Support Pursuit of A Biopharmaceutical Product Essay

Support Pursuit of A Biopharmaceutical Product Essay

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Instructions:

Support Pursuit of A Biopharmaceutical Product Essay

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

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.

As a regulatory expert, you are charged with developing a product development plan 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 in the clinical development plan?

◦ 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?◦ Are there

intellectual property issues that should be addressed?◦ How would you go about addressing pricing and reimbursement considerations?

The commercialization plan should take the form of a 10-12 page written document.

Support Pursuit of A Biopharmaceutical Product Essay

RUBRIC
Excellent Quality 95-100%	Introduction 45-41 points The background and significance of the problem and a clear statement of the research purpose is provided. The search history is mentioned.		Literature Support 91-84  points The background and significance of the problem and a clear statement of the research purpose is provided. The search history is mentioned.			Methodology 58-53 points Content is well-organized with headings for each slide and bulleted lists to group related material as needed. Use of font, color, graphics, effects, etc. to enhance readability and presentation content is excellent. Length requirements of 10 slides/pages or less is met.
Average Score 50-85%	40-38 points More depth/detail for the background and significance is needed, or the research detail is not clear. No search history information is provided.		83-76  points Review of relevant theoretical literature is evident, but there is little integration of studies into concepts related to problem. Review is partially focused and organized. Supporting and opposing research are included. Summary of information presented is included. Conclusion may not contain a biblical integration.			52-49  points Content is somewhat organized, but no structure is apparent. The use of font, color, graphics, effects, etc. is occasionally detracting to the presentation content. Length requirements may not be met.
Poor Quality 0-45%	37-1 points The background and/or significance are missing. No search history information is provided.		75-1 points Review of relevant theoretical literature is evident, but there is no integration of studies into concepts related to problem. Review is partially focused and organized. Supporting and opposing research are not included in the summary of information presented. Conclusion does not contain a biblical integration.			48-1 points There is no clear or logical organizational structure. No logical sequence is apparent. The use of font, color, graphics, effects etc. is often detracting to the presentation content. Length requirements may not be met
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