MSB 645 - Drug Discovery - Molecular Targets & Product Development

Credits: (3)
Students will learn the major steps in new product development for biopharmaceutical and pharmaceutical drug products. The first step begins with the identification of a small or large molecule, or biological product. This is followed by an intense animal pharmacological evaluation including toxicological screening. The course will address the major chemistry, manufacturing, and control sections of an Investigational New Drug Application (INDA), New Drug Application (NDA), and Biologics License Application (BLA). The course will describe the regulatory requirements for the design and implementation of various stages of clinical trials (Phase I through Phase IV). The course will describe the role of federal agencies in the drug development process including the Food and Food Administration (FDA) and its various divisions, as well as the Biomedical Advanced Research and Development Agency (BARDA) and the National Institute of Health (NIH). Other topics will include the regulations regarding the conduct including rules and regulations for the use of animals and humans in research trials. The course will conclude with a discussion of the risks and benefits of outsourcing development and commercial product manufacturing. Prerequisite(s): MSB 510 or MSB 520