Edward J Kelly
Provides a framework of the drug development process and its regulation. Prerequisite: ENV H 405 or ENV H 514, ENV H 515, and ENV H 516, or PCEUT 501, PCEUT 502, and PCEUT 503; or equivalent, or instructor permission. Offered: jointly with ENV H 587; A, even years.
The purpose of this course is to provide a framework of the drug development process and its regulation as well as its impact on workers and the environment. Graduate students in toxicology, pharmaceutics, comparative medicine, bioengineering, occupational and environmental health as well as professional disciplines such as medicine, pharmacology, and nursing interested in working with the biotechnology industry will find this course particularly useful. In addition to faculty, students will benefit from presentations from guest lecturers working in and with the industry. Students will develop a proposal for a pre-Investigational New Drug (IND) meeting with Food and Drug Administration (FDA) and present a summary of their proposal to a mock FDA Review Committee.
Student learning goals
• Explain the regulatory framework for controlling and managing drug development in the United States and Europe. • Describe risk assessment methods used in the drug development process, including in vitro (human and animal) and in vivo methods. • Explain the strengths and limitations of at least 2 animal models for testing drug safety and efficacy. • Explain the therapeutic mode of action, and understand structural considerations of at least four classes of biopharmaceutical agent. • Outline the drug manufacturing process including the role of quality control and quality assurance in protecting the public, workers, and the environment. • Describe human health effects and mechanisms of toxicity as presented in case studies of at least 2 biopharma agents. • Outline the requirements and process of a human clinical trial. • Organize data and information on a specific biopharmaceutical agent in the form of a pre-IND meeting regulatory submission. • Give an oral presentation to scientific audience on the biological mechanism of action and proposed evaluation of safety, efficacy and manufacturing controls on a biopharmaceutical agent.
General method of instruction
Class assignments and grading
Class Participation, written assignment and group presentation