Discovery and Preclinical Trials

Pharmaceutical companies are continuously analyzing thousands of compounds, seeking the ones that will offer the best therapeutic value. Once they have identified the target compounds they wish to pursue, they begin six to seven years of preclinical testing, during which time the company undertakes lab studies for synthesis and purification of the drug and conducts animal testing. The purpose of this phase is to assess safety, side effects, and appropriate dosages.

Out of thousands of compounds tested, only a handful will be promising enough to lead the company to file an Investigational New Drug Application (IND). If the IND is approved by the FDA and by an IRB (Institutional Review Board, an overseeing body representing the institution in which the research takes place, such as a hospital or university), the manufacturer may begin the Phase I clinical testing.

The importance of the design engineer when it comes to the testing facilities used to conduct these early stages of development can’t be stressed enough. The facilities and equipment developed must adhere to strict safety standards and maintain consistent performance over a long period of time. Redesigns may be required as compounds perform in unexpected ways, and the engineer will be called upon to do their part in maximizing the efficiency and speed of the process.