RGA6463 Regulatory Strategy for Product Development and Life-Cycle

Management
Case Study Write-Up
BKK: Commercializing a New Drug

Description
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

1. In 2-3 paragraphs please present a situational description of the case that
addresses:
a. What is BKK? Where is its intended geographic market? What is its intended
indication for use from a clinical perspective?
b. What are the alternative paths to market from a regulatory perspective? (A
description here is fine, as opposed to an analysis)
c. Who are the stakeholders involved in the commercialization process for BKK?

2. What is Worthington struggling with? What are the challenges he faces in

bringing BKK to market?
3. How does the opioid public health crisis relate to the aforementioned challenges,
regulatory or otherwise?
4. How would you evaluate the risks and benefits associated with each alternative
pathway for bringing BKK to market?
5. Should Worthington be concerned with the competitive landscape for products
that may serve the same clinical market that BKK purports to serve?
6. 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?

1
Instructions
• You may collaborate with your fellow classmates to complete the Assignment –
however, your work should be submitted independently and in your own words
• 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 market.
• 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

Due Date
Completed Case #1 Write-ups are due by 11:59 PM Eastern Time on Friday April 24,
2020 – please submit your completed work through the link provided in the
‘Assignments’ folder of the course Blackboard shell in the Course Materials section.

Weight
This Write-Up is worth 12.5 % of your grade for the course.