Course Descriptions
Principles of Pharmacodynamics and Pharmacokinetics
The goal of this course is to illuminate the fundamentals of pharmacology and clinical therapeutics by focusing in-depth on the principles of drug receptor interactions and the means of drug absorption, distribution, elimination and biotransformation. It includes physiochemical and biological factors affecting drug action and the physical and physiological conditions to be considered in drug formulations.
Pharmacogenomics
Personalized drug therapy, wherein the choice and dose of drugs are based on the patient’s genetic make-up, is plausible, if not yet a reality. This course concerns knowledge of the human genome that provides insight into patient-specific characteristics affecting drug efficacy, drug metabolism, and adverse drug reactions.
Principles of Immunology
This course is directed at an understanding of how the immune system recognizes foreignness outside and inside the body; the tissue damaging consequences of the immune system when it fails to distinguish between non-self and self and the value of immunological reagents in diagnosis and treatment of disease
Principles of Molecular Biotechnology
The purpose of this course is to introduce the field of molecular biology and the current methods of investigation. Emphasis is placed on product development, e.g. recombinant DNA applications, gene therapy, and products from transgenic animals.
Preclinical Product Evaluation
This course introduces approaches to preclinical drug, device and biologicals evaluation methods including in vitro, in silico, and animal models of human toxicity. Emphasis is placed on study protocols required by U.S. and international regulatory agencies.
Managing Information for Executive Decision Making
This course provides an overview of the theories, practices, and technologies used in the management of information systems for business decision-making. Topics include use of information systems, electronic business, business intelligence tools and knowledge management, customer relationship management systems, data warehousing, virtual teams and organizations, and information security and privacy, and their role in improving organizational decision-making capabilities
Accounting Fundamentals
This course is an introduction to financial accounting cycles and transactions, financial statement reporting, and internal managerial accounting and costing, and is designed to provide an understanding of accounting systems.
Ethical Issues in Scientific Research
This is a discussion of the ethical dilemmas encountered in the course of research including the role of trust in knowledge, the responsibility to be competent, authorship issues, conflict of interest, protection of human research subjects, and obligations in research on animals.
Legal and Ethical Issues in High Technology Environments
This course explores the legal and ethical issues affecting the operation of business in the high technology, networked, environment. It includes the interrelationship of ethics and law, the duties of directors and managers, and decision-making under uncertain regulatory parameters, and matters of intellectual property.
Biomaterials
This course covers the basic mechanical and immunological properties of biomaterials used in medicine and dentistry and includes considerations of the properties of natural hard and soft tissues; metallic, ceramic, and polymeric materials; and related implanted devices.
Manufacturing Processes
This is a survey of manufacturing processes, including casting, forming, machining, joining, and nontraditional processes such as laser and electrical discharge machining, as well as topics in product design, material selection, process planning, and manufacturing automation.
Drug Discovery and Product Development
This course is comprised of a series of seminars by specialists in drug discovery and development areas concerning both therapy and diagnostics. It is focused on the scientific, clinical, economic and regulatory processes as well as stewardship involved bringing a drug from the laboratory to the marketplace.
Medical and Diagnostic Device Design
This course is comprised of a series of seminars by specialists in medical device engineering and development. It covers a wide spectrum of devices from imaging systems and integrated surgical platforms to health enterprise networks to microscale implantable devices. The course includes discussions on the economic and regulatory processes involved in bringing a device from the research laboratory to the marketplace.
Biologicals Discovery and Development
This course is comprised of a series of seminars by specialists in discovery, development and regulation of biological products. Topics include blood and tissue products, cellular and gene therapy, vaccines, diagnostic test kits for infectious diseases, and allergen extracts and test patches.
Design and Conduct of Clinical Trials
Topics addressed in this course include: clinical trial designs for phases I, II, and III, randomization principle and procedures, blinded and unblinded trials, study population, inclusion and exclusion criteria decisions, recruitment of participants, data collection and analysis, and adverse event assessment. Particular emphasis is placed on protection of the human research subject, the role of the institutional review board and the data safety monitoring board, and the Common Rule governing conduct of research in human subjects.
Drug, Device and Biologicals Regulation
The focus of this course is on the laws and regulations governing development, manufacture and marketing of drugs, biological and medical device products. Topics discussed include both U.S. and international regulatory requirements, and the harmonization of laws, regulations and standards between and among trading partners.
Computational Biology
This course introduces basic mathematical and computational tools as applied to bioinformatics, computational biomodeling, and systems biology.
Program Management and Project Leadership
This course introduces the fundamentals of program and project management, beginning with project definition and culminating in the post-project review. Topics include: techniques, terms, and guidelines that are used to manage cost, schedules, risk, group dynamics, and technical aspects throughout the life cycle of a project.
Modeling Decision Making for Competitive Advantage
This course examines a number of topics in management science and their applications in dealing with managerial problem solving. Decision theory and optimization techniques such as decision-trees, linear programming, integer programming, networks and others are studied, modeled and solved from a managerial and applied perspective. Business and industry cases are used to demonstrate usefulness and effectiveness of the models constructed.
Principles of Financial Management
The goal of this course is to provide an understanding of the basic principles and concepts underlying the finance function, and the analytical tools for making financial decisions. The specific topics covered are Goals of a Corporate Firm and Agency Problem, Cash Flow Estimation and Financial Statement Analysis, Financial Assets and Markets, Time Value of Money, Risk and Return, Diversification and Capital Asset Pricing Model, Valuation of Stocks and Bonds, and Market Efficiency.
Leadership and Innovation in a Technology Environment
This course takes a general manager's perspective to examine the challenges of managing technology and innovation and their impacts on organizations. It provides students with a solid understanding of key concepts, tools, and frameworks useful in managing technology and innovation. Cases will also be used as a device for developing analytical and decision-making skills and for highlighting the reality of organizational and environmental complexities in managing technology and innovation.
Seminar in Current Business Issues
This course addresses current issues in business. Topics include theoretical, conceptual and practical concerns in business related functions such as accounting, information systems and technology, finance, management or marketing.
Team Assessment Project
The capstone project for the degree is the Team Assessment Project. Students work in teams of two or more, each track being represented on the team. The team as assigned a company, which it evaluates from the scientific and business profile of one of company’s products. Assessments to be made will include: innovation, efficacy, expected product lifespan, regulatory issues, risk of adverse events leading to litigation or market withdrawal, investment cost, financing structure, ROI, and potential “Hatch-Waxman” patent issues.
