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The complete arch from ideation of a new biomedical product to marketing authorization for the diagnosis or treatment of patients

The course is taught through taking as an example a family of drugs used to treat one the most prevalent chronic diseases today, the course will illustrate the critical analysis of all the steps necessary to progress a new idea into clinical development and to the market. Through carefully designed home assignments the students will learn the fundamentals of now to analyze the relevant literature and publicly available data. The students will also have opportunities to discuss with the faculty their real-life experience in the pharmaceutical industry.

Using drugs as the archetypal biomedical product you will learn how to perform critical analysis of the following tasks:

Evaluate the science behind the new concept and potential for translatability to humans
Determine which additional fundamental research may be needed
Assess whether real-world conditions are favorable for going into proof of concept in patients
Assess the regulatory environment
Determine what are the Investigational New Drug (IND) - enabling pre-clinical activities
Determine clinical development activities needed to reach proof of concept in patients
(the true translational step)
Determine clinical development activities needed to obtain drug approval for desired indication(s)
Assess market penetration and pricing
Assess post-marketing activities
Assess life cycle management and competition

Course Number: CLRE-238
Credit: 2.00 unit(s)
Related Certificate Programs: Translational Science

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