62 - Bringing a Drug to Market (w/ Josh Yoder!)

62. Bringing a Drug to Market

This podcast has discussed science and impacts of scientific discovery for one year now. We haven’t yet discussed how a laboratory, university, government, or company is capable of bringing a helpful small molecule to market. How does one bring a drug to market? Is it a simple process? Let’s learn to be scientifically conversational.  

General Learning Concepts

1)     Discussion questions:

a.     What is a drug? How does one identify a prospective drug or pharmaceutical?

b.     What are conditions that must be met in order to have a drug approved for sale (at least, in the United States)? (eg. Helping people more than no treatment / versus how much it hurts)

c.      Can anyone bring a drug to market? What are the limitations? Is it expensive?

d.     What are the different phases of clinical trials? How often does a prospective molecule make it through the different layers of clinical trials?

e.     Why is it so often that treatment of different illness is so expensive?

Definition of a drug and other terms:

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=glossary.page#:~:text= 

Drug review process including phases:

https://www.fda.gov/drugs/drug-information-consumers/fdas-drug-review-process-ensuring-drugs-are-safe-and-effective

Cost to develop a drug and percentage success:

https://www.policymed.com/2014/12/a-tough-road-cost-to-develop-one-new-drug-is-26-billion-approval-rate-for-drugs-entering-clinical-de.html

Trial phases including numbers of patients and typical success in each phase:

http://pharmwarthegame.blogspot.com/2018/12/clinical-trials-phases.html

 
Calvin YeagerComment