1. Chapter 1.3

2.  Sell 1 group of similar products.  Ex. The protocols for manufacturing recombinant human growth hormone are almost identical to those for producing recombinant human insulin. The majority of reagents, cells, & equipment are the same, so a company would specialize in manufacture of related human hormones as therapeutic drugs.

3.  Research teams discuss their work.  Scientists may envision new products.  Sometimes ideas come about rather serendiptiously!

4.  GOAL: Market product as fast as possible, but usually takes several years.  Steps in R & D  1. Drug demonstrates “proof of concept”. ▪ a. Can it be mass produced? ▪ b. Is it safe? ▪ c. Which characteristics are indicative of efficacy? ▪ d. Is it stable over time?

5.  2. Clinical Development  a. Procedures are determined for large scale production.  b. Undergo clinical trials (humans) under guidelines set by FDA.  c. 3 rounds of clinical trials take place.

6.  Takes 10 – 15 years for a company to move a pharmaceutical product through the “product pipeline”.  3. A Product Development Plan is Made.  a. Does the product meet a critical need?  b. Can the company make a profit?  c. How much will it cost to make the product?  d. Can a patent protection be secured?

7.  Drug is not effective after testing.  ex. Auriculin, a therapeutic drug developed to treat kidney failure was in pipeline for 5 years before it was pulled.  Millions of dollars were lost by the company called Scios, Inc.

8.  Environmental Protection Agency (EPA)  US Department of Agriculture (USDA)  Food and Drug Administration (FDA)  The government must perform its own testing which increases the time it takes a product to go through the pipeline.  Some believe that some of the risks of speeding the testing procedures are outweighed by the chance of improving the quality of life for very sick patients.

9.  What group of potential products must be tested in clinical trials before it can be marketed?  A drug discovery process can take nearly 15 years. Explain why.  Which questions must be answered to the satisfaction of company officials before a product goes into research and then into development?  Does every product in R & D make it to market? Explain.