placed on the theory and application of laboratory methods u in drug development, such as recombinant DNA techniques, antibody technology, protein purification, immunoassays, high throughput drug screening, chromatography, electrophoresis cell receptor characterization, pharmacokinetics, drug toxicity testing and evaluation of therapeutic drugs, diagnostics, and vaccines. Prerequisites: 410.303 Bioscience for Regulatory Affairs, OR 410.601 Biochemistry and 410.603 Advanced Cell Biology OR admissions to the MS in Regulatory Science OR Master of Biotechnology Enterprise and Entrepreneurship programs.

    Technology Fee: $175.00

    410.674.81 - Food Microbiology

    $4196

    Om Singh

    Online 8/28 - 12/16

    Food microbiology encompasses the study of microorganisms that have both beneficial and deleterious effects on the quality and safety of raw and processed meat, poultry, and egg products. Food microbiology focuses on the general biology of the microorganisms that are found in foods, including their growth characteristics, identification, and pathogenesis. Specifically, areas of interest that concern food microbiology are food poisoning, food spoilage, food preservation, and food legislation. Pathogens in product, or harmful microorganisms, result in major public health problems in the United States and worldwide, and are the leading causes of illnesses and death.

    Technology Fee: $175.00

    410.674.82 - Food Microbiology

    $4196

    Om Singh

    Online 8/28 - 12/21

    Food microbiology encompasses the study of microorganisms that have both beneficial and deleterious effects on the quality and safety of raw and processed meat, poultry, and egg products. Food microbiology focuses on the general biology of the microorganisms that are found in foods, including their growth characteristics, identification, and pathogenesis. Specifically, areas of interest that concern food microbiology are food poisoning, food spoilage, food preservation, and food legislation. Pathogens in product, or harmful microorganisms, result in major public health problems in the United States and worldwide, and are the leading causes of illnesses and death.

    Technology Fee: $175.00

    410.675.81 - International Regulatory Affairs

    $4196

    Suzanne Fitzpatrick

    Online 8/28 - 12/16

    Pharmaceutical/biotechnology product approval and marketing requires a good understanding of international regulatory affairs in order to successfully compete in today’s global marketplace. It is important for tomorrow’s leaders to understand and follow the regulatory differences to ensure optimum product development strategies, regulatory approvals, and designs for exports conforming to the foreign regulatory bodies. There are various product development strategies that industry is using to shorten the product development time by conducting preclinical programs outside the U.S., but the strategy requires careful planning and interaction with the U.S. and foreign regulatory agencies. With the increase in globalization of economy and exports, international regulations will have a bigger impact on the biotechnology business in the future. The course provides a review and analysis of the pharmaceutical/biotechnology product approval processes within the world’s major markets. The key strategies required in preclinical product development to marketing approval of the products in Europe, Japan, and the U.S. will be compared and discussed. Students will explore the European Union regulations and their overall importance on international markets. The course will cover the salient features of common technical and regulatory documents required for submission and approval to the leading regulatory bodies in the world, general guidance documents, international harmonization, and the General Agreement on Tariffs and Trade.

    Technology Fee: $175.00

    410.676.81 - Food And Drug Law

    $4196

    Loretta Chi

    Online 8/28 - 12/16

    The Food, Drug, and Cosmetic Act (FD&C Act) governs the regulatory approval process for bringing a drug, biologic, medical device, food, or cosmetic to market. The class will discuss administrative procedures followed by the FDA. The course includes an overview of the drug, biologic, and medical device approval processes, and the regulation of food and dietary supplements. Students then will be exposed to the enforcement activities of the FDA, including searches, seizure actions, injunctions, criminal prosecutions, and civil penalties authorized under the FD&C Act, as well as other statutes like the Public Health Service Act (which regulates the development and approval of biologics).

    Technology Fee: $175.00

    410.676.82 - Food And Drug Law

    $4196

    Emil Wang

    Online 8/28 - 12/16

    The Food, Drug, and Cosmetic Act (FD&C Act) governs the regulatory approval process for bringing a drug, biologic, medical device, food, or cosmetic to market. The class will discuss administrative procedures followed by the FDA. The course includes an overview of the drug, biologic, and medical device approval processes, and the regulation of food and dietary supplements. Students then will be exposed to the enforcement activities of the FDA, including searches, seizure actions, injunctions, criminal prosecutions, and civil penalties authorized under the FD&C Act, as well as other statutes like the Public Health Service Act (which regulates the development and approval of biologics).

    Technology Fee: $175.00

    410.676.83 - Food And Drug Law

    $4196

    Emil Wang

    Online 8/28 - 12/21

    The Food, Drug, and Cosmetic Act (FD&C Act) governs the regulatory approval process for bringing a drug, biologic, medical device, food, or cosmetic to market. The class will discuss administrative procedures followed by the FDA. The course includes an overview of the drug, biologic, and medical device approval processes, and the regulation of food and dietary supplements. Students then will be exposed to the enforcement activities of the FDA, including searches, seizure actions, injunctions, criminal prosecutions, and civil penalties authorized under the FD&C Act, as well as other statutes like the Public Health Service Act (which regulates the development and approval of biologics).

    Technology Fee: $175.00

    410.679.81 - Practicum in Regulatory Science

    $4196

    Thomas Colonna

    Online 8/28 - 12/16

    This integrative, case-based course will focus on applying knowledge gained from previous courses in the Master of Science in Regulatory Science program to actual cases from the FDA. For each case, students will assume the role of regulatory specialist, an FDA reviewer or senior-level policy-maker, or other involved stakeholders, such as a consumer group or an advocacy group. Students will be expected to research, evaluate, and present scientifically and legally justifiable positions on case studies from the perspective of their assigned roles. Students will present their perspectives to the class and be asked to debate the issues with the other students from the perspective of their assigned roles. The major responsibility of the students in this course will be to make scientifically and legally defensible recommendations and to justify them through oral and written communication. Please note this course is only open to students in the Master of Science in Regulatory Science and should only be taken after all required courses are completed.

    Technology Fee: $175.00

    410.680.81 - Finance for Biotechnology

    $4196

    Norman Marcus

    Online 8/28 - 12/16

    Students will build an understanding of the basics of contemporary global monetary systems and the essentials of financial management. This course will include a means to develop a working knowledge of the critical financial factors for decision-makers from the perspectives of key stakeholders. The syllabus is designed to provide students with limited or no background in finance an opportunity to establish a means to understand financial basics and communicate clearly in financial terms when conducting business. This course is uniquely designed to meet the current needs of those leading the global life science industry.

    Technology Fee: $175.00

    410.680.82 - Finance for Biotechnology

    $4196

    Anthony Schwartz

    Online 8/28 - 12/16

    Students will build an understanding of the basics of contemporary global monetary systems and the essentials of financial management. This course will include a means to develop a working knowledge of the critical financial factors for decision-makers from the perspectives of key stakeholders. The syllabus is designed to provide students with limited or no background in finance an opportunity to establish a means to understand financial basics and communicate clearly in financial terms when conducting business. This course is uniquely designed to meet the current needs of those leading the global life science industry.

    Technology Fee: $175.00

    410.683.81 - Introduction to cGMP Compliance

    $4196

    Nancy Karaszkiewicz

    Online 8/28 - 12/16

    Current Good Manufacturing Practice regulations are the minimum standards for the design, production, and distribution of drugs, biologics and medical devices in the U.S. and internationally. In the U.S., they are codified at the federal level, in the FD&C Act and the 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.

    Technology Fee: $175.00

    410.683.82 - Introduction to cGMP Compliance

    $4196

    Thomas Colonna

    Online 8/28 - 12/16

    Current Good Manufacturing Practice regulations are the minimum standards for the design, production, and distribution of drugs, biologics and medical devices in the U.S. and internationally. In the U.S., they are codified at the federal level, in the FD&C Act and the 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.

    Technology Fee: $175.00

    410.696.81 - Bioassay Development

    $4196

    Kyle Brimacombe

    Online 8/28 - 12/16

    This course will cover methodological approaches to bioassay development for high-throughput screening. Both cell-based (cytotoxicity; cytoprotection, high content imaging, and reporter systems) and cell-free assay systems (enzyme, FRET, time resolved fluorescence, quenching assays, and immunological assays) will be included with discussion of the potential prom and pitfalls associated with each assay system. Various assay formats, visualization techniques, and current developments in assay technology will be discussed. Project management techniques will be utilized to aid in the process of assay development. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I.

    Technology Fee: $175.00

    410.699.81 - Nanobiotechnology

    $4196

    Michael Mauk

    Online 8/28 - 12/16

    The emerging field of nanobiotechnology utilizes developments in nanotechnology and molecular biology for applications to biomedical science and clinical practice, as well as fundamental cell biology research and industrial biotechnology. Nanobiotechnology is an interdisciplinary field that exploits the unique functional properties of natural and synthetic biomolecular-sized (nanometer-scale) constructs, such as quantum dots, carbon nanotubes, nanostructured surfaces, liposomes, artificial membranes, and molecular machines for biotechnology and medicine. This course is designed for biotechnology majors and will survey the research, development, and applications of nanotechnology to medical diagnostics, imaging, and therapeutics (including drug delivery and anti-cancer treatments); cell biology and single-cell analysis, nanofluidics, bioassays, biosensors, and bio-inspired engineering. Prerequisites: 410.601 Biochemistry; 410.602 Molecular Biology; 410.603 Advanced Cell Biology I; 410.604 Advanced Cell Biology II.

    Technology Fee: $175.00

    410.708.81 - Medical Product Reimbursement

    $4196

    Rochelle Fink

    Online 8/28 - 12/18

    Medical products brought to market need to have a sound payment, coding, and coverage strategy. Medicare covers over 100 million Americans and it leads the way in all United States insurance policies. This course will provide insight into how medical product reimbursement works and allow students to understand how the Centers for Medicare & Medicaid Services (CMS) considers medical products for coverage, coding, and payment. We’ll review the history of Medicare coverage and the regulations. We’ll focus primarily on strategies used to get reimbursement for medical products—both at the national and local levels.

    Technology Fee: $175.00

    410.715.81 - Medical Device Regulation

    $4196

    Emil Wang

    Online 8/28 - 12/16

    This course provides a comprehensive introduction to 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, post-market 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.

    Technology Fee: $175.00

    410.718.81 - Food Safety Audits and Surveillance

    $4196

    Kantha Shelke

    Online 8/28 - 12/16

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

    Technology Fee: $175.00

    410.721.81 - In Vitro Diagnostic Regulation

    $4196

    Timothy Alcorn

    Online 8/28 - 12/16

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

    Technology Fee: $175.00

    410.727.81 - Regulatory Strategies in Biopharmaceuticals

    $4196

    Bharat Khurana

    Online 8/28 - 12/16

    Given the costly drug development process and the limited resources of emerging biopharmaceutical companies, developing an early regulatory strategy- starting well before clinical trials are initiated, is extremely important for the success of a company. This course will discuss different regulatory strategies that several players of the U.S. biopharmaceutical industry have employed. Students will learn about interacting with regulatory agencies, the orphan drug development, accelerated approval, fast track, priority review, and other regulatory mechanisms, pharmacogenomics and biomarkers, adaptive clinical trials, animal rule, generic drug development and biosimilars. Using case studies, the impact of these regulatory strategies on drug development and how these strategies have helped many biopharmaceutical companies will be discussed. At the end of this course, students will better understand federal regulations and the aspects involved in developing efficient regulatory strategies.

    Technology Fee: $175.00

    410.728.81 - Managing Innovation in the Life Sciences

    $4196

    Reid Adler
    Jill Sorensen

    Online 8/28 - 12/16

    Innovation is the creation of value from new ideas, concepts, methods, materials, and organizational structures. Life sciences organizations that seek to create value for their stakeholders must do so using available capital resources: financial capital, human capital, intellectual capital and physical capital. They should manage those resources to gain leverage and maximize value realized. They then seek to defend and control the value created. Why then, do most organizations treat innovation (and innovators) in ways similar to the body’s immune system (i.e., by identifying the innovators, isolating them, “killing” them, and ejecting them from the organization? This course will explore innovation, invention, and value creation as a driving force in the biotechnology or life sciences enterprise and the ways in which managers should plan to take full advantage of innovation as the only true competitive weapon for long-term success. A special emphasis will be placed on innovation as applied to life science applications (biotechnology, medical devices, health care delivery, drug discovery, development and packaging, bioinformatics, etc.). Topics include invention, ROI, disruption, creative destruction, types of innovation, technology brokering, organizational structures that foster innovation, planning and managing for innovation. Students are required to read extensively, participate actively in discussions, do case studies, and develop a convincing pitch for an innovation project.

    Technology Fee: $175.00

    410.734.81 - Practical Introduction to Metagenomics

    $4196

    Joshua Orvis

    Online 8/28 - 12/16

    The emerging field of metagenomics allows for the study of entire communities of microorganisms at once, with far-reaching applications in a wide array of fields such as medicine, agriculture and bioremediation. Students will learn the principles of metagenomics through exploration of published project data and guided readings of recent literature. Using data from the Human Microbiome Project, students will explore practical analysis tasks including sequence assembly, gene prediction and annotation, metabolic reconstruction, taxonomic community profiling and more. Pre-requisites: 410.601 Biochemistry, 410.602 Molecular Biology; 410.634 Practical Computer Concepts for Bioinformatics

    Technology Fee: $175.00

    410.753.81 - Stem Cell Biology

    $4196

    Lisa Selbie

    Online 8/28 - 12/16

    This course will involve discussion and debate on current topics concerning stem cell biology and the use of stem cells in biotechnology and therapeutics. Topics will include review and discussion of developmental and cell biology, stem cell characteristics, stem cell preparation and therapeutic uses, tissue engineering, global regulatory and ethical issues, and commercialization of stem cell therapy. Current peer-reviewed literature and guest experts in the field will provide up-to-date information for discussion. Prerequisites: All four core courses.

    Technology Fee: $175.00

    410.777.81 - BioFuels

    $4196

    Sherry Ogg

    Online 8/28 - 12/16

    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 Advanced Cell Biology I.

    Technology Fee: $175.00

    410.802.81 - Independent Studies in Regulatory Science

    $4196

    Thomas Colonna

    Online 8/28 - 12/16

    This course is open only to students in the MS in Regulatory Science program or the MS in Biotechnology with a concentration in Regulatory Affairs and may be taken only after the student has completed 5 courses and has compiled a strong academic record. Prior to proposing a project, interested students must have identified a study topic and a mentor who is familiar with their prospective inquiry and who is willing to provide guidance and oversee the project. The study project must be independent of current work-related responsibilities as determined by the project mentor. The mentor may be a faculty member, a supervisor from the student's place of work, or any expert with appropriate credentials. The goal of the study project should be a "publishable" article. Students are required to submit a formal proposal for review and approval by the regulatory science program committee. The proposal must be received by the Advanced Academic Programs office no later than one month prior to the beginning of the term in which the student wants to enroll in the course. Students must interact with a member of the program committee periodically for discussion of the project's progress, and a written document must be completed and approved by the program committee and project mentor for the student to receive graduate credit. Additional guidelines can be obtained from the AAP administrative office.

    Technology Fee: $175.00

    410.804.81 - Practicum in Biotechnology Enterprise & Entrepreneurship

    $4196

    Eric Langer

    Online 8/28 - 12/16

    This course synthesizes the knowledge and skills acquired in the Masters in Biotechnology Enterprise and Entrepreneurship program, while offering a real-world examination of a bioscience organization and the issues it faces. Students will form interdisciplinary teams and work with faculty and industry professionals on an authentic and current project from a local bioscience public or private company, an entrepreneurial startup, or a nonprofit organization. This course is only open to students completing the Masters in Biotechnology Enterprise and Entrepreneurship program.

    Technology Fee: $175.00

  • Online Courses (Cross-Listed)

    491.658.81 - Techniques of Science-Medical Writing

    $3035

    Kim O'Connell

    Online 6:00 - 8:45; 8/28 - 12/16

    This core course develops and hones the reporting, creative and explanatory skills demonstrated by the best science-medical writers. The course features writing assignments and exercises in journalistic and literary writing, plus interviewing, ethics and the use of scientific journals and databases. In some cases, students may be able to choose from a range of writing topics, including nature, technology, health, space, biology, medicine, or other scientific issues. Science Writing students should complete this course before enrolling in any writing workshop. Departmental approval and a writing sample required for students not enrolled in the Science Writing Program.

    Technology Fee: $175.00 Special Notes: Departmental approval and a writing sample are required to take this course as an elective. The writing sample should be work written for a general audience, such as a personal essay, journalistic article, op-ed, or blog post, rather than technical or academic writing. Interested students should contact Science Writing program coordinator Melissa Hendricks at mhendri1@jhu.edu.