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The discovery and development of a new drug is a complex, lengthy, and expensive process, and given that regulatory approval to market a drug is required before a company can generate revenue, it is one of the most risky endeavors that a company can undertake. In this course, you will examine this process -- from the discovery of small synthetic and generation of large biologic drug molecules through the preclinical efforts involved in evaluating and enhancing the pharmacologic properties of a potential drug for safety and efficacy. We’ll discuss the objectives, the overall mechanics, and ethics of testing investigational drugs in clinical studies with human volunteers. Lastly, we’ll take a look at how the U.S. Food and Drug Administration (FDA) reviews the marketing application for a new drug, and the post-approval requirements it imposes on biopharmaceutical sponsors. During the course, you’ll get a sense of what makes the biopharmaceutical industry a fascinating area for study when we consider the science and government regulations underlying the development of drugs, as well as the politics often associated with bringing a new drug to the marketplace. Many of the topics discussed in the course are infused with real-world examples to demonstrate the challenges that those employed in the biopharmaceutical industry routinely face as they try to advance a potential new drug through the developmental pathway to FDA approval. The course provides an important foundation in drug development for professionals from all disciplines who are currently working in or are considering a move to the biopharmaceutical industry.
- To be successful in this class all students should have working knowledge of Google’s G Suite or Microsoft Office, proper email etiquette, and essential understanding of Canvas.
At the conclusion of the course, you should be able to
- Appreciate what is involved in bringing a new drug to market.
- Understand how biopharmaceutical companies make decisions to advance investigational drugs through the non clinical and clinical stages of drug development.
- Identify the different phases and processes for the clinical evaluation of investigational drugs in humans.
- Understand the oversight role of the U.S. Food and Drug Administration (FDA) and the impact of associated regulations on the evaluation of investigational drugs in humans (including pharmaceutical law), compliance, Good Clinical Practice, ICH Guidances).
- Obtain a degree of understanding the science and state-of-the-art technologies essential for the discovery and development of drugs.
- Develop critical thinking skills about the challenges that bio-pharmaceutical companies face when developing a new drug.
- Be able to assess the benefit that this industry brings to society, and, as appropriate, offer informed criticism based on understanding their business model.
- The ethics of testing investigational drugs in clinical studies with human volunteers
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Estimated Cost: $965
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