Innovate & Regulate: Drug Research, Costs, Clinical Trials & Approval

In this course about the business of the pharmaceutical industry, students will learn how the economic, legal, and regulatory landscape affect the scientific research that leads to the discovery and development of new drugs. The three-week course starts with a general overview of drug regulation, recognition of patient needs, and listing the distinct stages of a drug campaign. The second week covers clinical trials, research costs, and the effect of patents and intellectual property. In the final week, students will learn about biological drugs, drug approval, drug research outside of large pharma, and the makeup of research pipelines in large drug firms.

No previous experience or knowledge is required to enroll. Students only need to have an interest in better understanding the various factors that affect the research of new drugs. The course is designed in modules. Each module opens with a short video on a selected topic. The module continues with a short reading or exercise with an assessment activity. Each module will require approximately 1 hour to complete, and the course includes 15 modules. Two approaches to the course are recommended. One, a student might spend an hour per day on the course and complete all 15 modules in approximately three weeks. Two, a student with additional available time may be able to work through the entire course in just a single week or over an extended weekend.

Students signed up for the Audit Track have access to the instructional video materials. Students enrolled through the Verified Track have access to the instructional videos, the readings and activities, the assessments, as well as selected additional videos related to the primary instructional videos.

• week 1

• the importance of research and development in pharma

• drug regulation: what is a drug?

• the identification of unmet medical needs

• distinctions between drug discovery and drug development

• the role of key scientific questions and a drug’s target product profile

week 2

• stages of clinical trials

• the cost of bringing a new drug to market

• intellectual property and drugs

• drug patents

• generic vs. branded drugs

week 3

• biologic drugs and biosimilars

• the importance of early identification of weak drug programs

• US FDA drug approval pathways

• roles of academia and biotech in drug discovery and development

• research pipelines of major pharmaceutical companies