Commercializing a New Drug

A major objective for the course is to give students an opportunity to study the compliance requirements required to formulate regulatory strategies to support product development and life-cycle management. This necessarily involves development and subsequent maintenance of an understanding of the specific regulations promulgated by the US Food and Drug Administration (FDA), or other global regulatory agencies, to commercialize biopharmaceutical, medical device and certain types of food products. One way to do this is to review case studies detailed by would be manufacturers of the aforementioned types of regulated products. The first case we study in this course is BKK: Commercializing a New Drug. This Case Study write-up involves your explanation of the case from a situational perspective, as well as your replies to specific questions presented by the case.

Case Write-Up Questions

In 2-3 paragraphs please present a situational description of the case that addresses:

What is BKK? Where is its intended geographic market? What is its intended indication for use from a clinical perspective?

What are the alternative paths to market from a regulatory perspective? (A description here is fine, as opposed to an analysis)

Who are the stakeholders involved in the commercialization process for BKK?

What is Worthington struggling with? What are the challenges he faces in bringing BKK to market?

How does the opioid public health crisis relate to the aforementioned challenges, regulatory or otherwise?

How would you evaluate the risks and benefits associated with each alternative pathway for bringing BKK to market?

Should Worthington be concerned with the competitive landscape for products that may serve the same clinical market that BKK purports to serve?

In your opinion is it a good idea to bring BKK to market? What do you think is the best pathway to the US market for BKK?

In addressing the questions presented, please ensure that you include a discussing of both the internal and external factors that are germane to making a decision regarding a pathway for BKK to be commercialized in the US

Please ensure that you integrate a listing of all critical considerations and factors that Worthington should take into account in making a decision regarding path to market

Completed write-ups should be approximately 5-7 pages in length, single or double-spaced (your choice) in 12 pt font

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