Description
The Final Paper for the course involvesassembling 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 willhave 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 differentkinds of “magicdust” 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.
2)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 planshould address the following “magic dust” associated questions and/or issues:◦What pre–clinical requirements should be summarized in the clinical developmentplan?◦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 ofthe “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.
3)The commercialization plan should take the form of either a 12–15 page paper ORa12–15slide Microsoft Power Point presentationthat is narrated with audio explanations for at minimum:a.An introduction and executive summary of the Project contentb.Responses to each of the questions/issues illustrated abovec.Any general conclusions regarding biopharmaceutical and/or medical device lifecycle management that you can draw from the Assignment
Expert Solution Preview
Introduction:
As a medical professor, I am responsible for designing and conducting lectures, evaluating student performance, and providing feedback through examinations and assignments. In this regard, one of the assignments for my medical college students involves assembling a regulatory compliant commercialization plan for a biopharmaceutical product from concept through launch and obsolescence. The final paper for the course focuses on developing a compliant life-cycle management strategy for a new class of biopharmaceutical products, and this involves practicing analytical thinking and effective communication of scientific and technical information.
Answer:
To evaluate and communicate the thinking on developing a compliance life-cycle management strategy, students were instructed to utilize a case study of an isolated tribe that uses magic dust to treat a wide variety of human ailments. As a regulatory expert, students were charged with developing a product development plan to support an NDA submission to the US Food and Drug Administration (FDA) and a post-market approval plan to ensure ongoing maintenance of regulatory compliance after receipt of an NDA approval.
In response to the questions, students should summarize the pre-clinical requirements in the clinical development plan, isolate and refine the indications for use for each magic dust, establish the risk vs. benefit profile associated with utilization of the magic dust for clinical purposes, and consider whether a randomized controlled trial design should be utilized to conduct clinical research or whether an adaptive platform design should be utilized instead. They should also address any intellectual property issues and consider pricing and reimbursement considerations.
The commercialization plan should take the form of either a 12-15 page paper or a 12-15 slide Microsoft Power Point presentation with audio explanations. It should include an introduction and executive summary of the project content, responses to each of the questions/issues illustrated above, and any general conclusions regarding biopharmaceutical and/or medical device lifecycle management that can be drawn from the assignment.
In conclusion, this assignment aims to provide students with an opportunity to use their analytical thinking and effective communication skills to demonstrate their understanding of the concepts involved in constructing a lifecycle management strategy for a new class of biopharmaceutical products. By completing this assignment, students will develop the necessary skills to translate regulatory requirements for medicinal products into broadly applicable regulatory strategies and submissions.
