At some point in their life, essentially everyone needs to use medication for some type of disease treatment or cure. While medications offer great benefits, the cost of drugs, especially new drugs, and the lack of treatment for some diseases can raise questions about business activity behind the creation of new drugs. Better understanding of how drugs are discovered and developed as well as the legal and regulatory factors that affect the industry can help one better recognize both the shortcomings and opportunities faced by the drug industry at large.
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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.
What you'll learn
- the process by which different stakeholders determine unmet medical needs, which drive the creation of new drug campaigns in the pharmaceutical industry
- clinical trial stages and the type of drug safety and efficacy information learned at each stage
- the research and development cost of advancing a drug from concept, through discovery and development, and ultimately it patients in the market
- types of intellectual property, including patents and trademarks, that are most relevant to newly marketed drugs
- different approval designations recognized by government regulatory authorities to enable more rapid approval of drug’s that meet particularly critical unmet needs
- the approval process for generic drugs after market exclusivity of a branded drug has elapsed
Syllabus
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
