Drug discovery and development is offered as a concentration within the professional science master's program described under Business and Science 137. The objective of the master of business and science degree with a concentration in drug discovery and development is to provide broad-based training for students in the area of drug discovery, drug development, regulatory affairs, and clinical trials management. Students will learn about the workings of the pharmaceutical development process and will acquire analytical and communication skills suitable for managerial and staff positions in laboratory and clinical research, clinical trials, contract research organizations, federal agencies for regulatory affairs (e.g., the Food and Drug Administration), and pharmaceutical marketing.
All students in the drug discovery and development concentration must take the following courses:
16:115:512 Molecular Biology and Biochemistry (3) or 16:148:514
Molecular Biology of Cells (3)
16:137:510 Drug Development from
Concept to Market (3) or 16:137:501 Fundamentals of Intellectual
Property (3)
16:137:511 Drug Discovery through Preclinical Development (3)
16:137:580 Practical Aspects of Clinical Trial Design/Conduct (3)
16:137:581 Statistics in Clinical and Translational Research (3)
16:137:583 Ethics and Regulations in Clinical Research (3)
Course Descriptions
16:137:501 Fundamentals of Intellectual Property (3)
Fundamentals of intellectual property, with a major emphasis on patents. Topics include invention and entrepreneurial spirit, patent creation process, patent classifications and prior art search, and technology transfer, licensing, and commercialization.
16:137:510 Drug Development from Concept to Market (3)
An introduction to the drug development process in the context of its scientific, economic, legal, and regulatory aspects. Student teams will develop industry specific teamwork and oral and written communication skills through a progressive competitive marketing analysis of an assigned therapeutic area. Analysis of the methods of the drug development pipeline from target selection through clinical trials and marketing, employing expert guest lecturers from different stages of the developmental process, and a team problem based approach. Basics of: 1) the developmental pipeline for small molecule and biological drugs; 2) economic aspects of small molecular and biological drug development; and 3) intellectual property and regulatory issues at transitional phases in the development process. Analysis of potential markets; communicating findings to decision makers.
16:137:511 Drug Discovery through Preclinical Development (3)
How pharmaceutical and biotechnology companies discover, develop, and characterize new drug candidates for clinical trials. The development of small molecule and biological drugs and the discovery path from target selection and identification of a potential candidate to the preclinical characterization of the drug necessary for the development of an IND for clinical trials. Critical steps involved in the discovery and optimization of the drug and managerial challenges at each point in the pathway. This problem-based course will involve industry partnerships in which student teams will research and identify potential drug targets in one or more therapeutic areas to develop a case study of how a specific drug was developed for a therapeutic condition.
16:137:580 Practical Aspects of Clinical Trial Design/Conduct (3)
Design, analysis, and interpretation of clinical research studies. A fundamental distinction in evidence-based medicine is between observational studies and randomized controlled trials. A randomized controlled trial is the study design that can provide the most compelling evidence that the study treatment causes the expected effect on human health. Designing randomized controlled trials. Taught in cooperation with the University of Medicine and Dentistry of New Jersey.
16:137:581 Statistics in Clinical and Translational Research (3)
Basic statistical terms and concepts. Epidemiologic methods to examine the benefits and risks of medications. Use of standard statistical packages. Random variation and bias. Applications of biostatistical methods to problems in medicine and public health; pitfalls in interpreting biomedical and public health data.
16:137:582 (S) Fundamentals of Regulatory Affairs (3)
Laws, regulations, and regulatory agencies governing pharmaceuticals, devices, biologics, and combination products marketed in the United States (Food and Drug Administration) and in the world.
Other electives can be found at: http://psm.rutgers.edu.
Concentration Coordinator:
Professor Charles Martin
martin@biology.rutgers.edu
|
