Course Schedule

January Intersession 2019

The following courses are offered during the January 2019 intersession, which runs from January 2nd to January 22nd. These courses are also listed below with the Spring 2019 courses, where you can view the course description, class dates & times by touching on the accordion tab by the title.

  • 410.633.72 Introduction to Bioinformatics
  • 410.643.01 Managing and Leading Biotechnology Professionals
  • 410.731.71 Bioprocessing and Scale-up Laboratory

Note to International Students with F1-visa: Each of these 4.0 credit January intersession courses count as one onsite course for the Spring 2019 Term.

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

    $4322

    Richa Tyagi

    Monday 6:00 - 9:30; 1/28 - 5/6

    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. S

    410.602.01 - Molecular Biology

    $4322

    Robert Horner

    Tuesday 6:00 - 9:30; 1/29 - 5/7

    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. S

    410.603.01 - Advanced Cell Biology I

    $4322

    Michael Lebowitz

    Thursday 6:00 - 9:30; 1/24 - 5/2

    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. S

    410.604.01 - Advanced Cell Biology II

    $4322

    Dr. Jonathon Bennett

    Thursday 6:00 - 9:30; 1/24 - 5/2

    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 hormone 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 pathway to oncogenes is and other disease states will be stressed. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I. S

    410.613.01 - Principles of Immunology

    $4322

    Richa Tyagi

    Tuesday 6:00 - 9:30; 1/29 - 5/7

    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. S

    410.615.01 - Microbiology

    $4322

    Sara Ruiz

    Wednesday 6:00 - 9:30; 1/23 - 5/1

    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. S

    410.622.01 - Molecular Basis of Pharmacology

    $4322

    Takashi Tsukamoto

    Monday 6:00 - 9:30; 1/28 - 5/6

    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. S

    410.643.01 - Managing and Leading Biotechnology Professionals

    $4322

    Bonnie Robeson

    TTh 6:00 - 9:20; 1/3 - 1/22
    Saturday 9:00 - 5:00; 1/5 - 1/19

    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.

    410.645.01 - Biostatistics

    $4322

    Robert Lessick

    Tuesday 6:00 - 9:20; 1/29 - 5/7

    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 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). S

    410.656.01 - Recombinant DNA Laboratory


    Tuesday 6:00 - 9:30; 1/29 - 5/7

    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, and applications of the polymerase chain reaction. This course is not recommended for students with substantial experience in these methodologies. Prerequisites: 410.602 Molecular Biology. S

    410.693.01 - Science, Medicine & Policy in Biodefense

    $4322

    John Carra

    Saturday 1:00 - 5:00; 1/26 - 5/4

    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. S

  • Montgomery County Campus

    410.601.71 - Biochemistry

    $4322

    Elena Schwartz

    Tuesday 6:00 - 9:30; 1/29 - 5/7

    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. S

    410.602.71 - Molecular Biology

    $4322

    Dr. Arti Varanasi

    Thursday 6:00 - 9:30; 1/24 - 5/2

    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. S

    410.603.71 - Advanced Cell Biology I

    $4322

    Michael Lebowitz

    Wednesday 6:00 - 9:30; 1/23 - 5/1

    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. S

    410.604.71 - Advanced Cell Biology II

    $4322

    Elena Schwartz

    Monday 6:00 - 9:30; 1/28 - 5/6

    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 hormone 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 pathway to oncogenes is and other disease states will be stressed. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I. S

    410.610.71 - Epigenetics, Gene Organization & Expression

    $4322

    Roza Selimyan

    Wednesday 5:15 - 8:45; 1/23 - 5/1

    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

    410.611.71 - Vaccinology

    $4322

    Robert Kaminski

    Tuesday 6:00 - 9:30; 1/29 - 5/7

    This course will cover the biological development, immunologic concepts, and methods for vaccine delivery. Specific topics include new technologies for vaccine development, such as DNA vaccines, recombinant mucosal vaccines, dendritic cells for antigen delivery, novel adjuvants, and methods to increase vaccine stability. Delivery systems for vaccines, both time tested and new methodologies, such as lipid-based systems, needle- free injection systems, and novel methods, such as the use of genetically modified foods, will be discussed. The underlying biological role of the innate and adaptive immune systems will be explored in light of new types of vaccines and delivery systems. Finally, the process of bringing vaccines to market will be covered, including government oversight and licensure. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I, 410.613 Principles of Immunology, or undergraduate immunology course. S

    410.618.71 - Parasitology

    $4322

    Mary Donohue

    Monday 6:00 - 9:30; 1/28 - 5/6

    The field of parasitology is immense. It covers a plethora of organisms and a multitude of disciplines. This course focuses on the parasites of medical importance that cause human morbidity and mortality throughout the world. It also introduces the student to the general aspects of parasitology. The developmental biology, natural history, and cell and molecular biology of the major eukaryotic parasites will be discussed. Also, the fundamental mechanisms of host-parasite relationships, diagnosis, pathogenesis, epidemiology, and control strategies will be emphasized. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I. S

    410.627.71 - Translational Biotechnology:From Intellectual Property to Licensing

    $4322

    James Karaszkiewicz

    Tuesday 6:00 - 9:30; 1/29 - 5/7

    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 I or admission to the MS in Regulatory Science OR Master of Biotechnology Enterprise and Entrepreneurship programs.

    410.631.71 - Infectious Diseases

    $4322

    Dr. Gregory

    Wednesday 6:00 - 9:30; 1/23 - 5/1

    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. S

    410.633.71 - Introduction to Bioinformatics

    $4322

    Robert Lessick

    Monday 6:00 - 9:30; 1/28 - 5/6

    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

    410.633.72 - Introduction to Bioinformatics

    $4322

    Robert Lessick

    TTh 6:00 - 9:50; 1/3 - 1/22
    Saturday 9:30 - 5:00; 1/5 - 1/19

    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

    Meeting times: Thursday, January 3: 6:00 - 9:50 Saturday, January 5: 9:30 - 5:00 Tuesday, January 8: 6:00 - 9:50 Thursday, January 10: 6:00 - 9:50 Saturday, January 12: 9:30 - 5:00 Tuesday, January 15: 6:00 - 9:50 Thursday, January 17: 6:00 - 9:50 Saturday, January 19: 9:30 - 5:00 Tuesday, January 22: 6:00 - 9:50

    410.638.71 - Cancer Biology

    $4322

    Jessica Faupel-Badger

    Tuesday 6:00 - 9:30; 1/29 - 5/7

    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

    410.656.71 - Recombinant DNA Laboratory

    $4322

    Kristin Mullins

    Wednesday 6:00 - 9:30; 1/23 - 5/1

    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, and applications of the polymerase chain reaction. This course is not recommended for students with substantial experience in these methodologies. Prerequisites: 410.602 Molecular Biology. S

    410.662.71 - Epidemiology: Diseases in Populations

    $4322

    Dr. Arti Varanasi

    Wednesday 2:00 - 5:30; 1/23 - 5/1

    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. S

    410.692.71 - Biological & Chemical Threat Response & Forensics

    $4322

    Calvin Chue
    Matthew Bender

    Wednesday 6:00 - 9:30; 1/23 - 5/1

    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. S

    410.696.71 - Bioassay Development

    $4322

    Rekha Panchal

    Tuesday 6:00 - 9:30; 1/29 - 5/7

    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. S

    410.705.71 - Communication for Health Care Professionals

    $4322

    Admon Alexander

    Thursday 6:00 - 9:45; 1/24 - 3/7
    Online 12:00 - 12:01; 1/23 - 3/12

    In this course, students will practice both oral and written communication techniques and learn how to effectively communicate in formal and informal arenas. Students will work together to improve daily communications with peers, colleagues and potential patients. Coursework will focus on specific oral competencies including interviewing and cross-culture communications as well as specific written competencies including essays writing, email communications and interview summaries. In all communications, an emphasis will be given to getting a clear and concise message across through logical and comprehensive writing techniques. Additionally, students will discuss how communication strategies can be used to encourage or hinder changes in patient behavior and incite changes in public health.

    This is a hybrid class that will meet Thursday evening and online. The online portion of the class is equivalent to 4 hours of class time per week. On the first night of class, your instructor will give you information about the online portion of the class.

    410.705.72 - Communication for Health Care Professionals

    $4322

    Admon Alexander

    Thursday 6:00 - 9:45; 3/14 - 5/2
    Online 12:00 - 12:01; 3/13 - 5/7

    In this course, students will practice both oral and written communication techniques and learn how to effectively communicate in formal and informal arenas. Students will work together to improve daily communications with peers, colleagues and potential patients. Coursework will focus on specific oral competencies including interviewing and cross-culture communications as well as specific written competencies including essays writing, email communications and interview summaries. In all communications, an emphasis will be given to getting a clear and concise message across through logical and comprehensive writing techniques. Additionally, students will discuss how communication strategies can be used to encourage or hinder changes in patient behavior and incite changes in public health.

    This is a hybrid class that will meet Thursday evening and online. The online portion of the class is equivalent to 4 hours of class time per week. On the first night of class, your instructor will give you information about the online portion of the class.

    410.707.71 - The Psychosocial Determinants of Health, Implications on Diagnostics

    $4322

    Bonnie Robeson

    Thursday 6:00 - 9:45; 1/23 - 3/7
    Online 12:00 - 12:01; 1/23 - 3/12

    In this capstone course, students will learn basic diagnostic techniques and use case studies to explore the relationship between physiological illnesses and diagnostic output. Through discussions and guided interviews, students will explore the role of psychology and sociology in patient care choices, as well as physician recommendations to patients. Students will practice cultural sensitivity through group activities and discussion of pressing public health issues. Students will undertake final group projects that identify needs in the local community and attempt to create solutions that could feasible be completed with limited resources.

    This is a hybrid class that will meet Thursday evening and online. The online portion of the class is equivalent to 4 hours of class time per week. On the first night of class, your instructor will give you information about the online portion of the class.

    410.707.72 - The Psychosocial Determinants of Health, Implications on Diagnostics

    $4322

    Bonnie Robeson

    Thursday 6:00 - 9:45; 3/14 - 5/2
    Online 12:00 - 12:01; 3/13 - 5/7

    In this capstone course, students will learn basic diagnostic techniques and use case studies to explore the relationship between physiological illnesses and diagnostic output. Through discussions and guided interviews, students will explore the role of psychology and sociology in patient care choices, as well as physician recommendations to patients. Students will practice cultural sensitivity through group activities and discussion of pressing public health issues. Students will undertake final group projects that identify needs in the local community and attempt to create solutions that could feasible be completed with limited resources.

    This is a hybrid class that will meet Thursday evening and online. The online portion of the class is equivalent to 4 hours of class time per week. On the first night of class, your instructor will give you information about the online portion of the class.

    410.731.71 - Bioprocessing and Scale-up Laboratory

    $4322

    Kristina Obom
    Jamie Austin

    TWTh 5:00 - 9:30; 1/8 - 1/22
    Saturday 9:00 - 5:00; 1/12 - 1/19
    Online 12:00 - 12:00; 1/2 - 1/8

    This course will provide students with hands-on experience in process development of biological product from a cell bank through purification. Students will develop two products; one produced in bacteria and the other in a mammalian cell culture system. Students will optimize growth conditions on a small scale and then produce the biologic in a bioreactor. Students then purify the product after optimizing purification condition Topics to be covered include microbial fermentation, cell cult production, bioassays, product purification, and the regulator engineering and business principles associated with scale-up a biologic product. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I. S

    This is a hybrid class where the first week of the course Jan 2nd to Jan 8th is online and then meets onsite Jan 8th, 9th, 10th, 12th, 15th, 16th, 17th, 19th, and 22nd onsite.

    410.736.71 - Genomic and Personalized Medicine

    $4322

    Beatrice Kondo

    Tuesday 5:00 - 8:30; 1/29 - 5/7
    Online 12:00 - 12:01; 1/23 - 5/7

    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. S

    This is a hybrid class which alternates between meeting online and meeting onsite. The first class meeting is onsite, January 29, 2019.

    410.752.71 - High Throughput Screening & Automation Lab

    $4322

    Brett Eaton
    Rekha Panchal

    Saturday 9:00 - 5:00; 1/26 - 5/4

    This course will utilize hands-on instruction in automated bioassay systems for high-throughput screening as an entry point to covering pertinent aspects of HTS, such as data manipulation, storage, and analysis; liquid handling robotics; microtiter plate washing, manipulation, and bar coding; HTS assay detectors; and automated devices for assay setup, validation, and visualization. Cost considerations, HTS amenable assay systems, and miniaturization and scale-up will also be discussed. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology, and 410.696 Bioassay Development. S

    This class meets on alternating Saturdays, section 71 begins on the first Saturday, and section 72 begins on the second Saturday

    410.752.72 - High Throughput Screening & Automation Lab

    $4322

    Rekha Panchal
    Brett Eaton

    Saturday 9:00 - 5:00; 1/26 - 5/4

    This course will utilize hands-on instruction in automated bioassay systems for high-throughput screening as an entry point to covering pertinent aspects of HTS, such as data manipulation, storage, and analysis; liquid handling robotics; microtiter plate washing, manipulation, and bar coding; HTS assay detectors; and automated devices for assay setup, validation, and visualization. Cost considerations, HTS amenable assay systems, and miniaturization and scale-up will also be discussed. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology, and 410.696 Bioassay Development. S

    This class meets on alternating Saturdays, section 71 begins on the first Saturday, and section 72 begins on the second Saturday

    410.800.71 - Independent Research in Biotechnology

    $4322

    Thomas Koval

    Sunday 12:00 - 12:00; 1/23 - 5/7

    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 core courses and four additional courses. S

    Please contact Dr. Koval if you wish to register for this course. tkoval@jhu.edu

    410.801.71 - Biotechnology Thesis

    $4322

    Kristina Obom

    Sunday 12:00 - 12:01; 1/23 - 5/7

    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: Successful completion of 410.800 Independent Research Project and 410.645 Biostatistics.

    410.806.71 - Independent Studies in Biotechnology Enterprise and Entrepreneurship

    $4322

    Lynn Johnson Langer

    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 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 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.?

  • Online Courses

    410.302.81 - Bio-Organic Chemistry

    $4322

    Jeffrey Froude

    Online 1/23 - 5/7

    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. S

    Technology Fee: $200.00

    410.303.81 - Foundations in Bioscience

    $4322

    Weiying Pan

    Online 1/23 - 5/7

    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

    $4322

    Karen Wells

    Online 1/23 - 5/7

    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. S

    Technology Fee: $200.00

    410.601.82 - Biochemistry

    $4322

    Karen Wells

    Online 1/23 - 5/7

    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. S

    Technology Fee: $200.00

    410.601.83 - Biochemistry

    $4322

    Satarupa Das

    Online 1/23 - 5/7

    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. S

    Technology Fee: $200.00

    410.601.84 - Biochemistry

    $4322

    Tyler Chavez

    Online 1/23 - 5/7

    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. S

    Technology Fee: $200.00

    410.602.81 - Molecular Biology

    $4322

    Sherry Ogg

    Online 1/23 - 5/7

    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. S

    Technology Fee: $200.00

    410.602.82 - Molecular Biology

    $4322

    Sherry Ogg

    Online 1/23 - 5/7

    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. S

    Technology Fee: $200.00

    410.602.83 - Molecular Biology

    $4322

    Dr. Mark Hollier

    Online 1/23 - 5/7

    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. S

    Technology Fee: $200.00

    410.602.84 - Molecular Biology

    $4322

    Valerie Divito

    Online 1/23 - 5/7

    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. S

    Technology Fee: $200.00

    410.602.85 - Molecular Biology

    $4322

    Melinda Maris

    Online 1/23 - 5/7

    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. S

    Technology Fee: $200.00

    410.603.81 - Advanced Cell Biology I

    $4322

    Thomas Koval

    Online 1/23 - 5/7

    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. S

    Technology Fee: $200.00

    410.603.82 - Advanced Cell Biology I

    $4322

    Thomas Koval

    Online 1/23 - 5/7

    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. S

    Technology Fee: $200.00

    410.603.83 - Advanced Cell Biology I

    $4322

    Lisa Selbie

    Online 1/23 - 5/7

    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. S

    Technology Fee: $200.00

    410.603.84 - Advanced Cell Biology I

    $4322

    Jeffrey Mahr

    Online 1/23 - 5/7

    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. S

    Technology Fee: $200.00

    410.603.85 - Advanced Cell Biology I

    $4322

    Mary Donohue

    Online 1/23 - 5/7

    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. S

    Technology Fee: $200.00

    410.604.81 - Advanced Cell Biology II

    $4322

    Thomas Koval

    Online 1/23 - 5/7

    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 hormone 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 pathway to oncogenes is and other disease states will be stressed. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I. S

    Technology Fee: $200.00

    410.604.82 - Advanced Cell Biology II

    $4322

    Nicole Glaser-George

    Online 1/23 - 5/7

    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 hormone 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 pathway to oncogenes is and other disease states will be stressed. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I. S

    Technology Fee: $200.00

    410.604.83 - Advanced Cell Biology II

    $4322

    Nicole Glaser-George

    Online 1/23 - 5/7

    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 hormone 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 pathway to oncogenes is and other disease states will be stressed. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I. S

    Technology Fee: $200.00

    410.604.84 - Advanced Cell Biology II

    $4322

    Lisa Selbie

    Online 1/23 - 5/7

    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 hormone 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 pathway to oncogenes is and other disease states will be stressed. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I. S

    Technology Fee: $200.00

    410.608.81 - Neurological Disease

    $4322

    Karen Wells

    Online 1/23 - 5/7

    Knowledge about neuronal structure, function, and circuitry will be applied in order to understand the genetic and molecular bases of a wide variety of diseases that affect the central and/or peripheral nervous systems. This course will incorporate explorations of the recent primary literature, as it relates to specific disease pathologies and treatments, and innovative research tools used in their study. The particular pathologies covered will vary by semester, but will include some of the following: brain/spinal cord injury, epilepsy, stroke, multiple sclerosis, Parkinson’s disease, Alzheimer’s disease, schizophrenia, depression/bipolar disorder, amyotrophic lateral sclerosis, Huntington’s disease, infectious disease, prion-based disease, addiction, autism spectrum disorder, and disorders of neural development. This course is a natural continuation of, and builds upon the foundations provided in, the Neurobiology course. Prerequisites: All four core courses; 410.628 Neurobiology.

    Technology Fee: $200.00

    410.608.82 - Neurological Disease

    Karen Wells

    Online 1/23 - 5/7

    Knowledge about neuronal structure, function, and circuitry will be applied in order to understand the genetic and molecular bases of a wide variety of diseases that affect the central and/or peripheral nervous systems. This course will incorporate explorations of the recent primary literature, as it relates to specific disease pathologies and treatments, and innovative research tools used in their study. The particular pathologies covered will vary by semester, but will include some of the following: brain/spinal cord injury, epilepsy, stroke, multiple sclerosis, Parkinson’s disease, Alzheimer’s disease, schizophrenia, depression/bipolar disorder, amyotrophic lateral sclerosis, Huntington’s disease, infectious disease, prion-based disease, addiction, autism spectrum disorder, and disorders of neural development. This course is a natural continuation of, and builds upon the foundations provided in, the Neurobiology course. Prerequisites: All four core courses; 410.628 Neurobiology.

    Technology Fee: $200.00

    410.610.81 - Epigenetics, Gene Organization & Expression

    $4322

    Jonathan Lochamy

    Online 1/23 - 5/7

    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

    $4322

    Md Mizanur Rahman

    Online 1/23 - 5/7

    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

    $4322

    Erin Morrey

    Online 1/23 - 5/7

    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

    $4322

    Patrick Cummings

    Online 1/23 - 5/7

    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. S

    Technology Fee: $200.00

    410.613.82 - Principles of Immunology

    $4322

    Farzaneh Sabahi

    Online 1/23 - 5/7

    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. S

    Technology Fee: $200.00

    410.616.81 - Virology

    $4322

    Bruce Brown

    Online 1/23 - 5/7

    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

    410.620.81 - Advanced Topics in Immunology

    $4322

    Meredith Safford

    Online 1/23 - 5/7

    This course integrates and expands concepts learned in an introductory immunology course. Students will be presented with advanced topics in immunology through literature reviews, clinical case studies, basic science and clinical research papers, and supported by leading-edge webinars. Topic areas may include, but are not limited to, acellular and cellular innate immunity, adaptive immunity, immune regulation, autoimmunity, immunosuppression, inflammation, neuroimmunology, immunobiology of pregnancy, immunogenomics, tumor immunology, standard and developing therapies for immunopathologies, and immunotherapies. Students will also be introduced to immunological tests used for disease screening and diagnoses. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cellular Biology I, and 410.613 Principles of Immunology or an undergraduate immunology course. S

    Technology Fee: $200.00

    410.627.81 - Translational Biotechnology:From Intellectual Property to Licensing

    $4322

    Timothy Alcorn

    Online 1/23 - 5/7

    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 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

    $4322

    Timothy Alcorn

    Online 1/23 - 5/7

    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 I or admission to the MS in Regulatory Science OR Master of Biotechnology Enterprise and Entrepreneurship programs.

    Technology Fee: $200.00

    410.629.81 - Genes & Disease

    $4322

    Kristina Obom

    Online 1/23 - 5/7

    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: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I. S

    Technology Fee: $200.00

    410.630.81 - Gene Therapy

    $4322

    Erin Morrey

    Online 1/23 - 5/7

    Due to recent advances, powerful diagnostics tools can now detect nucleotide changes that are responsible for genetic diseases as well as defects that can influence metabolism of drugs. In this course, using case studies, students will learn general genetic principles, genomic and molecular basis of disease single gene disorders, and the genetic basis for multifactorial diseases including cancer, cardiovascular disease, metabolic disease and neurological disease. The human microbiome and its role in disease will be discussed.  Molecular methods will be emphasized and bioinformatics tools and databases for genomic analysis will be introduced.   Students will discuss the ethical considerations of genetics and genomics.  Pre-requisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Cell Biology I or degree candidate in MS in Individualized Genomics and Health. 

    Technology Fee: $200.00

    410.632.81 - Emerging Infectious Diseases

    $4322

    Stacy Plum

    Online 1/23 - 5/7

    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, causative agent of anthrax, which ca be used in biological warfare weapons. Opinions from noted scientists and leaders concerning emerging diseases and the prospects for battling them successfully provide scientific and social perspective. Prerequisites: 410.601 Biochemistry, 410.602 Molecular Biology, 410.603 Advanced Cell Biology I. S

    Technology Fee: $200.00

    410.633.81 - Introduction to Bioinformatics

    $4322

    Sherry Ogg

    Online 1/23 - 5/7

    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

    $4322

    Sherry Ogg

    Online 1/23 - 5/7

    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

    410.633.83 - Introduction to Bioinformatics

    $4322

    Jarrett Morrow

    Online 1/23 - 5/7

    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

    $4322

    Joshua Orvis

    Online 1/23 - 5/7

    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 Pythonl 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. S

    Technology Fee: $200.00

    410.634.82 - Practical Computer Concepts for Bioinformatics

    $4322

    Joshua Orvis

    Online 1/23 - 5/7

    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 Pythonl 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. S

    Technology Fee: $200.00

    410.635.81 - Bioinformatics:Tools for Genome Analysis

    $4322

    Sajung Yun
    Sijung Yun

    Online 1/23 - 5/7

    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. S

    Technology Fee: $200.00

    410.635.82 - Bioinformatics:Tools for Genome Analysis

    $4322

    Sajung Yun
    Sijung Yun

    Online 1/23 - 5/7

    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. S

    Technology Fee: $200.00

    410.638.81 - Cancer Biology

    $4322

    Meredith Safford

    Online 1/23 - 5/7

    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

    410.638.82 - Cancer Biology

    $4322

    Laundette Jones

    Online 1/23 - 5/7

    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

    410.641.81 - Clinical & Molecular Diagnostics

    $4322

    Mathumathi Rajavel

    Online 1/23 - 5/7

    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, a 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. S

    Technology Fee: $200.00

    410.643.81 - Managing and Leading Biotechnology Professionals

    Bonnie Robeson

    Online 1/23 - 5/7

    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: $200.00

    410.643.82 - Managing and Leading Biotechnology Professionals

    $4322

    Bonnie Robeson

    Online 1/23 - 5/7

    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: $200.00

    410.644.81 - Marketing Aspects of Biotechnology

    $4322

    Phillip Farmer

    Online 1/23 - 5/7

    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 prove helpful to anyone in the industry.

    Technology Fee: $200.00

    410.644.82 - Marketing Aspects of Biotechnology

    $4322

    Steven Geimer

    Online 1/23 - 5/7

    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 prove helpful to anyone in the industry.

    Technology Fee: $200.00

    410.645.81 - Biostatistics

    $4322

    William McCarthy

    Online 1/23 - 5/7

    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 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). S

    Technology Fee: $200.00

    410.645.82 - Biostatistics

    $4322

    William McCarthy

    Online 1/23 - 5/7

    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 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). S

    Technology Fee: $200.00

    410.645.83 - Biostatistics

    $4322

    Martha Nason

    Online 1/23 - 5/7

    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 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). S

    Technology Fee: $200.00

    410.648.81 - Clinical Trial Design and Conduct

    $4322

    Christopher Breder

    Online 1/23 - 5/7

    Through a case study approach, this course will cover the basic design issues of clinical trials, specifically targeting the protocol, case report forms, analysis plan, and informed consent. The design of a specific trial will be studied to illustrate the major issues in the design of a study, such as endpoint definition, control group selection, and eligibility criteria. The course will also cover the analysis plan for a study, including approaches that are central to clinical trials, such as stratified analysis, adjustment factors, and “intention-to-treat” analysis. The planned analytical techniques will include the analysis of correlated data (i.e., clustered data, longitudinal data), survival analysis using the proportional hazards (Cox) Regression model, and linear models. A semester-long project will include the creation of a protocol, case report forms, and informed consent. Prerequisites: 410.645 Biostatistics or equivalent (recommended), 410.651 Clinical Development of Drugs and Biologics (recommended).

    Technology Fee: $200.00

    410.649.81 - Introduction to Regulatory Affairs

    $4322

    Susan Zecchini

    Online 1/23 - 5/7

    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: $200.00

    410.649.82 - Introduction to Regulatory Affairs

    $4322

    Suzanne Fitzpatrick

    Online 1/23 - 5/7

    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: $200.00

    410.649.83 - Introduction to Regulatory Affairs

    Alison St John

    Online 1/23 - 5/7

    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: $200.00

    410.650.81 - Legal Aspects of Biotechnology

    $4322

    Reid Adler

    Online 1/23 - 5/7

    This course is a survey of legal topics relevant to a biotech enterprise as it is established, conducts research, and brings innovative products to market. These include property, contracts, regulatory compliance, and patents. Students will be able to analyze common business situations and understand how associated legal risks are managed. Students who have taken 410.687 Ethical, Legal and Regulatory Aspects of the Biotechnology Enterprise will also benefit from this course, as they will analyze contracts, patents, and various statutes and court decisions that impact the biotechnology sector.

    Technology Fee: $200.00

    410.651.81 - Clinical Development of Drugs and Biologics

    $4322

    Jonathan Helfgott
    Michael Marcarelli

    Online 1/23 - 5/7

    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. S

    Technology Fee: $200.00

    410.651.82 - Clinical Development of Drugs and Biologics

    $4322

    Bharat Khurana

    Online 1/23 - 5/7

    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. S

    Technology Fee: $200.00

    410.653.81 - Regenerative Medicine: from Bench to Bedside

    $4322

    Jamie Austin

    Online 1/23 - 5/7

    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 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. S

    Technology Fee: $200.00

    410.662.81 - Epidemiology: Diseases in Populations

    $4322

    Elizabeth Golub

    Online 1/23 - 5/7

    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. S

    Technology Fee: $200.00

    410.666.81 - Next Generation DNA Sequencing and Analysis

    $4322


    Online 1/23 - 5/7

    The recent revolution in DNA sequencing technologies has transformed biology within a few short years, dropping the cost and ease of sequencing dramatically to the point where the “$1,000 human genome” is in sight. Armed with complete genome sequences, biologists need to identify the genes encoded within and the variation in these genes between individuals, assign functions to the genes, and put these into functional and metabolic pathways. This course will provide an overview of next-generation sequencing technologies in the historical context of DNA sequencing, the pros and cons of each technology, and the bioinformatics techniques used with this sequence information, beginning with quality control assessment, genome assembly, and annotation. Prerequisites: 410.602 Molecular Biology, 410.633 Introduction to Bioinformatics, 410.634 Practical Computer Concepts for Bioinformatics. S

    Technology Fee: $200.00

    410.666.82 - Next Generation DNA Sequencing and Analysis

    $4322


    Online 1/23 - 5/7

    The recent revolution in DNA sequencing technologies has transformed biology within a few short years, dropping the cost and ease of sequencing dramatically to the point where the “$1,000 human genome” is in sight. Armed with complete genome sequences, biologists need to identify the genes encoded within and the variation in these genes between individuals, assign functions to the genes, and put these into functional and metabolic pathways. This course will provide an overview of next-generation sequencing technologies in the historical context of DNA sequencing, the pros and cons of each technology, and the bioinformatics techniques used with this sequence information, beginning with quality control assessment, genome assembly, and annotation. Prerequisites: 410.602 Molecular Biology, 410.633 Introduction to Bioinformatics, 410.634 Practical Computer Concepts for Bioinformatics. S

    Technology Fee: $200.00

    410.673.81 - Biological Processes in Regulatory Affairs

    $4322

    Michael Manning

    Online 1/23 - 5/7

    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. S

    Technology Fee: $200.00

    410.673.82 - Biological Processes in Regulatory Affairs

    $4322

    Markus Yap

    Online 1/23 - 5/7

    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. S

    Technology Fee: $200.00

    410.673.83 - Biological Processes in Regulatory Affairs

    $4322

    Jamie Austin

    Online 1/23 - 5/7

    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. S

    Technology Fee: $200.00

    410.675.81 - International Regulatory Affairs

    Jonathan Helfgott
    Emil Wang

    Online 1/23 - 5/7

    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: $200.00

    410.676.81 - Food And Drug Law

    $4322

    Loretta Chi

    Online 1/23 - 5/7

    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 1/23 - 5/7

    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 1/23 - 5/7

    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: $200.00

    410.679.82 - Practicum in Regulatory Science

    Thomas Colonna

    Online 1/23 - 5/7

    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: $200.00

    410.680.81 - Finance for Biotechnology

    $4322

    Anthony Schwartz

    Online 1/23 - 5/7

    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.  S

    Technology Fee: $200.00

    410.680.82 - Finance for Biotechnology

    $4322

    Norman Marcus

    Online 1/23 - 5/7

    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.  S

    Technology Fee: $200.00

    410.682.81 - Validation in Biotechnology

    $4322

    Jonathan Helfgott

    Online 1/23 - 5/7

    Understanding validation and applying a comprehensive validation philosophy are essential in today’s biotechnology industry. First and foremost, validation allows a company to operate in compliance with the regulations and guidance set forth by FDA. Perhaps more importantly, it results in equipment assays and processes that are well-understood and robust, less prone to failure, and more cost-effective. This course will introduce the fundamentals of validation, validation master planning, resource management, types of validation and the associated documentation, departmental roles and interaction and the differences between commissioning and validation. Students will have an opportunity to solve real-world problems generate actual validation documents, and develop validation program elements that balance regulatory requirements, operational needs, and business expectations.

    Technology Fee: $200.00

    410.683.81 - Introduction to cGMP Compliance

    $4322

    Nancy Karaszkiewicz

    Online 1/23 - 5/7

    Current Good Manufacturing Practice regulations are the minimum standards for the design, production, and distribute 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 actively enforced by 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

    $4322

    William Roderick Freeman

    Online 1/23 - 5/7

    Current Good Manufacturing Practice regulations are the minimum standards for the design, production, and distribute 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 actively enforced by 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

    $4322

    Katherine Wellman

    Online 1/23 - 5/7

    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 and intellectual property and 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

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

    $4322

    Katherine Wellman

    Online 1/23 - 5/7

    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 and intellectual property and 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

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

    $4322

    James Gould

    Online 1/23 - 5/7

    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 and intellectual property and 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

    410.688.81 - Project Management in Biotechnology

    $4322

    Manojit Basu

    Online 1/23 - 5/7

    Today, many organizations use the approach called project management to handle activities that have a limited life span, as opposed to routine, ongoing operations. This course will answer the question, “What do I do to be successful?” The units will provide guidance for project management success by considering each phase in the life of a typical project, from concept to closeout. We will discuss the nature of project management, the structure of projects, working with teams of technical experts, and all the other activities that make project management different from any other discipline. The course will rely heavily on group discussions. Topics will include deciding what to do, developing a project plan, risk management, team leadership, monitoring and controlling during the project, scope change control, and traditional and modern approaches to project closeout. Concepts presented will be consistent with the Project Management Institute’s “Guide to the Project Management Body of Knowledge,” the U.S. standard for project management.

    Technology Fee: $200.00

    410.689.81 - Leading Change in Biotechnology

    $4322

    Jill Sorensen

    Online 1/23 - 5/7

    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 research bench to the consumer, and strategies to prevent failure will all be discussed.

    Technology Fee: $200.00

    410.690.81 - International Food Regulations

    $4322

    Michelle Wright
    Gavin Smith

    Online 1/23 - 5/7

    As the U.S. food industry expands into international markets, the same companies hoping to sell their products abroad find themselves forced to source ingredients and finished products from foreign suppliers to reduce costs and remain competitive; and to do so, they must comply with a myriad of rules and regulations in both the United States and elsewhere. The most visible enforcement agency at any U.S. border is Customs and Border Protection. However, food importers must also comply with regulations enacted by a host of other government agencies, most notably FDA, USDA Food Safety and Inspection Service, USDA Animal and Plant Health Inspection Service, and U.S. Fish & Wildlife Service. Food exporters have an even tougher burden, as they need to comply with Customs and food safety, quality, and labeling regulations and certification requirements in both U.S. and the country that is receiving the goods; and this is to mention nothing of the international regulatory infrastructure to which manufacturers must adhere when shipping food internationally. This course will cover each step of the importing and exporting process in detail, and explain where to go for key information and guidance.

    Technology Fee: $200.00

    410.700.81 - Food Labeling and Packaging Regulations

    $4322


    Online 1/23 - 5/7

    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

    410.701.81 - Introduction to Food Safety

    Thomas Colonna
    Om Singh

    Online 1/23 - 5/7

    This course is designed to understand the legal and regulatory complexities of the regulation of food products in the United States. The prone issues, including regulatory compliance in food safety and Hazard Analysis and Critical Control points (HACCP), are among major issues to control the food-supply. The FDA and the U.S. Department of Agriculture (USDA) have primary responsibility for safety of meat and food products. Based on the principles of HACCP, FDA-issued seafood regulations effective in December 1997. However, the regulation of food additives, labeling, dietary supplements, genetic modifications, and the protection of the food supply will provide the in-depth food regulation in the United States. The FDA and USDA regulate the safe practice of primary and secondary food products to the American public. Depending upon the source and nature of food product, the method of shipment, advertisement of nutritional values, etc., are being governed by FDA and USDA jurisdictions. The Food Safety Modernization Act overhauls the FDA in food surveillance, enforcing regulations on specific targets, inspection records examination, and exemptions. In this course, students will learn the existing food regulations and safety net by examining the product tracing, performance standards, and preventive control plans toward food safety, security, genetic modifications, dietary supplements, and food labeling. Students will have option to design projects to propose an effective food safety net that can assist in the supply chain of the nation’s food safety and security.

    Technology Fee: $200.00

    410.708.81 - Medical Product Reimbursement

    $4322

    Rochelle Fink

    Online 1/23 - 5/7

    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: $200.00

    410.712.81 - Advanced Practical Computer Concepts for Bioinformatics

    $4322

    Joshua Orvis

    Online 1/23 - 5/7

    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

    410.713.81 - Advanced Genomics and Genetics Analyses

    $4322

    Brandon Higgs

    Online 1/23 - 5/7

    The next generation of array and sequencing technologies provides the ability to investigate large quantities of genomics information with higher sensitivity, greater throughput, and lower costs. This also introduces new challenges in data management, novel algorithmic approaches, and general interpretation. This course builds on the topics in 410.671 Gene Expression Data Analysis and Visualization to address analysis of both genetic variation and genomics content including: splice variants, single nucleotide polymorphisms (SNPs) with family-based and case/control genome-wide association, copy number variation, somatic and germline single nucleotide variants, tumor clonality and ploidy estimates, and transcription factor binding sites. Data types will include array, RNA sequencing, and DNA sequencing (targeted and whole exome) with sequence assembly methods?presented?such as de novo and reference-based.?Prerequisites: 410.602 Molecular Biology, 410.633 Introduction to Bioinformatics, 410.671 Gene Expression Data Analysis and Visualization. S

    Technology Fee: $200.00

    410.715.81 - Medical Device Regulation

    $4322

    David Locke

    Online 1/23 - 5/7

    This course provides a comprehensive introduction to medical devices and how they are regulated by the FDA. Topics that w 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 a mock enforcement action. Upon completion of this course, the student will have a working knowledge of the requirements a policies of FDA regulation of medical devices.

    Technology Fee: $200.00

    410.716.81 - Food Toxicology

    $4322

    Suzanne Fitzpatrick

    Online 1/23 - 5/7

    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. S

    Technology Fee: $200.00

    410.716.82 - Food Toxicology

    Suzanne Fitzpatrick

    Online 1/23 - 5/7

    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. S

    Technology Fee: $200.00

    410.717.81 - Risk Assessment and Management

    $4322

    Calvin Chue

    Online 1/23 - 5/7

    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 the 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

    410.717.82 - Risk Assessment and Management

    Calvin Chue

    Online 1/23 - 5/7

    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 the 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

    410.718.81 - Food Safety Audits and Surveillance

    $4322

    Kantha Shelke

    Online 1/23 - 5/7

    Food safety audits provide a credible verification system to the entire food processing industry including retail environment 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 crisis situation.

    Technology Fee: $200.00

    410.719.81 - Post-market Surveillance of Medical Devices

    $4322

    Carrie Voycheck

    Online 1/23 - 5/7

    While review of devices prior to marketing plays a significant role in ensuring that patients and providers have access to safe and effective medical devices, continued postmarket surveillance of devices after they reach the market is crucial to protecting public health. The Office of Surveillance and Biometrics (OSB) within FDA’s Center for Devices and Radiologic Health (CDRH) is responsible for overseeing the continued postmarket surveillance of medical devices. This course covers regulatory requirements for industry once a device reaches the market as well as the postmarket surveillance requirements and activities performed by FDA. Students will discover the multifaceted approach to medical device postmarket surveillance through topics including: Postmarket Surveillance Studies, 522 Studies, Registries, Medical Device Reporting (MDR) & Complaint Handling, the MedSun Program, Medical Device Tracking, Unique Device Identification (UDI), MDEpiNet, and Real-World Data/Evidence & the National Evaluation System for health Technology (NEST).

    Technology Fee: $200.00

    410.721.81 - In Vitro Diagnostic Regulation

    $4322

    Timothy Alcorn

    Online 1/23 - 5/7

    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: $200.00

    410.732.81 - Funding a New Venture

    $4322

    Norman Marcus

    Online 1/23 - 5/7

    In this course, we study the nuts and bolts of putting together a new company and explore financial markets and the economics of life science companies. The course includes weekly discussions based upon textbook and outside reading materials; the latter are often topical and speak to the issues of the day, and how they may affect investor’s confidence and funding. Video presentations on the part of all students are required. We will examine the roles of corporate officers and the venture community. The students will learn what makes the startup process both attractive and difficult, and will work through that process in a realistic manner.

    Technology Fee: $200.00

    410.753.81 - Stem Cell Biology

    $4322

    Lisa Selbie

    Online 1/23 - 5/7

    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

    410.799.81 - Current Topics in Regulatory Policy

    $4322

    Michael Marcarelli
    David Burrow

    Online 1/23 - 5/7

    The ability to successfully navigate the intersections of law, regulation, guidance, and policy has never been more critical to the success of entities engaged in the medical product development and commercial marketing. The entities that make up this industry are very sophisticated in their abilities to innovate at a blazing speed. In contrast, regulators must us a regulatory model that evolves and adapts much slower than their industry counterparts. As a result, regulators are relying more heavily on policy to drive their strategy, actions, and outcomes. Therefore, a clear understanding of regulatory policy is an essential consideration for individuals engaged in the medical product development industry.

    This course provides introduction into several key areas of government regulatory policy (both old and new) and regulatory science. The topics covered in this course will serve as a road map for students who want to successfully navigate within this complex and change regulatory model.

    Technology Fee: $200.00

    410.802.81 - Independent Studies in Regulatory Science

    $4322

    Thomas Colonna

    Online 1/23 - 5/7

    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

    410.804.81 - Practicum in Biotechnology Enterprise & Entrepreneurship

    $4322

    Eric Langer

    Online 1/23 - 5/7

    This course synthesizes the knowledge and skills acquired in the Masters of 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 Master of Biotechnology Enterprise and Entrepreneurship program.

    Technology Fee: $200.00