This application requests continued support for the predoctoral training program in biotechnology at The University of Kansas-Lawrence Campus. This program trains pharmaceutical scientists qualified to conduct the types of physico-biochemical research (e.g., formulation, delivery, analysis) necessary to develop biotechnology products into useful therapeutic and diagnostic agents. The pharmaceutical industry in the United States is heavily dependent on biotechnology as a source of new drug entities. A major obstacle to commercialization of these entities is the development of safe and efficacious dosage forms. For the past 30 years the Department of Pharmaceutical Chemistry at the University of Kansas has had an internationally recognized program for training pharmaceutical scientists capable of handling the development of dosage forms for conventional drugs. In the mid 1980's the department recognized the need to train pharmaceutical scientists who were capable of properly handling the development of biotechnology products. Therefore, a multidisciplinary, multidepartmental predoctoral training program was developed which included faculty from he Departments of Pharmaceutical Chemistry, Molecular Biosciences, Chemistry, and Chemical Engineering. Trainees are required to satisfy the basic requirements for the Ph.D. degree in their home department. In addition, the trainees elect to pursue an analytical, delivery, formulation or self designed area of specialization which will give them more intense training in their area of emphasis. All trainees are required to take courses in molecular biology, pharmaceutical biotechnology and scientific integrity. In addition, all trainees are required to participate in a monthly Biotechnology Seminar Series and experience an internship (minimum of 3 months) in a pharmaceutical or biotechnology company. Major changes in the program since its last renewal include (1) the addition of a trainee/mentor designed area of specialization, (2) the inclusion of a required special topics course designed to widen student exposure to other areas of biotechnology and (3) expansion of course offerings in molecular biology. The trainees' dissertation research and industrial experience focus on basic research related to the formulation, delivery or analysis of biotechnology products. Students successfully completing this program have the expertise to assist in the development of biotechnology-derived drug candidates into agents useful in clinical and diagnostic medicine and are, therefore, highly recruited by the pharmaceutical industry.
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