The discovery and development of a new drug is a complex, lengthy, and expensive process. Given that regulatory approval to market a drug is required before a company can generate revenue, it is one of the riskiest 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 to evaluate and enhance 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. You’ll see 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. Course discussion is infused with real-world examples that demonstrate the challenges that people 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.

Learning Outcomes
At the conclusion of the course, students should be able to:

• Appreciate what is involved in bringing a new drug to market, including understanding:
* How biopharma companies make decisions to advance investigational drugs from discovery through the nonclinical and clinical stages of drug development.

* The different phases and processes of clinical evaluation of investigational drugs in humans, including clinical trial objectives, trial structure, and the kinds of data generated from these studies.

* The oversight role of the U.S. Food and Drug Administration and the impact of its regulations on the evaluation of investigational drugs in humans (which comprises pharmaceutical law, compliance, Good Clinical Practice, ICH Guidances, and the bioethics underlying the conduct of clinical trials).


• Obtain a sense of the science and state-of-the-art technologies underlying the discovery and development of drugs.


• Develop and use critical thinking skills to consider the challenges that biopharmaceutical companies face when developing a new drug.
* Ask questions about preconceived notions related to biopharma. Be able to assess the benefit that the biopharmaceutical industry brings to society, and offer informed criticism based on understanding their business model.

Major topics discussed during the course include:

• An overview of the key technologies employed to discover small synthetic and large biologic-based drug molecules such as. monoclonal antibodies
• Drug targets and their validation
• Key concepts related to the therapeutic use of drugs—drug safety, efficacy, risk/ benefit ratio, drug specificity, pharmacokinetics, drug metabolism— and pharmacodynamics
• Clinical trial design and associated ethical considerations, trial objectives, types of trial data generated, and how these data are used to advance drugs to the marketplace
• Selected drugs and their pharmacologic mechanisms of action (especially drugs related to treatment of cancer and infectious diseases such as , COVID-19, AIDS
• The mechanics of conducting a clinical trial from start to finish
• Oversight role of the FDA in the clinical development stage of testing drugs, drug patents and applicable pharmaceutical regulations, and FDA inspections of pharmaceutical sponsors and clinical trial sites
• Job opportunities and career pathways in the biotech and pharmaceutical industry

Additional Information

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