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The course encompasses the complete arch from ideation of a new biomedical product to it reaching the market such that it can be used to treat actual patients. Throughout the course a case study is explained step by step by a faculty team of experienced pharmaceutical industry leaders, including some who were key players in the real-world case being studied. The case study used is an example of a family of drugs used to treat one of the most prevalent chronic diseases today, and illustrates the critical analysis of all the steps necessary to progress a new idea into clinical development and eventually the market. 
 
Through carefully designed home assignments the students will learn the fundamentals of how to analyze the relevant literature and publicly available data. The students will also have opportunities to discuss with the faculty their real-world 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