Instructor: Paul Naylor
Course Time: TR 3:30-5:17 PM
General Education: Natural Science and Technology
Term: Winter 2014

Course Description:
Pharmaceutical Companies and the NIH have defined a new paradigm (Translational Research) which represents the integration of basic, applied and clinical research. The primary difficulty faced in successful translational research is the integration of two traditionally separate scientific fields ( basic and applied research) into a multidisciplinary and cross functional team focused on drug development. The objective of this course would be to explore facets of preclinical and clinical issues that are required for successfully developing a drug from concept (bench) through clinical trial (bedside) and ultimately to approval.

Topics will include, relationships between discovery, preclinical and clinical studies, information required for successful IND application to the FDA, and clinical trial design and execution. Important skills that will be learned include experimental design for preclinical and clinical studies, genomics studies and population selection for optimal response and orphan drug development, understanding of educational and career opportunities, and informatics approaches as relevant to data management and analysis.