RGA6463 Regulatory Strategy for Product Development and Life-Cycle

Description
The Final Paper for the course involves assembling a regulatory compliant
commercialization plan to support pursuit of a biopharmaceutical product from concept
through launch, through to obsolescence. As discussed throughout the course,
commercialization of a biomedical product involves consideration of many variables
unique to the healthcare sector including financial, technical, legal, regulatory,
manufacturing, and marketing concerns. A major objective for the course is to give
students an opportunity to translate regulatory requirements for medicinal products
into broadly applicable regulatory strategies and submissions. This necessarily involves
practicing analytical thinking, and effective communication of scientific and technical
information. In completing this Assignment students will have the opportunity to use
these skills to demonstrate their understanding of the concepts involved in constructing
a lifecycle management strategy for a new class of biopharmaceutical products.

Instructions
1) Utilize the following case study to evaluate and communicate your thinking on
developing a compliant life-cycle management strategy:
Imagine that you, as a regulatory science expert, go camping in a
remote area of the world, and find an isolated tribe of people that has
not yet communicated with the rest of the world. You discover that this
tribe uses several types of “magic dust” to treat a wide variety of human
ailments, each with varying safety profiles and degrees of efficacy. For
example, the tribe uses “magic dust #1” to treat headaches, nausea,
fever and mild systemic pain, “magic dust #2” to treat cuts and bruises,
and “magic dust #3” to treat insect bites. In fact, you observe that the
tribe has isolated or developed at least 12 different kinds of “magic
dust” and your observations suggest that the “magic dust” category as
a whole seems to have a novel mechanism of action. You ask the tribe if
you can have samples of each magic dust type to bring back home with
you for analysis and they agree. When you get home, you give these
samples to the medical research community, which discovers that
indeed, these “magic dusts” might possibly be used effectively in the US
to treat the conditions for which they are utilized by the tribe, and that
their pharmacodynamic mechanism of action is, indeed, unique.
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2) As a regulatory expert, you are charged with developing a product development plan
right from an IND filing to NDA to support an NDA submission to the US Food and
Drug Administration (FDA) for each magic dust type. You are also responsible for
developing a post-market approval plan to ensure ongoing maintenance of
regulatory compliance after receipt of an NDA approval. Your plan should address
the following “magic dust” associated questions and/or issues:
◦ What pre-clinical requirements should be summarized to support the IND?
◦ How can the indications for use for each “magic dust” be isolated and
refined? Why is it important to do this?
◦ How can the risk vs. benefit profile associated with utilization of the
“magic dust” for clinical purposes be established?
◦ Should a randomized controlled trial design be utilized to conduct clinical
research to support an NDA submission for the “magic dusts” or should an
adaptive platform design be utilized instead?
◦ What formulation will you consider for the magic dust i.e. tablet, capsules,
injections etc? Provide justification for selected formulation.
◦ Are you planning to have any meetings with the FDA? If yes, what
questions will you discuss with the FDA (give 2-3 examples). If no, why no
meetings are planned?
◦ Are there intellectual property issues that should be addressed?
◦ How would you go about addressing pricing and reimbursement
considerations?
3) You may collaborate with and submit your work with one or two colleagues (no
more than two colleagues) from the course in completing your work – collaboration
with a course colleague is an option rather than a requirement of the Assignment
4) The commercialization plan should take the form of a 10-12 page written document
supported by a 10-12 slide MS Power Point presentation
5) When submitting your work please ensure that your name(s) are on the first page of
the document (s) that you submit. Two separate submission links will be provided in
the Assignment section
a. RGA6463 Final Paper: submit word file
b. RGA6463 Final PowerPoint: submit presentation
Due Date
The submission for this in class exercise is due by April 1, 2022
Weight
The written portion of this Assignment is worth 15% of your Final Grade for the course,
while the Power Point portion of the Assignment is worth 10% of your Final grade for
the course.

RGA6463 Regulatory Strategy for Product Development and Life-Cycle

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