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Actuarial Sciences
African Studies 016
Anthropology 070
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Atmospheric Science 107
Biochemistry 115
Biomedical Engineering 125
Biotechnology 126
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Business and Science 137
Required Courses in Business and Management
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Actuarial Sciences Concentration
Biotechnology and Genomics Concentration
Chemistry and Personal Care Chemistry Concentration
Drug Discovery and Development
Engineering Management Concentration
Geospatial Information Systems and Technology Concentration
Horticulture and Turgrass Science Concentration
Information Technology Concentration
International Agriculture Concentration
Kinesiology and Applied Physiology Concentration
Quality and Reliability Engineering Concentration
Sustainability Concentration
Cell and Developmental Biology 148
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Chemistry and Chemical Biology 160
Chemistry and Personal Care Chemistry
Chinese 165
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Civil and Environmental Engineering 180
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Cognitive Science 185
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College and University Leadership 187
Communication, Information and Library Studies 194
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Comparative Literature 195
Computational Biology and Molecular Biophysics 118
Computer Science 198
Cultural Heritage and Preservation Studies (CHAPS)
Curatorial Studies
Drug Discovery and Development
Ecology and Evolution 215
Economics 220
Education 300
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Electrical and Computer Engineering 332
Endocrinology and Animal Biosciences 340
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Engineering Management
English, Literatures in (English 350, Composition Studies 352)
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Entomology 370
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Interdisciplinary Ph.D. Program 554
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Mathematics 640, 642, 644
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Medieval Studies 667
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Microbiology and Molecular Genetics 681
Molecular Biophysics 696
Molecular Biosciences 695
Music 700
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Oceanography 712
Operations Research 711
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Pharmaceutical Science 720
Pharmaceuticals and Clinical Trials Management 725
Pharmacology, Cellular and Molecular 718
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Physiology and Integrative Biology 761
Planning and Public Policy 762
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Political Science 790
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Russian, Central and East European Studies 859
Science and Technology Management 885
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Spanish 940
Statistics and Biostatistics 960
Financial Statistics and Risk Management 958
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Women's and Gender Studies 988
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Camden Newark New Brunswick/Piscataway
  Graduate School–New Brunswick 2010–2012 Programs, Faculty, and Courses Business and Science 137 Drug Discovery and Development  

Drug Discovery and Development

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:

Concentration Coordinator:

Professor Charles Martin

For additional information, contact RU-info at 732-445-info (4636) or
Comments and corrections to: Campus Information Services.

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