Biological Drug Development Process



According to the Pharmaceutical Research and Manufacturers of America, it takes, on average, 10-13 years to take a new drug from initial discovery to market.

For every 5,000- 10,000 compounds that enter the pipeline, only one receives approval.

This process of researching and developing each drug is costly, averaging about $800M- $1B.

Out of the 250 drugs that enter preclinical testing, less than 10 are approved to enter clinical testing. Only 1 receives approval by the FDA.

Anti-Drug Antibody & The Immune System

The ability of the immune system to protect humans and animals from infection derives in part from its ability to distinguish "foreign" proteins that enter the body from "self" proteins.  The protective immune response triggered by foreign proteins is mediated in part by the generation of circulating proteins called antibodies that can bind and sometimes directly inactivate the foreign protein or pathogen.

Often, biological medicinal products are immunogenic, causing an immune response in the animal in which they are testing. Often, the immune response elicits the development of anti-drug antibodies (ADA) that can lead to the loss of drug efficacy and the necessary sacrifice of the animal being tested in PK studies.