From Discovery to Drug Development: Processes and Challenges in Creating New Medicines

The creation of novel medicinal molecules, transforming them into pharmaceutical formulations, and introducing them into human health systems, is one of the most complex activities undertaken by scientists of diverse disciplines. Though it represents the utilization of research ideas and the application of testing procedures common to many sciences, its primary objective is to address and amend health deficits in humans. This is an activity founded on a century and a half of scientific research into the basic biological mechanism of human metabolism and diseases, as well as research into the means to use those mechanisms. It is an activity that requires regulatory pathways and compliance with a structure that places the patient's safety above all concerns. It is an activity, most importantly, that aims to correct disease processes in living humans. The process is driven by both public and private interests, with input from public health activity design, patent legislation, research funding, and fostering business environments.