Developing a compliant life-cycle management strategy

Assignment Help Biology
Reference no: EM133620004 , Length: 12 Pages

ASSIGNMENT:

The Final Project for the course will involve assembling a regulatory compliant commercialization plan to support pursuit of a biopharmaceutical or medical device product from concept through launch through to obsolescence.

As discussed throughout the course, commercialization of a biomedical products involves consideration of many variables unique to the healthcare sector including financial, technical, legal, regulatory, manufacturing and marketing concerns.

The commercialization plan should take the form of a 10 to 12 page written document supported by a separate slide deck presentation.

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.

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 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?

3) The commercialization plan should take the form of a 10 to 12 page written document supported by a 10 to 12 slide MS Power Point presentation

Use tables and images when needed while writing the paper.

Please provide references in APA style (in-text and list of citations).

Reference no: EM133620004

Questions Cloud

Which non-pathogenic organisms commonly inhabit the skin : Which non-pathogenic organisms commonly inhabit the skin? What are the common characteristics of Staphylococcus aureus?
What are kingtides or sunny day flooding : What are kingtides or sunny day flooding? What is said about seawater versus freshwater (aquifer) flooding with kingtides?
Why is testing of the father for d antigen important : Why is testing of the father for D antigen important?
Discuss the cardiovascular : Discuss the cardiovascular and renal mechanisms involved in returning blood pressure to normal following a sharp fall in blood pressure caused by blood loss.
Developing a compliant life-cycle management strategy : Evaluate and communicate your thinking on developing a compliant life-cycle management strategy: Imagine that you, as a regulatory science expert.
Describe alpha growth in blood agar : Describe alpha growth in blood agar?
What type of tissue membrance lines body cavities : What type of tissue membrance lines body cavities and hollow passageways that open to the external environment?
What is the general role of cpg methylation of junk dna : What is the general role of CpG methylation of junk DNA?
How do you streak a plate for culture : How do you streak a plate for culture?

Reviews

Write a Review

Biology Questions & Answers

  Immune response to infectious disease

It is a very curcial concept to understand how the immune response is mounted against viruses, bacteria, protozoans and helminthes. For an effective immune response, both innate and adaptive immunity should work together.

  A review on advanced glycated end products (ages)

This Project report elaborates a critical review of important elements attached to Advanced Glycated End Products (AGEs). It is very crucial to understand the process called Millard reaction.

  Plastic as a soil stabilizer

Soil stabilization is the permanent physical and chemical alteration of soils to enhance their physical properties. Stabilization can increase the shear strength of a soil and control the shrink-swell properties.

  Principles of microbiology

This assignment has three parts which contains questions related to Microbiology. It contains basic principles of microscopy, staining techniques in microbiology and microbial growth in the food industry.

  List the biologic functions

Lipid metabolites are often seen as key elements in cellular signaling. Is this unique? Please provide several examples of the function of lipids as key elements in signal arrays and list the biologic functions these signals affect?

  Biologic function relationships

Please describe how one might search for chemical structure, biologic function relationships, involving small molecular weight lipophylic compounds. Provide one example.

  Case study on patient in the haematology laboratory

Write a case study which detailing a scenario of a patient being investigated in the Haematology laboratory.

  Use of pcr and genetic approaches in biotechnology

The use of PCR and genetic approaches in biotechnology

  Describe the role of this enzyme in honey

Glucose oxidase is an enzyme that can be used for measurements of glucose levels by combining this reaction with an oxygen probe.

  Genetic problems

What phenotypic ratio would you get if you crossed a white mouse and a heterozygous brown mouse?

  Prepare an essay on nosocomial infection

Prepare an essay on nosocomial infection.

  Monitoring and recording the blood pressure

To increase the awareness of monitoring and recording the blood pressure of patients and practice measuring blood pressure in a safe environment.

Free Assignment Quote

Assured A++ Grade

Get guaranteed satisfaction & time on delivery in every assignment order you paid with us! We ensure premium quality solution document along with free turntin report!

All rights reserved! Copyrights ©2019-2020 ExpertsMind IT Educational Pvt Ltd