This course will explore the scientific, regulatory and financial hurdles involved in translating laboratory breakthroughs into treatments that can improve human health. Students will learn about the pre-clinical development process, including pre-clinical modeling and other tests a potential therapeutic undergoes prior to human trials. Students will also learn about the clinical research trials process, including the requirements for first-in-human trials, through the phase II and III trials that are required to bring a drug, biologic, or device to market.
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