Support Pursuit of A Biopharmaceutical Product Essay
Order ID 53563633773 Type Essay Writer Level Masters Style APA Sources/References 4 Perfect Number of Pages to Order 5-10 Pages
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.
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
QUALITY OF RESPONSE NO RESPONSE POOR / UNSATISFACTORY SATISFACTORY GOOD EXCELLENT Content (worth a maximum of 50% of the total points) Zero points: Student failed to submit the final paper. 20 points out of 50: The essay illustrates poor understanding of the relevant material by failing to address or incorrectly addressing the relevant content; failing to identify or inaccurately explaining/defining key concepts/ideas; ignoring or incorrectly explaining key points/claims and the reasoning behind them; and/or incorrectly or inappropriately using terminology; and elements of the response are lacking. 30 points out of 50: The essay illustrates a rudimentary understanding of the relevant material by mentioning but not full explaining the relevant content; identifying some of the key concepts/ideas though failing to fully or accurately explain many of them; using terminology, though sometimes inaccurately or inappropriately; and/or incorporating some key claims/points but failing to explain the reasoning behind them or doing so inaccurately. Elements of the required response may also be lacking. 40 points out of 50: The essay illustrates solid understanding of the relevant material by correctly addressing most of the relevant content; identifying and explaining most of the key concepts/ideas; using correct terminology; explaining the reasoning behind most of the key points/claims; and/or where necessary or useful, substantiating some points with accurate examples. The answer is complete. 50 points: The essay illustrates exemplary understanding of the relevant material by thoroughly and correctly addressing the relevant content; identifying and explaining all of the key concepts/ideas; using correct terminology explaining the reasoning behind key points/claims and substantiating, as necessary/useful, points with several accurate and illuminating examples. No aspects of the required answer are missing. Use of Sources (worth a maximum of 20% of the total points). Zero points: Student failed to include citations and/or references. Or the student failed to submit a final paper. 5 out 20 points: Sources are seldom cited to support statements and/or format of citations are not recognizable as APA 6th Edition format. There are major errors in the formation of the references and citations. And/or there is a major reliance on highly questionable. The Student fails to provide an adequate synthesis of research collected for the paper. 10 out 20 points: References to scholarly sources are occasionally given; many statements seem unsubstantiated. Frequent errors in APA 6th Edition format, leaving the reader confused about the source of the information. There are significant errors of the formation in the references and citations. And/or there is a significant use of highly questionable sources. 15 out 20 points: Credible Scholarly sources are used effectively support claims and are, for the most part, clear and fairly represented. APA 6th Edition is used with only a few minor errors. There are minor errors in reference and/or citations. And/or there is some use of questionable sources. 20 points: Credible scholarly sources are used to give compelling evidence to support claims and are clearly and fairly represented. APA 6th Edition format is used accurately and consistently. The student uses above the maximum required references in the development of the assignment. Grammar (worth maximum of 20% of total points) Zero points: Student failed to submit the final paper. 5 points out of 20: The paper does not communicate ideas/points clearly due to inappropriate use of terminology and vague language; thoughts and sentences are disjointed or incomprehensible; organization lacking; and/or numerous grammatical, spelling/punctuation errors 10 points out 20: The paper is often unclear and difficult to follow due to some inappropriate terminology and/or vague language; ideas may be fragmented, wandering and/or repetitive; poor organization; and/or some grammatical, spelling, punctuation errors 15 points out of 20: The paper is mostly clear as a result of appropriate use of terminology and minimal vagueness; no tangents and no repetition; fairly good organization; almost perfect grammar, spelling, punctuation, and word usage. 20 points: The paper is clear, concise, and a pleasure to read as a result of appropriate and precise use of terminology; total coherence of thoughts and presentation and logical organization; and the essay is error free. Structure of the Paper (worth 10% of total points) Zero points: Student failed to submit the final paper. 3 points out of 10: Student needs to develop better formatting skills. The paper omits significant structural elements required for and APA 6th edition paper. Formatting of the paper has major flaws. The paper does not conform to APA 6th edition requirements whatsoever. 5 points out of 10: Appearance of final paper demonstrates the student’s limited ability to format the paper. There are significant errors in formatting and/or the total omission of major components of an APA 6th edition paper. They can include the omission of the cover page, abstract, and page numbers. Additionally the page has major formatting issues with spacing or paragraph formation. Font size might not conform to size requirements. The student also significantly writes too large or too short of and paper 7 points out of 10: Research paper presents an above-average use of formatting skills. The paper has slight errors within the paper. This can include small errors or omissions with the cover page, abstract, page number, and headers. There could be also slight formatting issues with the document spacing or the font Additionally the paper might slightly exceed or undershoot the specific number of required written pages for the assignment. 10 points: Student provides a high-caliber, formatted paper. This includes an APA 6th edition cover page, abstract, page number, headers and is double spaced in 12’ Times Roman Font. Additionally, the paper conforms to the specific number of required written pages and neither goes over or under the specified length of the paper.
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