Explores the key responsible conduct of research topics that are the foundation of scientific integrity. Through reading assignments, learning modules, simulations, cases studies, role-play, and a team project, students learn about, discuss, and debate the ethical dilemmas and challenges research scientists encounter. NOTE: This online course does not fulfill requirements for participation in NIH-sponsored research. Students interested in conducting NIH-sponsored research should instead enroll in IDPT 500S Responsible Conduct of Research.

College/Department: COM School of Biomedical Sciences & Professional Studies

Repeat Status: Not repeatable for credit

This two credit course is offered twice a year, one evening a week. It is presented using lecture, discussion and problem-based curriculum approaches, with associated required readings in texts. Some topics additionally require web-based exercises and quizzes. Graduate students, postdoctoral researchers and faculty discuss current issues of scientific integrity that all scientists encounter in their research. Solutions to hypothetical and real research challenges and ethical dilemmas are discussed and debated by trainees and faculty. Course sessions and discussions are led by a team of faculty leaders, including department head, deans and provosts. Grades are based on quizzes, class participation, web-based exercises, a term paper and a PowerPoint presentation.

College/Department: COM School of Biomedical Sciences & Professional Studies

Repeat Status: Can be repeated 1 times for 4 credits

Introduces the fundamental aspects of normal eukaryotic cell structure, function, and the processes that control cell growth and communication. Emphasis is on cellular macromolecules (i.e., proteins, nucleic acids, polysaccharides and membranes) and how normal cellular processes and regulatory mechanisms can be dysregulated in disease states, such as cancer and infections. Will provide the scientific foundations that can be applied to biomedical innovation and discoveries.

College/Department: COM School of Biomedical Sciences & Professional Studies

Repeat Status: Not repeatable for credit

Introduces students to the different stages of the biomedical technology development and commercialization process from ideation or discovery through its delivery to the hands of consumer. Emphasis is given primarily to FDA-regulated biomedical products (i.e., drugs, devices, and diagnostics).

College/Department: COM School of Biomedical Sciences & Professional Studies

Repeat Status: Not repeatable for credit

An interdisciplinary capstone course. Students select a biomedical technology, and apply concepts and skills learned throughout the program to develop a full-length technology development and commercialization plan. Students are expected to conduct significant independent research throughout the course to complete this project.

College/Department: COM School of Biomedical Sciences & Professional Studies

Repeat Status: Not repeatable for credit

Prerequisites: MIIM 518S [Min Grade: B] and MIIM 519S [Min Grade: B]

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This class explores the legal and ethical issues surrounding the development of new biological technologies. Topics may include the research bioethics, assisted reproductive technology, genetics, issues surrounding death and dying, and organ transplantation.

College/Department: Thomas R. Kline School of Law

Repeat Status: Not repeatable for credit

Explores the key responsible conduct of research topics that are the foundation of scientific integrity. Through reading assignments, learning modules, simulations, cases studies, role-play, and a team project, students learn about, discuss, and debate the ethical dilemmas and challenges research scientists encounter. NOTE: This online course does not fulfill requirements for participation in NIH-sponsored research. Students interested in conducting NIH-sponsored research should instead enroll in IDPT 500S Responsible Conduct of Research.

College/Department: COM School of Biomedical Sciences & Professional Studies

Repeat Status: Not repeatable for credit

This course will begin to help students "think like lawyers" by providing an overview of the United States legal system. It will explain the legislative and judicial processes, so that students will gain an understanding of where the power to regulate originates and the basis of federal law and regulations. The course will then focus on substantive areas of the law, such as torts, contracts, and criminal law.

College/Department: Thomas R. Kline School of Law

Repeat Status: Can be repeated 1 times for 6 credits

The focus of this course will be the privacy and security provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the foundation for federal protections of health care information. Additionally, the course will examine the interplay between HIPAA and other federal and state health privacy laws and the application and enforcement of those laws in a variety of health care settings. The class will incorporate discussions about the close and evolving relationships among health care policy, evolving social norms, and health privacy laws.

College/Department: Thomas R. Kline School of Law

Repeat Status: Not repeatable for credit

Restrictions: Can enroll if major is CHCC or major is LSTU

An intensive introduction to statistical methods. Students learn to apply principles of statistical reasoning, underlying assumptions, and careful interpretation of results. In addition, students learn how to present statistical data within various contexts applicable to the field of biomedicine, such as laboratory research, scientific publications, bioethics, intellectual property, business decisions, entrepreneurship, and visual representation of data. Students will use statistical software to supplement learning and applications of statistics.

College/Department: COM School of Biomedical Sciences & Professional Studies

Repeat Status: Can be repeated 2 times for 6 credits

Introduction to the theory of probability, frequency distribution, correlation's and regression analysis, probability, chi-square and analysis of variance, applications of statistics in the laboratory.

College/Department: COM School of Biomedical Sciences & Professional Studies

Repeat Status: Can be repeated 9 times for 999 credits

A seminar series on diverse topics in biomedicine, public health, technology commercialization and entrepreneurship. Faculty and students meet in an informal way to discuss selected subjects, hear guest speakers or discuss scholarly articles and current news. The topics will vary by session, and range from current events in the biomedical industry, to various aspects of new product development, commercialization, entrepreneurship, and/or technical aspects of new discoveries.

College/Department: COM School of Biomedical Sciences & Professional Studies

Repeat Status: Can be repeated 3 times for 12 credits

Provides practical experience in various areas related to biomedicine (e.g., research, business, entrepreneurship, law, digital media, public health). Students participate in planning and selecting the type of experiential learning that best fits their career plans and professional needs.

College/Department: COM School of Biomedical Sciences & Professional Studies

Repeat Status: Not repeatable for credit

This is an open forum for students, faculty and guest speakers to discuss career paths in biomedicine. It will explore traditional biomedical careers such as academia, biotechnology and private industry, as well as less traditional career paths such as bioentrepreneurship, intellectual property law, biomedical communications and media, among others. Students will also have an opportunity to work on their resumes and other job-readiness skills.

College/Department: COM School of Biomedical Sciences & Professional Studies

Repeat Status: Can be repeated 3 times for 8 credits

Topics decided upon by faculty will vary within the area of study.

College/Department: COM School of Biomedical Sciences & Professional Studies

Repeat Status: Can be repeated multiple times for credit

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The goal of this course is to focus on the various trends that impact the research and development process inherent in the medical device industry. Case studies representing several therapeutic categories will be discussed from a business, medical scientific, ethical, regulatory and bio-medical engineering perspective.

College/Department: COM School of Biomedical Sciences & Professional Studies

College/Department: COM School of Biomedical Sciences & Professional Studies

Repeat Status: Not repeatable for credit

College/Department: COM School of Biomedical Sciences & Professional Studies

Repeat Status: Not repeatable for credit

This course introduces regulatory responsibilities of clinical investigators, sponsors, monitors, IRBs, FDA -all those parties intimately involved in clinical research. Information and exercises are designed to reinforce the elements of Good Clinical Practices.

College/Department: COM School of Biomedical Sciences & Professional Studies

Repeat Status: Not repeatable for credit

This course teaches the medical professional the ability to read for understanding, and evaluate validity of information a medical or scientific paper. In addition, the student learns how to recognize various types of medical literature and the basics of how to perform a review of the medical literature.

College/Department: COM School of Biomedical Sciences & Professional Studies

Repeat Status: Not repeatable for credit

College/Department: COM School of Biomedical Sciences & Professional Studies

Repeat Status: Not repeatable for credit

Presents principles and practices of the Federal Food, Drug and Cosmetic Act governing the research and development of pharmaceuticals and biologics for both humans and animals including an analysis of legal and social constructs affecting industry and the academic clinical investigator with emphasis on FDA enforcement actions.

College/Department: COM School of Biomedical Sciences & Professional Studies

Repeat Status: Not repeatable for credit

This course focuses on measuring and improving clinical trial performance as a means of saving time and money, while ensuring quality health care, as well as offering to patients both safe and effective therapeutic products. Students are required to develop milestone efficiencies through the use of process-performance data.

College/Department: COM School of Biomedical Sciences & Professional Studies

Repeat Status: Not repeatable for credit

Designers and ethical, clinical, strategic issues surrounding clinical drug research are the focus of this course. Topics include design of trials for Phases one though four, an overview of the statistical component of a clinical trial, monitoring of the trial, and managing clinical data.

College/Department: COM School of Biomedical Sciences & Professional Studies

Repeat Status: Not repeatable for credit

Prerequisites: CR 515S [Min Grade: C]

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The first of a three-part course series, which provides a foundation in essential topics in biochemistry, cellular and molecular biology and genetics. Focuses on macromolecules (i.e., proteins, nucleic acids, polysaccharides and membranes) and their microenvironment within the eukaryotic cell. It is recommended that students also enroll in MIIM 534S Molecular Medicine Journal Club I for practical application of concepts learned in the analysis and interpretation of original scientific research and data.

College/Department: COM School of Biomedical Sciences & Professional Studies

Repeat Status: Not repeatable for credit

Introduces basic concepts of eukaryotic cell organization and function, with emphasis on macromolecules (i.e., proteins, nucleic acids, polysaccharides and membranes) and their microenvironment. Will provide a foundation to normal body functions at the cellular and molecular level.

College/Department: COM School of Biomedical Sciences & Professional Studies

Repeat Status: Not repeatable for credit

The second of a three-part course series, which provides a foundation in essential topics in biochemistry, cellular and molecular biology and genetics. Focuses on processes that control eukaryotic cell growth and function, with emphasis on biochemical pathways and regulatory mechanisms, cell cycle, and cellular communication mechanisms. It is recommended that students also enroll in MIIM 533S Molecular Medicine Journal Club II for practical application of concepts learned in the analysis and interpretation of original scientific research and data.

College/Department: COM School of Biomedical Sciences & Professional Studies

Repeat Status: Not repeatable for credit

Prerequisites: MIIM 530S [Min Grade: B]

Introduces basic aspects of fundamental eukaryotic cellular processes that control cell growth and function, with emphasis on biochemical pathways and regulatory mechanisms, cell cycle, intracellular trafficking networks, and cellular communication mechanisms. Will provide a foundation to normal cellular processes that are dysregulated in disease states such as cancer and infections.

College/Department: COM School of Biomedical Sciences & Professional Studies

Repeat Status: Not repeatable for credit

Introduction to the journal club format of in depth discussion of published primary scientific literature. Develop skills to analyze, interpret and represent scientific data in various topics in biochemistry, molecular biology and genetics, with emphasis on mammalian cells. Discussion topics are aligned with topics discussed in MIIM 530S Fundamentals of Molecular Medicine I.

College/Department: COM School of Biomedical Sciences & Professional Studies

Repeat Status: Can be repeated 1 times for 2 credits

In depth discussion of published primary scientific literature. Develop skills to analyze, interpret and represent scientific data in various topics in biochemistry, molecular biology and genetics, with emphasis on mammalian cells. Discussion topics are aligned with topics discussed in MIIM 531S Fundamentals of Molecular Medicine II.

College/Department: COM School of Biomedical Sciences & Professional Studies

Repeat Status: Can be repeated 1 times for 2 credits

A review of the molecular, cellular and computational methods that underlie modern biotechnology, drug discovery and development. The focus is on experimental techniques used to manipulate nucleic acids and to research the interaction of proteins with nucleic acids. Strengths and limitations of the procedures are considered, and their suitability for either a basic or industrial research setting evaluated. Complements MIIM 522S Biotechniques II.

College/Department: COM School of Biomedical Sciences & Professional Studies

Repeat Status: Not repeatable for credit

A review of current immunologically-based experimental techniques and how they are applied to many different areas of research. Provides basic information central to the concepts and techniques pertinent to the study of immunology, the analysis of immune responses, and development of vaccines. Complements MIIM 521S Biotechniques I.

College/Department: COM School of Biomedical Sciences & Professional Studies

Repeat Status: Not repeatable for credit

Introduces fundamental concepts in molecular virology through presentation and discussion of viruses that cause disease in humans. Students learn about important aspects of virus infection, including virus structure, replication, molecular pathogenesis, antiviral immune responses, the development of antiviral drug therapies, and the use of viruses in gene therapy. Students also learn to read and critically evaluate virology-related papers published in the primary literature.

College/Department: COM School of Biomedical Sciences & Professional Studies

Repeat Status: Not repeatable for credit

Introduces fundamental concepts in bacteria and the infections they cause, including microorganism structure and replication, pathogenesis and treatment.

College/Department: COM School of Biomedical Sciences & Professional Studies

Repeat Status: Not repeatable for credit

Introduces basic aspects of the biology of fungi and fungal infections, such as fungal cell structure, function, replication, pathogenesis, and their impact on humans. Antifungal agents; mode of action and molecular mechanism of resistance are also discussed.

College/Department: COM School of Biomedical Sciences & Professional Studies

Repeat Status: Not repeatable for credit

Introduces basic aspects of the biology of parasites and parasitic infections, including microorganism structure, replication and pathogenesis, as well as public health and economic impact of parasitic infections. Antiparasitic drug and vaccine development are also discussed. Primary literature is also read and discussed.

College/Department: COM School of Biomedical Sciences & Professional Studies

Repeat Status: Not repeatable for credit

Introduces known human pathogens that cause infectious diseases of major public health importance. Bacterial, fungal, parasitic, and viral pathogens are comprehensively overviewed, with an emphasis on their transmission, pathogenesis, clinical presentation, prevention, and treatment. Learning materials and approaches are derived from the scientific literature and the medical school curriculum. Offers opportunities for primary literature discussions and evaluation of clinical case studies.

College/Department: COM School of Biomedical Sciences & Professional Studies

Repeat Status: Not repeatable for credit

This course will provide a comprehensive introduction to Medical Immunology. The basis for the course will be the recorded video of the medical immunology lectures delivered to the medical students, which will be accessed and viewed by the enrolled students during the weeks identified in the schedule. At the end of each week, a review and discussion period (3 hours) will be moderated by one or more faculty members familiar with the material covered by the lectures viewed during the week.

College/Department: COM School of Biomedical Sciences & Professional Studies

Repeat Status: Not repeatable for credit

Faculty and students meet in an informal way to discuss selected subjects, hear guest lecturers or explore topics related to the biomedical sciences of interest to the group.

College/Department: COM School of Biomedical Sciences & Professional Studies

Repeat Status: Can be repeated multiple times for credit

In depth discussion of the emergence and spread of infectious agents, including species jumping, mutation and global transport. Learn about recently emerged pathogenic agents as well as possible future outbreaks or reemergence of viral, bacterial, parasitic and novel agents.

College/Department: COM School of Biomedical Sciences & Professional Studies

Repeat Status: Not repeatable for credit

This course will serve as an advanced learning experience to correlate the basic aspects of infection with the clinical aspects of diagnosis and treatment. The course will introduce concepts that relate to understanding how the clinical aspects of infectious diseases can be translated into basic research.

College/Department: COM School of Biomedical Sciences & Professional Studies

Repeat Status: Not repeatable for credit

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Reproductive rights have been a central and sometimes divisive topic in our country's recent history. This seminar will explore the legal regulation of human reproduction through caselaw and a variety of theoretical frameworks. It will consider constitutional, bioethical, moral, religious, and social issues around birth control, abortion, cloning, and embryonic selection.

College/Department: Thomas R. Kline School of Law

Repeat Status: Not repeatable for credit

This course examines the major federal and state legislation for providers who seek reimbursement under governmentally funded health care programs including the Medicare and Medicaid Anti-Kickback statute, the False Claims Act, and the Stark I and Stark II legislation and regulations.

College/Department: Thomas R. Kline School of Law

Repeat Status: Not repeatable for credit

This course will examine the entrepreneurial process and the role of law in entrepreneurship. In context of a start-up formation, the course will consider intellectual property, tax, and employment law, business regulation, and the formation and financing process. Students will develop a basic understanding of the substantive legal regimes affecting these areas and assess the impact of these regimes on entrepreneurial activity and economic growth.

College/Department: Thomas R. Kline School of Law

Repeat Status: Not repeatable for credit

This course examines all aspects of medical errors and quality in health care, including malpractice suits, licensing, staff privileging of doctors, and current regulatory approaches. It will also look at issues of patient rights and autonomy, including consent, medical information, clinical research, and issues in death and dying.

College/Department: Thomas R. Kline School of Law

Repeat Status: Not repeatable for credit

This course examines the history of the American health care system and will consider the tensions between costs and the access to care. Topics will include the federal Medicare and Medicaid systems, cost controls through health insurance and federal regulation, antitrust issues, ERISA, EMTALA, and other federal regulatory regimes.

College/Department: Thomas R. Kline School of Law

Repeat Status: Not repeatable for credit

This course will use case studies to examine regulatory choices in health care. The course will first examine the tools available to regulators in the U.S. health care system. The course will then consider regulatory strategies that a regulator might consider to handle several case studies.

College/Department: Thomas R. Kline School of Law

Repeat Status: Not repeatable for credit

Prerequisites: LAW 780S

This class will consider basic economic concepts related to health care finance and private insurance.

College/Department: Thomas R. Kline School of Law

Repeat Status: Not repeatable for credit

This course explores the regulatory entities and schemes governing the research and development, management, financing, and reporting requirements of clinical trials in the pharmaceutical and life sciences sectors. Topics include the role of the Institutional Review Board, compliance with Good Clinical Practice standards, informed consent, pharmacovigilance and the protection of human research subjects, payments and financial transparency, conflicts of interest, ethical considerations in designing and executing clinical trials, and reporting requirements.

College/Department: Thomas R. Kline School of Law

Repeat Status: Not repeatable for credit

This course explores the law governing pharmaceutical and medical device sales and marketing practices, including product pricing, advertising, labeling, promotion and distribution. Topics may include identification of the entities regulating pharmaceutical and medical device manufacturers, disclosure and transparency requirements, payments to doctors and institutions, fraud and abuse, anti-bribery laws, direct-to-consumer advertising including internet advertising, off-label marketing and promotion, labeling over-the-counter (OTC) drugs, and limitations on the government’s ability to regulate commercial speech.

College/Department: Thomas R. Kline School of Law

Repeat Status: Not repeatable for credit

This course covers medical liability issues arising from the treatment relationship between health care providers and their patients. Topics include the history of the medical malpractice tort, its evolution as a "crisis," informed consent, the framework for a medical malpractice lawsuit, and an analysis of proposals for medical malpractice reforms.

College/Department: Thomas R. Kline School of Law

Repeat Status: Not repeatable for credit

This course considers the federal regulation of products subject to FDA jurisdiction, including food, human prescription and nonprescription drugs, animal feed and drugs, biologics and blood products, medical devices, and cosmetics. The course examines the public policy choices underlying the substantive law, FDA enforcement power, and agency practice and procedure.

College/Department: Thomas R. Kline School of Law

Repeat Status: Not repeatable for credit

The goal of this course is to provide students with the tools necessary to perform effective legal research in all areas of health care law. Students will learn how to use electronic and print resources and techniques to research health law statutes, legislative history, case law, regulations, and literature, as well as medical and health sciences information. Overviews and explanations of research tools and sources will be given.

College/Department: Thomas R. Kline School of Law

Repeat Status: Not repeatable for credit

Prerequisites: LAW 565S and LAW 566S

This is a skills course that provides students opportunities to develop internal audit skills and strategies, conduct internal investigation work plans, and draft executive level communications. The skills taught will include work plan development, investigative techniques, interviewing methods, class presentations, and drafting of projects plans and board/executive level reporting.

College/Department: Thomas R. Kline School of Law

Repeat Status: Not repeatable for credit

Restrictions: Can enroll if major is CHCC or major is CHEC or major is CHRC or major is CNCA or major is CRMM or major is LSTU

Students will learn how to research topics and distill their research in written form through a series of exercises. They will also be expected to complete numerous written communications of increasing length and complexity. Detailed feedback will be provided on all written exercises by the professor.

College/Department: Thomas R. Kline School of Law

Repeat Status: Not repeatable for credit

Restrictions: Can enroll if major is CHCC or major is CNCA or major is LSTU

This course is designed to provide students with an understanding of the laws and regulations encountered by compliance professionals. The course will equip students to apply statutory and regulatory principles to situations that they will encounter in their work.

College/Department: Thomas R. Kline School of Law

Repeat Status: Not repeatable for credit

Restrictions: Can enroll if major is LSTU

This course will examine methods and tools for managing quality in health facilities, physician practices, managed care, and public health; including developments in quality assurance and improvement, utilization review, risk management, and patient satisfaction.

College/Department: Thomas R. Kline School of Law

Repeat Status: Not repeatable for credit

Restrictions: Can enroll if major is CHCC or major is CNCA or major is LSTU

Risk assessment and management has become a crucially important field for private sector business as well as government sector agencies and organizations, particularly over the past decade following the passage of laws such as Sarbanes-Oxley and Dodd-Frank. This course will examine regulatory compliance and risk management issues that impact various corporate and governmental entities, providing students the opportunity to explore risk analysis and compliance in a variety of legal environments. This course will help familiarize students with issues that might arise in corporate risk management departments, contracts departments, risk management consulting, and the regulatory compliance departments of financial services industries, banking, insurance, credit, risk assessment, and benefits management.

College/Department: Thomas R. Kline School of Law

Repeat Status: Not repeatable for credit

Restrictions: Can enroll if major is CHCC or major is CHEC or major is CHRC or major is CNCA or major is CRMM or major is LSTU

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This course will define failure, analyze the causes of it, and present students with a framework they can use to help them be better prepared for learning from failure in order to drive the entrepreneur's level of entrepreneurial preparedness for further enterprising activities. Through a series of in-depth reflections of personal and professional "failures" and challenges, graduate students will develop a portfolio of resilience mechanisms to better prepare them for an entrepreneurial life.

College/Department: Close School of Entrepreneurship-3145

Repeat Status: Not repeatable for credit

This course provides students with tools, methods, and self-reflection techniques necessary to bring new ideas to reality while also providing them with ways to learn about how to test the viability of and response to their ideas in the market. Learning through iteration is a key component of this course as it is expected that the first version of any idea is not likely the last. Human-centered design methodologies will be front-and-center in this course from the perspective of how to innovate based not on the ideas of the innovator but based first on the needs of the customer. This course reviews the importance of innovation, not only in new products and services, but also in the underlying business models where unexpected sources of innovation can be found.

College/Department: Close School of Entrepreneurship-3145

Repeat Status: Not repeatable for credit

This course develops skills that are important for students who are interested in pursuing careers in an entrepreneurial setting and corporate venture activities. This course should be of interest to anyone who wants to develop their entrepreneurial thinking on various innovation approaches.

College/Department: Close School of Entrepreneurship-3145

Repeat Status: Not repeatable for credit

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