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.)

SwatchforWeb Courses that are highlighted are Regulatory Science.

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

    410.800.01 - Independent Research in Biotechnology

    Thomas Koval

    Sunday 12:00 - 12:00; 5/31 - 8/16

    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 graduate-level courses and has compiled a strong academic record. Prior to proposing a project, interested students must have identified a research topic and a mentor who is familiar with their prospective inquiry and 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 core courses and four additional courses.

  • Online Courses

    410.302.81 - Bio-Organic Chemistry


    Online 5/27 - 8/18

    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, nucleophilic 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: $200.00

    410.303.81 - Foundations in Bioscience

    Weiying Pan

    Online 5/27 - 8/18

    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 regulatory science and is required as a prerequisite course for some students entering the Master of Science in Regulatory Science. Pre-requisites: one year of college chemistry and one year of college biology or permission of program director. S

    Technology Fee: $200.00

    410.601.81 - Biochemistry

    Karen Wells

    Online 5/27 - 8/18

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

    Technology Fee: $200.00

    410.601.82 - Biochemistry

    Tyler Chavez

    Online 5/27 - 8/18

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

    Technology Fee: $200.00

    410.601.83 - Biochemistry

    Satarupa Das

    Online 5/27 - 8/18

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

    Technology Fee: $200.00

    410.601.84 - Biochemistry

    Richa Tyagi

    Online 5/27 - 8/18

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

    Technology Fee: $200.00

    410.601.85 - Biochemistry

    Richa Tyagi

    Online 5/27 - 8/18

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

    Technology Fee: $200.00

    410.601.86 - Biochemistry

    Satarupa Das

    Online 5/27 - 8/18

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

    Technology Fee: $200.00

    410.602.81 - Molecular Biology

    Valerie Divito

    Online 5/27 - 8/18

    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 the remodeling and regulation of gene expression in prokaryotes and eukaryotes. Extended topics to be covered include methods in recombinant DNA technology, microarrays, and microRNA.

    Technology Fee: $200.00

    410.602.82 - Molecular Biology

    Tyler Goralski

    Online 5/27 - 8/18

    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 the remodeling and regulation of gene expression in prokaryotes and eukaryotes. Extended topics to be covered include methods in recombinant DNA technology, microarrays, and microRNA.

    Technology Fee: $200.00

    410.602.83 - Molecular Biology

    Dr. Mark Hollier

    Online 5/27 - 8/18

    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 the remodeling and regulation of gene expression in prokaryotes and eukaryotes. Extended topics to be covered include methods in recombinant DNA technology, microarrays, and microRNA.

    Technology Fee: $200.00

    410.602.84 - Molecular Biology

    Kristin Mullins

    Online 5/27 - 8/18

    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 the remodeling and regulation of gene expression in prokaryotes and eukaryotes. Extended topics to be covered include methods in recombinant DNA technology, microarrays, and microRNA.

    Technology Fee: $200.00

    410.602.85 - Molecular Biology

    Robert Horner

    Online 5/27 - 8/18

    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 the remodeling and regulation of gene expression in prokaryotes and eukaryotes. Extended topics to be covered include methods in recombinant DNA technology, microarrays, and microRNA.

    Technology Fee: $200.00

    410.603.81 - Advanced Cell Biology I

    Thomas Koval

    Online 5/27 - 8/18

    This course covers cell organization and subcellular structure. Students examine the evolution of the cell, chromosome, and plasma membrane structures and behaviors, as well as the 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: $200.00

    410.603.82 - Advanced Cell Biology I

    Tyler Goralski

    Online 5/27 - 8/18

    This course covers cell organization and subcellular structure. Students examine the evolution of the cell, chromosome, and plasma membrane structures and behaviors, as well as the 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: $200.00

    410.603.83 - Advanced Cell Biology I

    Jeffrey Mahr

    Online 5/27 - 8/18

    This course covers cell organization and subcellular structure. Students examine the evolution of the cell, chromosome, and plasma membrane structures and behaviors, as well as the 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: $200.00

    410.603.84 - Advanced Cell Biology I

    Jeffrey Mahr

    Online 5/27 - 8/18

    This course covers cell organization and subcellular structure. Students examine the evolution of the cell, chromosome, and plasma membrane structures and behaviors, as well as the 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: $200.00

    410.603.85 - Advanced Cell Biology I

    Michael Lebowitz

    Online 5/27 - 8/18

    This course covers cell organization and subcellular structure. Students examine the evolution of the cell, chromosome, and plasma membrane structures and behaviors, as well as the 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: $200.00

    410.603.86 - Advanced Cell Biology I

    Dr. Arti Varanasi

    Online 5/27 - 8/18

    This course covers cell organization and subcellular structure. Students examine the evolution of the cell, chromosome, and plasma membrane structures and behaviors, as well as the 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: $200.00

    410.603.87 - Advanced Cell Biology I

    Elena Schwartz

    Online 5/27 - 8/18

    This course covers cell organization and subcellular structure. Students examine the evolution of the cell, chromosome, and plasma membrane structures and behaviors, as well as the 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: $200.00

    410.604.81 - Advanced Cell Biology II

    Dr. Jonathon Bennett

    Online 5/27 - 8/18

    This course is a continuation of 410.603 Advanced Cell Biology and further explores cell organization and subcellular structure. Students examine cell-to-cell signaling that involves hormones and receptors, signal transduction pathways, second messenger molecules, cell adhesion, extracellular matrix, cell cycle, programmed cell death, methylation of DNA, modification of chromatin structure, and mechanisms of the cell. The roles that defects in signal transduction pathways play in the development of cancer and other disease states will be stressed. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I.

    Technology Fee: $200.00

    410.604.82 - Advanced Cell Biology II

    Elena Schwartz

    Online 5/27 - 8/18

    This course is a continuation of 410.603 Advanced Cell Biology and further explores cell organization and subcellular structure. Students examine cell-to-cell signaling that involves hormones and receptors, signal transduction pathways, second messenger molecules, cell adhesion, extracellular matrix, cell cycle, programmed cell death, methylation of DNA, modification of chromatin structure, and mechanisms of the cell. The roles that defects in signal transduction pathways play in the development of cancer and other disease states will be stressed. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I.

    Technology Fee: $200.00

    410.604.83 - Advanced Cell Biology II

    Lisa Selbie

    Online 5/27 - 8/18

    This course is a continuation of 410.603 Advanced Cell Biology and further explores cell organization and subcellular structure. Students examine cell-to-cell signaling that involves hormones and receptors, signal transduction pathways, second messenger molecules, cell adhesion, extracellular matrix, cell cycle, programmed cell death, methylation of DNA, modification of chromatin structure, and mechanisms of the cell. The roles that defects in signal transduction pathways play in the development of cancer and other disease states will be stressed. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I.

    Technology Fee: $200.00

    410.604.84 - Advanced Cell Biology II

    Michael Lebowitz

    Online 5/27 - 8/18

    This course is a continuation of 410.603 Advanced Cell Biology and further explores cell organization and subcellular structure. Students examine cell-to-cell signaling that involves hormones and receptors, signal transduction pathways, second messenger molecules, cell adhesion, extracellular matrix, cell cycle, programmed cell death, methylation of DNA, modification of chromatin structure, and mechanisms of the cell. The roles that defects in signal transduction pathways play in the development of cancer and other disease states will be stressed. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I.

    Technology Fee: $200.00

    410.607.81 - Proseminar in Biotechnology

    Ron Rudnick

    Online 5/27 - 8/18

    The Biotechnology Proseminar introduces students to issues and challenges facing leaders of public and private-sector organizations as well as t0 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.

    Technology Fee: $200.00

    410.610.81 - Epigenetics, Gene Organization & Expression

    Jonathan Lochamy

    Online 5/27 - 8/18

    Students use genetic analysis and molecular biology techniques to investigate chromosome organization, chromatin structure, functional genomics, and mechanisms of differential gene expression. Other topics include DNA methylation, silencers, enhancers, genomic imprinting, and microarray analysis. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology. S

    Technology Fee: $200.00

    410.610.82 - Epigenetics, Gene Organization & Expression

    Tyshia Wellman

    Online 5/27 - 8/18

    Students use genetic analysis and molecular biology techniques to investigate chromosome organization, chromatin structure, functional genomics, and mechanisms of differential gene expression. Other topics include DNA methylation, silencers, enhancers, genomic imprinting, and microarray analysis. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology. S

    Technology Fee: $200.00

    410.612.81 - Human Molecular Genetics

    Erin Morrey

    Online 5/27 - 8/18

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

    Technology Fee: $200.00

    410.613.81 - Principles of Immunology

    Kristin Mullins

    Online 5/27 - 8/18

    This course covers molecular and cellular immunology. Topics include innate immunity, adaptive immunity, the development and function of B cell and T cell antigen receptors, the major histocompatibility complexes, innate effector mechanisms, humoral and cellular immune responses, and regulation of immune responses. Special topics include immunomodulation, immunodeficiency diseases, autoimmunity, evasion and subversion of the immune system by pathogens, immunotherapies, and vaccines. Students are also introduced to the applied aspects of immunology, which include protein and cellular-based immunoassays. Prerequisites: 410.601 Biochemistry; 410.602 Molecular Biology, 410.603 Advanced Cell Biology I.

    Technology Fee: $200.00

    410.616.81 - Virology

    Bruce Brown

    Online 5/27 - 8/18

    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. S

    Technology Fee: $200.00

    410.621.81 - Agricultural Biotechnology

    Sherry Ogg

    Online 5/27 - 8/18

    This course is designed to provide an introduction to the application of recombinant DNA technology in agriculture. We will study methods for the introduction of foreign DNA into plant and animal cells and the generation of stably transformed plants and animals. We will discuss specific examples of the use of transgenic plants and animals in biotechnology, which can provide protection against insects, diseases, and tolerance to specific herbicides. We will also investigate how recombinant growth hormones can result in leaner meat, greater milk yield, and better feed utilization, as well as how transgenic plants and animals can serve as bioreactors for the production of medicinals or protein pharmaceuticals. Because recombinant agricultural products are released into the environment or consumed as foods, we will also discuss environmental safety issues. Prerequisites: 410.601 Biochemistry 410.602 Molecular Biology, 410.603 Advanced Cell Biology I.

    Technology Fee: $200.00

    410.622.81 - Molecular Basis of Pharmacology

    Lisa Selbie

    Online 5/27 - 8/18

    This course begins by reviewing receptor binding and enzyme kinetics. Various cellular receptors and their physiology are discussed, as are 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.

    Technology Fee: $200.00

    410.622.82 - Molecular Basis of Pharmacology

    Lisa Selbie

    Online 5/27 - 8/18

    This course begins by reviewing receptor binding and enzyme kinetics. Various cellular receptors and their physiology are discussed, as are 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.

    Technology Fee: $200.00

    410.627.81 - Translational Biotechnology:From Intellectual Property to Licensing

    Timothy Alcorn

    Online 5/27 - 8/18

    This course provides an extensive overview of a process for the 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, manufacturing, and eventual sale of biotechnological products. Hands-on solving of practical problems and guest lecturers who are experts in the field familiarize students with the intricacies of the process. Prerequisites: 410.303 Bioscience for Regulatory Affairs, OR 410.601 Biochemistry and 410.603 Advanced Cell Biology I or admission to the MS in Regulatory Science OR Master of Biotechnology Enterprise and Entrepreneurship programs.

    Technology Fee: $200.00

    410.627.82 - Translational Biotechnology:From Intellectual Property to Licensing

    Adora Ndu

    Online 5/27 - 8/18

    This course provides an extensive overview of a process for the 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, manufacturing, and eventual sale of biotechnological products. Hands-on solving of practical problems and guest lecturers who are experts in the field familiarize students with the intricacies of the process. Prerequisites: 410.303 Bioscience for Regulatory Affairs, OR 410.601 Biochemistry and 410.603 Advanced Cell Biology I or admission to the MS in Regulatory Science OR Master of Biotechnology Enterprise and Entrepreneurship programs.

    Technology Fee: $200.00

    410.630.81 - Gene Therapy

    Erin Morrey

    Online 5/27 - 8/18

    In this course, students learn about how gene therapy can be used to treat or prevent genetic disease in the human population. This course is centered around how disease-causing variations in the human genome, including inherited diseases, mutations, epigenetic modifications, and viral infections, can be targeted using molecular technologies. Students will learn about the benefits and limitations of gene therapy as well as about the bioethical concerns involved with this field of research and medicine. Pre-requisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Cell Biology I.

    Technology Fee: $200.00

    410.630.82 - Gene Therapy

    Erin Morrey

    Online 5/27 - 8/18

    In this course, students learn about how gene therapy can be used to treat or prevent genetic disease in the human population. This course is centered around how disease-causing variations in the human genome, including inherited diseases, mutations, epigenetic modifications, and viral infections, can be targeted using molecular technologies. Students will learn about the benefits and limitations of gene therapy as well as about the bioethical concerns involved with this field of research and medicine. Pre-requisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Cell Biology I.

    Technology Fee: $200.00

    410.632.81 - Emerging Infectious Diseases

    Kristina Obom

    Online 5/27 - 8/18

    This course focuses on emerging infectious diseases from many different perspectives. The maladies addressed range from diseases that have reappeared in altered genetic forms, such as the influenza virus and West Nile virus, to the lethal hemorrhagic fever caused by the Ebola virus. Also discussed is the threat of recombinant and ancient infectious agents, such as Bacillus anthracis, the causative agent of anthrax, which can be used in biological warfare weapons. Opinions from noted scientists and leaders concerning emerging diseases and the prospects for battling them successfully provide scientific and social perspectives. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I.

    Technology Fee: $200.00

    410.633.81 - Introduction to Bioinformatics

    Jarrett Morrow

    Online 5/27 - 8/18

    This course explores the theory and practice of biological database searching and analysis. In particular, students are introduced to integrated systems where a variety of data sources are connected through internet access. Information retrieval and interpretation are discussed, and many practical examples in a computer laboratory setting enable students to improve their data mining skills. Methods included in the course are searching the biomedical literature, sequence homology searching and multiple alignment, phylogeny, gene prediction, protein sequence motif analysis and secondary structure prediction, and several genome browsing methods. Introductory analysis using the R programming language is introduced. Computer access is required. Prerequisites: 410.601 Biochemistry. Corequisite: 410.602 Molecular Biology. S

    Technology Fee: $200.00

    410.633.82 - Introduction to Bioinformatics

    Md Mizanur Rahman

    Online 5/27 - 8/18

    This course explores the theory and practice of biological database searching and analysis. In particular, students are introduced to integrated systems where a variety of data sources are connected through internet access. Information retrieval and interpretation are discussed, and many practical examples in a computer laboratory setting enable students to improve their data mining skills. Methods included in the course are searching the biomedical literature, sequence homology searching and multiple alignment, phylogeny, gene prediction, protein sequence motif analysis and secondary structure prediction, and several genome browsing methods. Introductory analysis using the R programming language is introduced. Computer access is required. Prerequisites: 410.601 Biochemistry. Corequisite: 410.602 Molecular Biology. S

    Technology Fee: $200.00

    410.634.81 - Practical Computer Concepts for Bioinformatics

    Jarrett Morrow

    Online 5/27 - 8/18

    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. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology.

    Technology Fee: $200.00

    410.634.82 - Practical Computer Concepts for Bioinformatics

    Joshua Orvis

    Online 5/27 - 8/18

    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. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology.

    Technology Fee: $200.00

    410.635.81 - Bioinformatics: Tools for Genome Analysis

    Sajung Yun
    Sijung Yun

    Online 5/27 - 8/18

    Large-scale DNA sequencing efforts have resulted in increasingly large numbers of DNA sequences being deposited in public databases. Assigning annotations, such as exon boundaries, repeat regions, and other biologically relevant information accurately in the feature tables of these sequences requires a significant amount of human intervention. This course instructs students on computer analytical methods for gene identification, promoter analysis, and introductory gene expression analysis using software methods. Additionally, students are introduced to comparative genomics and proteomic analysis methods. Students will become proficient in annotating large genomic DNA sequences. This course covers customizing genome browsers with novel data. Next-generation sequence analysis is covered through sequence quality control and assembly and analysis of ChIP-seq and RNA-seq data. Students complete two large sequence analysis projects during the course. Prerequisites: 410.601 Biochemistry; 410.602 Molecular Biology; 410.633 Introduction to Bioinformatics or equivalent.

    Online Technology Fee: $200.00

    410.638.81 - Cancer Biology

    Meredith Safford

    Online 5/27 - 8/18

    This course provides students with knowledge of the fundamental principles of the molecular and cellular biology of cancer cells. The course explores the role of growth factors and signal transduction mechanisms, oncogenes, tumor suppressor genes, tumor viruses, and angiogenesis in tumorigenesis and metastasis. Special topics include cancer prevention and the array of cancer therapies, which include surgery, chemotherapy, radiation therapy, hormonal therapy, stem cell transplant, and immunotherapies. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cellular Biology I , 410.604 Advanced Cell Biology II. S

    Technology Fee: $200.00

    410.639.81 - Protein Bioinformatics

    Catherine Campbell

    Online 5/27 - 8/18

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

    Technology Fee: $200.00

    410.640.81 - Molecular Phylogenetic Techniques

    Elizabeth Humphries

    Online 5/27 - 8/18

    This course will provide a practical, hands-on introduction to the study of phylogenetics and comparative genomics. Theoretical background on molecular evolution will be provided only as needed to inform the comparative analysis of genomic data. The emphasis of the course will be placed squarely on the understanding and use of a variety of computational tools designed to extract meaningful biological information from molecular sequences. Lectures will provide information on the conceptual essence of the algorithms that underlie various sequence analysis tools and the rationale behind their use. Only programs that are freely available as either downloadable executables or as Web servers will be used in this course. Students will be encouraged to use the programs and approaches introduced in the course to address questions relevant to their own work. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.633 Introduction to Bioinformatics.

    Technology Fee: $200.00

    410.644.81 - Marketing Aspects of Biotechnology

    David Locke

    Online 5/27 - 8/18

    This course introduces students to the strategic and tactical approaches used in the marketing of biotechnological produce and services. Students gain a thorough understanding of the research and planning necessary to develop a marketing plan, the relationship between the marketing and sales functions, the difference between marketing a scientific product and a scientific service, pricing strategies, distribution alternatives, communications, promotion, and the importance of perception. Knowledge of marketing terminology and techniques proves helpful to anyone in the industry.

    Technology Fee: $200.00

    410.645.81 - Biostatistics

    William McCarthy

    Online 5/27 - 8/18

    This course introduces statistical concepts and analytical methods as applied to data encountered in biotechnology and biomedical sciences. It emphasizes the basic concepts of experimental design, quantitative analysis of data, and statistical inferences. Topics include probability theory and distributions; population parameters and their sample estimates; descriptive statistics for central tendency and dispersion; hypothesis testing and confidence intervals for means, variances, and proportions; categorical data analysis; linear correlation and regression model; logistic regression; analysis of variance; and nonparametric methods. The course provides students a foundation with which 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).

    Technology Fee: $200.00

    410.645.82 - Biostatistics

    William McCarthy

    Online 5/27 - 8/18

    This course introduces statistical concepts and analytical methods as applied to data encountered in biotechnology and biomedical sciences. It emphasizes the basic concepts of experimental design, quantitative analysis of data, and statistical inferences. Topics include probability theory and distributions; population parameters and their sample estimates; descriptive statistics for central tendency and dispersion; hypothesis testing and confidence intervals for means, variances, and proportions; categorical data analysis; linear correlation and regression model; logistic regression; analysis of variance; and nonparametric methods. The course provides students a foundation with which 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).

    Technology Fee: $200.00

    410.646.81 - Creating a Biotechnology Enterprise

    Eran Steinberg

    Online 5/27 - 8/18

    This course provides a foundation to start or help guide a young biotechnology company from inception through early growth. Topics include market assessment of innovative technology, patents and licensing, corporate law, preparing a business plan, raising money from angels and venture capitalists, government grants, strategic alliances, sales and marketing, real estate, human resources, and regulatory affairs. The course provides a survey and overview of the key tasks and challenges typically faced by biotech entrepreneurs, their management team, and directors. Students will prepare a business plan for a biotech startup and present the plan to a panel of industry experts and financiers. Leaders from our local bioscience community will be guest lecturers for many of the classes.

    Technology Fee: $200.00

    410.649.81 - Introduction to Regulatory Affairs

    Susan Zecchini

    Online 5/27 - 8/18

    Regulatory affairs are comprised of the rules and regulations that 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 partnerships 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: $200.00

    410.649.82 - Introduction to Regulatory Affairs

    Suzanne Fitzpatrick

    Online 5/27 - 8/18

    Regulatory affairs are comprised of the rules and regulations that 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 partnerships 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: $200.00

    410.651.81 - Clinical Development of Drugs and Biologics

    Jonathan Helfgott
    Michael Marcarelli

    Online 5/27 - 8/18

    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: $200.00

    410.651.82 - Clinical Development of Drugs and Biologics

    Christopher Breder

    Online 5/27 - 8/18

    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: $200.00

    410.653.81 - Regenerative Medicine: from Bench to Bedside

    Jamie Austin

    Online 5/27 - 8/18

    Regenerative Medicine is a multidisciplinary field developing next-generation therapies that aim to augment, repair, replace or regenerate tissues and organs. This field can be broadly defined by three overlapping technology domains: cell therapy, gene therapy, and tissue engineering. In this course, we will explore these regenerative medicines from bench to bedside. We will discuss relevant biological, engineering, clinical, legal, regulatory, and ethical principles and perspectives to understand the emerging field of regenerative medicine. Specific topics will include induced pluripotent stem cells, bioartificial organs, cell-based immunotherapy, and gene editing techniques such as a CRISPR/Cas-9. In addition to gaining a scientific foundation, students will become familiar with the current state of the industry and the process of bringing these regenerative medicine products to market, including market trends and opportunities, process development and manufacturing, and commercialization challenges and successes. Readings will be drawn primarily from scientific journals. Prerequisites: 410.601 Biochemistry; 410.602 Molecular Biology; 410.603 Advanced Cell Biology I.

    Technology Fee: $200

    410.665.81 - Bioscience Communication

    Manojit Basu

    Online 5/27 - 8/18

    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: $200.00

    410.671.81 - Gene Expression Data Analysis and Visualization

    Brandon Higgs

    Online 5/27 - 8/18

    This course will introduce students to various methods for analyzing and interpreting transcriptomics data generated from technologies such as oligonucleotides 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: $200.00

    410.673.81 - Biological Processes in Regulatory Affairs

    Michael Manning

    Online 5/27 - 8/18

    This course provides an overview of the biological processes and laboratory techniques utilized for the discovery, development, and evaluation of therapeutic drugs. Students investigate drug development processes, such as gene cloning, culture scale-up, downstream processing, and product purification. Emphasis is placed on the theory and application of laboratory methods used in drug development, such as recombinant DNA techniques, antibody technology, protein purification, immunoassays, high- throughput drug screening, chromatography, electrophoresis cell receptor characterization, pharmacokinetics, drug toxicity testing and evaluation of therapeutic drugs, diagnostics, and vaccines. Prerequisites: 410.303 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: $200.00

    410.673.82 - Biological Processes in Regulatory Affairs

    Markus Yap

    Online 5/27 - 8/18

    This course provides an overview of the biological processes and laboratory techniques utilized for the discovery, development, and evaluation of therapeutic drugs. Students investigate drug development processes, such as gene cloning, culture scale-up, downstream processing, and product purification. Emphasis is placed on the theory and application of laboratory methods used in drug development, such as recombinant DNA techniques, antibody technology, protein purification, immunoassays, high- throughput drug screening, chromatography, electrophoresis cell receptor characterization, pharmacokinetics, drug toxicity testing and evaluation of therapeutic drugs, diagnostics, and vaccines. Prerequisites: 410.303 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: $200.00

    410.674.81 - Food Microbiology

    Om Singh

    Online 5/27 - 8/18

    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 products, 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: $200.00

    410.675.81 - International Regulatory Affairs

    Darin Oppenheimer

    Online 5/27 - 8/18

    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 strategies require careful planning and interaction with the U.S. and foreign regulatory agencies. With the increased 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 phases from 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 to 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: $200.00

    410.676.81 - Food And Drug Law

    Loretta Chi

    Online 5/27 - 8/18

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

    Technology Fee: $200.00

    410.676.82 - Food And Drug Law

    Emil Wang

    Online 5/27 - 8/18

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

    Technology Fee: $200.00

    410.679.81 - Practicum in Regulatory Science

    Thomas Colonna

    Online 5/27 - 8/18

    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 a regulatory specialist, an FDA reviewer or senior-level policy-maker, or other involved stakeholders, such as a consumer group or an advocacy group. Students will be expected to research, evaluate, and present scientifically and legally justifiable positions on case studies from the perspective of their assigned roles. Students will present their perspectives to the class and be asked to debate the issues with the other students from the perspective of their assigned roles. The major responsibility of the students in this course will be to make scientifically and legally defensible recommendations and to justify them through oral and written communication.

    Technology Fee: $200.00

    410.679.82 - Practicum in Regulatory Science

    Thomas Colonna

    Online 5/27 - 8/18

    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 a regulatory specialist, an FDA reviewer or senior-level policy-maker, or other involved stakeholders, such as a consumer group or an advocacy group. Students will be expected to research, evaluate, and present scientifically and legally justifiable positions on case studies from the perspective of their assigned roles. Students will present their perspectives to the class and be asked to debate the issues with the other students from the perspective of their assigned roles. The major responsibility of the students in this course will be to make scientifically and legally defensible recommendations and to justify them through oral and written communication.

    Technology Fee: $200.00

    410.680.81 - Finance for Biotechnology

    Anthony Schwartz

    Online 5/27 - 8/18

    Students will build an understanding of the basics of contemporary global monetary systems and the essentials of financial management. This course will include the 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 an understanding of 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: $200.00

    410.683.81 - Introduction to cGMP Compliance

    Nancy Karaszkiewicz

    Online 5/27 - 8/18

    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 Code of Federal Regulations and are actively enforced by the FDA. These regulations, however, only begin to describe the practices used in the pharmaceutic and biotech industries. Additional sources of insight and guidance include the 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 the 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: $200.00

    410.683.82 - Introduction to cGMP Compliance

    William Roderick Freeman

    Online 5/27 - 8/18

    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 Code of Federal Regulations and are actively enforced by the FDA. These regulations, however, only begin to describe the practices used in the pharmaceutic and biotech industries. Additional sources of insight and guidance include the 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 the 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: $200.00

    410.687.81 - Ethical,Legal & Regulatory Aspects of the Biotechnology Enterprise

    Concetta Dudley

    Online 5/27 - 8/18

    This course provides an overview of the important ethical, legal, and regulatory issues that are critical to the biotechnology industry. The course shares current trends and essential elements of ethics, legal issues, and regulations in a way that allows for an appreciation of how each influences the others. Students will examine core ethical values that guide the practice of science in the biotechnology industry. The course will provide an overview of legal issues, such as protecting inventions, intellectual property, licensing, and the range of regulatory oversight mechanisms with which the biotech industry must comply. This course will review the implications of strategic ethical, legal, and regulatory choices that add value to the biotechnology firm, customers, and society.

    Technology Fee: $200.00

    410.689.81 - Leading Change in Biotechnology

    Larry Hampton

    Online 5/27 - 8/18

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

    Technology Fee: $200.00

    410.693.81 - Science, Medicine & Policy in Biodefense

    Mohamed Ibrahim

    Online 5/27 - 8/18

    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.

    Technology Fee: $200.00

    410.694.81 - FDA Premarket Applications

    Emil Wang

    Online 5/27 - 8/18

    This course provides a comprehensive overview of the U.S. Food and Drug Administration’s (FDA’s) regulation of the research and development, and marketing of new drugs, biologics, and medical devices. The regulatory requirements for investigational (Investigational New Drug (IND) and Investigational Device Exemption (IDE)) and premarket approval (New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Biologics License Application (BLA), premarket notification (510(k)), Premarket Approval (PMA)) applications will be addressed. The content and format requirements for the preparation, submission, and maintenance of these applications will be covered.

    Technology Fee: $200.00

    410.700.81 - Food Labeling and Packaging Regulations

    Jesse Zuehlke

    Online 5/27 - 8/18

    The Nutrition Labeling and Education Act of 1990, which amended the FD&C Act, requires most foods to bear nutrition labeling and requires food labels that bear nutrient content claims and certain health messages to comply with specific requirements. The NLEA and the final regulations to implement the NLEA provide for a number of fundamental changes in how food is labeled, including requiring that nutrition labeling be placed on most foods, requiring that terms that characterize the level of nutrients in a food be used in accordance with definitions established by the FDA, and providing for the use of claims about the relationship between nutrients and diseases or health-related conditions. These changes apply to virtually all foods in the food supply, including, in large measure, to foods sold in restaurants. Food labeling is required for most prepared foods, such as breads, cereals, canned and frozen foods, snacks, desserts, drinks, etc. Nutrition labeling for raw produce (fruits and vegetables) and fish is voluntary.

    Technology Fee: $200.00

    410.702.81 - Biomedical Software Regulation

    Thomas Colonna
    Jonathan Helfgott

    Online 5/27 - 8/18

    Software continually grows more complex and is becoming relied upon by health care professionals in the treatment of patients. This course describes how the U.S. government regulates software used in delivering health care, including the regulations utilized by the FDA and the Centers for Medicare and Medicaid Services. This course covers a wide range of topics, including FDA regulation of software as a medical device and software validation, medical imaging software regulation, electronic record keeping and software used in clinical trials, laboratory information management systems, and HIPAA privacy rules and security standards.

    Technology Fee: $200.00

    410.706.81 - Building and Leading Teams in Health Care

    Christopher Dreisbach

    Online 5/27 - 8/18

    In order to provide the best care possible, health care professionals are working together more now than ever before. As a result, strong leadership and teamwork skills are becoming necessities in joining the health care field. This course will provide hands-on activities to help students develop problem-solving skills, learn basic negotiation and mediation strategies, and understand their own tendencies as leaders and team members. Using real-world examples, students will explore how strong leadership and teamwork can drive innovative solutions to public health issues.

    Technology Fee: $200.00

    410.706.82 - Building and Leading Teams in Health Care

    Christopher Dreisbach

    Online 5/27 - 8/18

    In order to provide the best care possible, health care professionals are working together more now than ever before. As a result, strong leadership and teamwork skills are becoming necessities in joining the health care field. This course will provide hands-on activities to help students develop problem-solving skills, learn basic negotiation and mediation strategies, and understand their own tendencies as leaders and team members. Using real-world examples, students will explore how strong leadership and teamwork can drive innovative solutions to public health issues.

    Technology Fee: $200.00

    410.706.83 - Building and Leading Teams in Health Care

    Christopher Dreisbach

    Online 5/27 - 8/18

    In order to provide the best care possible, health care professionals are working together more now than ever before. As a result, strong leadership and teamwork skills are becoming necessities in joining the health care field. This course will provide hands-on activities to help students develop problem-solving skills, learn basic negotiation and mediation strategies, and understand their own tendencies as leaders and team members. Using real-world examples, students will explore how strong leadership and teamwork can drive innovative solutions to public health issues.

    Technology Fee: $200.00

    410.712.81 - Advanced Practical Computer Concepts for Bioinformatics

    Joshua Orvis

    Online 5/27 - 8/18

    This intermediate-to-advanced-level course, intended as a follow-on to 410.634 Practical Computer Concepts for Bioinformatics (a prerequisite for this new class), will integrate and expand on the concepts from that introductory class to allow students to create working, Web-based bioinformatics applications in a project-based course format. After a review of the concepts covered in 410.634, students will learn how to create functional Web applications on a UNIX system, using Python and CGI to create forms that can be acted upon, and using the Perl DBI module to interface with MySQL relational databases that they will create and populate to retrieve and present information. This will be demonstrated by building an in-class, instructor-led project. More advanced SQL concepts and database modeling will also be covered, as well as introductions to HTML5, CSS3, and Javascript/JQuery. Class time in the latter weeks of the class will be devoted to individual assistance on student projects and to short lectures on advanced topics. Once again, whenever possible, this course will emphasize relevance to solving problems in molecular biology and bioinformatics. Prerequisites: 410.601 Biochemistry; 410.602 Molecular Biology; 410.634 Practical Computer Concepts. S

    Technology Fee: $200.00

    410.715.81 - Medical Device Regulation

    Richard McCall

    Online 5/27 - 8/18

    This course provides a comprehensive introduction to medical devices and how they are regulated by the FDA. Topics that will be covered include an overview of the laws and regulations that govern medical devices, the FDA’s organizational structure and responsibilities for medical device regulation, and administrative and legal requirements for medical devices throughout the full product life cycle. Particular focus will be placed on the premarket review, post-market programs enforcement (e.g., Quality Systems Regulation, and FDA inspectional programs). Included will be discussions on the responsible offices and major program requirements and resources. Students will be given various case studies to examine the application of regulations and participate in a 510(k)/PMA workshop, mock inspectional audit, and 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: $200.00

    410.716.81 - Food Toxicology

    Suzanne Fitzpatrick

    Online 5/27 - 8/18

    Food toxicology is the study of the nature, properties, effects, and detection of toxic substances in food, and their disease manifestation in humans. This course will provide a general understanding of toxicology related to food and the human food chain. Fundamental concepts will be covered, including dose-response relationships, absorption of toxicants, distribution and storage of toxicants, biotransformation and elimination of toxicants, target organ toxicity, teratogenesis, mutagenesis carcinogenesis, food allergy, and risk assessment. The course will examine chemicals of food interest, such as food additive mycotoxins and pesticides, and how they are tested and regulated.

    Technology Fee: $200.00

    410.717.81 - Risk Assessment and Management

    Tiea Theurer

    Online 5/27 - 8/18

    Risk analysis is composed of three separate but integrated elements, namely, risk assessment, risk management, and risk communication. Risk communication is an interactive process of exchange of information and opinion on risk among risk assessors, risk managers, and other interested parties. Risk management is the process of weighing policy alternatives in light of the results of risk assessment and, if required, selecting and implementing appropriate control options, including regulatory measures. Students will learn how to integrate risk assessment, risk management, and risk communication using case studies.

    Technology Fee: $200.00

    410.727.81 - Regulatory Strategies in Biopharmaceuticals

    Bharat Khurana

    Online 5/27 - 8/18

    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: $200.00

    410.736.81 - Genomic and Personalized Medicine

    Beatrice Kondo
    Farzaneh Sabahi

    Online 5/27 - 8/18

    With the advent of rapid, low-cost whole-genome sequencing, the field of personalized medicine is growing from a niche field to becoming the new standard of practice in medicine. Already, oncology makes use of genomic sequencing to inform treatment decisions based on tumor types, and patients are seeking knowledge about their genetic and environmental risk factors to make informed health decisions. This class explores the evolving field of personalized medicine, examining genomics as well as proteomics, metabolomics, epigenetics, and the microbiome. Students will read and discuss new developments in pharmacogenomics, rare and complex diseases, genomics for the healthy person, and the ethical, economic, and social implications of these new technologies. These topics will be approached with a view toward application in clinical practice. Prerequisites: 410.602 Molecular Biology; 410.633 Introduction to Bioinformatics.

    Technology Fee: $200.00

    410.736.82 - Genomic and Personalized Medicine

    Beatrice Kondo
    Farzaneh Sabahi

    Online 5/27 - 8/18

    With the advent of rapid, low-cost whole-genome sequencing, the field of personalized medicine is growing from a niche field to becoming the new standard of practice in medicine. Already, oncology makes use of genomic sequencing to inform treatment decisions based on tumor types, and patients are seeking knowledge about their genetic and environmental risk factors to make informed health decisions. This class explores the evolving field of personalized medicine, examining genomics as well as proteomics, metabolomics, epigenetics, and the microbiome. Students will read and discuss new developments in pharmacogenomics, rare and complex diseases, genomics for the healthy person, and the ethical, economic, and social implications of these new technologies. These topics will be approached with a view toward application in clinical practice. Prerequisites: 410.602 Molecular Biology; 410.633 Introduction to Bioinformatics.

    Technology Fee: $200.00

    410.753.81 - Stem Cell Biology

    Mary Donohue

    Online 5/27 - 8/18

    This course will involve discussion and debate on current topics concerning stem cell biology and the use of stem cells in biotechnology and therapeutics. Topics will include review and discussion of developmental and cell biology, stem cell characteristics, stem cell preparation and therapeutic uses, tissue engineering, global regulatory and ethical issues, and commercialization of stem cell therapy. Current peer-reviewed literature and guest experts in the field will provide up-to-date information for discussion. Prerequisites: 410.601 Biochemistry, 410.602 Molecule Biology, 410.603 Advanced Cell Biology I, 410.604 Advanced Cell Biology II. S

    Technology Fee: $200.00

    410.802.81 - Independent Studies in Regulatory Science

    Thomas Colonna

    Online 5/27 - 8/18

    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: $200.00

    410.806.81 - Independent Studies in Biotechnology Enterprise and Entrepreneurship

    Thomas Colonna

    Online 5/27 - 8/18

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

    Technology Fee: $200.00