Case Studies in Drug Development Systems

 Case Study Assignment #1 Sustainable Practices in Drug Development The drug development process is a long, risky, expensive and inefficient process. The number of safe and effective new drugs being approved is limited by a high attrition rate, a strict regulatory environment, a complicated reimbursement system and often difficult market conditions. For this Case Study Assignment, please review the media pieces posted and answer the following questions about the potential solutions to increase the efficiency of the process, making changes to the current status quo, which would lead to a more efficient and sustainable drug development pipeline as we move into the future. Each assignment should be approximately 3 pages in length and will: Outline the Central Problem: After reading each of the provided media pieces, write a paragraph that outlines the central problem or issue posed by the case, supported by specific evidence, events, quotes, etc. from the media pieces as supporting data. This is not a summary of each media piece, rather an overview of the common theme threaded throughout them. This includes a description of the scientific and strategic aspects of the problem. The central problem may not be explicitly stated or thoroughly explained, so you may have to make inferences based on the media pieces to draw conclusions. This is not a summary of each media piece, rather an overview of the common theme threaded throughout them. Ask the Right Questions: After you have identified the central problem outlined by the case, what critical evidence do you need before identifying the potential strategic approaches to solving the problem? What do you want/need to know more about? What questions do you need answered in order to understand the topic further and define potential outcomes? Include a list of 5 thought provoking questions (yes, an ACTUAL list) that would further your understanding and drive conversation and insight into this topic. Questions should be well written, higher-order (not simple) questions that show your understanding of the central problem and the contributing factors. Solve the Problem: What are the 2 BEST strategies to approach this problem? What are the potential outcomes of each? Shortcomings? Draw a conclusion as to which you think would be most effective and describe why. Take Your Thinking Further: Are these the only approaches? Can you think of other approaches that might help to solve this problem? Research and discuss ONE other innovative approach which would change the future of drug development. What effect(s) would they have on the process? Draw a Conclusion: From the evidence presented in the case, draw a conclusion as to what the best way forward is to transform the drug development process into a more efficient and sustainable process. Describe where you stand on the issue, and be sure to include how this case furthered your understanding of the innovative and sustainable approaches to drug development.