Questions:
1. What disease are you working on? (0 points)
2. What sorts of issues might you have to overcome to manufacture your drugs for human and animal trials? What points of GMP (good manufacturing practice), GLP (good lab practice), or GCP (good clinical practice) do you need to be considering before you move to either animal or human clinical trials? (4 points)
3. Give an estimate of potential income from your drug per year in the United States:
A. Number of people in US with disease X appropriate cost of drug per year (how many doses per year x how much per dose)? (4 points)
B. Will you treat for a few weeks or months or all year? (3 points)
C. Will you ever make a profit on the drug? Why or why not? Is it worth moving forward? (4 points)
4. How will you get funding for moving through the drug development pipeline? Describe likely funding possibilities at each stage of the process listed below:
A. Lead Identification and improvement? (2 points)
B. Animal studies? (2 points)
C. Phase 1 and 2 clinical trials? (2 points)
D. Phase 3 clinical trials? (2 points)
E. Post-approval marketing? (2 points)
PLS, ANSWER THE QUESTION ONLY, DON’T WRITE AN ESSAY
